Intanza Suspension for Injection 15mcg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

INFLUENZA VIRUS (NH) A/California/7/2009 (H1N1)pdm09-Derived Strain

Fáanlegur frá:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC númer:

J07BB02

Skammtar:

15 mcg HA/0.1ml

Lyfjaform:

INJECTION, SUSPENSION

Stjórnsýsluleið:

INTRADERMAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

SANOFI WINTHROP INDUSTRIE

Leyfisdagur:

2011-11-03

Upplýsingar fylgiseðill

INTANZA 15 MICROGRAMS, SUSPENSION FOR INJECTION *
NAME OF THE MEDICINAL PRODUCT
Intanza 15 microgram/strain suspension for injection.
Influenza vaccine (split virion, inactivated).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/California/7/2009 (H1N1)pdm09-derived strain used (NYMC X-179A)
……15 micrograms HA**
A/Texas/50/2012 (H3N2)-derived strain used (NYMC X-223A). . . . . . .
. . . . . . . . . . . . . . . . . .………………15 micrograms
HA**
B/Massachusetts/2/2012……………………………………………………..15
micrograms HA** Per 0.1 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the 2014/2015 season.
For the full list of excipients, see section 6.1.
Intanza may contain residues of eggs such as ovalbumin and residues of
neomycin, formaldehyde and octoxinol 9, which are used during the
manufacturing process (see section 4.3).
3. PHARMACEUTICAL FORM
Suspension for injection.
Colourless and opalescent suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza in individuals 60 years of age and over,
especially in those who run an increased risk of associated
complications.
The use of Intanza should be based on official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals 60 years of age and over: 0.1 ml.
Method of admistration
Immunisation should be carried out by intradermal route.
The recommended site of administration is the region of the deltoid.
_Precaution to be taken before handling or administering the medicinal
product_
For instructions on preparation of the medicinal product before
administration, see section 6.6.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to any of the excipients
listed in section 6.1, or to any residues such as eggs (ovalbumin and
to chicken proteins), neomycin, formaldehyde and oc