CASODEX 50 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

BICALUTAMIDE

제공처:

LTT Pharma Limited

INN (International Name):

BICALUTAMIDE

복용량:

50 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

Product subject to prescription which may not be renewed (A)

승인 상태:

Withdrawn

승인 날짜:

2013-03-05

제품 특성 요약

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
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_Date Printed 14/02/2012_
_CRN 2103544_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment shou