Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml pre-filled syringes

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Influenza virus split virion

Beschikbaar vanaf:

split virion, inactivated

ATC-code:

J07BB01

INN (Algemene Internationale Benaming):

Influenza virus split virion

farmaceutische vorm:

Suspension for injection

Toedieningsweg:

Intramuscular; Subcutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Never Valid To Prescribe As A VMP

Product samenvatting:

BNF: 14040000; GTIN: 9317109034548 9317109034531

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Suspension for injection, pre-filled syringe
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This vaccine has been prescribed for you or your child only. Do not
pass it on to others.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Influenza Vaccine is and what it is used for
2.
What you need to know before you or your child use Influenza Vaccine
3.
How to use Influenza Vaccine
4.
Possible side effects
5.
How to store Influenza Vaccine
6.
Contents of the pack and other information
1.
WHAT INFLUENZA VACCINE IS AND WHAT IT IS USED FOR
Influenza Vaccine is a vaccine. This vaccine helps to protect you or
your child against influenza (flu),
particularly in people who run a high risk of associated
complications.
Influenza Vaccine is indicated in adults and children from 5 years of
age.
The use of Influenza Vaccine should be based on official
recommendations.
When a person is given the vaccine Influenza Vaccine, the immune
system (the body’s natural defence
system) will produce its own protection (antibodies) against the
disease. None of the ingredients in the
vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different
types of strains that can change every
year. Therefore, this is why you or your child might need to be
vaccinated every year. The greatest risk
of catching flu is during the cold months between October and March.
If you or your child were not
vaccinated in the autumn, it is still sensible to be vaccinated up
until the spring since you or your child
run the risk of catching flu until then. Your doctor will be able to
recommend

Productkenmerken

OBJECT 1
INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 13-Jul-2017 | Pfizer
Limited
1. Name of the medicinal product
Influenza Vaccine (split virion, inactivated)
Suspension for injection, pre-filled syringe
2. Qualitative and quantitative composition
Influenza virus* (inactivated with β-Propiolactone, split) of the
following strains:
A/Michigan/45/2015 (H1N1) pdm09 - like strain
(A/Singapore/GP1908/2015, IVR-180A)
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/46/2015, 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 WHO recommendation (Northern
Hemisphere) and EU decision for the
2017/2018 season.
For the full list of excipients, see section 6.1.
Influenza Vaccine (split virion, inactivated) may contain traces of
eggs such as ovalbumin and residues of
neomycin and polymyxin, which are used during the manufacturing
process (see section 4.3).
3. Pharmaceutical form
Suspension for injection in a pre-filled syringe.
Clear to slightly opaque liquid with some sediment that resuspends
upon shaking.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of influenza, especially in those who run an increased
risk of associated complications.
Influenza Vaccine (split virion, inactivated) is indicated in adults
and children from 5 years of age.
The use of Influenza Vaccine (split virion, inactivated) should be
based on official recommendations.
4.2 Posology and method of administration
_Posology_
Adults:
0.5 ml
Paediatric population
Children from 5 years onwards:
0.5 ml
For children aged less than 9 years, who have not previously been
vaccinated, a second dose should be
given after an interval of at least 4 weeks.
_Method of administration_
Immunisation should be carried out by intramuscular or deep
subcutaneous injection.