"理奧" 必瑞錠

Država: Tajvan

Jezik: kitajščina

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

Prenos Navodilo za uporabo (PIL)
22-03-2024
Prenos Javno poročilo o oceni (PAR)
10-04-2020

Aktivna sestavina:

BUMETANIDE

Dostopno od:

禾利行股份有限公司 台北市松山區敦化北路311號3樓 (03126405)

Koda artikla:

C03CA02

Farmacevtska oblika:

錠劑

Sestava:

BUMETANIDE (4028000400) MG

Enote v paketu:

盒裝

Razred:

製 劑

Tip zastaranja:

須由醫師處方使用

Izdeluje:

Karo Pharma AB Box 16184, 103 24 Stockholm, Sweden SE

Terapevtsko območje:

bumetanide

Terapevtske indikacije:

水腫、利尿

Povzetek izdelek:

有效日期: 2024/04/27; 英文品名: BURINEX TABLETS 1MG

Datum dovoljenje:

2018-10-31

Navodilo za uporabo

                                1
BURINEX®INJECTION 0.5 MG/ML
BURINEX® TABLET 1MG
1.
NAME OF THE MEDICINAL PRODUCT
Burinex
®
Bumetanide
Carefully read this insert before administering this product. It
contains information about your
treatment. If you have any doubt or you are not sure about something,
please ask your physician or
Pharmacist chemist.
Keep this insert as you might need to read it again.
Verify this product fully corresponds to the one prescribed by your
physician.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets:
Bumetanide 1mg
Excipients the clinician should be aware of:
Lactose
Ampoules:
Bumetanide 0.50 mg/ml
For the full list of excipients, see section 6.1.
Not all pack sizes, strengths and formulations may be marketed
Sale under prescription
3.
PHARMACEUTICAL FORM
Tablets:
1mg:
White, circular, flat tablets embossed with the number 133 on one side
and an Assyrian lion on the
other side.
The tablets have a score line
Ampoules:
Solution for injection
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oedema, diuretic.
Physician use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
[FOR BURINEX® TABLET ONLY] ORALLY:
1 mg daily.
In refractory cases the dose can be increased gradually till a
satisfactory response has been obtained.
Rarely will it be necessary to exceed a dose of 4 mg daily. In high
dose therapy consideration should
be given to a twice daily dosing.
_Children:_
The dose is calculated on the basis of 0.03–0.06 mg/kg daily.
_Elderly:_
Adjust dosage according to response; a dose of 0.5 mg daily may be
sufficient in some elderly
patients.
Where intramuscular administration is considered appropriate a dose of
1 mg should be given initially
and the dose then be adjusted according to the diuretic response.
[FOR BURINEX® SOLUTION FOR INJECTION ONLY] PARENTERALLY:
Usually 1–2 mg intravenously or
intramuscularly.
_Pulmonary oedema: _
Initially 2 mg by intravenous injection.
This can be repeated, if necessary, after 20 minutes. In those
conditions in which an infusion
appropriate, 2–5
                                
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