Flucelvax Quad Quadrivalent influenza vaccine (surface antigen inactivated) suspension for injection pre-filled syringe with attached needle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin, Quantity: 15 microgram

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

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

Administration route:

Intramuscular

Units in package:

Flucelvax Quad Quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures), suspension for injection with attached needle 10s, Flucelvax Quad Quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures), suspension for injection with attached needle 1s

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. The vaccine is indicated for use in adults and children 6 months of age and older. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Product summary:

Visual Identification: Flucelvax Quad is a sterile, aqueous, clear to slightly opalescent suspension for injection in pre-filled syringe.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-09-01

Patient Information leaflet

Flucelvax® Quad
1
FLUCELVAX
® QUAD
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, nurse or
pharmacist.
1.
WHY AM I BEING GIVEN FLUCELVAX
® QUAD?
Flucelvax
®
Quad Quadrivalent Influenza Vaccine (surface antigen, inactivated,
prepared in cell cultures) contains the active
ingredient influenza virus haemagglutinin. Flucelvax® Quad is used to
help prevent certain types of influenza or “flu”.
For more information, see Section 1. Why am I being given Flucelvax
®
Quad? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN FLUCELVAX
® QUAD?
Tell your doctor, nurse or pharmacist if you or your child have ever
had a severe allergic reaction to any influenza vaccine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD 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 being
given Flucelvax
®
Quad? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Flucelvax
®
Quad 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 FLUCELVAX
® QUAD GIVEN?
•
Flucelvax® Quad is given as an injection, usually into your upper arm
muscle by a doctor, nurse or pharmacist.
•
Flucelvax® Quad is given once every year, as follows:
•
Adults and children 9 years and older: one injection of 0.5 mL.
•
Children 2 years to less than 9 years of age: One or two 0.5 mL doses.
Children less than 9 years of age who have
not been previously vaccinated against influenza, should receive a
second dose (at least 4 weeks after the first
dose).
More instructions can be found in Section 4. How is Flucelvax
®
Quad given? in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUCELVAX
® QUAD?
THINGS YOU
SHOULD DO
Call your doctor s

Summary of Product characteristics

Seqirus
Flucelvax
®
Quad
AUST R 319093 & AUST R 341450
QIVc AU 20220328 Version 13
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
FLUCELVAX
® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ)
FOR SEASON 2022
1
NAME OF THE MEDICINE
Quadrivalent influenza vaccine (surface antigen, inactivated, prepared
in cell cultures),
suspension for injection containing Influenza virus haemagglutinin as
active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a purified, inactivated, subunit influenza vaccine. Each 0.5
mL dose contains
influenza virus surface antigens (haemagglutinin and neuraminidase)*,
for the 2022
influenza season representative of the following types:
A/Wisconsin/588/2019 (H1N1)pdm09-like virus
(A/Washington/19/2020)
15 micrograms HA**
A/Darwin/6/2021 (H3N2)-like virus
(A/Darwin/11/2021)
15 micrograms HA**
B/Austria/1359417/2021-like virus
(B/Singapore/WUH4618/2021)
15 micrograms HA**
B/Phuket/3073/2013-like virus
(B/Singapore/INFTT-16-0610/2016)
15 micrograms HA**
per 0.5 ml dose
* propagated in Madin Darby Canine Kidney (MDCK) cells
** haemagglutinin
Flucelvax
®
Quad is prepared in MDCK cells, adapted to grow freely in suspension
in
culture medium. The virus is inactivated with ß-propiolactone,
disrupted by the detergent
cetyltrimethylammonium bromide and purified through several process
steps. Therefore
Flucelvax
®
Quad may contain traces of propiolactone, cetyltrimethylammonium
bromide
and polysorbate 80 (refer to
SECTION 4.3 CONTRAINDICATIONS
). Eggs are not used
in the manufacturing process, therefore, Flucelvax
®
Quad does not contain egg proteins.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
The vaccine complies with the World Health Organization (WHO)
recommendation and
Australian Influenza Vaccine Committee (AIVC) for the 2022 Southern
Hemisphere
Influenza season. The strains chosen for vaccine manufacture are
endorsed by the AIVC
as being antigenically equivalent to the reference virus.
Seqirus
Flucelvax
®
Quad
AUST R 319093 & AUST R 341450
QIVc AU 20220328 Version 13