Ketalar 10

Package Leaflet: Information for the User

Ketalar 10,10 mg/ml, solution for injection
Ketamine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• You should 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ketalar 10 and what is it used for
• 2. Important information before using Ketalar 10
• 3. How to use Ketalar 10
• 4. Possible side effects
• 5. How to store Ketalar 10
• 6. Contents of the pack and other information

1. What is Ketalar 10 and what is it used for

Ketalar 10 is a fast-acting anesthetic used for general anesthesia, administered by intravenous or intramuscular injections.
Ketalar 10 is used:

• as a single anesthetic agent, for short diagnostic and surgical procedures that do not require skeletal muscle relaxation;
• as an introduction to general anesthesia before the use of other anesthetic agents;
• in combination with other anesthetic agents.

Special types of applications or procedures:

• If intramuscular administration is more indicated.
• Surgical treatment of wounds, painful dressings, skin grafts in burned patients, and other surgical procedures involving the body surface.
• Certain neurological procedures, radiodiagnostic and therapeutic procedures in children, requiring immobilization.
• If airway control is difficult.

Ketamine is indicated for use in children and adults.
Note:Ketamine should be used with caution in surgical procedures involving the throat, larynx, or trachea, as it increases salivation and tracheobronchial secretions, and inadequately suppresses laryngeal and pharyngeal reflexes.

2. Important information before using Ketalar 10

When not to use Ketalar 10

• in patients under 3 months of age;
• in patients with high blood pressure;
• if the patient is allergic to ketamine or any of the other ingredients of this medicine (listed in section 6);
• in patients with preeclampsia or eclampsia;
• in patients with severe coronary artery disease or other heart disease;
• in patients with cerebrovascular disorders (e.g., stroke);
• in patients with a history of psychiatric disorders;
• in patients suspected of or diagnosed with schizophrenia, or acute psychosis (even if well-controlled with medication).

Warnings and precautions

Before starting treatment with Ketalar 10, discuss it with your doctor or pharmacist. Particular caution should be exercised:

• in patients with increased intracranial pressure before anesthesia;
• in patients with chronic alcohol abuse and alcohol intoxication;
• in patients with liver cirrhosis or other types of liver function disorders. Ketamine is metabolized in the liver and may therefore have a longer duration of action in patients with liver function disorders. Abnormal liver function test results have been reported with the use of ketamine, especially with prolonged use (more than 3 days) or abuse of the medicinal product. In such cases, the doctor may consider reducing the dose;
• in patients with increased intraocular pressure (e.g., glaucoma), as this pressure may increase significantly even after a single dose of ketamine;
• in patients with neurotic tendencies;
• in patients with acute intermittent porphyria (inherited or acquired hemoglobin synthesis disorders);
• in patients with a history of seizures;
• in patients with hyperthyroidism, treated with thyroid hormones;
• in patients with pulmonary or upper respiratory tract infections (ketamine exacerbates the cough reflex, which can cause laryngospasm);
• in patients with intracranial changes, post-head injury conditions, brain contusions, or hydrocephalus;
• in patients with hypovolemia - decreased vascular filling due to blood loss (bleeding), plasma (burns), or extracellular fluids (e.g., diarrhea, vomiting), dehydration, or heart disease, especially coronary artery disease (e.g., congestive heart failure, myocardial ischemia, myocardial infarction);
• in patients with mild to moderate hypertension and cardiac arrhythmia with rapid heart rate.

Additional notes on the use of Ketalar 10:

• The medicine is intended for use only in hospital settings or under the supervision of an experienced anesthesiologist, unless there is a need for emergency use.
• As with other general anesthetics, during the use of Ketalar 10, access to resuscitation equipment should be ensured.
• The use of Ketalar 10 must always be preceded by the administration of an appropriate dose of atropine, hyoscine, or another saliva-reducing agent.
• During recovery from anesthesia, hallucinations may occur.
• Since laryngeal and pharyngeal reflexes are generally preserved during anesthesia, ketamine should not be used as a single anesthetic agent in surgical or diagnostic procedures involving the throat, larynx, or tracheobronchial tree. If ketamine is used as a single anesthetic agent, mechanical stimulation of the throat should be avoided as much as possible.

You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Patients with liver function disorders

The doctor will consider reducing the dose of Ketalar 10 in patients with liver cirrhosis or other liver function disorders.

Ketalar 10 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tell your doctor if you are taking any of the following medicines:

• barbiturates (sleeping pills and anticonvulsants) or narcotic agents - when used concomitantly with ketamine, may prolong the recovery time from anesthesia, as well as the use of premedication with benzodiazepines;
• diazepam - increases the half-life of ketamine and prolongs its pharmacodynamic action. Therefore, dose adjustment may be necessary;
• diazepam or other benzodiazepines (sleeping pills and sedatives) - increase blood levels and reduce ketamine clearance;
• thyroid hormones - increase the risk of hypertension and tachycardia;
• other central nervous system depressants (e.g., alcohol, phenothiazines, H1 receptor blockers with sedative effects, muscle relaxants) - may enhance central nervous system depression and (or) increase the risk of respiratory depression. Dose reduction of ketamine may be necessary when used concomitantly with other anxiolytic, sedative, or hypnotic agents;
• antihypertensive agents - when used concomitantly with ketamine, may increase the risk of hypotension;
• sympathomimetics (acting directly or indirectly) and vasopressin - may enhance the stimulating effect of ketamine on the sympathetic nervous system;
• ergometrine - may lead to increased blood pressure;
• theophylline, aminophylline - may cause unpredictable seizures;
• when ketamine is administered concomitantly with CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, nefazodone, cyclosporine, gemfibrozil), a dose reduction of ketamine may be necessary;
• when ketamine is administered concomitantly with CYP3A4 inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine), a dose increase of ketamine may be necessary.

Other interactions:

• Barbiturates and Ketalar 10 - as chemically incompatible due to precipitation, should not be administered from the same syringe.
• Other general anesthetics - block the stimulation of the cardiovascular system by ketamine, which depends on the central nervous system. After concomitant use with halothane or enflurane anesthesia, significant inhibition of cardiovascular function was observed. Halothane slows down the distribution and redistribution of ketamine and inhibits its hepatic metabolism.
• Nitrous oxide - concomitant use with ketamine reduces the required dose of ketamine.
• Gallamine - concomitant use with ketamine leads to tachycardia; the use of ketamine with pancuronium (a muscle relaxant) leads to hypertension. Neither of these muscle relaxants should be used concomitantly with ketamine.
• Atracurium and tubocurarine (muscle relaxants leading to respiratory arrest with apnea) - ketamine may accelerate the onset of apnea.
• Anesthetics - concomitant use with ketamine (especially in high doses or with rapid administration) may increase the risk of bradycardia, decreased blood pressure, or decreased cardiac minute volume.
• Thiopental - it has been shown that ketamine may reduce the hypnotic effect of thiopental.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, ask your doctor or pharmacist for advice before using this medicine.
Ketalar 10 crosses the placenta. The use of the medicine is not recommended during pregnancy, except for administration during cesarean section or natural childbirth. Some newborns exposed to ketamine administered intravenously to mothers during childbirth experienced respiratory depression and achieved lower Apgar scores.
In obstetrics, there is a lack of data on the use of Ketalar 10 administered intramuscularly and on the maintenance dose administered intravenously, and recommended doses cannot be established.
Due to the lack of safety data, the use of Ketalar 10 is not recommended in breastfeeding women.

Driving and using machines

Do not drive or operate any machinery or perform hazardous activities for 24 hours or longer after anesthesia.

Ketalar 10 contains sodium

The medicine contains 53 mg of sodium (the main component of common salt) in each 20 ml vial. This corresponds to 2.65% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ketalar 10

Ketalar 10 should be used only in hospital settings or under the supervision of an experienced anesthesiologist. During the use of Ketalar 10, access to resuscitation equipment should be ensured.

Ketalar 10 can be administered as intravenous or intramuscular injections.
Adults, elderly patients (over 65 years) and children
In elderly patients, ketamine may be used as a single anesthetic agent or in combination with other anesthetic agents.

Preparation for the procedure

• 1. Ketalar 10 was safe when administered as a single anesthetic agent in patients who were not fasting. However, for planned surgical procedures, it is recommended that the patient does not take anything orally for at least 6 hours before anesthesia, as ketamine may cause vomiting. The use of other anesthetic or muscle relaxant agents cannot be ruled out. The use of Ketalar 10 is possible in non-fasting patients if, according to the doctor's assessment, the benefits of using the medicine outweigh the potential risks.
• 2. Ketamine increases salivation. Before anesthesia, the doctor will decide on the administration of atropine, hyoscine, or glycopyrrolate, or another saliva-reducing agent.
• 3. Midazolam, diazepam, lorazepam, or flunitrazepam administered during preparation for anesthesia or concomitantly with ketamine reduced the frequency of adverse reactions during recovery from anesthesia.

Onset and duration of anesthesia

As with other general anesthetics, the individual response to Ketalar 10 varies depending on the dose, route of administration, patient age, and concomitantly used agents, so specific dosing recommendations cannot be established. The dose should be adjusted to the needs of the individual patient.
Due to the rapid onset of action after intravenous administration, during the administration of the medicine, the patient should be in a supported position. Recovery of consciousness occurs gradually.

Overdose of Ketalar 10

Overdose of Ketalar 10 may lead to respiratory depression. In such cases, symptomatic treatment should be administered.

4. Possible side effects

Like all medicines, Ketalar 10 can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):

• hallucinations
• dreams
• nightmares
• confusion
• agitation
• irrational behavior
• nystagmus
• hypertonia
• tonic-clonic movements
• double vision
• increased blood pressure
• increased heart rate
• increased respiratory rate
• nausea
• vomiting
• flushing
• rash

Uncommon(may affect up to 1 in 100 people):

• anorexia
• anxiety
• bradycardia
• arrhythmia
• hypotension
• respiratory depression
• laryngospasm
• injection site pain
• injection site rash

Rare(may affect up to 1 in 1,000 people):

• anaphylactic reactions
• delirium
• flashback episodes (recurrence of past psychotic experiences)
• dysphoria
• insomnia
• disorientation
• airway obstruction
• apnea
• excessive salivation
• urinary tract infection and (or) dysuria, possible hematuria
• hemorrhagic cystitis

Frequency not known(cannot be estimated from the available data):

• increased intraocular pressure
• abnormal liver function tests
• drug-induced liver damage

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketalar 10

Store the medicine out of sight and reach of children.
There are no special storage temperature requirements. Store the vials in the outer packaging. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
The vial is for single use only. After opening, considering microbiological safety, if the opening method does not exclude the risk of microbiological contamination, the medicine should be used immediately. Any unused medicine should be discarded.
Before administration, the medicine should be visually inspected for particulate matter and discoloration, if the solution and packaging allow.
If the medicine is not used immediately, the user is responsible for the storage conditions and storage time.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ketalar 10 contains

• The active substance is ketamine; 1 ml of solution contains 10 mg of ketamine in the form of ketamine hydrochloride.
• The other ingredients are sodium chloride (see section 2 "Ketalar 10 contains sodium"), benzethonium chloride, water for injections.

What Ketalar 10 looks like and contents of the pack

Ketalar 10 is a clear, colorless solution for injection. The medicine is in vials made of colorless glass type I, closed with a bromobutyl rubber stopper and sealed with an aluminum cap with a PP plug, in a cardboard box.
The pack contains: 5 vials of 20 ml

Marketing authorization holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer:

Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the package leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://www.pfizer.pl/ulotka-ketalar10 and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl .
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Information intended for healthcare professionals only

NOTE: All doses are given in terms of ketamine base.

Ketalar 10 shows chemical incompatibility with barbiturates and diazepam due to precipitation. Therefore, these medicines should not be mixed in the same syringe or infusion solution.

Dosage

Adults, elderly patients (over 65 years) and children
It has been shown that in surgical procedures in elderly patients, ketamine can be used alone or in combination with other anesthetic agents.

Preparation for the procedure

• 1. Ketalar 10 was safe when administered as a single anesthetic agent in patients who were not fasting. However, due to the possibility of vomiting and the inability to predict the need for other anesthetic or muscle relaxant agents, for planned surgical procedures, it is recommended that the patient does not take anything orally and is fasting for at least 6 hours before anesthesia. The use of ketamine is possible in non-fasting patients if, according to the doctor's assessment, the benefits of using the medicine outweigh the potential risks.
• 2. Ketamine increases salivation. Before anesthesia, the doctor will decide on the administration of atropine, hyoscine, or glycopyrrolate, or another saliva-reducing agent.
• 3. Midazolam, diazepam, lorazepam, or flunitrazepam used as premedication or concomitantly with ketamine effectively reduced the frequency of negative reactions during recovery from anesthesia.

Onset and duration of anesthesia

As with other general anesthetics, the individual response to Ketalar 10 varies depending on the dose, route of administration, patient age, and concomitantly used agents, so specific dosing recommendations cannot be established. The dose should be adjusted to the needs of the individual patient.
Due to the rapid onset of action after intravenous administration, during the administration of the medicine, the patient should be in a supported position. The intravenous dose of 1 to 2 mg/kg body weight usually causes anesthesia for surgery within 30 seconds to 1 minute after injection, and the anesthetic effect usually lasts for 5 to 10 minutes. The intramuscular dose of 10 mg/kg body weight usually causes anesthesia for surgery within 3 to 4 minutes after injection, and the anesthetic effect usually lasts for 12 to 25 minutes. Recovery of consciousness occurs gradually.

A. Ketalar 10 used as a single anesthetic agent.

Intravenous infusion

Ketalar 10 should not be diluted.
For the preparation of the infusion solution, Ketalar 50 is used.
Dosing in obstetrics
In obstetrics, for natural childbirth or cesarean section, doses of 0.2 to 1 mg/kg body weight are recommended intravenously.
However, there is a lack of data on the maintenance dose of ketamine used in infusion in obstetrics, and recommended doses cannot be established.

Intermittent administration

Induction of anesthesia
Intravenous administration
The initial dose of ketamine administered intravenously may be 1 mg/kg body weight to 4.5 mg/kg body weight.
The average dose required to achieve anesthesia for a surgical procedure lasting 5 to 10 minutes is 2.0 mg/kg body weight. It is recommended to administer the ketamine solution intravenously slowly (over 60 to 120 seconds). Faster administration may cause respiratory depression and increased blood pressure.
Intramuscular administration
The initial dose of ketamine administered intramuscularly may be 6.5 to 13 mg/kg body weight, usually 10 mg/kg body weight. A low initial intramuscular dose of 4 mg/kg body weight has been used in less painful diagnostic procedures. A dose of 10 mg/kg body weight usually provides 12 to 25 minutes of anesthesia for surgical procedures.
Dosing in obstetrics
There is a lack of data on the intramuscular use of ketamine in obstetrics, and recommended doses cannot be established. Available pharmacokinetic data are presented in section 5.2 of the Summary of Product Characteristics.
Maintenance of anesthesia
A decrease in the depth of anesthesia is indicated by nystagmus, movement in response to stimuli, and vocalization. Anesthesia is maintained by administering additional doses of ketamine intravenously or intramuscularly. However, there is a lack of data on the maintenance dose of ketamine used in obstetrics, and recommended doses cannot be established.
Each additional maintenance dose is ½ to the full dose recommended for induction of anesthesia by the chosen route, regardless of the route of administration of the induction dose.

B. Ketalar 10 as an induction agent before the use of other general anesthetics.

Induction of anesthesia is achieved by intravenous or intramuscular administration of a full dose of ketamine as specified above. If ketamine is administered intravenously and the main anesthetic agent has a slow onset of action, a second dose of ketamine may be necessary within 5 to 8 minutes after the initial dose. If ketamine is administered intramuscularly and the main anesthetic agent has a rapid onset of action, the administration of the main anesthetic agent can be delayed for 15 minutes after the injection of ketamine.

C. Ketalar 10 used with other anesthetic agents.

Ketamine can be combined with commonly used general and local anesthetic agents, provided that adequate ventilation is maintained. The range of ketamine doses used concomitantly with other anesthetic agents is generally similar to that specified above; the second anesthetic agent may sometimes allow for a reduction in the dose of ketamine.

Procedure during recovery from anesthesia

After the procedure, the patient should be observed and kept calm. This does not exclude monitoring of vital signs. If the patient experiences any hallucinations during recovery, the administration of diazepam (5 to 10 mg IV in adults) should be considered. To interrupt severe reactions during recovery from anesthesia, a hypnotic dose of thiopental (50 to 100 mg IV) can be administered. If any of these medicines are used, the recovery period may be prolonged.

Use in patients with liver function disorders

A dose reduction should be considered in patients with liver cirrhosis or other liver function disorders (see section 4.4 of the Summary of Product Characteristics).

Method of administration

Intravenous and intramuscular administration.