ERGOMETRINE Injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ergometrine Injection BP 0.05% w/v.
Qualitative and quantitative composition
500 micrograms of Ergometrine in 1ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sterile Injection.
Therapeutic indications
Ergometrine Injection is used in the active management of the third stage of labour and in the treatment of post-partum haemorrhage. Ergometrine Injection may be given by intramuscular or intravenous injection. ...
Posology and method of administration
Ergometrine Injection should be used under medical supervision only. Adults Active Management of the Third Stage of Labour Ergometrine Injection is administered (often in combination with synthetic oxytocin ...
Contraindications
Hypersensitivity to the active substance 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 of ...
Special warnings and precautions for use
Ergometrine may give rise to widespread vasoconstriction and rarely acute pulmonary oedema. Active management of the third stage of labour requires expert obstetric supervision. In breech presentations ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of Ergometrine Injection with the following medicinal products is not recommended: Vasoconstrictors/Sympathomimetics: Ergometrine Injection may enhance the vasopressor effects of vasoconstrictors ...
Pregnancy and lactation
Pregnancy Ergometrine has potent uterotonic activity. Therefore, Ergometrine Injection is contraindicated during pregnancy, during induction of labour, and during first and second stage labour prior to ...
Effects on ability to drive and use machines
Receiving Ergometrine Injection 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 ...
Undesirable effects
Immune system disorders: Anaphylactic/Anaphylactoid reactions with associated symptoms of dyspnoea, hypotension, collapse or shock Nervous system disorders: Headache, dizziness Ear & labyrinth disorders: ...
Overdose
Symptoms of acute poisoning include nausea, vomiting, diarrhoea, extreme thirst, coldness, tingling and itching of the skin, tachycardia, vasospastic reactions, respiratory depression, confusion, convulsions ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ergot alkaloids ATC code: G02AB03 Ergometrine produces sustained tonic uterine contraction via agonist or partial agonist effects at myometrial 5-HT<sub>2</sub> receptors and ...
Pharmacokinetic properties
Absorption Ergometrine is rapidly absorbed after administration by mouth or by intramuscular injection. Uterotonic effect can be observed within 10 minutes following oral administration and within 7 minutes ...
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.
List of excipients
Maleic acid BP QS Water for injections EP to 100%
Incompatibilities
Ergometrine Injection is incompatible with various drugs according to resulting Ph, temperature and concentration of drugs. Mixing with other drugs in the same syringe should therefore be avoided. Ergometrine ...
Shelf life
Shelf life: 36 months.
Special precautions for storage
Ergometrine should be stored between 2°C and 8°C and protected from light.
Nature and contents of container
1ml clear type I glass ampoules. Packed in cartons to contain 10 ampoules.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Hameln pharmaceuticals ltd, Gloucester, UK
Marketing authorization number(s)
01502/0008R
Date of first authorization / renewal of the authorization
10<sup>th</sup> January 1989/25<sup>th</sup> September 2002
Date of revision of the text
20/04/2018
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