Caspofungin Hikma 50 mg powder for concentrate for solution for infusion

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

CASPOFUNGIN ACETATE

Διαθέσιμο από:

Hikma Farmacêutica (Portugal),SA Estrada do Rio da Mó, 8, 8A e 8B, Fervença, Terrugem, SNT, 2705-906, Portugal

Φαρμακολογική κατηγορία (ATC):

J02AX04

INN (Διεθνής Όνομα):

CASPOFUNGIN ACETATE 50 mg

Φαρμακοτεχνική μορφή:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Σύνθεση:

CASPOFUNGIN ACETATE 50 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIMYCOTICS FOR SYSTEMIC USE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-01-24

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN HIKMA 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
CASPOFUNGIN HIKMA 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 Hikma is and what it is used for
2.
What you need to know before you are given Caspofungin Hikma
3.
How to use Caspofungin Hikma
4.
Possible side effects
5.
How to store Caspofungin Hikma
6.
Contents of the pack and other information
1.
What Caspofungin Hikma is and what it is used for
What Caspofungin Hikma is
Caspofungin Hikma contains a medicine called caspofungin. This 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

Αρχείο Π.Χ.Π.

SPC118900101-2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Caspofungin Hikma 50 mg powder for concentrate for solution for
infusion
Caspofungin Hikma 70 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caspofungin Hikma 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 Hikma 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 is recommended (see section 5.2). No dosage
adjustment is necessary
based on gender or race (see section 5.2).
_Paediatric