INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for injection in prefilled syringe.Influenza vaccine (split virion,

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275); A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b); B/brisbane/60/2008 - like strain (b/brisbane/60/2008)

Pieejams no:

Sanofi Pasteur

ATĶ kods:

J07BB; J07BB02

SNN (starptautisko nepatentēto nosaukumu):

A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275); A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b); B/brisbane/60/2008 - like strain (b/brisbane/60/2008)

Deva:

15/15/15mc percent volume/volume

Zāļu forma:

Suspension for injection

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Influenza vaccines; influenza, inactivated, split virus or surface antigen

Autorizācija statuss:

Marketed

Autorizācija datums:

1998-05-01

Lietošanas instrukcija

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 administered to you or your child from 6 months of age
helps to protect you or your
child against influenza (flu).
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.
When given during pregnancy the vaccine helps to protect the pregnant
women but also helps to
protect her baby from birth to less than 6 months of age through the
transmission of protection from
mother to baby during pregnancy (see also Sections 2 and 3).
None of the ingredients in the vaccine can cause flu.
The use of INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP should be
based on
official recommendations.
Flu is a disease that can spread rapidly and

Produkta apraksts

Health Products Regulatory Authority
24 May 2019
CRN008JTP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
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/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain
(A/Singapore/INFIMH-16-0019/2016, IVR-186)
.........................................................................................................
15 micrograms HA**
B/Colorado/06/2017 - like strain (B/Maryland/15/2016, NYMC BX-69A)
.........................................................................................................
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 2018/2019 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 for the
prevention of