TAZOCIN Powder for solution for infusion Ref.[50867] Active ingredients: Piperacillin Tazobactam

Posology

The dose and frequency of Tazocin depends on the severity and localisation of the infection and expected pathogens.

Adult and adolescent patients

Infections

The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours.

For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin / 0.5 g tazobactam administered every 6 hours. This regimen may also be applicable to treat patients with other indicated infections when particularly severe.

The following table summarises the treatment frequency and the recommended dose for adult and adolescent patients by indication or condition:

Patients with renal impairment

The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

For patients on haemodialysis, one additional dose of piperacillin / tazobactam 2 g / 0.25 g should be administered following each dialysis period, because haemodialysis removes 30%-50% of piperacillin in 4 hours.

Patients with hepatic impairment

No dose adjustment is necessary (see section 5.2).

Elderly patients

No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.

Paediatric population (2-12 years of age)

Infections

The following table summarises the treatment frequency and the dose per body weight for paediatric patients 2-12 years of age by indication or condition:

^* Not to exceed the maximum 4 g / 0.5 g per dose over 30 minutes.

Patients with renal impairment

The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.

Use in children aged below 2 years

The safety and efficacy of Tazocin in children 0- 2 years of age has not been established.

No data from controlled clinical studies are available.

Treatment duration

The usual duration of treatment for most indications is in the range of 5-14 days. However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient’s clinical and bacteriological progress.

Method of administration

Tazocin 2 g / 0.25 g is administered by intravenous infusion (over 30 minutes).

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

Symptoms

There have been post-marketing reports of overdose with piperacillin / tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhoea, have also been reported with the usual recommended dose. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).

Treatment

In the event of an overdose, piperacillin / tazobactam treatment should be discontinued. No specific antidote is known.

Treatment should be supportive and symptomatic according to the patient’s clinical presentation.

Excessive serum concentrations of either piperacillin or tazobactam may be reduced by haemodialysis (see section 4.4).

Unopened vial: 3 years.

Reconstituted solution in vial

Chemical and physical in-use stability has been demonstrated for up to 12 hours when stored in a refrigerator at 2-8°C, when reconstituted with one of the compatible solvents for reconstitution (see section 6.6).

Diluted reconstituted solution, for infusion

The diluted reconstituted solution when using one of the compatible solvents at the suggested dilution volume (see section 6.6), demonstrated chemical and physical in-use stability for up to 12 hours when stored in a refrigerator at 2-8°C.

From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 2-8°C.

Unopened vials: Do not store above 25°C.

For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

30 ml Type I glass vial with a bromo-butyl rubber stopper and flip-off seal.

Pack sizes: 1, 5, 10, 12, 25 or 50 vials per carton.

Not all pack sizes may be marketed.

The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.

Intravenous use

Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved. When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).

^* Compatible solvents for reconstitution:

• 0.9% (9 mg/ml) sodium chloride solution for injection
• Sterile water for injections^1^
• Glucose 5%

¹ Maximum recommended volume of sterile water for injection per dose is 50 ml.

The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.

The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:

• 0.9% (9 mg/ml) sodium chloride solution for injection
• Glucose 5%
• Dextran 6% in 0.9% (9 mg/ml) sodium chloride
• Lactated Ringers injection
• Hartmann’s solution
• Ringer’s acetate
• Ringer’s acetate/malate

Co-administration with aminoglycosides

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Tazocin and the aminoglycoside are recommended for separate administration. Tazocin and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.

In circumstances where co-administration is recommended, Tazocin is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:

^* The dose of aminoglycoside should be based on patient weight, status of infection (serious or life-threatening) and renal function (creatinine clearance).

Compatibility of Tazocin with other aminoglycosides has not been established. Only the concentration and diluents for amikacin and gentamicin with the dose of Tazocin listed in the above table have been established as compatible for co-administration via Y-site infusion. Simultaneous co-administration via Y-site in any manner other than listed above may result in inactivation of the aminoglycoside by Tazocin.

See section 6.2 for incompatibilities.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

For single use only. Discard any unused solution.