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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: CANCIDAS (formerly Caspofungin MSD) (2012)

Εκδότης

Εκδότης Merck Sharp & Dohme Limited
Διεύθυνση Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Περιεχόμενα

Name of the medicinal product

CANCIDAS® 50 mg powder for concentrate for solution for infusion. CANCIDAS® 70 mg powder for concentrate ...

Qualitative and quantitative composition

CANCIDAS 50 mg powder for concentrate for solution for infusion: Each vial contains 50 mg caspofungin ...

Pharmaceutical form

Powder for concentrate for solution for infusion. Before reconstitution, the powder is a white to off-white ...

Therapeutic indications

Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis ...

Posology and method of administration

Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by ...

Interaction with other medicinal products and other forms of interaction

Studies in vitro show that caspofungin is not an inhibitor of any enzyme in the cytochrome P450 (CYP) ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited data from the use of caspofungin in pregnant women. Caspofungin should ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, angio-oedema, ...

Overdose

Inadvertent administration of up to 400 mg of caspofungin in one day has been reported. These occurrences ...

Pharmacodynamic properties

Pharmacotherapeutic group: antimycotics for systemic use ATC Code: J02AX04 Caspofungin acetate is a semi-synthetic ...

Pharmacokinetic properties

Distribution Caspofungin is extensively bound to albumin. The unbound fraction of caspofungin in plasma ...

Preclinical safety data

Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed ...

List of excipients

Sucrose Mannitol Glacial acetic acid Sodium hydroxide (to adjust the pH)

Incompatibilities

Do not mix with diluents containing glucose, as CANCIDAS is not stable in diluents containing glucose. ...

Shelf life

2 years. Reconstituted concentrate: should be used immediately. Stability data have shown that the concentrate ...

Special precautions for storage

Unopened vials: store in a refrigerator (2°C 8°C). For storage conditions after reconstitution and dilution ...

Nature and contents of container

CANCIDAS 50 mg powder for concentrate for solution for infusion: 10 ml Type I glass vial with a grey ...

Special precautions for disposal and other handling

Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents ...

Marketing authorization holder

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom

Marketing authorization number(s)

CANCIDAS 50 mg Powder for concentrate for solution for infusion: EU/1/01/196/001 CANCIDAS 70 mg Powder ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 October 2001 Date of lastest renewal: 07 September 2011

Date of revision of the text

July 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.