Optaflu vaccine suspension for injection 0.5ml pre-filled syringes

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Influenza virus surface antigens

Dostępny od:

Seqirus Vaccines Ltd

Kod ATC:

J07BB02

INN (International Nazwa):

Influenza virus surface antigens

Forma farmaceutyczna:

Suspension for injection

Droga podania:

Intramuscular

Klasa:

No Controlled Drug Status

Typ recepty:

Never Valid To Prescribe As A VMP

Podsumowanie produktu:

BNF: 14040000; GTIN: 5060025631233 5060025631288

Ulotka dla pacjenta

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTAFLU SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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, pharmacist or
nurse.
-
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 Optaflu is and what it is used for
2.
What you need to know before you receive Optaflu
3.
How Optaflu is given
4.
Possible side effects
5.
How to store Optaflu
6.
Contents of the pack and other information
1.
WHAT OPTAFLU IS AND WHAT IT IS USED FOR
Optaflu is a vaccine against flu (influenza). Due to the kind of
manufacturing Optaflu is free of
chicken/egg protein.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection against the influenza virus. None of the
ingredients in the vaccine can
cause the flu.
Optaflu is used to prevent flu in adults, especially in those who run
an increased risk of experiencing
associated complications in case they fall ill with flu.
The vaccine targets three strains of influenza virus following the
recommendations by the World
Health Organisation for the 2015/2016 season.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE OPTAFLU
YOU SHOULD NOT RECEIVE OPTAFLU

if you are allergic to influenza vaccine or any of the other
ingredients of this vaccine (listed in
section 6)

if you have an acute infection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving Optaflu.
BEFORE receiving the vaccine

YOU should tell your doctor if your immune system is impaired, or if
you are undergoing
treatment which affects the immune system, e.g. with medicine against
cancer (chemothera

Charakterystyka produktu

OBJECT 1
OPTAFLU SUSPENSION FOR INJECTION IN A PRE-FILLED
SYRINGE
Summary of Product Characteristics Updated 25-Sep-2015 | Seqirus
Vaccines Limited
1. Name of the medicinal product
OPTAFLU suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
(2015/2016 season)
2. Qualitative and quantitative composition
Influenza virus surface antigens (haemagglutinin and neuraminidase)*,
inactivated, of the following
strains:
A/California/7/2009 (H1N1)pdm09 - like strain
(A/Brisbane/10/2010, wild type)
15 micrograms HA**
A/Switzerland/9715293/2013 (H3N2) - like strain
(A/South Australia/55/2014, wild type)
15 micrograms HA**
B/Phuket/3073/2013 – like strain
(B/Utah/9/2014, wild type)
15 micrograms HA**
per 0.5 ml dose
–––––––––––––––.
* propagated in Madin Darby Canine Kidney (MDCK) cells
** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere)
and EU decision for the
2015/2016 season.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection in pre-filled syringe.
Clear to slightly opalescent.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of influenza for adults, especially in those who run an
increased risk of associated
complications.
Optaflu should be used in accordance to Official guidance.
4.2 Posology and method of administration
Posology
Adults from the age of 18 years:
One dose of 0.5 ml
_Paediatric population_
The safety and efficacy of Optaflu in children and adolescents less
than 18 years of age have not yet been
established. No data are available. Therefore, Optaflu is not
recommended for use in children and
adolescents less than 18 years of age (see section 5.1).
Method of administration
Immunisation should be carried out by intramuscular injection into the
deltoid muscle.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Immunisation shall be postponed in patients with febrile