Casokan 50mg powder for concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE 50 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN ACETATE 50 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-09-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASOKAN 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 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 Casokan is and what it is used for
2.
What you need to know before you are given Casokan
3.
How to use Casokan
4.
Possible side effects
5.
How to store Casokan
6.
Contents of the pack and other information
1.
WHAT CASOKAN IS AND WHAT IT IS USED FOR
WHAT CASOKAN IS
Casokan contains the active substance caspofungin. This belongs to a
group of medicines called
antifungals.
WHAT CASOKAN IS USED FOR
Casokan 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 of
getting a fungal infection
include those who hav

Summary of Product characteristics

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Casokan 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
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) _
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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/m² loading dose (not to exceed an
actual dose of 70 mg) should
be administered on Day 1, followed by 50 mg/m² daily thereafter (