CASODEX Film-coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Casodex 150 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 150 mg bicalutamide (INN). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). White.
Therapeutic indications
Casodex 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1). ...
Posology and method of administration
Posology Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day. Casodex 150 mg should be taken continuously for at least 2 years or until disease progression. ...
Contraindications
Casodex 150 mg is contraindicated in females and children (see section 4.6). Casodex 150 mg must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any ...
Special warnings and precautions for use
Initiation of treatment should be under the direct supervision of a specialist. Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe ...
Interaction with other medicinal products and other forms of interaction
In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4, with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Although clinical studies using antipyrine as a marker of cytochrome ...
Fertility, pregnancy and lactation
Pregnancy Bicalutamide is contraindicated in females and must not be given to pregnant women. Breast-feeding Bicalutamide is contraindicated during breast-feeding. Fertility Reversible impairment of male ...
Effects on ability to drive and use machines
Casodex is unlikely to impair the ability of patients to drive or operate machinery. However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise caution. ...
Undesirable effects
In this section, undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known ...
Overdose
There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiandrogen ATC code: L02BB03 Mechanism of action Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to the wild type or normal androgen ...
Pharmacokinetic properties
Absorption Bicalutamide is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on bioavailability. Distribution Bicalutamide is highly protein bound ...
Preclinical safety data
Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. Target organ changes, including tumour induction (Leydig cells, thyroid, liver) in animals, are related to ...
List of excipients
Tablet Core: Lactose monohydrate Magnesium stearate Povidone Carboxymethyl amidon sodium Film-coating material: Hypromellose Macrogol 300 Titanium dioxide
Incompatibilities
Not applicable.
Shelf life
Shelf life: 4 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/Aluminium foil blister pack comprising strips of 5, 10 and 14 tablets to give pack sizes of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
PL 17901/0006
Date of first authorization / renewal of the authorization
Date of first authorisation: 18<sup>th</sup> June 2000 Date of latest renewal: 16<sup>th</sup> June 2004
Date of revision of the text
12<sup>th</sup> February 2018
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