FluQuadri

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021 SAN-010 ); Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN-013); Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Michigan/01/2021 wild type ); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013 wild type )

Disponible desde:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Designación común internacional (DCI):

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Michigan/45/2015, X-275)

Dosis:

60 mcg

formulario farmacéutico:

Suspension for injection

Composición:

Active: Influenza virus A/Darwin/9/2021 (H3N2)-like strain 15ug (A/Darwin/9/2021 SAN-010 ) Influenza virus A/Sydney/5/2021 (H1N1) pdm09-like strain 15ug (A/Sydney/5/2021, SAN-013) Influenza virus B/Austria/1359417/2021-like strain 15ug (B/Michigan/01/2021 wild type ) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013 wild type ) Excipient: Octoxinol 9 Phosphate Buffered Saline

tipo de receta:

Prescription

Fabricado por:

Sanofi Pasteur Inc

indicaciones terapéuticas:

FluQuadri is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri is indicated for use in adults and children 6 months and older.

Resumen del producto:

Package - Contents - Shelf Life: Syringe, 0.5 mL in type I USP glass cylinder with 5 needles - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5 mL in type I USP glass cylinder - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Fecha de autorización:

2013-08-13

Información para el usuario

FluQuadri™
1
FLUQUADRI™
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 FLUQUADRI?
FluQuadri is a vaccine. This vaccine helps to protect you against
influenza (flu). FluQuadri is used to prevent flu in persons of 6
months of age and older.
For more information, see Section 1. Why am I using FluQuadri?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN FLUQUADRI?
Do not use if you have ever had an allergic reaction to FluQuadri or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU 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 FluQuadri?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FluQuadri and affect how it works.
Tell your doctor, nurse or pharmacist if you are taking,
have recently taken or might take any other vaccines or medicines,
including medicines obtained without a prescription.
For more information, see Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW IS FLUQUADRI GIVEN?
FluQuadri is given by your doctor, nurse or pharmacist.
More instructions can be found in Section 4. How is FluQuadri given?
in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT BEING GIVEN FLUQUADRI?
THINGS YOU
SHOULD DO
Tell your doctor, nurse or pharmacist after you or your child receive
the vaccine
•
have 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 MEDICINE
FluQuadri is usually stored in the surgery or clinic, or at the
pharmacy. However, if you need to store
FluQuadri:
•
keep in the fridge between 2-8°C. Do not freeze.
For more information,

Ficha técnica

fluquadri-ccdsv2-dsv8-02dec22
1
NEW ZEALAND DATA SHEET – FLUQUADRI™ INFLUENZA VIRUS
HAEMAGGLUTININ
1
NAME OF THE MEDICINE
FluQuadri™
Inactivated Quadrivalent Influenza Vaccine, Split Virion (Influenza
Virus Haemagglutinin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FluQuadri for intramuscular injection is an inactivated influenza
virus vaccine, prepared from
influenza viruses propagated in embryonated chicken eggs. The
virus-containing allantoic fluid
is harvested and inactivated with formaldehyde. Influenza virus is
concentrated and purified in
a linear sucrose density gradient solution using a continuous flow
centrifuge. The virus is then
chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton
®
X-100), producing a
“split virus”. The split virus is further purified and then
suspended in sodium phosphate-
buffered isotonic sodium chloride solution. Antigens from the four
strains included in the
vaccine are produced separately and then combined to make the
quadrivalent formulation.
It is formulated to contain the following four influenza strains
recommended for the 2023
influenza season:
ACTIVE SUBSTANCE
QUANTITY
(PER 0.5ML DOSE)
A/Sydney/5/2021 (H1N1)pdm09 - like strain (A/Sydney/5/2021, SAN-013)
15 micrograms HA**
A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, SAN-010)
15 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
15 micrograms HA**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
15 micrograms HA**
** haemagglutinin
FluQuadri contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL
dose in the
recommended ratio of 15 µg HA of each of the four strains.
The type and amount of viral antigens contained in FluQuadri conform
to the annual
requirements of the Australian Influenza Vaccine Committee (AIVC) and
the World Health
Organization (WHO) recommendations for the season.
Neither antibiotics nor preservative are used during manufacture.
FluQuadri is presented in prefilled syringes that are not made with
natural rubber latex