Țară: Suedia
Limbă: suedeză
Sursă: Läkemedelsverket (Medical Products Agency)
adrenalin
Orifarm AB
C01CA24
adrenaline
0,3 mg/dos
Injektionsvätska, lösning
adrenalin 0,3 mg Aktiv substans; natriummetabisulfit Hjälpämne
Receptbelagt
Adrenalin
Avregistrerad
2004-11-24
PACKAGE LEAFLET: INFORMATION FOR THE USER EPIPEN 300 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What EpiPen is and what it is used for 2. What you need to know before you use EpiPen 3. How to use EpiPen 4. Possible side effects 5. How to store EpiPen 6. Contents of the pack and other information 1. WHAT EPIPEN IS AND WHAT IT IS USED FOR EpiPen is a sterile solution in pre-filled pen for emergency injection into the muscle (intramuscular). EpiPen (adrenaline) Auto-Injectors are to be used in the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens in e.g. foods, drugs, insect stings or bites as well as triggered by exercise or by unknown causes. EpiPen Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Symptoms that signal the onset of an anaphylactic reaction include: itching of the skin; raised rash (like a nettle rash); flushing; swelling of the lips, throat, tongue, hands and feet; wheezing; hoarseness; nausea; vomiting; abdominal cramps and in some cases, loss of consciousness. The medicine in the Auto-Injector (the pen) is adrenaline which is an adrenergic drug. It works directly on the cardiovascular (heart and circulation) system and respiratory (lung) system, countering the potentially fatal effects of anaphylaxis by rapidly constricting the b Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT EpiPen 300 micrograms, solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 1 mg adrenaline (epinephrine). A single dose (0.3 ml) contains 300 micrograms (0.3 mg) adrenaline. Excipient: Sodium Metabisulfite (E223) 0.5 mg/dose, sodium chloride 1.8 mg/dose. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (Auto-Injector). Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EpiPen (adrenaline) Auto-Injectors are indicated in the emergency treatment of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens, as well as idiopathic or exercise induced anaphylaxis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population_ Usual paediatric dose is 0.01 mg/kg body weight. However, the prescribing physician has the option of prescribing more or less than these amounts based on careful assessment of each individual patient and recognizing the life-threatening nature of reactions for which this is being described. A dosage below 150 micrograms cannot be administered with EpiPen adrenaline Auto-Injector. The physician should consider using other forms of injectable adrenaline if lower doses are felt to be necessary for small children. _Children and adolescents over 30 kg weight:_ The usual dose is 300 micrograms for intramuscular use. _Children between 15 kg and 30 kg in weight*:_ The usual dose is 150 micrograms for intramuscular use. *For these patients EpiPen Jr. Auto-Injector containing 150 micrograms adrenaline per dose is available _Children below 15 kg in weight:_ The suitability of EpiPen Jr. has to be judged individually. The use in children weighing less than 7.5 kg is not recommended unless in a life-threatening situation and under medical advice. _Adults_ The usual dose is 300 micrograms for intramuscular use. An initial dose should be administered a Citiți documentul complet