CASPOFUNGIN PFIZER 70 Milligram Pdr/Conc/Soln for Infus

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

CASPOFUNGIN

Dostopno od:

Pfizer Healthcare Ireland

Koda artikla:

J02AX04

INN (mednarodno ime):

CASPOFUNGIN

Odmerek:

70 Milligram

Farmacevtska oblika:

Pdr/Conc/Soln for Infus

Tip zastaranja:

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

Terapevtsko območje:

Other mycotics for systemic use

Status dovoljenje:

Authorised

Datum dovoljenje:

2016-12-02

Navodilo za uporabo

0004162-MC06
Black:
COMPONENT SPECIFICATION
Item number:
0004162-MC06
Request number:
PAR-2016-0004162
Country:
Ireland
I have checked this artwork against the registered 
text including spelling, layout, size, colours, 
registration numbers and scientific equations, the 
name and address and trademarks. Also for any 
possible changes to related items.
This artwork is in conformance with the Marketing 
Authorisation and can now proceed to the 
printing stage.
Previous Item Number:  N/A

Signed:
Date:
VERSION 1
Technician: CS
Date: 07/Jun/16
VERSION 2
Technician: KM
Date: 15/Jun/16
VERSION 3
Technician: KM
Date: 22/Jun/16
VERSION 4
Technician: CS
Date: 22/Sep/16
VERSION 5
Technician: XX
Date: dd/mmm/yy
VERSION 6
Technician: XX
Date: dd/mmm/yy
VERSION 7
Technician: XX
Date: dd/mmm/yy
VERSION 8
Technician: XX
Date: dd/mmm/yy
VERSION 9
Technician: XX
Date: dd/mmm/yy
VERSION 10
Technician: XX
Date: dd/mmm/yy
OI template:
Amalia version:
FAI001-1
N/A
Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:
360 x 390 mm
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Pharma code:
Pharma code length:
N/A
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COLOURS
REQUESTER
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN PFIZER 70 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 pack and other informatio

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin Pfizer 70 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 70 mg vial contains 70 mg caspofungin (as acetate)
The concentration of the reconstituted vials is 7.2 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,�