Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Indinavir sulfate 416.3mg equivalent to 333 mg Indinavir; ;
Merck Sharp & Dohme (New Zealand) Limited
Indinavir sulfate 416.3 mg (equivalent to 333 mg Indinavir)
333 mg
Capsule
Active: Indinavir sulfate 416.3mg equivalent to 333 mg Indinavir Excipient: Gelatin Lactose Magnesium stearate
Bottle, plastic, HDPE, 135 capsules
Prescription
Prescription
Merck Sharp & Dohme Corp
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 135 capsules - 36 months from date of manufacture stored at or below 30°C
1998-09-18
CRIXIVAN ® _indinavir sulfate _ 200 mg & 400 mg capsules WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CRIXIVAN. 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 CRIXIVAN 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 NZ AIDS Foundation. Keep this leaflet with the medicine. You may need to read it again. WHAT CRIXIVAN IS USED FOR CRIXIVAN, a protease inhibitor, is used to help treat HIV (Human Immunodeficiency Virus) infection. It should be used in combination with other appropriate medicines used to treat the HIV virus, including zidovudine (AZT, Retrovir), didanosine (ddI, Videx) or lamivudine (3TC). CRIXIVAN belongs to a group of medicines called HIV protease inhibitors. It works in a different way to the other medicines used to treat HIV. CRIXIVAN works by interrupting the formation of new HIV particles in already infected cells. When HIV is attacked by CRIXIVAN, the virus is not able to reproduce normally. This helps reduce the amount of virus in the body and helps protect new cells from infection. CRIXIVAN helps reduce the amount of virus in the body and thus increases the CD4 count, it also improves survival and slows the progression of the disease. You may continue to develop infections or other illnesses associated with HIV disease while you are taking CRIXIVAN. BEFORE YOU TAKE CRIXIVAN WHEN YOU MUST NOT TAKE IT Do not take CRIXIVAN if: • you have an allergy to CRIXIVAN 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. If you are not sure whether you should start taking CRIXIVAN, talk to your doctor. Do not give CRIX Lue koko asiakirja
NAME OF MEDICINE CRIXIVAN ® _indinavir sulfate _ 200 mg & 400 mg capsules PRESENTATION CRIXIVAN 200 mg: A #1 white semi-translucent capsule with ‘CRIXIVAN™ 200 mg’ printed in blue ink. Each capsule contains 200 mg of indinavir (250 mg indinavir sulphate). Dimensions are approximately 19.4 mm in length and 6.91 mm in diameter. CRIXIVAN 400 mg: A #00 white semi-translucent capsule with ‘CRIXIVAN™ 400 mg’ printed in green ink. Each capsule contains 400 mg of indinavir (500 mg indinavir sulfate). Dimensions are approximately 25.3 mm in length and 8.53 mm in diameter. THERAPEUTIC CLASS CRIXIVAN (indinavir sulfate) is a specific protease inhibitor active against the Human Immunodeficiency Virus (HIV-1). INDICATIONS CRIXIVAN is indicated for the treatment of adults with HIV-1 infection. Clinical studies demonstrated: • reduced risk of progression to an AIDS-defining illness or death • increased overall survival • durable reduction in serum viral RNA • durable increase in CD4 cell counts DOSAGE AND ADMINISTRATION The recommended dosage of CRIXIVAN is 800 mg (usually given as two 400 mg capsules) orally every 8 hours. Therapy with CRIXIVAN must be initiated at the recommended dose of 2.4 gm/day. It should be noted that the decrease in suppression of viral RNA levels was seen more frequently when therapy with indinavir was initiated at doses lower than the recommended oral dose of 2.4 gm/day. Therefore, therapy with indinavir should be initiated at the recommended dose to increase suppression of viral replication and therefore inhibit the emergence of resistant virus. CRIXIVAN should be used: • in combination with approved antiretroviral agents (e.g. nucleoside and non-nucleoside reverse transcriptase inhibitors), for the treatment of adult patients with HIV-1 infection. Since CRIXIVAN must be taken at intervals of 8 hours, a schedule convenient for the patient should be developed. For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a mea Lue koko asiakirja