Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Esketamine
Sintetica Ireland Limited
N01AX14
Esketamine
25 milligram(s)/millilitre
Solution for injection/infusion
esketamine
Marketed
2020-10-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESKETAMINE SINTETICA 5 MG/ML SOLUTION FOR INJECTION/INFUSION ESKETAMINE SINTETICA 25 MG/ML SOLUTION FOR INJECTION/INFUSION esketamine 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 Esketamine Sintetica is and what it is used for 2. What you need to know before you are given Esketamine Sintetica 3. How to use Esketamine Sintetica 4. Possible side effects 5. How to store Esketamine Sintetica 6. Contents of the pack and other information 1. WHAT ESKETAMINE SINTETICA AND WHAT IT IS USED FOR Esketamine Sintetica belongs to one of a group of medicines called general anaesthetics, which is used to put you to sleep during an operation. Esketamine Sintetica is used: - to initiate and perform general anaesthesia, as the only anaesthetic or possibly in combination with sleeping pills (hypnotics), - to supplement regional anaesthesia (local anaesthesia), - for anaesthesia and pain relief (analgesia) in emergency situations, - for pain control in artificial respiration (intubation). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ESKETAMINE SINTETICA _ _ ESKETAMINE SINTETICA MUST NOT BE USED: - if you are allergic to esketamine or any of the other ingredients of this medicine (listed in section 6), - if high blood pressure or increased pressure in the brain is a serious risk for you, - if you have poorly controlled or untreated high blood pressure, - if you have a condition called eclampsia or pre-eclampsia (which is a complication of pregnancy that causes high blood pressure), - if you have an overactive thyroid (insufficiently treated hyperthyroidism), - in situations during childbirth which require r Lugege kogu dokumenti
Health Products Regulatory Authority 05 March 2021 CRN00C75W Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esketamine Sintetica 25 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection/infusion contains 25 mg of esketamine as 28.83 mg of esketamine hydrochloride. 1 ampoule of 2 ml solution for injection/infusion contains 50 mg of esketamine as 57.66 mg of esketamine hydrochloride. 1 ampoule containing 10 ml solution for injection/infusion contains 250 mg of esketamine as 288.30 mg of esketamine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution. pH 3.0 – 4.0. Osmolality = 270 – 310 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Induction and maintenance of general anaesthesia, as the only anaesthetic or possibly in combination with hypnotics. - Supplementation of regional or local anaesthesia. - Anaesthesia and pain relief (analgesia) in emergency medicine. - Pain control in artificial respiration (intubation). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Esketamine should be administered only by specialist of anaesthesiology or emergency medicine. Esketamine is for hospital use only. As aspiration cannot be completely excluded and due to the possibility of respiratory depression, intubation and ventilation equipment must be available. Posology For induction of general anaesthesia 0.5 to 1 mg/kg of esketamine is given intravenously or 2 to 4 mg/kg intramuscularly, half the initial dose is re-injected as needed, generally every 10 to 15 minutes. As an alternative to injection, esketamine can be administered as a continuous infusion at a dose of 0.5 to 3 mg esketamine/kg/h. In case of multiple injuries (polytrauma) and in patients with poor general condition a dose reduction may be necessary. For analgesic supplementation of regional and local anaesthesia 0.125 to 0.25 mg esketamine/kg/h is administered as intravenou Lugege kogu dokumenti