Verotin-GR

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Verotin-GR (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Verotin-GR resources

• Verotin-GR Use in Pregnancy & Breastfeeding
• Verotin-GR Drug Interactions
• Verotin-GR Support Group
• 0 Reviews for Verotin-GR - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Verotin-GR with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

MICRhoGAM

Pronunciation: roe D ih-MYOON GLAH-byoo-lin
Generic Name: Rho(D) Immune Globulin (Human)
Brand Name: Examples include MICRhoGAM and RhoGAM

MICRhoGAM is used for:

Preventing certain blood problems that may occur during pregnancy or blood transfusion. It may also be used for other conditions as determined by your doctor.

MICRhoGAM is an immunoglobulin (Ig), which contains antibodies to the Rho(D) antigen. Exactly how it works is unknown.

Do NOT use MICRhoGAM if:

• you are allergic to any ingredient in MICRhoGAM


• you have had an allergic reaction to other human immune globulins


• you have anti-immunoglobulin A (IgA) antibodies

Contact your doctor or health care provider right away if any of these apply to you.

Before using MICRhoGAM:

Some medical conditions may interact with MICRhoGAM. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had an allergic reaction to blood or blood products


• if you have other blood problems (eg, anemia), bleeding problems, or IgA deficiency


• if you are Rho(D) negative or if your spleen has been removed

Some MEDICINES MAY INTERACT with MICRhoGAM. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• Live vaccines (eg, measles, mumps, and rubella) because the effectiveness may be decreased by MICRhoGAM

This may not be a complete list of all interactions that may occur. Ask your health care provider if MICRhoGAM may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use MICRhoGAM:

Use MICRhoGAM as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• MICRhoGAM is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using MICRhoGAM at home, carefully follow the injection procedures taught to you by your health care provider.


• If MICRhoGAM contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of MICRhoGAM, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use MICRhoGAM.

Important safety information:

• MICRhoGAM may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to MICRhoGAM. Using MICRhoGAM alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) for 3 months after using MICRhoGAM. Vaccinations may be less effective.


• MICRhoGAM is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using MICRhoGAM. Discuss any questions or concerns with your doctor.


• MICRhoGAM may affect certain lab test results. Make sure your doctor and other lab personnel know you are using MICRhoGAM.


• LAB TESTS, including blood counts and antibody titers, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using MICRhoGAM during pregnancy. If you are or will be breast-feeding while you are using MICRhoGAM, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of MICRhoGAM:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild fever; mild pain, swelling, or redness at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; blood in the urine; dark urine; decreased urination; fast heartbeat; nausea; severe or persistent fever; shaking and/or chills; shortness of breath; sudden weight gain; swelling; unusual tiredness or weakness; wheezing; vomiting; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: MICRhoGAM side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; unusual tiredness or weakness; yellowing of the eyes or skin.

Proper storage of MICRhoGAM:

MICRhoGAM is usually handled and stored by a health care provider. If you are using MICRhoGAM at home, store MICRhoGAM as directed by your pharmacist or health care provider. Keep MICRhoGAM out of the reach of children and away from pets.

General information:

• If you have any questions about MICRhoGAM, please talk with your doctor, pharmacist, or other health care provider.


• MICRhoGAM is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about MICRhoGAM. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More MICRhoGAM resources

• MICRhoGAM Side Effects (in more detail)
• MICRhoGAM Use in Pregnancy & Breastfeeding
• MICRhoGAM Drug Interactions
• MICRhoGAM Support Group
• 0 Reviews for MICRhoGAM - Add your own review/rating

• BayRho-D Advanced Consumer (Micromedex) - Includes Dosage Information


• Bayrho-D full dose


• HyperRHO S/D Full Dose Prescribing Information (FDA)


• RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)


• Rhophylac Prescribing Information (FDA)


• Rhophylac Consumer Overview

Compare MICRhoGAM with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Anxiolytics, sedatives, and hypnotics

Anxiolytics, sedatives and hypnotics are drugs that work on the central nervous system to treat anxiety and insomnia. The main classes of drugs are benzodiazepines and barbiturates.

See also

• barbiturates
• benzodiazepines
• miscellaneous anxiolytics, sedatives and hypnotics

Drug List:

Pediaderm AF Cream

Pronunciation: nye-STAT-in
Generic Name: Nystatin
Brand Name: Pediaderm AF

Pediaderm AF Cream is used for:

Treating certain fungal infections that cause diaper rash. It may also be used for other conditions as determined by your doctor.

Pediaderm AF Cream is a topical antifungal and barrier cream combination. The antifungal works by killing sensitive fungi. The cream works by providing a protective barrier to prevent skin irritation.

Do NOT use Pediaderm AF Cream if:

• you are allergic to any ingredient in Pediaderm AF Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pediaderm AF Cream:

Some medical conditions may interact with Pediaderm AF Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Pediaderm AF Cream. However, no specific interactions with Pediaderm AF Cream are known at this time.

Ask your health care provider if Pediaderm AF Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pediaderm AF Cream:

Use Pediaderm AF Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gently cleanse the diaper area with very mild soap and lukewarm water before you apply Pediaderm AF Cream. Pat the area dry with a soft towel.


• Apply enough medicine to cover the affected area. Rub in gently.


• Wash your hands immediately after using Pediaderm AF Cream.


• Use the protective barrier cream as directed by your doctor.


• To clear up the infection completely, use Pediaderm AF Cream for the full course of treatment. Keep using it even if the condition improves within a few days.


• If you miss a dose of Pediaderm AF Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pediaderm AF Cream.

Important safety information:

• Pediaderm AF Cream is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse immediately with cool water.


• Do not get Pediaderm AF Cream inside the vagina.


• Be sure to use Pediaderm AF Cream for the full course of treatment. If you do not, the medicine may not clear up the infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pediaderm AF Cream while you are pregnant. It is not known if Pediaderm AF Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Pediaderm AF Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pediaderm AF Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild burning or itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning, irritation, itching, pain, or redness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pediaderm AF side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pediaderm AF Cream:

Store Pediaderm AF Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Pediaderm AF Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Pediaderm AF Cream, please talk with your doctor, pharmacist, or other health care provider.


• Pediaderm AF Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pediaderm AF Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pediaderm AF resources

• Pediaderm AF Side Effects (in more detail)
• Pediaderm AF Use in Pregnancy & Breastfeeding
• 0 Reviews for Pediaderm AF - Add your own review/rating

Compare Pediaderm AF with other medications

• Cutaneous Candidiasis
• Vaginal Yeast Infection

Cenogen Ultra

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Cenogen Ultra (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cenogen Ultra resources

• Cenogen Ultra Use in Pregnancy & Breastfeeding
• Cenogen Ultra Drug Interactions
• Cenogen Ultra Support Group
• 0 Reviews for Cenogen Ultra - Add your own review/rating

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• Docosavit Prescribing Information (FDA)


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• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


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• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


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• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


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• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


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• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


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• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


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• Zatean-CH Prescribing Information (FDA)

Compare Cenogen Ultra with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

In Control Nicotine Lozenge

Dosage Form: lozenge
HEB Nicotine Polacrilex Lozenge 2 mg (Nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 2 mg (nicotine)

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet


• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur


• persistent indigestion or severe sore throat occurs


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

• each lozenge contains: sodium 15 mg


• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge


• sugar alcohol content: 1 g mannitol per lozenge


• store at 20-25°C (68-77°F)


• keep vial closed and protect from light

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

Compare to the active ingredient of Commit® Lozenge

Nicotine Polacrilex Lozenge 2 mg (nicotine)

Stop Smoking Aid

Quit Tube

Mint

2 mg

Actual Size

Includes Users' Guide

For those who smoke their first cigarette more than 30 minutes after waking up.

If you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Lozenge, 4 mg

Sugar Free

2 mg each

(# QuitTube™ containers of #)

Nicotine Polacrilex Lozenge 2 mg (Nicotine) Carton

IN CONTROL NICOTINE  nicotine polacrilex  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 37808-344 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code L344 Contains

Packaging # NDC Package Description Multilevel Packaging 1 37808-344-03 1 VIAL In 1 CARTON contains a VIAL 1 24 LOZENGE In 1 VIAL This package is contained within the CARTON (37808-344-03) 2 37808-344-05 3 VIAL In 1 CARTON contains a VIAL 2 24 LOZENGE In 1 VIAL This package is contained within the CARTON (37808-344-05) 3 37808-344-06 4 VIAL In 1 CARTON contains a VIAL 3 24 LOZENGE In 1 VIAL This package is contained within the CARTON (37808-344-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077007	07/25/2007

Labeler - H E B (007924756)

Revised: 06/2009H E B

More In Control Nicotine Lozenge resources

• In Control Nicotine Lozenge Side Effects (in more detail)
• In Control Nicotine Lozenge Use in Pregnancy & Breastfeeding
• In Control Nicotine Lozenge Drug Interactions
• In Control Nicotine Lozenge Support Group
• 42 Reviews for In Control Nicotine - Add your own review/rating

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• Smoking Cessation

Calcet

Generic Name: calcium and vitamin D combination (KAL see um and VYE ta min D)

Brand Names: Calcarb with D, Calcet, Calcio Del Mar, Calcitrate with D, Calcium 600+D, Caltrate 600 with D, Caltrate 600 with D Plus Soy, Caltrate Colon Health, Citracal + D, Citracal 250 mg + D, Citracal Creamy Bites, Citracal Maximum + D, Citracal Petites, Citrus Calcium with Vitamin D, Dical-D, Os-Cal 250 with D, Os-Cal 500 + D, Os-Cal with D, Oysco 500 with D, Oysco D, Oyst-Cal-D, Oyster Shell Calcium with Vitamin D, Oyster-D, Oystercal-D, Posture-D H/P, Risacal-D

What is Calcet (calcium and vitamin D combination)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance.

Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcium and vitamin D combination is used to prevent or to treat a calcium deficiency.

Calcium and vitamin D combination may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Calcet (calcium and vitamin D combination)?

Before you take calcium and vitamin D combination, tell your doctor if you have kidney disease, past or present kidney stones, heart disease, circulation problems, a parathyroid disorder, or if you are pregnant or breast-feeding.

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Before taking calcium and vitamin D combination, tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I tell my healthcare provider before taking Calcet (calcium and vitamin D combination)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take calcium and vitamin D combination, tell your doctor if you have:

• kidney disease;


• past or present kidney stones;


• 
  

  heart disease;

  
  


• 
  

  circulation problems; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium and vitamin D combination if you are pregnant. Talk to your doctor before taking calcium and vitamin D combination if you are breast-feeding.

How should I take Calcet (calcium and vitamin D combination)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the calcium and vitamin D regular tablet with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Store calcium and vitamin D combination at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include irregular heartbeat, stomach pain, nausea, vomiting, dry mouth, a metallic taste in your mouth, confusion, loss of appetite, constipation, weakness, headache, confusion, or fainting.

What should I avoid while taking Calcet (calcium and vitamin D combination)?

Avoid taking any other vitamin or mineral supplements that contain calcium or vitamin D without first talking to your doctor.

Calcet (calcium and vitamin D combination) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  an irregular heartbeat;

  
  


• 
  

  nausea, vomiting, or decreased appetite;

  
  


• 
  

  dry mouth;

  
  


• 
  

  constipation;

  
  


• 
  

  weakness;

  
  


• 
  

  headache;

  
  


• 
  

  a metallic taste;

  
  


• 
  

  muscle or bone pain; or

  
  


• 
  

  drowsiness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Calcet (calcium and vitamin D combination)?

Before taking calcium and vitamin D combination, tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids containing calcium, aluminum, or magnesium;

  
  


• 
  

  other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or other vitamin D supplements; or

  
  


• 
  

  a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and there may be other drugs that can interact with calcium and vitamin D combination. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Calcet resources

• Calcet Use in Pregnancy & Breastfeeding
• Drug Images
• Calcet Drug Interactions
• Calcet Support Group
• 0 Reviews for Calcet - Add your own review/rating

Compare Calcet with other medications

• Dietary Supplementation
• Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about calcium and vitamin D combination.

Primovist 0.25 mmol / ml, solution for injection, prefilled syringe

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

Each ml contains 0.25 mmol gadoxetate disodium (Gd-EOB-DTPA disodium),equivalent to 181.43 mg gadoxetate disodium.

1 prefilled syringe with 5.0 ml contains 907 mg gadoxetate disodium,

1 prefilled syringe with 7.5 ml contains 1361 mg gadoxetate disodium,

1 prefilled syringe with 10.0 ml contains 1814 mg gadoxetate disodium.

Contains 11.7 mg sodium/ ml.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection, prefilled syringe:

Clear, colourless to pale yellow liquid free from visible particles.

4. Clinical Particulars

4.1 Therapeutic Indications

Primovist is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).

This medicinal product is for diagnostic use by intravenous administration only.

4.2 Posology And Method Of Administration

Method of administration

Primovist is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection of the contrast medium the intravenous cannula / line should be flushed using sterile 9 mg/ml (0.9 %) saline solution.

For detailed imaging information refer to section 5.1.

For additional instructions see section 6.6.

Posology

The recommended dose of Primovist is:

Adults:

0.1 ml per kg body weight Primovist.

Repeated use:

No clinical information is available about repeated use of Primovist.

Additional information on special populations

• Impaired renal function

Use of Primovist should be avoided in patients with severe renal impairment (GFR < 30 ml/min/1.73m²) and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If use of Primovist cannot be avoided, the dose should not exceed 0.025 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Primovist injections should not be repeated unless the interval between injections is at least 7 days.

• Patients with hepatic impairment:

No dosage adjustment is necessary.

• Paediatric population

The safety and efficacy of Primovist has not been established in patients under 18 years old. Therefore, use of Primovist in this patient group cannot be recommended.

• Elderly population (aged 65 years and above)

No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

The usual safety precautions for MRI must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants.

Diagnostic procedures that involve the use of contrast agents should be carried out under the direction of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.

After the injection, the patient should be kept under observation for at least 30 minutes, since experience with contrast media shows that the majority of undesirable effects occur within this time.

• Impaired renal function

Prior to administration of Primovist, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min/1.73 m²). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with Primovist, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.

Haemodialysis shortly after Primovist administration may be useful at removing Primovist from the body.

There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

• Elderly

As the renal clearance of gadoxetate may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

• Patients with cardiovascular disease

Caution should be exercised when Primovist is administered to patients with severe cardiovascular problems because only limited data are available so far.

Primovist should not be used in patients with uncorrected hypokalemia.

Primovist should be used with special care in patients

- with known congenital long QT syndrome or a family history of congenital long QT syndrome

- with known previous arrhythmias when on drugs that prolong cardiac repolarisation

- who are currently taking a drug that is known to prolong cardiac repolarisation e.g. a class III antiarrhythmic, (e.g. amiodarone, sotalol).

Primovist may cause transient QT-prolongation in individual patients. (see section 5.3).

• Hypersensitivity

Allergy-like reactions, including shock, are known to be rare events after administration of gadolinium-based MRI contrast media. Most of these reactions occur within half an hour after administration of contrast media. However, as with other contrast media of this class, delayed reactions may occur after hours to days in rare cases. Medication for the treatment of hypersensitivity reactions as well as preparedness for institution of emergency measures are necessary.

The risk of hypersensitivity reactions is higher in case of:

- previous reaction to contrast media

- history of bronchial asthma

- history of allergic disorders.

In patients with an allergic disposition (especially with a history of the above mentioned conditions) the decision to use Primovist must be made after particularly careful evaluation of the risk-benefit ratio.

Hypersensitivity reactions can be more intense in patients on beta-blockers, particularly in the presence of bronchial asthma. It should be considered that patients on beta-blockers may be refractory to standard treatment of hypersensitivity reactions with beta-agonists.

If hypersensitivity reactions occur, injection of the contrast medium must be discontinued immediately.

• Local intolerance

Intramuscular administration may cause local intolerance reactions including focal necrosis and must therefore be strictly avoided (see section5.3).

• Excipients

This medicinal product contains 11.7 mg sodium per ml, and the dosage is 0.1 ml/kg body weight. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As transport of gadoxetate to the liver may be mediated by OATP transporters it cannot be excluded that potent OATP inhibitors could cause drug interactions reducing the hepatic contrast effect. However, no clinical data have been presented to support that theory.

An interaction study in healthy subjects demonstrated that the co-administration of erythromycin did not influence efficacy and pharmacokinetics of Primovist. No further clinical interaction studies with other medicinal products have been performed.

• Interference from elevated bilirubin or ferritin levels in patients

Elevated levels of bilirubin or ferritin can reduce the hepatic contrast effect of Primovist (see section 5.1).

• Interference with diagnostic tests

Serum iron determination using complexometric methods (e.g. Ferrocine complexation method) may result in false values for up to 24 hours after the examination with Primovist because of the free complexing agent contained in the contrast medium solution.

4.6 Pregnancy And Lactation

• Pregnancy

There are no data from the use of gadoxetate in pregnant women. Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3). Primovist should not be used during pregnancy unless the clinical condition of the woman requires use of gadoxetate.

• Lactation

Gadolinium containing contrast agents are excreted into breast milk in very small amounts (see section 5.3). At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of Primovist, should be at the discretion of the doctor and lactating mother.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

• Summary of the safety profile

The overall safety profile of Primovist is based on data from more than 1,900 patients in clinical trials, and from post-marketing surveillance.

The most frequently observed adverse drug reactions (

The most serious adverse drug reaction in patients receiving Primovist is anaphylactoid shock.

Delayed allergoid reactions (hours later up to several days) have been rarely observed.

Most of the undesirable effects were transient and of mild to moderate intensity.

• Tabulated list of adverse reactions

The adverse drug reactions observed with Primovist are represented in the table below. They are classified according to System Organ Class (MedDRA version 12.1). The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

Adverse drug reactions from clinical trials are classified according to their frequencies. Frequency groupings are defined according to the following convention: common:

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1: Adverse drug reactions reported in clinical trials or during post-marketing surveillance in patients treated with Primovist

System Organ Class (MedDRA)	Common	Uncommon	Rare	Not known
Immune system disorders				Hypersensitivity / anaphylactoid reaction (e.g. shock*, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough, pallor)
Nervous system disorders	Headache	Vertigo Dizziness Dysgeusia Paresthesia Parosmia	Tremor Akathisia	Restlessness
Cardiac disorders			Bundle branch block Palpitation	Tachycardia
Vascular disorders		Blood pressure increased Flushing
Respiratory, thoracic and mediastinal disorders		Respiratory disorders (Dyspnea*, Respiratory distress)
Gastrointestinal disorders	Nausea	Vomiting Dry mouth	Oral discomfort Salivary hypersecretion
Skin and subcutaneous tissue disorders		Rash Pruritus**	Maculopapular rash Hyperhidrosis
Musculoskeletal and connective tissue disorders		Back pain
General disorders and administration site conditions		Chest pain Injection site reactions (various kinds)*** Feeling hot Chills Fatigue Feeling abnormal	Discomfort Malaise

* Life-threatening and/or fatal cases have been reported. These reports originated from post-marketing experience.

**Pruritus (generalized pruritus, eye pruritus)

***Injection site reactions (various kinds) comprise the following terms: Injection site extravasation, injection site burning, injection site coldness, injection site irritation, injection site pain

• Description of selected adverse reactions

Laboratory changes such as elevated serum iron, elevated bilirubin, increases in liver transaminases, decrease of hemoglobin, elevation of amylase, leucocyturia, hyperglycemia, elevated urine albumin, hyponatremia, elevated inorganic phosphate, decrease of serum protein, leucocytosis, hypokalemia, elevated LDH were reported in clinical trials. ECGs were regularly monitored during clinical studies and transient QT prolongation was observed in some patients without any associated adverse clinical events.

Cases of nephrogenic systemic fibrosis (NSF) have been reported with other gadolinium-containing contrast agents (see section 4.4).

4.9 Overdose

No cases of overdose have been reported and no symptoms could be characterised.

Single doses of Primovist as high as 0.4 ml/kg (0.1mmol/kg) body weight were tolerated well.

In a limited number of patients, a dose of 2.0 ml/kg (0.5 mmol/kg) body weight was tested in clinical trials, more frequent occurrences of adverse events but no new undesirable effects were found in these patients.

In the event of excessive inadvertent overdose, the patient should be carefully observed including cardiac monitoring. In this case induction of QT prolongations is possible (see section 5.3).

Primovist can be removed by hemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: paramagnetic contrast media, ATC code: V08 C A10

• Mechanism of action

Primovist is a paramagnetic contrast agent for magnetic resonance imaging.

The contrast-enhancing effect is mediated by gadoxetate (Gd EOB DTPA), an ionic complex consisting of gadolinium (III) and the ligand ethoxybenzyl-diethylenetriamine-pentaacetic acid (EOB-DTPA)

When T1-weighted scanning sequences are used in proton magnetic resonance imaging, the gadolinium ion-induced shortening of the spin-lattice relaxation time of excited atomic nuclei leads to an increase of the signal intensity and, hence, to an increase of the image contrast of certain tissues.

• Pharmacodynamic effects

Gadoxetate disodium leads to a distinct shortening of the relaxation times even at low concentrations. At pH 7, a magnetic field strength of 0.47 T and 40°C the relaxivity (r₁) - determined from the influence on the spin-lattice relaxation time (T₁) of protons in plasma - is about 8.18 l/mmol^/sec and the relaxivity (r₂) - determined from the influence on the spin-spin relaxation time (T₂)- is about 8.56 l/mmol/sec. At 1.5 T and 37°C the respective relaxivities in plasma are r₁ = 6.9 l/mmol/sec and r₂ = 8.7 l/mmol/sec. The relaxivity displays a slight inverse dependency on the strength of the magnetic field.

EOB-DTPA forms a stable complex with the paramagnetic gadolinium ion with extremely high thermodynamic stability (log K_Gdl = –23.46). Gd-EOB-DTPA is a highly water-soluble, hydrophilic compound with a partition coefficient between n-butanol and buffer at pH 7.6 of about 0.011.

Due to its lipophilic ethoxybenzyl moiety gadoxetate disodium exhibits a biphasic mode of action: first, distribution in the extracellular space after bolus injection and subsequently selective uptake by hepatocytes. The relaxivity r1 in liver tissue is 16.6 l/mmol/sec (at 0.47T) resulting in increased signal intensity of liver tissue. Subsequently gadoxetate disodium is excreted into the bile.

Lesions with no or minimal hepatocyte function (cysts, metastases, the majority of hepatocellular carcinoma) will not accumulate Primovist. Well-differentiated hepatocellular carcinoma may contain functioning hepatocytes and can show some enhancement in the hepatocyte imaging phase. Additional clinical information is therefore needed to support a correct diagnosis.

The substance does not display any significant inhibitory interaction with enzymes at clinically relevant concentrations.

• Imaging

After bolus injection of Primovist, dynamic imaging during arterial, portovenous and equilibrium phases utilizes the different temporal enhancement pattern of different liver lesions as basis for the radiological lesion characterization.

The enhancement of liver parenchyma during the hepatocyte phase assists in the identification of the number, segmental distribution, visualization, and delineation of liver lesions, thus improving lesion detection. The differential enhancement/washout pattern of liver lesions contributes to the information from the dynamic phase.

The delayed (hepatocyte) phase can be investigated at 20 minutes post injection with an imaging window lasting at least 120 minutes. The diagnostic and technical efficacy results of the clinical studies show a minimal improvement at 20 minutes post injection over those at 10 minutes post injection.

The imaging window is reduced to 60 minutes in patients requiring hemodialysis and in patients with elevated bilirubin values (> 3 mg/dl).

Hepatic excretion of Primovist results in enhancement of biliary structures.

The physico-chemical characteristics of the ready-to-use solution of Primovist are as follows:

Osmolality at 37 °C (mOsm/kg H2O)	688
Viscosity at 37 °C (mPa·s)	1.19
Density at 37 °C (g/ ml)	1.0881
pH	7.4

5.2 Pharmacokinetic Properties

• Distribution

After intravenous administration the concentration time profile of Gd-EOB-DTPA was characterised by a bi-exponential decline.

Gd-EOB-DTPA distributes in the extracellular space (distribution volume at steady state about 0.21 l/kg).

The substance elicits only minor protein binding (less than 10%).

The compound does not pass the intact blood-brain barrier and diffuses through the placental barrier only to a small extent.

• Metabolism

Gadoxetate disodium is not metabolized.

• Elimination

Gd-EOB-DTPA is equally eliminated via the renal and hepatobiliary routes. The half–life of Gd-EOB-DTPA was approximately 1.0 hour. The pharmacokinetics was dose-linear up to the dose of 0.4 ml/kg (100 micromol/kg).

A total serum clearance (Cl_tot) of about 250 ml/min was recorded, whereas the renal clearance (Cl_r) corresponds to about 120 ml/min.

• Characteristics in special patient populations

Elderly population (aged 65 years and above)

In accordance with the physiological changes in renal function with age, the plasma clearance of gadoxetate disodium was reduced from 210 ml/min in non-elderly subjects to 163 ml/min in elderly subjects aged 65 years and above. Terminal half-life and systemic exposure were higher in the elderly (2.3 h and 197 µmol*h/l, compared to 1.6 h and 153 µmol*h/l, respectively). The renal excretion was complete after 24 h in all subjects with no difference between elderly and non-elderly healthy subjects.

Renal and/or hepatic impairment

In patients with mild and moderate hepatic impairment, a slight to moderate increase in plasma concentration, half-life and urinary excretion, as well as decrease in hepatobiliary excretion have been observed in comparison to subjects with normal liver function. However, no clinically relevant differences in hepatic signal enhancement were observed. In patients with severe hepatic impairment, especially in patients with abnormally high ( > 3 mg/dl) serum bilirubin levels, the AUC was increased to 259 µmol*h/l compared to 160 µmol*h/l in the control group. The elimination half-life was increased to 2.6 h compared to 1.8 h in the control group. The hepatobiliary excretion substantially decreased to 5.7% of the administered doseand the hepatic signal enhancement is reduced in these patients.

In patients with end-stage renal failure the AUC increased 6-fold to about 903 µmol*h/l and the terminal half-life was prolonged to about 20 h. Hemodialysis increased the clearance of gadoxetate disodium (see section 4.4). In an average dialysis session of about 3-hour duration, about 30% of the gadoxetate disodium dose was removed by hemodialysis starting 1 hour post injection. In addition to clearance by hemodialysis, a significant fraction of the administered gadoxetate dose is biliary excreted in these patients as shown by a mean recovery of about 50% in faeces within 4 days (range 24.6 to 74.0%, n=6 patients).

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of acute and subchronic toxicity, genotoxicity and contact-sensitising potential.

• Cardiac safety

In telemetered conscious dogs a small and transient QT prolongation was observed at the highest dose tested of 0.5 mmol/kg, which represents 20 times the human dose. At high concentrations, Gd-EOB-DTPA blocked the HERG channel and prolonged the action potential duration in isolated guinea pig papillary muscles. This indicates a possibility that Primovist might induce QT prolongation when overdosed.

No findings have been observed in safety pharmacology studies in other organ systems.

• Reproduction toxicology and lactation

In a rabbit embryotoxicity study, an increased number of postimplantational losses and increased abortion rate were observed after repeated administration of 2.0 mmol/kg of Gd-EOB-DTPA, representing 25.9 times (based on body surface area) or approx. 80 times (based on body weight) the recommended human dose.

In lactating rats, less than 0.5% of the intravenously administered dose (0.1 mmol/kg) of radioactively labelled gadoxetate was excreted into the breast milk. Absorption after oral administration was very low in rats with 0.4%.

• Local tolerance

Local intolerance reactions were only observed after intramuscular administration of Gd-EOB-DTPA.

• Carcinogenicity

No carcinogenicity studies were performed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Caloxetate trisodium

Hydrochloric acid (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Trometamol

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

5 years.

The product should be used immediately after opening.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage precautions.

6.5 Nature And Contents Of Container

10 ml prefilled syringes consisting of a colourless siliconized PhEur type I glass barrel, a siliconized chlorobutyl elastomer plunger stopper, a chlorobutyl elastomer rubber tip cap, a polysulfone Luer Lock adapter and a polypropylene safety cap.

• Package sizes:

1, 5 and 10 x 5 ml (in 10 ml prefilled syringe)

1, 5 and 10 x 7.5 ml (in 10 ml prefilled syringe)

1, 5 and 10 x 10 ml (in 10 ml prefilled syringe)

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

• Inspection

This medicinal product is a clear, colourless to pale yellow solution. It should be visually inspected before use.

Primovist should not be used in case of severe discolouration, the occurrence of particulate matter or a defective container.

• Handling

The prefilled syringe must be taken from the pack and prepared for the injection immediately before the examination.

The tip cap should be removed from the prefilled syringe immediately before use

• Disposal

Any unused product should be disposed of in accordance with local requirements.

The peel-off tracking label on the pre-filled syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berks RG14 1JA

8. Marketing Authorisation Number(S)

PL 00010/0555

9. Date Of First Authorisation/Renewal Of The Authorisation

27 April 2009

10. Date Of Revision Of The Text

28 September 2011