Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
ibuprofennatriumdihydrat; paracetamol
Vale Pharmaceuticals Ltd
N02BE51
ibuprofennatriumdihydrat; paracetamol
10 mg/ml+3 mg/ml
Infusionsvätska, lösning
ibuprofennatriumdihydrat 3,85 mg Aktiv substans; mannitol Hjälpämne; paracetamol 10 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 10 x 100 ml
Godkänd
2020-07-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Paracetamol/Ibuprofen Vale Pharma10 mg/ml + 3 mg/ml solution for infusion paracetamol/ibuprofen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - You should not use this medicine for longer than 2 days. WHAT IS IN THIS LEAFLET 1. What /.../ is and what it is used for 2. What you need to know before you are given /.../ 3. How you are given /.../ 4. Possible side effects 5. How to store /.../ 6. Contents of the pack and other information 1. WHAT /.../ IS AND WHAT IT IS USED FOR /.../ contains the active substances paracetamol and ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). Paracetamol works in a different way to ibuprofen, but both substances work together to reduce pain. /.../ is used in adults for the short-term symptomatic treatment of acute moderate pain, where an intravenous route of administration is necessary and/or when other routes of administration are not possible. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN /.../ YOU SHOULD NOT BE GIVEN /.../: • if you are allergic to the active substances, other NSAIDs, or any of the other ingredients of this medicine (listed in section 6); • if you have severe heart failure, liver failure or kidney failure; • if you regularly drink large quantities of alcohol; • if you have asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs; • if you have a history with gastrointestinal bleeding or perforation related to previous N Lestu allt skjalið
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Paracetamol/Ibuprofen Vale Pharma 10 mg/ml + 3 mg/ml solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 10 mg paracetamol and ibuprofen sodium dihydrate corresponding to 3 mg ibuprofen. Excipient with known effect: Sodium 35 mg per 100 ml (0.35 mg/ml). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution, free from visible particles, with a pH of 6.3-7.3 and an osmolality of 285- 320 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /.../ is indicated in adults for the short-term symptomatic treatment of acute moderate pain, where an intravenous route of administration is considered clinically necessary and/or when other routes of administration are not possible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For intravenous administration and short term use only for a maximum of two days. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS (WEIGHING >50 KG)_ Administer one vial (100 ml) /.../ as a 15-minute infusion every 6 hours, as necessary. Do not exceed a total daily dose of four vials (400 ml), which equates to 4000 mg (4 g) paracetamol and 1200 mg ibuprofen. _ADULTS (WEIGHING ≤50 KG)_ Adults weighing 50 kg or under should be dosed according to their weight, at a dosage of 1.5 ml/kg, as a 15-minute infusion every 6 hours, as necessary. This equates to a maximum single dose of 75 ml (discard remaining medicine in vial), and a total daily dose of 3000 mg (3 g) paracetamol and 900 mg ibuprofen. 3 _PAEDIATRIC POPULATION_ /…/ is contraindicated in patients under the age of 18 years (see section 4.3). _SPECIAL POPULATIONS_ _Elderly_ Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functi Lestu allt skjalið