PRIORIX

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS

Prieinama:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kodas:

J07BJ51

Vaisto forma:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sudėtis:

LIVE ATTENUATED MUMPS VIRUS 10^3.7 CCID50; LIVE ATTENUATED RUBELLA VIRUS 10^3.0 CCID50; LIVE ATTENUATED MEASLES VIRUS 10^3.0 CCID50

Vartojimo būdas:

S.C, I.M

Recepto tipas:

Required

Pagaminta:

GLAXO SMITH KLINE BIOLOGICALS S.A

Farmakoterapinė grupė:

RUBELLA, COMBINATIONS WITH MUMPS, LIVE ATTENUATED

Gydymo sritis:

RUBELLA, COMBINATIONS WITH MUMPS, LIVE ATTENUATED

Terapinės indikacijos:

Priorix is indicated for active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.

Leidimo data:

2023-08-31

Pakuotės lapelis

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
PRIORIX
POWDER AND SOLUTION FOR PREPARATION OF A SOLUTION FOR INJECTION
Each dose (0.5 ml) contains:
NLT 10
3.0
CCID
50
–
Live attenuated measles virus
NLT 10
3.7
CCID
50
–
Live attenuated mumps virus
NLT 10
3.0
CCID
50
–
Live attenuated rubella virus
For a list of the inactive and allergenic ingredients in the
preparation, see section 2 –
“Important information about some of the ingredients of the
medicine” and section 6 –
“Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Active immunisation of children from the age of 9 months or older,
adolescents and adults
against measles, mumps and rubella.
THERAPEUTIC GROUP: viral vaccines.
HOW DOES THE VACCINE WORK?
When a person is vaccinated with Priorix, the immune system (the
body’s natural defense
system) will make antibodies to protect the person from measles, mumps
and rubella
virus infections.
Although Priorix contains live viruses, they are too weak to cause
measles, mumps or
rubella in healthy people.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
-
you are sensitive (allergic) to one of the active ingredients or to
any of the additional
ingredients contained in the medicine (listed in section 6 “Further
information”). Signs
of an allergic reaction may include itchy skin rash, shortness of
breath and swelling
of the face or tongue.
-
you are known to be allergic to neomycin (an antibiotic agent). A
known contact
dermatitis (skin rash when the skin is in direct contact with
allergens such as
neomycin) should not be a

Prekės savybės

Page 1 of 10
PRIORIX
1
.
NAME OF THE MEDICINAL PRODUCT
PRIORIX
Powder and solvent for solution for injection
Measles, Mumps and Rubella vaccine (live)
2.
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
3.7
CCID
50
3
Live attenuated rubella virus
2
(Wistar RA 27/3 strain)
not less than 10
3.0
CCID
50
3
1
produced in chick embryo cells
2
produced in human diploid (MRC-5) cells
3
Cell Culture Infective Dose 50%
This vaccine contains a trace amount of neomycin. See section 4.3.
Excipients with known effect:
The vaccine contains 9 mg of sorbitol.
The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose
and 334
micrograms of phenylalanine per dose (see section 4.4).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The lyophilised Measles-Mumps-Rubella component is a white to slightly
pink
powder.
The solvent is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
PRIORIX is indicated for active immunisation of children from the age
of 9 months or older,
adolescents and adults against measles, mumps and rubella.
For use in children between 9 to 12 months of age see sections 4.2,
4.4 and 5.1.
4.2 Posology and method of administration
Posology
The use of PRIORIX should be based on official recommendations.
Individuals 12 months of age or older
The dose is 0.5 ml. A second dose should be given according to
official recommendations.
Page 2 of 10
PRIORIX may be used in individuals who have previously been vaccinated
with another
monovalent or combined measles, mumps and rubella vaccine.
Infants between 9 and 12 months of age
Infants in their first year of life may not respond sufficiently to
the components of the vaccines.
In case an epidemiological situation requires vaccinating infants in
their f