Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
LAMIVUDINE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF05
SOLUTION (ORAL)
LAMIVUDINE 10 MG/ML
PER OS
Required
VIIV HEALTHCARE UK LIMITED, UK
LAMIVUDINE
LAMIVUDINE
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
2014-03-31
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 Soma hati kamili
Page 1 of 15 EPIVIR ORAL SOLUTION 1. NAME OF THE MEDICINAL PRODUCT Epivir oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 10 mg of lamivudine. Excipient(s) with known effect: Each 15 ml dose contains 3 g sucrose (20% w/v). Methyl parahydroxybenzoate Propyl parahydroxybenzoate Each 15 ml dose contains 300 mg propylene glycol. Each 15 ml dose contains 39 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, colourless to pale yellow solution. 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. _ _ Epivir is also available as a tablet formulation for patients who weigh at least 14 kg (see section 4.4). Patients changing between lamivudine tablets and lamivudine oral solution should follow the dosing recommendations that are specific for the formulation (see section 5.2). 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): _ Page 2 of 15 _ _ The recommended dose of Epivir is 300 mg daily. This may be administered as either 150 mg (15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4). _Children (weighing less than 25 kg): _ _ _ _Children from one year of age: _ The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5). _Children from three months to one year of age:_ The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered. Soma hati kamili