Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Adrenaline
International Medication Systems (UK) Ltd
C01CA; C01CA24
Adrenaline
1 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Adrenergic and dopaminergic agents; epinephrine
Not marketed
1978-01-25
ADRENALINE (EPINEPHRINE) 1:1,000 MINIJET 1MG/ML SOLUTION FOR INJECTION FOR ADMINISTRATION BY HEALTHCARE PROFESSIONALS ONLY READ ALL OF THIS LEAFLET CAREFULLY Please note this medicine is mainly used in emergency situations and the doctor will have decided that you needed it. It is unlikely therefore, that you will have read this leaflet before the medicine was administered to you. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask the 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. − In this leaflet, Adrenaline 1:1,000 Minijet 1mg/ml Solution for Injection will be called Adrenaline Minijet. WHAT IS IN THIS LEAFLET: 1. What Adrenaline Minijet is and what it is used for 2. What you need to know before you are given Adrenaline Minijet 3. How Adrenaline Minijet is used 4. Possible side effects 5. How to store Adrenaline Minijet 6. Further information. 1. WHAT ADRENALINE MINIJET IS AND WHAT IT IS USED FOR Adrenaline is a type of drug that constricts blood vessels, makes the heart pump more strongly and opens airways. It is used in life-threatening emergencies such as severe allergic reactions or asthma. It will have been used to save your life. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE MINIJET In emergencies, it may be impossible for the people looking after you to get all your details before they have to treat you. They will have assessed the situation and decided it was better to give you the injection now and ask questions later. PLEASE TELL YOUR DOCTOR IF: • You are allergic to any of the ingredients in this medicine (listed in section 6) • You suffer from hyperthyroidism (overactive thyroid gland) • You suffer from hypertension (high blood pressure) • You suffer from heart disease or long standing chest disease like asthma or emphysema • You suffer from diabetes • You suffer from closed angle glaucoma (an eye condition that causes sudden blu Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adrenaline (Epinephrine) Injection 1:1,000 Minijet (1ml) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Adrenaline (Epinephrine) 1 mg per ml. Excipients: sodium metabisulfite (E222) 2.5 mg in 1 ml and total sodium 3 mg in 1 ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency treatment of anaphylaxis or acute angioneurotic oedema with airways obstruction, or acute allergic reactions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the relief of life-threatening angioneurotic oedema and anaphylactic shock, adrenaline should be administered by intramuscular injection. For acute allergic reactions due to insect stings etc.: Intramuscular or subcutaneous injection. The presentation with the 1 integral needle is for paramedic use by subcutaneous or intramuscular injection. Adults and children over 12 years: 0.5 ml (0.5 mg), administered slowly. The dose may be repeated every 5 to 15 minutes as needed. This presentation may not be suitable for small or prepubertal patients over 12 years of age who require a smaller dose. Elderly: as for adults, use with caution. Children (up to age of 12): Not recommended. 4.3 CONTRAINDICATIONS Contraindications are relative as this product is intended for use in life-threatening emergencies. Other than in the emergency situation, the following contraindications should be considered: hyperthyroidism, hypertension, ischaemic heart disease, diabetes mellitus, closed angle glaucoma and hypersensitivity to sympathomimetic amines. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочетете целия документ