PRIORIX-TETRA POWDER AND DILUENT FOR SOLUTION FOR INJECTION

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED VARICELLA OKA STRAIN VIRUS

Beszerezhető a:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (nemzetközi neve):

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED VARICELLA OKA STRAIN VIRUS

db csomag:

1Units Units; 1Units Units

Gyártó:

GLAXOSMITHKLINE BIOLOGICALS S.A

Betegtájékoztató

Not Applicable

Termékjellemzők

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PRIORIX-TETRA
MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Live attenuated measles virus
1
(Schwarz strain)
not less than 10
3.0
CCID
50
3
Live attenuated mumps virus
1
(RIT 4385 strain, derived from Jeryl Lynn strain)
not less than 10
4.4
CCID
50
3
Live attenuated rubella virus
2
(Wistar RA 27/3 strain)
not less than 10
3.0
CCID
50
3
Live attenuated varicella virus
2
(OKA strain)
not less than 10
3.3
PFU
4
1
produced in chick embryo cells
2
produced in human diploid (MRC-5) cells
3
Cell Culture Infective Dose 50%
4
Plaque forming units
The powder is white to slightly pink.
The solvent is clear and colourless.
CLINICAL -INFORMATION
INDICATIONS
Priorix-Tetra
_ _
is indicated for active immunisation in subjects from the age of 9
months up
to 12 years of age inclusive against measles, mumps, rubella and
varicella.
(see also
“Warnings and Precautions”).
DOSAGE AND ADMINISTRATION
POSOLOGY
Primary immunisation consists of one dose of vaccine.
If official recommendations call for additional doses of measles,
mumps, rubella and/or varicella,
Priorix-Tetra
_ _
can be used for these doses.
The dose interval should preferably be between 6 weeks and 3 months.
In no circumstances should
this interval be less than 4 weeks.
MMR-varicella vaccination at the age of 9-11 months should be
considered in certain cases in
infants at increased risk of measles. However it should then be borne
in mind that infants in their
first year of life may not respond sufficiently to the components of
the vaccine due to the possible
interference with maternal antibodies. A second dose of Priorix-Tetra
_ _
should be
given three
months after the first dose.
METHOD OF ADMINISTRATION
The vaccine is to be injected subcutaneously (SC) or intramuscularly
(IM) in the deltoid region or
in the anterolateral area of the thigh.
The vaccine should be administered subcutaneously in subjects with
bleeding dis