Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Ephedrine hydrochloride
Laboratoire AGUETTANT
C01CA26
Ephedrine hydrochloride
3 milligram(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
ephedrine
Marketed
2018-12-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPHEDRINE HYDROCHLORIDE 3MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE EPHEDRINE HYDROCHLORIDE (REFERRED TO AS “EPHEDRINE INJECTION” IN THIS LEAFLET) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ephedrine Injection is and what it is used for 2. What you need to know before you are given Ephedrine Injection 3. How Ephedrine Injection is given 4. Possible side effects 5. How to store Ephedrine Injection 6. Contents of the pack and other information 1. WHAT EPHEDRINE INJECTION IS AND WHAT IT IS USED FOR This medicine is used for the management of low blood pressure induced by anaesthesia. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPHEDRINE INJECTION DO NOT USE EPHEDRINE INJECTION IF: - you are allergic to ephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6). - you are taking another indirect sympathomimetic agent such as phenylpropanolamine, phenylephrine, pseudoephedrine (medicines used to RELIEVE BLOCKED NOSE ) or methylphenidate (medicine used to TREAT “ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) ”), - you are taking an alpha sympathomimetic agent (medicines used to TREAT LOW BLOOD PRESSURE ), - you are taking or have taken in the last 14 days a non-selective monoamine oxidase inhibitor (medicines used to TREAT DEPRESSION ). WARNINGS AND PRECAUTIONS Talk to your doctor before using Ephedrine Injection if: - you are a diabetic; - you suffer from heart disease or any other Đọc toàn bộ tài liệu
Health Products Regulatory Authority 22 February 2023 CRN00DFQR Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ephedrine Hydrochloride 3 mg/ml solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Solution for Injection contains 3 mg ephedrine hydrochloride, corresponding to 2.46 mg ephedrine. Each 10 ml pre-filled syringe contains 30 mg ephedrine hydrochloride, corresponding to 24.6 mg ephedrine. Excipient with known effect: This medicinal product contains sodium. Each ml of Solution for Injection contains 3.39 mg equivalent to 0.15 mmol of sodium. Each 10 ml pre-filled syringe contains 33.9 mg equivalent to 1.5 mmol of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (Injection). Clear, colourless liquid pH = 4.5 to 5.5 Osmolality: between 270 – 300 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypotension from spinal, epidural and general anaesthesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Slow intravenous injection of 3 to 6 mg (maximum 9 mg), repeated as needed every 3-4 min to a maximum of 30 mg. A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent. The dose administered for 24 hours must not exceed 150 mg. _Paediatric population_ Ephedrine Hydrochloride 3 mg/ml solution for Injection in Prefilled Syringe is generally not recommended for use in children due to insufficient data on efficacy, safety and dosage recommendations. ● Children under 12 years The safety and efficacy of ephedrine in paediatric patients under 12 years have not been established. No data are available. ● Children over 12 years The posology and method of administration is the same as for adults. _Patients with renal or hepatic impairment_ There are no dose adjustment recommended for patients with renal or hepatic impairment. _Elderly_ Health Products Regulatory Authority 22 February 2023 CRN00DFQR Page 2 of Đọc toàn bộ tài liệu