CASPOFUNGIN ACTAVIS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

Actavis Group PTC ehf

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosage:

50 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

caspofungin

Authorization status:

Authorised

Authorization date:

2016-10-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN ACTAVIS 50 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Caspofungin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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 Actavis is and what it is used for
2.
What you need to know before you use Caspofungin Actavis
3.
How to use Caspofungin Actavis
4.
Possible side effects
5.
How to store Caspofungin Actavis
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN ACTAVIS IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN ACTAVIS IS
Caspofungin Actavis contains a medicine called caspofungin. This
belongs to a group of medicines
called anti-fungals.
WHAT CASPOFUNGIN ACTAVIS IS USED FOR
Caspofungin Actavis 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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Actavis 50 mg Powder for Concentrate for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains caspofungin acetate equivalent to 50 mg
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 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 population (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
loading dose
(not to exceed an actual dose of 70 mg) should be administered on Day
1, followed by 50 mg/m
2
daily thereafter (not to
exceed an actual dose of 70 mg daily). If the 50-mg/m
2
daily dose is well tolerated but does not provide an ad