Rotarix Oral Suspension (Oral Applicator)

Country: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN

Disponibbli minn:

GLAXOSMITHKLINE PTE LTD

Kodiċi ATC:

J07BH01

Dożaġġ:

Not less than 10⁶ CCID₅₀/dose (1.5 ml)

Għamla farmaċewtika:

SUSPENSION

Kompożizzjoni:

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN Not less than 10⁶ CCID₅₀/dose (1.5 ml)

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

GlaxoSmithKline Biologicals s.a.

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2009-12-04

Fuljett ta 'informazzjoni

- 1 - 
Current package insert 
ROTARIX
TM

ROTAVIRUS VACCINE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 dose (1.5 ml) contains: 
Live attenuated human rotavirus RIX4414 strain* of the G1P[8] type:
not less than 10
6.0

CCID
50 

*Produced on Vero cells  

PHARMACEUTICAL FORM 
ORAL suspension. 
The vaccine is a clear and colourless liquid. 

CLINICAL PARTICULARS 
INDICATIONS 
_ROTARIX_
_TM_
 is indicated for the active immunisation of infants from the age
of 6 weeks for 
prevention of gastro-enteritis due to rotavirus infection (_see
sections Dosage and _
_Administration, 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 preferably be given before 16 weeks of age,
but must be completed 
by the age of 24 weeks.  
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 spits out or regurgitates most of the vaccine dose, a single
replacement dose may be 
given at the same vaccination visit. 
It is recommended that infants who receive a first
dose of _ROTARIX_
_TM_
 complete the 2-dose 
regimen with _ROTARIX_
_TM_
. There are no data on safety, immunogenicity or efficacy when 
_ROTARIX_
_TM_
 is administered for the first dose and another rotavirus
vaccine is administered for 
the second dose or vice versa. 

METHOD OF ADMINISTRATION 
_ROTARIX_
_TM_
 is for ORAL use only. Administer the entire content (1.5 ml) of
the ORAL applicator 
ORALLY on the inside of the cheek. 
_ROTARIX_
_TM_
 SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. 

There are no restrictions on the infant’s consumption of food
or liquid, including breas

Karatteristiċi tal-prodott

- 1 -
ROTARIX
ROTAVIRUS VACCINE
ORAL SUSPENSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1.5 ml) contains:
Live attenuated human rotavirus RIX4414 strain* of the G1P[8] type:
not less than 10
6.0
CCID
50
*Produced on Vero cells
The vaccine is a clear and colourless liquid.
CLINICAL INFORMATION
INDICATIONS
_ROTARIX_ is indicated for the active immunisation of infants from the
age of 6 weeks for
prevention of gastro-enteritis due to rotavirus infection (_see
sections Dosage and _
_Administration, 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 preferably be given before 16 weeks of age,
but must be completed
by the age of 24 weeks.
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 spits out or regurgitates most of the vaccine dose, a single
replacement dose may be
given at the same vaccination visit.
It is recommended that infants who receive a first dose of _ROTARIX_
complete the 2-dose
regimen with _ROTARIX_. There are no data on safety, immunogenicity or
efficacy when _ROTARIX_
is administered for the first dose and another rotavirus vaccine is
administered for the second
dose or vice versa.
METHOD OF ADMINISTRATION
_ROTARIX_ is for ORAL use only. Administer the entire content (1.5 ml)
of the ORAL applicator
ORALLY on the inside of the cheek.
_ _
_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.
- 2 -
Based on evidence generated in clinical trials, breast-feeding does
not reduce the protection
against rotavirus gastro-enteritis afforded by _ROTARIX_. Therefore,
breast-feeding may be
continued d