VOLTAREN CAIRAN INJEKSI 25 MG/ML

Country: Indónesía

Tungumál: indónesíska

Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Virkt innihaldsefni:

DICLOFENAC SODIUM

Fáanlegur frá:

NOVARTIS INDONESIA - Indonesia

INN (Alþjóðlegt nafn):

DICLOFENAC SODIUM

Skammtar:

25 MG/ML

Lyfjaform:

CAIRAN INJEKSI

Einingar í pakka:

DUS, 5 AMPUL @ 3 ML

Framleitt af:

LEK PHARMACEUTICALS D.D.

Leyfisdagur:

2015-08-25

Vara einkenni

PAGE 1 OF 14
VOLTAREN
®
ANTIRHEUMATIC, ANTI-INFLAMMATORY
CARDIOVASCULAR RISK

NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction and stroke, which can be fatal. This may
increase with dose and
duration of use. Voltaren is contraindicated in established congestive
heart failure (New
York
Heart
Association
[NYHA]
classification
II-IV),
ischemic
heart
disease,
peripheral arterial disease and/or cerebrovascular disease. Patients
with congestive heart
failure (NYHA-I) or risk factors for cardiovascular disease may be at
greater risk (See
WARNINGS).

Voltaren is contraindicated for the treatment of peri-operative pain
in the setting of
coronary artery bypass graft (CABG) surgery (See WARNINGS).
GASTROINTESTINAL RISK

NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration and perforation of the stomach or intestines,
which can be fatal.
These events can occur at any time during use and without warning
symptoms. Elderly
patients are at greater risk for serious gastrointestinal events (See
WARNINGS).
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Solution for injection.
ACTIVE SUBSTANCE(S)
The active substance is diclofenac sodium.
One Voltaren ampoule of 3 mL contains 75 mg of diclofenac sodium.
For excipients, see section List of excipients.
ACTIVE MOIETY
Diclofenac
LIST OF EXCIPIENTS
Mannitol;
sodium
metabisulphite
(E223);
benzyl
alcohol;
propylene
glycol;
sodium
hydroxide; water for injection.
CLINICAL PHARMACOLOGY
PHARMACOTHERAPEUTIC GROUP, ATC
Anti-inflammatory and antirheumatic products, non-steroids, acetic
acid derivatives and
related substances (ATC code: M01A B05).
MECHANISM OF ACTION (MOA)
Voltaren
contains
diclofenac
sodium,
a
non-steroidal
compound
with
pronounced
antirheumatic,
anti-inflammatory,
analgesic,
and
antipyretic
properties.
Inhibition
of
prostaglandin biosynthesis, which has been demonstrated in
experiments, is considered to be
fundamental to its mechanism of action. Prostaglandins p