SIVEXTRO Powder for concentrate for solution for infusion Ref.[9877] Active ingredients: Tedizolid

Posology

Adults, as well as adolescents and children weighing at least 35 kg

The recommended dosage of tedizolid phosphate is 200 mg once daily for 6 days.

Tedizolid phosphate tablets or powder for concentrate for solution for infusion may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated.

Adolescents and children weighing less than 35 kg

The recommended intravenous dosage of tedizolid phosphate is presented in Table 1. In these patients, tedizolid phosphate is administered twice daily for 6 days, as an IV infusion over 1 hour.

Table 1. Intravenous dosage of tedizolid phosphate for paediatric patients weighing less than 35 kg:

If a dose is missed it should be given to the patient as soon as possible anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remains before the next dose, then the physician should wait until the next scheduled dose. A double dose should not be given to compensate for a missed dose.

Special populations

Elderly (≥65 years)

No dosage adjustment is required (see section 5.2). The clinical experience in patients ≥75 years is limited.

Hepatic impairment

No dosage adjustment is required (see section 5.2).

Renal impairment

No dosage adjustment is required (see sectio n 5.2).

Paediatric population

Tedizolid phosphate is available as 200 mg tablets for adolescents and children weighing at least 35 kg.

Method of administration

Sivextro must be administered by intravenous infusi on over a 60 -minute period.

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

In the event of overdose, Sivextro should be discontinued and general supportive treatment given. Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation. The highest single dose administered in clinical studies was 1 200 mg. All adverse reactions at this dose level were mild or moderate in severity.

3 years.

The combined storage time (from reconstitution to dilution to administration) must not exceed 24 hours when stored at either room temperature or in a refrigerator (2°C-8°C).

This medicinal product does not require any special storage conditions. For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Type I (10 mL) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper. Available in packs of 1 vial and 6 vials.

Not all pack sizes may be marketed.

Sivextro vials are intended for single use only.

It must be administered as an intravenous infusion only. It must not be administered as an intravenous bolus.

Aseptic technique must be followed in preparing the infusion solution. The contents of the vial should be reconstituted with 4 mL of water for injections, and be swirled gently until the powder has dissolved entirely. Shaking or rapid movement should be avoided as it may cause foaming.

For administration, the reconstituted solution must be further diluted in sodium chloride 0.9% solution for injection as described below. The bag should not be shaken. The resulting solution is a clear colourless or light-yellow solution and should be administered over approximately 1 hour.

Only limited data are available on the compatibility of Sivextro with other intravenous substances, therefore additives or other medicinal products should not be added to Sivextro single use vials or infused simultaneously. If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride.

The reconstituted solution should be inspected visually for particulate matter prior to administration. Reconstituted solutions containing visible particles should be discarded.

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

Preparation of doses

For preparation of the 200 mg Sivextro dose for onc e-daily infusion (adults, as well as adolescents and children weighing ≥ 35 kg):

1. Withdraw 4 mL of the reconstituted solution from the vial using a syringe and add to an infusion bag containing 250 mL of sodium chloride 0.9% for injection.

2. Infuse the entire bag over 1 hour.

For preparation of weight-based doses for twice -daily infusion (for adolescents and children weighing <35 kg):

1. Preparing the stock solution (100 mL of 0.8 mg/mL tedizolid phosphate): Withdraw 1.6 mL of the reconstituted solution from the vial using a syringe and add it to an infusion bag containing 98.4 mL of 0.9% sodium chloride for injection.

2. Preparing the required volume of stock solution for infusion:

a. Determine the appropriate amount of Sivextro in mg by consulting the dosing table below.

b. Transfer the appropriate volume of stock solution to an adequately sized infusion bag or infusion syringe. It may be necessary to round to the nearest graduation mark of an appropriately sized syringe for smaller volumes.

Table 1. Preparation of Sivextro for infusion for paediatric patients weighing <35 kg body weight from the 100 mL stock solution of 0.8 mg/mL tedizolid phosphate:

c. Infuse over 1 hour via infusion or syringe pump

d. This process is repeated for the second dose of the day

Note: Both doses should be used within the required duration of storage (see section 6.3).