CASPOFUNGIN B. Braun 70 mg powder for concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE 70 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN ACETATE 70 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-01-04

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN B. BRAUN 70 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 Caspofungin is and what it is used for
2.
What you need to know before you are given Caspofungin
3.
How to use Caspofungin
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 belongs to a group of medicines called antifungals.
WHAT CASPOFUNGIN IS USED FOR
Caspofungin 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
incl

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CASPOFUNGIN B. Braun 70 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 70 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
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.
Before reconstitution, the product is a 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, 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 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
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Formula). For all indications, a single 70-mg/m
2
loading dose (not to exceed an actual
dose of 70 mg) should be administered on Day 1, followed by 50 mg/m
2