CELDOL 200 CAPSULES 200MG

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Celecoxib

Հասանելի է:

APOTHECA MARKETING PTE LTD

ATC կոդը:

M01AH01

Դեղագործական ձեւ:

CAPSULE

Կազմը:

Celecoxib 200mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

AUROBINDO PHARMA LIMITED (UNIT VII)

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2021-05-06

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
CELDOL
CELECOXIB CAPSULES 100 MG AND 200 MG
_R_
_X_
_ ONLY_
NAME OF DRUG PRODUCT : Celecoxib Capsules 100 mg
Celecoxib Capsules 200 mg
(TRADE) NAME OF PRODUCT : CELDOL 100
CELDOL 200
STRENGTH : 100 mg and 200 mg.
PHARMACEUTICAL DOSAGE FORM: Capsules.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Celecoxib Capsules 100 mg: _
Each hard gelatin capsule contains Celecoxib Ph.Eur. 100 mg.
_Celecoxib Capsules 200 mg: _
Each hard gelatin capsule contains Celecoxib Ph.Eur. 200 mg.
‘Not all strength is marketed locally’.
PHARMACEUTICAL FORM:
_CELECOXIB CAPSULES 100 MG:_
White cap and White body, Size ‘4’ hard gelatin capsule filled
with white to off white granular powder, imprinted with ‘Y’ on cap
and ‘100’ on body with blue ink.
_CELECOXIB CAPSULES 200 MG_
White cap and White body, Size ‘2’ hard gelatin capsule filled
with white to off white granular powder, imprinted with ‘Y’ on cap
and ‘200’ on body with gold ink.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis
(RA).
•
Management of acute pain in adults.
•
Treatment of primary dysmenorrhea.
•
Relief of signs and symptoms of ankylosing spondylitis (AS).
•
Management of chronic low back pain.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual patient’s overall risks, taking
into consideration other available therapeutic
options.
POSOLOGY AND METHOD OF ADMINISTRATION
Celecoxib capsules, at doses up to 200 mg twice per day, can be taken
with or without food.
As the cardiovascular (CV) risks of celecoxib may increase with dose
and duration of exposure, the shortest duration possible and the
lowest effective daily dose should be used.
_SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS (OA)_: The recommended dose
of celecoxib is 200 mg administered as a single dose or as 100 mg
twice per day.
_SYMPTOMATIC RELIEF IN THE TREATMENT OF RHEUMATOID ARTHRITIS (RA)_:
The recommended daily dose of cel