Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK)
Mysodelle 200 micrograms vaginal delivery system.
| Pharmaceutical Form |
|---|
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Vaginal delivery system. The polymer insert is contained within a retrieval system consisting of an inert woven polyester pouch and tail. The polymer insert is rectangular in shape with radiused corners, is buff coloured, semi-transparent, non-biodegradable and measures approximately 30 mm in length, 10 mm in width and 0.8 mm in thickness. Mysodelle swells in the presence of moisture. |
Mysodelle contains 200 micrograms misoprostol.
Misoprostol is released in vivo at a mean rate of approximately 7 micrograms/hour over a period of 24 hours. Drug release continues as long as Mysodelle is in the vagina.
Excipients with known effect: 0.13 mg butylated hydroxyanisole per dose (see Section 4.4).
For the full list of excipients, see Section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Misoprostol |
Misoprostol is an analogue of naturally occurring prostaglandin E1 which promotes peptic ulcer healing and symptomatic relief. Misoprostol protects the gastroduodenal mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions, the proteolytic activity of the gastric fluid, and increasing bicarbonate and mucus secretion. |
| List of Excipients |
|---|
|
Cross-linked hydrogel polymer (comprised of macrogol, 1,2,6- hexanetriol and dicyclohexyl-methane-4,4'-diisocyanate). |
1 × 200 micrograms vaginal delivery system
5 × 200 micrograms vaginal delivery system
5 × 200 micrograms vaginal delivery system (multipack)
Each vaginal delivery system is contained within an individual foil sachet produced from an aluminium foil laminate strip containing a desiccant and packed in a carton.
Not all pack sizes may be marketed.
Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK)
PL 03194/0112
17th October 2013
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