歐樂得爽注射劑

国家: 台湾

语言: 中文

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

资料单张 资料单张 (PIL)
01-06-2020
公众评估报告 公众评估报告 (PAR)
01-06-2020

有效成分:

DEXAMETHASONE SODIUM PHOSPHATE

可用日期:

安沛國際有限公司 台北市大安區敦化南路二段207號20樓 (53957116)

ATC代码:

H02AB02

药物剂型:

注射劑

组成:

DEXAMETHASONE SODIUM PHOSPHATE (6804000640) MG

每包单位数:

小瓶

类:

製 劑

处方类型:

限由醫師使用

厂商:

N.V. ORGANON KLOOSTERSTRAAT 6 5349 AB OSS,THE NETHERLANDS NL

治疗领域:

dexamethasone

疗效迹象:

風濕性關節炎、休克

產品總結:

註銷日期: 2020/04/06; 註銷理由: 許可證已逾有效期; 有效日期: 2018/07/09; 英文品名: ORADEXON INJECTION

授权状态:

已註銷

授权日期:

1998-09-11

资料单张

                                Tekeningnr.: 12.234/12.509 Formaat: 160 x 600 mm
■
Process Black
36150.165
36150.R
RA 3360 TW S1(REF1.0)
Qualitative and quantitative
composition
One mL contains 5 mg of the
glucocorticoid dexamethasone
sodium phosphate as active
ingredient.
For excipients, see section ‘List of
excipients’.
Pharmaceutical form
Colourless aqueous solution.
Clinical particulars
Therapeutic indications
Injectable glucocorticoids may be
indicated in the following
conditions, especially if oral therapy
is impossible or undesirable.
1.
Immuno-allergology: in some
cases, especially in
exacerbation, of systemic lupus
erythematosus, nephrotic
syndrome with mininal change
lesions, polyarthritis nodosa,
connective tissue disease,
arteritis temporalis; usually in
combination with adrenaline in
anaphylaxis, hypersensitivity
angioneurotic oedema, severe
hay-fever, Stevens-Johnson
syndrome; to combat an acute
allograft rejection.
2.
Rheumatology: in general as
adjunctive therapy for short-
term administration (either
systemically or locally) in
serious cases of rheumatoid
arthritis and rheumatic
osteoarthritis, synovitis,
ankylosing spondylitis,
polymyalgia rheumatica, acute
rheumatic carditis; for local
adminstration in cases of acute
and subacute bursitis, synovitis,
epicondylitis, tendovaginitis.
3.
Endocrinology: primary or
secondary adrenocortical
insufficiency, adrenogenital
syndromes, polycystic ovary
syndrome, non suppurative
thyroiditis, thyreotoxic crisis; in
surgery, severe stress or
trauma in cases of decreased or
doubtful adrenocortical
function.
4.
Dermatology: severe cases of
pemphigus and pemphigoid,
exfoliative and other serious
cases of dermatitis, mycosis
fungoides, erythema
multiforme; locally, in keloids
and some cases of alopecia
areata.
myastenia gravis resistant to
anticholinesterase therapy and
thymectomy, in some cases of
acute multiple sclerosis and
peripheral neuritis.
11.Other indications: in the
prevention of inflammatory
oedema and adhesions in
surgery; in most cases of
tuberculous meningitis,
pericarditis, 
                                
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