FLUBIO

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Karakteristik produk Karakteristik produk (SPC)
01-01-2021

Bahan aktif:

A/SINGAPORE/GP1908/2015(IVR-180)(H1N1)PDM09 VIRUS, A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE VIRUS (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/MARYLAND/15/2016(NYMC BX-69A) VIRUS

Tersedia dari:

BIO FARMA - Indonesia

INN (Nama Internasional):

A/SINGAPORE/GP1908/2015(IVR-180)(H1N1)PDM09 VIRUS, A/SINGAPORE/INFIMH-16-0019/2016 (H3N2)-LIKE VIRUS (A/SINGAPORE/INFIMH-16-0019/2016, IVR-186), B/MARYLAND/15/2016(NYMC BX-69A) VIRUS

Dosis:

15 MCG /15 MCG /15 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 2 VIAL @ 2,5 ML (5 DOSIS)

Diproduksi oleh:

BIO FARMA - Indonesia

Tanggal Otorisasi:

2019-07-29

Karakteristik produk

                                100 %
200 %
Label Vaksin Flubio 1 ds (0.5 mL)
01082021 (strain 2021/2022)
48 x 18 mm ± 1 mm, roll label : 60 gsm
PMS 299 C
PMS Red 032 C
PMS Black C
NAME
EDITION
DIMENSION
COLOR
On medical prescription only
Store between +2 ºC and +8 ºC
DO NOT FREEZE
Avoid direct sunlight
* For further information see leaflet
Batch No.:
Exp. Date:
FOR ADULT AND PEDIATRIC*
SUSPENSION FOR INJECTION
INTRAMUSCULAR
0.5 ML
Reg. No.: DKL0902906343A1
Manufactured by: PT Bio Farma (Persero)
This vaccine complies with the WHO recommendations
(Northern hemisphere) for the 2021/2022 season.
Each 0.5 mL contains:
01082021
A/VICTORIA/1/2020(IVR-217) (H1N1)PDM09
A/TASMANIA/503/2020(IVR-221) (H3N2)
B/VICTORIA/705/2018(BVR-11) (B/VICTORIA LINEAGE)
THIMEROSAL
15µg HA
15µg HA
15µg HA
4 µg
On medical prescription only
Store between +2 ºC and +8 ºC
DO NOT FREEZE
Avoid direct sunlight
* For further information see leaflet
Batch No.:
Exp. Date:
FOR ADULT AND PEDIATRIC*
SUSPENSION FOR INJECTION
INTRAMUSCULAR
0.5 ML
Reg. No.: DKL0902906343A1
Manufactured by: PT Bio Farma (Persero)
This vaccine complies with the WHO recommendations
(Northern hemisphere) for the 2021/2022 season.
Each 0.5 mL contains:
01082021
A/VICTORIA/1/2020(IVR-217) (H1N1)PDM09
A/TASMANIA/503/2020(IVR-221) (H3N2)
B/VICTORIA/705/2018(BVR-11) (B/VICTORIA LINEAGE)
THIMEROSAL
15µg HA
15µg HA
15µg HA
4 µg
DISETUJUI OLEH BPOM : 20/09/21
ID EREG100409VR12100180
Box Vaksin Flubio 1 ds (0.5 mL)
01082021 (strain 2021/2022)
35 x 24 x 45 mm ± 2 mm, Ivory : 300-310 gsm
NAME
EDITION
DIMENSION
COLOR
PMS 299 C
PMS Red 032 C
PMS Black C
PMS 291 C
01082021
Batch No.:
Mfg. Date:
Exp. Date:
This vaccine complies with the WHO
recommendations (Northern hemisphere)
for the 2021/2022 season.
Vaksin ini sesuai dengan rekomendasi WHO
(Northern hemisphere)
tahun 2021/2022.
JANGAN DIBEKUKAN
HET.:
Komposisi: Tiap 0,5 mL mengandung:
Composition: each 0.5 mL contains:
•
A/VICTORIA/1/2020(IVR-217)
(H1N1)PDM09
•
A/TASMANIA/503/2020(IVR-221)
(H3N2)
•
B/VICTORIA/705/2018(BVR-11)
(B/VICTORIA LINEAGE)

                                
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