CUBICIN Powder for concentrate for solution for injection or infusion (2019)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Novartis Pharmaceuticals UK Ltd |
|---|---|
| Διεύθυνση | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR |
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Δωρεάν εγγραφή
Περιεχόμενα
Pharmaceutical form
Powder for solution for injection or infusion A pale yellow to light brown lyophilised powder.
Qualitative and quantitative composition
Cubicin 350 mg powder for solution for infusion or injection: Each vial contains 350 mg daptomycin. One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) ...
Incompatibilities
Cubicin is not physically or chemically compatible with glucose-containing solutions. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Interaction with other medicinal products and other forms of interaction
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system. ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions of the reconstituted or reconstituted and diluted medicinal product see section 6.3.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Undesirable effects
Summary of the safety profile In clinical studies, 2,011 subjects received Cubicin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy ...
Name of the medicinal product
Cubicin 350 mg powder for solution for injection or infusion. Cubicin 500 mg powder for solution for injection or infusion.
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 January 2006 Date of latest renewal: 29 November 2010
Fertility, pregnancy and lactation
Pregnancy No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials ATC code: J01XX09 Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive ...
Special warnings and precautions for use
General If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated ...
Special precautions for disposal and other handling
Daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes (see sections 4.2 and 5.2). Preparation of the solution for infusion requires an additional ...
Nature and contents of container
Cubicin 350 mg powder for solution for injection or infusion: Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps. Cubicin 500 ...
Overdose
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis ...
Posology and method of administration
Clinical studies in patients employed infusion of daptomycin over 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode ...
Therapeutic indications
Cubicin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). ...
List of excipients
Sodium hydroxide
Marketing authorization number(s)
Cubicin 350 mg powder for solution for injection or infusion: EU/1/05/328/001 EU/1/05/328/003 Cubicin 500 mg powder for solution for injection or infusion: EU/1/05/328/002 EU/1/05/328/004
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. On the basis of reported adverse drug reactions, Cubicin is presumed to be unlikely to produce an effect on the ability ...
Shelf life
Shelf life: 3 years. After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C–8°C. Chemical ...
Pharmacokinetic properties
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy volunteers. ...
Preclinical safety data
In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog. Microscopic ...
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