康肯2.5公絲

Land: Taiwan

Sprog: kinesisk

Kilde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktiv bestanddel:

BISOPROLOL HEMIFUMARATE

Tilgængelig fra:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATC-kode:

C07AB07

Lægemiddelform:

膜衣錠

Sammensætning:

主成分 () ; BISOPROLOL HEMIFUMARATE (1216002820) (2:1)MG

Enheder i pakken:

鋁箔盒裝

Klasse:

製　劑

Recept type:

須由醫師處方使用

Fremstillet af:

MERCK KGaA FRANKFURTER STRASSE 250, 64293 DARMSTADT/GERMANY、POSTFACH：64271 DARMSTADT/GERMANY DE

Terapeutisk område:

bisoprolol

Terapeutiske indikationer:

穩定型慢性中度至重度心衰竭。

Produkt oversigt:

註銷日期: 2016/05/31; 註銷理由: 許可證已逾有效期; 有效日期: 2014/06/29; 英文品名: CONCOR 2.5

Autorisation status:

已註銷

Autorisation dato:

2004-06-29

Indlægsseddel

CONCOR
® 1.25
CONCOR
® 2.5
ACTIVE INGREDIENT: BISOPROLOL FUMARATE
COMPOSITION
Concor
®
1.25
Each film-coated tablet contains 1.25 mg bisoprolol fumarate as active
ingredient.
Excipients: Tablet core:
Silica, colloidal anhydrous; magnesium stearate, crospovidone,
microcrystalline cellulose, pregelatinized maize starch, maize starch,
calcium hydrogen phosphate, anhydrous.
Film coating:
Dimethicone, talcum, macrogol 400, titanium dioxide, hypromellose.
Concor
®
2.5
Each fil
m-coated tablet contains 2.5 mg bisoprolol fumarate as active
ingredient.
Excipients: Tablet core:
Silica, colloidal anhydrous; magnesium stearate, crospovidone,
microcrystalline cellulose, maize starch, calcium hydrogen phosphate,
anhydrous.
Film coating:
Dimethicone, macrogol 400, titanium dioxide, hypromellose.
PROPERTIES
PHARMACODYNAMICS
Bisoprolol, the active ingredient of Concor
®
, is a beta1-selective-adrenoceptor blocking agent,
lacking intrinsic stimulating and relevant membrane stabilising
activity. It only shows very low
affinity to the beta2-receptor of the smooth muscles of bronchi and
vessels as well as to the
beta2-receptors concerned with metabolic regulation. Therefore,
bisoprolol is generally not
to be expected to influence the airway resistance and beta2-mediated
metabolic effe
cts. Its
beta1-selectivity extends beyond the therapeutic dose range.
PHARMACOKINETICS
ABSORPTION.
Bisoprolol is almost completely (> 90%) absorbed from the
gastrointestinal tract
and, because of its small first pass metabolism of approximately 10%,
has an bioavailability
of approximately 90% after oral administration. The bioavailability is
not affected by food
intake. Bisoprolol shows linear kineti
cs and the plasma concentrations are proportional to the
administered dose over the dose range 5 to 20 mg. Peak plasma
concentrations occur within
2-3 hours.
DISTRIBUTION.
Bisoprolol is extensively distributed. The volume of distribution is
3.5 l/kg. Binding
to plasma proteins is approximately 30%.
METABOLISM.
Bisoprolol is metabolised via oxidative pa