AGRIPPAL S1 INFLUENZA VACCINE

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

INFLUENZA VIRUS (SH) A/CALIFORNIA/07/2009 (H1N1) pdm09- LIKE STRAIN; INFLUENZA VIRUS (SH) A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN; INFLUENZA VIRUS (SH) B/BRISBANE/60/2008 - LIKE STRAIN

Disponible des:

SEQIRUS PTE. LTD.

Codi ATC:

J07BB02

Dosis:

15 mcg HA/0.5ml

formulario farmacéutico:

INJECTION

Composición:

INFLUENZA VIRUS (SH) A/CALIFORNIA/07/2009 (H1N1) pdm09- LIKE STRAIN 15 mcg HA/0.5ml; INFLUENZA VIRUS (SH) A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN 15 mcg HA/0.5ml; INFLUENZA VIRUS (SH) B/BRISBANE/60/2008 - LIKE STRAIN 15 mcg HA/0.5ml

Vía de administración:

SUBCUTANEOUS, INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricat per:

Glaxosmithkline Vaccines S.r.l.

Estat d'Autorització:

ACTIVE

Data d'autorització:

2001-04-18

Informació per a l'usuari

AGRIPPAL S1-Novartis Vaccines and Diagnostics S.r.l. 
PIL - GB 
Page 1 of 5 
March 2014 
Confidential 

AGRIPPAL
™ 
S1, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 
INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED) 
2014/2015 Season 

COMPOSITION. 
One  dose    (0.5    ml)    contains:    ACTIVE    INGREDIENTS:    Influenza    virus    surface    antigens 
(haemagglutinin  and  neuraminidase),  propagated  in  fertilized  hen’s  eggs  from  healthy  chicken 
flocks, and inactivated with formaldehyde, of
the following strains: 

A/California/7/2009 (H1N1)pdm09-like strain 
(A/California/7/2009, NYMC X-181)                      

    15 micrograms HA* 

A/Texas/50/2012(H3N2)-like strain 
(A/Texas/50/2012, NYMC X-223)                      

  15 micrograms HA* 

B/Massachusetts/2/2012-like strain 
(B/Massachusetts/2/2012 wild type)                     

  15 micrograms HA* 

*haemagglutinin 

This vaccine complies with the WHO recommendations (northern hemisphere) and
EU decision 
for the 2014/2015 season. 

EXCIPIENTS:  sodium  chloride;  potassium  chloride;  potassium  dihydrogen  phosphate;  disodium 
phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate and water for 
injection. 

AGRIPPAL  S1  may  contain  traces  of  eggs  such  as  ovalbumin  or  chicken  proteins,  kanamycin 
sulphate,  neomycin  sulphate,  formaldehyde,  cetyltrimethylammonium  bromide  (CTAB), 
polysorbate 80 and barium sulphate which are used
during the manufacturing process. 

PHARMACEUTICAL FORM AND CONTENTS. 
Suspension for injection in pre-filled syringe. 
0.5 ml in pr

Fitxa tècnica

AGRIPPAL S1-Seqirus S.r.l
January 2016
PIL -
GB
Page 1 of
5
Confidential
AGRIPPAL
™
S1, SUSPENSION FOR INJECTION IN PRE-FILLED SY
RINGE
INFLUENZA VACCINE (SURFACE ANTIGEN,
I
N
ACTIVATE
D)
2016 S
ea
son
COMPOSITION.
One dose (0.5 ml) contains: ACTIVE INGREDIENTS: Influenza virus
surface antigens
(haemagglutinin and neuraminidase), propagated in fertilized hen’s
eggs from healthy chicken
flocks, and inactivated with formaldehyde, of the following strains:
A/California/7/2009 (H1N1)pdm09-like strain
(A/California/7/2009, NYMC X-181) 15 micrograms HA*
A/Hong Kong/4801/2014 (H3N2)-like strain
(A/New Caledonia/71/2014, NYMC X-257A) 15 micrograms HA*
B/Brisbane/60/2008-like
strain
(B/Brisbane/60/2008, wild type) 15 micrograms HA*
*haemagglutinin
This vaccine complies with the WHO recommendations (southern
hemisphere) for the 2016
season.
EXCIPIENTS: sodium chloride; potassium chloride; potassium dihydrogen
phosphate; disodium
phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride
dihydrate and water for
injection.
AGRIPPAL S1 may contain traces of eggs such as ovalbumin or chicken
proteins, kanamycin
sulphate,
neomycin
sulphate,
formaldehyde,
cetyltrimethylammonium
bromide
(CTAB),
polysorbate 80 and barium sulphate which are used during the
manufacturing process.
PHARMACEUTICAL FORM AND CONTENTS.
Suspension for injection in pre-filled syringe.
0.5 ml in pre-filled syringe in box of 1 or 10.
The vaccine appears as a clear liquid.
Not all pack sizes may be marketed.
PHARMACOTHERAPEUTIC CATEGORY.
Influenza vaccine, ATC code: J07BB02.
INDICATIONS.
Prophylaxis of influenza (flu), especially in those who run an
increased risk of associated
complications.
AGRIPPAL S1 is indicated in adults and children from 6 months of age.
The use of AGRIPPAL S1 should be based on official recommendations.
CONTRAINDICATIONS.
AGRIPPAL S1-Seqirus S.r.l
January 2016
PIL -
GB
Page 2 of
5
Confidential
Hypersensitivity to the active substances, to any of the excipients or
residues (e.g., egg or
chicken proteins, such as ovalbumin