Страна: Израиль
Язык: английский
Источник: Ministry of Health
ATAZANAVIR AS SULFATE
TEVA ISRAEL LTD
J05AE08
CAPSULES
ATAZANAVIR AS SULFATE 150 MG
PER OS
Required
TEVA ISRAEL LTD, ISRAEL
ATAZANAVIR
Atazanavir Teva ® is indicated in combination with other antiretroviral agents for for the treatment of HIV-1 infection.
2023-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only ATAZANAVIR TEVA 150 MG CAPSULES _Composition:_ Each capsule contains: Atazanavir (as sulfate) 150 mg ATAZANAVIR TEVA 200 MG CAPSULES _Composition:_ Each capsule contains: Atazanavir (as sulfate) 200 mg ATAZANAVIR TEVA 300 MG CAPSULES _Composition:_ Each capsule contains: Atazanavir (as sulfate) 300 mg For information regarding inactive ingredients and allergens, see section 2 - “Important information about some ingredients of the medicine” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. THIS MEDICINE IS INTENDED FOR ADULTS AND CHILDREN ABOVE 6 YEARS OF AGE. THIS MEDICINE IS NOT INTENDED FOR BABIES UNDER THREE MONTHS OF AGE. 1. WHAT IS THE MEDICINE INTENDED FOR? Atazanavir Teva is intended for treatment of HIV-1 (Human Immunodeficiency Virus type 1) and is given in combination with other antiretroviral medicines intended to treat HIV-1 (antiretroviral agents) in adults and children above 6 years of age. Atazanavir Teva is not intended for babies under three months of age. THERAPEUTIC CLASS: Protease inhibitors. Atazanavir Teva is a prescription medicine against HIV-1 (Human Immunodeficiency Virus type 1), which is given in combination with other antiretroviral medicines intended to treat HIV-1 infections. HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome). When used with other antiretroviral medicines to treat HIV-1 infection, Atazanavir Teva may help reduce the amount of the HIV-1 virus in the blood (also called viral load), and to increase the number of CD4+ (T) cells in the blood that help fight o Прочитать полный документ
Atazanavir Teva 150/200/300mg KL SPC Notification 2023 - 12 Atazanavir Teva 150 mg Atazanavir Teva 200 mg Atazanavir Teva 300 mg (ATAZANAVIR as SULFATE) CAPSULES _Per os _ 1. INDICATIONS AND USAGE Atazanavir Teva (atazanavir as sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks duration in antiretroviral-treatment- experienced adult and pediatric patients at least 6 years of age. The following points should be considered when initiating therapy with Atazanavir Teva: In Study AI424-045, atazanavir /ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that atazanavir /ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection [see Clinical Studies (13.2)]. The number of baseline primary protease inhibitor mutations affects the virologic response to atazanavir /ritonavir [see Clinical Pharmacology (11.4)]. 2. DOSAGE AND ADMINISTRATION 2.1. overview Atazanavir Teva Capsules must be taken with food. Do not open the capsules. The recommended oral dosage of Atazanavir Teva depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration (2.3,2.4,2.5 and 2.6) and drug interactions (7)]. When coadministered with didanosine buffered or enteric-coated formulations, Atazanavir Teva should be given (with food) 2 hours before or 1 hour after didanosine. Atazanavir Teva without ritonavir is not recommended for treatment-experienced adult or pediatric patients with pri Прочитать полный документ