CRINONE

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

PROGESTERONE

Tersedia dari:

MERCK TBK - Indonesia

INN (Nama Internasional):

PROGESTERONE

Dosis:

90 MG

Bentuk farmasi:

VAGINAL GEL

Unit dalam paket:

DUS, 15 SINGLE USE PRE-FILLED APPLICATOR @ 1,125 G

Diproduksi oleh:

FLEET LABORATORIES LIMITED - United Kingdom

Tanggal Otorisasi:

2019-10-30

Karakteristik produk

Page 1 of 4
CRINONE® 8%
PROGESTERONE
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
mg/dose % w/w
Progesterone
90
8.0
Excipients with known effect: Contains sorbic acid 0.08% w/w (0.9
mg/1.125 g dose).
For the full list of excipients, see section 5.1 List of excipients.
2.
PHARMACEUTICAL FORM
Vaginal gel
3.
CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
•
Treatment of infertility due to inadequate luteal phase.
•
For use during in-vitro fertilisation, where infertility is mainly due
to tubal, idiopathic or endometriosis
linked sterility associated with normal ovulatory cycles.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Intravaginal application.
TREATMENT OF INFERTILITY DUE TO INADEQUATE LUTEAL PHASE
One application (1.125 g 8% gel) every day, starting after documented
ovulation or arbitrarily on the 18
th
-
21
st
day of the cycle.
USE DURING IN-VITRO FERTILISATION
Daily application of Crinone 8% gel should be continued for 30 days if
there is laboratory evidence of
pregnancy.
PAEDIATRIC POPULATION
Not applicable.
ELDERLY
Not applicable.
METHOD OF ADMINISTRATION
Crinone is applied directly from the specially designed sealed
applicator into the vagina. The applicator
should be removed from the sealed wrapper. The twist-off cap should
not be removed at this time.
1.
The applicator should be gripped firmly by the thick end. It should be
shaken down like a thermometer
to ensure that the contents are at the thin end.
2.
The tab should be twisted off and discarded.
3.
The applicator may be inserted while patient is in a sitting position
or when lying on her back with the
knees bent. The thin end of applicator should be gently inserted well
into the vagina.
4.
The thick end of the applicator should be pressed firmly to deposit
gel. The applicator should be
removed and discarded in a waste container.
DISETUJUI OLEH BPOM: 1/12/2021
EREG10014912100135
Page 2 of 4
3.3 CONTRAINDICATIONS
1.
Hypersensitivity to progesterone or to any of the excipients listed in
section 5.1 List of excipients
2.
Und