Influvac Sub-unit vaccine suspension for injection 0.5ml pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Influenza virus surface antigens

Available from:

Viatris UK Healthcare Ltd

ATC code:

J07BB02

INN (International Name):

Influenza virus surface antigens

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 14040000; GTIN: 8002660011374 5012781040255

Summary of Product characteristics

OBJECT 1
INFLUVAC SUB-UNIT
Summary of Product Characteristics Updated 28-Jul-2017 | Mylan
Products Limited
1. Name of the medicinal product
Influvac sub-unit, suspension for injection (influenza vaccine,
surface antigen, inactivated).
2. Qualitative and quantitative composition
Influenza virus surface antigens (haemagglutinin and neuraminidase) of
the following strains*:
- A/Michigan/45/2015 (H1N1)pdm09-like strain
(A/Singapore/GP1908/2015, IVR-180)
15 micrograms HA **
- A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014,
NYMC X-263B)
15 micrograms HA **
- B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, 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 2017/2018 season.
For a full list of excipients see section 6.1.
Influvac 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 prefilled syringes; a colourless clear
liquid, filled in single-dose syringes
(glass, type I).
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac is indicated in adults and children from 6 months of age.
The use of Influvac should be based on official recommendations.
4.2 Posology and method of administration
Posology
Adults: 0.5 ml.
_Paediatric population_
Children from 36 months onwards: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited.
Dosages of 0.25 ml or 0.5 ml may be
given, for detailed instructions on administering a 0.25ml or 0.5ml
dose, see section 6.6. The dose given
should be in accordance with existing national recommendations.
For children who have not previously been