מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Paracetamol
Carelide
N02BE; N02BE01
Paracetamol
10 milligram(s)/millilitre
Solution for infusion
Anilides; paracetamol
Not marketed
2011-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION PARACETAMOL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Paracetamol 10 mg/ml Solution for Infusion is and what it is used for 2. What you need to know before you use Paracetamol 10 mg/ml Solution for Infusion 3. How to use Paracetamol 10 mg/ml Solution for Infusion 4. Possible side effects 5. How to store Paracetamol 10 mg/ml Solution for Infusion 6. Contents of the pack and other information 1. WHAT PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Paracetamol is an analgesic agent (it relieves pain) and an antipyretic agent (it reduces body temperature). The 100-ml bag is for use in adults, adolescents and children weighing more than 33 kg (approximately 11 years of age) only. The 50-ml bag is for use in full-term newborns, infants and children weighing less than 33 kg. The 10 ml bag is adapted for use in full-term newborns, infants and children weighing less than 10 kg. It is indicated in the short-term treatment of moderate pain, particularly post-surgery pain, and in the short-term treatment of fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION DO NOT USE PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION: if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients. if you are allergic (hypersensitive) to propacetamol (another analgesic agent used for infusions, a precursor of paracetamol). if you suffer fro קרא את המסמך השלם
Health Products Regulatory Authority 06 April 2022 CRN00CP0Q Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 10 mg/ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 10.00 mg for 1 ml of solution for infusion: One 100-ml bag contains 1000 mg paracetamol. One 50-ml bag contains 500 mg paracetamol. One 10-ml bag contains 100 mg paracetamol. Excipients-contains Sodium 2.52 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol is indicated in the short-term treatment of moderate pain, particularly post-surgery pain, and in the short-term treatment of fever, when the intravenous route is clinically justified by the urgent need to treat pain or hyperthermia and/or when other routes of administration cannot be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous use. 100-ml bag: for use in adults, adolescents and children weighing more than 33 kg only. 50-ml bag: for use in newborns, infants and children weighing less than 33 kg. 10-ml bag: for use in newborns, infants and children weighing less than 10 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 PARACETAMOL (10 MG/ML) PER ADMINISTRATION BASED ON UPPER WEIGHT LIMITS OF GROUP (ML)*** MAXIMUM DAILY DOSE** ≤10 KG* 7.5 mg/kg 0.75 ml/kg 7.5 ml 30 mg/kg >10KG TO ≤33 KG 15 mg/kg 1.5 ml/kg 49.5 ml 60 mg/kg not exceeding 2 g Health Products Regulatory Authority 06 April 2022 CRN00CP0Q Page 2 of 8 >33 KG TO ≤50 KG 15 mg/kg 1.5 ml/kg 75 ml 60 mg/kg not exceeding 3 g >50 KG WITH ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1g 100 ml 100 ml 3 g >50 KG AND NO ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1g 100 ml 100 ml 4 g * PRE-TERM NEWBORN INFANTS:No safety and efficacy data are available for pre-term newborn infants (see section 5.2). ** MAXIMUM DAILY DOSE קרא את המסמך השלם