Rotavirus Vaccine 2 dose Lyophilisade for the preparation of injection suspension with diluent 10^5.6 FFU/Serotype

البلد: تانزانيا

اللغة: الإنجليزية

المصدر: Tanzania Medicinces & Medical Devices Authority

العنصر النشط:

Live Attenuated Rotavirus Vaccine

متاح من:

Serum Institute of India Pvt. Ltd. (SIIPL), INDIA

ATC رمز:

Infectious bursa disease

INN (الاسم الدولي):

Live Attenuated Rotavirus Vaccine

جرعة:

10^5.6 FFU/Serotype

الشكل الصيدلاني:

Lyophilisade for the preparation of injection suspension with diluent

المصنعة من قبل:

Serum Institute of India Limited, INDIA

ملخص المنتج:

Physical description: Pinkish to yellowish-white mass; Local technical representative: JILICHEM (T) Limited (5053)

الوضع إذن:

Registered/Compliant

تاريخ الترخيص:

2021-11-26

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rotavirus Vaccine, Live Attenuated, (Oral) (Freeze-Dried)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2.5 mL contains:
Live Attenuated Bovine-Human Rotavirus Reassortant
[G1, G2, G3, G4 and G9]* ≥ 10
5.6
FFU / serotype.
Reconstitute with Diluent for Rotavirus Vaccine.
Diluent is a sterile solution (Citrate Bicarbonate Buffer) prepared
using
9.6 mg/mL citric acid and 25.6 mg/mL sodium bicarbonate.
* Grown on vero cells.
Excipient(s) with known effect
Eagle's MEM (Minimum Essential Medium with Hank's Salts, Glutamine
and Sodium bicarbonate). Sucrose and Glycine.
The vaccine is supplied along with a 2.5 mL vial for one dose and 5 mL
vial for two
doses of buffered diluent. This vaccine contains no preservatives.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lyophilized powder to be reconstituted with buffered diluent for oral
administration.
Description: Pinkish to yellowish white mass.
Appearance: Pinkish to yellowish liquid when reconstituted with
diluent and may contain
inherent product aggregates.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rotavirus Vaccine, Live Attenuated, (Oral) is indicated for active
immunization of
healthy infants from the age of 6 weeks for the prevention of
gastroenteritis due to
rotavirus infection when administered as a 3-dose series.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL) IS FOR ORAL ADMINISTRATION
ONLY AND MUST _
_NOT BE INJECTED_.
_DOSAGE:_ Rotavirus Vaccine, Live Attenuated (Oral) should be
administered as a 3-dose
regimen, 4 weeks apart, beginning at 6 weeks of age. Based on
recommendations
from the World Health Organization, if the routine childhood
immunizations are initiated
later than 6 weeks of age and/or at a longer dose interval than
4-weeks, Rotavirus
Vaccine, Live Attenuated (Oral) can still be administered, by itself
or concomitantly
with
DTP,
inactivated
poliovirus
vaccine
(IPV),
oral
poliovirus
vaccine
(OPV),
H.