Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Paracetamol
Baxter Holding B.V.
N02BE01
Paracetamol
Solution for infusion
paracetamol
Marketed
2022-02-18
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. • 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 is and what it is used for 2. What you need to know before you use Paracetamol 3. How to use Paracetamol 4. Possible side effects 5. How to store Paracetamol 6. Contents of the pack and other information 1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR This medicine contains the active substance paracetamol, and it is an analgesic (it relieves pain) and an antipyretic (it lowers fever). The medicine is restricted to adults, adolescents and children weighing more 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. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL DO NOT USE PARACETAMOL • if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6). • if you are allergic to propacetamol hydrochloride. This is another painkiller that the body converts to paracetamol. • if you have a severe liver disease. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING PARACETAMOL , IF ANY OF THESE APPLY TO YOU: • if you could take painkillers through the mouth (orally) instead, since that is the recommended administration route. • if you have reduced liver or kidney function, or if you drink too much alcohol. • if you are taking other medicines that have paracetamol in them. • in cases of malnutrition or dehydration. • If you have a glucose-6-phosphate dehydrogenase deficiency. This is a disease of the blood. OTHER MEDICINES Read the complete document
Health Products Regulatory Authority 07 July 2022 CRN00CXV9 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 10 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 10 mg paracetamol Each bag of 100 ml contains 1000 mg paracetamol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is clear, colourless to slightly yellowish and free from visible particles. pH: 5.0 – 6.5 Osmolality 270 to 310 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol Baxter 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. This medicinal product is indicated in adults, adolescents and children weighing more than 33 kg. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous use. This medicinal product is restricted to adults, adolescents and children weighing more 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 Paracetamol Baxter (10 mg/mL) per administration based on upper weight limits of group (mL)** Maximum Daily Dose * > 33 kg to ≤50kg 15 mg/kg 1.5mL/kg 75 mL 60mg/kg not exceeding 3g >50 kg with additional risk factors for hepatotoxicity 1g 100mL 100mL 3g > 50 kg and no additional risk factors for hepatotoxicity 1g 100mL 100mL 4g * MAXIMUM DAILY DOSE: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account. ** Patients weighing less will require smaller volumes. The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be Read the complete document