FluQuadri Junior

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5ug (A/Michigan/45/2015, X-275); Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 7.5ug (A/Singapore/INFIMH-16-0019/2016, NIB-104); Influenza virus B/Brisbane/60/2008 - like strain 7.5ug (B/Brisbane/60/2008 (Victoria lineage)); Influenza virus B/Phuket/3073/2013 - like strain 7.5ug (B/Phuket/3073/2013 (Yamagata lineage))

Disponible desde:

sanofi-aventis new zealand limited

Designación común internacional (DCI):

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5 µg (A/Michigan/45/2015, X-275)

Dosis:

30 mcg

formulario farmacéutico:

Suspension for injection

Composición:

Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5ug (A/Michigan/45/2015, X-275) Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 7.5ug (A/Singapore/INFIMH-16-0019/2016, NIB-104) Influenza virus B/Brisbane/60/2008 - like strain 7.5ug (B/Brisbane/60/2008 (Victoria lineage)) Influenza virus B/Phuket/3073/2013 - like strain 7.5ug (B/Phuket/3073/2013 (Yamagata lineage)) Excipient: Octoxinol 9 Phosphate Buffered Saline

tipo de receta:

Prescription

Fabricado por:

Sanofi Pasteur Inc

indicaciones terapéuticas:

FluQuadri Junior is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri Junior is indicated for use in children aged 6 months to 35 months inclusive.

Resumen del producto:

Package - Contents - Shelf Life: Syringe, 0.25 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, 0.25 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™
FLUQUADRI™ JUNIOR
_Inactivated Quadrivalent Influenza Vaccine (Split Virion) Influenza
Virus Haemagglutinin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE VACCINATED.
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This vaccine has been prescribed
for you. Do not pass it on to
others.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
•
What FluQuadri/FluQuadri Junior
are and what they are used for
•
Before you are given
FluQuadri/FluQuadri Junior
•
How FluQuadri/FluQuadri Junior
are given
•
Possible side effects
•
Storing FluQuadri/FluQuadri
Junior
•
Further information
WHAT
FLUQUADRI/FLUQUADRI
JUNIOR ARE AND WHAT
THEY ARE USED FOR
FluQuadri and FluQuadri Junior are
vaccines. Vaccines are used to
protect you against infectious
diseases.
FluQuadri and FluQuadri Junior are
recommended to help protect you
against influenza. FluQuadri may be
administered to persons aged 36
months and older, especially who run
an increased risk of influenza-
associated complications. FluQuadri
Junior is designed for use in children
aged 6 to 35 months.
Influenza (flu) is a disease caused by
different types of virus. Influenza
viruses can spread rapidly, especially
in homes or institutions, where it can
be very easy for someone to catch flu
and spread the disease. The greatest
risk of catching flu is during the cold
months between May and October.
Your doctor will be able to
recommend the best time for you to
be vaccinated. Flu is present every
year, even when epidemics or
outbreaks are not reported.
The vaccine will only help to prevent
flu if it is caused by one of the four
strains of virus contained in the
vaccine, or other strains closely
related to them. FluQuadri/FluQuadri
Junior will not prevent flu if you are
incubating the disease before
vaccination or

Ficha técnica

NEW ZEALAND DATA SHEET – FLUQUADRI / FLUQUADRI JUNIOR
(INFLUENZA VIRUS HAEMAGGLUTININ)
1
NAME OF THE MEDICINE
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 2019
influenza season:
•
A/Michigan/45/2015 (H1N1) pdm09-like virus (A/Michigan/45/2015 X-275)
•
A/Switzerland/8060/2017 (H3N2)- like virus (A/Brisbane/1/2018 X-311
•
B/Phuket/3073/2013-like virus (B/Phuket/3073/2013; Yamagata lineage)
•
B/Colorado/06/2017-like virus (B/Maryland/15/2016 BX-69A; Victoria
lineage)
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. FluQuadri
Junior contains 30 µg
HA per 0.25 mL dose in the recommended ratio of 7.5 µg HA of each of
the four strains.
The type and amount of viral antigens contained in FluQuadri/FluQuadri
Junior conform to the
annual requirements of the Australian Influenza Vaccine Committee
(AIVC) and the World
Health Organization (WHO) recommendations for the season.
The amounts of HA and other ingredients per dose of vaccine are listed
in Table 1. Neither
antibiotics nor preservative are used during manufactu