TENKASI Powder for solution for infusion Ref.[50255] Active ingredients: Oritavancin

Posology

1,200 mg administered as a single dose by intravenous infusion over 3 hours.

Special populations

Elderly (≥65 years)

No dosage adjustment is required for patients ≥65 years of age (see section 5.2).

Renal impairment

No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2). The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated. Oritavancin is not removed from blood by haemodialysis procedures.

Hepatic impairment

No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2). The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure. Therefore no dose adjustment is required, even if caution should be exercised when prescribing oritavancin to patients with severe hepatic impariment (Child-Pugh Class C).

Paediatric population

The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been established. No data are available.

Method of administration

Intravenous use.

Intravenous infusion over 3 hours (see section 6.6).

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

In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.

Oritavancin is not removed from blood by haemodialysis procedures. In the event of overdose, supportive measures should be taken.

4 years.

After reconstitution:

The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.

After dilution:

The diluted solution should be used immediately.

From a microbiological point of view, the product should be used immediately. If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C following dilution in a glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

Do not store above 25°C.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap.

3 individual vials are packaged in a carton.

For single use only. Tenkasi should be prepared under aseptic techniques in a pharmacy.

The powder must be reconstituted with water for injections and the resulting concentrate must be diluted in a glucose 5% intravenous infusion bag prior to use. Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pale yellow solution. Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.

Reconstitution:

• 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
• To avoid excessive foaming, it is recommended that WFI should be added carefully, along the walls of the vials.
• Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.

Dilution: Three reconstituted vials are needed for dilution for administration of a single 1,200 mg intravenous infusion. Only glucose 5% intravenous bag (D5W) should be used for dilution. Sodium chloride solution should not be used for dilution (see section 6.2).

Dilution:

• Withdraw and discard 120 mL from a 1,000 mL D5W intravenous bag.
• Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1,000 mL. This yields a concentration of 1.2 mg/mL of oritavancin. PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.

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