CERVIDIL

Šalis: Indonezija

kalba: indoneziečių

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

Veiklioji medžiaga:

DINOPROSTONE

Prieinama:

ABBOTT INDONESIA - Indonesia

INN (Tarptautinis Pavadinimas):

DINOPROSTONE

Dozė:

10 MG

Vaisto forma:

PESSARY

Vienetai pakuotėje:

DUS, 1 SACHET @ 1 PESSARY

Pagaminta:

FERRING CONTROLLED THERAPEUTICS LIMITED - United Kingdom

Leidimo data:

2020-07-08

Prekės savybės

PROPOSED PACKAGING MATERIAL
Code
PROP-I-ID-01.02
Size
1’s
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
PROP-I-ID-01.01
Changes
BPOM Deficiency Letter 25 Jul 2019 to revise the indication, posology
and contraindications.
Reference

CCDS version: R-Company Core Data
Sheet-5971 Ver 2.0, 29 Feb 2016
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
INS, 13-Aug-2019
1
CERVIDIL
DINOPROSTONE
Vaginal delivery system 10 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal delivery system consists of a non-biodegradable polymeric
drug delivery device containing
10 mg dinoprostone (Prostaglandin E2) dispersed throughout its matrix.
CERVIDIL is a thin, flat, semi-transparent polymeric slab which is
rectangular in shape with rounded corners
contained within a knitted polyester retrieval system.
Each insert contains 10 mg dinoprostone (prostaglandin E2) dispersed
throughout its matrix, and releases
approximately 0.3 mg/hour PGE2 over a 12 hour period. The reservoir of
10 mg dinoprostone serves to
maintain constant release. The retrieval system consists of a
one-piece knitted polyester pouch and withdrawal
tape. This ensures easy and reliable removal of the insert when the
patient’s requirement for PGE2 has been
fulfilled or an obstetric event makes it necessary to stop further
drug administration.
Each insert contains 10 mg of dinoprostone in 236 mg of a cross-linked
polyethylene oxide/urethane polymer
which is a semi-transparent, beige coloured, flat, 0.8 mm thick
rectangular slab measuring 29 mm by 9.5 mm.
The insert and its retrieval system, made of polyester yarn, are
non-toxic and when placed in a moist
environment, absorb water, swell, and release dinoprostone.
Excipients: Crosslinked polyethylene glycol (hydrogel); Polyester yarn
PHARMACEUTICAL FORM
Vaginal delivery system
CERVIDIL is presented as a thin, flat, semi-transparent polymeric
vaginal delivery system which is rectangular
in shape with rounded corners contained within a knitted p