Tenoxin powder lyophilized for solution for injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

tenoxicam

Disponibil de la:

Anfarm Hellas S.A.

Codul ATC:

M01AC02

INN (nume internaţional):

tenoxicam

Dozare:

20mg

Forma farmaceutică:

powder lyophilized for solution for injection

Unități în pachet:

(1) glass vial 3ml and (1) solvent in ampoule 2ml

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-02-03

Caracteristicilor produsului

-1-
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
TENOXIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_2.1 GENERAL DESCRIPTION _
Yellow to green-yellow lyophilized cake powder with cylinder shape in
the colorless glass vial.
Solvent: water for injection - clear sterile colorless liquid
preserved in single dose colorless glass
containers.
_2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION _
Each vial contains 20mg tenoxicam as lyophilized sterile powder for
reconstitution.
Each ampoule of solvent contains 2 ml of water for injection.
Excipients with known effect: each vial contains 2 mg of sodium
metabisulfite.
For full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Lyophilized powder for solution for IM/IV injection.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
_ _
TENOXIN
is indicated for the symptomatic treatment of the following painful
inflammatory and
degenerative disorders of the musculoskeletal system:
-
rheumatoid arthritis
-
osteoarthritis
-
ankylosing spondylitis, other seronegative vertebral diseases
-
painful extra-articular syndromes, such as tendonitis, bursitis,
periarthritis of the shoulder
(arm syndrome)
-
acute gout
-
postoperative pain
-
primary dysmenorrhea
-2-
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
_Posology _
_Adults _
For all indications, apart from primary dysmenorrhea, postoperative
pain and acute gout, a single
daily dose of 20mg should be administered at the same time each day.
The recommended dose for primary dysmenorrhea is 20 to 40 mg once
daily.
For postoperative pain, the recommended daily dose is 40mg once daily.
The administration period
must not exceed five days.
For acute gout, the recommended dose is 40mg once daily for two days,
followed by 20mg once daily
for the next five days. Where required, treatment may be initiated by
intravenous or intramuscular
administration once every one or two days and continued orally.
In the treatment of chronic conditions, the therapeutic effect of
tenoxicam is evident from the
beginning of treatment