Movalis solution for i/m injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

meloxicam

Available from:

Boehringer Ingelheim Espana S.A.

ATC code:

M01AC06

INN (International Name):

meloxicam

Dosage:

15mg/1,5ml

Pharmaceutical form:

solution for i/m injection

Units in package:

(3) ampoules 1,5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-11-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Movalis 15 mg / 1.5 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 10 mg meloxicam.
One ampoule with 1.5 ml solution contains 15 mg meloxicam in the form
of the enolate salt which is
formed in situ during the manufacturing process.
Excipient(s) with known effect
Contains less than 1 mmol sodium (23mg) per 1.5 ml ampoule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A yellow solution with a greenish tinge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Short-term symptomatic treatment of acute exacerbations of rheumatoid
arthritis and ankylosing
spondylitis, when other routes of administration are not appropriate.
-
Movalis solution for injection is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One 15 mg injection once a day.
DO NOT EXCEED THE DOSE OF 15 mg/day.
The treatment should normally be limited to a single injection for
treatment initiation with a
maximum extension to 2 to 3 days in substantiated exceptional cases
(i.e. when other routes are not
possible). Undesirable effects may be minimised by using the lowest
effective dose for the shortest
duration necessary to control symptoms (see section 4.4).
The patient's need for symptomatic relief and response to therapy
should be re-evaluated periodically.
Special populations
_Elderly patients (see section 5.2) _
The recommended dose in elderly patients is 7.5 mg per day (half an
1.5 ml ampoule) (see also
sections 4.2 ‘Patients with increased risks for adverse reaction’
and 4.4).
1
2
_Patients with increased risks for adverse reaction (see section 4.4)
_
In patients with increased risks for adverse reactions, e.g. a history
of gastro -intestinal disease or risk
factors for cardiovascular disease, the treatment should be started at
a dose of 7.5 mg per day (half a
1.5 ml ampoule).
_Renal impairment (see section 5.2) _
This medicine is contraindicated in non-dia