ROTARIX

Riik: Indoneesia

keel: indoneesia

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

Toimeaine:

LIVE ATTENUATED HUMAN ROTAVIRUS (RIX4414 STRAIN)

Saadav alates:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

LIVE ATTENUATED HUMAN ROTAVIRUS (RIX4414 STRAIN)

Annus:

NLT 1000000 CCID_50

Ravimvorm:

SUSPENSI

Ühikuid pakis:

DUS, 1 ORAL APPLICATOR @ 1,5 ML

Valmistatud:

GlaxoSmithKline Biologicals SA - Belgium

Loa andmise kuupäev:

2021-12-31

Toote omadused

ERS_leaROTOA_Update PI GDS018IPI1 (PCV free)_circ2_5Sep22
_Page 1 of 10 _
ROTARIX
ROTAVIRUS VACCINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1.5 mL) contains:
Live attenuated human rotavirus RIX4414 strain
not less than 10
6.0
CCID
50
PHARMACEUTICAL FORM
ORAL suspension.
The vaccine is a clear and colourless liquid.
CLINICAL PARTICULARS
INDICATIONS
_ROTARIX_ is indicated for the prevention of gastroenteritis caused by
rotavirus (_see sections Warnings _
_and Precautions and Pharmacodynamics_).
DOSAGE AND ADMINISTRATION
POSOLOGY
The vaccination course consists of two doses. The first dose may be
administered from the age of 6
weeks. There should be an interval of at least 4 weeks between doses.
The vaccination course should
be completed by the age of 24 weeks.
_ROTARIX_ may be given to preterm infants with the same posology (_see
sections Adverse Reactions _
_and Pharmacodynamics_).
In clinical trials, spitting or regurgitation of the vaccine has
rarely been observed and, under such
circumstances, a replacement dose was not given. However, in the
unlikely event that an infant s pits
out or regurgitates most of the vaccine dose, a single replacement
dose may be given at the same
vaccination visit.
It is strongly recommended that infants who receive a first dose of
_ROTARIX_ complete the 2-dose
regimen with _ROTARIX_.
METHOD OF ADMINISTRATION
_ROTARIX_ is for ORAL use only.
_ROTARIX_ SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
There are no restrictions on the infant’s consumption of food or
liquid, including breast -milk, either
before or after vaccination.
Based on evidence generated in clinical trials, breast-feeding does
not reduce the protection against
rotavirus gastroenteritis afforded by _ROTARIX_. Therefore,
breast-feeding may be continued during the
vaccination schedule.
For information on instructions for administration _see section
Instructions for Use/Handling_.
CONTRAINDICATIONS
_ROTARIX_ should not be administered to subjects with known
hypersensitivity after previous
administration of _ROTARI