Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPIRUBICIN HYDROCHLORIDE
Pharmachemie BV
EPIRUBICIN HYDROCHLORIDE
2 Micromol
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epirubicin hydrochloride 2mg/ml, solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 1 ml of solution for injection or infusion contains 2 mg Epirubicin hydrochloride 1 vial of 5 ml solution contains 10 mg Epirubicin hydrochloride 1 vial of 10 ml solution contains 20 mg Epirubicin hydrochloride 1 vial of 25 ml solution contains 50 mg Epirubicin hydrochloride. 1 vial of 75 ml solution contains 150 mg Epirubicin hydrochloride. 1 vial of 100 ml solution contains 200 mg Epirubicin hydrochloride Excipient: 1 ml of solution for injection or infusion contains 3.5 mg sodium 1 vial of 5 ml solution contains 17.7 mg sodium 1 vial of 10 ml solution contains 35.4 mg sodium 1 vial of 25 ml solution contains 88.5 mg sodium. 1 vial of 75 ml solution contains 265.5 mg sodium. 1 vial of 100 ml solution contains 354.1 mg sodium For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. A clear red solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epirubicin is used in the treatment of a range of neoplastic conditions including; Breast carcinoma Gastric carcinoma When administered intravesically, epirubicin has been shown to be beneficial in the treatment of: Papillary transitional cell carcinoma carcinoma of the bladder Carcinoma in-situ Intravesical prophylaxis of recurrence of superficial bladder carcinoma following transurethral resection. For intravesical use a positive benefit-risk ratio could only be established in patients in whom live attenuated BCG is contra-indicated or inappropriate. Epirubicin hydrochloride 2 mg/ml can be used in polychemotherapy schedules. IRISH MEDICINES BOARD _________________________________________________ Read the complete document