CASPOFUNGIN ROWEX 50 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

Rowex Ltd

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:

Other mycotics for systemic use

Authorization status:

Authorised

Authorization date:

2016-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you are given Caspofungin Rowex
3.
How to use Caspofungin Rowex
4.
Possible side effects
5.
How to store Caspofungin Rowex
6.
Contents of the pack and other information
1.
WHAT CASPOFUNGIN ROWEX IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN ROWEX IS
Caspofungin Rowex contains a medicine called caspofungin. This belongs
to a group of medicines
called antifungals.
WHAT CASPOFUNGIN ROWEX IS USED FOR
Caspofungin Rowex 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 anti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Rowex 50 mg Powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate). The concentration
of the reconstituted vial is 5.2 mg/ml.
Excipient with known effect
Sodium less than 1 mmol (23 mg) per vial.
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
Caspofungin Rowex 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
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 m