Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CASPOFUNGIN
Pfizer Healthcare Ireland
J02AX04
CASPOFUNGIN
50 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Other mycotics for systemic use
Authorised
2016-12-02
0004162-MC03 Black: COMPONENT SPECIFICATION Item number: 0004162-MC03 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: 08/Jun/16 VERSION 2 Technician: KM Date: 20/Jun/16 VERSION 3 Technician: KM Date: 22/Jun/16 VERSION 4 Technician: KM Date: 20/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 N/A N/A N/A N/A N/A N/A Pharma code: Pharma code length: N/A N/A 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 Les hele dokumentet
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, Les hele dokumentet