Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
PARACETAMOL
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
N02BE01
SOLUTION FOR INFUSION
PARACETAMOL 10 MG/ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
PARACETAMOL
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.
2020-02-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Paracetamol B. Braun 10 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution for infusion contains 10 mg paracetamol. Each 10 ml ampoule contains 100 mg paracetamol Each 50 ml bottle contains 500 mg paracetamol. Each 100 ml bottle contains 1000 mg paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is clear and colourless to slightly pinkish-orangish. Perception may vary. Theoretical Osmolarity 305 mOsm/l pH 4.5 – 5.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol B. Braun 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 hy- perthermia and/or when other routes of administration are not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The 100 ml bottle is restricted to adults, adolescents and children weighing more than 33 kg. The 50 ml bottle is restricted to toddlers and children weighing more than 10 kg and up to 33 kg. The 10 ml ampoule is restricted to term newborn infants, infants and toddlers weighing up to 10 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) 10 ML AMPOULE PATIENT WEIGHT DOSE PER ADMINISTRATION VOLUME PER AD- MINISTRATION MAXIMUM VOLUME OF PARACETA- MOL B. BRAUN 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 50 ML BOTTLE 100 ML BOTTLE PATIENT WEIGHT DOSE (PER ADMIN- ISTRATION) Lestu allt skjalið