FLUCELVAX QUAD

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Influenza virus A (H1N1) haemagglutinin 15ug (A/Wisconsin/67/2022 (H1N1)pdm09-like virus (A/Georgia/12/2022 (CVR-167))); Influenza virus A (H3N2) haemagglutinin 15ug (A/Massachusetts/18/2022 (H3N2)-like virus (A/Sydney/1304/2022)); Influenza virus B (Victoria) haemagglutinin 15ug (B/Austria/1359417/2021-like virus (B/Victoria lineage) (B/Singapore/WUH4618/2021)); Influenza virus B (Yamagata) haemagglutinin 15ug (B/Phuket/3073/2013-like virus (B/Yamagata lineage) (B/Singapore/INFTT-16-0610/2016))

Beschikbaar vanaf:

Seqirus (NZ) Ltd

Dosering:

60 mcg/0.5mL

farmaceutische vorm:

Suspension for injection

Samenstelling:

Active: Influenza virus A (H1N1) haemagglutinin 15ug (A/Wisconsin/67/2022 (H1N1)pdm09-like virus (A/Georgia/12/2022 (CVR-167))) Influenza virus A (H3N2) haemagglutinin 15ug (A/Massachusetts/18/2022 (H3N2)-like virus (A/Sydney/1304/2022)) Influenza virus B (Victoria) haemagglutinin 15ug (B/Austria/1359417/2021-like virus (B/Victoria lineage) (B/Singapore/WUH4618/2021)) Influenza virus B (Yamagata) haemagglutinin 15ug (B/Phuket/3073/2013-like virus (B/Yamagata lineage) (B/Singapore/INFTT-16-0610/2016)) Excipient: Dibasic sodium phosphate dihydrate Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Water for injection

Prescription-type:

Prescription

therapeutische indicaties:

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

Product samenvatting:

Package - Contents - Shelf Life: Syringe, glass, 2024: 0.5 mL pre-filled syringe, needle attached - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 2024: 0.5 mL pre-filled syringe, needle free - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 2024: 0.5 mL pre-filled syringe, needle attached - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 2024: 0.5 mL pre-filled syringe, needle free - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisatie datum:

2020-09-29

Bijsluiter

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 contains the active ingredient influenza virus haemagglutinin.
Flucelvax® Quad is a vaccine used to help
prevent certain types of influenza or “flu”. It is for use in
people in people aged 6 months and older.
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 an 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.
•
In young children, the injection may be given in the thigh muscle of
the leg.
•
Flucelvax® Quad is given once every year, as follows:
•
Adults and children 9 years and older: one injection of 0.5 mL.
•
Children 6 months 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 F

Productkenmerken

Seqirus
Flucelvax
®
Quad
Datasheet - clean
Version October 2023
Page 1 of 25
NEW ZEALAND DATA SHEET
FOR SEASON 2024
1
PRODUCT NAME
FLUCELVAX
® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ)
Quadrivalent influenza vaccine (surface antigen, inactivated, prepared
in cell cultures),
suspension for injection 60 micrograms per 0.5 mL 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
2024 influenza season
representative of the following types:
A/Wisconsin/67/2022 (H1N1)pdm09-like virus
(A/Georgia/12/2022 CVR-167)
15 micrograms HA**
A/Massachusetts/18/2022 (H3N2)-like virus
(A/Sydney/1304/2022)
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) and the New Zealand
Ministry of Health for
the 2024 Southern Hemisphere Influenza season. The strains chosen for
vaccine manufacture
are endorsed by the AIVC as being antigenically equivalent to the
reference virus.
3
PHARMACEUTICAL FORM
Flucelvax
®
Quad i