País: Malta
Língua: inglês
Origem: Medicines Authority
EPINEPHRINE
Lincoln Medical Limited
C01CA24
EPINEPHRINE
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
EPINEPHRINE 150 µg
POM
CARDIAC THERAPY
Authorised
2011-08-02
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ANAPEN JUNIOR 150 MICROGRAMS IN 0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE ADRENALINE (EPINEPHRINE) 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 or your pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Anapen Junior is and what it is used for 2. What you need to know before you use Anapen Junior 3. How to use Anapen Junior 4. Possible side effects 5. How to store Anapen Junior 6. Contents of the pack and other information 1. WHAT ANAPEN JUNIOR IS AND WHAT IT IS USED FOR Anapen Junior consists of a pre-filled syringe of adrenaline contained in an automatic injection device (Auto-Injector). This injects a single dose of adrenaline into muscle. This medicine is for EMERGENCY only and you should seek immediate medical attention after using your Auto-Injector. Adrenaline is a natural hormone released in response to stress. In acute allergic reactions it improves blood pressure, heart function and breathing, and reduces swelling. Adrenaline is also known as epinephrine. Anapen Junior is used for the emergency treatment of serious allergic reactions or anaphylaxis caused by peanuts or other foods, drugs, insect bites or stings and other allergens as well as exercise or an unknown cause. Page 2 of 8 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANAPEN JUNIOR DO NOT USE ANAPEN JUNIOR There is no known reason why anyone should not use Anapen Junior during an allergic emergency. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Anapen Junior. Your doctor sh Leia o documento completo
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre contains 0.5 mg of adrenaline (epinephrine) One dose of 0.3ml contains 150 micrograms of adrenaline (epinephrine) Excipients with known effect: sodium metabisulfite (E223), sodium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled syringe. Clear colourless solution practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency treatment for acute allergic reactions (anaphylaxis) caused by peanuts or other foods, drugs, insect bites or stings, and other allergens as well as exercise-induced or idiopathic anaphylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should always carry 2 units of auto injectors in case the first administration fails or if one dose is not sufficient. Posology The effective dose is typically in the range 0.005-0.01 mg/kg but higher doses may be necessary in some cases. Use in children: The appropriate dose may be 150 micrograms (Anapen Junior) or 300 micrograms (Anapen) of adrenaline (epinephrine), depending on the body weight of the child and the discretion of the doctor. Children and adolescents over 30 kg in weight should be prescribed Anapen 300 micrograms. Larger children may require more than one injection to reverse the effect of an allergic reaction. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Anapen Junior may be administered 5–15 minutes after the first injection. It is recommended that patients are prescribed two Anapen Junior which they should carry at all times. The auto-injector of Anapen Junior is designed to deliver a single dose of 150 micrograms adrenaline (epinephrine). A dosage below 150 micrograms cannot be administered in sufficient accuracy in children weighing less than 1 Leia o documento completo