SYNTOMETRINE Solution for injection (2019)

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Περιεχόμενα

1. Name of the medicinal product

Syntometrine 500 micrograms/5 IU Solution for Injection.

2. Qualitative and quantitative composition

Each 1ml ampoule contains 500 micrograms ergometrine maleate and 5IU oxytocin. Excipient with known effect: Sodium chloride 7.000 mg. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection. The solution is clear, colourless, faintly bluish fluorescent.

4.1. Therapeutic indications

The active management of the third stage of labour (as a means to promote separation of the placenta and to reduce blood loss), or routinely, following the birth of the placenta, to prevent or treat postpartum ...

4.2. Posology and method of administration

Syntometrine should be used under medical supervision only. Adults Active management of third stage of labour: Intramuscular injection of 1ml after delivery of the anterior shoulder, or at the latest, ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Pregnancy and labour (induction of labour, first stage labour and second stage labour prior to the delivery ...

4.4. Special warnings and precautions for use

Active management of the third stage of labour requires expert obstetric supervision. In breech presentations and other abnormal presentations, Syntometrine should not be given until after delivery of ...

4.5. Interaction with other medicinal products and other forms of interaction

Interactions related to both oxytocin and ergometrine administration Interactions resulting in concomitant use not recommended (see section 4.4 Special warnings and precautions for use) Vasoconstrictors/Sympathomimetics ...

4.6. Pregnancy and lactation

Pregnancy Ergometrine has potent uterotonic activity. Therefore Syntometrine is contraindicated during pregnancy and during induction of labour; first stage labour and second stage labour prior to the ...

4.7. Effects on ability to drive and use machines

Taking Syntometrine can start labour. Women with contractions should not drive or use machines. Patients should be warned of the possibility of dizziness and hypotension (see section 4.8 Undesirable effects). ...

4.8. Undesirable effects

The following adverse drug reactions have been reported during post-approval use of Syntometrine via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from ...

4.9. Overdose

In the event of maternal intoxication the most likely symptoms would be those of ergometrine intoxication: nausea, vomiting, hypertension or hypotension, vasospastic reactions, respiratory depression, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Ergot alkaloids and oxytocin incl. analogues, in combination ATC code: G02AC Syntometrine combines the known sustained oxytocic action of ergometrine with the more ...

5.2. Pharmacokinetic properties

Oxytocin Absorption Oxytocin is rapidly absorbed from the IM site. Distribution The steady-state volume of distribution determined in 6 healthy men after IV injection is 12.2 L or 0.17 L/kg. Plasma protein ...

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6.1. List of excipients

Sodium chloride Maleic acid Water for injections Chlorobutanol Sodium acetate trihydrate Acetic acid

6.2. Incompatibilities

None.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

For prolonged periods store between 2° and 8°C. Protect from light. Syntometrine may be stored up to 25°C for 2 months when protected from light, but must then be discarded.

6.5. Nature and contents of container

Uncoloured borosilicate glass Type I snap ampoule. Packs of 5 ampoules.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

8. Marketing authorization number(s)

PL16853/0021

9. Date of first authorization / renewal of the authorization

25 June 1998

10. Date of revision of the text

October 2019

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