Auxilen solution for injection/infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dexketoprofen (dexketoprofen trometamol)

Available from:

Kalceks JSC

ATC code:

M01AE17

INN (International Name):

dexketoprofen (dexketoprofen trometamol)

Dosage:

50mg/2ml

Pharmaceutical form:

solution for injection/infusion

Units in package:

(5/1x5/) ampoules 2ml in plastic liner

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUXILEN 50 MG/2 ML SOLUTION FOR INJECTION/INFUSION
_Dexketoprofenum _
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 Auxilen is and what it is used for
2.
What you need to know before you use Auxilen
3.
How to use Auxilen
4.
Possible side effects
5.
How to store Auxilen
6.
Contents of the pack and other information
1.
WHAT AUXILEN IS AND WHAT IT IS USED FOR
Auxilen is a pain killer from the group of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDs).
Auxilen is used to treat acute moderate to severe pain, when taking
tablets is not appropriate, such as
post-operative pain, renal colic (severe kidney pain) and low back
pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AUXILEN
DO NOT USE AUXILEN AND TELL THE DOCTOR:
­
if you are allergic to dexketoprofen or any of the other ingredients
of this medicine (listed in
section 6);
­
if you are allergic to acetylsalicylic acid or to other NSAIDs;
­
if you have asthma or have suffered attacks of asthma, acute allergic
rhinitis (a short period of
inflamed lining of the nose), nasal polyps (lumps within the nose due
to allergy), urticaria (skin
rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory
distress) or wheezing in
the chest, after taking aspirin or other NSAIDs;
­
if you have suffered from photoallergic or phototoxic reactions (a
particular form of reddening
and/or blistering of the skin exposed to sunlight) while taking
ketoprofen (NSAIDs) or fibrates
(medicines used to low

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Auxilen 50 mg/2mL solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains dexketoprofen trometamol corresponding to 25
mg of dexketoprofen.
One ampoule (2 ml) contains dexketoprofen trometamol corresponding to
50 mg of dexketoprofen.
Excipients with known effect: 200 mg ethanol (96 %) and 8.0 mg sodium
chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless solution, free from visible particles.
pH 7.0

8.0
Osmolarity 270

328 mOsmol/l
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of acute pain of moderate to severe intensity,
when oral administration is not
appropriate such as post-operative pain, renal colic and low back
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
The recommended dose is 50 mg every 8 to 12 hours. If necessary, the
administration can be repeated 6
hours apart. The total daily dose should not exceed 150 mg.
Auxilen is intended for short term use and the treatment must be
limited to the acute symptomatic period
(no more than 2 days).
Patients should be switched to an oral analgesic treatment when
possible.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
In case of moderate to severe postoperative pain, Auxilen can be used
in combination with opioid
analgesics, if indicated, at the same recommended doses in adults (see
section 5.1).
_Pediatric population:_
SPC004238/1 - en - Poland (Page 1 of 13)
Auxilen has not been studied in children and adolescents. Therefore
the safety and efficacy of Auxilen in
children and adolescents have not been established and the medicine
should not be used in children and
adolescents.
_Elderly:_
No dosage adjustment is generally necessary in older patients. However
because of the physiological
decline in renal function in elder