Caspofungin 70mg powder for concentrate for solution for infusion vials

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Caspofungin acetate

제공처:

Zentiva

ATC 코드:

J02AX04

INN (International Name):

Caspofungin acetate

복용량:

70mg

약제 형태:

Powder for solution for infusion

관리 경로:

Intravenous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 05020400; GTIN: 5000283658771

제품 특성 요약

OBJECT 1
CASPOFUNGIN 70 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 28-Jun-2017 | Zentiva
1. Name of the medicinal product
Caspofungin Zentiva 70 mg powder for concentrate for solution for
infusion
2. Qualitative and quantitative composition
Each 70 mg vial contains 70 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of the
concentrate contains 7.2 mg
caspofungin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White to off-white lyophilized powder.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of invasive candidiasis in adult or paediatric patients.
• Treatment of invasive aspergillosis in adult or paediatric
patients who are refractory to or intolerant of
amphotericin B, lipid formulations of amphotericin B and/or
itraconazole. Refractoriness is defined as
progression of infection or failure to improve after a minimum of 7
days of prior therapeutic doses of
effective antifungal therapy.
• Empirical therapy for presumed fungal infections (such as Candida
or Aspergillus) in febrile,
neutropaenic adult or paediatric patients.
4.2 Posology and method of administration
Caspofungin should be initiated by a physician experienced in the
management of invasive fungal
infections.
Posology
_Adult patients_
A single 70 mg loading dose should be administered on Day-1, followed
by 50 mg daily thereafter. In
patients weighing more than 80 kg, after the initial 70 mg loading
dose, caspofungin 70 mg daily is
recommended (see section 5.2). No dosage adjustment is necessary based
on gender or race (see section
5.2).
_Paediatric population (12 months to 17 years)_
In paediatric patients (12 months to 17 years of age), dosing should
be based on the patient's body surface
area (see Instructions for Use in Paediatric Patients, Mosteller
1
Formula). For all indications, a single 70-
mg/m
2
loading dose (not to exceed an actual dose of 70 mg) shoul