TECHNETIUM TC 99M SESTAMIBI injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

TECHNETIUM TC-99M SESTAMIBI (UNII: 971Z4W1S09) (TECHNETIUM TC-99M SESTAMIBI - UNII:971Z4W1S09)

Dostupné z:

Jubilant HollisterStier General Partnership

INN (Medzinárodný Name):

TECHNETIUM TC-99M SESTAMIBI

Zloženie:

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg in 10 mL

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Súhrn charakteristických

TECHNETIUM TC 99M SESTAMIBI- TECHNETIUM TC 99M SESTAMIBI INJECTION
JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP
----------
SES TAMIBI
PRINCIPAL DISPLAY PANEL
SESTAMIBI 10 COUNT
TECHNETIUM TC 99M SESTAMIBI
technetium tc 99m sestamibi injection
PRODUCT INFORMATION
Jubilant HollisterStier General Partnership
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:76 112-141
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TECHNETIUM TC-9 9 M SESTAMIBI (UNII: 9 71Z4W1S0 9 )
(TECHNETIUM TC-9 9 M SESTAMIBI - UNII:9 71Z4W1S0 9 )
TETRAKIS(2-
METHOXYISOBUTYLISOCYANIDE)COPPER(I)
TETRAFLUOROBORATE
1 mg
in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)
2.6 mg in 10 mL
CYSTEINE HYDRO CHLO RIDE (UNII: ZT9 34N0 X4W)
1 mg in 10 mL
MANNITO L (UNII: 3OWL53L36 A)
20 mg in 10 mL
STANNO US CHLO RIDE (UNII: 1BQV3749 L5)
0 .0 75 mg in 10 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 112-141-10
10 in 1 KIT
0 7/0 1/20 0 9
1
10 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR
MONOGRAPH CITATION
MARKE TING START
DATE
MARKE TING END
DATE
APPROVED DRUG PRODUCT MANUFACTURED
UNDER CONTRACT
ANDA0 78 8 0 6
0 7/0 1/20 0 9
LABELER -
Jubilant HollisterStier General Partnership (246762764)
Revised: 11/2017