FLUAD QUAD inactivated quadrivalent influenza vaccine (surface antigen) adjuvanted suspension for injection 60 mcg HA/ 0.5 mL PFS with attached needle, 2024 Season

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Influenza virus haemagglutinin, Quantity: 15 microgram

Dostupné z:

Seqirus Pty Ltd

Forma lieku:

Injection, suspension

Zloženie:

Excipient Ingredients: monobasic potassium phosphate; magnesium chloride hexahydrate; sorbitan trioleate; squalene; sodium citrate dihydrate; citric acid monohydrate; calcium chloride dihydrate; potassium chloride; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80

Spôsob podávania:

Intramuscular

Počet v balení:

Prefilled syringe with attached needle, 10x 0.5 mL, Prefilled syringe with attached needle, 1 x 0.5 mL

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Active immunisation against influenza in persons 65 years of age and older.

Prehľad produktov:

Visual Identification: Milky-white suspension; 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

Stav Autorizácia:

Registered

Dátum Autorizácia:

2019-10-01

Príbalový leták

Fluad Quad
1
FLUAD® 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 USING FLUAD® QUAD?
Fluad® Quad contains the active ingredient influenza virus
haemagglutinin. Fluad® Quad is a vaccine used to help prevent
certain types of influenza or “flu”. It is for use in people aged
65 years and older only.
For more information, see Section 1. Why am I using Fluad® Quad?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN FLUAD® QUAD?
Tell your doctor, nurse or pharmacist if you have ever had a severe
allergic reaction to Fluad® Quad or any of the ingredients
listed at the end of the CMI or any other influenza vaccines.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS OR TAKE
ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before being
given Fluad® Quad?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fluad® 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 FLUAD® QUAD GIVEN?
Fluad® Quad is given as an injection usually into your shoulder
muscle by a doctor, nurse or pharmacist.
More instructions can be found in Section 4. How is Fluad® Quad
given?
in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUAD® QUAD?
THINGS YOU
SHOULD DO
Call your doctor straight away if you do not feel well after having
Fluad® Quad.
Keep an updated record of your vaccinations.
Keep any follow-up appointments with your doctor or clinic.
For more information, see Section 5. What should I know about being
given Fluad® Quad? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects may include local reaction around the injection
site, fatigue and headache. Mostly these are mild and
usually disappear within 3 days without treatment. Serious side
effects are rare.
Sudden signs of allergy may be

Súhrn charakteristických

Seqirus
Fluad
®
Quad
AUST R 313724 & AUST R 316323
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
FLUAD
® QUAD (INFLUENZA VIRUS HAEMAGGLUTININ)
1.
NAME OF THE MEDICINE
FLUAD
® QUAD
Inactivated quadrivalent influenza vaccine (surface antigen),
adjuvanted, suspension for
injection; containing Influenza virus haemagglutinin as active
ingredient.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose contains influenza virus surface antigens
(haemagglutinin and
neuraminidase) of each of four antigens representative of the
influenza virus types
expected to circulate in the Southern Hemisphere winter according to
WHO
recommendations for the 2022 season:
-
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
Fluad
®
Quad vaccine is prepared from virus grown in embryonated hens’ eggs
and
inactivated with formaldehyde before purification and combination with
MF59C.1, an
adjuvant known to increase the immunogenicity of vaccines. MF59C.1
adjuvant is a
squalene based oil-in-water emulsion. Squalene is of fish origin. It
is also a normal
component in the human body and is easily metabolized and excreted.
For a full list of
excipients, see
SECTION 6.1 – LIST OF EXCIPIENTS
.
The type and amount of viral antigens in Fluad
®
Quad conform to the requirements of the
Australian Influenza Vaccine Committee for the 2022 Southern
Hemisphere Influenza
season. The strains chosen for vaccine manufacture are endorsed by the
Australian
Influenza Vaccine Committee as being antigenically equivalent to the
reference virus.
Seqirus
Fluad
®
Quad
AUST R 313724 & AUST R 316323
Page 2 of 15
Fluad
®
Quad is manufactured in eggs and trace amounts of kanamycin sulfate,
neomycin
sulfate, ovalbumin (�