Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Paracetamol
Baxter Holding B.V.
N02BE01
Paracetamol
10 milligram(s)/millilitre
Solution for infusion
paracetamol
Marketed
2021-12-03
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). NEWBORN INFANTS, INFANTS, TODDLERS AND CHILDREN (LESS THAN OR EQUAL TO 33 KG) Use 50 ml fill vial. ADULTS, ADOLESCENTS AND CHILDREN (ABOVE 33 KG) Use 100 ml fill vial. 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-pho Belgenin tamamını okuyun
Health Products Regulatory Authority 27 February 2023 CRN00D8FW 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 1 ml contains 10 mg paracetamol. Each vial of 50 ml contains 500 mg paracetamol. Each vial 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. Osmolality 270 to 310 mOsm/kg pH: 4.5 – 6.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol 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 use. NEWBORN INFANTS, INFANTS, TODDLERS AND CHILDREN (LESS THAN OR EQUAL TO 33 KG) Use 50 ml fill vial. ADULTS, ADOLESCENTS AND CHILDREN (ABOVE 33 KG) Use 100 ml fill vial. 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 7.5mL 30 mg/kg > 10 kg to ≤33 kg 15 mg/kg 1.5 mL/kg 49.5mL 60 mg/kg not exceeding 2g > 33 kg to ≤50 kg 15 mg/kg 1.5 mL/kg 75 mL 60 mg/kg not exceeding 3g Patient weight Dose per administration Volume per administration Maximum volume per administration ** Maximum Daily Dose *** >50 kg 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 Health Products Regulatory Authority 27 February 2023 CRN00D8FW Page 2 of 7 * PRE-TERM NEWBORN INFANTS: No safety a Belgenin tamamını okuyun