Caspofungin 50 mg powder for concentrate for solution for infusion

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Caspofungin

متاح من:

Ethypharm

ATC رمز:

J02AX; J02AX04

INN (الاسم الدولي):

Caspofungin

جرعة:

50.00 milligram(s)

الشكل الصيدلاني:

Powder for concentrate for solution for infusion

المجال العلاجي:

Other antimycotics for systemic use; caspofungin

الوضع إذن:

Not marketed

تاريخ الترخيص:

2017-05-12

خصائص المنتج

HealthProductsRegulatoryAuthority
12June2019
CRN008YFF
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caspofungin50mgpowderforconcentrateforsolutionforinfusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Caspofungin50mgpowderforconcentrateforsolutionforinfusion
Eachvialcontains50mgcaspofungin(asacetate).
Afterreconstitutionin10.5mlofwaterforinjection,1mlof
concentratecontains5.2mgofCaspofungin.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Powderforconcentrateforsolutionforinfusion.
Beforereconstitution,thepowder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 th