CASPOFUNGIN MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosage:

70 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:

Not Marketed

Authorization date:

2017-07-28

Patient Information leaflet

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310 x 600 mm
11 pt
11 pt
Caspofungin Acetate 70 mg 1
Leaflet
1223925
NA
1223925
NA
Galenicum Health, S.L.
(Madrid - SP)
PR1223925
NA
NA
315476
2
Ireland
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Black
16:29
10 Jul 2017
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
Caspofungin Mylan
70
mg
powder for concentrate for solution for infusion
Caspofungin
What is in this leaflet
1.
What Caspofungin is and what it is used for
What Caspofungin is
Caspofungin 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Mylan 70 mg powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 caspofungin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Before reconstitution, the product 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 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 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