Caspofungin Pdr/Conc/Soln for Infus 70mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CASPOFUNGIN ACETATE

Available from:

Antibiotice S.A. 1 Valea Lupului Street, 707410, Iasi, Romania

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN ACETATE 75.6 mg

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN ACETATE 75.6 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-01-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN ATB 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 Atb is and what it is used for
2.
What you need to know before you are given Caspofungin Atb
3.
How to use Caspofungin Atb
4.
Possible side effects
5.
How to store Caspofungin Atb
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN ATB IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN ATB IS
Caspofungin Atb
contains a medicine called caspofungin. This belongs to a group of
medicines
called antifungals.
WHAT CASPOFUNGIN ATB IS USED FOR
Caspofungin Atb 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CASPOFUNGIN ATB 50 mg powder for concentrate for solution for infusion
CASPOFUNGIN ATB 70 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CASPOFUNGIN ATB 50 mg powder for concentrate for solution for infusion
Each vial contains 50 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of
concentrate contains 5.2. mg of
caspofungin.
CASPOFUNGIN ATB 70 mg powder for concentrate for solution for infusion
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 of
caspofungin.
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 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
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is recommended (see section 5.2). No dosage adjustment is necessary
based on gender or race (see
section 5.2).
_Paediatric