Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg; ; ;
GlaxoSmithKline NZ Limited
Dolutegravir sodium 52.6 mg (equivalent to Dolutegravir 50 mg)
50 mg
Film coated tablet
Active: Dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg Excipient: Mannitol Microcrystalline cellulose Opadry yellow 85F92461 Povidone Sodium starch glycolate Sodium stearyl fumarate
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
TIVICAY is indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age and weighing 40 kg or more.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant closure - 30 tablets - 60 months from date of manufacture stored at or below 30°C
2014-02-12
TIVICAY Film Coated Tablets 1 TIVICAY FILM COATED TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TIVICAY? TIVICAY contains the active ingredient dolutegravir. TIVICAY is used to treat HIV (human immunodeficiency virus) infection in adults and in children. For more information, see Section 1. Why am I using TIVICAY? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TIVICAY? Do not use if you (or your child, if they are the patient) have ever had an allergic reaction to dolutegravir or any of the ingredients listed at the end of the CMI. Do not use if taking the following medicines dofetilide or pilsicainide (to treat heart conditions); or fampridine (to treat multiple sclerosis). TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use TIVICAY? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TIVICAY and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TIVICAY? For children, your doctor will decide on the correct dose of TIVICAY for your child, depending on their weight and age. For adults, the usual dose of TIVICAY film coated tablets is 50 mg, once a day. For HIV infection that is resistant to other medicines similar to TIVICAY, the usual dose of TIVICAY film coated tablets is 50 mg taken twice a day. More instructions can be found in Section 4. How do I use TIVICAY? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TIVICAY? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using TIVICAY. If you become pregnant while taking this medicine, tell your doctor immediately. Keep all of your doctor's appointments so that Lire le document complet
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TIVICAY dolutegravir 50 mg film-coated tablets TIVICAY film-coated tablets contain dolutegravir (as dolutegravir sodium) which is an integrase inhibitor active against Human Immunodeficiency Virus (HIV). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TIVICAY is supplied as film-coated tablets each containing 52.6 mg of dolutegravir sodium, equivalent to 50 mg of dolutegravir free acid. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow, film-coated, round, biconvex tablets, debossed with ‘SV 572’ on one side and ‘50’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TIVICAY is indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age and weighing 40 kg or more (see Section 4.4 Special warnings and precautions for use). 4.2. DOSE AND METHOD OF ADMINISTRATION TIVICAY therapy should be initiated by a physician experienced in the management of HIV infection. DOSE Adults _Patients infected with HIV-1 without resistance to the integrase class _ The recommended dose of TIVICAY is 50 mg once daily. _Patients infected with HIV-1 with resistance to the integrase class (documented or clinically _ _suspected) _ The recommended dose of TIVICAY is 50 mg twice daily. The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern (see_ _section 5.1 Pharmacodynamic properties). 2 The following should be considered prior to initiating treatment with TIVICAY 50 mg twice daily: Reduced virologic response was observed in patients treated with TIVICAY 50 mg twice daily with an INI-resistance Q148H/K/R mutation plus 2 or more additional INI- resistance mutations including, but not limited to G140A/C/S, E138A/K/T, or L74I (see section 5.1 Pharmacodynamic properties). Adolescents In patients who have not previously been treated with an integrase inhi Lire le document complet