Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ergometrine maleate
hameln pharma Ltd
G02AB03
Ergometrine maleate
500microgram/1ml
Solution for injection
Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 07010100; GTIN: 5016386000089
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERGOMETRINE INJECTION ergometrine maleate 1. WHAT ERGOMETRINE INJECTION IS AND WHAT IT IS USED FOR Ergometrine Injection is a medicine that causes contraction of the muscles of the womb and is used: • in the active management of the third stage of labour • to control bleeding after the birth. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ERGOMETRINE INJECTION YOU MUST NOT BE GIVEN ERGOMETRINE INJECTION: • if you are allergic to ergometrine maleate or any of the other ingredients in this injection (listed in section 6) • if you have severe or very high blood pressure • if you have heart disease • if you suffer from severe liver, kidney, heart or circulation problems • if you are suffering from eclampsia or pre- eclampsia (which causes high blood pressure, protein in the urine, swelling) • if your womb is not contracting properly • if you are pregnant or if you are in labour but the baby’s shoulder still cannot be seen • if you have a serious infection • if you have Raynaud’s disease or phenomenon (poor circulation which makes the toes and fingers numb and pale) WARNINGS AND PRECAUTIONS: TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE BEING GIVEN THE INJECTION: • if you have raised blood pressure • if you have liver or kidney problems • if you have an infection • if you have any heart problems • if you are going to have an operation under general anaesthetic • if your baby is in a breech position (or any other abnormal position) before birth, Ergometrine Injection will not be given until after your baby has been born. • if you have a multiple pregnancy (e.g. twins, triplets), Ergometrine Injection will not be given until after the last baby has been born. If any of the above applies to you, or you are not sure, speak to your doctor or nurse before you receive Ergometrine Injection. OTHER MEDICINES AND ERGOMETRINE INJECTION: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine Prečítajte si celý dokument
OBJECT 1 ERGOMETRINE INJECTION BP 0.05% W/V Summary of Product Characteristics Updated 08-May-2018 | hameln pharmaceuticals ltd 1. Name of the medicinal product Ergometrine Injection BP 0.05% w/v. 2. Qualitative and quantitative composition 500 micrograms of Ergometrine in 1ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sterile Injection. 4. Clinical particulars 4.1 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. 4.2 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 5 units) intramuscularly as a dose of 500 micrograms following the delivery of the anterior shoulder of the infant or at the latest immediately after delivery of the baby. Prevention and Treatment of Postpartum Haemorrhage Doses of 200 micrograms to 500 micrograms of Ergometrine are given intramuscularly, following expulsion of the placenta or when bleeding occurs. In emergencies, Ergometrine Injection may be given intravenously at a dose of 250 micrograms to 500 micrograms. USE IN SPECIAL POPULATIONS _Patients with renal impairment or hepatic impairment _ No studies have been performed in patients with renal or hepatic impairment. However, considering the metabolic pathway of ergometrine, use is contraindicated in severe hepatic and renal impairment and caution is required in mild or moderate hepatic and renal impairment (see sections 4.3 Contraindications, 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties). _Paediatric population _ No data are available. _Elderly _ Not applicable. METHOD OF ADMINISTRATION Intramuscular injection is the recommended route. Intravenous administration of Ergometrine Injection at a do Prečítajte si celý dokument