Posology : מינונים

4.2 Posology and method of administration

Intravenous route.
The 100 ml vial is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml vial is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg.
Posology:

Dosing based on patient weight (please see the dosing table here below) 


Patient weight     Dose per          Volume per     Maximum                  Maximum administratio     administration volume of                Daily Dose *** n                                Perfalgan (10 mg/mL) per administration based on upper weight limits of group (mL)**
≤10 kg *           7.5 mg/kg          0.75 mL/kg     7.5mL                   30 mg/kg 
> 10 kg to         15 mg/kg           1.5mL/kg          49.5mL               60mg/kg not ≤33kg                                                                        exceeding 2g > 33 kg to         15 mg/kg           1.5mL/kg          75 mL                60mg/kg not ≤50kg                                                                        exceeding 3g 
Patient weight     Dose per           Volume per     Maximum               Maximum Daily administration     administration volume per            Dose *** administration **

>50kg with           1g                100mL            100mL                3g additional risk factors for hepatotoxicity
> 50 kg and no       1g                100mL            100mL                4g additional risk factors for hepatotoxicity

* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn infants (see section 5.2).

** 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 given in 24 hours.
The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

*** 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.
Severe renal insufficiency:
It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), to reduce the dose and increase the minimum interval between each administration to 6 hours (See section 5.2).

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), dehydration:
The maximum daily dose must not exceed 3 g (see section 4.4).


Method of administration:

Take care when prescribing and administering PERFALGAN to avoid dosing errors due to confusion between milligram (mg) and milliliter (mL), which could result in accidental overdose 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 dose in volume. Take care to ensure the dose is measured and administered accurately.

The paracetamol solution is administered as a 15-minute intravenous infusion.

Patients weighing ≤ 10 kg:
• The glass vial of Perfalgan should not be hung as an infusion due to the small volume of the medicinal product to be administered in this population
• The volume to be administered should be withdrawn from the vial and could be administered undiluted or diluted (from one to nine volumes diluent) in a 0.9% sodium chloride solution or 5% glucose solution and administered in 15 -minute.
Use the diluted solution within the hour following its preparation (infusion time included).
• A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. However, this should never exceed 7.5ml per dose
• The user should be referred to the product information for dosing guidelines.

To remove solution, use a 0.8 mm needle (21 gauge needle) and vertically perforate the stopper at the spot specifically indicated.
As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.

Text for the 50ml vial:
Perfalgan of 50ml vial can also be diluted in a 0.9% sodium chloride solution or 5% glucose solution (from one to nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).