Land: Malta
Språk: engelsk
Kilde: Medicines Authority
DEXKETOPROFEN
Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg
M01AE17
DEXKETOPROFEN 25 mg/ml
SOLUTION FOR INJECTION CONCENTRATE FOR SOLUTION FOR INFUSION
DEXKETOPROFEN 25 mg/ml
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Authorised
2006-03-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KERAL 50 MG/2 ML SOLUTION FOR INJECTION/ INFUSION Dexketoprofen 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 pharmacis. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Keral is and what it is used for 2. What you need to know before you use Keral 3. How to use Keral 4. Possible side effects 5. How to store Keral 6. Contents of the packs and other information 1. WHAT KERAL IS AND WHAT IT IS USED FOR Keral is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It 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 KERAL DO NOT USE KERAL: • 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 non-steroidal anti-inflammatory medicines; • 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 acetylsalicylic acid or other non-steroidal anti-inflammatory medicines; • 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 k Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Keral 50 mg/2ml Solution for injection/ infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 2 ml contains: dexketoprofen 50 mg (as dexketoprofen trometamol). Each ml of solution for injection/ infusion contains dexketoprofen 25 mg (as dexketoprofen trometamol) Excipients with known effects: Each ampoule of 2 ml contains 200 mg ethanol (96 per cent). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/ infusion. Clear and colourless solution. 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 – 12 hours. If necessary, the administration can be repeated 6 hours apart. The total daily dose should not exceed 150 mg. Keral solution for injection/ infusion is intended for short term use and the treatment must be limited to the acute symptomatic period (no more than two 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, Keral solution for injection/ infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults (see section 5.1). _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 case of mild renal function impairment: 50 mg total daily dose (see section 4.4). _Hepatic impairment _ The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate ( Les hele dokumentet