País: Israel
Idioma: inglés
Fuente: Ministry of Health
PARACETAMOL
NEOPHARM (ISRAEL) 1996 LTD
N02BE01
SOLUTION FOR INFUSION
PARACETAMOL 10 MG/ML
I.V
Required
FRESENIUS KABI AUSTRIA GmbH
PARACETAMOL
Paracetamol – Fresenius 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.
2020-05-31
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PARACETAMOL FRESENIUS 10 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution for infusion contains 10 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol Fresenius 10 mg/ml is indicated for: ● short-term treatment of moderate pain, especially following surgery, ● 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 The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml vial is restricted to toddlers and children weighing more than 10 kg and up to 33 kg. _POSOLOGY: _ _ _ THE DOSE TO BE ADMINISTERED AND THE BOTTLE SIZE TO BE USED DEPEND EXCLUSIVELY ON THE PATIENT`S WEIGHT. THE VOLUME TO BE ADMINISTERED MUST NOT EXCEED THE DETERMINED DOSE. IF APPLICABLE, THE DESIRED VOLUME MUST BE DILUTED IN A SUITABLE SOLUTION FOR INFUSION PRIOR TO ADMINISTRATION (SEE SECTION 6.6) OR A SYRINGE DRIVER MUST BE USED. Dosing based on patient weight (please see the dosing table here below) 50 ML VIAL 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 to 33 kg 15 mg/kg 1.5 ml/kg 49.5 ml 60 mg/kg not exceeding 2 g Take care when prescribing and administering Paracetamol 10 mg/ml to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental over- dose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dos Leer el documento completo