Bicalaccord

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Bicalutamide 50mg

Disponible depuis:

Teva Pharma (New Zealand) Limited

DCI (Dénomination commune internationale):

Bicalutamide 50 mg

Dosage:

50 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Bicalutamide 50mg Excipient: Hypromellose E-5 Lactose monohydrate Macrogol 400 Magnesium stearate Povidone Purified water   Sodium starch glycolate Titanium dioxide

Unités en paquet:

Blister pack, PVC/PVdC Al, 28 tablets, 28 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Hetero Labs Limited

indications thérapeutiques:

Treatment of advanced prostate cancer in combination with GnRH (LHRH) agonist therapy or surgical castration. Prevention of disease flare associated with the use of LHRH agonists.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC Al, 28 tablets - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2009-09-16

Résumé des caractéristiques du produit

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Bicalaccord, 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of Bicalutamide.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in adult males aged 18 years and
older in combination with
GnRH (LHRH) agonist therapy or surgical castration. Prevention of
disease flare associated with the
use of LHRH agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
AS COMBINATION THERAPY IN ADULT MALES INCLUDING THE ELDERLY
One tablet (50 mg) once a day.
Treatment with BICALACCORD should be started at the same time as
treatment with a
GnRH (LHRH) agonist or surgical castration.
CHILDREN
BICALACCORD is contraindicated in children.
USE IN ADULT MALES WITH RENAL IMPAIRMENT
No dosage adjustment is necessary for patients with renal impairment.
USE IN ADULT MALES WITH 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
WARNINGS AND PRECAUTIONS).
4.3
CONTRAINDICATIONS
BICALACCORD is contraindicated in females and children.
BICALACCORD must not be given to any patient who has shown a
hypersensitivity reaction
to its use.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
BICALACCORD
is
extensively
metabolised
in
the
liver.
On
the
basis
of
currently
available
investigations, there may be slower excretion and accumulation of
bicalutimide in instances of severe
hepatic impairment. Caution is therefore required with patients with
moderate to severe hepatic
impairment. In these cases regular liver function tests (bilirubin,
transaminases, alkaline phosphatase)
must be carried out.
Severe hepatic changes and hepatic failure have been observed rarely
with BICALACCORD (see
ADVERSE EFFECTS). If there is clinical and/or biochemical evidence of
severe hepatotoxicity,
consideration should be given to discontinue BICALACCORD therapy