Imuvac vaccine suspension for injection 0.5ml pre-filled syringes

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Influenza virus surface antigens

Διαθέσιμο από:

Viatris UK Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

J07BB02

INN (Διεθνής Όνομα):

Influenza virus surface antigens

Φαρμακοτεχνική μορφή:

Suspension for injection

Οδός χορήγησης:

Subcutaneous; Intramuscular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Never Valid To Prescribe As A VMP

Περίληψη προϊόντος:

BNF: 14040000; GTIN: 5012871243337 5012781245551

Αρχείο Π.Χ.Π.

OBJECT 1
IMUVAC
Summary of Product Characteristics Updated 28-Jul-2017 | Mylan
Products Limited
1. Name of the medicinal product
Imuvac, 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.
Imuvac 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.
Imuvac is indicated in adults and children from 6 months of age.
The use of Imuvac 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 0.25 ml or 0.5 ml
dose, see section 6.6. The dose given
should be in accordance with existing national recommendations.
For children who have not previously been vaccinated, a second dose