Priorix-Tetra

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Live attenuated measles virus (Schwarz strain); Live attenuated mumps virus (RIT4385 strain); Live attenuated rubella virus (Wistar RA 27/3 strain); Live attenuated varicella virus (OKA strain)

Saatavilla:

GLAXOSMITHKLINE PTE LTD

ATC-koodi:

J07BD54

Annos:

≥ 10 3.0 CCID50 /dose

Lääkemuoto:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Koostumus:

Live attenuated measles virus (Schwarz strain) ≥ 10³ CCID50/dose; Live attenuated mumps virus (RIT4385 strain) ≥ 10⁴·⁴ CCID50/dose; Live attenuated rubella virus (Wistar RA 27/3 strain) ≥ 10³ CCID50/dose; Live attenuated varicella virus (OKA strain) ≥ 10³·³ PFU/dose

Antoreitti:

SUBCUTANEOUS, INTRAMUSCULAR

Prescription tyyppi:

Prescription Only

Valmistaja:

GlaxoSmithKline Biologicals s.a.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2009-04-03

Pakkausseloste

_GLAXOSMITHKLINE _
Priorix-Tetra™  
- 1 - 

PRIORIX-TETRA™ 
MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE
(LIVE, ATTENUATED) 
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 
PHARMACEUTICAL FORM 
Powder and diluent for solution for injection. 
CLINICAL PARTICULARS 
INDICATIONS 
_Priorix-Tetra_
_TM_
 is indicated for active immunisation in subjects from the age of
12 months 
onwards up to 12 years of age inclusive against measles, mumps,
rubella and varicella. (see 
also Warnings and Precautions, Pharmacodynamics). 
DOSAGE AND ADMINISTRATION 
POSOLOGY 
Primary immunisation consists of one dose of vaccine. 
A second dose of measles-containing vaccine should be administered
according to the 
Singapore’s national immunization program
.

It is preferable to respect an interval of at least 6 weeks between
doses. In no circumstances  
should this interval be less than 4 weeks. 
METHOD OF ADMINISTRATION 
For subcutaneous injection, preferably into the outer aspect of
upper arm. 
For information on instructions for preparation or reconstitution
please refer to the Use and 
handling section. 

_GLAXOSMITHKLINE _
_ _
Priorix-Tetra™  
- 2 - 
CONTRAINDICATIONS 
_Priorix-Tetra_
_TM_
 is contraindicated in subjects with known hypersensitivity to
neomycin or to 
any other component of the vaccine (for egg allergy, see Warnings and
Precautions). A 
history of contact dermatitis to

Valmisteyhteenveto

_ _
_ _
- 1 -
PRIORIX-TETRA
MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE (LIVE, ATTENUATED)
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 of subjects from the age of 12
months
against measles, mumps, rubella and varicella. (see also
_Warnings and Precautions, _
_Pharmacodynamics_
).
The use of
_Priorix-Tetra_
should be based on official recommendations.
DOSAGE AND ADMINISTRATION
POSOLOGY
Primary immunisation consists of one dose of vaccine.
A second dose of measles-containing vaccine should be administered
according to the
Singapore’s national immunization program.
It is preferable to respect an interval of at least 6 weeks between
doses. In no circumstances
should this interval be less than 4 weeks.
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.
_ _
_ _
- 2 -
The vaccine should be administered subcutaneously in subjects with
bleeding disorders (e.g.
thrombocytopenia or any coagulation disorder).
For instructions on reconstitution of the medicinal product before
administration, see
_Instructions for Use/Handling_
.
CONTRAINDICATIONS
_Priorix-Tetra_
is contraindicated in subjects with known hypersensitivity to neomycin
or to
any other component of the vaccine (for egg allergy,