Country: Israel
Language: English
Source: Ministry of Health
PARACETAMOL
RAZ PHARMACEUTICS LTD, ISRAEL
N02BE01
SOLUTION FOR INFUSION
PARACETAMOL 10 MG / 1 ML
I.V
Required
S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY
PARACETAMOL
Paracetamol is indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when intravenous administration is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible.
2020-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PARACETAMOL S.A.L.F 10 MG/ML 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution for infusion contains 10 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, colorless solution or slightly colored from amber-yellow to pink-pale orange (perception may vary). pH 4.8 – 5.2 4. CLINICAL PARTICULARS 4.1 Therapeutic indications PARACETAMOL S.A.L.F 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 bottle is restricted to adults, adolescents and children weighing more than 33 kg. _Posology:_ The dose to be administered depends 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) * 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. The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours. No more than 4 doses to be given in 24 hours. Severe renal insufficiency: It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 m Read the complete document