The drug is intended for intravenous infusion (see "Preparation and administration of the solution").
The recommended dosing regimen in patients aged 18 years and older:
- with complicated infections of the skin and soft tissues 200 mg once a day for 6 days, the infusion duration is 60 minutes.
When switching from an intravenous to an oral application preparation of Sivextro dosage adjustment is not required.
In case of missing the infusion time the missed infusion should be administered as soon as possible at any time, but no later than 8 hours before the next scheduled infusion. If before the next scheduled infusion remains less than 8 hours,it is recommended to wait until the scheduled introduction of the drug.
Preparation and administration of an infusion solution
Sievextro is a lyophilizate for the preparation of a concentrate for the preparation of a solution for infusion in a vial containing 200 mg of active substance (1 dose). The lyophilizate should be reconstituted in a vial with sterile water for injections, and subsequently further diluted with 0.9% sodium chloride solution for injection.
Flavors of the drug Sievextro do not contain antimicrobial preservatives and are intended only for single use.
Preparing the preparation
The contents of the vial should be restored in accordance with the rules of asepsis as follows:
Note: To minimize foaming, avoid vigorous shaking or shaking of the vial during or after reconstitution.
1. Using a 5 ml syringe, add 4 ml of sterile water for injection to the contents of the Sivextro's vial, then remove the syringe.
2. Carefully rotate the contents and leave the vial in a vertical position, until the lyophilized mass is completely dissolved and the foam does not settle.
3. Consider the vial to make sure that the solution does not contain any suspended particles, and that the lyophilized mass does not stick to the walls of the vial. If necessary, flip the bottle to dissolve the remaining mass, and gently rotate to prevent foaming. A reconstituted concentrated solution is prepared for subsequent dilution. The reconstituted solution is transparent and has a color from colorless to pale yellow. The total storage time of the reconstituted concentrated solution should not exceed 24 hours at room temperature or when stored in a refrigerator at a temperature of 2 ° C to 8 ° C.
4. Collect 4 ml of the reconstituted concentrated solution with a 5 ml syringe and a standard injection needle.
5. The reconstituted concentrated solution should then be diluted in 250 ml of a 0.9% solution of sodium chloride for injection: slowly inject 4 ml of reconstituted solution into a 250 ml container containing 0.9% solution of sodium chloride for injection. Carefully turn the container over so that the contents are mixed. Do not shake the bag, as this may result in foaming.
Administration of the drug
The drug Sivextro is administered intravenously in the form of infusion. Do not inject the drug with bolus or bolus, or mix with other drugs when given. The drug Sievextro is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal or subcutaneous administration.
The container containing the prepared solution for intravenous administration should be thoroughly examined before administration for the content of suspended particles. In the presence of suspended particles, the solution must be disposed of.
The resulting solution should be clear and colorless or transparent and pale yellow in color.
After reconstitution and dilution, the drug Sievextro should be administered as an intravenous infusion with a total duration of 1 hour.
The total time from reconstitution to administration should not exceed 24 hours at room temperature or when stored in a refrigerator (at a temperature of 2 ° C to 8 ° C).
The drug Sievextro is compatible with 0.9% solution of sodium chloride.
The drug Sievextro is incompatible with any solution containing divalent cations (for example, Ca2+, Mg2+), including Ringer's lactate solution and Hartman's solution.
Special patient groups
Patients with impaired hepatic function
In patients with hepatic insufficiency, dose adjustment is not required.
Patients with impaired renal function
In patients with renal insufficiency or on hemodialysis, dose adjustment is not required.
Children
The safety and efficacy of Sivextro in children under 18 years of age have not been established.
Elderly patients
In elderly patients, dose adjustment of tadizolide is not required. Clinical studies using Sievextro did not include a sufficient number of patients aged 75 years and older to determine if their response to treatment differs from that of younger patients. In general, there was no difference in the pharmacokinetics between the elderly and younger patients (see also the section "Pharmacological properties").