Enzira vaccine suspension for injection 0.5ml pre-filled syringes

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Influenza virus split virion

Dostupné z:

Pfizer Ltd

ATC kód:

J07BB02

INN (Medzinárodný Name):

Influenza virus split virion

Forma lieku:

Suspension for injection

Spôsob podávania:

Intramuscular; Subcutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Never Valid To Prescribe As A VMP

Prehľad produktov:

BNF: 14040000; GTIN: 5060025630663 5060025630670

Príbalový leták

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENZIRA

Suspension for injection, pre-filled syringe
Influenza vaccine (split virion, inactivated)
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 ENZIRA is and what it is used for
2.
What you need to know before you or your child use ENZIRA
3.
How to use ENZIRA
4.
Possible side effects
5.
How to store ENZIRA
6.
Contents of the pack and other information
1.
WHAT ENZIRA IS AND WHAT IT IS USED FOR
ENZIRA 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.
ENZIRA is indicated in adults and children from 5 years of age.
The use of ENZIRA should be based on official recommendations.
When a person is given the vaccine ENZIRA, 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 the best time to be
vaccinated.
ENZIRA will help protect you or your child against the t

Súhrn charakteristických

OBJECT 1
ENZIRA SUSPENSION FOR INJECTION, PRE-FILLED
SYRINGE/INFLUENZA VACCINE (SPLIT VIRION,
INACTIVATED) PH. EUR.
Summary of Product Characteristics Updated 13-Jul-2017 | Pfizer
Limited
1. Name of the medicinal product
ENZIRA
®
Suspension for injection, pre-filled syringe
Influenza vaccine (split virion, inactivated)
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.
ENZIRA 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.
ENZIRA is indicated in adults and children from 5 years of age.
The use of ENZIRA 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.
For instructions for preparation of the medicinal product before
a