Xefocam powder lyophilized for solution for i/v and i/m injection

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

lornoxicam

Tilgængelig fra:

Takeda Austria GmbH

ATC-kode:

M01AC05

INN (International Name):

lornoxicam

Dosering:

8mg

Lægemiddelform:

powder lyophilized for solution for i/v and i/m injection

Enheder i pakken:

(5) glass vial

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2017-09-25

Produktets egenskaber

January 2015
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xefocam liofilizate for solution for intravenous and intramuscular
injection 8mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains:
_Active substance_: lornoxicam 8.0 mg*.
*Amount of lornoxicam, including an excess of 7.5%, is 8.6 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liofilizate for solution for intravenous and intramuscular injection.
APPEARANCE
Yellow dense mass.
Reconstituted solution - yellow clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of mild or moderate acute pain syndrome.
Symptomatic therapy of
pain and inflammation in patients with osteoarthritis.
Symptomatic therapy of pain and inflammation in patients with
rheumatoid arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For parenteral administration.
January 2015
The solution for injection should be prepared immediately before the
use by dissolving
the contents of one vial (8 mg of lornoxicam) with water for injection
(2 ml).
When the solution is prepared, the needle should be replaced.
Intramuscular injections
should be administered with the use of a long needle.
The prepared solution should be administered intravenously or
intramuscularly in patients
with
postoperative
pain
and
intramuscularly
in
patients
with
acute
attack
of
lumbago/sciatica.
The duration of intravenous administration of the solution should be
not less than 15
seconds, intramuscular - not less than 5 seconds.
The recommended single dose: 8 mg intravenously or intramuscularly.
The daily dose
should not exceed 16 mg. Some patients may require an additional dose
of 8 mg during
the first 24 hours.
The lowest effective dose should be used within the minimum possible
short course.
Additional information for specific patient groups
_Children and adolescents_
Lornoxicam is not intended for use in children and adolescents under
18 years of age, as
data on its safety and efficacy are not sufficient.
_Elderly pat