Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Efavirenz 50mg
Merck Sharp & Dohme (New Zealand) Limited
Efavirenz 50 mg
50 mg
Film coated tablet
Active: Efavirenz 50mg Excipient: Carnauba wax Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 03B12896 Sodium laurilsulfate
Bottle, HDPE bottle with plastic cap 30 tablets, 30 tablets
Prescription
Prescription
F.I.S. Fabbrica Italiana Sintetici SpA
Package - Contents - Shelf Life: Bottle, HDPE bottle with plastic cap - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2005-11-29
STOCRIN _efavirenz _ 50 mg, 200 mg & 600 mg tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about STOCRIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking STOCRIN against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor, pharmacist or treatments officer at your local AIDS Council. Keep this leaflet with the medicine. You may need to read it again. WHAT STOCRIN IS USED FOR STOCRIN is used to help treat HIV (Human Immunodeficiency Virus) infection. It is used in combination with other appropriate medicines used to treat the HIV virus. Examples include protease inhibitors such as indinavir (CRIXIVAN ® ) and nelfinavir (Viracept*). They also include nucleoside analogue reverse transcriptase inhibitors (NRTIs) such as zidovudine (AZT, Retrovir*) or lamivudine (3TC*). STOCRIN belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors. It works by interrupting the formation of new HIV particles in already infected cells. When HIV is attacked by STOCRIN, the virus is not able to reproduce normally. This helps reduce the amount of virus in the blood. Although STOCRIN helps reduce the amount of virus in the blood and thus increases the CD4 count, it has not yet been shown to improve survival or slow the progression of the disease. You may continue to develop infections or other illnesses associated with HIV disease while you are taking STOCRIN. BEFORE YOU TAKE STOCRIN WHEN YOU MUST NOT TAKE IT Do not take STOCRIN if: • you have an allergy to STOCRIN or any of the ingredients listed at the end of this leaflet • the packaging is torn or shows signs of tampering • you are breast-feeding or plan to breast-feed. You should not breast-feed if you are taking STOCRIN because of the possibility that your baby can be infected with HIV through your Lire le document complet
NEW ZEALAND DATA SHEET 1 PRODUCT NAME STOCRIN ® 50 mg tablet STOCRIN ® 200 mg tablet STOCRIN ® 600 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION STOCRIN is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). STOCRIN is chemically described as (S) -6- chloro-4-(cyclopropylethynyl)-1,4-dihydro-4- (trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14 H 9 ClF 3 NO 2 and its structural formula is: STOCRIN is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 µg/mL). ACTIVE INGREDIENTS _STOCRIN 50 mg tablet: _ Each tablet contains 50 mg of efavirenz. _STOCRIN 200 mg tablet: _ Each tablet contains 200 mg of efavirenz. _STOCRIN 600 mg tablet: _ Each tablet contains 600 mg of efavirenz. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM STOCRIN 50 mg tablet A yellow round shaped tablet engraved with “113” on one side and plain on the other. STOCRIN 200 mg tablet A yellow round shaped tablet engraved with “223” on one side and plain on the other. O N O Cl H F 3 C STOCRIN 600 mg tablet A yellow modified capsular shaped tablet with “225” engraved on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STOCRIN is indicated in antiviral combination treatment of HIV-1 infected adults, adolescents and children. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults The recommended dosage of STOCRIN in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. STOCRIN may be taken with or without food, as desired. In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8). Concomitant Antiretroviral Therapy: STOCRIN must be given in combination with other antiretroviral medications (see section 4.5). Adolescents and Children Lire le document complet