Fluarix Tetra

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180); Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15ug (A/Brisbane/1/2018, NYMC X-311); Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A (Victoria lineage)); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type (Yamagata lineage))

Prieinama:

GlaxoSmithKline NZ Limited

INN (Tarptautinis Pavadinimas):

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15 µg (A/Singapore/GP1908/2015, IVR-180))

Dozė:

0.5 mL

Vaisto forma:

Suspension for injection

Sudėtis:

Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180) Influenza virus A/Switzerland/8060/2017 (H3N2) like strain 15ug (A/Brisbane/1/2018, NYMC X-311) Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A (Victoria lineage)) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type (Yamagata lineage)) Excipient: D-alpha-Tocopheryl acid succinate Dibasic sodium phosphate dodecahydrate Magnesium chloride hexahydrate Monobasic potassium phosphate Octoxinol Polysorbate 80 Potassium chloride Sodium chloride Water for injection

Recepto tipas:

Prescription

Pagaminta:

GlaxoSmithKline Biologicals (Dresden)

Terapinės indikacijos:

Fluarix Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine. The use of Fluarix Tetra should be based on official recommendations.

Produkto santrauka:

Package - Contents - Shelf Life: Syringe, glass, + steel injection needles - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, + steel injection needles - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leidimo data:

2014-05-02

Pakuotės lapelis

FLUARIX
TETRA
1
FLUARIX TETRA
_Inactivated Split Influenza Vaccine _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about FLUARIX
TETRA vaccine. It does not contain
all the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you or
your child having FLUARIX TETRA
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING FLUARIX TETRA TALK
TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT FLUARIX TETRA
IS USED FOR
FLUARIX TETRA is used to help
prevent certain types of influenza.
The vaccine works by causing the
body to produce its own protection
(antibodies) against four different
types of influenza virus.
The types of influenza antigen
contained in FLUARIX TETRA may
change from one year to another.
Each year, the Australian Influenza
Vaccine Committee (AIVC)
recommends which ones to include.
This decision is based on the types of
influenza virus thought most likely to
occur during the next flu season.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT FLUARIX
TETRA WILL ONLY PROTECT YOU
AGAINST THE FOUR TYPES OF INFLUENZA
VIRUS USED TO MAKE THE VACCINE. IT
WILL NOT PROTECT YOU FROM INFLUENZA
CAUSED BY OTHER TYPES OF INFLUENZA
VIRUS OR FROM INFECTIONS WITH OTHER
AGENTS CAUSING FLU-LIKE SYMPTOMS
(SUCH AS THE COMMON COLD).
FLUARIX TETRA cannot give you
or your child influenza because the
viruses in the vaccine have been
killed.
Influenza is an infectious illness and
is spread by small droplets from the
nose, throat or mouth of an infected
person. The most common
symptoms of influenza include fever,
sore throat, runny nose, coughing,
general aches and pains, headache,
weakness and tiredness, Most people
recover completely within a week.
The risk of serious complications
(e.g. pneumonia and death) is greater
in very y

Prekės savybės

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
FLUARIX TETRA Quadrivalent influenza vaccine (split virion,
inactivated) 0.5 mL
suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUARIX TETRA is an inactivated and purified split influenza vaccine.
The antigen
composition and strains for the 2019 influenza season corresponds to
the following
types:
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Singapore/GP1908/2015,
IVR-
180)
A/Switzerland/8060/2017 (H3N2) – like strain (A/Brisbane/1/2018,
NYMC X-311)
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
B/Colorado/06/2017 – like strain (B/Maryland/15/2016, NYMC BX-69A)
FLUARIX TETRA is prepared using whole virus cultivated in embryonated
hens'
eggs. The virus is concentrated and purified by clarification,
adsorption and
centrifugation. The purified whole virus is then treated with the
detergent sodium
deoxycholate and again centrifuged, and the resulting antigen
suspension is
inactivated with formaldehyde.
Each 0.5 mL vaccine dose contains 15
µ
g haemagglutinin of each of four influenza
strains in phosphate buffered saline.
May
contain
residual
amounts
of
the
following
process
related
impurities:
hydrocortisone,
gentamicin
sulphate,
ovalbumin,
formaldehyde,
and
sodium
deoxycholate.
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalopathy) has resulted from the administration of any
vaccine
product.
FLUARIX TETRA meets the WHO requirements for biological substances and
influenza vaccines and the European Pharmacopoeia requirements for
influenza
vaccines.
The type and amount of viral antigens in FLUARIX TETRA conform to the
annual
requirements of the Australian Influenza Vaccine Committee (AIVC) and
the New
Zealand Ministry of Health.
For full list of excipients see section 6.1 List of excipients.
2
3.
PHARMACEUTICAL FORM
FLUARIX TETRA is a colourless to slightly opalescent suspension.
4.
CLINICAL PARTICUL