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

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Influenza virus split virion

Διαθέσιμο από:

split virion, inactivated

Φαρμακολογική κατηγορία (ATC):

J07BB01

INN (Διεθνής Όνομα):

Influenza virus split virion

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: 5015973611011 5015973671107

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, SUSPENSION FOR
INJECTION IN
PREFILLED SYRINGE.
Influenza vaccine (split virion, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
THIS VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you or your child get any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is and what it is
used
for
2.
What you need to know before you or your child use INACTIVATED
INFLUENZA
VACCINE (SPLIT VIRION) BP
3.
How to use INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP
4.
Possible side effects
5.
How to store INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP
6.
Contents of the pack and other information
1.
WHAT INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP IS AND WHAT IT IS
USED FOR
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is a vaccine.
This vaccine helps to protect you or your child against influenza
(flu). The use of INACTIVATED
INFLUENZA VACCINE (SPLIT VIRION) BP should be based on official
recommendations.
When a person is given the vaccine INACTIVATED INFLUENZA VACCINE
(SPLIT VIRION) BP,
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 sensibl

Αρχείο Π.Χ.Π.

OBJECT 1
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP
Summary of Product Characteristics Updated 20-Apr-2018 | Sanofi
Pasteur
1. Name of the medicinal product
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for
injection in prefilled
syringe.
Influenza vaccine (split virion, inactivated).
2. Qualitative and quantitative composition
Influenza virus (inactivated, split) of the following strains*:
• A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015,
NYMC X-275)
............................................................................................................................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 WHO recommendations (Northern
Hemisphere) and EU decision for the
2017/2018 season.
For the full list of excipients, see Section 6.1.
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP may contain traces of
eggs, such as
ovalbumin, and of neomycin, formaldehyde and octoxinol- 9, which are
used during the manufacturing
process (see Section 4.3).
3. Pharmaceutical form
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and
opalescent liquid.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of influenza.
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP is indicated in adults
and children from
6 months of age.
The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be
based on official
recommendations.
4.2 Posology and method of administration
Posology
Adults: