Caspofungin 50mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin

Available from:

Demo S.A.

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin

Dosage:

50 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antimycotics for systemic use; caspofungin

Authorization status:

Marketed

Authorization date:

2016-09-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
CASPOFUNGIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor, nurse
or pharmacist.
-
If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Caspofungin is and what it is used for
2.
What you need to know before you are given Caspofungin
3.
How will Caspofungin be given to you
4.
Possible side effects
5.
How to store Caspofungin
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN IS
Caspofungin contains a medicine called caspofungin. This belongs
to a group of medicines called anti-fungals.
WHAT CASPOFUNGIN IS USED FOR
This medicine is used to treat the following infections in children,
adolescents and adults:
•
serious fungal infections in your tissues or organs (called
‘invasive candidiasis’). This infection is caused by fungal
(yeast)
cells called Candida. People who might get this type of infection
include those who have just had an operation or those whose
immune systems are weak. Fever and chills that do not respond
to an antibiotic are the most common signs of this type of
infection.
•
fungal infections in your nose, nasal sinuses or lungs (called
‘invasive aspergillosis’) if other anti-fungal treatments have not
worked or have caused side effects. This infection is caused by
a mould called Aspergillus. People who might get this type of
infection include those having chemotherapy, those who have
had a transplant and those whose immune systems are weak.
•
suspected fungal infections if you have a fever and a low
white cell count that have not improved on treatment with an
antibiotic. People who are at risk

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2021
CRN009Y8T
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin 50mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate).
The concentration of the reconstituted vial will be 5.2 mg/mL.
Excipients with known effect:
Each 50 mg vial contains 35.71 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Before reconstitution, the powder is a white to off-white-compact,
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Treatment of invasive candidiasis inadult or paediatric patients.
• Treatment of invasive aspergillosis inadult or paediatric patients
who are refractory to or intolerant ofamphotericin B, lipid
formulations of amphotericin B and/or itraconazole.Refractoriness is
defined as progression of infection or failure to
improveafter a minimum of 7 days of prior therapeutic doses of
effectiveantifungal therapy.
• Empirical therapy for presumed fungalinfections (such as _Candida_
or _Aspergillus_) in febrile, neutropaenicadult 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