Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Cobicistat 150mg; ; ;
Gilead Sciences (NZ)
Cobicistat 150 mg
150 mg
Film coated tablet
Active: Cobicistat 150mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry orange 85F93642
Prescription
Flamma S.p.A.
Tybost is indicated as a pharmacokinetic enhancer of appropriate HIV-1 protease inhibitors in adults
Package - Contents - Shelf Life: Bottle, plastic, - 30 tablets - 24 months from date of manufacture stored at or below 25°C
2013-11-04
TYBOST Consumer Medicine Information v5.0 – (2 November 2016) Page 1 of 4 TYBOST ® TABLETS (150 MG COBICISTAT) _Cobicistat _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some of the common questions about TYBOST tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist about your medical condition or treatment. If you have further questions, please ask your doctor or your pharmacist. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. MEDICINES ARE SOMETIMES PRESCRIBED FOR CONDITIONS THAT ARE NOT MENTIONED IN THIS LEAFLET. DO NOT USE TYBOST FOR A CONDITION FOR WHICH IT WAS NOT PRESCRIBED. KEEP THIS LEAFLET WITH YOUR TYBOST MEDICINE. You may need to read it again. WHAT IS TYBOST _HOW TYBOST WORKS _ TYBOST contains the active substance cobicistat. TYBOST is a type of medicine called a pharmacokinetic enhancer (or “booster”), which is used with one of the two following medicines for the treatment of HIV: Reyataz (atazanavir) and Prezista (darunavir). TYBOST helps increase the levels of these HIV medicines in your body. _USE IN CHILDREN _ TYBOST is for adults. TYBOST has not been studied in children under the age of 18 or adults aged 65 and over. DOES TYBOST CURE HIV OR AIDS TYBOST DOES NOT TREAT HIV INFECTION OR AIDS; IT HELPS IMPROVE THE EFFECT OF THE HIV MEDICINES: Reyataz (atazanavir) and Prezista (darunavir). The long-term effects of TYBOST are not known at this time. People taking TYBOST may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are: pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. THIS MEDICINE IS Pročitajte cijeli dokument
TYBOST Data Sheet v3.0 – (17 January 2017) Page 1 of 21 DATA SHEET TYBOST ® (COBICISTAT) 150 MG TABLETS NAME OF THE MEDICINE TYBOST (cobicistat) 150 mg tablets. The active substance in TYBOST tablets is cobicistat. Cobicistat is a mechanism-based inhibitor of cytochrome P-450 (CYP) enzymes of the CYP3A family. Cobicistat is one of the active substances in the single tablet regimens; STRIBILD ® , GENVOYA. DESCRIPTION _COBICISTAT: _ the chemical name for cobicistat is 1,3-Thiazol-5-ylmethyl [(2 _R_ ,5 _R_ )-5-{[(2 _S_ )-2- [(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4- yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C 40 H 53 N 7 O 5 S 2 and a molecular weight of 776.0. It has the following structural formula: H N N H O O N S O N H N O O N N S CAS registry number: 1004316-88-4 Cobicistat is a white to pale yellow solid with a solubility of 0.1 mg/mL in water at 20 °C. The partition coefficient ( _log p_ ) for cobicistat is 4.3 and the pKa is 6.4. TYBOST tablets each contain 150 mg of cobicistat and the following ingredients as excipients: _Tablet _ _core: _ cellulose-microcrystalline (E460), silicon dioxide, croscarmellose sodium, magnesium stearate (E572). _Film-coating: _ Sunset yellow FCF (FD&C yellow #6) aluminum lake (E110), polyethylene glycol, polyvinyl alcohol, talc (E553B), titanium dioxide (E171), yellow iron oxide (E172). Each TYBOST tablet is round, film-coated and orange in colour. Each tablet is debossed with ‘GSI’ on one side and plain faced on the other side. The tablets are supplied in bottles with child resistant closures. TYBOST Data Sheet v3.0 – (17 January 2017) Page 2 of 21 PHARMACOLOGY _Pharmacotherapeutic group:_ all other therapeutic products, ATC code: V03AX03. _ _ MECHANISM OF ACTION Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily. Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as atazanavir or dar Pročitajte cijeli dokument