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Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Esketiv 5 mg/ml, solution for injection Esketiv 25 mg/ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Esketiv 5 mg/ml, solution for injection Each ml solution for injection contains esketamine hydrochloride equivalent to 5 mg esketamine. 1 ampoule of 5 ml contains esketamine hydrochloride equivalent to 25 mg esketamine. 1 ampoule of 20 ml contains esketamine hydrochloride equivalent to 100 mg esketamine. Esketiv 25 mg/ml, solution for injection Each ml solution for injection contains esketamine hydrochloride equivalent to 25 mg esketamine. 1 ampoule of 10 ml contains esketamine hydrochloride equivalent to 250 mg esketamine. Excipients with known effect: sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear and colourless. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Esketiv is indicated in children and in adults Esketiv is an anaestetic and is used: - for the induction and maintenance of general anaesthesia and as a supplement to other anaesthetics , - in short-term diagnostic procedures and small surgical procedures that do not require muscle relaxation 4.2 Posology and method of administration Esketiv should only be administered by or under supervision of medically qualified anaesthetists or emergency physicians. Equipment to ensure the vital functions should be available. Premedication: Atropine or glycopyrrolate should be given preoperatively to inhibit mucus secretion. Benzodiazepine derivate such as midazolam, as premedication (intravenous or rectal), can be given to supress the initial hyperkinetic circulation and reduce the frequency of anxiety during awakening. Posology 1 The individual dose response to Esketiv may vary depending on the dose, route of administration, co- medication and age of the patient. The dose should be individually adjusted based on its clinical effect. The recommended dose Esketiv in combination with other anesthetic agents is usually the same as the advice below. The use of another anesthetic agent can possibly induce a dose reduction of Esketiv. Anaesthesia: Intravenous administration For the induction of anesthesia 0.5 – 1.0 mg esketamine / kilogram body weight should be used. Intravenous administration should be performed slowly for 60 seconds. When needed, half of the dose can be used for maintenance in general every 10 to 15 minutes. Intramuscular administration 3,3 – 6,5 mg esketamine / kilogram body weight should be used. When needed, half of the dose can be used for maintenance in general every 10 to 15 minutes. In case of multiple injuries (polytrauma) and in patients in poor general condition dose reduction is required. Hepatic impairment When insufficient liver function has been described, a dose reduction should be considered in patients diagnosed with cirrhosis or other liver impairments (see section 4.4) Paediatric population The dose for subgroups of the paediatric population of different ages has not been investigated sufficiently. On the basis of the limited available data it is unlikely that the dose regimens differ significantly between adults and children/adolescents. Method of administration For intravenous injection or infusion as solution for injection or solution of infusion. For intramuscular injection as solution for injection. For instructions on dilution of the medicinal product before administration, see section 6.6. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Esketiv is contra-indicated in persons: - in whom an elevation of blood pressure or intracranial pressure would constitute a serious hazard (see section 4.8) - with high blood pressure and proteinuria (pre-eclampsia) and convulsions (eclampsia) due to pregnancy - as a sole anaesthetic agent in patients with manifest ischaemic cardiac diseases - when combined with xanthine derivatives, e.g. aminophylline, theophylline (see section 4.5) - when combined with ergometrine (see section 4.5) 4.4 Special warnings and precautions for use Esketiv should be used with caution in patients with: - hypovolemia, dehydration or heart disease especially coronary artery disease (e.g. congestive heart failure, myocardial ischemia and myocardial infarction), because of the substantial increase in myocardial oxygen consumption. - in patients with unstable angina pectoris or myocardial infarction in the last 6 months, 2 - mild to moderate hypertension and tachyarrhythmias. - chronic or acute alcohol intoxication. - neurotic traits or psychiatric history ( e.g. schizophrenia and acute psychosis).(see section 4.8) - acute intermittent porphyria (because of the possibility of triggering a porphyric reaction). - hyperthyroidism or patients receiving thyroid replacement (increased risk of hypertension and tachycardia). - pulmonary or upper respiratory infection (esketamine sensitises the gag reflex, potentially causing laryngospasm). - situations in which the myometrium of the uterus should be calm (e.g. threatening uterus rupture, prolapsed umbilical cord). - in patients with cardiac insufficiency - in patients with increased intracranial pressure except under appropriate ventilation, and injuries or diseases of the central nervous system, since an increase in cerebrospinal fluid pressure has been reported during esketamine use - in patients with increased intraocular pressure (e.g. glaucoma), penetrating eye injury, and examinations or surgery of the eye, where increased intraocular pressure is undesirable - cerebrovascular accident or cerebral trauma. - if hypertension is poorly adjusted or not treated (arterial hypertension - systolic / diastolic blood pressure above 180/100 mmHg at rest) High and quick intravenous dosing can cause respiratory depression. Although pharyngeal and laryngeal reflexes usually remain active, aspiration (liquid or solid material entering the airway) cannot be ruled out completely. Therefore, and because of a potential respiratory depression with high doses or after rapid intravenous injection, the equipment and facilities necessary for intubation and ventilation of the patient must be available. Prophylactic atropine should be given to prevent increased secretion of saliva with esketamine. The induction of the anaesthesia is accompanied by occasional tachycardia, elevation of the blood pressure and cardiac output, which return to baseline within 15 minutes after the injection. The median peak rise of the blood pressure in clinical studies has ranged from 20 to 25 percent of the initial values. Depending on the condition of the patient, this elevation of the blood pressure may be considered an adverse reaction or a beneficial effect of esketamine. If esketamine is used on an outpatient basis, the patient should be accompanied home and should not drink alcohol for the next 24 hours. Esketamine is metabolised in the liver and hepatic clearance is required for termination of the clinical effects. Abnormal liver function tests in connection with esketamine have been reported, especially in patients after prolonged use (> 3 days) or in abuse. A prolonged duration of action may occur in patients with cirrhosis or other types of liver impairment. Dose reduction should be considered in these patients (see section 4.2). In case of insufficient ventilation there is a regular increase in intracranial pressure, intraocular pressure and muscle tone. In rare cases, the skin may turn red. In a few cases hypersensitivity reactions (anaphylaxis). Patients in shock can have an extra lower blood pressure. In diagnostic and therapeutic interventions of the upper respiratory tract hyperreflexia and laryngospasm may occur, especially in children. Interventions in pharynx, larynx and bronchial tree will possibly require muscle relaxation with artificial respiration. ln surgical procedures involving visceral pain pathways, esketamine should be supplemented with a muscle relaxant, additional analgesia, controlled ventilation and the administration of nitrous oxide/oxygen. The effect of non-depolarizing (for example pancuronium) and depolarizing (for example 3 suxamethonium) muscle relaxants may be prolonged due to the use of esketamine Continuous monitoring of cardiac function during surgery is required in patients with hypertension or cardiac decompensation. The risk of psychiatric reactions during the recovery period can be significantly reduced by additional administration of benzodiazepines (see sections 4.8 and 4.2). If esketamine is used in the shock patient the principles of shock therapy (volume substitution, oxygen supply) must be considered. special caution is required in severe states of shock where blood pressure can be hardly measured or not at all. As the need for additional anaesthetics or muscle relaxants cannot always be predicted it is recommended that the patient fasts for 4-6 hours prior to surgery to prevent aspiration. Because pharyngeal reflexes usually remains active, mechanical stimulation of the pharynx should be avoided unless muscle relaxants with proper attention are used. Abuse and dependence The abuse of racemic ketamine has been reported. These reports suggest that racemic ketamine produces a variety of symptoms including (but not limited to) flashbacks, hallucinations, dysphoria, anxiety, insomnia, or disorientation. Moreover, cases of cystitis including haemorrhagic cystitis and cases of hepatotoxicity have also been reported. Therefore, similar effects
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