EPIRUBICINE HCL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
EPIRUBICIN HYDROCHLORIDE
Available from:
Pharmachemie BV
Dosage:
2
Pharmaceutical form:
Solution for Inj/Inf
Authorization date:
2009-01-16
Summary of Product characteristics
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
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