SPC, UK: ECALTA 100 mg powder for concentrate for solution for infusion
||Ramsgate Road, Sandwich, Kent, CT13 9NJ
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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 ...
Powder for concentrate for solution for infusion. White to off-white lyophilised solid. The reconstituted ...
Treatment of invasive candidiasis in adult non-neutropenic patients. ECALTA has been studied primarily ...
Posology and method of administration
Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal ...
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Hypersensitivity ...
Special warnings and precautions for use
The efficacy of ECALTA in neutropenic patients with candidaemia and in patients with deep tissue Candida ...
Interaction with other medicinal products and other forms of interaction
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes ...
Fertility, pregnancy and lactation
Pregnancy There are no data regarding the use of anidulafungin in pregnant women. Slight developmental ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Summary of the safety profile Nine hundred and twenty-nine (929) subjects received single or multiple ...
As with any overdose, general supportive measures should be utilised as necessary. In case of overdose, ...
Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use ATC code: ...
General pharmacokinetic characteristics The pharmacokinetics of anidulafungin have been characterised ...
Preclinical safety data
In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, ...
List of excipients
Fructose Mannitol Polysorbate 80 Tartaric acid Sodium hydroxide (for pH-adjustment) Hydrochloric acid ...
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned ...
3 years Excursions for 96 hours up to 25°C are permitted, and the powder can be returned to refrigerated ...
Special precautions for storage
Store in a refrigerator (2°C – 8°C). For storage conditions after reconstitution and dilution of the ...
Nature and contents of container
30 ml Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the ...
Special precautions for disposal and other handling
There are no special requirements for disposal. ECALTA must be reconstituted with water for injections ...
Marketing authorization holder
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 September 2007 Date of latest renewal: 23 August 2012
Date of revision of the text
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.