Adjupanrix Pandemic Influenza Vaccine (split virion inactivated AS03 adjuvanted)

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Split influenza virus, inactivated, containing antigen eqv A/Vietnam/1194/2004 (H5N1)

Հասանելի է:

GLAXOSMITHKLINE PTE LTD

ATC կոդը:

J07BB02

Դեղագործական ձեւ:

INJECTION, EMULSION

Կազմը:

Split influenza virus, inactivated, containing antigen eqv A/Vietnam/1194/2004 (H5N1) 3.75 µg haemagglutinin/dose

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Glaxo Operations UK Ltd., (trading as Glaxo Wellcome Operations) (Antigen: filling)

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2017-05-17

Ապրանքի հատկությունները

ADJUPANRIX
TM
PANDEMIC INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED, AS03
ADJUVANTED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen* equivalent to:
A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75
micrograms**
* propagated in eggs
** haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for
the
pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams),
DL-α-tocopherol (11.86
milligrams) and polysorbate 80 (4.86 milligrams).
The suspension and emulsion vials once mixed form a multidose
container. See
section
_Nature and Contents of Container_
for the number of doses per vial.
Excipient with known effect:
The vaccine contains 5 micrograms thiomersal (see section
_List of Excipients_
).
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
CLINICAL PARTICULARS
INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation.
Pandemic
influenza vaccine should be used in accordance with official guidance.
DOSAGE AND ADMINISTRATION
ADULTS
Adults from the age of 18 years onwards will receive two doses of
ADJUPANRIX™
, 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.
Only 1 dose of
ADJUPANRIX™
may be given to adults previously vaccinated with one
or two doses of Prepandrix containing antigen derived from a different
clade of the
same influenza subtype as the pandemic influenza virus.
Vaccination should be carried out by intramuscular injection
preferably into the
deltoid muscle or anterolateral thigh (depending on the muscle mass).
CHILDREN
The experience in children is limited. (see “
_Adverse Reactions_
” and
“
_Pharmacodynamic_
”).
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 deoxycholat