樂伯克持續性藥效錠0.375毫克

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:

PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE)

Tilgængelig fra:

台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)

ATC-kode:

N04BC05

Lægemiddelform:

持續性藥效錠

Sammensætning:

PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) (7600001520) (0.375)MG

Enheder i pakken:

鋁箔盒裝

Klasse:

製　劑

Recept type:

須由醫師處方使用

Fremstillet af:

Rottendorf Pharma GmbH Am Fleigendahl 3, 59320 Ennigerloh, Germany DE

Terapeutisk område:

pramipexole

Terapeutiske indikationer:

治療巴金森氏症的徵候及症狀

Produkt oversigt:

有效日期: 2025/08/24; 英文品名: Mirapex 0.375mg prolonged-release tablets

Autorisation dato:

2010-08-24

Indlægsseddel

MIRAPEX
®
abcd
PROLONGED-RELEASE TABLETS
0.375 MG &
0.75 MG &
1.5 MG
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
Treatment of the signs and symptoms of Parkinson’s disease.
2
DOSAGE AND ADMINISTRATION
2.1
GENERAL DOSING CONSIDERATIONS
MIRAPEX PR tablets are taken orally once daily, with or without food.
MIRAPEX PR tablets must be swallowed whole and must not be chewed,
crushed, or divided.
If a significant interruption in therapy with MIRAPEX PR tablets has
occurred, re-titration of therapy
may be warranted.
2.2
DOSING FOR PARKINSON’S DISEASE
The starting dose is 0.375 mg given once per day. Based on efficacy
and tolerability, dosages may be
increased gradually, not more frequently than every 5 to 7 days, first
to 0.75 mg per day and then by
0.75 mg increments up to a maximum recommended dose of 4.5 mg per day.
In clinical trials, dosage was initiated at 0.375 mg/day and gradually
titrated based on individual
therapeutic response and tolerability. Doses greater than 4.5 mg/day
have not been studied in
clinical trials. Patients should be assessed for therapeutic response
and tolerability at a minimal
interval of 5 days or longer after each dose increment.
Due to the flexible dose design used in clinical trials, specific
dose-response information could not
be determined.
When discontinuing therapy with MIRAPEX PR, taper the dose gradually
over a period of one week
(see Warnings and Precautions). In some studies with immediate-release
pramipexole tablets,
however, abrupt discontinuation was uneventful.
_Dosing in Patients with Renal Impairment _
The elimination of pramipexole is dependent on renal function [_see
Clinical Pharmacology (12.3)_].
Patients with mild renal impairment (a creatinine clearance above 50
mL/min) require no reduction
in daily dose.
In patients with moderate renal impairment (creatinine clearance
between 30 and 50 mL/min),
MIRAPEX PR tablets should initially be taken every other day. Caution
should be exercised and
careful assessment of therapeutic response and tolerability should