Influvac

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180); Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15ug (A/Singapore/INFIMH-16-0019/2016, NIB-104); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type)

Disponible depuis:

Viatris Limited

DCI (Dénomination commune internationale):

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

Dosage:

0.5 mL

forme pharmaceutique:

Suspension for injection

Composition:

Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 15ug (A/Singapore/GP1908/2015, IVR-180) Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 15ug (A/Singapore/INFIMH-16-0019/2016, NIB-104) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/Phuket/3073/2013, wild type) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate dihydrate Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Water for injection

Unités en paquet:

Syringe, glass, single dose x, 1 dose unit

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Abbott Biologicals BV

indications thérapeutiques:

For the prevention of influenza virus, types A and B in adults and children older than 6 months in accordance with the recommendations in the National Immunisation Guideline.

Descriptif du produit:

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

Date de l'autorisation:

2003-04-28

Notice patient

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
INFLUVAC
®
_INACTIVATED INFLUENZA VACCINE _
_SUSPENSION FOR INJECTION 15/15/15 MICROGRAM PER 0.5 ML _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Influvac.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Influvac
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT INFLUVAC IS
USED FOR
Influvac is used to prevent certain
types of influenza (commonly called
flu). The vaccine works by causing
the body to produce its own
protection (antibodies) against three
different types of influenza virus.
Each year new types of influenza
virus can appear, so every year
Influvac is changed to contain
fragments of the new types of virus.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT INFLUVAC WILL ONLY
PROTECT YOU AGAINST THE THREE
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).
Influenza is an infectious illness.
Influenza is spread by small
droplets from the nose, throat or
mouth of an infected person.
Symptoms of influenza begin 48
hours after coming into contact with
the virus. These consist of chills,
fever, generalised aches and pains,
headache and respiratory
symptoms (sore throat, runny nose,
cough). The severity and type of
symptoms can vary. Most people
recover completely within a week.
The risk of serious complications
(e.g. pneumonia and death) is
greater in very young, very old and
chronically ill persons.
Influvac can be used in adults and
in children over the age of 6
months.
For full details regarding
recommendat

Résumé des caractéristiques du produit

Page 1 of 7
NEW ZEALAND DATA SHEET
INFLUVAC
®
_ _
1. PRODUCT NAME
Influvac, 45 microgram haemagglutinin per 0.5 mL, Suspension for
injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influvac is a purified, inactivated influenza vaccine (surface
antigen), each 0.5 mL of which contains
antigens representative of the following type:
A/Michigan/45/2015 (H1N1)pdm09-like strain
15 microgram haemagglutinin/dose
(A/Singapore/GP1908/2015, IVR-180)
A/Singapore/INFIMH-16-0019/2016 (H3N2)-like strain
15
microgram haemagglutinin/dose
(A/Singapore/INFIMH-16-0019/2016, NIB-104)
B/Phuket/3073/2013-like strain
15 microgram haemagglutinin/dose
(B/Phuket/3073/2013, wild type)
For the full list of excipients, see section 6.1.
Influvac antigens have been produced from eggs and is inactivated by
formaldehyde treatment. Each
0.5 mL may also contain not more than 100 ng ovalbumin, 0.01 mg
formaldehyde, 15 microgram
cetrimonium bromide, 1 mg sodium citrate, 0.2 mg sucrose, 1 ng
gentamicin sulfate, traces of
tylosine tartrate, hydrocortisone and polysorbate 80 which are used
during the manufacturing
process.
3. PHARMACEUTICAL FORM
Influvac is a clear colourless suspension for injection. It is an
egg-grown, inactivated influenza virus
vaccine based on isolated surface antigens of A and B strains of
myxovirus influenza. The type and
amount of viral antigens in Influvac conform to the requirements of
the Australian Influenza Vaccine
Committee (AIVC) and the New Zealand Ministry of Health for the winter
of 2018. The strains chosen
for vaccine manufacture are endorsed by the AIVC as being
antigenically equivalent to the reference
virus.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
For the prevention of influenza caused by influenza virus, types A and
B in adults and children older
than 6 months in accordance with the recommendations in the National
Immunisation Guideline.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
Page 2 of 7
One dose is sufficient for persons previously exposed to viruses of
similar antigenic compositio