מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 10 mg/mL
AFT Pharmaceuticals Pty Ltd
Paracetamol
Injection, intravenous infusion
Excipient Ingredients: hydrochloric acid; cysteine hydrochloride monohydrate; dibasic sodium phosphate dihydrate; mannitol; nitrogen; water for injections; sodium hydroxide
Intravenous
10 x 100 mL vials
Medicine Registered
(S4) Prescription Only Medicine
PARACETAMOL-AFT 10mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.
Visual Identification: Clear, slightly yellowish solution in a colourless type II 100 ml glass vial, closed with light gray bromobutyl rubber stopper and sealed with aluminium lever capsule with gold lever; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2013-01-11
1 PARACETAMOL-AFT (Paracetamol) SOLUTION FOR INJECTION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PARACETAMOL-AFT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PARACETAMOL-AFT against the benefits that are expected. This leaflet does not contain everything about PARACETAMOL-AFT. Your doctor has been provided with full information and can answer any questions you may have. Follow your doctor's advice even if it differs from what is in this leaflet. Please read this leaflet carefully and keep it in a safe place so you may refer to it later. What PARACETAMOL-AFT is used for PARACETAMOL-AFT contains paracetamol an analgesic medicine which relives pain and reduces fever. PARACETAMOL-AFT is a solution of paracetamol which is given by intravenous infusion (IV) directly into a vein, and is used to relieve pain or reduce fever following surgery. This medicine is available only with a doctor's prescription. Before you are given PARACETAMOL-AFT When you must not be given PARACETAMOL-AFT You must not be given PARACETAMOL-AFT if you have an allergy to paracetamol or to any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to PARACETAMOL-AFT may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin You must not be given PARACETAMOL-AFT if you have liver failure or severe liver disease. 2 If you are not sure whether you should be given PARACETAMOL-AFT, talk to your doctor or pharmacist. Before you are given PARACETAMOL-AFT Tell your doctor or pharmacist if you have allergies to: • any other medicines • any other substances, such as foods, preservatives or dyes Tell your doctor or pharmacist if you are pregnant PARACETAMOL-AFT may be given to pregnant women, but your doctor must be tol קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION PARACETAMOL – AFT (PARACETAMOL) SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Paracetamol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PARACETAMOL-AFT solution for infusion contains 10 mg/mL of paracetamol (100 mL vial contains 1 g of paracetamol). For the full list of excipients, see 6.1 List of excipients 3 PHARMCEUTICAL FORM PARACETAMOL-AFT (paracetamol) solution for infusion is a clear, colourless to slightly yellowish solution. It contains 10 mg/mL of paracetamol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PARACETAMOL-AFT 10 mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE DOSING IS BASED ON PATIENT WEIGHT . Dosing recommendations are presented in the table below: Patient weight Paracetamol dose (10 mg/mL) per administration Minimum interval between each administration Maximum daily dose # > 50 kg 1 g (i.e. one 100 mL vial) Up to 4 times per day 4 hours* ≤ 4 g Must not exceed 4 g in 24 hours > 33 kg and ≤ 50 kg 15 mg/kg (i.e. 1.5 mL solution per kg) Up to 4 times per day 4 hours* ≤ 60 mg/kg without exceeding 3 g Must not exceed 3 g in 24 hours > 10 kg and ≤ 33 kg 15 mg/kg (i.e. 1.5 mL solution per kg) Up to 4 times per day 6 hours ≤ 60 mg/kg, without exceeding 2 g Must not exceed 2 g in 24 hours ≤ 10 kg** 7.5 mg/kg (i.e. 0.75 mL solution per kg) The volume must not exceed 7.5 mL per dose Up to 4 times per day 6 hours ≤ 30 mg/kg Must not exceed 30 mg/kg in 24 hours 2 * The minimum interval between each administration must be 4 hours in patients without hepatic or renal impairment. However, in patients with renal and/or hepatic impairment the minimum interval between doses must not be less than 6 hours. # The maximum daily dose takes into account all medicines containing paracetamol or propacetamol. ** No safety and efficacy data are available for premature neonates. There i קרא את המסמך השלם