ALKERAN melphalan hydrochloride

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

MELPHALAN HYDROCHLORIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9510P)

Dostupno od:

Glaxo Operations UK Ltd

INN (International ime):

MELPHALAN HYDROCHLORIDE

Sastav:

MELPHALAN 50 mg in 10 mL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Svojstava lijeka

ALKERAN- MELPHALAN HYDROCHLORIDE
GLAXO OPERATIONS UK LTD
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ALKERAN
(MELPHALAN HYDROCHLORIDE)
FOR INJECTION
PRINCIPAL DISPLAY PANEL
NDC 52609-3001-0
ALKERAN
(MELPHALAN HYDROCHLORIDE)
FOR INJECTION
SINGLE-USE
R ONLY
One vial of Alkeran for injection containing sterile, nonpyrogenic,
freeze-dried melphalan
hydrochloride equivalent to 50 mg melphalan and 20 mg povidone.
One vial of sterile, nonpyrogenic diluent containing 0.2 g sodium
citrate, 6.0 mL propylene glycol, 0.52
mL ethanol (96%), and Water for Injection to a total of 10 mL.
FOR INTRAVENOUS INFUSION.
Reconstitute with enclosed diluent. See enclosed package insert for
additional reconstitution and
administration instructions.
See prescribing information for Dosage and Administration.
Store at controlled room temperature, 15 to 30 C (59 to 86 F) and
protect from light.
ADD DILUENT RAPIDLY.
IMMEDIATELY SHAKE VIAL VIGOROUSLY.
ALKERAN and Diluent
Manufactured by: GlaxoSmithKline
Research Triangle Park, NC 27709
Distributed by: ApoPharma USA Inc
Rockville, MD 20850
10000000101311 Rev. 11/11
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ALKERAN
melphalan hydrochloride kit
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 3379 -0 18
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 3379 -0 18 -0 0
1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct
0 1/0 1/20 11
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 VIAL, SINGLE-DOSE
10 mL
PA RT 2
1 VIAL, SINGLE-USE
10 mL
PART 1 OF 2
ALKERAN
melphalan hydrochloride injection, powder, for solution
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:6 3379 -0 19
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MELPHALAN HYDRO CHLO RIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9
510 P)
MELPHALAN
50 mg in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE