Priorix powder lyophilized and solvent for solution for injection

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

live attenuated measles virus(Schwarz strain), live attenuated mumps virus(RIT 4385 strain), live attenuated rubella virus(Wistar RA 27/3 strain)

Beschikbaar vanaf:

GlaxoSmithKline Biologicals s.a.

ATC-code:

J07BD52

INN (Algemene Internationale Benaming):

live attenuated measles virus(Schwarz strain), live attenuated mumps virus(RIT 4385 strain), live attenuated rubella virus(Wistar RA 27/3 strain)

Dosering:

not less than 103.0CCID50/dose+ not less than 103.7CCID50/dose+ not less than 103.0CCID50/dose

farmaceutische vorm:

powder lyophilized and solvent for solution for injection

Eenheden in pakket:

glass vial/dose and 0.5ml solvent in ampoule

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2016-06-08

Bijsluiter

Qualitative and Quantitative composition
_Priorix_
_TM_
is a lyophilised mixed preparation of the
attenuated Schwarz measles, RIT 4385 mumps (derived
from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of
viruses, separately obtained by propagation either in chick
embryo tissue cultures (mumps and measles) or MRC-5
human diploid cells (rubella).
_Priorix_
_TM_
meets the World Health Organisation requirements
for manufacture of biological substances and for measles,
mumps and rubella vaccines and combined vaccines (live).
Each 0.5 ml dose of the reconstituted vaccine contains not
less than 10
3.0
CCID
50
of the Schwarz measles, not less
than 10
3.7
of the RIT 4385 mumps, and not less than 10
3.0
CCID
50
of the Wistar RA 27/3 rubella virus strains.
The powder is white to slightly pink.
The solvent is clear and colourless.
pharmaceutical form
Powder and solvent for solution for injection.
clinical particulars
indications
_Priorix_
_TM_
is indicated for the active immunisation against measles,
mumps and rubella.
dosage and administration
posology
A single 0.5 ml dose of the reconstituted vaccine is recommended.
As vaccination schemes vary from country to country, the advised
schedule for each country must be in accordance with the national
recommendations.
method of administration
_Priorix_
_TM_
is for subcutaneous injection, although it can also be given by
intramuscular injection, in the deltoid region or in the anterolateral
area
of the thigh (see “Warnings and Precautions”).
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_
_TM_
is contraindicated in subjects with known systemic
hypersensitivity to neomycin or to any other component of the vaccine
(for egg allergy, see “Warnings and Precautions”). A history of
contact
dermatitis to neomycin is not a contra-indic

Productkenmerken

- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PRIORIX
TM
,
MEASLES, MUMPS AND RUBELLA VACCINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIORIX

is a lyophilised mixed preparation of the attenuated Schwarz measles,
RIT 4385
mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella
strains of viruses,
separately obtained by propagation either in chick embryo tissue
cultures (mumps and
measles) or MRC-5 human diploid cells (rubella).
PRIORIX

meets the World Health Organisation requirements for manufacture of
biological
substances and for measles, mumps and rubella vaccines and combined
vaccines (live).
Each 0.5 ml dose of the reconstituted vaccine contains not less than
10
3.0
CCID
50
of the
Schwarz measles, not less than 10
3.7
of the RIT 4385 mumps, and not less than 10
3.0
CCID
50
of the Wistar RA 27/3 rubella virus strains.
The powder is white to slightly pink.
The solvent is clear and colourless.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
PRIORIX

is indicated for the active immunisation against measles, mumps and
rubella.
4.2 DOSAGE AND ADMINISTRATION
_ _
POSOLOGY
A single 0.5 ml dose of the reconstituted vaccine is recommended.
As vaccination schemes vary from country to country, the advised
schedule for each country
must be in accordance with the national recommendations.
METHOD OF ADMINISTRATION
PRIORIX

is for subcutaneous injection, although it can also be given by
intramuscular
injection, in the deltoid region or in the anterolateral area of the
thigh (see “Warnings and
Precautions”).
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”.
- 2 -
4.3 CONTRAINDICATIONS
PRIORIX

is contraindicated in subjects with known systemic hypersensitivity to
neomycin or
to any other compone