TRIUMEQ dolutegravir sodium abacavir sulfate lamivudine tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1)

Commercializzato da:

Glaxo Operations UK Ltd

INN (Nome Internazionale):

DOLUTEGRAVIR SODIUM

Composizione:

DOLUTEGRAVIR 50 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Scheda tecnica

TRIUMEQ- DOLUTEGRAVIR SODIUM, ABACAVIR SULFATE, LAMIVUDINE TABLET,
FILM COATED
GLAXO OPERATIONS UK LTD
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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