Agrippal Suspension for injection in pre-filled syringe, Influenza Vaccine Surface Antigen, Inactivated(2017/2018 season)

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

A/Guangdong-Maonan/SWL 1536/2019 (H1N1)pdm09-like strain (A/Guangdong-Maonan/SWL 1536/2019, CNIC-1909); A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019, IVR-208); B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Disponible depuis:

Seqirus S.r.l.

Code ATC:

J07BB; J07BB02

DCI (Dénomination commune internationale):

A/Guangdong-Maonan/SWL 1536/2019 (H1N1)pdm09-like strain (A/Guangdong-Maonan/SWL 1536/2019, CNIC-1909); A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019, IVR-208); B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Dosage:

.

forme pharmaceutique:

Suspension for injection in pre-filled syringe

Mode d'administration:

Intramuscular or deep subcutaneous injection

Unités en paquet:

0.5 ml of suspension in pre-filled syringe, with or without needle

Type d'ordonnance:

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

Fabriqué par:

Novartis Vaccines and Diagnostics Limited

Groupe thérapeutique:

Influenza vaccine

Domaine thérapeutique:

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

indications thérapeutiques:

Prophylaxis of influenza, especially in those who run an increased risk of associated complications

Statut de autorisation:

Not marketed

Date de l'autorisation:

1999-02-19

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
AGRIPPAL 2020/2021, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Influenza vaccine, Surface Antigen, Inactivated
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD
RECEIVES THIS VACCINE 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 or pharmacist.
-
This vaccine has been prescribed for you or your child. Do not pass it
on to others. It may harm
them, even if their symptoms are the same as yours.
-
If you 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 Agrippal is and what it is used for
2.
What you need to know before you or your child use Agrippal
3.
How to use Agrippal
4.
Possible side effects
5.
How to store Agrippal
6.
Contents of the pack and other information
1.
WHAT AGRIPPAL IS AND WHAT IT IS USED FOR
Agrippal is a vaccine. This vaccine helps to protect you or your child
against influenza (flu),
particularly in subjects who run a high risk of associated
complications. The use of Agrippal should be
based on official recommendations.
When a person is given the vaccine Agrippal, 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 was not
vaccinated in the autumn, it is still sensible to be vaccinated up
until the spring since you or your child
runs the risk of catching flu until then. Your doctor will be able to
recommend the best time to be
vaccinated.
Agrippal will protect you or your child against the thre

Résumé des caractéristiques du produit

Health Products Regulatory Authority
21 August 2020
CRN009T5X
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agrippal Suspension for injection in pre-filled syringe, Influenza
Vaccine Surface Antigen, Inactivated (2020/2021 SEASON)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase),
of strains*:
A/Guandong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain
(A/Victoria/2454/2019 IVR-207)
15 micrograms HA**
A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019
IVR-208)
15 micrograms HA**
B/Washington/02/2019-like strain (B/Victoria/705/2018 BVR-11)
15 micrograms HA**
*propagated in fertilized hens' eggs from healthy chicken flocks
**haemagglutinin
For one dose of 0.5 ml
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern hemisphere) and EU
recommendation for the 2020/2021 season.
Agrippal may contain traces of eggs such as ovalbumin or chicken
proteins, kanamycin and neomycin sulphate, formaldehyde,
cetyltrimethylammonium bromide (CTAB), polysorbate 80 and
hydrocortisone, which are used during the manufacturing
process (see section 4.3).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine appears as a clear liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased
risk of associated complications.
Agrippal is indicated in adults and children from 6 months of age.
The use of Agrippal 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. The dose given
should be in accordance with the existing national recommendation. For
children who have not previously been vaccinated, a
Health Products Regulatory Authority
21 August