INFLUVAC TETRA influenza virus haemagglutinin 0.5mL vaccine prefilled syringe without needle 2024

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Influenza virus haemagglutinin, Quantity: 15 microgram

Disponible desde:

Viatris Pty Ltd

formulario farmacéutico:

Suspension

Composición:

Excipient Ingredients: magnesium chloride hexahydrate; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; water for injections; potassium chloride; calcium chloride dihydrate; sodium chloride

Vía de administración:

Intramuscular, Subcutaneous

Unidades en paquete:

Tens pack (10 x syringes), Singles pack (1 x syringe)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: Colourless clear liquid, filled in single-dose syringes (glass, type I); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2017-11-02

Información para el usuario

INFLUVAC TETRA
_Inactivated Quadrivalent Influenza Vaccine (surface antigen)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
INFLUVAC TETRA vaccine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. Please read it carefully
and keep it for future reference.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you
having INFLUVAC TETRA against
the expected benefits.
TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT RECEIVING
INFLUVAC TETRA.
Your doctor and pharmacist have
more information.
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 over the age of 18 years.
TALK

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
INFLUVAC
® TETRA
_(Influenza virus haemagglutinin) Suspension for Injection _
1
NAME OF THE MEDICINE
Quadrivalent Influenza Vaccine, surface antigen, inactivated
(influenza virus haemagglutinin)
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 amount 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 the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
INFLUVAC TETRA is a clear colourless liquid for injection in
pre-filled syringes (glass, type I).
4
CLINICAL PARTICULARS
4.1
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 6 MONTHS OF AGE AND OLDER
: 0.5 mL dose
For children less than 9 years of age who have not previously been
vaccinated, a second dose of 0.5 mL should
be given after an interval of at least 4 weeks.
INFLUVAC
®
TETRA – PRO