Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 – Siena, Italy
Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Focetria should be used in accordance with Official Guidance.
The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.
One dose of 0.5 ml at an elected date.
Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient.
If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
One dose of 0.5 ml at an elected date.
A second dose of vaccine should be given after an interval of at least three weeks.
One dose of 0.5 ml at an elected date.
Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient. If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
One dose of 0.5 ml at an elected date.
There is a further immune response to a second dose of 0.5 ml administered after an interval of three weeks.
No data are available in children aged less than 6 months (see sections 4.8 and 5.1).
Vaccination is not currently recommended in this age group.
It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
No case of overdose has been reported.
1 year.
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber). Packs of 1 and 10.
Not all pack sizes may be marketed.
The vaccine should be allowed to reach room temperature before use. Gently shake before use.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
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