ECALTA Powder for concentrate for solution for infusion (2020)
Active ingredients: Anidulafungin
Product Name and Form
ECALTA 100 mg powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
White to off-white solid.
The reconstituted solution has a pH of 3.5 to 5.5.
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 mg per vial.
For the full list of excipients, see section 6.1.
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)
Pack sizes and Marketing
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 bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
Pack size of 1 vial.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Date of first authorisation: 20 September 2007
Date of latest renewal: 28 August 2017