Posology : מינונים

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                   Volume per            Maximum volume of        Maximum daily per administration          administration        Paracetamol 10 mg/ml           dose* per administration based on upper weight limits of group (ml)**
> 10 kg to            15 mg/kg                1.5 ml/kg                    49.5 ml               60 mg/kg  33 kg                                                                                     not exceeding 2 g 100 ml vial
Patient weight          Dose (per               Volume per            Maximum volume of               Maximum administration)            administration      Paracetamol 10 mg/ml per            daily administration based on upper         dose* weight limits of group (ml)**
> 33 kg to             15 mg/kg                1.5 ml/kg                    75 ml                    60 mg/kg  50 kg                                                                                                not exceeding
3g
> 50 kg with additional risk
100 ml                       100 ml                       3g factors for               1g hepatotoxicity
> 50 kg and no additional risk
100 ml                       100 ml                       4g factors for               1g hepatotoxicity

Preterm newborn infants:
No safety and efficacy data are available for premature newborn infants (see also section 5.2) 
* 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 ac- count.

***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 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 3000 mg (see section 4.4).

Method of administration

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 dose in volume. Take care to ensure the dose is measured and administered accurately.
Intravenous use.
The paracetamol solution is administered as a 15-minute intravenous infusion.

Paracetamol Fresenius 10 mg/ml can be diluted in a 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution or a combination of both solutions up to one tenth (one volume Paracetamol Fresenius 10 mg/ml into nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).

For instructions on dilution of the medicinal product before administration, see section 6.6.

For single use only. Any unused solution should be discarded.
Before administration, the product should be visually inspected for any particulate matter and discolouration.

As for all solutions for infusion presented in containers with air space inside, 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 infusion applies particularly for central route infusions, in order to avoid air embolism.