Diclo-Denk 75 Injection solution for injection

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

diclofenac (diclofenac sodium)

Inapatikana kutoka:

Haupt Pharma Wulfing GmbH

ATC kanuni:

M01AB05

INN (Jina la Kimataifa):

diclofenac (diclofenac sodium)

Kipimo:

25mg/ml

Dawa fomu:

solution for injection

Vitengo katika mfuko:

(10) ampoules 3ml

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2018-02-27

Taarifa za kipeperushi

_Diclo-Denk 75 Injection_
Solution for injection – intramuscular (intragluteal) use
Non-steroidal antiphlogistic/antirheumatic
Active substance: Diclofenac sodium
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
WHAT DICLO-DENK 75 INJECTION IS
AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
USE DICLO-DENK 75 INJECTION
3.
HOW TO USE DICLO-DENK 75 INJECTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DICLO-DENK 75 INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Diclo-Denk 75 Injection is and what
it is used for
Diclo-Denk 75 Injection is a pain-relieving and anti-in-
flammatory drug and belongs to the class of nonsteroidal
antiphlogistic/antirheumatic agents (NSAIDs).
Therapeutic indications
Symptomatic treatment of acute severe pain in case of:
•
acute joint inflammation (acute arthritides) including
gout attack
•
chronic joint inflammation (chronic arthritides),
especially in case of rheumatoid arthritis (chronic
polyarthritis)
•
Bechterew’s disease (ankylosing spondylitis) and other
inflammatory rheumatoid disorders of the spine
•
acute inflammatory condition of degenerative joint or
spinal disorders (arthroses and spondylarthroses)
•
inflammatory soft tissue rheumatisms
•
painful swelling or inflammation after injuries.
Please note: The solution for injection is only indicated if a
very rapid onset of effect is required or if it is not possible
to give the medicine orally or as a suppository.
In this case, the

Tabia za bidhaa

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclo-Denk 75 Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: diclofenac sodium
Each ampoule of 3 ml solution contains 75 mg diclofenac sodium, 105 mg
benzyl alcohol, 3 mg
acetylcysteine, 600 mg propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for
intramuscular
(intragluteal) injection.
Colourless to slightly yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of acute severe pain in case of:
-
acute arthritides (including gout attack)
-
chronic arthritides, especially rheumatoid arthritis (chronic
polyarthritis)
-
ankylosing spondylitis (Bechterew’s disease) and other inflammatory
rheumatoid disorders of the
spine
-
inflammatory condition of degenerative joint or spinal disorders
(arthroses and spondylarthroses)
-
inflammatory soft tissue rheumatisms
-
painful swelling or inflammation after injuries.
Please note: The solution for injection is only indicated if a
particularly rapid onset of effect is required or
if it is not possible to give the medicine orally or as a suppository.
In this case, the treatment should
generally be given as a single injection for initiating therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Diclo-Denk 75 Injection should be administered as a single injection
treatment (75 mg diclofenac
sodium). If further treatment appears necessary, tablets or
suppositories should be given. A maximum
daily dose of 150 mg of diclofenac sodium should not be exceeded on
the day of receiving the
injection.
Method of administration
Diclo-Denk 75 Injection is administered by deep intragluteal
injection.
Due to the possible occurrence of anaphylactic reactions ranging to
shock, patients should be observed for
at least 1 hour after being injected with Diclo-Denk 75 Injection and
emergency equipment in full
2
working order should be kept within reach. The patient should be
informed about why this me