Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Remifentanil hydrochloride
Aspen Pharma Trading Limited
N01AH; N01AH06
Remifentanil hydrochloride
2 milligram(s)
Powder for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Opioid anesthetics; remifentanil
Marketed
1999-05-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ULTIVA 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ULTIVA 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ULTIVA 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION remifentanil 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, pharmacist or nurse. − If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ultiva is and what it is used for 2. What you need to know before you are given Ultiva 3. How Ultiva is given 4. Possible side effects 5. How to store Ultiva 6. Contents of the pack and other information 1. WHAT ULTIVA IS AND WHAT IT IS USED FOR Ultiva contains a medicine called remifentanil. This belongs to a group of medicines known as opioids. It is used: • to help put you to sleep BEFORE an operation in combination with other medicines • to keep you asleep and stop you feeling pain DURING an operation in combination with other medicines, while your breathing and heart are monitored and supported • alone or in combination with other medicines, to make you feel sleepy and stop you feeling pain while you receive treatment in an Intensive Care Unit (ICU). • 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ULTIVA DO NOT HAVE ULTIVA IF: • you are allergic (hypersensitive) to remifentanil or any of the other ingredients of this medicine (listed in Section 6) • you are allergic (hypersensitive) to fentanyl analogues (pain relieving medicines which are similar to fentanyl and which are related to the class of medicines known as opioids). If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given Ultiva. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are read_full_document
Health Products Regulatory Authority 29 November 2023 CRN00DKL1 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ultiva 2 mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 2 mg remifentanil (as remifentanil hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion A white to off-white, lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ultiva is indicated as an opioid analgesic adjunct for use with other agents during induction and/or maintenance of general anaesthesia in conjunction with controlled ventilation. Ultiva is indicated for provision of analgesia in mechanically ventilated intensive care patients of 18 years of age and over. Ultiva is not indicated for use for post-operative analgesia or for use during spontaneous ventilation anaesthesia until further information becomes available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ultiva shall be administered in hospitals 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 Ultiva 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 Ultiva to the patient’s anaesthetic needs). Care should be taken to avoid obstruction or disconnection of infusion lines and to adequately clear the lines to remo read_full_document