Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Abacavir sulfate 702mg equivalent to Abacavir 600 mg; ; Dolutegravir sodium 52.6mg equivalent to Dolutegravir 50 mg; ; ; ; Lamivudine 300mg;
GlaxoSmithKline NZ Limited
Abacavir sulfate 702 mg (equivalent to Abacavir 600 mg)
50mg/600mg/300mg
Film coated tablet
Active: Abacavir sulfate 702mg equivalent to Abacavir 600 mg Dolutegravir sodium 52.6mg equivalent to Dolutegravir 50 mg Lamivudine 300mg Excipient: Magnesium stearate Mannitol Microcrystalline cellulose Opadry purple 85F90057 Povidone Sodium starch glycolate
Prescription
Piramal Enterprises Limited
Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in Triumeq.
Package - Contents - Shelf Life: Bottle, HDPE Bottle with Child-Resistant Closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture
2015-02-04
TRIUMEQ 1 TRIUMEQ _Film-coated tablets _ _50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as abacavir sulfate) / 300 mg lamivudine _ CONSUMER MEDICINE INFORMATION PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING TRIUMEQ IF: 1) YOU GET A SKIN RASH OR 2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS: FEVER SHORTNESS OF BREATH, SORE THROAT OR COUGH NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIUMEQ TABLETS, NEVER TAKE TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIZIVIR & ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ PACK, TO REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE TRIUMEQ. WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you take TRIUMEQ. This leaflet answers some common questions about TRIUMEQ (dolutegravir/abacavir/lamivudine). It does not contain all of 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 expected benefits of you taking TRIUMEQ against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS TRIUMEQ USED FOR? TRIUMEQ contains three active ingredients that are used to treat HIV infection in adults and children over 12 years old weighing 40 kg or more who have never received treatment for HIV or are infected Les hele dokumentet
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TRIUMEQ dolutegravir 50 mg, abacavir 600 mg and lamivudine 300 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TRIUMEQ is supplied as film-coated tablets each containing 50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir (as abacavir sulfate) and 300 mg of lamivudine. Each film-coated tablet contains 50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir (as abacavir sulphate) and 300 mg of lamivudine. For the full list of excipients, see section 6.1 List of excipients. Data Sheets for TIVICAY(dolutegravir), ZIAGEN (abacavir), 3TC (lamivudine) and KIVEXA (abacavir and lamivudine) contain additional information. 3. PHARMACEUTICAL FORM Film-coated tablet. Purple, film-coated, oval, biconvex tablets, debossed with ‘572 Trı’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in TRIUMEQ. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Therapy should be initiated by a physician experienced in the management of HIV infection. The recommended dose of TRIUMEQ in adults and adolescents weighing at least 40 kg is one tablet once daily, taken with or without food. Because TRIUMEQ is a fixed dose tablet, it should not be prescribed for patients requiring dose adjustment: • Adults or adolescents weighing <40 kg • Children <12 years of age • Patients with creatinine clearance <30 mL/min • Patients with mild hepatic impairment 2 • Patients resistant to integrase inhibitors SPECIAL POPULATIONS Elderly There are limited data available on the use of dolutegravir, abacavir and lamivudine in patients aged 65 years and over. However, there is no evidence that elderly patients require a different Les hele dokumentet