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Powder for concentrate for solution for infusion, for I.V infusion after reconstitution and dilution
Treatment with Anidulafungin Teva should be initiated by a physician experienced in the management of invasive fungal infections.
Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Duration of treatment
There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Patients with renal and hepatic impairment
No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Anidulafungin Teva can be given without regard to the timing of haemodialysis.
Other special populations
No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.
The safety and efficacy of anidulafungin in children below 18 years have not been established. Anidulafungin Teva is not indicated for children and adolescents below 18 years of age.
Method of administration
For intravenous use only.
Anidulafungin Teva should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL. It is recommended that Anidulafungin Teva be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min. Anidulafungin Teva must not be administered as a bolus injection.
Please refer to the license holder for further details.
Treatment of invasive candidiasis in adult patients.
Hypersensitivity to the active substance or to any of the excipient.
Hypersensitivity to other medicinal products of the echinocandin class.