EPIRUBICINE HCL
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
05-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
EPIRUBICIN HYDROCHLORIDE
थमां उपलब्ध:
Pharmachemie BV
डोज़:
2
फार्मास्यूटिकल फॉर्म:
Solution for Inj/Inf
प्राधिकरण की तारीख:
2009-01-16
उत्पाद विशेषताएं
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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