Caspofungin 50mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caspofungin

Available from:

Pinewood Laboratories Ltd

ATC code:

J02AX; J02AX04

INN (International Name):

Caspofungin

Dosage:

50 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

Other antimycotics for systemic use; caspofungin

Authorization status:

Marketed

Authorization date:

2017-02-03

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 50 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 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 risk of
getting a fu

Summary of Product characteristics

Health Products Regulatory Authority
17 June 2021
CRN00C9MK
Page 1 of 14
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