XYDALBA Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Xydalba 500 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains dalbavancin hydrochloride equivalent to 500 mg dalbavancin. After reconstitution each ml contains 20 mg dalbavancin. The diluted solution for infusion must have a final concentration ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white to pale yellow powder.
Therapeutic indications
Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate ...
Posology and method of administration
Posology Recommended dose and duration of treatment for adults The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity reactions Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction ...
Interaction with other medicinal products and other forms of interaction
Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1). ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of dalbavancin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Xydalba is not recommended during pregnancy, unless the ...
Effects on ability to drive and use machines
Xydalba may have a minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients (see section 4.8).
Undesirable effects
Summary of the safety profile In Phase ⅔ clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg. The ...
Overdose
No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been ...
Pharmacodynamic properties
Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials ATC code: J01XA04 Mechanism of action Dalbavancin is a bactericidal lipoglycopeptide. Its mechanism of action in ...
Pharmacokinetic properties
The pharmacokinetics of dalbavancin have been characterised in healthy subjects, patients, and special populations. Systemic exposures to dalbavancin are dose proportional following single doses over a ...
Preclinical safety data
Dalbavancin toxicity has been evaluated after daily intravenous administration for durations of up to 3 months in rats and dogs. Dose-dependent toxicity included serum chemistry and histological evidence ...
List of excipients
Mannitol (E421) Lactose monohydrate Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Incompatibilities
Sodium chloride solutions may cause precipitation and must not be used for reconstitution or dilution (see section 6.6). This medicinal product must not be mixed with other medicinal products or intravenous ...
Shelf life
Dry powder: 4 years. Chemical and physical in-use stability of Xydalba has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25°C. The total ...
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
Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal. Each pack contains 1 vial.
Special precautions for disposal and other handling
Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5%) glucose solution for infusion. Xydalba vials are for single-use only. Instructions for reconstitution ...
Marketing authorization holder
Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Marketing authorization number(s)
EU/1/14/986/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 February 2015
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