服他寧注射液７５公絲 / ３公撮

Negara: Taiwan

Bahasa: China

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

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

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)

Kode ATC:

M01AB05

Bentuk farmasi:

注射劑

Komposisi:

DICLOFENAC SODIUM (2808400410) 75.0MG

Unit dalam paket:

盒裝

Kelas:

製　劑

Jenis Resep:

限由醫師使用

Diproduksi oleh:

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

Area terapi:

diclofenac

Indikasi Terapi:

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。

Ringkasan produk:

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

Status otorisasi:

已註銷

Tanggal Otorisasi:

2013-04-10

Selebaran informasi

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