Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)
Glaxo Operations UK Ltd
DOLUTEGRAVIR SODIUM
DOLUTEGRAVIR 50 mg
PRESCRIPTION DRUG
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
TRIUMEQ- DOLUTEGRAVIR SODIUM, ABACAVIR SULFATE, LAMIVUDINE TABLET, FILM COATED GLAXO OPERATIONS UK LTD ---------- PRINICPAL DISPLAY PANEL NDC 49702-231-13 TRIUMEQ (abacavir, dolutegravir, and lamivudine) 600 MG/50 MG/300 MG TABLETS Each film-coated tablet contains abacavir sulfate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg of dolutegravir, and 300 mg of lamivudine. Store in original package at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP). Keep bottle tightly closed; protect from moisture. Do not remove desiccant. DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. See prescribing information for dosage information. NOTICE TO AUTHORIZED DISPENSER: Each time TRIUMEQ is dispensed, give the patient a Medication Guide and Warning Card from the carton. RX ONLY 30 Tablets 10000000147131 Rev. 8/17 TRIUMEQ dolutegravir sodium, abacavir sulfate, lamivudine tablet, film coated PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:6 3379 -0 53 ROUTE OF ADMINISTRATION ORAL Glaxo Operations UK Ltd ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DO LUTEGRAVIR SO DIUM (UNII: 1Q1V9 V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9 H7M1) DOLUTEGRAVIR 50 mg ABACAVIR SULFATE (UNII: J220 T4J9 Q2) (ABACAVIR - UNII:WR2TIP26 VS) ABACAVIR 6 0 0 mg LAMIVUDINE (UNII: 2T8 Q726 O9 5) (LAMIVUDINE - UNII:2T8 Q726 O9 5) LAMIVUDINE 30 0 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MANNITO L (UNII: 3OWL53L36 A) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U) PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E) SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B) FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357) FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75) PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A) PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) PRODUCT CHARACTERISTICS COLOR Perskaitykite visą dokumentą