CASODEX Film Coated Tablet 50 Milligram
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
03-05-2024
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:
BICALUTAMIDE
थमां उपलब्ध:
LTT Pharma Limited
डोज़:
50 Milligram
फार्मास्यूटिकल फॉर्म:
Film Coated Tablet
प्राधिकरण की तारीख:
2010-10-08
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Casodex 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 50mg bicalutamide
Excipient: contains lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Italy_
Round, white, biconvex tablet intagliated with "Cdx50" on one face and a logo on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult males including the elderly: One tablet (50mg) once a day. Treatment with Casodex should be started at the same
time as treatment with an LHRH analogue or surgical castration.
Children: Casodex is contraindicated in children.
Renal Impairment: No dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased
accumulation may occur in patients with moderate to severe hepatic impairment (_see section 4.4, Special warnings and_
_precautions for use_).
4.3 CONTRAINDICATIONS
Casodex is contra-indicated in females and children (see section 4.6).
Casodex must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of
the excipients of this product.
Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/02/2012_
_CRN 2103544_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment shou
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