服他寧注射液75公絲 / 3公撮

국가: 대만

언어: 중국어

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

환자 정보 전단 환자 정보 전단 (PIL)
03-06-2020
공공 평가 보고서 공공 평가 보고서 (PAR)
03-06-2020

유효 성분:

DICLOFENAC SODIUM

제공처:

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 코드:

M01AB05

약제 형태:

注射劑

구성:

DICLOFENAC SODIUM (2808400410) 75.0MG

패키지 단위:

盒裝

수업:

製 劑

처방전 유형:

限由醫師使用

Manufactured by:

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

치료 영역:

diclofenac

치료 징후:

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。

제품 요약:

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

승인 상태:

已註銷

승인 날짜:

2013-04-10

환자 정보 전단

                                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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