Naklofen solution for injection

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

diclofenac (diclofenac sodium)

Dostupné z:

KRKA d.d.

ATC kód:

M01AB05

INN (Medzinárodný Name):

diclofenac (diclofenac sodium)

Dávkovanie:

75mg/3ml

Forma lieku:

solution for injection

Počet v balení:

(5) ampoules 3ml

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2017-05-11

Súhrn charakteristických

PI_Text008165_1
– Updated:
Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Naklofen 75 mg/3 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
3 ml of solution for injection (1 ampoule) contains 75 mg diclofenac
sodium.
Excipients with known effect:
-
benzyl alcohol: 120 mg/3 ml solution
-
sodium: 0.29736 mmol/3 ml solution
-
sodium metabisulphite: 3 mg/3 ml solution
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution for injection is a clear, colourless to slightly yellow
solution, practically free from
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diseases in which anti-inflammatory and/or analgesic activity is
required:
-
inflammatory rheumatic diseases: rheumatoid arthritis,
spondyloarthritides, chronic idiopathic
juvenile arthritis, other arthritides,
-
degenerative rheumatism of the joints and spine: arthrosis,
spondylosis,
-
crystal-induced arthritides: gout and pseudogout,
-
extra-articular rheumatism: periarthritis, bursitis, myositis,
tendinitis, synovitis,
-
other inflammatory and painful states of the musculoskeletal system.
As an analgesic, Naklofen is used in soft tissue injuries, in various
dental procedures, after surgery, in
severe migraine attacks, in renal and biliary colics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the suppression of severe pain, 1 ampoule is administered
intramuscularly once to twice daily. As
soon as possible, treatment should be continued with other forms of
the drug (gastro-resistant tablets,
prolonged-release tablets, capsules, suppositories).
In renal colics, a second injection may be given 30 minutes after the
first one.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control (relieve) symptoms (see section 4.4).
_Patients with renal insufficiency_
The drug should be administered with caution to patients with renal
insufficiency (see section 4.4).
CONFIDENTIAL
Naklofen 75 mg/3 ml solution for injection