Caspofungin Sandoz 50mg powder for concentrate for solution for infusion

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

CASPOFUNGIN ACETATE

Mevcut itibaren:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC kodu:

J02AX04

INN (International Adı):

CASPOFUNGIN ACETATE 50 mg

Farmasötik formu:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Kompozisyon:

CASPOFUNGIN ACETATE 50 mg

Reçete türü:

POM

Terapötik alanı:

ANTIMYCOTICS FOR SYSTEMIC USE

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2017-01-05

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN SANDOZ 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
caspofungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Caspofungin Sandoz is and what it is used for
2.
What you need to know before you are given Caspofungin Sandoz
3.
How to use Caspofungin Sandoz
4.
Possible side effects
5.
How to store Caspofungin Sandoz
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN SANDOZ IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN SANDOZ IS
Caspofungin Sandoz contains a medicine called caspofungin. This
belongs to a group of medicines
called antifungals.
WHAT CASPOFUNGIN SANDOZ IS USED FOR
Caspofungin Sandoz 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 treat

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Caspofungin Sandoz 50 mg powder for concentrate for solution for
infusion}
Caspofungin Sandoz 70 mg powder for concentrate for solution for
infusion}
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caspofungin Sandoz 50 mg powder for concentrate for solution for
infusion}: Each vial contains 50 mg
caspofungin (as acetate). The concentration of the reconstituted vial
is 5.2 mg/ml.
Caspofungin Sandoz 70 mg powder for concentrate for solution for
infusion}: Each vial contains 70 mg
caspofungin (as acetate). The concentration of the reconstituted vial
is 7.2 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
The powder is a 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
{Nationally completed name} 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 patien