Страна: Малта
Език: английски
Източник: Medicines Authority
EPHEDRINE HYDROCHLORIDE
Martindale Pharmaceuticals Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom
R03CA02
EPHEDRINE HYDROCHLORIDE 30 mg/ml
SOLUTION FOR INJECTION
EPHEDRINE HYDROCHLORIDE 30 mg/ml
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2007-07-09
100MM MEASUREMENT VERIFICATION BAR 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 Ephedrine belongs to a group of medicines called sympathomimetics. Sympathomimetic drugs affect the part of your nervous system that works automatically. Ephedrine Injection is used to relieve low blood pressure during spinal or epidural anaesthesia. It raises blood pressure by temporarily reducing the blood supply to small blood vessels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPHEDRINE INJECTION You should not be given Ephedrine Injection if: • you are allergic to ephedrine hydrochloride or to any of the other ingredients in 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 suffer from diabetes • you suffer from heart disease or any other heart conditions, including angina; • you suffer from weakness in a blood vessel wall leading to a bulge developing (aneurysm); • you have high blood pressure; • you have a narrowing and/or blockage of blood vessels (occlusive vascular disorders) • you have an overactive thyroid gland (hyperthyroidism); • you know or suspect that you suffer from glaucoma (increased pressure in your eyes) or prostatic hypertrophy (enlarged prostate g Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ephedrine Hydrochloride 30 mg per 1 ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ephedrine Hydrochloride 3% w/v. Each ml of Solution for Injection contains 30 mg ephedrine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear, colourless solution for Injection pH = 5.00 – 7.00 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reversal of hypotension from spinal or epidural anaesthesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and the elderly _ Up to 30 mg in increments of 3 - 7.5 mg. After the development of hypotension, by slow intravenous administration. _Paediatric Population _ _ _ 0.5 - 0.75 mg / kg body weight or 17 - 25 mg / m 2 body surface. After the development of hypotension, by slow intravenous administration. 4.3 CONTRAINDICATIONS Hypersensitivity to Ephedrine Hydrochloride or to any of the excipients listed in section 6.1 • In combination with other indirect sympathomimetic agents such as phenylpropanolamine, phenylephrine, pseudoephedrine and methylphenidate. • In combination with alpha sympathomimetic agents. • In combination with non-selective Monoamine Oxidase Inhibitors (MAOI) or within 14 days of their withdrawal. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Warnings Ephedrine should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Angina pain may be precipitated in patients with angina pectoris. Care is also required when Ephedrine is given to patients with diabetes mellitus, closed-angle glaucoma or prostatic hypertrophy. Ephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated a Прочетете целия документ