Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Remifentanil hydrochloride
Pinewood Laboratories Ltd,
N01AH; N01AH06
Remifentanil hydrochloride
5 milligram(s)
Powder for concentrate for solution for injection/infusion
Opioid anesthetics; remifentanil
Marketed
2010-10-08
PACKAGE LEAFLET: INFORMATION FOR THE USER REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION 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 any further questions, ask your doctor. - 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 of the side effects talk to your doctor. 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 are given Remifentanil 3. How Remifentanil is given 4. Possible side effects 5. How to store Remifentanil 6. Contents of the pack and any other information 1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR Remifentanil belongs to a group of medicines known as opioids. These medicines are used widely to cause anaesthesia and or/ to relieve pain during an operation. Remifentanil is used: • as an analgesic, which helps to relieve pain, for use at the onset or during anaesthesia in conjunction with anaesthetic agents • as an analgesic for patients 18 years of age or older who are mechanically ventilated in the intensive care unit. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN REMIFENTANIL REMIFENTANIL MUST NOT BE GIVEN - 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 medicine used in operations or if you had a side effect during an operation. - Remifentanil must not be administered by epidural or intrathecal injection, because this medicine contains glycine. - as sole medicine to initiate anaesthesia. WARNINGS AND PRECAUTIONS Tell y Đọc toàn bộ tài liệu
Health Products Regulatory Authority 24 May 2022 CRN00CXJ8 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remifentanil 5 mg powder for concentrate for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Remifentanil 5 mg powder for concentrate for solution for injection or infusion 1 vial contains 5 mg remifentanil (as remifentanil hydrochloride). After reconstitution the solution contains 1 mg/ml, if prepared as recommended (see section 6.6). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for injection or infusion. White to off white, powder 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 over. This medicinal product is exclusive for hospital use. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION REMIFENTANIL SHALL BE ADMINISTERED ONLY IN A SETTING FULLY EQUIPPED FOR THE MONITORING AND SUPPORT OF RESPIRATORY AND CARDIOVASCULAR FUNCTION, AND BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANAESTHETIC DRUGS AND THE RECOGNITION AND MANAGEMENT OF THE EXPECTED ADVERSE EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. Continuous infusions of remifentanil must be administered by a calibrated infusion device into a fast flowing IV line or via a dedicated IV line. This infusion line should be connected at, or close to, the venous cannula and primed to minimise the potential dead space (see section 6.6 for additional information, including tables with examples of infusion rates by body weight to help titrate remifentanil to the patient’s anaesthetic needs). Remifentanil may be given by target controlled infusion (TCI) with an approved infusi Đọc toàn bộ tài liệu