国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Adrenaline (epinephrine)
Mercury Pharmaceuticals (Ireland) Ltd
C01CA; C01CA24
Adrenaline (epinephrine)
1 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Adrenergic and dopaminergic agents; epinephrine
Marketed
1979-04-01
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution for Injection. It will be referred to as Adrenaline Injection for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Adrenaline Injection is and what it is used for 2. What you need to know before you are given Adrenaline Injection 3. How Adrenaline Injection will be given to you 4. Possible side effects 5. How to store Adrenaline Injection 6. Contents of the pack and other Information 1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR Adrenaline belongs to a class of drugs called sympathomimetic agent. Adrenaline Injection may be used to rapidly relieve severe allergic reactions to drugs or other substances causing allergy. It may also be used in the emergency treatment of shock due to a severe allergic reaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE INJECTION YOU SHOULD NOT BE GIVEN ADRENALINE INJECTION: • if you are allergic to adrenaline, or to any of the other ingredients of this medicine (listed in section 6) • when you are in labour • if you are suffering from any infection, disease or tumour of the brain • if you have atherosclerosis which is a narrowing, and hardening of the body’s blood vessels (your doctor will advise you). Adrenaline injection should not be used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate. Speak to your doctor if one of these applies to you before you are given this medicine. In an emergency, your doctor may still give you adrenaline even if you suffer from any of the above, as the potential benefit may be greater than the risk. WARNINGS AND PRECAUTIO 阅读完整的文件
Health Products Regulatory Authority 01 December 2021 CRN00CP17 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adrenaline (Epinephrine) 1:1,000 Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains Adrenaline (Epinephrine) Acid Tartrate equivalent to 1mg Adrenaline (Epinephrine) Excipients with known effect: Sodium Metabisulphate (E223) This medicinal product contains 3.389 mg/ml (0.147mmoles/ml) of sodium, less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adrenaline Injection may be used to relieve bronchial spasm in acute attacks of asthma. It may also be used to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and in the emergency treatment of anaphylactic shock. Adrenaline Injection may be used in follow-up treatment in cardiopulmonary resuscitation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: The usual dose is 0.3 to 0.5mg (0.3 to 0.5ml). If necessary, this may be repeated at 15 to 20 minute intervals for two doses, then subsequently every four hours as required. A dose of 1mg (1ml) can be given as a single injection in severe allergic reactions and anaphylactic shock. _PAEDIATRIC POPULATION_ The following doses of adrenaline 1/1,000 are recommended: AGE DOSE Over 12 years 0.5mg IM (0.5ml 1:1000 solution) 6-12 years 0.3mg IM (0.3ml 1:1000 solution) 6 months – 6 years 0.15mg IM (0.15ml 1:1000 solution) Under 6 months 0.01mg/kg IM (0.01ml/kg 1:1000 solution) If necessary, these doses may be repeated at 5-15 minute intervals according to blood pressure, pulse and respiratory function. A small volume syringe should be used. Elderly: The dosage is the same as for younger adults but particular caution is required when administering adrenaline to elderly patients (see section 4.4). Renal impairment: 阅读完整的文件