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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Sharp & Dohme Limited
Διεύθυνση :
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Name of the medicinal product

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

Qualitative and quantitative composition

CANCIDAS 50 mg powder for concentrate for solution for infusion: Each vial contains 50 mg caspofungin (as acetate). Excipients with known effect: Each 50 mg vial contains 35.7 mg of sucrose. CANCIDAS 70 ...

Pharmaceutical form

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

Therapeutic indications

Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations ...

Posology and method of administration

Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections. Posology Adult patients A single 70 mg loading dose should be administered on Day-1, followed ...

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 caspofungin. The efficacy of caspofungin against these fungal pathogens has not been established. ...

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) system. In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances. ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited data from the use of caspofungin in pregnant women. Caspofungin should not be used during pregnancy unless clearly necessary. Animal studies have shown developmental toxicity ...

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, pruritus, sensation of warmth, or bronchospasm. Anaphylaxis has been reported during administration ...

Overdose

Inadvertent administration of up to 400 mg of caspofungin in one day has been reported. These occurrences did not result in clinically important adverse reactions. Caspofungin is not dialysable.

Pharmacodynamic properties

Pharmacotherapeutic group: antimycotics for systemic use ATC Code: J02AX04 Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea ...

Pharmacokinetic properties

Distribution Caspofungin is extensively bound to albumin. The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis. Distribution ...

Preclinical safety data

Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence ...

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. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

2 years. Reconstituted concentrate: should be used immediately. Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C ...

Special precautions for storage

Unopened vials: store in a refrigerator (2°C 8°C). For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Nature and contents of container

CANCIDAS 50 mg powder for concentrate for solution for infusion: 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with a red aluminium band. CANCIDAS 70 mg powder for concentrate for ...

Special precautions for disposal and other handling

Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are ...

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 for concentrate for solution for infusion: EU/1/01/196/003

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