PRIORIX TETRA

Ország: Indonézia

Nyelv: indonéz

Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktív összetevők:

LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN), LIVE ATTENUATED MUMPS VIRUS (RIT4385 STRAIN), LIVE ATTENUATED RUBELLA VIRUS (RA27/3 STRAIN), LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Beszerezhető a:

SMITHKLINE BEECHAM PHARMACEUTICALS - Indonesia

INN (nemzetközi neve):

LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN), LIVE ATTENUATED MUMPS VIRUS (RIT4385 STRAIN), LIVE ATTENUATED RUBELLA VIRUS (RA27/3 STRAIN), LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Adagolás:

LEBIH BESAR DARI ATAU SAMA DENGAN 10 PANGKAT 3.0 CCID_50 /LEBIH BESAR DARI ATAU SAMA DENGAN 10 PANGK

Gyógyszerészeti forma:

SERBUK INJEKSI + PELARUT

db csomag:

DUS, 1 VIAL + 1 PREFILLED SYRINGE PELARUT @ 0,5 ML + 2 JARUM

Gyártó:

GlaxoSmithKline Biologicals SA - Belgium

Engedély dátuma:

2022-04-05

Termékjellemzők

ERS_leaPRItetinj_MA Transfer SBP to GWI (Project
Rinjani)_circ1_24Jan22
Page 1 of 8
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 12 months up to 6 years of
age inclusive against measles, mumps, rubella and varicella (see also
“_Warnings and Precautions)._
DOSAGE AND ADMINISTRATION
Posology
Subjects from the age of 12 months up to 6 years of age should receive
2 doses of _PRIORIX-TETRA_ to ensure
optimal protection against measles, mumps, rubella and varicella (see
_Pharmacodynamics_). 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.
Alternatively, and in accordance with applicable official
recommendations*:
-
A single dose of _PRIORIX-TETRA_ may be administered to children who
have already received a single
dose of another measles, mumps and rubella (MMR) vaccine and/or a
single dose of another
varicella vaccine**.
-
A single dose of _PRIORIX-TETRA_ may be administered followed by a
single dose of another measles,
mumps and rubella (MMR) vaccine and/or a single dose of another
varicella vaccine.
_* Applicable official recommendations may vary regarding the interval
between doses of measles, mumps_
_and rubella and of