Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
stavudine
Bristol-Myers Squibb Pharma EEIG
J05AF04
stavudine
Antivirals for systemic use
HIV Infections
Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.
Revision: 31
Withdrawn
1996-05-08
57 B. PACKAGE LEAFLET Approved 1.0 v 58 PACKAGE LEAFLET: INFORMATION FOR THE USER ZERIT 15 MG HARD CAPSULES Stavudine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zerit is and what it is used for 2. What you need to know before you take Zerit 3. How to take Zerit 4. Possible side effects 5. How to store Zerit 6. Contents of the pack and other information 1. WHAT ZERIT IS AND WHAT IT IS USED FOR Zerit belongs to a particular group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection. This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level. It also increases CD4 cell counts. These CD4 cells play an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Zerit varies between patients. Your doctor will therefore be monitoring the effectiveness of your treatment. Zerit may improve your condition, but it is not a cure for your HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. During treatment, other infections linked to a weakened immunity (opportunistic infections) may arise. These will require specific and sometimes preventive treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZERIT Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Approved 1.0 v 2 1. NAME OF THE MEDICINAL PRODUCT Zerit 15 mg hard capsules Zerit 20 mg hard capsules Zerit 30 mg hard capsules Zerit 40 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zerit 15 mg hard capsules Each hard capsule contains 15 mg of stavudine. Excipients with known effect Each hard capsule contains 80.84 mg of lactose anhydrous. Each hard capsule contains 40.42 mg of lactose monohydrate. Zerit 20 mg hard capsules Each hard capsule contains 20 mg of stavudine. Excipients with known effect Each hard capsule contains 121.30 mg of lactose anhydrous. Each hard capsule contains 60.66 mg of lactose monohydrate. Zerit 30 mg hard capsules Each hard capsule contains 30 mg of stavudine. Excipients with known effect Each hard capsule contains 121.09 mg of lactose anhydrous. Each hard capsule contains 60.54 mg of lactose monohydrate. Zerit 40 mg hard capsules Each hard capsule contains 40 mg of stavudine. Excipients with known effect Each hard capsule contains 159.06 mg of lactose anhydrous. Each hard capsule contains 79.53 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Zerit 15 mg hard capsules The hard capsule is red and yellow, opaque and imprinted with “BMS” over a BMS code “1964” on one side and “15” on the other side. Zerit 20 mg hard capsules The hard capsule is brown, opaque and imprinted with “BMS” over a BMS code “1965” on one side and “20” on the other side. Zerit 30 mg hard capsules The hard capsule is light and dark orange, opaque and imprinted with “BMS” over a BMS code “1966” on one side and “30” on the other side. Approved 1.0 v 3 Zerit 40 mg hard capsules The hard capsule is dark orange, opaque and imprinted with “BMS” over a BMS code “1967” on one side and “40” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zerit is indicated in combination with other antiretroviral medicinal products for the treatmen Lestu allt skjalið