CASPOFUNGIN PFIZER 50 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CASPOFUNGIN

Available from:

Pfizer Healthcare Ireland

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:

2016-12-02

Patient Information leaflet

0004162-MC03
Black:
COMPONENT SPECIFICATION
Item number:
0004162-MC03
Request number:
PAR-2016-0004162
Country:
Ireland
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Date:
VERSION 1
Technician: CS
Date: 08/Jun/16
VERSION 2
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Date: 20/Jun/16
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COLOURS
REQUESTER
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN PFIZER 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 Pfizer is and what it is used 
for
2.  What you need to know before you are given 
Caspofungin Pfizer
3.  How to use Caspofungin Pfizer
4.  Possible side effects
5.  How to store Caspofungin Pfizer
6.  Contents of the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Pfizer 50 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg vial contains 50 mg caspofungin (as acetate).
The concentration of the reconstituted vials is 5.2 mg/ml.
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 Pfizer 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,