Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Caspofungin
Accord Healthcare Ireland Ltd.
J02AX; J02AX04
Caspofungin
70 milligram(s)
Pdr/Conc/Soln for Infus
Other antimycotics for systemic use; caspofungin
2016-10-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CASPOFUNGIN ACTAVIS 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Caspofungin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Caspofungin Actavis is and what it is used for 2. What you need to know before you use Caspofungin Actavis 3. How to use Caspofungin Actavis 4. Possible side effects 5. How to store Caspofungin Actavis 6. Contents of the pack and other information 1. WHAT CASPOFUNGIN ACTAVIS IS AND WHAT IT IS USED FOR WHAT CASPOFUNGIN ACTAVIS IS Caspofungin Actavis contains a medicine called caspofungin. This belongs to a group of medicines called anti-fungals. WHAT CASPOFUNGIN ACTAVIS IS USED FOR Caspofungin Actavis 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 a Read the complete document
Health Products Regulatory Authority 07 March 2019 CRN008RCF Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caspofungin Actavis 70 mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains caspofungin acetate equivalent to 70 mg caspofungin. For the full list ofexcipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Before reconstitution, the powder is a white to off-white 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 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 population (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/m 2 loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/m 2 daily thereafter (not to exceed an actual dose of 70 mg dai Read the complete document