Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Paracetamol
Fresenius Kabi Deutschland GmbH
N02BE; N02BE01
Paracetamol
10 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Anilides; paracetamol
Marketed
2010-12-21
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET 1 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 of the 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 infusion is and what it is used for 2. What you need to know before you use Paracetamol infusion 3. How to use Paracetamol infusion 4. Possible side effects 5. How to store Paracetamol infusion 6. Contents of the pack and other information 1. WHAT PARACETAMOL INFUSION IS AND WHAT IT IS USED FOR This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). It is indicated - for the short-term treatment of moderate pain, especially following surgery, and - for the short-term treatment of fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL INFUSION DO NOT USE PARACETAMOL INFUSION - if you are ALLERGIC (hypersensitive) TO PARACETAMOL or any of the other ingredients of Paracetamol infusion (listed in section 6). - if you are ALLERGIC (hypersensitive) TO PROPACETAMOL (another pain killer and a precursor of Paracetamol). - if you suffer from a SEVERE LIVER DISEASE . WARNINGS AND PRECAUTIONS Talk to your doctor before using Paracetamol infusion . TAKE SPECIAL CARE WITH PARACETAMOL INFUSION - if you suffer from a LIVER OR KIDNEY DISEASE , or from ALCOHOL ABUSE . - if you suffer from a inherited liver function disorder called MEULENGRACHT GILBERT'S SYNDROME . - if you suffer from GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY. - if you are taking OTHER MEDICINES CONTAINING Citiți documentul complet
Health Products Regulatory Authority 12 July 2022 CRN008LQR Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 10 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 10 mg paracetamol. Each 10 ml ampoule contains 100 mg paracetamol. Each 50 ml vial contains 500 mg paracetamol. Each 100 ml vial contains 1000 mg paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear and slightly yellowish solution. The solution is iso-osmotic and its pH is between 5.0 and 7.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol is indicated for: the short-term treatment of moderate pain, especially following surgery, 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 use. The 100 ml vial or bag is restricted to adults, adolescents and children weighing more than 33 kg. The 10 ml ampoule and the 50 ml vial or bag is restricted to term newborn infants, infants, toddlers and children weighing up to 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 PARACETAMOL 10 MG/ML SOLUTION FOR INFUSION PER ADMINISTRATION BASED ON UPPER WEIGHT LIMITS OF GROUP (ML)*** MAXIMUM DAILY DOSE** Health Products Regulatory Authority 12 July 2022 CRN008LQR Page 2 of 9 ≤ 10 KG* 7.5 mg/kg 0.75 mL/kg 7.5 mL 30 mg/kg > 10 KG TO ≤ 33 KG 15 mg/kg 1.5 mL/kg 49.5 mL 60 mg/kg, not exceeding 2 g > 33 KG TO ≤ 50 KG 15 mg/kg 1.5 mL/kg 75 mL 60 mg/kg, not exceeding 3 g > 50 KG AND WITH ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1 g 100 mL 100 mL 3 g > 50 KG AND NO ADDITIONAL RISK FACTORS FOR HEPATOTOXICITY 1 g 100 mL 100 mL 4 g *PRE-TERM NEWBORN INFANTS: No safety and efficacy data are ava Citiți documentul complet