Vaxigrip vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Influenza virus A/Wellington/I/2004(H3N2)-like strain 10ug ([Influenza virus A/Wellington/I/2004 IVR-139(10 µg/HA)]);  ; Influenza virus B/Shanghai/361/2002-like strain 15ug ([B/Jiangsu/10/2003 (15µg/HA)]);  ; Influenza virus haemagglutinin type A/New Caledonia/20/99 H1N1-like strain 15ug ([A/New Caledonia/20/99 IVR-116 (15µg/HA)]);  

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Influenza virus A/Wellington/I/2004(H3N2)-like strain 10 µg ([Influenza virus A/Wellington/I/2004 IVR-139(10 µg/HA)])

Dosage:

10µg/15µg/15µg per dose

Pharmaceutical form:

Solution for injection

Composition:

Active: Influenza virus A/Wellington/I/2004(H3N2)-like strain 10ug ([Influenza virus A/Wellington/I/2004 IVR-139(10 µg/HA)])   Influenza virus B/Shanghai/361/2002-like strain 15ug ([B/Jiangsu/10/2003 (15µg/HA)])   Influenza virus haemagglutinin type A/New Caledonia/20/99 H1N1-like strain 15ug ([A/New Caledonia/20/99 IVR-116 (15µg/HA)])   Excipient: Dibasic sodium phosphate dihydrate Monobasic potassium phosphate Neomycin Sodium chloride Water for injection

Units in package:

Syringe, glass, single dose,

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Pasteur SA

Product summary:

Package - Contents - Shelf Life: Syringe, glass, single dose - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 10 x pre-filled syringe - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2005-04-01

Patient Information leaflet

VAXIGRIP
®
1
VAXIGRIP
®
_Inactivated Influenza Vaccine (split virion) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU OR YOUR CHILD IS
VACCINATED.

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.

If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:

What VAXIGRIP is and what
they are used for

Before you or your child is given
VAXIGRIP

How VAXIGRIP is given

Possible side effects

Storing VAXIGRIP

Further Information
WHAT VAXIGRIP IS AND
WHAT THEY ARE USED FOR
VAXIGRIP is a vaccine.
These vaccines help to protect you or
your child against influenza (flu),
particularly if you or your child runs
a high risk of associated
complications.
VAXIGRIP should be used
according to official
recommendations.
When a person is given VAXIGRIP,
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 virus strains that can change
every year. This is why you or your
child may need to be vaccinated
every year. The greatest risk of
catching flu is during the cold
months. If you or your child was not
vaccinated in the autumn, it is still
possible to do it until 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.
VAXIGRIP will protect you or your
child against the three strains of virus
contained in the vaccine after about 2
to 3 weeks following the injection.
The incubation period for flu is a few
days, so if you or your child is
exposed to flu immediately before or
after your vaccination, you or your
child c

Summary of Product characteristics

2017 Season
vax-vax-jr-ccdsv8-dsv3-2-22nov16
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NEW ZEALAND DATA SHEET
NAME OF THE MEDICINE
VAXIGRIP
®
INACTIVATED INFLUENZA VACCINE (SPLIT VIRION)
DESCRIPTION
VAXIGRIP is a sterile suspension of influenza virus for intramuscular
or deep
subcutaneous injection. It is a purified, inactivated, split virion
vaccine.
VAXIGRIP contains the following strains of influenza virus:

A/Michigan/45/2015 NYMC X-275 (A/Michigan/45/2015 [H1N1]pdm09-
like),

A/Hong Kong/4801/2014 NYMC X-263B (A/Hong Kong/4801/2014 [H3N2]-
like) and

B/Brisbane/60/2008 wild type (B/Brisbane/60/2008-like)
Each 0.5 mL pre-filled syringe contains 15 µg haemagglutinin of each
of the 3 strains
in a buffered saline solution. A buffered saline solution contains the
following
excipients
–
sodium
chloride,
potassium
chloride,
sodium
phosphate
–
dibasic
dihydrate, potassium phosphate – monobasic and water for injection.
The vaccine is prepared from virus grown in the allantoic cavity of
embryonated eggs,
concentrated, purified by zonal centrifugation in a sucrose gradient,
split by octoxinol
9 (Triton X-100), inactivated by formaldehyde and then diluted in
phosphate buffered
saline solution to the required concentration. No adjuvant or
preservative is added.
The vaccine may contain traces of formaldehyde (≤ 30 µg), octoxinol
9 (≤ 200 µg)
and neomycin (≤ 20 picogram). VAXIGRIP does not contain more than
0.05 µg
ovalbumin per dose.
The type and amount of viral antigens contained in VAXIGRIP conform to
the annual
requirements of the Australian Influenza Vaccine Committee (AIVC) and
the World
Health Organization (WHO) recommendations for the season.
PHARMACOLOGY
Influenza vaccines have been shown to give antibody responses and to
provide
protection against clinical illness in a proportion of vaccinees.
Because the influenza
virus is capricious antigenically and because significant changes in
its antigenic
behaviour may occur from time to time, protection afforded by VAXIGRIP
is limited
to the strains from which the vaccine h