AFLURIA QUAD

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Influenza virus haemagglutinin, Quantity: 15 microgram

זמין מ:

Seqirus Pty Ltd

טופס פרצבטיות:

Injection, suspension

הרכב:

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

מסלול נתינה (של תרופות):

Intramuscular, Subcutaneous

יחידות באריזה:

1 x 0.5 mL syringe, 10 x 0.5 mL syringe

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. The vaccine is indicated for use only in persons aged 5 years and over. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

leaflet_short:

Visual Identification: A clear to slightly opaque liquid with some sediment that resuspends upon shaking; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Registered

תאריך אישור:

2018-01-09

עלון מידע

Afluria® Quad
1
AFLURIA® 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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING AFLURIA® QUAD?
Afluria® Quad contains the active ingredient influenza virus
haemagglutinin. Afluria® Quad is a vaccine that helps prevent
influenza, often called “the flu’. Afluria® Quad is indicated for
use only in persons aged 5 years and over.
For more information, see Section 1. Why am I using Afluria® Quad?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN AFLURIA® QUAD?
Tell your doctor, nurse or pharmacist if you or your child have ever
had an allergic reaction to Afluria® Quad or any of the
ingredients listed at the end of the CMI or any other influenza
vaccine.
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?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Afluria® 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 AFLURIA® QUAD GIVEN?
•
Afluria® Quad is given as an injection, usually into the muscle or
under the skin of your upper arm by a doctor, nurse or
pharmacist.
•
Afluria® Quad is given once every year for adults and children 5
years and over in one injection of 0.5 mL.
•
For children 5 to under 9 years old who are receiving influenza
vaccine for the first time, it is recommended that a follow-
up (booster) dose of Afluria® Quad is given at least 4 weeks after
the first dose.
More instructions can be found in Section 4. How is Afluria® Quad
given?
in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT

מאפייני מוצר

Seqirus
Afluria
®
Quad
AUST R 262428 & AUST R 294907
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
AFLURIA
® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ)
WARNING: AFLURIA
® QUAD VACCINE IS INDICATED FOR USE ONLY IN PERSONS AGED 5 YEARS
AND OVER.
IT MUST NOT BE USED IN PERSONS UNDER 5 YEARS (SEE CONTRAINDICATIONS).
FOR SEASON 2022
1
NAME OF THE MEDICINE
AFLURIA
® QUAD
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 contains
antigens for the 2022 influenza season representative of the following
types:
-
A/Victoria/2570/2019 (H1N1)pdm09-like virus (A/Victoria/2570/2019
IVR-215):
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
Afluria
®
Quad is manufactured in eggs and trace amounts of sodium
taurodeoxycholate
(TDOC) (≤5 micrograms), ovalbumin (<1 microgram/0.5mL 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 vaccine conform to the
requirements of the Australian Influenza Vaccine Committee for the
winter of 2022. The
strains chosen for vaccine manufacture are endorsed by the Australian
Influenza Vaccine
Committee as being antigenically equivalent to the reference virus.
Seqirus
Afluria
®
Quad
AUST R 262428 & AUST R 294907
Page 2 of 17
The vaccine is prepared from virus grown in the allantoic cavity of
embryonated eggs,
purified by zonal centrifugation, inactivated by propiolactone and
disrupted by TDOC.
Afluria
®
Quad vaccine conforms in saf