ANIDACCORD 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG [SIN16106P]

Product Info

ANIDACCORD 100 POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG

[SIN16106P]

4.1 Therapeutic indications

Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Treatment with ANIDACCORD 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.

Posology
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. ANIDACCORD can be given without regard to the timing of haemodialysis (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Other special populations
No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The experience in children is limited. Use in patients under 18 years of age is not recommended until further data becomes available.

Method of administration
For intravenous use only.

ANIDACCORD 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. For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

It is recommended that ANIDACCORD 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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

ANIDACCORD must not be administered as a bolus injection.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Hypersensitivity to other medicinal products of the echinocandin class.