Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Remifentanil
Actavis Group PTC ehf
N01AH; N01AH06
Remifentanil
5 milligram(s)
Powder for concentrate for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Opioid anesthetics; remifentanil
Not marketed
2011-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION remifentanil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINES 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. - 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. WHAT IS IN THIS LEAFLET: 1. What Remifentanil is and what it is used for 2. What you need to know before you use Remifentanil 3. How to use Remifentanil 4. Possible side effects 5. How to store Remifentanil 6. Contents of the pack and other information 1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR Remifentanil contains the active substance remifentanil. Remifentanil belongs to a group called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action. Remifentanil may be used to stop you feeling pain before or while you are having an operation. Remifentanil may be used to relieve pain while you are under controlled mechanical ventilation in an Intensive Care Unit (for patients 18 years of age and over). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMIFENTANIL DO NOT USE REMIFENTANIL - if you are allergic to remifentanil or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other fentanyl derivates (such as alfentanil, fentanyl, sufentanil). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience - as injection into the spinal canal - as sole medicine to initiate anaesthesia WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using R Prečítajte si celý dokument
Health Products Regulatory Authority 16 April 2019 CRN008JHZ Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remifentanil 5mg powder for concentrate for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Remifentanil 5 mg powder for concentrate for solution for injection/infusion 1 vial contains 5 mg remifentanil (as remifentanil hydrochloride). After reconstitution the solution contains 1 mg/ml remifentanil (as hydrochloride), if prepared as recommended (see section 6.6) Excipient with known effect: sodium 1.15 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for injection/infusion Lyophilized white to slightly yellow cake or powdery mass. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Remifentanil is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia. Remifentanil is indicated for provision of analgesia in mechanically ventilated intensive care patients of 18 years of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology General Anaesthesia The administration of Remifentanil must be individualised based on the patient's response. _Adults_ _Administration by manually-controlled infusion (MCI)_ Dosing guidelines for adults REMIFENTANIL BOLUS INJECTION (micrograms /kg) REMIFENTANIL CONTINUOUS INFUSION (micrograms/kg/min) Starting Rate Range 1 (within at least 30 seconds) 0.5 to 1 _ Maintenance of anaesthesia in ventilated patients • Nitrous oxide (66 %) 0.5 to 1 0.4 0.1 to 2 • Isoflurane (starting dose 0.5 MAC) 0.5 to 1 0.25 0.05 to 2 • Propofol (Starting dose 100 microtrams /kg/min) 0.5 to 1 0.25 0.05 to 2 Health Products Regulatory Authority 16 April 2019 CRN008JHZ Page 2 of 19 When given by bolus injection at induction Remifentanil should be administered over not less than 30 seconds. At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, iso Prečítajte si celý dokument