** ECALTA® (Anidulafungin) 100mg Powder for concentrate for solution for infusion. 1 vial of powder for injection.
** For Intravenous Use only.
Each via of powder contains:
Anidulafungin …. 100 mg
fructose …. 118 mg
mannitol …. 500 mg
polysorbate 80 …. 250 mg
tartaric acid …. 11.2 mg
** Therapeutic indications:
Treatment of invasive candidiasis in adult patients.
** 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 from a fermentation product of Aspergillus nidulans.
Anidulafungin selectively inhibits 1,3-beta-D glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-beta-D-glucan, an essential component of the fungal cell wall. Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
** Directions for use:
Refer to package insert.
Reconstitute and dilute before use. (reconstituted with water for injections)
The reconstituted solution contains 3.33 mg/mL Anidulafungin and the diluted solution contains 0.77 mg/mL Anidulafungin.
Rate of infusion should not exceed 1.1 mg/minute.
Use in one patient on one occasion only.
** Medicinal product subject to medical prescription.
** Store at 2 to 8 degrees C (Refrigerate. Do not freeze).
Excursions for 96 hours up to 25 degrees C are permitted and the powder can be returned to refrigerated storage.
Contains no antimicrobial agent.
Keep out of reach and sight of children.
** Manufactured by:
Pharmacia & Upjohn Company, 7000 Portage Road, Kalamazoo, Michigan, 49001 USA.
Batch release and Packager:
Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs Belgium.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT 13 9NJ, United Kingdom.
ANIDULAFUNGIN 100 MG (100 MG / 30 ML) - (FOR I.V. INFUSION AFTER RECONSTITUTION AND DILUTION)