Caspofungin Accord

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

caspofungin acetate

זמין מ:

Accord Healthcare S.L.U.

קוד ATC:

J02AX04

INN (שם בינלאומי):

caspofungin

קבוצה תרפויטית:

Antimycotics for systemic use

איזור תרפויטי:

Candidiasis; Aspergillosis

סממני תרפויטית:

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.

leaflet_short:

Revision: 6

מצב אישור:

Withdrawn

תאריך אישור:

2016-02-11

עלון מידע

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN ACCORD 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
CASPOFUNGIN ACCORD 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 any further questions, 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 Accord is and what it is used for
2.
What you need to know before you are given Caspofungin Accord
3.
How to use Caspofungin Accord
4.
Possible side effects
5.
How to store Caspofungin Accord
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN ACCORD IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN ACCORD IS
Caspofungin Accord contains a medicine called caspofungin. This
belongs to a group of medicines
called anti-fungals.
WHAT CASPOFUNGIN ACCORD IS USED FOR
Caspofungin Accord 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.

sus

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Caspofungin Accord 50 mg powder for concentrate for solution for
infusion
Caspofungin Accord 70 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Caspofungin Accord 50 mg powder for concentrate for solution for
infusion
Each vial contains 50 mg caspofungin (as acetate).
Caspofungin Accord 70 mg powder for concentrate for solution for
infusion
Each vial contains 70 mg caspofungin (as acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white, 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
1
Formula). For all indications, a
single 70-mg/m
2
lo