ASTRAZENECA COVID-19 VACCINE- azd1222 injection, suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

şimdi satın al

Ürün özellikleri Ürün özellikleri (SPC)
22-12-2020

Aktif bileşen:

AZD-1222 (UNII: B5S3K2V0G8) (AZD-1222 - UNII:B5S3K2V0G8)

Mevcut itibaren:

AstraZeneca Pharmaceuticals LP

Uygulama yolu:

INTRAMUSCULAR

Yetkilendirme durumu:

unapproved drug other

Ürün özellikleri

                                ASTRAZENECA COVID-19 VACCINE- AZD1222 INJECTION, SUSPENSION
ASTRAZENECA PHARMACEUTICALS LP
----------
ASTRAZENECA COVID-19 VACCINE
PACKAGE/LABEL DISPLAY PANEL – VIAL LABEL
AstraZeneca COVID-19 Vaccine NDC 0310-1222-10
FOR USE UNDER EMERGENCY USE AUTHORIZATION
Suspension for Intramuscular Injection
After first use, discard after:
6 hours at 20°-25°C (68°-77°F), or
48 hours at 2°-8°C (36°-46°F)
For Exp Date: see
www.azcovid-19.com
Multi-dose vial (10 doses of 0.5 mL)
PACKAGE/LABEL DISPLAY PANEL – VIAL CARTON
NDC 0310-1222-15
ASTRAZENECA COVID-19 VACCINE
FOR USE UNDER EMERGENCY USE AUTHORIZATION
Suspension for Intramuscular Injection
STORE AT 2°-8°C (36°-46°F) IN ORIGINAL CARTON TO PROTECT FROM
LIGHT.
Do not freeze or shake. NO PRESERVATIVE.
DISCARD 6 HOURS AFTER FIRST USE WHEN HELD AT 20°-25°C (68°-77°F).
DISCARD 48 HOURS AFTER FIRST USE WHEN HELD AT 2°-8°C (36°-46°F).
10 Multi-dose vials
(each vial contains 10 doses of 0.5 mL)
AstraZeneca
AstraZeneca
ASTRAZENECA COVID-19 VACCINE
azd1222 injection, suspension
PRODUCT INFORMATION
PRODUCT T YPE
VACCINE
ITE M CODE (SOURCE )
NDC:0 310 -1222
ROUTE OF ADMINISTRATION
INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
AZD-12 2 2 (UNII: B5S3K2V0 G8 ) (AZD-1222 - UNII:B5S3K2V0 G8 )
AZD-1222
50 0 0 0 0 0 0 0 0 0 {VP} in 0 .5 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
HISTIDINE (UNII: 4QD39 79 8 7E)
HISTIDINE MO NO HYDRO CHLO RIDE (UNII: 1D5Q9 32XM6 )
AstraZeneca Pharmaceuticals LP
MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O)
PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)
ALCO HO L (UNII: 3K9 9 58 V9 0 M)
SUCRO SE (UNII: C151H8 M554)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0 310 -1222-
15
10 in 1 CARTON
1
NDC:0 310 -1222-
10
5 mL in 1 VIAL, MULTI-DOSE; Type 0 : No t a Co mbinatio n
Pro duc t
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRA
                                
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