TARGOCID Powder for solution for injection, infusion or oral solution Ref.[7885] Active ingredients: Teicoplanin

Posology

The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function.

Measurement of serum concentrations

Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached:

• For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method.
• For endocarditis and other severe infections, teicoplanin trough levels of 15-30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method.

During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.

Adults and elderly patients with normal renal function:

¹ Measured by FPIA

The dose is to be adjusted on bodyweight whatever the weight of the patient.

Duration of treatment

The duration of treatment should be decided based on the clinical response. For infective endocarditis a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months.

Combination therapy

Teicoplanin has a limited spectrum of antibacterial activity (Gram positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

Clostridium difficile infection-associated diarrhoea and colitis

The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days.

Elderly population

No dose adjustment is required, unless there is renal impairment (see below).

Adults and elderly patients with impaired renal function

Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.

After the fourth day of treatment:

• In mild and moderate renal insufficiency (creatinine clearance 30-80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.
• In severe renal insufficiency (creatinine clearance less than 30 mL/min) and in haemodialysed patients: dose should be one-third the usual dose, either by administering the initial unit dose every third day or by administering one-third of this dose once a day.

Teicoplanin is not removed by haemodialysis.

Patients in continuous ambulatory peritoneal dialysis (CAPD)

After a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week and then 20 mg/L in the overnight bag in the third week.

Paediatric population

The dose recommendations are the same in adults and children above 12 years of age.

Neonates and infants up to the age of 2 months

Loading dose: One single dose of 16 mg/kg body weight, administered intravenously by infusion on the first day.

Maintenance dose: One single dose of 8 mg/kg body weight administered intravenously by infusion once a day.

Children (2 months to 12 years)

Loading dose: One single dose of 10 mg/kg body weight administered intravenously every 12 hours, repeated 3 times.

Maintenance dose: One single dose of 6-10 mg/kg body weight administered intravenously once a day.

Method of administration

Teicoplanin should be administered by the intravenous or intramuscular route. The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion.

Only the infusion method should be used in neonates.

For Clostridium difficile infection-associated diarrhoea and colitis, the oral route is to be used.

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

Symptoms

Cases of accidental administration of excessive doses to paediatric patients have been reported. In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously (95 mg/kg).

Management

Treatment of teicoplanin overdose should be symptomatic.

Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.

Shelf life

Shelf life of powder as packaged for sale: 3 years.

Shelf life of reconstituted solution:

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

From a microbiological point of view, the medicinal product 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 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Shelf life of diluted medicinal product:

Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.

From a microbiological point of view, the medicinal product 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 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Powder as packaged for sale:

This medicinal product does not require any special storage condition.

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

Primary packaging:

The freeze-dried medicinal product is packaged in:

Type I, colourless glass vial of useful volume of 10 mL for 200 mg closed with bromobutyl rubber stopper and plastic flip-off top aluminium yellow overseal.

Pack sizes:

• 1 powder vial
• 5x1 powder vials
• 10x1 powder vials
• 25x1 powder vials

Not all pack sizes may be marketed.

This medicinal product is for single use only.

Preparation of reconstituted solution

The solution is reconstituted by adding 3.14 mL of water for injection to the 200 mg and 400 mg powder vial. The water is slowly added to the vial which should be rotated until all the powder is dissolved to avoid foaming. If foam is developed, allow the solution to stand for approximately 15 minutes so that the foam disappears. Only clear and yellowish solutions should be used.

The reconstituted solution may be injected directly or alternatively further diluted, or orally administered.

Preparation of the diluted solution before infusion

Targocid can be administered in the following infusion solutions:

• sodium chloride 9 mg/mL (0.9%) solution
• Ringer solution
• Ringer-lactate solution
• 5% dextrose injection
• 10% dextrose injection
• 0.18% sodium chloride and 4% glucose solution
• 0.45% sodium chloride and 5% glucose solution
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

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