Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ADRENALINE (EPINEPHRINE)
Lincoln Medical Ltd
500 Microgram
Solution for Injection
2011-08-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anapen 500 micrograms in 0.3ml solution for injection in a pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mililitre contains 1.7 mg of adrenaline (epinephrine) One dose of 0.3ml contains 500 micrograms of adrenaline (epinephrine) Excipients: sodium metabisulphite (E223), sodium chloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection 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 Use only by the intramuscular route. Anapen consists of a pre-filled syringe of adrenaline (epinephrine) contained in an auto-injection device. The whole is referred to as an auto-injector. One Anapen injection should be administered intramuscularly immediately on the appearance of the signs and symptoms of anaphylactis shock. These may occur within minutes of exposure to the allergen and are most commonly manifested by urticaria, flushing or angioedema; more severe reactions involve the circulatory and respiratory systems. Inject Anapen only into the anterolateral aspect of the thigh, not the buttock. The injected area may be lightly massaged for 10 seconds following injection. _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 adults: The usual dose is 300 micrograms. Larger adults may require Anapen 500 micrograms to reverse the effect of an allergic reaction. In some circumstances a single dose of adr Read the complete document