VAKSIN BCG KERING

Land: Indonesia

Språk: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Last ned Preparatomtale (SPC)
23-07-2023

Aktiv ingrediens:

BCG VACCINE

Tilgjengelig fra:

BIO FARMA - Indonesia

INN (International Name):

BCG VACCINE

Dosering :

0,375 MG/ML

Legemiddelform:

SERBUK INJEKSI

Enheter i pakken:

DUS, 10 AMPUL @ 20 DOSIS + DUS, 10 AMPUL PELARUT @ 4 ML

Produsert av:

BIO FARMA - Indonesia

Autorisasjon dato:

2018-10-23

Preparatomtale

                                100 %
200 %
Manufactured
Address
Jl. Pasteur No 28 Bandung 40161
PT Bio Farma (Persero)
Product
BCG Vaccine Label
Material
LW 60 FSC/S2090
Dimension
48 x 18 mm, ± 1 mm
Scale
100 %
Edition
020723-BCGV
Note
Area Printing Dimension
27,00 x 10,00
Color : Black Doff
Direction on roll
Color
6 Color
:
:
:
:
:
:
:
:
:
:
1 2
3
4
_Ornamen_
PMS 287 C
PMS 301 C
PMS 2995 C
PMS 2905 C
PMS RED
032 C
PMS BLACK C
1
2
3
4
LATAR BELAKANG
LOGO OBAT KERAS
TEKS UMUM
HARUS DENGAN RESEP DOKTER
COMPOSITION:
Each dose (0.05 mL) contains:
Live, attenuated BCG Vaccine
(Bacillus Calmette Guerin strain)
1-4 x 10⁵ C.F.U
Reconstitute with 1.1 mL of
diluent solution BCG Vaccine
O
O
Store at between +2 C and 8 C.
DO NOT EXPOSE TO SUNLIGHT
POWDER FOR INJECTION
VAKSIN BCG
KERING
FREEZE DRIED
BCG VACCINE
Use immediately after reconstitution.
Read the package leaflet before use.
GTIN:
08994957000508
Reg. No.:
Manufactured by:
PT Bio Farma (Persero)
Jl. Pasteur No. 28,
Bandung - INDONESIA
Edition: 020723-BCGV
Batch No.:
Exp. Date:
DISETUJUI OLEH BPOM TANGGAL 3 AGUSTUS 2023
ID REG EREG100409VR12300130
Manufactured
Address
Jl. Pasteur No 28 Bandung 40161
PT Bio Farma (Persero)
Product
Box BCG vial (2D Barcode)
(1 box isi 10 vial @ 2 mL)
Material
Ivory
310 gsm
Dimension
86 x 39,5 x 44,5 mm, ± 2 mmv
Scale
100 %
Edition
020723
Note
Area printing dimension
20 x 50 mm (yupo)
Pattern
Color
Lock bottom carton
-
6 Colors
1 2
3
4
_Ornamen_
PMS 287 C
PMS 301 C
PMS 2995 C
PMS 2905 C
PMS RED
032 C
PMS BLACK C
1
2
3
4
LATAR BELAKANG
LOGO OBAT KERAS
TEKS UMUM
020723
FREEZE DRIED
BCG VACCINE
Powder for injection
FOR BABIES
Manufactured by/Diproduksi oleh:
PT Bio Farma (Persero)
Jl Pasteur No 28, Bandung-INDONESIA
Reg. No.: GKL8502900444A1
HET
VAKSIN BCG KERING
UNTUK BAYI
10 VIAL VAKSIN BCG
Untuk injeksi intradermal
Rekonstitusi dengan 1,1 mL
Pelarut Vaksin BCG
Gunakanlah segera setelah
rekonstitusi.
Baca leaflet sebelum digunakan
SERBUK INJEKSI
KOMPOSISI:
Tiap dosis (0,05 mL) mengandung:
BCG hidup 1-4 x 10⁵ C.F.U
Rekonstitusi dengan 1,1 mL
pelarut vaksin BCG
CO
                                
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