Prepandrix Injection 3.75μg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

PURIFIED ANTIGEN FRACTIONS OF INACTIVATED SPLIT VIRIONS - A/INDONESIA/05/2005 (H5N1)/PR8-IBCDC-RG2

Доступно од:

GLAXOSMITHKLINE PTE LTD

АТЦ код:

J07BB02

Дозирање:

3.75 µg haemagglutinin/0.25 ml

Фармацеутски облик:

INJECTION, EMULSION

Састав:

PURIFIED ANTIGEN FRACTIONS OF INACTIVATED SPLIT VIRIONS - A/INDONESIA/05/2005 (H5N1)/PR8-IBCDC-RG2 3.75 µg haemagglutinin/0.25 ml

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

Prescription Only

Произведен од:

GlaxoSmithKline Biologicals (previously known as Sachsisches Serumwerk Dresden) (for H5N1)

Статус ауторизације:

ACTIVE

Датум одобрења:

2009-03-24

Информативни летак

1 

PREPANDRIX™ 
PREPANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03 
ADJUVANTED) 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
PREPANDRIX™ is an inactivated influenza vaccine (split virion)
of a strain with 
pandemic potential containing antigen (propagated in embryonated eggs)
equivalent 
to A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1) adjuvanted with AS03
composed 
of squalene (10.69 milligrams), DL-
α
-tocopherol (11.86 milligrams) and polysorbate 
80 (4.86 milligrams). 
Each 0.5 ml vaccine dose contains 3.75 µg haemagglutinin of the
recommended strain 
and is adjuvanted with AS03. 

Excipients: It contains 5 micrograms thiomersal.            
PHARMACEUTICAL FORM 
Suspension and emulsion for emulsion for injection. 
CLINICAL PARTICULARS 
INDICATIONS   
Active immunisation against H5N1 subtype of Influenza A virus. This
indication is 
based on immunogenicity data from healthy subjects from the age of
18 years 
onwards following administration of two doses of vaccine prepared
from 
A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1). PREPANDRIX™ should be
used in 
accordance with official recommendations.  
DOSAGE AND ADMINISTRATION 
Adults from the age of 18 years onwards will receive two doses
of PREPANDRIX™, the 
first administered at an elected date, the second at least three
weeks after the first dose 
for maximum efficacy. 
The experience in children is limited (see Adverse Reactions and
Pharmacodynamic 
Effects).   
Vaccination should be carried out by intramuscular injection
preferably into the 
deltoid muscle or anterolateral thigh (depending on the muscle
mass). 

2 
CONTRAINDICATIONS 
History of an anaphylactic reaction (i.e. life-threatening) to any
of the constituents or 
trace residues (egg and chicken protein, ovalbumin, formaldehyde,
gentamicin 
sulphate and sodium deoxycholate) of this vaccine. 

Acute severe febrile illness. Immunisation should be postponed. 

WARNINGS AND PRECAUTIONS 
C

Карактеристике производа

1
PREPANDRIX™
PREPANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03
ADJUVANTED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREPANDRIX™
is an inactivated influenza vaccine (split virion) of a strain with
pandemic potential containing antigen (propagated in embryonated eggs)
equivalent to
A/Indonesia/05/2005 PR8-IBCDC-RG2 (H5N1) adjuvanted with AS03 composed
of
squalene (10.69 milligrams), DL-
α
-tocopherol (11.86 milligrams) and polysorbate 80
(4.86 milligrams).
Each 0.5 ml vaccine dose contains 3.75 µg haemagglutinin of the
recommended strain
and is adjuvanted with AS03.
Excipients: It contains 5 micrograms thiomersal.
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
CLINICAL PARTICULARS
INDICATIONS
Active immunisation against H5N1 subtype of Influenza A virus. This
indication is
based on immunogenicity data from healthy subjects from the age of 18
years onwards
following administration of two doses of vaccine prepared from
A/Indonesia/05/2005
PR8-IBCDC-RG2 (H5N1).
PREPANDRIX™
should be used in accordance with official
recommendations.
DOSAGE AND ADMINISTRATION
Adults from the age of 18 years onwards will receive two doses of
PREPANDRIX™
, the
first administered at an elected date, the second at least three weeks
and up to twelve
months after the first dose for maximum efficacy.
The experience in children is limited (see
_Adverse Reactions_
and
_Pharmacodynamic _
_Effects_
).
Vaccination should be carried out by intramuscular injection
preferably into the
deltoid muscle or anterolateral thigh (depending on the muscle mass).
2
CONTRAINDICATIONS
History of an anaphylactic reaction (i.e. life-threatening) to any of
the constituents or
trace residues (egg and chicken protein, ovalbumin, formaldehyde,
gentamicin
sulphate and sodium deoxycholate) of this vaccine.
Acute severe febrile illness. Immunisation should be postponed.
WARNINGS AND PRECAUTIONS
Caution is needed when administering this vaccine to persons with a
known
hypersensitivity (other than anaphylactic reaction) to th