Misoprostol -  New Indications

Member of Farmavita.net is offering dossier in European CTD format for Misoprostol, 100 - 200 mcg, tablets.

Dossier is submitted in reference member state. License for use of Dossier is related to initial downpayment and commitment to bulk purchase.  

Misoprostol is classified as an alimentary tract and metabolism medicine, according ATC index.

Misoprostol was previously approved for reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcer and for medical abortion (<49 days) with Mifepristone. Recently, Misoprost has now been approved for:

Dosage and method of administration is as follows:
For Prevention of Post Partum Haemorrhage

For prevention of post partum haemorrhage - 600 µg misoprostol orally immediately after cord clamping.

 For Cervical Ripening

• Cervical ripening prior to uterine instrumentation
Dosage: 400 µg misoprostol vaginally, 2-3 hours before the procedure.

• Cervical ripening for induction of labour (live baby >28 weeks)
Dosage: 25 µg misoprostol vaginally, every 3- 4 hours until contractions

Maximum: Six doses

Should be used in institutions that are able to perform caesarean sections. Foetal well-being and uterine contractions should be monitored. Beware of uterine hyperstimulation with the risk of uterine rupture and foetal distress.

• Cervical ripening for induction of labour (intrauterine foetal death >28 weeks)
Dosage: 50 µg misoprostol vaginally, every 3-4 hours until delivery

Maximum: Six doses.

Offer is valid subject to confirmation, country by country. Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.

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