Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
efavirenz
Merck Sharp & Dohme (Australia) Pty Ltd
Registered
STOCRIN ® _Efavirenz_ CONSUMER MEDICINE INFORMATION 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 (NNRTIs). 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 • THE EXPIRY DATE ON THE PACK HAS PASSED. If you take this medicine after the expiry date has passed, it may not work. • YOU ARE BREAST FEEDING OR PLAN TO BREAST FEED It is po Διαβάστε το πλήρες έγγραφο
AUSTRALIAN PRODUCT INFORMATION STOCRIN ® (efavirenz) Tablets and Oral Solution 1 NAME OF THE MEDICINE Efavirenz 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Efavirenz is a white to slightly pink crystalline powder. STOCRIN is available as tablets for oral administration. Each STOCRIN tablet contains 50, 200, 300 or 600 mg of efavirenz. STOCRIN is also available as an oral solution containing 30 mg efavirenz per mL. FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STOCRIN is indicated for use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children (See section 5.1; Use in Children). 4.2 DOSE AND METHOD OF ADMINISTRATION STOCRIN should be taken in the fasted state, preferably at bedtime. Food increases the bioavailability of STOCRIN and this may be associated with a higher frequency of side effects. 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). 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 when using the tablets or 24 mL orally once daily when using the oral solution. Adolescents and Children (17 years and under): The recommended dose of STOCRIN in combination with a protease inhibitor and/or NRTIs for patients 17 years of age and under is described in the table below. STOCRIN tablets should only be administered to children who are able to reliably swallow tablets. STOCRIN tablets or oral solution have not been adequately studied in children under the age of 3 years or children weighing less than 13 Kg (see section 4.4, USE IN CHILDREN). P Διαβάστε το πλήρες έγγραφο