Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Adrenaline
PharmaSwiss Ceska republika s.r.o.
C01CA; C01CA24
Adrenaline
150 microgram(s)
Solution for injection in pre-filled pen
intramuscular injection
Pack sizes: 1 or 2 pre-filled pens
Product subject to prescription which may be renewed (B)
Rechon Life Science AB
Cardiac stimulants excl. cardiac glycosides - Adrenergic and dopaminergic agents – Adrenaline
Adrenergic and dopaminergic agents; epinephrine
Emerade is indicated for the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens as well as for exercise-induced or idiopathic anaphylaxis
Not marketed
2015-09-11
PACKAGE LEAFLET: INFORMATION FOR THE USER EMERADE 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN EMERADE 300 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN EMERADE 500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN adrenaline 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 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 Emerade is and what it is used for 2. What you need to know before you use Emerade 3. How to use Emerade 4. Possible side effects 5. How to store Emerade 6. Contents of the pack and other information 1. WHAT EMERADE IS AND WHAT IT IS USED FOR Emerade is an auto-injector that contains adrenaline in a solution for injection into the muscle (intramuscular). Adrenaline counteracts the fall of blood pressure in anaphylactic reactions. It also stimulates the heart and facilitates breathing. Emerade is used for emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens in foods, medicines, insect stings or bites and other allergens as well as triggered by exercise or unknown causes. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMERADE Your doctor should have explained when and how you should use Emerade. If you are not completely sure or you have questions you must contact your doctor. WARNINGS AND PRECAUTIONS Emerade can always be used during an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulphite or to any of the other ingredients of Emerade, your doctor will need to instruct you under which circumstances Emerade should be used. Talk to your doctor before using Eme Lestu allt skjalið
Health Products Regulatory Authority 24 February 2022 CRN00CHPH Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emerade 150 micrograms solution for injection in pre-filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The pre-filled pen contains 0.5 ml of adrenaline solution 1 mg/ml. Emerade 150 micrograms delivers a single dose of 0.15 ml containing 150 micrograms of adrenaline (as tartrate). Each 0.15 ml (150 micrograms) dose contains 0.075 mg sodium meta-bisulphite (E223). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in a pre-filled pen (auto-injector). Clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emerade is indicated for the emergency treatment of severe acute allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens as well as for exercise-induced or idiopathic anaphylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The effective dose is usually within the range 5- 10 micrograms per kg bodyweight but higher doses may be necessary in some cases. _Paediatric population_ Use in children: Emerade 500 micrograms is not recommended for use in children. _Children below 15 kg bodyweight_ A dosage below 150 micrograms cannot be administered with sufficient accuracy in children weighing less than 15 kg and use is therefore not recommended unless during a life-threatening situation and under medical advice. _ _ _Children between 15 kg and 30 kg bodyweight_ The usual dose is 150 micrograms. _ _ _Children over 30 kg bodyweight_ The usual dose is 300 micrograms. _Adolescent patients over 30 kg bodyweight_ The dosage recommendations for adult patients should be followed. _Adults_ The recommended dose is 300 micrograms for individuals under 60 kg bodyweight. The recommended dose is 300 to 500 micrograms for individuals over 60 kg bodyweight, depending on clinical judgement. An initial dose should be administered as soon as symptoms of an Lestu allt skjalið