ROTATEQ

Country: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G1, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G2, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G3, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G4, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE P1

Fáanlegur frá:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Alþjóðlegt nafn):

LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G1, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G2, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G3, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G4, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE P1

Skammtar:

2,2 X 10 PANGKAT 6 IU /2,8 X 10 PANGKAT 6 IU /2,2 X 10 PANGKAT 6 IU /2,0 X 10 PANGKAT 6 IU /2,3 X 10

Lyfjaform:

CAIRAN ORAL

Einingar í pakka:

DUS, 10 POUCH @ 1 TUBE @ 2 ML

Framleitt af:

MERCK SHARP & DOHME CORP. - United States of America

Leyfisdagur:

2021-08-05

Vara einkenni

_ _
SOLUTION FOR ORAL ADMINISTRATION
ROTATEQ
(ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT, MSD)
I. THERAPEUTIC CLASS
RotaTeq is a live, oral liquid pentavalent vaccine which protects
against rotavirus gastroenteritis.
II. COMPOSITION
ACTIVE INGREDIENTS
Each 2 mL dose contains the following human-bovine rotavirus
reassortants: G1, G2, G3, G4, and
P1A[8]. The minimum dose levels of the reassortants are as follows:
G1 2.2 X 10
6
infectious units
G2 2.8 X 10
6
infectious units
G3 2.2 X 10
6
infectious units
G4 2.0 X 10
6
infectious units
P1A[8] 2.3 X 10
6
infectious units
The reassortants are propagated in Vero cells using standard tissue
culture techniques in the
absence of antifungal agents.
INACTIVE INGREDIENTS
The reassortant are suspended in a buffered stabilizer solution. Each
vaccine dose contains
sucrose,
sodium
citrate,
sodium
phosphate
monobasic
monohydrate,
sodium
hydroxide,
polysorbate 80 and also culture media. There are no preservatives or
thimerosal present.
III. INDICATIONS
RotaTeq is an oral pentavalent vaccine indicated for the prevention of
rotavirus gastroenteritis in
infants and caused by the serotypes G1, G2, G3, G4, and G-serotypes
that contain P1A[8] (e.g.,
G9). RotaTeq may be administered as early as six weeks of age.
DISETUJUI OLEH BPOM: 18/10/2023
ID EREG100373VR12300309
_ _
IV. DOSAGE AND ADMINISTRATION
FOR ORAL USE ONLY. NOT FOR INJECTION.
Posology
The vaccination series consists of three ready-to-use liquid doses of
RotaTeq administered orally to
infants.
The first dose of RotaTeq should be administered at 6 to 12 weeks of
age; the subsequent doses
should be administered at a minimum interval of 4 weeks between each
dose.
There are no restrictions on the infant’s consumption of food or
liquid, including breast milk, either
before or after vaccination with RotaTeq.
RotaTeq may be given to pre-term infants according to their
chronological age.
If for any reason an incomplete dose is administered (e.g., infant
spits or regurgitates the vaccine),
a replacement dose is not recommended, since