البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
LAMIVUDINE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF05
FILM COATED TABLETS
LAMIVUDINE 300 MG
PER OS
Required
GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND
LAMIVUDINE
LAMIVUDINE
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 28/10/2018 בקשה לשינוי משטר מינון
2014-09-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only. EPIVIR ORAL SOLUTION EACH ML OF ORAL SOLUTION CONTAINS LAMIVUDINE 10 MG. For the list of the inactive and allergenic ingredients, see section 2 - “Important information about some of the ingredients of Epivir” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. This medicine has been prescribed for you or for your child. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? EPIVIR IS USED TO TREAT HIV INFECTION (HUMAN IMMUNODEFICIENCY VIRUS) IN ADULTS AND CHILDREN. THERAPEUTIC GROUP: Epivir is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called _nucleoside _ _analogue reverse transcriptase inhibitors (NRTIs)._ Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Epivir in the same way. Your physician will monitor the effectiveness of your treatment. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to lamivudine or to any of the additional ingredients contained in the medicine (listed in section 6). → CHECK WITH YOUR PHYSICIAN if you think this applies to you. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks: • if you have ever had LIVER DISEASE, including hepatitis B or C (if you have hepati اقرأ الوثيقة كاملة
Page 1 of 16 The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in July 2019 _ _ _ _ EPIVIR 150 MG EPIVIR 300 MG 1. NAME OF THE MEDICINAL PRODUCT Epivir 150 mg Epivir 300 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Epivir 150 mg Each film-coated tablet contains 150 mg lamivudine. Epivir 300 mg Each film-coated tablet contains 300 mg lamivudine Excipient(s) with known effect: Each 150 mg tablet contains 0.378 mg sodium. Each 300 mg tablet contains 0.756 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Epivir 150 mg Film-coated tablet White, diamond shaped scored tablets engraved with “GX CJ7” on both faces. Epivir 300 mg Film-coated tablet Grey, diamond shaped and engraved with “GX EJ7” on one face 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The therapy should be initiated by a physician experienced in the management of HIV infection. Epivir may be administered with or without food. Page 2 of 16 To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. _ _ Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4). Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2) Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). _Adults, adolescents and children (weighing at least 25 kg): _ _ _ The recommended dose of Epivir is 300 mg daily. This may be administered as either 150 mg tw اقرأ الوثيقة كاملة