Intanza 15microgram strain vaccine suspension for injection 0.1ml pre-filled syringes

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Influenza virus split virion

Mevcut itibaren:

sanofi pasteur MSD Ltd

ATC kodu:

J07BB01

INN (International Adı):

Influenza virus split virion

Farmasötik formu:

Suspension for injection

Uygulama yolu:

Intradermal

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 14040000; GTIN: 5015973861010 5015973991106

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
INTANZA 15 MICROGRAM/STRAIN SUSPENSION FOR INJECTION
Influenza vaccine (split virion, inactivated)
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.
-
This vaccine has been prescribed for you 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 INTANZA is and what it is used for
2.
What you need to know before you use INTANZA
3.
How to use INTANZA
4.
Possible side effects
5.
How to store INTANZA
6.
Contents of the pack and other information
1.
WHAT INTANZA IS AND WHAT IT IS USED FOR
INTANZA is a vaccine. This vaccine is recommended to help to protect
you against flu.
The vaccine may be administered to individuals of 60 years of age and
over, especially in those who
run an increased risk of associated complications.
When an injection of INTANZA is given, the immune system (body's
natural defences) will develop
protection against flu infection.
INTANZA will help to protect you against the three strains of virus
contained in the vaccine, or other
strains closely related to them. Full effect of the vaccine is
generally achieved 2-3 weeks after the
vaccination.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INTANZA
DO NOT USE INTANZA:
-
If you are allergic to:

The active substances,

Any of the other ingredients of this vaccine (listed in section 6),

Any component that may be present in very small amounts such as eggs
(ovalbumin,
chicken proteins), neomycin, formaldehyde and octoxinol 9.
-
If you have an illness with fever or acute infection, the vaccination
shall be postponed until
after you have recovered.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using INTANZA.
-
You should tell

Ürün özellikleri

OBJECT 1
INTANZA 15 MICROGRAM/STRAIN
Summary of Product Characteristics Updated 14-Sep-2017 | Sanofi
Pasteur
1. Name of the medicinal product
INTANZA 15 microgram/strain suspension for injection
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 0.1 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.
INTANZA may contain residues of eggs such as ovalbumin and residues of
neomycin, formaldehyde and
octoxinol 9, which are used during the manufacturing process (see
section 4.3).
3. Pharmaceutical form
Suspension for injection.
Colourless and opalescent suspension.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of influenza in individuals 60 years of age and over,
especially in those who run an increased
risk of associated complications.
The use of INTANZA should be based on official recommendations.
4.2 Posology and method of administration
Posology
Individuals 60 years of age and over: 0.1 ml.
_Paediatric population_
INTANZA is not recommended for use in children and adolescents below
18 years due to insufficient
data on safety and efficacy.
Method of administration
Immunisation should be carried out by intradermal route.
The recommended site of administration is the reg