Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
abacavir sulfate, Quantity: 702 mg (Equivalent: abacavir, Qty 600 mg); lamivudine, Quantity: 300 mg; dolutegravir, Quantity: 50 mg
ViiV Healthcare Pty Ltd
Abacavir sulfate,Dolutegravir,Lamivudine
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; purified water; mannitol; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
30 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: Purple, biconvex, film coated oval tablets (approximately 22 x 11 mm), debossed with 572 Tri on one face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2015-01-14
TRIUMEQ FILM-COATED TABLETS _50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as abacavir sulfate) / 300mg 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: dolutegravir, abacavir, and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines c Přečtěte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION TRIUMEQ (DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE) FILM-COATED TABLETS ABACAVIR, A COMPONENT OF TRIUMEQ TABLETS, IS ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL. TRIUMEQ TABLETS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA [ABACAVIR/LAMIVUDINE], TRIZIVIR [ABACAVIR/LAMIVUDINE/ZIDOVUDINE] AND ZIAGEN [ABACAVIR]) MUST NEVER BE RESTARTED FOLLOWING A HYPERSENSITIVITY REACTION (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). 1 NAME OF THE MEDICINE Dolutegravir (as sodium), abacavir (as sulfate) and lamivudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TRIUMEQ film-coated tablets contain 50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. Product Information for TIVICAY (dolutegravir), ZIAGEN (abacavir), 3TC (lamivudine) and KIVEXA (abacavir and lamivudine) contain additional information. Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Abacavir sulfate is a white to off-white crystalline powder with a solubility of approximately 77 mg/mL in water at 25°C. Lamivudine is a white to off-white crystalline solid which is highly soluble in water. TRIUMEQ tablets also contain mannitol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Purple, film-coated, oval, biconvex tablets, debossed with ‘572 Trı’ on one side. Each film- coated tablet contains 50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir (as abacavir sulphate) and 300 mg of lamivudine. 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, abaca Přečtěte si celý dokument