Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
efavirenz
Merck Sharp & Dohme B.V.
J05AG03
efavirenz
Antivirals for systemic use
HIV Infections
Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.
Revision: 49
Authorised
1999-05-28
85 B. PACKAGE LEAFLET 86 PACKAGE LEAFLET: INFORMAT ION FOR THE USER STOCRIN 30 MG/ML ORAL SOLUTION efavirenz READ ALL OF T HIS LEAFLET C AREFULLY BEFORE Y OU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMP ORTANT INFORMATION FOR YOU . Keep this leaf let. You may need to read it again. If you have any furt her questions, ask y o ur doctor, pharmacist or n urse. This medicine has bee n 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, phar maci st or nurse. Thi s includes any possible sid e effects not listed in thi s leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Stocrin is and what it is used for 2. What you need to know before you take Stocrin 3. How to take Stocrin 4. Possible side effects 5. How to s tore Stocrin 6. Contents o f the pack and other inform ation 1. WH AT STOCRIN IS AND WHAT IT IS USED FOR Stocrin, which contains the act ive substance efavirenz, belongs to a class of antiretroviral medicines called non- nucleoside rever se t ranscriptase inh i bitors (NNRTIs). It is AN ANTIRETROVIRAL MEDICINE THA T FIGHTS HUMA N IMMUNODEFICIENC Y VIRUS (HIV) infection by reducing the amount of the virus in blood. It is used by adults , adol escents and children 3 years of age and older. Your doctor has prescribed S t ocrin for you because you have HIV infection. Stocrin taken in com bination with oth er antiretroviral medicines reduces the amount of the virus in the blood. This will strengthen y our immune system and reduce the risk of developing illn esse s linked to HIV infection. 2. WHAT YOU NE ED TO KNOW BEFORE YOU TAKE STOCRIN DO N OT TAKE STOCRIN IF YOU ARE ALLERGIC to efavirenz or any of the other ingredients of this medicine (listed i n section 6). Contact your doctor or pharmacist for advice. IF Y OU HAVE SEVERE LI VER DISEASE. IF YOU HAVE A HEART CONDITION, SUCH AS CHANGES IN TH E RHYTHM OR RATE OF THE HEART BEAT, A SLOW HEART BEAT, OR SEVE Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF T HE MEDICINAL P RODUCT STOCRIN 30 mg/mL oral solution 2. QUALITATIVE AND Q UANTITATIVE C OMPOSITIO N Each mL contains 30 mg of efavirenz. Excipients w ith known effect Each mL contains 1 mg of benzoic acid (E210). Each mL contains up to 0.816 mg of benzyl alcohol (E1519). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL F ORM Oral solution Colourless to sl ight ly yellow cle ar liquid. 4. CLINICAL PART ICULARS 4.1 THERAPEUTIC INDI CATIONS STOCRIN oral solution is indicated in antiviral combination tr eatment of human immunodeficiency virus-1 (HIV- 1) infected adults, adolesc ents and children 3 years of age and old er, who are u nable to swallow the film -coated tablets. STOCRIN has not bee n adequately studied in patients with a dvanced HIV di sease, namely in patients with CD4 counts < 50 cells/mm 3 , or after failure of protease i nhibitor (PI ) containing regimens. Although cross-resistance o f efavirenz with PIs has not been documented, the re a re at present insufficient data on the efficacy of su bsequent use o f PI based combination therapy after fa ilure of regimens containing STOCRI N. For a su mmary of clinical and ph arma codynamic inf ormation, see section 5.1. 4.2 P OSOLOGY AND METHOD OF ADM INISTRATION Therapy should be initiated by a physician e xperienced in the management of HIV infection. Posology Efavirenz must be given in com bination wit h other antiretroviral m edicines (see section 4.5). Efavirenz oral soluti on may be taken with or w itho ut food (see section 5.2). In order to improve the t olerability of nervous system adverse reactions, bedt ime dosing is recommended during th e first two to four weeks of therapy and in patients who conti nue to experience these symptoms (see section 4.8). Adults T he recommended dose of efavirenz in combinati on with nucleo side analogue reverse transcriptase inh ibitors (NRTIs) with or without a P I (see section 4.5) is 24 mL orally, once daily. 3 Dose adjustment If efaviren Lestu allt skjalið