Active Ingredient: Mifepristone
In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 600 milligrams mifepristone, one dose.
Regimen B: Oral, 200 milligrams mifepristone, one dose.
The method of administration will be as follows:
Up to 49 days of amenorrhea:
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 μg orally, or gemeprost 1 mg per vaginam.
Between 50-63 days of amenorrhea:
Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Alternatively, 200 mg of mifepristone (i.e. 1 tablet of 200 mg) can also be used in a single oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Information on the posology of misoprostol or gemeprost can be found in the respective product information.
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