The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive scientific opinion in accordance with Article 58 of Regulation ( EC ) No 726/2004, for the medicinal product Hemoprostol, 200 mcg, tablet, intended for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous Oxytocin is not available.
The active substance of Hemoprostol is Misoprostol, a prostaglandin and its mode of action is by inducing contractions of the smooth muscle fibers in the myometrium.
The benefits with Hemoprostol are its ability to reduce post partum bleeding due to uterine atony ( although in a lesser extent than Oxytocin ), and thus may offer a treatment option in situations where intravenous Oxytocin is not available.
The most common side effects are shivering, fever, nausea ( very common ).
The approved indication is: Hemoprostol is indicated in women of childbearing age for treatment of post partum haemorrhage due to uterine atony in situations where intravenous Oxytocin is not available.
The recommended posology for treatment of post partum hemorrhage is four tablets ( 800 micrograms ) to be taken in a single sublingual intake.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Hemoprostol.
The medicinal product Hemoprostol ( 200 mcg, tablet ) is exclusively intended for markets outside the European Union. ( Xagena )
Source: EMA ( European Medicines Agency ), 2014