ECALTA Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
ECALTA 100 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 100 mg anidulafungin. The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin. Excipient with known effect: Fructose 102.5 ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white solid. The reconstituted solution has a pH of 3.5 to 5.5.
Therapeutic indications
Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Posology and method of administration
Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections. Posology Specimens for fungal culture should be obtained prior to therapy. Therapy ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other medicinal products of the echinocandin class.
Special warnings and precautions for use
ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1). ...
Interaction with other medicinal products and other forms of interaction
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). Of note, in vitro studies do not fully exclude possible in ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). ECALTA is not recommended during pregnancy unless the ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), ...
Overdose
As with any overdose, general supportive measures should be utilised as necessary. In case of overdose, adverse reactions may occur as mentioned in section 4.8. During clinical trials, a single 400 mg ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use ATC code: JO2AX06 Mechanism of action Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised ...
Pharmacokinetic properties
General pharmacokinetic characteristics The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients. A low intersubject variability in systemic exposure ...
Preclinical safety data
In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical ...
List of excipients
Fructose Mannitol Polysorbate 80 Tartaric acid Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Shelf life
3 years. Excursions for 96 hours up to 25°C are permitted, and the powder can be returned to refrigerated storage. Reconstituted solution: The reconstituted solution may be stored at up to 25°C for up ...
Special precautions for storage
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
30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively ...
Special precautions for disposal and other handling
There are no special requirements for disposal. ECALTA must be reconstituted with water for injections and subsequently diluted with ONLY sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
EU/1/07/416/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
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