देश: दक्षिण अफ़्रीका
भाषा: अंग्रेज़ी
स्रोत: 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 पूरा दस्तावेज़ पढ़ें
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 पूरा दस्तावेज़ पढ़ें