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HSA Approval

CRINONE PROGESTERONE VAGINAL GEL 8%

SIN10884P

CRINONE PROGESTERONE VAGINAL GEL 8%

CRINONE PROGESTERONE VAGINAL GEL 8%

April 21, 1999

MERCK PTE. LTD.

MERCK PTE. LTD.

Regulatory Information

MERCK PTE. LTD.

MERCK PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

GEL

**Posology and method of administration** 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 18th–21st day of the cycle. - When used during in-vitro fertilisation, daily application of Crinone® 8 % gel should be continued for 30 days if there is laboratory evidence of pregnancy. Children: not applicable.

VAGINAL

Medical Information

**Therapeutic Indications** Treatment of disorders associated with progesterone deficiency, such as: - 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.

**Contra-indications** - known sensitivity to Crinone® (progesterone or any of the other ingredient) - undiagnosed vaginal bleeding - known or suspected malignancy of the breast or genital organ - acute porphyria - thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a history of these conditions - missed abortion

G03DA04

progesterone

Manufacturer Information

MERCK PTE. LTD.

DENDRON BRANDS LTD

maropack ag

Active Ingredients

PROGESTERONE

8%

Progesterone

Documents

Package Inserts

Crinone PI.pdf

Approved: November 10, 2021

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