Afluria Quad Junior

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Influenza virus A (H1N1) haemagglutinin 7.5ug (A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022 (IVR-238))); Influenza virus A (H3N2) haemagglutinin 7.5ug (A/Thailand/8/2022 (H3N2)-like virus (A/Thailand/8/2022 (IVR-237))); Influenza virus B (Victoria) haemagglutinin 7.5ug (B/Austria/1359417/2021(B/Victoria lineage)-like virus (B/Austria/1359417/2021 (BVR-26))); Influenza virus B (Yamagata) haemagglutinin 7.5ug (B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 (BVR-1B)))

Available from:

Seqirus (NZ) Ltd

Dosage:

30 mcg/0.25mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Influenza virus A (H1N1) haemagglutinin 7.5ug (A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022 (IVR-238))) Influenza virus A (H3N2) haemagglutinin 7.5ug (A/Thailand/8/2022 (H3N2)-like virus (A/Thailand/8/2022 (IVR-237))) Influenza virus B (Victoria) haemagglutinin 7.5ug (B/Austria/1359417/2021(B/Victoria lineage)-like virus (B/Austria/1359417/2021 (BVR-26))) Influenza virus B (Yamagata) haemagglutinin 7.5ug (B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 (BVR-1B))) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate Monobasic potassium phosphate Monobasic sodium phosphate Potassium chloride Sodium chloride Water for injection

Prescription type:

Prescription

Therapeutic indications:

For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. Afluria Quad Junior vaccine is indicated for use in children aged 6 months to 35 months inclusive. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 2024: Type I, prefilled (0.25 mL), with attached 25G stainless steel needle&latex-free rubber shie - 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: (Type I), prefilled (0.25 mL), without needle - 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: Type I, prefilled (0.25 mL), with attached 25G stainless steel needle&latex-free rubber shield - 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: (Type I), prefilled (0.25 mL), without needle - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2019-05-31

Patient Information leaflet

Afluria® Quad / Afluria® Quad Junior
1
AFLURIA® QUAD
AFLURIA® QUAD JUNIOR
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN AFLURIA® QUAD / AFLURIA® QUAD JUNIOR?
Afluria® Quad / Afluria® Quad Junior contains the active ingredient
influenza virus haemagglutinin. Afluria® Quad / Afluria
®
Quad Junior is a vaccine used to help prevent certain types of
influenza or “flu”. Afluria
®
Quad is for use only in people aged 3
years and older. Afluria
®
Quad Junior is for use only in children aged 6 months to 35 months.
For more information, see Section 1. Why am I being given Afluria®
Quad? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN AFLURIA® QUAD / AFLURIA® QUAD
JUNIOR?
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 Afluria® Quad / Afluria® Quad Junior? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Afluria® Quad / Afluria® Quad
Junior 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 AFLURIA® QUAD / AFLURIA® QUAD JUNIOR GIVEN?

Afluria® Quad / Afluria® Quad Junior is given as an injection,
usually into the upper arm muscle by a doctor, nurse or
pharmacist.

Afluria® Quad / Afluria® Quad Junior is given once every year as
follows:

Adults and children 3 years and older: one injection of 0.5 mL.

Children 6 months

Summary of Product characteristics

Seqirus
Afluria
®
Quad/ Afluria
®
Quad Junior
Data Sheet TT50-10075/ TT50-10075/2
Page 1 of 24
NEW ZEALAND DATA SHEET
AFLURIA
® QUAD / AFLURIA
® QUAD JUNIOR
FOR SEASON 2023
1
PRODUCT NAME
AFLURIA
®
QUAD / AFLURIA
®
QUAD JUNIOR
Inactivated quadrivalent influenza vaccine (split virion) suspension
for injection;
containing Influenza virus haemagglutinin as active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a purified, inactivated, split virion (split virus) vaccine.
Each 0.5 mL dose of
Afluria
®
Quad contains antigens for the 2023 influenza season representative of
the
following types:
-
A/Sydney/5/2021 (H1N1)pdm09-like virus (A/Sydney/5/2021 IVR-229):
15 micrograms HA* per dose
-
A/Darwin/9/2021 (H3N2)-like virus (A/Darwin/6/2021 IVR-227):
15 micrograms HA* per dose
-
B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26):
15 micrograms HA* per dose
-
B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 BVR-1B):
15 micrograms HA* per dose
*HA - haemagglutinin
A 0.25 mL dose of Afluria
®
Quad Junior contains 7.5 micrograms of haemagglutinin of
each of the same four influenza strains.
Afluria
®
Quad / Afluria
®
Quad Junior is manufactured in eggs and trace amounts of
sodium taurodeoxycholate (TDOC) (≤ 5 micrograms per 0.5 mL dose; ≤
2.5 micrograms
per 0.25 mL dose), ovalbumin (< 1 microgram per 0.5 mL dose; < 0.5
microgram per 0.25
mL dose), sucrose, neomycin sulfate, polymyxin B sulfate,
propiolactone and
hydrocortisone may be present. For the full list of excipients, see
SECTION 6.1 - LIST OF
EXCIPIENTS
.
The type and amount of viral antigens in Afluria
®
Quad / Afluria
®
Quad Junior vaccine
conform to the requirements of the Australian Influenza Vaccine
Committee and the New
Zealand Ministry of Health for the winter of 2023. The strains chosen
for vaccine
Seqirus
Afluria
®
Quad/ Afluria
®
Quad Junior
Data Sheet TT50-10075/ TT50-10075/2
Page 2 of 24
manufacture are endorsed by the Australian Influenza Vaccine Committee
as being
antigenically equivalent to the reference v