SIVEXTRO Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Sivextro 200 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate. After reconstitution each mL contains 50 mg tedizolid phosphate. For the full list of excipients, see section ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder.
Therapeutic indications
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older (see sections 4.4 and 5.1). Consideration should ...
Posology and method of administration
Posology Tedizolid phosphate film-coated 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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Patients with neutropenia The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts <1,000 cells/mm³) have not been investigated. In an animal model of infection, the ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interactions In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer Resistant Protein [BCRP] substrate) alone or in combination with tedizolid ...
Pregnancy and lactation
Pregnancy There are no data from the use of tedizolid phosphate in pregnant women. Studies in mice and rats showed developmental effects (see section 5.3). As a precautionary measure, it is preferable ...
Effects on ability to drive and use machines
Sivextro may have a minor influence on the ability to drive and use machines as it may cause dizziness, fatigue or, uncommonly, somnolence (see section 4.8).
Undesirable effects
Summary of the safety profile Adults The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in the pooled controlled Phase 3 clinical studies (tedizolid phosphate ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials ATC code: J01XX11 Mechanism of action Tedizolid phosphate is an oxazolidinone phosphate prodrug. The antibacterial activity ...
Pharmacokinetic properties
Oral and intravenous tedizolid phosphate is a prodrug that is rapidly converted by phosphatases to tedizolid, the microbiologically active moiety. Only the pharmacokinetic profile of tedizolid is discussed ...
Preclinical safety data
Long-term carcinogenicity studies have not been conducted with tedizolid phosphate. Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month toxicology studies produced ...
List of excipients
Mannitol Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Sivextro is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), ...
Shelf life
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).
Special precautions for storage
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.
Nature and contents of container
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.
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/15/991/002 EU/1/15/991/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 March 2015 Date of latest renewal: 09 January 2020
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