Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Ibuprofen
B. Braun Melsungen AG
M01AE; M01AE01
Ibuprofen
600 milligram(s)
Solution for infusion
Product subject to prescription which may not be renewed (A)
Propionic acid derivatives; ibuprofen
Not marketed
2017-10-06
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBUPROFEN B. BRAUN 600 MG SOLUTION FOR INFUSION ibuprofen 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 Ibuprofen B. Braun is and what it is used for 2. What you need to know before you are given Ibuprofen B. Braun 3. How Ibuprofen B. Braun is given 4. Possible side effects 5. How to store Ibuprofen B. Braun 6. Contents of the pack and other information 1. WHAT IBUPROFEN B. BRAUN IS AND WHAT IT IS USED FOR Ibuprofen belongs to the group of medicines called “nonsteroidal anti-inflammatory drugs” or (NSAIDs). This medicine is used in adults for the short-term symptomatic treatment of acute moderate pain when administration by intravenous route is clinically justified, when other routes of administration are not possible. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IBUPROFEN B. BRAUN_ _ IBUPROFEN B. BRAUN MUST NOT BE GIVEN: - If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). - If you have ever suffered from shortness of breath, have had asthma, skin rash, itchy runny nose or facial swelling, when previously taking ibuprofen, acetylsalicylic acid or other similiar painkiller (NSAIDs). - If you have a condition which increases your tendency or active bleeding. - If you have active, or history of recurrent (two or more episodes) stomach ulcer or bleeding. - If you have ever had bleeding or a tear in your stomach or gut when taking NSAIDs. - If you are suffering from bleeding in the brain (cerebrovascular bleeding) or other active bleeding. - If you suffer from severe kidney, liver or heart problems. - If you are suffering from severe dehydration (caused Прочетете целия документ
Health Products Regulatory Authority 25 April 2023 CRN00D6DT Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen B. Braun 600 mg solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 6 mg of ibuprofen. Each 100 ml bottle contains 600 mg of ibuprofen. Excipient with known effect: Each ml of solution contains 9.15 mg of sodium chloride (3.60 mg of sodium). Each 100 ml bottle contains 915 mg of sodium chloride (360 mg of sodium). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear and colourless to pale yellow solution for infusion, without any particulate matter. pH: 6.8-7.8 Osmolarity: 310-360 mOsm/L 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibuprofen B. Braun is indicated in adults for the short-term symptomatic treatment of acute moderate pain when administration by intravenous route is clinically justified when other routes of administration are not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Use should be limited to situations where oral administration is inappropiate. Patients must switch to oral treatment as soon as this is possible. This medicinal product is indicated for short-term acute treatment only and should not be used for more than 3 days. Adequate hydration of the patient should be maintained to minimize the risk of possible adverse reactions at renal level. ADULTS One dose of 600 mg. If clinically justified, another 600 mg dose can be administered after 6 to 8 hours depending on the intensity of the condition and response to treatment. The maximum total daily dose is 1200 mg. ELDERLY PATIENTS Like with all non-steroidal anti-inflammatory drugs (NSAIDs), precautions should be takenwhen treating elderly patients as they, are generally more prone to adverse effects (see section 4.4 and 4.8), and are more l Прочетете целия документ