Dosing regimen
Unintentional excess of recommended doses can lead to a serious impairment of liver function, including fatalities. When determining the dose, individual risk factors for hepatotoxicity in the patient, including hepatic insufficiency, chronic alcoholism, chronic eating disorders, dehydration, should also be considered.
Calculation of doses is based on the patient's body weight.
| Weight bodies the patient | Single entry dose | Input amount | Maximum are admissibleth amount introduction of *** | Maximum dose** |
| ≤ 10 kg * | 7,5 mg / kg | 0,75 ml / kg | 7.5 ml | 30 mg / kg |
| > 10 kg ≤ 30 kg | 15 mg / kg | 1,5 ml / kg | 49 ml | 60 mg / kg, but not more than 2 g |
| > 33 kg ≤ 50 kg | 15 mg / kg | 1,5 ml / kg | 75 ml | 60 mg / kg, but not more than 3 g |
| > 50 kg, if there are risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 3 grams |
| > 50 kg, in the absence of risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 4 grams |
* The safety and efficacy of the drug in premature infants is not established.
** The maximum daily dose, taking into account the use of all drugs containing paracetamol or propacetamol.
*** With a lower body weight, it is recommended to inject a low volume of the drug. The interval between the introduction should not be less than 4 hours. More than 4 introductions per day is not allowed. The interval between administration for severe renal failure should not be less than 6 hours.
Special patient groups
In case of severe impairment of kidney function (creatinine clearance <30 ml / min), the interval between injections should be at least 6 hours.
In case of violations of liver function in adults and patients with chronic alcoholism, eating disorders or dehydration, the daily dose should not exceed 3 g.
Dose adjustments in elderly patients are not required.
Method of administration
Intravenous (iv) single infusion for 15 minutes.
The drug should not be mixed in one vial for infusions with other medications.
Infusion should be performed immediately after opening the vial; The unused residue of the drug is destroyed.Before starting the infusion, the vial with the drug should be carefully inspected for lack of visible mechanical particles and discoloration of the solution.
Additional dilution is possible with 0.9% sodium chloride solution or 5% dextrose solution, in addition for 1/10 part of the original volume. The diluted solution should be used within an hour after preparation, including the infusion time. Before starting the infusion, the vial with diluted drug should be carefully inspected for lack of visible mechanical particles and discoloration of the solution.
For infusion, use a needle with a diameter of 0.8 mm, which is injected into the vial in a place marked on the rubber stopper, holding the bottle strictly vertically. As in the case of other solutions for infusions supplied in glass containers, Avoidance of air embolism should be particularly cautious, especially at the end of the infusion, regardless of which vein is injected.
When the drug is administered to children and adolescents, the vial with the drug can not be suspended as an infusion vessel due to a small amount of contents.
To avoid mistakes in the calculation of doses for children weighing less than 10 kg, it is recommended to specify the volume for a single injection in milliliters (ml),In this category of patients, the injected volume of the drug should not exceed 7.5 ml per infusion.
In order to measure the dose of the drug taking into account the child's body weight and the required volume, a 5 or 10 ml syringe should be used.
The volume of the preparation necessary for the patient's administration should be extracted from the vial and diluted in a 0.9% solution of sodium chloride or 5% dextrose solution in a ratio of 1:10 (one volume of the preparation in nine volumes of the dilution solution) and administered within 15 minutes.