PROGESTERONE ADVZ (Boucher & Muir Pty Ltd)

PROGESTERONE ADVZ 100mg and 200mg capsules:

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

PROGESTERONE BNM 200mg vaginal capsules: 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 (midtrimester 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).