MYSODELLE Vaginal delivery system (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Mysodelle 200 micrograms vaginal delivery system.
Qualitative and quantitative composition
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 ...
Pharmaceutical form
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, ...
Therapeutic indications
Mysodelle is indicated for induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.
Posology and method of administration
Posology Mysodelle 200 micrograms is a controlled release formulation that releases misoprostol at a rate of approximately 7 micrograms/hour over a period of 24 hours. The maximum recommended dose is one ...
Contraindications
Mysodelle is contraindicated: When there is hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 When labour has started When there is suspicion or evidence of fetal ...
Special warnings and precautions for use
Mysodelle can cause excessive uterine tachysystole that may not respond to tocolytic treatment and that may not subside before delivery. Mysodelle can also cause excessive uterine stimulation if left in ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Mysodelle. Concurrent use of oxytocic drugs or other labour induction agents is contraindicated due to the potential of increased uterotonic effects (see ...
Fertility, pregnancy and lactation
Fertility From fertility and early embryonic development studies in rats, there is evidence of a possible adverse effect of misoprostol on implantation, however this is not relevant for the indicated clinical ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Clinical Studies Experience. Summary of the safety profile The adverse reaction profile in Table 1 is based upon five clinical studies conducted with Misodel in 874 pregnant women at term gestation. The ...
Overdose
There is no experience with the use of more than one application of Mysodelle. The controlled release formulation and ability to remove Mysodelle thereby stopping misoprostol delivery limits the risk of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other gynaecologicals, oxytocics, prostaglandins ATC-code: G02AD06 Mechanism of action Misoprostol is a synthetic analogue of Prostaglandin E1 (PGE1), a naturally occurring oxytocic ...
Pharmacokinetic properties
Misoprostol, an ester, is rapidly metabolised to its active metabolite misoprostol acid. Only misoprostol acid is detectable in plasma. The acid is further metabolised to inactive dinor and tetranor acid ...
Preclinical safety data
The active component in Mysodelle, misoprostol, revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity. No ...
List of excipients
Cross-linked hydrogel polymer (comprised of macrogol, 1,2,6- hexanetriol and dicyclohexyl-methane-4,4'-diisocyanate). Butylated Hydroxyanisole Polyester retrieval system (knitted polyester yarn)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in a freezer (-10 to -25°C). No thawing is required prior to use.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Mysodelle should be removed from the freezer and taken out of the laminated aluminium foil sachet just prior to insertion. Any unused medical product or waste material should be disposed of in accordance ...
Marketing authorization holder
Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, (UK)
Marketing authorization number(s)
PL 03194/0112
Date of first authorization / renewal of the authorization
17th October 2013
Date of revision of the text
10th November 2017
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