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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cubicin powder for concentrate for solution for injection or infusion (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Cubicin 350 mg powder for solution for injection or infusion. Cubicin 500 mg powder for solution for ...

Qualitative and quantitative composition

Cubicin 350 mg powder for solution for infusion or injection: Each vial contains 350 mg daptomycin. ...

Pharmaceutical form

Powder for solution for injection or infusion A pale yellow to light brown lyophilised powder.

Therapeutic indications

Cubicin is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1). ...

Posology and method of administration

Clinical studies in patients employed infusion of daptomycin over 30 minutes. There is no clinical experience ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

General If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin therapy ...

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 ...

Fertility, pregnancy and lactation

Pregnancy No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate ...

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 ...

Undesirable effects

Summary of the safety profile In clinical studies, 2,011 subjects received Cubicin. Within these trials, ...

Overdose

In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials ATC code: J01XX09 Mechanism ...

Pharmacokinetic properties

Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered ...

Preclinical safety data

In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with ...

List of excipients

Sodium hydroxide

Incompatibilities

Cubicin is not physically or chemically compatible with glucose-containing solutions. This medicinal ...

Shelf life

3 years. After reconstitution: Chemical and physical in-use stability of the reconstituted solution in ...

Special precautions for storage

Store in a refrigerator (2°C – 8°C). For storage conditions of the reconstituted or reconstituted and ...

Nature and contents of container

Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with blue ...

Special precautions for disposal and other handling

Daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 ...

Marketing authorization holder

Cubicin 350mg powder for solution for injection or infusion: EU/1/05/328/001 & 003 Cubicin 500mg powder ...

Marketing authorization holder

Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 January 2006 Date of latest renewal: 19 January 2011

Date of revision of the text

21 February 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.