Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Adrenaline acid tartrate
1 in 1,000) solution for injection auto-injectors (Bausch & Lomb UK Ltd
C01CA24
Adrenaline acid tartrate
1mg/1ml
Solution for injection
Intramuscular
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 03040300; GTIN: 7046260412163
Graphics&Packing Technology Section ICN POLFA RZESZÓW S.A. ULOTKA PIL Nazwa produktu Product Name EMERADE 150ΜG/300ΜG/500ΜG _/adrenaline/_ Kolor nadruku Colours Cyan Black - - Kraj Country (ISO) UK/IE Nr wykrojnika Spec No - Opracowane przez Designed by 5599 Kod Wytwórcy Manufacturer code 620314 Nr korekty Proof No 1 Data Date 23-09-2016 Kod farmaceutyczny Pharmacode - Kod wersji Valeant version code P9UKIE03 Inny kod Other code - Rozmiar czcionki Font size MINIMUM 9 PT Wymiar ulotki PIL size 170 X 320 MM Krój czcionki Font used TIMES NEW ROMAN FONT FAMILY Gramatura papieru Paper weight - Komentarze Comments (Reason for the change) - CHANGES IN THE TEXT - PACKING SITE: RECHON LIFE SCIENCE AB - PMR_ICN-16-1025 Akceptacja Techniczna Technical Approval Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval 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. Adrenaline counteracts the fall of blood pressure in anaphy Lire le document complet
OBJECT 1 EMERADE, 500 MICROGRAMS, SOLUTION FOR INJECTION IN PRE-FILLED PEN Summary of Product Characteristics Updated 20-Jan-2017 | Bausch & Lomb U.K Limited 1. Name of the medicinal product Emerade 500 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 500 micrograms delivers a single dose of 0.5 ml containing 500 micrograms of adrenaline (as tartrate). Each 0.5 ml (500 micrograms) dose contains 0.25 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 Lire le document complet