Posology : מינונים

4.2 Posology and method of administration
Intravenous use.
The 100 ml infusion bag is restricted to adults, adolescents and children weighing more than 33 kg.
The 50 ml infusion bag 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 volume of          Maximum daily administration        administration     Paracetamol ALTAN 10            dose** mg/ml per administration based on upper weight limits of group (ml)***
 10 kg*              7.5 mg/kg            0.75 ml/kg                7.5 ml                  30 mg/kg > 10 kg to             15 mg/kg              1.5 ml/kg               49.5 ml                  60 mg/kg  33 kg                                                                                  not exceeding 2 g > 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
1g                  100 ml                  100 ml                    3g factors for hepatotoxicity
> 50 kg and no additional risk
1g                 100 ml                      100 ml                       4g factors for hepatotoxicity

*Preterm newborn infants:
No safety and efficacy data are available for premature newborn infants (see also 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 3000 mg (see section 4.4).

Method of administration

Take care when prescribing and administering Paracetamol Altan 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.

The paracetamol solution is administered as a 15-minute intravenous infusion. The paracetamol solution is administered slowly, with an infusion time that must never be less than 15 minutes. It is essential to follow this infusion regimen to prevent the occurrence of local reactions, especially pain at the injection site. If such reactions occur, the infusion rate must be reduced.

Patients weighing 10 kg:
• The volume is administered as a 15- minute intravenous infusion.
• The user should be referred to the product information for dosing guidelines .

As for all solutions for infusion presented in infusion bags, 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.