CANCIDAS Powder for solution for infusion (2018)
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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 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
Anaphylaxis has been reported during administration of caspofungin. If this occurs, caspofungin should be discontinued and appropriate treatment administered. Possibly histamine-mediated adverse reactions, ...
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
Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4). Also reported in patients with invasive aspergillosis were pulmonary oedema, ...
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 Mechanism of action Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation ...
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
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 ...
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 B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/01/196/001 EU/1/01/196/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 October 2001 Date of latest renewal: 07 September 2011
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