Arcoxia tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

etoricoxib

Disponibil de la:

Merck Sharp & Dohme B.V. Waarderweg 39

Codul ATC:

M01AH05

INN (nume internaţional):

etoricoxib

Dozare:

120mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(7/1x7/) in blister, (28/4x7/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-12-23

Caracteristicilor produsului

2
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
30 mg film-coated tablets
60 mg film-coated tablets
90 mg film-coated tablets
120 mg film-coated tablets
[To be completed nationally]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect:
30 mg tablet: 1.3 mg lactose (as monohydrate)
60 mg tablet: 2.7 mg lactose (as monohydrate)
90 mg tablet: 4.0 mg lactose (as monohydrate)
120 mg tablet: 5.3 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablets).
30 mg tablets: Blue-green, apple-shaped biconvex tablets .
60 mg tablets: Dark green, apple-shaped, biconvex tablets .
90 mg tablets: White, apple-shaped, biconvex tablets .
120 mg tablets: Pale-green, apple-shaped, biconvex tablets .
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated in adults and adolescents 16 years of age and
older for the symptomatic relief
of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing
spondylitis, and the pain and signs of
inflammation associated with acute gouty arthritis.
is indicated in adults and adolescents 16 years of age and
older for the short-term treatment
of moderate pain associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual
patient's overall risks (see sections 4.3, 4.4).
4
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used.
The pat