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

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Influenza virus split virion

Sẵn có từ:

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

Mã ATC:

J07BB02

INN (Tên quốc tế):

Influenza virus split virion

Dạng dược phẩm:

Suspension for injection

Tuyến hành chính:

Intramuscular; Subcutaneous

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Never Valid To Prescribe As A VMP

Tóm tắt sản phẩm:

BNF: 14040000; GTIN: 5000283658962 5000283658979

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), SUSPENSION
FOR INJECTION IN PRE-FILLED
SYRINGE
Quadrivalent influenza vaccine (split virion, inactivated)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of Section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED 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 or your child only. Do not
pass it on to others.
-
If you or your child 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 Quadrivalent Influenza Vaccine (split virion, inactivated) is and
what it is used for
2.
What you need to know before you or your child use Quadrivalent
Influenza Vaccine (split
virion, inactivated)
3.
How to use Quadrivalent Influenza Vaccine (split virion, inactivated)
4.
Possible side effects
5.
How to store Quadrivalent Influenza Vaccine (split virion,
inactivated)
6.
Contents of the pack and other information
1.
WHAT QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) IS AND
WHAT IT IS USED FOR
Quadrivalent Influenza Vaccine (split virion, inactivated) is a
vaccine. This vaccine helps to protect you
or your child against influenza (flu). The use of Quadrivalent
Influenza Vaccine (split virion, inactivated)
should be based on official recommendations.
When a person is given Quadrivalent Influenza Vaccine (split virion,
inactivated), 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

Đặc tính sản phẩm

OBJECT 1
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION,
INACTIVATED)
Summary of Product Characteristics Updated 10-Jan-2018 | Sanofi
Pasteur
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
Quadrivalent Influenza Vaccine (split virion, inactivated), suspension
for injection in pre-filled syringe
Quadrivalent 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**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, 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.
Quadrivalent Influenza Vaccine (split virion, inactivated) 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 pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
4. Clinical particulars
4.1 Therapeutic indications
Quadrivalent Influenza Vaccine (split virion, ina