CELEBREX

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

CELECOXIB

Tillgänglig från:

PFIZER INDONESIA - Indonesia

INN (International namn):

CELECOXIB

Dos:

100.00 MG

Läkemedelsform:

KAPSUL

Enheter i paketet:

DUS, 10 BLISTER @ 10 KAPSUL

Tillverkad av:

PFIZER PHARMACEUTICALS LLC - United States of America

Tillstånd datum:

2020-02-24

Produktens egenskaper

Generic Name: Celecoxib
Trade Name: Celebrex
CDS Effective Date: November 01, 2019
Supersedes: August 16, 2018
Approved by BPOM:
2019-0053572
Page 1 of 30
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Celecoxib
Trade Name: Celebrex
CDS Effective Date: November 01, 2019
Supersedes: August 16, 2018
CARDIOVASCULAR RISK
•
NSAID
S
may cause an increased risk of serious cardiovascular (CV) thrombotic
events, myocardial
infarction (MI), and stroke, which can be fatal. This risk may
increase with dose and duration of
use. Patients with CV disease or CV risk factors may be at greater
risk (see WARNINGS and
CLINICAL STUDIES).
•
CELEBREX 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).
ASTHMA AND SKIN REACTION
CELEBREX is contraindicated to patients who have experienced asthma,
urticaria, or allergic-type
reactions after taking aspirin or other NSAIDs (see WARNINGS and
PRECAUTIONS).
CONGESTIVE HEART FAILURE AND EDEMA
CELEBREX should be used with caution in patients with fluid retention
or heart failure (see
WARNINGS).
HEPATIC EFFECTS
Patients with symptoms and/or signs suggesting liver dysfunction, or
in whom abnormal liver test has
occurred, should be evaluated for evidence of the development of a
more severe hepatic reaction while
on therapy with CELEBREX (see PRECAUTIONS).
RENAL EFFECTS
Long-term administration of NSAIDs has resulted in renal papillary
necrosis and other renal injury.
Renal toxicity has also been seen in patients in whom renal
prostaglandins have a compensatory role in
the maintenance of renal perfusion (see WARNINGS).
DESCRIPTION
CELEBREX (celecoxi