Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
nelfinavir
Roche Registration Ltd.
J05AE04
nelfinavir
Antivirals for systemic use
HIV Infections
Viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children of three years of age and older.In protease-inhibitor (PI)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
Revision: 25
Withdrawn
1998-01-22
58 B. PACKAGE LEAFLET Medicinal product no longer authorised 59 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRACEPT 50 MG/G ORAL POWDER Nelfinavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Viracept is and what it is used for 2. Before you take Viracept 3. How to take Viracept 4. Possible side effects 5. How to store Viracept 6. Further information 1. WHAT VIRACEPT IS AND WHAT IT IS USED FOR WHAT VIRACEPT IS Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor’. This belongs to a group of medicines called ‘anti-retrovirals’. WHAT VIRACEPT IS USED FOR Viracept is used with other ‘anti-retroviral’ medicines to: • Work against the Human Immunodeficiency Virus (HIV). It helps to reduce the number of HIV particles in your blood. • Increase the number of some cells in your blood that help fight infection. These are called CD4 white blood cells. They are particularly reduced in numbers when you have HIV infection. This can lead to an increased risk of many types of infections. Viracept is not a cure for HIV infection. You may continue to get infections or other illnesses due to your HIV. Treatment with Viracept does not stop you giving HIV to others through contact with blood or sexual contact. Therefore you must keep taking appropriate precautions to avoid giving the virus to others when you are taking Viracept. 2. BEFORE YOU TAKE VIRACEPT DO NOT TAKE VIRACEPT IF: • You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further information’). • You are taking any o সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT VIRACEPT 50 mg/g oral powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The bottle contains 144 g of oral powder. Each gram of oral powder contains nelfinavir mesilate corresponding to 50 mg of nelfinavir. Excipients : - Contains sucrose palmitate: 10.0 mg per gram of oral powder. 10.0 mg of sucrose palmitate, which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully hydrolysed. - Contains aspartame (E951): 20.0 mg of aspartame per gram of oral powder. - Contains potassium: 50.0 mg of dibasic potassium phosphate corresponding to 22.5 mg of potassium per gram of oral powder. See section 4.4 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. White to off-white amorphous powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older. In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history. See section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection. VIRACEPT is administered orally and should always be ingested with food (see section 5.2). _Patients older than 13 years:_ VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets). The recommended dose of VIRACEPT 50 mg/g oral powder is 1250 MG TWICE A DAY (BID) OR 750 MG THREE TIMES A DAY (TID), for patients unable to take tablets. All patients older than 13 years should take EITHER 5 level scoops of the blue 5 gram spoon twice daily OR 3 level scoops of the blue 5 gram spoon three times daily. The efficacy of the BID (twice daily) regimen has been ev সম্পূর্ণ নথি পড়ুন