Aurotaz (piperacillin) powder for solution for injections 4.5 g. №1 vial

Dosage.

The dose and frequency of administration of the drug Aurotaz-R depend on the severity and location of the infection, as well as possible pathogens.

Adults and children from 12 years old.

Infections.

The usual dose of Aurotaz-R (4 g piperacillin/0.5 g tazobactam) is 4.5 g every 8 hours.

For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin/0.5 g tazobactam every 6 hours. This regimen is also applicable to the treatment of patients with particularly severe forms of other identified infections.

The table below shows the recommended frequency of use for adults and children over 12 years of age, indicating indications or conditions:

Patients with renal insufficiency.

The intravenous dose should be adjusted according to the degree of renal impairment, as follows (each patient should be checked for signs of toxicity of the active substances; the dose and interval of administration of the drug should be adjusted accordingly):

Due to the fact that hemodialysis removes 30-50% of piperacillin in 4 hours, it is necessary to administer an additional dose of piperacillin/tazobactam 2 g/0.25 g after each dialysis session.

Patients with liver failure.

Dose adjustment is not required.

Elderly patients.

For elderly patients with normal renal function or creatinine clearance greater than 40 ml / min, dose adjustment is not required.

Children from 2 to 12 years old.

Infections.

The table below shows the recommended frequency of use and dosage according to the body weight of children aged 2 to 12 years, indicating indications or conditions:

* Do not exceed the maximum dose of 4.5 g administered over 30 minutes.

Patients with renal insufficiency.

The intravenous dose should be adjusted according to the degree of renal dysfunction, as follows (each patient should be checked for signs of toxicity of the active substances; the dose and interval of drug administration should be adjusted accordingly):

For children on hemodialysis, an additional dose of 40 mg piperacillin/5 mg tazobactam per kg of body weight is required after each dialysis session.

Children under 2 years old.

The efficacy and safety of Aurotaz-R for the treatment of children under 2 years of age has not been established.

There are no data from controlled clinical trials.

duration of treatment.

Usually the duration of treatment for most indications is 5-14 days. However, to determine the duration of treatment, one must be guided by the patient’s condition, the severity of the infection, the results of clinical and bacteriological examination.

Instructions for preparing a solution for intravenous use.

The preparation of a solution for intravenous use must be carried out under aseptic conditions. Before use, the prepared solution should be visually checked for the absence of mechanical inclusions and signs of discoloration. Only a solution that is clear and free of mechanical impurities should be used.

The contents of the vial must be diluted with the solvent in the amount indicated in the table below. Shake the vial until the powder is completely dissolved. During constant shaking, the recovery of the solution occurs within 5-10 minutes.

* Compatible recovery solvents:

• Sterile water for injections1

• 0.9% sodium chloride solution

• 5% aqueous glucose solution

1 The maximum recommended volume of sterile water for injection per dosage is 50 ml.

Reconstituted solutions must be withdrawn from the vial using a syringe. If the solution has been reconstituted as recommended, withdrawing the contents of the vial with a syringe will ensure that the stated amount of piperacillin/tazobactam is available. Reconstituted solutions may be further diluted to the required volume (50 ml to 150 ml) with one of the following compatible solvents:

• Sterile water for injection
• 0.9% sodium chloride solution
• 5% aqueous glucose solution.