Rotarix suspension oral

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

human rotavirus vaccine live

Dostupno od:

GlaxoSmithKline Biologicals s.a.

ATC koda:

J07BH01

INN (International ime):

human rotavirus vaccine live

Doziranje:

not less than 10^6CCID^50/dose

Farmaceutski oblik:

suspension oral

Jedinice u paketu:

(50) plastic tube 1.5ml (1 dose)

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2017-07-10

Svojstava lijeka

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rotarix ORAL suspension
Rotavirus vaccine, live
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1.5 ml) contains:
Human rotavirus RIX4414 strain (live, attenuated)*
not less than 10
6.0
CCID
50
*Produced on Vero cells
Excipient with known effect:
This product contains sucrose 1,073 mg (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ORAL suspension.
Rotarix is a clear and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rotarix is indicated for the active immunisation of infants aged 6 to
24 weeks for prevention of gastro-
enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
The use of Rotarix should be based on official recommendations.
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.
Rotarix may be given with the same posology to preterm infants born
after at least 27 weeks of
gestational age (see sections 4.8 and 5.1).
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.
_Paediatric population _
Rotarix should not be used in children over 24 weeks of age.
Method of administration
Rotarix is for ORAL use only.
ROTARIX