RotaTeq solution oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rotavirus type G1, rotavirus type G2, rotavirus type G3, rotavirus type G4, rotavirus type P1A

Available from:

Merck Sharp & Dohme B.V. Waarderweg 39

ATC code:

J07BH02

INN (International Name):

rotavirus type G1, rotavirus type G2, rotavirus type G3, rotavirus type G4, rotavirus type P1A

Dosage:

not less than 2,2x10^6IU+ not less than 2,8x106IU+ not less than 2,2x10^6IU+ not less than 2x10^6IU+ not less than 2,3x10^6IU

Pharmaceutical form:

solution oral

Units in package:

(1) plastic tube 2ml and (10) plastic tube 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-06-29

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
RotaTeq
Solution for oral administration
RotaTeq is a live, oral pentavalent vaccine for use in the prevention
of rotavirus gastroenteritis.
The vaccine contains 5 live reassortant rotaviruses. The rotavirus
parent strains of the reassortants
were isolated from human and bovine hosts. Four reassortant
rotaviruses express one of the outer
capsid VP7 proteins (serotype G1, G2, G3, or G4) from the human
rotavirus parent strains and
the VP4 attachment protein (serotype P7[5]) from the bovine rotavirus
parent strain. The fifth
reassortant virus expresses the VP4 attachment protein (serotype
P1A[8]) from the human
rotavirus parent strain and the outer capsid VP7 protein (serotype G6)
from the bovine rotavirus
parent strain.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (2.0 mL) contains:
_ACTIVE INGREDIENTS_
: human-bovine rotavirus reassortants (live), produced in Vero cells:
G1, G2,
G3, G4, and P1A[8].
The minimum dose levels of the reassortants are as follows:
rotavirus type G1
not less than 2.2 x 10
6
infectious units
rotavirus type G2
not less than 2.8 x 10
6
infectious units
rotavirus type G3
not less than 2.2 x 10
6
infectious units
rotavirus type G4
not less than 2.0 x 10
6
infectious units
rotavirus type P1A[8]
not less than 2.3 x 10
6
infectious units
This vaccine contains 1 080 mg sucrose.
3.
PHARMACEUTICAL FORM
Solution for oral administration
Pale yellow clear liquid that may have a pink tint
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RotaTeq is indicated for the active immunisation of infants from the
age of 6 weeks to 32 weeks
for prevention of gastroenteritis due to rotavirus infection.
RotaTeq is to be used on the basis of official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology. _
_From birth to 6 weeks _
RotaTeq is not indicated in this subset of pediatric population.
The safety and efficacy of RotaTeq in individuals from birth to 6
weeks of age have not been
established.
_From 6 weeks to 32 wee