FLUZONE HIGH-DOSE QIV inactivated quadrivalent influenza vaccine (Split Virion) influenza virus haemagglutinin 240 mcg, suspension for injection PFS, SH2024 Season

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Influenza virus haemagglutinin, Quantity: 60 microgram

Disponible desde:

Sanofi-Aventis Australia Pty Ltd

formulario farmacéutico:

Injection, suspension

Composición:

Excipient Ingredients: octoxinol 9; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; sodium chloride

Vía de administración:

Intramuscular

Unidades en paquete:

10 pre-filled syringes without needle, 5 pre-filled syringes with needles, 5 pre-filled syringes without needle

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Fluzone High-Dose Quadrivalent (QIV) is indicated for active immunisation for the prevention of influenza disease. Fluzone High-Dose Quadrivalent is indicated for use in persons 60 years of age and older., The use of Fluzone High-Dose Quadrivalent (QIV) should be based on official recommendations., See Section 5.1 Clinical Trials for information on the effects on influenza associated complications.

Resumen del producto:

Visual Identification: A colorless opalescent liquid; 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

Estado de Autorización:

Registered

Fecha de autorización:

2020-07-31

Información para el usuario

FLUZONE
® HIGH-DOSE QUADRIVALENT
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this vaccine, speak to your doctor, nurse or
pharmacist.
1.
WHY AM I USING FLUZONE HIGH-DOSE QUADRIVALENT?
Fluzone High-Dose Quadrivalent is a vaccine. This vaccine is
recommended to help protect against influenza (flu) and associated
pneumonia in persons aged 60 years and older.
For more information, see Section 1. Why am I using Fluzone High-Dose
Quadrivalent? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN FLUZONE HIGH-DOSE QUADRIVALENT?
Do not use if you have ever had an allergic reaction to Fluzone
High-Dose Quadrivalent or any of the ingredients listed at the end of
the CMI.
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 I am
given Fluzone High-Dose Quadrivalent? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fluzone High-Dose Quadrivalent 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 FLUZONE HIGH-DOSE QUADRIVALENT GIVEN?
Fluzone High-Dose Quadrivalent is administered to you by a health care
professional.
More instructions can be found in Section 4. How is Fluzone High-Dose
Quadrivalent given? in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUZONE HIGH-DOSE QUADRIVALENT?
THINGS YOU
SHOULD DO
Tell your doctor, nurse or pharmacist if you notice
•
signs of allergic reactions that may include difficulty breathing,
shortness of breath, swelling of the face,
lips, throat or tongue, cold, clammy skin, palpitations, dizziness,
weakness, fainting, rash or itching.
LOOKING AFTER
YOUR VACCINE
Fluzone High-Dose Quadrivalent is usually stored in the doctor’s
surgery or clinic, or at the pharmacy.
However, if you need to store Fluzone High-Dose Quadrivale

Ficha técnica

1
fluz-hd-qiv-ccdsv3-4-piv3-07dec21
AUSTRALIAN PRODUCT INFORMATION – FLUZONE HIGH-DOSE
QUADRIVALENT (INFLUENZA VIRUS HAEMAGGLUTININ)
1
NAME OF THE MEDICINE
Inactivated quadrivalent influenza vaccine, split virion (Influenza
virus haemagglutinin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluzone High-Dose Quadrivalent for intramuscular injection is an
inactivated influenza virus
vaccine. It contains 240 micrograms (µg) influenza virus
haemagglutinin (HA) per 0.7 mL
dose in the recommended ratio of 60 µg HA of each of the four strains
recommended for the
2022 influenza season:
•
A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019,
IVR-215)
•
A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, SAN-010)
•
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
•
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013; wild type)
The type and amount of viral antigens contained in Fluzone High-Dose
Quadrivalent conform
to
the
annual
requirements
of
the
Australian
Influenza
Vaccine
Committee
(AIVC)
recommendations for the season.
Fluzone
High-Dose
Quadrivalent
is
prepared
from
influenza
viruses
propagated
in
embryonated
chicken
eggs
and
inactivated
with
formaldehyde.
The
influenza
virus
is
concentrated and purified, and is then chemically disrupted to produce
a “split virus”. The split
virus is further purified by diafiltration and diluted to appropriate
concentration. Antigens from
the four strains included in the vaccine are produced separately and
then combined to make the
quadrivalent formulation.
For the full list of excipients, see Section 6.1 List of excipients.
Fluzone High-Dose Quadrivalent is presented in prefilled syringes that
are not made with
natural rubber latex.
3
PHARMACEUTICAL FORM
Fluzone High-Dose Quadrivalent suspension for injection is clear and
slightly opalescent in
colour.
2
fluz-hd-qiv-ccdsv3-4-piv3-07dec21
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluzone High-Dose Quadrivalent is indicated for active immunisation
for the prevention of
influenza