Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
parecoxib sodium
Pfizer Europe MA EEIG
M01AH04
parecoxib
Coxibs, Antiinflammatory and antirheumatic products
Pain, Postoperative
For the short-term treatment of postoperative pain in adults.,
Revision: 32
Authorised
2002-03-22
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER DYNASTAT 40 MG POWDER FOR SOLUTION FOR INJECTION parecoxib 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 further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dynastat is and what it is used for 2. What you need to know before you use Dynastat 3. How to use Dynastat 4. Possible side effects 5. How to store Dynastat 6. Contents of the pack and other information 1. WHAT DYNASTAT IS AND WHAT IT IS USED FOR Dynastat contains the active substance parecoxib. Dynastat is used for the short-term treatment of pain in adults after an operation. It is one of a family of medicines called COX-2 inhibitors (this is short for _cyclo-oxygenase-2 inhibitors_ ). Pain and swelling are sometimes caused by substances in the body called _prostaglandins_ . Dynastat works by lowering the amount of these prostaglandins. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DYNASTAT DO NOT USE DYNASTAT - if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines - if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections) - if you currently have a gastric or intestinal ulcer or bleeding in the stomach or gut - if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g. ibuprofen) or to COX-2 inhibitors. Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines - if you are more than 6 months p Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Dynastat 40 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). After reconstitution, the concentration of parecoxib is 20 mg/ml. Each 2 ml of reconstituted powder contains 40 mg of parecoxib. Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per dose. When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mmol of sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection). White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short-term treatment of postoperative pain in adults. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. There is limited clinical experience with Dynastat treatment beyond three days (see section 5.1). Concomitant use with opioid analgesics _ _ Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above. In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis. Elderly No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose Прочетете целия документ