VALCYTE 450MG FILM-COATED TABLETS
Active substance: VALGANCICLOVIR HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
10119260 GB 1004.1076
Valcyte 450 mg
lm-coated tablets
valganciclovir
Read all of this leaet carefully before you start taking this medicine. - Keep this leaet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What VALCYTE is and what it is used for 2. Before you take VALCYTE 3. How to take VALCYTE 4. Possible side effects 5. How to store VALCYTE 6. Further information
- vincristine, vinblastine, adriamycin, hydroxyurea or similar kinds of drugs to treat cancer - cidofovir, foscarnet, or nucleoside analogues used against viral infections - trimethoprim, trimethoprim/sulpha combinations and dapsone (antibiotics) - pentamidine (drug to treat parasites or lung infections) - ucytosine or amphotericin B (antifungal agents)
Taking VALCYTE with food and drink
VALCYTE should be taken with food. If you are unable to eat for any reason, you should still take your dose of VALCYTE as usual.
Pregnancy and breast feeding
You should not take VALCYTE if you are pregnant unless your doctor recommends it. If you are pregnant or planning to become pregnant you must tell your doctor. Taking VALCYTE when you are pregnant could harm your unborn baby. You must not take VALCYTE if you are breastfeeding. If your doctor wants you to begin treatment with VALCYTE you must stop breastfeeding before you start to take your tablets.
1. WHAT VALCYTE IS AND WHAT IT IS USED FOR
VALCYTE belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, valganciclovir, is changed into ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause an infection in the bodys organs. This can be life threatening. VALCYTE is used: for treatment of CMV-infections of the retina of the eye in patients with acquired immunodeciency syndrome (AIDS). CMV-infection of the retina of the eye can cause vision problems and even blindness. to prevent CMV-infections in patients who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV.
Women of childbearing age
Women of childbearing age must use effective contraception when taking VALCYTE.
Men
Men whose partners could become pregnant should use condoms while taking VALCYTE and should continue to use condoms for 90 days after treatment has nished.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy, tired, shaky or confused while taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
3. HOW TO TAKE VALCYTE
Always take your tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. You have to be careful when handling your tablets. Do not break or crush them. You should swallow them whole and with food whenever possible. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if you do not have sterile water.
2. BEFORE YOU TAKE VALCYTE Do not take VALCYTE
- if you are allergic (hypersensitive) to valganciclovir or any of the other ingredients of VALCYTE - if you are allergic (hypersensitive) to ganciclovir, acyclovir or valaciclovir, which are medicines used to treat other virus infections. - if you are breastfeeding.
Take special care with VALCYTE
- if you have low numbers of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will carry out blood tests before you start taking VALCYTE tablets and more tests will be done while you are taking the tablets. - if you are having radiotherapy or haemodialysis. - if you have a problem with your kidneys. Your doctor may need to prescribe a reduced dose for you and may need to check your blood frequently during treatment. - if you are currently taking ganciclovir capsules and your doctor wants you to switch to VALCYTE tablets. It is important that you do not take more than the number of tablets prescribed by your doctor or you could risk an overdose. Present studies do not sufciently show how the medicine is working in children.
You must stick to the number of tablets as instructed by your doctor to avoid overdose.
VALCYTE tablets should, whenever possible, be taken with food see section 2.
Adults: Prevention of CMV disease in transplant patients
You should start to take this medicine within 10 days of your transplant. The usual dose is two tablets taken ONCE daily. You should continue with this dose for up to 100 days following your transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200 days.
Treatment of active CMV retinitis in AIDS patients (called induction treatment)
Taking other medicines
Tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take other medicines at the same time as taking VALCYTE the combination could affect the amount of drug that gets into your blood stream or could cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following: - imipenem-cilastatin (an antibiotic). Taking this with VALCYTE can cause convulsions (ts) - zalcitabine, zidovudine, didanosine or similar kinds of drugs used to treat AIDS - probenecid (a medicine against gout). Taking probenecid and VALCYTE at the same time could increase the amount of ganciclovir in your blood - mycophenolate mofetil (used after transplantations)
The usual dose of VALCYTE is two tablets taken TWICE a day for 21 days (three weeks). Do not take this dose for more than 21 days unless your doctor tells you to, as this may increase your risk of possible side effects.
Longer term treatment to prevent recurrence of active inammation in AIDS patients with CMV retinitis (called maintenance treatment)
The usual dose is two tablets taken ONCE daily. You should try to take the tablets at the same time each day. Your doctor will advise you how long you should continue to take VALCYTE. If your retinitis worsens while you are on this dose, your doctor may tell you to repeat the induction treatment (as above) or may decide to give you a different medicine to treat the CMV infection.
Elderly patients
VALCYTE has not been studied in elderly patients.
If your kidneys are not working properly, your doctor may instruct you to take fewer tablets each day or only to take your tablets on certain days each week. It is very important that you only take the number of tablets prescribed by your doctor.
Patients with kidney problems
Effects on eating: loss of appetite (anorexia), weight loss General effects: tiredness, fever, pain, chest pain, loss of energy (asthenia), generally feeling unwell (malaise) Effects on mood or behaviour: depression, feeling anxious, confused, having unusual thoughts Uncommon side effects (may affect 1 to 10 users in 1000): Effects in the heart: changes to the normal heart beat (arrhythmia) Effects on circulation: low blood pressure (hypotension), which can cause you to feel light headed or faint Effects on the blood: a decrease in the production of blood cells in the bone marrow Effects in the nerves: shaking or trembling (tremor) Effects in the eyes: red, swollen eyes (conjunctivitis), abnormal vision Effects in the ears: deafness Effects on the stomach or digestion: swollen stomach, mouth ulcers, inammation of the pancreas (pancreatitis) where you may notice severe pain in the stomach and back Effects on the skin: hair loss (alopecia), itchy rash or swellings (urticaria), dry skin Effects in the kidneys: blood in the urine (haematuria), kidney failure Effects in the liver: a rise in the liver enzyme called alanine aminotransferase (which will only be seen during blood tests) Effects on fertility: infertility in men Effects on mood or behaviour: having unusual changes in mood and behaviour, losing contact with reality such as hearing voices or seeing things that are not there, feeling agitated If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Patients with liver problems
VALCYTE has not been studied in patients with liver problems.
If you take more VALCYTE than you should
Contact your doctor or hospital immediately if you have taken, or think that you have taken, more tablets than you should. Taking too many tablets can cause serious side effects, particularly affecting your blood or kidneys. You may need hospital treatment.
If you forget to take VALCYTE
If you forget to take your tablets take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablets.
If you stop taking VALCYTE
You must not stop taking your medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VALCYTE can cause side effects, although not everybody gets them. Up to 1 in every 100 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOP taking VALCYTE and go to the accident and emergency department at your nearest hospital if you experience any of the following: - a raised, itchy skin rash (hives) - sudden swelling of the throat, face, lips and mouth which may cause difculty swallowing or breathing - sudden swelling of the hands, feet or ankles. The side effects that have occurred during treatment with valganciclovir or ganciclovir are given below. Very common means that the effect may occur in more than 1 in every 10 patients. Common means that the effect may occur in 1 to 10 users in 100. Uncommon means that the effect may occur in 1 to 10 users in 1000. Very rare means that the effect may occur in less than 1 user in 10,000. Very common side effects (may affect more than 1 in 10 users): Effects on the blood: a reduction in the number of white blood cells in the blood (neutropenia) - which will make you more likely to get infections, a reduction in the pigment in the blood that carries oxygen (anaemia) which can cause tiredness and breathlessness when you exercise Effects on breathing: feeling short of breath or having trouble breathing (dyspnoea) Effects on the stomach and digestive system: diarrhoea Common side effects (may affect 1 to 10 users in 100): Effects on the blood: a reduction in the number of leucocytes (blood cells that ght infection) in the blood (leucopenia), a reduction in the number of platelets in the blood (thrombocytopenia) - which can cause bruising and bleeding, a reduction in the number of several types of blood cells at the same time (pancytopenia) Effects on the nervous system: headache, difculty sleeping (insomnia), strange tastes (dysgeusia), becoming less sensitive to touch (hypoaesthesia), prickly or tingling skin (paraesthesia), loss of feeling in the hands or feet (peripheral neurophathy), dizziness, ts (convulsions) Effects in the eye: eye pain, swelling within the eye (oedema), separation of the back of the eye (detached retina), seeing oaters Effects in the ear: earache Effects on breathing: coughing Effects on the stomach and digestion: feeling and being sick, stomach ache, constipation, wind, indigestion (dyspepsia), difculty swallowing (dysphagia) Effects on the skin: inamed skin (dermatitis), itching (pruritis), sweating at night Effects on the muscles, joints or bones: back pain, pain in the muscles (myalgia) or joints (arthralgia), stiff muscles (rigor), muscle cramps Infections: fungal infection in the mouth (oral candidiasis), infections caused by bacteria or viruses in the blood, inammation of cellular tissue (cellulitis), inammation or infection of the kidneys or bladder Effects in the liver: a rise in some liver enzymes, which will only be seen during blood tests Effects in the kidney: changes to the normal working of the kidneys
Allergic reactions
5. HOW TO STORE VALCYTE
Keep out of the reach and sight of children. Do not use VALCYTE after the expiry date, which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage condition. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What VALCYTE contains
The active substance is 450 mg of valganciclovir, present as 496.3 mg of valganciclovir hydrochloride. The other ingredients in the tablet are Povidone K30, crospovidone, microcrystalline cellulose and stearic acid. The ingredients in the lm-coat are hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172) and polysorbate 80.
What VALCYTE looks like and contents of the pack
VALCYTE tablets are pink oval lmcoated tablets marked VGC on one side and 450 on the other side. They are packed in bottles containing 60 lm-coated tablets.
Marketing Authorisation Holder
Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom
Manufacturer (UK only)
Manufacturer (Ireland only)
Roche Pharma AG Emil-Barell-Str. 1 D-79639 Grenzach-Wyhlen Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
VALCYTE: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, The Netherlands, Norway, Poland, Romania, Slovak Republic, Spain, Sweden, United Kingdom RoVALCYTE: France, Portugal This leaet was last approved in June 2011
10119260 GB 1004.1076
Valcyte 450 mg
lm-coated tablets
valganciclovir
Read all of this leaet carefully before you start taking this medicine. - Keep this leaet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What VALCYTE is and what it is used for 2. Before you take VALCYTE 3. How to take VALCYTE 4. Possible side effects 5. How to store VALCYTE 6. Further information
- vincristine, vinblastine, adriamycin, hydroxyurea or similar kinds of drugs to treat cancer - cidofovir, foscarnet, or nucleoside analogues used against viral infections - trimethoprim, trimethoprim/sulpha combinations and dapsone (antibiotics) - pentamidine (drug to treat parasites or lung infections) - ucytosine or amphotericin B (antifungal agents)
Taking VALCYTE with food and drink
VALCYTE should be taken with food. If you are unable to eat for any reason, you should still take your dose of VALCYTE as usual.
Pregnancy and breast feeding
You should not take VALCYTE if you are pregnant unless your doctor recommends it. If you are pregnant or planning to become pregnant you must tell your doctor. Taking VALCYTE when you are pregnant could harm your unborn baby. You must not take VALCYTE if you are breastfeeding. If your doctor wants you to begin treatment with VALCYTE you must stop breastfeeding before you start to take your tablets.
1. WHAT VALCYTE IS AND WHAT IT IS USED FOR
VALCYTE belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, valganciclovir, is changed into ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause an infection in the bodys organs. This can be life threatening. VALCYTE is used: for treatment of CMV-infections of the retina of the eye in patients with acquired immunodeciency syndrome (AIDS). CMV-infection of the retina of the eye can cause vision problems and even blindness. to prevent CMV-infections in patients who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV.
Women of childbearing age
Women of childbearing age must use effective contraception when taking VALCYTE.
Men
Men whose partners could become pregnant should use condoms while taking VALCYTE and should continue to use condoms for 90 days after treatment has nished.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy, tired, shaky or confused while taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
3. HOW TO TAKE VALCYTE
Always take your tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. You have to be careful when handling your tablets. Do not break or crush them. You should swallow them whole and with food whenever possible. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if you do not have sterile water.
2. BEFORE YOU TAKE VALCYTE Do not take VALCYTE
- if you are allergic (hypersensitive) to valganciclovir or any of the other ingredients of VALCYTE - if you are allergic (hypersensitive) to ganciclovir, acyclovir or valaciclovir, which are medicines used to treat other virus infections. - if you are breastfeeding.
Take special care with VALCYTE
- if you have low numbers of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will carry out blood tests before you start taking VALCYTE tablets and more tests will be done while you are taking the tablets. - if you are having radiotherapy or haemodialysis. - if you have a problem with your kidneys. Your doctor may need to prescribe a reduced dose for you and may need to check your blood frequently during treatment. - if you are currently taking ganciclovir capsules and your doctor wants you to switch to VALCYTE tablets. It is important that you do not take more than the number of tablets prescribed by your doctor or you could risk an overdose. Present studies do not sufciently show how the medicine is working in children.
You must stick to the number of tablets as instructed by your doctor to avoid overdose.
VALCYTE tablets should, whenever possible, be taken with food see section 2.
Adults: Prevention of CMV disease in transplant patients
You should start to take this medicine within 10 days of your transplant. The usual dose is two tablets taken ONCE daily. You should continue with this dose for up to 100 days following your transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200 days.
Treatment of active CMV retinitis in AIDS patients (called induction treatment)
Taking other medicines
Tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take other medicines at the same time as taking VALCYTE the combination could affect the amount of drug that gets into your blood stream or could cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following: - imipenem-cilastatin (an antibiotic). Taking this with VALCYTE can cause convulsions (ts) - zalcitabine, zidovudine, didanosine or similar kinds of drugs used to treat AIDS - probenecid (a medicine against gout). Taking probenecid and VALCYTE at the same time could increase the amount of ganciclovir in your blood - mycophenolate mofetil (used after transplantations)
The usual dose of VALCYTE is two tablets taken TWICE a day for 21 days (three weeks). Do not take this dose for more than 21 days unless your doctor tells you to, as this may increase your risk of possible side effects.
Longer term treatment to prevent recurrence of active inammation in AIDS patients with CMV retinitis (called maintenance treatment)
The usual dose is two tablets taken ONCE daily. You should try to take the tablets at the same time each day. Your doctor will advise you how long you should continue to take VALCYTE. If your retinitis worsens while you are on this dose, your doctor may tell you to repeat the induction treatment (as above) or may decide to give you a different medicine to treat the CMV infection.
Elderly patients
VALCYTE has not been studied in elderly patients.
If your kidneys are not working properly, your doctor may instruct you to take fewer tablets each day or only to take your tablets on certain days each week. It is very important that you only take the number of tablets prescribed by your doctor.
Patients with kidney problems
Effects on eating: loss of appetite (anorexia), weight loss General effects: tiredness, fever, pain, chest pain, loss of energy (asthenia), generally feeling unwell (malaise) Effects on mood or behaviour: depression, feeling anxious, confused, having unusual thoughts Uncommon side effects (may affect 1 to 10 users in 1000): Effects in the heart: changes to the normal heart beat (arrhythmia) Effects on circulation: low blood pressure (hypotension), which can cause you to feel light headed or faint Effects on the blood: a decrease in the production of blood cells in the bone marrow Effects in the nerves: shaking or trembling (tremor) Effects in the eyes: red, swollen eyes (conjunctivitis), abnormal vision Effects in the ears: deafness Effects on the stomach or digestion: swollen stomach, mouth ulcers, inammation of the pancreas (pancreatitis) where you may notice severe pain in the stomach and back Effects on the skin: hair loss (alopecia), itchy rash or swellings (urticaria), dry skin Effects in the kidneys: blood in the urine (haematuria), kidney failure Effects in the liver: a rise in the liver enzyme called alanine aminotransferase (which will only be seen during blood tests) Effects on fertility: infertility in men Effects on mood or behaviour: having unusual changes in mood and behaviour, losing contact with reality such as hearing voices or seeing things that are not there, feeling agitated If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
Patients with liver problems
VALCYTE has not been studied in patients with liver problems.
If you take more VALCYTE than you should
Contact your doctor or hospital immediately if you have taken, or think that you have taken, more tablets than you should. Taking too many tablets can cause serious side effects, particularly affecting your blood or kidneys. You may need hospital treatment.
If you forget to take VALCYTE
If you forget to take your tablets take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablets.
If you stop taking VALCYTE
You must not stop taking your medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VALCYTE can cause side effects, although not everybody gets them. Up to 1 in every 100 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOP taking VALCYTE and go to the accident and emergency department at your nearest hospital if you experience any of the following: - a raised, itchy skin rash (hives) - sudden swelling of the throat, face, lips and mouth which may cause difculty swallowing or breathing - sudden swelling of the hands, feet or ankles. The side effects that have occurred during treatment with valganciclovir or ganciclovir are given below. Very common means that the effect may occur in more than 1 in every 10 patients. Common means that the effect may occur in 1 to 10 users in 100. Uncommon means that the effect may occur in 1 to 10 users in 1000. Very rare means that the effect may occur in less than 1 user in 10,000. Very common side effects (may affect more than 1 in 10 users): Effects on the blood: a reduction in the number of white blood cells in the blood (neutropenia) - which will make you more likely to get infections, a reduction in the pigment in the blood that carries oxygen (anaemia) which can cause tiredness and breathlessness when you exercise Effects on breathing: feeling short of breath or having trouble breathing (dyspnoea) Effects on the stomach and digestive system: diarrhoea Common side effects (may affect 1 to 10 users in 100): Effects on the blood: a reduction in the number of leucocytes (blood cells that ght infection) in the blood (leucopenia), a reduction in the number of platelets in the blood (thrombocytopenia) - which can cause bruising and bleeding, a reduction in the number of several types of blood cells at the same time (pancytopenia) Effects on the nervous system: headache, difculty sleeping (insomnia), strange tastes (dysgeusia), becoming less sensitive to touch (hypoaesthesia), prickly or tingling skin (paraesthesia), loss of feeling in the hands or feet (peripheral neurophathy), dizziness, ts (convulsions) Effects in the eye: eye pain, swelling within the eye (oedema), separation of the back of the eye (detached retina), seeing oaters Effects in the ear: earache Effects on breathing: coughing Effects on the stomach and digestion: feeling and being sick, stomach ache, constipation, wind, indigestion (dyspepsia), difculty swallowing (dysphagia) Effects on the skin: inamed skin (dermatitis), itching (pruritis), sweating at night Effects on the muscles, joints or bones: back pain, pain in the muscles (myalgia) or joints (arthralgia), stiff muscles (rigor), muscle cramps Infections: fungal infection in the mouth (oral candidiasis), infections caused by bacteria or viruses in the blood, inammation of cellular tissue (cellulitis), inammation or infection of the kidneys or bladder Effects in the liver: a rise in some liver enzymes, which will only be seen during blood tests Effects in the kidney: changes to the normal working of the kidneys
Allergic reactions
5. HOW TO STORE VALCYTE
Keep out of the reach and sight of children. Do not use VALCYTE after the expiry date, which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage condition. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What VALCYTE contains
The active substance is 450 mg of valganciclovir, present as 496.3 mg of valganciclovir hydrochloride. The other ingredients in the tablet are Povidone K30, crospovidone, microcrystalline cellulose and stearic acid. The ingredients in the lm-coat are hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172) and polysorbate 80.
What VALCYTE looks like and contents of the pack
VALCYTE tablets are pink oval lmcoated tablets marked VGC on one side and 450 on the other side. They are packed in bottles containing 60 lm-coated tablets.
Marketing Authorisation Holder
Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW, United Kingdom
Manufacturer (UK only)
Manufacturer (Ireland only)
Roche Pharma AG Emil-Barell-Str. 1 D-79639 Grenzach-Wyhlen Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
VALCYTE: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemburg, The Netherlands, Norway, Poland, Romania, Slovak Republic, Spain, Sweden, United Kingdom RoVALCYTE: France, Portugal This leaet was last approved in June 2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
