Influvac Tetra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021, SAN 010); Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN 013); Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Austria/1359417/2021, BVR-26); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type)

Available from:

Viatris Limited

INN (International Name):

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Singapore/GP1908/2015, IVR-180)

Dosage:

0.5 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021, SAN 010) Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN 013) Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Austria/1359417/2021, BVR-26) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate as dihydrate 0.67 mg Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Abbott Biologicals BV

Therapeutic indications:

For the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines. Influvac Tetra is indicated in adults and children from 6 months of age and older.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled 0.5 mL - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Pre-filled 0.5 mL - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2016-08-16

Patient Information leaflet

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
INFLUVAC
®
TETRA
_INACTIVATED INFLUENZA VACCINE_
_SUSPENSION FOR INJECTION 60 MICROGRAM PER 0.5 ML_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Influvac Tetra.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Influvac
Tetra against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT INFLUVAC TETRA
IS USED FOR
Influvac Tetra is used to prevent
certain types of influenza
(commonly called flu). The vaccine
works by causing the body to
produce its own protection
(antibodies) against four different
types of influenza virus.
Each year new types of influenza
virus can appear, so every year
Influvac Tetra is changed to contain
fragments of the new types of virus.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT INFLUVAC TETRA
WILL ONLY PROTECT YOU AGAINST THE
FOUR TYPES OF INFLUENZA VIRUS USED
TO MAKE THE VACCINE. IT WILL NOT
PROTECT YOU FROM INFLUENZA
CAUSED BY OTHER TYPES OF
INFLUENZA VIRUS OR FROM INFECTIONS
WITH OTHER AGENTS CAUSING FLU-LIKE
SYMPTOMS (SUCH AS THE COMMON
COLD).
Influenza is an infectious illness.
Influenza is spread by small
droplets from the nose, throat or
mouth of an infected person.
Symptoms of influenza begin 48
hours after coming into contact with
the virus. These consist of chills,
fever, generalised aches and pains,
headache and respiratory
symptoms (sore throat, runny nose,
cough). The severity and type of
symptoms can vary. Most people
recover completely within a week.
The risk of serious complications
(e.g. pneumonia and death) is
greater in very young, very old and
chronically ill persons.
Influvac Tetra can be used in adults
and in children over the age of 3
years.
For f

Summary of Product characteristics

Page 1 of 8
NEW ZEALAND DATA SHEET
INFLUVAC
® TETRA
1. PRODUCT NAME
Influvac Tetra, 60 microgram haemagglutinin per 0.5 mL, Suspension for
injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influvac Tetra
is a purified, inactivated influenza vaccine (surface antigen),
containing the following
four influenza strains recommended for the 2021 influenza season:

A/Victoria/2570/2019 (H1N1)pdm09-like strain
(A/Victoria/2570/2019, IVR-215)

A/Hong Kong/2671/2019 (H3N2)-like strain
(A/Hong Kong/2671/2019, IVR-208)

B/Washington/02/2019-like strain (B/Victoria lineage)
(B/Washington/02/2019, wild type)

B/Phuket/3073/2013-like strain (B/Yamagata lineage)
(B/Phuket/3073/2013, wild type)
Each 0.5 mL dose contains 15 micrograms haemagglutinin per each of the
above mentioned viral
strains, for a combined total of 60 micrograms. Each strain has been
propagated in fertilised hens’
eggs from healthy chickens.
The type and amount of viral antigens in Influvac Tetra conform to the
requirements of the Australian
Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of
Health for the 2021 southern
hemisphere influenza season.
For a full list of excipients, see section 6.1.
Influvac Tetra antigens have been produced from eggs and are
inactivated by formaldehyde
treatment. Each 0.5 mL may also contain not more than 100 nanograms
ovalbumin, 0.01 mg
formaldehyde, 0.02 mg cetrimonium bromide, 1 mg sodium citrate, 0.2 mg
sucrose, 1 nanograms
gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and
polysorbate 80 which are used
during the manufacturing process.
3. PHARMACEUTICAL FORM
Influvac Tetra is a clear colourless liquid for injection in
pre-filled syringes.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
For the prevention of influenza caused by influenza virus, types A and
B.
Page 2 of 8
For full details regarding recommendations for influenza vaccination,
please refer to the relevant
National Immunisation Guidelines.
Influvac Tetra is indicated in adults and children from 3 years o