País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dexketoprofen (dexketoprofen trometamol)
Kalceks JSC
M01AE17
dexketoprofen (dexketoprofen trometamol)
50mg/2ml
solution for injection/infusion
(5/1x5/) ampoules 2ml in plastic liner
Prescription
Registered
2022-02-02
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 Llegiu el document complet
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: _ 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 elderly patients a lower dose is recommended in Llegiu el document complet