INFLUVAC TETRA NH

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR 180), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/PHUKET/3073/2013-LIKE STRAI

Tersedia dari:

ABBOTT INDONESIA - Indonesia

INN (Nama Internasional):

A/HONG KONG/4801/2014 (H3N2)-LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/SINGAPORE/GP1908/2015, IVR 180), B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), B/PHUKET/3073/2013-LIKE STRAI

Dosis:

15 MCG /15 MCG /15 MCG /15 MCG

Bentuk farmasi:

SUSPENSI INJEKSI

Unit dalam paket:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML (1 DOSIS)

Diproduksi oleh:

ABBOTT BIOLOGICALS B.V. - Netherlands

Tanggal Otorisasi:

2019-08-29

Karakteristik produk

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INFLUVAC
®
TETRA
NH 2020/2021
1.
NAME OF THE MEDICINAL PRODUCT
Influvac
®
Tetra, suspension for injection in pre-filled syringe 0.5 ml (single
dose)
(influenza vaccine, surface antigen, inactivated).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following strains*:
- A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
15 micrograms HA **
- A/Hong Kong/2671/2019 (H3N2)-like virus
(A/Hong Kong/2671/2019, IVR-208)
15 micrograms HA **
- B/Washington/02/2019-like virus
(B/Washington/02/2019, wild type)
15 micrograms HA **
-
B/Phuket/3073/2013-like virus
(B/Phuket/3073/2013, wild type)
15 micrograms HA **
per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
haemagglutinin.
_ _
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern hemisphere)
and EU recommendation for the 2020/2021 season.
For a full list of excipients see section 6.1.
Influvac
®
Tetra
may
contain
traces
of
eggs
(such
as
ovalbumin,
chicken
proteins),
formaldehyde,
cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which
are used during the manufacturing
process (see section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe;
A colourless clear liquid, filled in single-dose syringes. _ _
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac
®
Tetra is indicated in adults and children from 3 years of age.
The use of Influvac
®
Tetra should be based on official recommendations.
Vaccination is particularly recommended for the following categories
of patients:
-
Persons aged ≥ 65 years, regardless their health condition.
-
Adults and children from 3 years of age with chronic disorders of the
pulmonary or
cardiovascular systems, including asthma.
-
Adults and children from 3 years of age with chronic