服他寧注射液75公絲 / 3公撮

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)
03-06-2020
公众评估报告 公众评估报告 (PAR)
03-06-2020

有效成分:

DICLOFENAC SODIUM

可用日期:

臺灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

ATC代码:

M01AB05

药物剂型:

注射劑

组成:

DICLOFENAC SODIUM (2808400410) 75.0MG

每包单位数:

盒裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE CH-4332 STEIN, SWITZERLAND CH

治疗领域:

diclofenac

疗效迹象:

無法口服情況下,短期使用於緩解發炎及因發炎反應引起之疼痛。

產品總結:

註銷日期: 2014/06/11; 註銷理由: 自請註銷; 有效日期: 2018/09/17; 英文品名: VOLTAREN, AMPOULES 75MG/3ML

授权状态:

已註銷

授权日期:

2013-04-10

资料单张

                                VOLTAREN

NSAIDs: non-steroid anti-inflammatory drug
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for injection.
ACTIVE SUBSTANCE
The
active
substance
is
sodium-[o-[(2,6-dichlorophenyl)-
amino]-phenyl]-acetate (= diclofenac sodium).
One Voltaren ampoule of 3 mL contains 75 mg of diclofenac
sodium.
ACTIVE MOIETY
Diclofenac
EXCIPIENTS
Mannitol;
sodium
metabisulphite
(E223);
benzyl
alcohol;
propylene glycol; water for injection; sodium hydroxide.
Pharmaceutical formulations may vary between countries.
INDICATIONS
For relief of inflammation and painful conditions due to
inflammatory if oral admission is not appropriate.
DOSAGE AND ADMINISTRATION
The dose is generally one 75 mg ampoule daily, given by
deep intragluteal injection into the upper outer quadrant.
CONTRAINDICATIONS

Severe blood disorders.

Severe hepatic disorders

Severe renal disorders

Known hypersensitivity to the diclofenac or any of the
other excipients.

Active gastric or intestinal ulcer, bleeding or perforation.

Diclofenac should not be given to patients who have
experienced
asthma,
urticaria,
or
other
allergic-type
reactions after taking aspirin or other NSAIDs. Severe,
rarely fatal, anaphylactic-like reactions to NSAIDs have
been reported in such patients.

Diclofenac
is
contraindicated
for
the
treatment
of
perioperative
pain
in
the
setting
of
coronary
artery
bypass graft (CABG) surgery.

Last trimester of pregnancy
WARNINGS AND PRECAUTIONS
1.
CARDIOVASCULAR EFFECTS
Treatment with NSAIDs including diclofenac, particularly at
high dose and in long term, may be associated with a small
increased risk of serious cardiovascular thrombotic events
(including myocardial infarction and stroke).
Treatment with Voltaren is generally not recommended in
patients with established cardiovascular disease (congestive
heart failure, established ischemic heart disease, peripheral
arterial
disease)
or
uncontrolled
hypertension.
If
needed,
patients with established cardiovascular disease, uncontrolled
hypertension, or signifi
                                
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