ZINPLAVA Concentrate for solution for infusion Ref.[6508] Active ingredients: Bezlotoxumab

Posology

ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).

ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6).

The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).

Special populations

Elderly

No dose adjustment is necessary in patients ≥65 years of age (see section 5.2).

Renal impairment

No dose adjustment is necessary for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established.

No data are available.

Method of administration

• Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. ZINPLAVA should not be administered as an intravenous push or bolus.
• The diluted solution can be infused via a central line or peripheral catheter.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line.

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

There is no clinical experience with overdosage of ZINPLAVA. In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.

Shelf life

Unopened vial: 3 years.

Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C–8°C or 16 hours at room temperature (at or below 25°C). These time limits include storage of the infusion solution in the IV bag through the duration of infusion. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C–8°C or 16 hours at room temperature (at or below 25°C).

Store in a refrigerator 2 °C to 8 °C. Do not freeze. Keep vial in the outer carton in order to protect from light.

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

Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.

Each carton contains one vial.

Preparation of diluted solution:

• Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
• Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid. Do not use the vial if the solution is discoloured or contains visible particles.
• Do not shake the vial.
• Withdraw the required volume from the vial(s) based on the patient’s weight (in kg) and transfer into an IV bag containing either 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Mix diluted solution by gentle inversion.
• Discard vial(s) and all unused contents.
• If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
• Do not freeze the diluted solution.

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