SPEDIFEN

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

IBUPROFEN

제공처:

TUNGGAL IDAMAN ABDI- Indonesia

INN (International Name):

IBUPROFEN

복용량:

600 MG

약제 형태:

GRANULA

패키지 단위:

DUS, 40 SACHET @ 600 MG

Manufactured by:

ZAMBON SWITZERLAND Ltd - Swiss

승인 날짜:

2018-01-04

제품 특성 요약

PIL_Eng _SDF600_11_20
SPEDIFEN
®
IBUPROFEN
600 MG
GRANULE
CARDIOVASCULAR RISK
-
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with
duration of use. Patients with cardiovascular disease or risk factors
for cardiovascular
disease may be at greater risk
-
NSAIDs is contraindicated for the treatment of perioperative pain in
the setting of
coronaryartery bypass graft (CABG) surgery
GASTROINTESTINAL RISK
-
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomatch 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.
COMPOSITIONS
Each tablet SPEDIFEN 600 mg granule contains:
ACTIVE INGREDIENT: 600 mg Ibuprofen as L-arginine salt, equal to
ibuprofen 600 mg.
EXCIPIENTS: L-arginine, Sodium hydrogen carbonate, Saccharin sodium,
Aspartame, Mint-
anise flavour and Sucrose.
THERAPEUTIC INDICATIONS :
SPEDIFEN is indicated for relieving pain of various etiology:
headache, pain after tooth
extraction and postoperative pain, as well as for the treatment of
primary dysmenorrhea.
SPEDIFEN is also indicated for the relief of signs and symptoms of
rheumatoid arthritis and
_osteoarthritis_, as well as for the musculoskeletal and traumatic
alterations implying pain and
inflammation
PHARMACOLOGICAL PROPERTIES
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMIC PROPERTIES
GENERAL PROPERTIES
_Pharmacotherapeutic _
_group_:
Antiinflammatory and anti-rheumatic
products,
non-steroids,
Propionic acid derivatives.
ATC code: M01AE01.
Ibuprofen is a synthetic analgesic-antiinflammatory drug with a marked
antipyretic action.
_Mechanism of action _
Ibuprofen is the first phenylpropionic acid derivative. It is a
prostaglandin synthetase inhibitor
with analgesic, antipyretic and anti-inflammatory properties.
It possesses a non-narcotic anal