Страна: Малта
Език: английски
Източник: Medicines Authority
REMIFENTANIL
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
N01AH06
REMIFENTANIL 1 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
REMIFENTANIL 1 mg
POM
ANESTHETICS
Withdrawn
2011-12-02
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. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Remifentanil is and what it is used for 2. Before Remifentanil is used 3. How to use Remifentanil 4. Possible side effects 5. How to store Remifentanil 6. Further information 1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR 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. BEFORE REMIFENTANIL IS USED REMIFENTANIL SHOULD NOT BE USED - if you are allergic (hypersensitive) to remifentanil, any of the other ingredients (see list of ingredients in Section 6) or fentanyl derivates (such as alfentanil, fentanyl, sufentanil). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS: 1. NAME OF THE MEDICINAL PRODUCT 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 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Remifentanil 1 mg powder for concentrate for solution for injection/infusion: 1 vial contains 1 mg remifentanil (as remifentanil hydrochloride). Remifentanil 2 mg powder for concentrate for solution for injection/infusion 1 vial contains 2 mg remifentanil (as remifentanil hydrochloride). 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) Excipients: sodium 1.15 mg 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 18 years of age and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Remifentanil should 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 Прочетете целия документ