Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
cobicistat, Quantity: 150 mg
Gilead Sciences Pty Ltd
Cobicistat
Tablet
Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sunset yellow FCF aluminium lake; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
30 Tablets, Bottle
(S4) Prescription Only Medicine
TYBOST is indicated as a pharmacokinetic enhancer of appropriate HIV-1 protease inhibitors in adults (See Dosage and Administration).
Visual Identification: Tablet, film-coated, orange in colour, debossed with 'GSI' on one side and plain faced on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-10-23
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 Perskaitykite visą dokumentą
TYBOST Product Information v10.0 – (24 August 2021) Page 1 AUSTRALIA PRODUCT INFORMATION - TYBOST ® COBICISTAT TABLETS 1 NAME OF THE MEDICINE TYBOST (cobicistat). Cobicistat is one of the active substances in the single tablet regimens; STRIBILD ® , GENVOYA ® . 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of cobicistat. _ _ Cobicistat is a white to pale yellow solid. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TYBOST is indicated as a pharmacokinetic enhancer of appropriate HIV-1 protease inhibitors in adults (see Section 4.2 Dose and method of administration). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) TYBOST must be coadministered with atazanavir or darunavir. The recommended dose of TYBOST is one tablet, once daily taken orally with food. The recommended dose of TYBOST and that of the coadministered protease inhibitor, atazanavir or darunavir, are presented in Table 1. As TYBOST is used in combination with atazanavir or darunavir, also consult the Product Information for atazanavir or darunavir. TABLE 1. RECOMMENDED DOSING REGIMENS DOSE OF TYBOST DOSE OF RECOMMENDED HIV-1 PROTEASE INHIBITOR 150 mg once daily Atazanavir 300 mg once daily Darunavir 800 mg once daily TYBOST is not recommended for use with HIV-1 protease inhibitors other than those presented in Table 1. TYBOST Product Information v10.0 – (24 August 2021) Page 2 DOSAGE ADJUSTMENT _Renal impairment_ No dose adjustment of TYBOST is required in patients with renal impairment, including those with severe renal impairment (see Section 5.1 Pharmacodynamic properties). TYBOST has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. This effect Perskaitykite visą dokumentą