Caspofungin 50mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Caspofungin acetate

Available from:

Wockhardt UK Ltd

ATC code:

J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

50mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020400; GTIN: 5012727913094

Patient Information leaflet

410
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Selectchemie AG
107706/2
PI Caspofungin 50mg
Schwarz
210x480 mm
13.02.2017 hu

Summary of Product characteristics

OBJECT 1
CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 15-Nov-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Caspofungin 50 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 50 mg caspofungin (as acetate). After
reconstitution each ml concentrate for solution
for infusion contains 5.2 mg caspofungin.
Excipient with known effect
Sodium less than 1 mmol (23 mg) per vial.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion
White to off-white compact 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,
neutropenic 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 patients (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 (no