Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Bristol-Myers Squibb Pharmaceuticals Ltd
N02BE01
Paracetamol
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5012712003595
PACKAGE LEAFLET: INFORMATION FOR THE USER PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION Paracetamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What PERFALGAN 10 mg/ml, solution for infusion is and what it is used for 2. Before you use PERFALGAN 10 mg/ml, solution for infusion 3. How to use PERFALGAN 10 mg/ml, solution for infusion 4. Possible side effects 5. How to store PERFALGAN 10 mg/ml, solution for infusion 6. Further information 1. WHAT PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml vial is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg. It is indicated for the short-term treatment of moderate pain, especially following surgery, and for the short-term treatment of fever. 2. BEFORE YOU USE PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION DO NOT USE PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION • if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of Perfalgan. • if you are allergic (hypersensitive) to propacetamol (another analgesic for infusion and a precursor of paracetamol). • if you suffer from a severe liver disease. TAKE SPECIAL CARE WITH PERFALGAN 10 MG/ML, SOLUTION FOR INFUSION • use a suitable analgesic oral treatment as soon as this administration route is possible. • if you suffer from a liver or kidney disease, or from alcohol abuse. • if you are taking other medici Đọc toàn bộ tài liệu
OBJECT 1 PERFALGAN 10MG/ML SOLUTION FOR INFUSION Summary of Product Characteristics Updated 05-Apr-2017 | Bristol-Myers Squibb Pharmaceuticals limited 1. Name of the medicinal product PERFALGAN 10 mg/ml, solution for infusion. 2. Qualitative and quantitative composition One ml contains 10 mg paracetamol One 50 ml vial contains 500 mg paracetamol One 100 ml vial contains 1000 mg paracetamol Excipients: Sodium 0.04 mg/ml For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion. The solution is clear and slightly yellowish. 4. Clinical particulars 4.1 Therapeutic indications Perfalgan is indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible. 4.2 Posology and method of administration Intravenous route. The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml vial is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg. POSOLOGY: Dosing based on patient weight (please see the dosing table here below) PATIENT WEIGHT DOSE PER ADMINISTRATION VOLUME PER ADMINISTRATION MAXIMUM VOLUME OF PERFALGAN (10 MG/ML) PER ADMINISTRATION BASED ON UPPER WEIGHT LIMITS OF GROUP MAXIMUM DAILY DOSE *** (ML)** ≤10 KG * 7.5 mg/kg 0.75 mL/kg 7.5mL 30 mg/kg > 10 KG TO ≤33KG 15 mg/kg 1.5mL/kg 49.5mL 60mg/kg not exceeding 2g > 33 KG TO ≤50KG 15 mg/kg 1.5mL/kg 75 mL 60mg/kg not exceeding 3g PATIENT WEIGHT Dose per administration Volume per administration Maximum volume per administration ** Maximum Daily Dose *** >50KG WITH ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1g 100mL 100mL 3g > 50 KG AND NO ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1 g 100mL 100mL 4g * PRE-TERM NEWBORN INFANTS: No safety and efficacy data are available for pre-term newborn infants (see section 5.2). ** Pati Đọc toàn bộ tài liệu