PROGESTERONE-TEVA (Teva Pharma Australia Pty Ltd)

PROSARI 200 soft vaginal capsules:

PROSARI 200 soft vaginal capsules are indicated for:

Luteal phase support

• Luteal Support of Assisted Reproductive Technology (ART) cycles

Support during pregnancy

• Prevention of preterm birth in women with singleton pregnancy who have a short cervix (mid-trimester sonographic cervix ≤25 mm) and/or a history of spontaneous preterm birth.
• Treatment of unexplained threatened miscarriage in women with bleeding in the current pregnancy and a history of at least three or more previous miscarriages.

Use in women with less than three miscarriages may be warranted in those with reduced chances of future pregnancy such as those undergoing IVF treatment with limited viable egg and/or embryo availability or advanced fertility age. However, the benefit of treatment in clinical trials was limited to women with three or more miscarriages. (See Section 5 Pharmacological properties; Clinical trials; Threatened Unexplained Miscarriage).

PROGESTERONE-TEVA 100 and 200 capsules: PROGESTERONE-TEVA soft capsules are indicated for:

Treatment of menstrual irregularities

• In women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION)

Hormone replacement therapy

• Hormone replacement therapy – adjunctive use with an estrogen in postmenopausal women with an intact uterus