Rotarix

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J07BH01

Dosage:

Not less than 10⁶ CCID₅₀/dose (1.0 ml)

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN Not less than 10⁶ CCID₅₀/dose (1.0 ml)

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Biologicals s.a.

Authorization status:

ACTIVE

Authorization date:

2005-10-05

Patient Information leaflet

  
1 

R
OTARIX
TM

ROTARIX
TM
 IS FOR ORAL USE ONLY AND SHOULD UNDER NO CIRCUMSTANCES BE 
INJECTED.

1 – NAME OF THE MEDICINAL PRODUCT 
ROTARIX
TM

Rotavirus vaccine, Live, Oral.   

2 - QUALITATIVE AND QUANTITATIVE COMPOSITION 
After reconstitution, 1 dose (1 ml) contains : 

Live attenuated human rotavirus RIX4414 strain of the G1P[8] type:
 not less than 10
6.0

CCID
50

For excipients, see section 6.1. 

3 - PHARMACEUTICAL FORM 
Lyophilised vaccine to be reconstituted with a liquid diluent
before ORAL administration. 

4 - CLINICAL PARTICULARS 
4.1 THERAPEUTIC 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
section 4.2 and 5.1).   

4.2 POSOLOGY AND METHOD OF 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 (1.0 mL) of
the ORAL 
applicator ORALLY on the insid

Summary of Product characteristics

1
R
OTARIX
TM
ROTARIX
TM
IS FOR
ORAL
USE ONLY AND SHOULD UNDER NO CIRCUMSTANCES BE
INJECTED.
1 – NAME OF THE MEDICINAL PRODUCT
ROTARIX
TM
Rotavirus vaccine, Live, Oral.
2 - QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1 ml) contains :
Live attenuated human rotavirus RIX4414 strain of the G1P[8] type: not
less than 10
6.0
CCID
50
For excipients, see section 6.1.
3 - PHARMACEUTICAL FORM
Lyophilised vaccine to be reconstituted with a liquid diluent before
ORAL
administration.
4 - CLINICAL PARTICULARS
4.1 THERAPEUTIC 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 section
4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF 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 (1.0 mL) of the
ORAL
applicator
ORALLY
on the inside of the cheek. The vaccine should be administered
immediately after reconstitution.
ROTARIX
TM
SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
2
There are no restrictions on the infant’s consumption of food or
liq