Cancidas (previously Caspofungin MSD)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

caspofungin (as acetate)

Saatavilla:

Merck Sharp & Dohme B.V.

ATC-koodi:

J02AX04

INN (Kansainvälinen yleisnimi):

caspofungin

Terapeuttinen ryhmä:

Antimycotics for systemic use

Terapeuttinen alue:

Candidiasis; Aspergillosis

Käyttöaiheet:

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 seven 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.

Tuoteyhteenveto:

Revision: 32

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2001-10-23

Pakkausseloste

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CANCIDAS 50
mg p
owder for concentrate for solution for infusion
CANCIDAS
70
mg powder for concentrate for solution for infusion
2.
QUALITAT
IVE AND QUAN
TITATIVE COMPOSITION
CANCIDAS 50
mg powder for concentrate for solution for infusion
Each vial conta
ins 50 mg caspofungin (as acetate).
CANCIDAS
70
mg powder for concentrate fo
r 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 fo
r s
olution 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 aspergillos
is in adult
or paediatric
patients who are refractory to or
intolerant of am
photericin B, lipid formulations of amphotericin B and/or itr
aconazole.
Refract
oriness 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 therap
y for
presumed fungal infections (such as Candida or Aspergillus) i
n febrile,
neutrop
aenic adult
or paediatric
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Caspofungin should be in
itiated by a physician experienced in the management of invasive fu
ngal
infections.
Posology
Adult patients
A single 70 mg loading dose sh
ould be admi
nistered 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 (se
e Inst
ructions for Use in Paediatric Patients, Mosteller
1
Formula). For all indications,

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CANCIDAS 50
mg p
owder for concentrate for solution for infusion
CANCIDAS
70
mg powder for concentrate for solution for infusion
2.
QUALITAT
IVE AND QUAN
TITATIVE COMPOSITION
CANCIDAS 50
mg powder for concentrate for solution for infusion
Each vial conta
ins 50 mg caspofungin (as acetate).
CANCIDAS
70
mg powder for concentrate fo
r 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 fo
r s
olution 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 aspergillos
is in adult
or paediatric
patients who are refractory to or
intolerant of am
photericin B, lipid formulations of amphotericin B and/or itr
aconazole.
Refract
oriness 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 therap
y for
presumed fungal infections (such as Candida or Aspergillus) i
n febrile,
neutrop
aenic adult
or paediatric
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Caspofungin should be in
itiated by a physician experienced in the management of invasive fu
ngal
infections.
Posology
Adult patients
A single 70 mg loading dose sh
ould be admi
nistered 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 (se
e Inst
ructions for Use in Paediatric Patients, Mosteller
1
Formula). For all indications,