VESIERRA

Posology Only for hospital use or prehospital emergency care. Esketamine can only be administered by or under the supervision of a specialist of anaesthesiology. The equipment for maintenance of vital functions should be available. Where possible, the use of esketamine should follow the ordinary guidelines regarding fasting, 4 to 6 hours before anaesthesia.

Although esketamine has only a minor effect on the protective reflexes of the pharynx and the airways, the possibility of aspiration of fluid or solid materials cannot be completely excluded. High doses or too rapid intravenous administration can cause respiratory depression.

Increased salivation may be associated with the use of esketamine and can be prevented by giving the patient atropine or another anticholinergic. Esketamine is given as a slow intravenous or intramuscular injection. If needed, injection can be repeated or the preparation can be administered as an infusion.

5 to 1 mg/kg of esketamine is given intravenously or 2 to 4 mg/kg intramuscularly. For maintenance of general anaesthesia, half the initial dose is injected as needed, generally every 10 to 15 minutes. 5 to 3 mg/kg/h. Dose reduction is required in patients with multiple injuries and in patients with a poor general condition.

For example the dose in patients in shock should be reduced; as a guideline about half the normal dose should be administered. 25 mg esketamine/kg/h is administered as intravenous infusion. 25 mg/kg as a slow intravenous injection. As with other general anaesthetic agents, the individual response to esketamine is somewhat varied depending on the dose, route of administration, age of patient, and concomitant use of other agents, so that dosage recommendation cannot be absolutely fixed.

The dose should be titrated against the patient’s requirements. Paediatric population Dosage of esketamine across subgroups of paediatric patients of different ages has not been adequately studied. Based on the limited information available, dosage in paediatric patients is not expected to differ substantially from that in adults.

Note:

In paediatric surgery, as well as in emergency medicine, esketamine is mostly used on its own; in case of other indications a combination with hypnotics is recommended. 6.

Adverse effects are usually dependent on the dose and speed of injection and are spontaneously reversible. Nervous system and psychiatric (CNS) adverse effects are more common if esketamine is given as the only anaesthetic. The adverse reaction terms were categorised utilising the incidence rate as follows: Very common ≥1/10 Common ≥1/100 and <1/10 Uncommon ≥1/1 000 and <1/100 Rare ≥1/10 000 and <1/1 000 Very rare <1/10 000 Not known Cannot be estimated from the available data Immune system disorder Rare Anaphylaxis.

Psychiatric disorders Common Recovery reactions1. These include vivid dreams, including nightmares, dizziness and motor restlessness2. Not known Hallucinations, dysphoria, anxiety and disorientation. Nervous system disorders Uncommon Tonic and clonic movements, which can resemble convulsions (as a result of increased muscle tonus), and nystagmus.

Eye disorders Common Blurred vision. Uncommon Diplopia, increased intraocular pressure. Cardiac disorders Common Temporary tachycardia, increase in blood pressure and heart rate (of about 20 % of the starting level is common. Rare Arrhythmia, bradycardia.

Vascular disorders Rare Hypotension (especially in connection with circulatory shock). Respiratory, thoracic and mediastinal disorders Common Increase in vascular resistance in pulmonary circulation, and increase in mucus secretion.

Increased oxygen consumption, laryngospasm, and temporary respiratory depression. ) Gastrointestinal Disorders Common Nausea and vomiting, increased salivation. Hepatobiliary Disorders Not Known Liver function test abnormal Drug-induced liver injury3 Skin and subcutaneous tissue disorders Uncommon Morbilliform rash, and exanthema.

General disorders and administration site conditions Uncommon Pain and erythema at the injection site. 1 When esketamine is used the only anaesthetic, the recovery phase may involve dose- dependent reactions in up to 30% of the patients.

2 The incidence of these events can be greatly reduced by the administration of a benzodiazepine. 3 Extended period use (>3 days) or drug abuse. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

g. threatening uterus rupture, prolapsed umbilical cord) Esketamine is metabolised in the liver and hepatic clearance is required for termination of clinical effects. Abnormal liver function tests associated with esketamine use have been reported, particularly with extended use (>3 days) or drug abuse.

A prolonged duration of action may occur in patients with cirrhosis or other types of liver impairment. Dose reductions should be considered in these patients. In case of high dosage and rapid intravenous injection respiratory depression might occur.

As aspiration cannot be completely excluded and due to the possibility of respiratory depression intubation and ventilation equipment must be available. Increased salivation should be prophylactically treated with atropine. In diagnostic and therapeutic procedures of the upper respiratory tract, hyperreflexia and laryngospasms are possible, especially in children.

Muscle relaxants and controlled ventilation may therefore be necessary in procedures on the pharynx, larynx and bronchi. In surgical procedures that may involve visceral pain, muscle relaxation and supplemental analgesia (controlled ventilation and administration of nitrous oxide/oxygen) are indicated.

After outpatient anaesthesia the patient should be accompanied home and should not consume alcohol within the next 24 hours. Long-Term Use Cases of cystitis, including haemorrhagic cystitis, acute kidney injury, hydronephrosis, and ureteral disorder have been reported in patients using racemic ketamine on a long-term basis (one month to several years), especially in the setting of ketamine abuse.

Similar effects may also occur following esketamine abuse (see below). Hepatotoxicity has also been reported in patients with extended use (> 3 days). Drug Abuse and Dependence Racemic ketamine has been reported being used as a drug of abuse.

Reports suggest that racemic ketamine produces a variety of symptoms including, among others, flashbacks, hallucinations, dysphoria, anxiety, insomnia, or disorientation. Adverse effects have also been reported: see “Long-Term Use”.

Similar effects therefore cannot be ruled out following esketamine use. Esketamine dependence and tolerance may develop in individuals with a history of drug abuse or dependence. Therefore, esketamine should be prescribed and administered with caution.

2 mg sodium per ml. 8) can be greatly reduced by the co-administration of a benzodiazepine.

Patients to whom elevation of blood pressure or intracranial pressure forms a serious risk. As sole anaesthetic agent in patients with manifest ischemic cardiac disorders. Eclampsia and pre-eclampsia. 1. Please see section