Posology : מינונים

4.2     Posology and method of administration
Treatment with ERAXIS® 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

Adult population (dosing and treatment duration)
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.

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. ERAXIS® can be given without regard to the timing of haemodialysis (see section 5.2).

Other special populations

No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).

Paediatric population
(1 month to < 18 years) (dosing and treatment duration)
A single loading dose of 3.0 mg/kg (not to exceed 200 mg) should be administered on Day 1 followed by a daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg) 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.

The safety and efficacy of ERAXIS® have not been established in neonates (< 1 month old) (see section 4.4) .

Method of administration
For intravenous use only.

ERAXIS® should be reconstituted with water for injection to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL for the final infusion solution. For a paediatric patient, the volume of infusion solution required to deliver the dose will vary depending on the weight of the child. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

It is recommended that ERAXIS® 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).

ERAXIS® must not be administered as a bolus injection.