Caspofungin 50mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin

Available from:

Wockhardt UK Limited

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin

Dosage:

50 milligram(s)

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

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

Therapeutic area:

Other antimycotics for systemic use; caspofungin

Authorization status:

Marketed

Authorization date:

2017-02-03

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
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 is and what it is used for
2. What you need to know before you are given Caspofungin
3. How to use Caspofungin
4. Possible side effects
5. How to store Caspofungin
6. Contents of the pack and other information
1. WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
WHAT CASPOFUNGIN IS
Caspofungin contains the active substance 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 and a low white
cell
count that have not improved on treatment with an antibiotic.
People who are at ris

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin 50mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg caspofungin (as acetate). After
reconstitution each ml concentrate for solution for infusion
contains 5.2 mg caspofungin.
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
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, neutropenic 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 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/m² loading dose
(not to exceed an actual dose of 70 mg) should be administered on Day
1, followed by 50 mg/m² daily thereafter (not to