Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Parecoxib
Noridem Enterprises Limited
M01AH04
Parecoxib
40 milligram(s)
Powder and solvent for solution for injection
parecoxib
Not marketed
2021-10-08
PACKAGE LEAFLET: INFORMATION FOR THE USER PARECOXIB 40 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION parecoxib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 Parecoxib is and what it is used for 2. What you need to know before you are given Parecoxib 3. How Parecoxib is given 4. Possible side effects 5. How to store Parecoxib 6. Contents of the pack and other information 1. WHAT PARECOXIB IS AND WHAT IT IS USED FOR Parecoxib contains the active substance parecoxib. Parecoxib is used for the short-term treatment of pain in adults after an operation. It belongs to the group 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. Parecoxib works by lowering the amount of these prostaglandins. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PARECOXIB PARECOXIB MUST NOT BE GIVEN: • 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 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 Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 26 October 2021 CRN009JLJ Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Parecoxib 40 mg powder and solvent for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). After reconstitution with 2 ml solvent, the concentration of parecoxib is 20 mg/mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: white to off white powder. Solvent: clear and colourless solution. 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 parecoxib 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 of Parecoxib and reduce the maximum daily dose to 40 mg (see section 5.2). _Hepatic impairment_ There is no clinical experience in patients with severe h Διαβάστε το πλήρες έγγραφο