TOPOTECAN MARTINDALE PHARMA 1 Milligram Pdr/Conc/Soln for Infus
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
01-06-2024
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:
TOPOTECAN HYDROCHLORIDE
थमां उपलब्ध:
Martindale Pharmaceuticals Ltd
INN (इंटरनेशनल नाम):
TOPOTECAN HYDROCHLORIDE
डोज़:
1 Milligram
फार्मास्यूटिकल फॉर्म:
Pdr/Conc/Soln for Infus
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
0000-00-00
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topotecan Martindale Pharma 1 mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg topotecan (as hydrochloride)
1ml of reconstituted solution contains 1mg of topotecan.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Light yellow to greenish powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topotecan monotherapy is indicated for the treatment of:
• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
• patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not
considered appropriate (see section 5.1).
• Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after
radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained
treatment free interval to justify treatment with the combination (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and
should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section
6.6).
When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of
≥ 1.5 x 10
9
/l, a
platelet count of
≥ 100 x 10
9
/l, and a haemoglobin level of
≥ 9g/dl (after transfusion if necessary).
Topotecan must be reconstituted and further dil
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