Influvac Tetra

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Influenza virus A/Brisbane/02/2018 (H1N1) pdm09-like strain 15ug (A/Brisbane/02/2018, IVR-190); Influenza virus A/Kansas/14/2017 (H3N2) like strain 15ug (A/Kansas/14/2017, NYMC X-327); Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A); Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/ Phuket/3073/2013, wild type)

Beschikbaar vanaf:

Viatris Limited

Dosering:

0.5 mL

farmaceutische vorm:

Suspension for injection

Samenstelling:

Active: Influenza virus A/Brisbane/02/2018 (H1N1) pdm09-like strain 15ug (A/Brisbane/02/2018, IVR-190) Influenza virus A/Kansas/14/2017 (H3N2) like strain 15ug (A/Kansas/14/2017, NYMC X-327) Influenza virus B/Colorado/06/2017 - like strain 15ug (B/Maryland/15/2016, NYMC BX-69A) Influenza virus B/Phuket/3073/2013 - like strain 15ug (B/ Phuket/3073/2013, wild type) Excipient: Calcium chloride dihydrate Dibasic sodium phosphate as dihydrate 0.67 mg Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Water for injection

Prescription-type:

Prescription

therapeutische indicaties:

For the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines. Influvac Tetra (Saison 2019/2020) is indicated in adults and children 3 years of age and older at low risk of complications from influenza.

Product samenvatting:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled 0.5 mL - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Pre-filled 0.5 mL - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisatie datum:

2020-04-29

Productkenmerken

Page 1 of 9
NEW ZEALAND DATA SHEET
INFLUVAC
® TETRA (SAISON 2019/2020)
_ _
1. PRODUCT NAME
Influvac Tetra (Saison 2019/2020), 15/15/15/15 microgram
haemagglutinin per 0.5 mL, Suspension
for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influvac Tetra (Saison 2019/2020)
is a purified, inactivated influenza vaccine (surface antigen),
containing the following four influenza strains:
•
A/Brisbane/02/2018 (H1N1)pdm09-like strain
(A/Brisbane/02/2018, IVR-190)
•
A/Kansas/14/2017 (H3N2)-like strain
(A/Kansas/14/2017, NYMC X-327)
•
B/Colorado/06/2017-like strain
(B/Maryland/15/2016, NYMC BX-69A)
•
B/Phuket/3073/2013-like strain
(B/Phuket/3073/2013, wild type)
Each 0.5 mL dose contains 15 micrograms haemagglutinin per each of the
above mentioned viral
strains, for a combined total of 60 micrograms. Each strain has been
propagated in fertilised hens’
eggs from healthy chickens.
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the 2019/2020 season.
For a full list of excipients, see section 6.1.
Influvac Tetra antigens have been produced from eggs and are
inactivated by formaldehyde
treatment. Each 0.5 mL may also contain not more than 100 nanograms
ovalbumin, 0.01 mg
formaldehyde, 0.02 mg cetrimonium bromide, 1 mg sodium citrate, 0.2 mg
sucrose, 1 nanograms
gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and
polysorbate 80 which are used
during the manufacturing process.
3. PHARMACEUTICAL FORM
Influvac Tetra is a clear colourless liquid for injection in
pre-filled syringes.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
For the prevention of influenza caused by influenza virus, types A and
B.
Page 2 of 9
For full details regarding recommendations for influenza vaccination,
please refer to the relevant
National Immunisation Guidelines.
Influvac Tetra (Saison 2019/2020) is indicated in adults and children
3 years of age and older at low
risk of complications from influenza.
_4.2 _
_DOSE AND METHOD OF ADM