Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Pharma-Q Holdings (Pty) Ltd
See ingredients
INJECTION
EACH 1 ml LIQUID CONTAINS EPINEPHRINE BITARTRATE 1,80 mg EQUIVALENT TO EPINEPHRINE 1 mg
Registered
1996-11-11
Pharma-Q Holdings (Pty) Ltd PHARMA-Q ADRENALINE 1 mg/ml INJECTION Injection 1 mg/ml Page 1 of 11 SCHEDULING STATUS S4 PHARMA-Q ADRENALINE INJECTION 1 MG/ML SOLUTION FOR INJECTION ADRENALINE (EPINEPHRINE) BASE AS TARTRATE SUGAR FREE _ _ READ THIS FULL LEAFLET CAREFULLY BEFORE YOUR MEDICAL PRACTITIONER ADMINISTERS PHARMA-Q ADRENALINE INJECTION 1 MG/ML. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist, nurse or other health care provider. • PHARMA-Q ADRENALINE INJECTION 1 mg/ml has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours._ _ WHAT IS IN THIS LEAFLET 1. What PHARMA-Q ADRENALINE INJECTION 1 mg/ml is and what it is used for. 2. What you need to know before your doctor administers Pharma-Q Adrenaline Injection 1 mg/ml. 3. How PHARMA-Q ADRENALINE INJECTION 1 mg/ml will be given to you. 4. Possible side effects that you may experience. 5. How to store PHARMA-Q ADRENALINE INJECTION 1 mg/ml. 6. Contents of the pack and other information. Pharma-Q Holdings (Pty) Ltd PHARMA-Q ADRENALINE 1 mg/ml INJECTION Injection 1 mg/ml Page 2 of 11 1. WHAT PHARMA-Q ADRENALINE INJECTION 1 MG/ML IS AND WHAT IT IS USED FOR. The active substance of PHARMA-Q ADRENALINE INJECTION 1 mg/ml is: Adrenaline (epinephrine) belongs to a group of medicines called sympathomimetic substances. Each 1 ml contains 1 mg adrenaline (epinephrine) as the acid tartrate. PHARMA-Q ADRENALINE INJECTION 1 mg/ml is used in life-threatening emergencies, such as acute allergic reactions 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHARMA-Q ADRENALINE INJECTION 1 MG/ML. PHARMA-Q ADRENALINE INJECTION 1 mg/ml should not be administered to you: • if you are hypersensitive (allergic) to adrenaline (epinephrine) or any of the other ingredients of PHARMA-Q ADRENALINE INJECTION 1 mg/ml (listed in section 6). _ _ • If you are receiving mono-amine oxidase inhibitors as adrenaline (epinephri read_full_document
Pharma-Q Holdings (Pty) Ltd PHARMA-Q ADRENALINE 1 mg/ml INJECTION Injection 1 mg/ml Page 1 of 16 PROFESSIONAL INFORMATION SCHEDULING STATUS S4 1 NAME OF THE MEDICINE PHARMA-Q ADRENALINE INJECTION 1 MG/ML solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 1 mg adrenaline (epinephrine) base as tartrate _Excipients with known effect: _ Antioxidant: sodium metabisulphite 0,1 % _m/v_._ _ For full list of excipients, see section 6.1 Sugar free. 3 PHARMACEUTICAL FORM Solution for injection A clear, practically colourless, slightly acid liquid. Gradually turns dark on exposure to light and air. The pH of the solution is between 2,2 to 5,0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMA-Q ADRENALINE INJECTION 1 mg/ml may be used in the treatment of acute allergy and anaphylactic shock. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Discard contents if discoloured. Pharma-Q Holdings (Pty) Ltd PHARMA-Q ADRENALINE 1 mg/ml INJECTION Injection 1 mg/ml Page 2 of 16 The dosage of PHARMA-Q ADRENALINE INJECTION 1 mg/ml is: By subcutaneous or intramuscular injection. Adults: 0,2 to 0,5 ml Children: 0,1 to 0,3 ml ADULTS _Bronchodilator_: Subcutaneous injection: 0,2 to 0,5 mg every 20 minutes to 4 hours if necessary (maximum of 1 mg per dose). _Anaphylactic reaction_: Intramuscular or subcutaneous injection: 0,2 to 0,5 mg repeated every 10 to 15 min if necessary (maximum 1 mg per dose). CHILDREN _Bronchodilator or anaphylactic reactions_: Subcutaneous 0,01 mg per kg body weight (maximum of 0,5 mg per dose) every 15 min for 2 doses and then every 4 hours as needed. The patient must be continuously monitored. ADULTS _Vasopressor (anaphylactic shock): _0,1 mg to 0,25 mg (base) administered slowly. May be repeated every five to fifteen minutes as needed. CHILDREN _Vasopressor (anaphylactic shock): _0,01 mg (base) per kg of body weight every five to fifteen minutes as needed, if an inadequate response to IM or SC administration. METHOD OF ADMINISTRATION By subcutaneous or intramuscular inje read_full_document