FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled syringe without needle, SH2024 influenza season

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Influenza virus haemagglutinin, Quantity: 15 microgram

Disponível em:

GlaxoSmithKline Australia Pty Ltd

DCI (Denominação Comum Internacional):

Influenza virus haemagglutinin

Forma farmacêutica:

Injection, suspension

Composição:

Excipient Ingredients: dl-alpha-tocopheryl acid succinate; potassium chloride; sodium chloride; water for injections; polysorbate 80; dibasic sodium phosphate dodecahydrate; magnesium chloride hexahydrate; octoxinol 10; monobasic potassium phosphate

Via de administração:

Intramuscular

Unidades em pacote:

1, 10

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

FLUARIX TETRA is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).,The use of FLUARIX TETRA should be based on official recommendations.

Resumo do produto:

Visual Identification: 1.25 ml glass syringes with Luer lock adapter and plastic rigid tip cap (PRTC); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2013-08-28

Folheto informativo - Bula

FLUARIX TETRA
1
FLUARIX TETRA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I RECEIVING FLUARIX TETRA?
FLUARIX TETRA contains inactivated influenza virus as the active
ingredient. FLUARIX TETRA is used to vaccinate against some
strains of the influenza virus.
For more information, see Section 1. Why am I receiving FLUARIX TETRA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE FLUARIX TETRA?
Do not use if you have ever had an allergic reaction to FLUARIX TETRA,
any other influenza vaccine or any of the ingredients listed
at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I
receive FLUARIX TETRA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLUARIX TETRA and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS FLUARIX TETRA GIVEN?
•
Your doctor, nurse or pharmacist will give you FLUARIX TETRA as an
injection into your upper arm or upper thigh muscle.
•
For adults and older children: FLUARIX TETRA is generally given as a
single injection.
•
For children aged between 6 months and 9 years of age who have not
received an influenza vaccine before: a second dose is
given 4 weeks after the first dose.
More instructions can be found in Section 4. How is FLUARIX TETRA
given? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER RECEIVING FLUARIX TETRA?
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how FLUARIX TETRA affects
you.
•
FLUARIX TETRA may cause dizziness or light-headedness in some people.
LOOKING AFTER
YOUR MEDICINE
•
FLUARIX TETRA will normally be stored at the doctor’s surgery or in
the pharmacy.
•
If you

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION
FLUARIX TETRA (INFLUENZA VIRUS HAEMAGGLUTININ) SUSPENSION FOR
INJECTION
1
NAME OF THE MEDICINE
Quadrivalent influenza vaccine (split virion, inactivated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUARIX
TETRA
is
an
inactivated
and
purified
split
influenza
vaccine.
The
antigen
composition and strains for the 2022 influenza season corresponds to
the following types:
A/Victoria/2570/2019 (H1N1)pdm09-like virus
A/Darwin/9/2021 (H3N2)-like virus
B/Austria/1359417/2021-like (B/Victoria lineage) virus
B/Phuket/3073/2013-like (B/Yamagata lineage) virus
FLUARIX TETRA is prepared using whole virus cultivated in embryonated
hens' eggs. The
virus is concentrated and purified by clarification, adsorption and
centrifugation. The purified
whole virus is then treated with the detergent sodium deoxycholate and
again centrifuged, and
the resulting antigen suspension is inactivated with formaldehyde.
Each 0.5 mL vaccine dose contains 15 micrograms haemagglutinin of each
of four influenza
strains in phosphate buffered saline.
The manufacture of this product includes exposure to bovine derived
materials. No evidence
exists that any case of vCJD (considered to be the human form of
bovine spongiform
encephalopathy) has resulted from the administration of any vaccine
product.
FLUARIX TETRA meets the WHO requirements for biological substances and
influenza
vaccines and the European Pharmacopoeia requirements for influenza
vaccines.
The type and amount of viral antigens in FLUARIX TETRA conform to the
annual requirements
of the Australian Influenza Vaccine Committee (AIVC) and the New
Zealand Ministry of Health.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
2
3
PHARMACEUTICAL FORM
Suspension for injection.
FLUARIX TETRA is a colourless to slightly opalescent suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLUARIX TETRA is a quadrivalent vaccine indicated for active
immunisation of adults and
children from 6 months of age for the prevention of influenza disease
caused