Caspofungin 70mg 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:

Flynn Pharma Ltd

ATC code:

J02AX04

INN (International Name):

Caspofungin acetate

Dosage:

70mg

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: 5060106551559

Summary of Product characteristics

OBJECT 1
CASPOFUNGIN 70 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 10-Apr-2018 | Flynn Pharma
Ltd
1. Name of the medicinal product
Caspofungin 70 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 70 mg caspofungin (as acetate). After
reconstitution each ml concentrate for solution
for infusion contains 7.2 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 (not