Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
EPINEPHRINE
Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
C01CA24
EPINEPHRINE 1 mg/ml
SOLUTION FOR INJECTION
EPINEPHRINE 1 mg/ml
POM
CARDIAC THERAPY
Withdrawn
2006-12-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ADRENALINE (EPINEPHRINE) 1:1,000 SOLUTION FOR INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution for Injection. It will be referred to as Adrenaline Injection for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Adrenaline Injection is and what it is used for 2. What you need to know before you are given Adrenaline Injection 3. How Adrenaline Injection will be given to you 4. Possible side effects 5. How to store Adrenaline Injection 6. Contents of the pack and other information 1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR Adrenaline belongs to a class of drugs called sympathomimetic agents. Adrenaline Injection may be used to rapidly relieve severe allergic reactions to drugs or other substances causing allergy. It may also be used in the emergency treatment of shock due to a severe allergic reaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE INJECTION YOU SHOULD NOT BE GIVEN ADRENALINE INJECTION: • if you are allergic to adrenaline, or to any of the other ingredients of this medicine (listed in section 6). • when you are in labour • if you have severe heart disease particularly if it is associated with an increased heart rate • if you are suffering from any infection, disease or tumour of the brain • if you have atherosclerosis which is a narrowing, and hardening of the body's blood vessels (your doctor will advise you). Adrenaline injection should not be used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate. WARNINGS AND PRECAUTION Talk to your doctor or nurse b Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adrenaline (Epinephrine) 1:1,000 Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains adrenaline acid tartrate BP equivalent to 1mg of adrenaline Excipient with known effect: Sodium metabisulphite For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear, colourless, sterile, aqueous solution, intended for parenteral administration to human beings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adrenaline is a direct-acting sympathomimetic agent. Adrenaline may be used to provide rapid relief of severe hypersensitivity reaction to drugs and other allergens, and in the emergency treatment of anaphylactic shock. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Severe hypersensitivity reactions, anaphylactic shock _ _IM Injection_ : _ _ _Adults_ : The usual dose is 500 micrograms (0.5ml of adrenaline 1/1000). If necessary, this dose may be repeated several times at 5-minute intervals according to blood pressure, pulse and respiratory function. Half doses of adrenaline may be safer for patients who are taking amitriptyline, imipramine or a beta blocker. _PAEDIATRIC POPULATION_ The following doses of adrenaline 1/1,000 are recommended: AGE DOSE Over 12 years 0.5 mg IM (0.5ml 1:1000 solution) 6 - 12 years 0.3 mg IM (0.3ml 1:1000 solution) 6 months - 6 years 0.15 mg IM (0.15ml 1:1000 solution) Under 6 months 0.01mg/kg IM (0.01ml/kg 1:1000 solution) If necessary, these doses may be repeated at 5-15 -minute intervals according to blood pressure, pulse and respiratory function. _ELDERLY _ The dosage is the same as for younger adults but particular caution is required when administering adrenaline to elderly patients (see section 4.4). _RENAL IMPAIRMENT _ Adrenaline should be used with caution in patients with severe renal impairment (see section 4.4). METHOD OF ADMINISTRATION Adrenaline Injection BP. 1/1000 (1mg/ml) may be administered undiluted by S.C. or IM injection. In the shocked pat Baca dokumen lengkapnya