MYSODELLE Vaginal delivery system Ref.[7775] Active ingredients: Misoprostol

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 Mysodelle vaginal delivery system (200 micrograms).

Remove Mysodelle:

*At the onset of labour:

• • When contractions are rhythmic (3 or more in 10 minutes), firm and of adequate quality and cause cervical change and/or at the latest when cervical dilation is 4 cm
• If excessive uterine contractions occur:
  • Tachysystole: more than 5 contractions in a 10-minute window, averaged over a 30 minute window
  • Prolonged contractions: single contractions lasting 2 minutes or more
  • Hypertonic contractions: contractions are too frequent and a high resting tone in the uterus.
• If there is a clinical concern for the mother and/or baby
• If 24 hours have elapsed since insertion.

If Mysodelle falls out, do not replace it.

In case of subsequent administration of oxytocin, a waiting period of at least 30 minutes is recommended following the removal of the vaginal delivery system (see Section 4.5).

An unfavourable cervix (modified Bishop score ≤ 4) was an inclusion criteria in the pivotal phase III clinical study

Paediatric population

The safety and efficacy of Mysodelle in pregnant women aged less than 18 years has not been established.

No data are available.

Method of administration

Mysodelle should only be administered by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring is available. The condition of the cervix should be assessed carefully before Mysodelle is used. After insertion, uterine activity and fetal condition must be carefully monitored by staff trained in cardiotocography interpretation. Mysodelle should only be used in hospitals where facilities for emergency Caesarean delivery are readily available.

Mysodelle is supplied in an individual aluminium foil sachet, and must be stored in the freezer. No thawing is required prior to use.

There is a “tear mark” on one side of the foil sachet. Open the package along the tear mark across the top of the sachet. Do not use scissors or other sharp objects which may cut the retrieval system.

Place Mysodelle high in the posterior vaginal fornix (Figure a). To ensure that Mysodelle remains in situ, it should be turned 90° so that it lies transversely in the posterior fornix of the vagina (Figure b). Water-soluble lubricants may be used to aid insertion when necessary.

After the vaginal delivery system has been inserted, the withdrawal tape may be cut with scissors always ensuring there is sufficient tape outside the vagina to allow removal.

The patient is to remain in bed for 30 minutes after insertion, but may be ambulatory thereafter. Take care not to inadvertently remove Mysodelle during toileting and vaginal examinations.

Removal

Mysodelle is removed by gently pulling the tail of the retrieval system (Figure c).

The vaginal delivery system should NEVER be removed from the retrieval system.

Mysodelle is a controlled release formulation that swells in the presence of moisture, causing drug release to occur. During insertion, Mysodelle will swell to 2-3 times its original size and be pliable. After removal, ensure that the entire product (insert and retrieval system) has been removed from the vagina.

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 overdose. Accidentally leaving Mysodelle in place after onset of active labour may lead to symptoms of prostaglandin overdose (excessive uterine stimulation). If this occurs, remove Mysodelle and manage in accordance with local protocol.

3 years.

Store in a freezer (-10 to -25°C). No thawing is required prior to use.

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.

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 with local requirements. The whole product should be disposed following removal.