ANIDULAFUNGIN TEVA

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

ANIDULAFUNGIN

可用日期:

ABIC MARKETING LTD, ISRAEL

ATC代码:

J02AX06

药物剂型:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

ANIDULAFUNGIN 100 MG/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

治疗领域:

ANIDULAFUNGIN

疗效迹象:

Treatment of invasive candidiasis in adult patients.

授权日期:

2020-06-17

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
ANIDULAFUNGIN TEVA
1. NAME OF THE MEDICINAL PRODUCT
Anidulafungin Teva 100 mg
2. 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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off white powder, free of visible evidence of contamination.
The reconstituted solution has a pH of 3.5 to 5.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of invasive candidiasis in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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. Anidulafungin Teva 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_
The safety and efficacy of anidulafungin
in children below 18 years have not be