Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
indinavir sulfate ethanolate
Merck Sharp & Dohme B.V.
J05AE02
indinavir
Antivirals for systemic use
HIV Infections
Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.,
Revision: 39
Withdrawn
1996-10-04
63 B. PACKAGE LEAFLET Medicinal Product no longer authorised 64 PACKAGE LEAFLET: INFORMATION FOR THE USER CRIXIVAN 200 MG HARD CAPSULES indinavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CRIXIVAN is and what it is used for 2. What you need to know before you take CRIXIVAN 3. How to take CRIXIVAN 4. Possible side effects 5. How to store CRIXIVAN 6. Contents of the pack and other information 1. WHAT CRIXIVAN IS AND WHAT IT IS USED FOR WHAT CRIXIVAN IS CRIXIVAN contains a substance called indinavir. It belongs to a group of medicines called ‘protease inhibitors’. WHAT CRIXIVAN IS USED FOR CRIXIVAN is used to treat Human Immunodeficiency Virus (HIV) in adults. CRIXIVAN is used at the same time as other HIV treatments (antiretroviral medicines). This is called combination antiretroviral therapy. An example of another medicine that might be given to you, at the same time as CRIXIVAN, is ritonavir. HOW CRIXIVAN WORKS CRIXIVAN treats HIV and helps to lower the number of HIV particles in your blood. CRIXIVAN helps to: lower the risk that you get illnesses related to HIV lower the amount of HIV in your body (your ‘viral load’) raise your CD4 (T) cell count. CD4 cells are an important part of your immune system. The main role of the immune system is to protect you from infections. CRIXIVAN may not do these things in all patients. Your doctor will monitor how this medicine works for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CRIXIVAN DO NOT TAKE CRIXIV Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT CRIXIVAN 200 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains indinavir sulphate corresponding to 200 mg of indinavir. Excipient with known effect Each 200 mg capsule contains 74.8 mg lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard capsule. The capsules are semi–translucent white and coded ‘CRIXIVAN ™ 200 mg’ in blue. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CRIXIVAN is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV–1 infected adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CRIXIVAN should be administered by physicians who are experienced in the treatment of HIV infection. On the basis of current pharmacodynamic data, indinavir must be used in combination with other antiretroviral agents. When indinavir is administered as monotherapy resistant viruses rapidly emerge (see section 5.1). Posology The recommended dose of indinavir is 800 mg orally every 8 hours. Data from published studies suggest that CRIXIVAN 400 mg in combination with ritonavir 100 mg, both administered orally twice daily, may be an alternative dosing regimen. The suggestion is based on limited published data (see section 5.2). A dose reduction of indinavir to 600 mg every 8 hours should be considered when administering itraconazole or ketoconazole concurrently (see section 4.5). Special populations _Hepatic impairment_ In patients with mild–to–moderate hepatic impairment due to cirrhosis, the dose of indinavir should be reduced to 600 mg every 8 hours. The recommendation is based on limited pharmacokinetic data (see section 5.2). Patients with severe hepatic impairment have not been studied; therefore, no dosing recommendations can be made (see section 4.4). _Renal impairment_ Safety in patients with impaired renal function has not been studied; however, less than 20 % of indinavir is Lestu allt skjalið