Ketalar 50

Package Leaflet: Information for the User

Ketalar 50,50 mg/ml, solution for injection
Ketaminum

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

• Keep this package 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 only. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Ketalar 50 is and what it is used for
• 2. Important information before using Ketalar 50
• 3. How to use Ketalar 50
• 4. Possible side effects
• 5. How to store Ketalar 50
• 6. Contents of the pack and other information

1. What Ketalar 50 is and what it is used for

Ketalar 50 is a fast-acting anesthetic used for general anesthesia, administered by intravenous infusion, intravenous injection, or intramuscular injection.
Ketalar 50 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 body surfaces.
• 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.
Caution:Ketamine should be used with caution in surgical procedures involving the throat, larynx, or trachea, as it increases salivation and tracheobronchial secretion, and inadequately suppresses laryngeal and pharyngeal reflexes.

2. Important information before using Ketalar 50

When not to use Ketalar 50

• 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 threatened preeclampsia;
• 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 50, 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 ketamine use, 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 it may significantly increase;
• in patients with neurotic tendencies;
• in patients with acute intermittent porphyria (inherited or acquired disorders of hemoglobin synthesis);
• in patients with a history of seizures;
• in patients with hyperthyroidism, treated with thyroid hormones;
• in patients with pulmonary infections 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 filling of the circulatory system 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 hypertension and cardiac arrhythmia with frequent heart rate.

Additional notes on the use of Ketalar 50:

• The product is intended for use only in a hospital setting or under the supervision of an experienced anesthesiologist, unless it is necessary to use it in emergency situations.
• As with other general anesthetics, during the use of Ketalar 50, access to resuscitation equipment should be ensured.
• The use of Ketalar 50 must always be preceded by the administration of an appropriate dose of atropine, hioscine, or another saliva-reducing agent.
• During emergence from anesthesia, hallucinations may occur.
• Since the pharyngeal and laryngeal reflexes are generally preserved during anesthesia, ketamine should not be used as a single anesthetic agent in surgical or diagnostic procedures in 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. In these cases, the doctor may recommend the use of muscle relaxants, while maintaining appropriate respiratory control.

It is recommended to 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 50 in patients with liver cirrhosis or other liver function disorders.

Ketalar 50 and other medicines

Tell your doctor or pharmacist about all the 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, they may prolong the recovery time from anesthesia, as well as the use of premedication using 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 (the body's clearance of the medicine);
• thyroid hormones - increase the risk of hypertension and tachycardia (rapid heart rate);
• other central nervous system depressants (e.g., alcohol, phenothiazines, H receptor blockers with sedative effects, muscle relaxants) - may enhance the central nervous system depressant effect and (or) increase the risk of respiratory depression. A reduction in the ketamine dose may be necessary when used concomitantly with other anxiolytic, sedative, or hypnotic agents;
• antihypertensive agents - when used concomitantly with ketamine, they increase the risk of hypotension;
• sympathomimetics (acting directly or indirectly) and vasopressin - may enhance the sympathomimetic effect of ketamine;
• 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 reduction in the ketamine dose may be necessary;
• when ketamine is administered concomitantly with CYP3A4 inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine), an increase in the ketamine dose may be necessary.

Other interactions:

• Barbiturates and Ketalar 50 - 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 is dependent 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 (movement of the medicine between tissues) of ketamine and inhibits its liver metabolism.
• Nitrous oxide - concomitant use with ketamine reduces the required dose of ketamine.
• Gallamine - concomitant use with ketamine leads to tachycardia (rapid heart rate); 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 (slow heart rate), decreased blood pressure, or decreased cardiac output.
• 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 baby, ask your doctor or pharmacist for advice before using this medicine.
Ketalar 50 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 had lower Apgar scores.
In obstetrics, there is a lack of data on the use of Ketalar 50 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 50 is not recommended in breastfeeding women.

Driving and using machines

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

3. How to use Ketalar 50

Ketalar 50 should only be used in a hospital setting or under the supervision of an experienced anesthesiologist. During the use of Ketalar 50, access to resuscitation equipment should be ensured.

Ketalar 50 can be administered as an intravenous infusion, intravenous injection, or intramuscular injection.
Adults, elderly patients (over 65 years), and children
Ketamine may be used as a single anesthetic agent or in combination with other anesthetic agents in elderly patients.

Preparation for the procedure

• 1. Ketalar 50 was safe when administered as a single anesthetic agent to patients who were not fasting. However, due to the possibility of causing vomiting and the unpredictability of the need for other anesthetic or muscle relaxant agents, it is recommended that patients should not take any oral medications and should be fasting for at least 6 hours before anesthesia. The use of ketamine is possible in non-fasting patients if the benefits of using the product outweigh the potential risks, as assessed by the doctor.
• 2. Ketamine increases salivation. Before anesthesia, the doctor will decide to administer atropine, hioscine, or glikopyrrolate, or another saliva-reducing agent.
• 3. Midazolam, diazepam, lorazepam, or flunitrazepam used as premedication or concomitantly with ketamine effectively reduced the frequency of negative emergence reactions.

Onset and duration of anesthesia

As with other general anesthetics, the individual response to Ketalar 50 varies depending on the dose, route of administration, patient age, and concomitantly used agents.
The dose range may vary from 1 mg/kg body weight to 4.5 mg/kg body weight intravenously and from 6.5 mg/kg body weight to 13 mg/kg body weight intramuscularly. The doctor will recommend the appropriate dosage for each patient.
Detailed information on dosage and administration intended for medical personnel or healthcare professionals is provided at the end of the package leaflet.
Due to the rapid onset of action after intravenous administration, during administration, the patient should be in a supported position. Recovery of consciousness occurs gradually.

Overdose of Ketalar 50

Overdose of Ketalar 50 may lead to respiratory depression. In this case, symptomatic treatment should be used.

4. Possible side effects

Like all medicines, Ketalar 50 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
• pain at the injection site
• rash at the injection site Rare(may affect up to 1 in 1,000 people):
• anaphylactic reactions
• emergence reactions
• flashback episodes (recurrence of past psychotic experiences)
• dysphoria
• insomnia
• disorientation
• respiratory obstruction
• apnea
• excessive salivation
• urinary tract infection and (or) pain when urinating, possible hematuria
• hemorrhagic cystitis

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

• increased intraocular pressure
• abnormal liver function test results
• hepatic toxicity

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported 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
Side effects can also be reported 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 50

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine. Store the ampoules 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 ampoule is for single use only. After opening, taking into account 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 nature of the solution and packaging allows.
If the medicine is not used immediately, the user is responsible for the storage time and conditions.
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 50 contains

• The active substance is ketamine; 1 ml of solution contains 50 mg of ketamine as ketamine hydrochloride.
• The other ingredients are benzethonium chloride, water for injections.

What Ketalar 50 looks like and contents of the pack

Ketalar 50 is a clear, colorless solution for injection. The medicine is in ampoules 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 ampoules of 10 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 about 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-ketalar50 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 50 is chemically incompatible 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 50 was safe when administered as a single anesthetic agent to patients who were not fasting. However, due to the possibility of causing vomiting and the unpredictability of the need for other anesthetic or muscle relaxant agents, it is recommended that patients should not take any oral medications and should be fasting for at least 6 hours before anesthesia. The use of ketamine is possible in non-fasting patients if the benefits of using the product outweigh the potential risks, as assessed by the doctor.
• 2. Ketamine increases salivation. Before anesthesia, the doctor will decide to administer atropine, hioscine, or glikopyrrolate, or another saliva-reducing agent.

3. Midazolam, diazepam, lorazepam, or flunitrazepam used as premedication or concomitantly with ketamine effectively reduced the frequency of negative emergence reactions.

• 3. Midazolam, diazepam, lorazepam, or flunitrazepam used as premedication or concomitantly with ketamine effectively reduced the frequency of negative emergence reactions.

Onset and duration of anesthesia

As with other general anesthetics, the individual response to Ketalar 50 varies depending on the dose, route of administration, patient age, and concomitantly used agents, and therefore, no specific dosage recommendations can be made. The dose should be adjusted to the needs of the individual patient.
Due to the rapid onset of action after intravenous administration, during administration, the patient should be in a supported position. The intravenous dose of 1 to 2 mg/kg body weight usually produces 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 produces 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 50 used as a single anesthetic agent.

Intravenous infusion

The use of Ketalar 50 in continuous infusion allows for more precise dosing, thereby reducing the total amount of medicine used compared to intermittent administration. This shortens the recovery time and affects the stability of vital parameters.
For infusion, a solution containing 1 mg of ketamine/ml is usually used, in 5% glucose solution or 0.9% sodium chloride solution.
In cases where fluid administration needs to be limited, the contents of one ampoule of Ketalar 50 can be added to 250 ml of infusion solution, resulting in concentrations of approximately 2 mg of ketamine/ml.
Induction of anesthesia
The total induction dose of anesthesia administered as an infusion is 0.5 to 2 mg/kg body weight.
Maintenance of anesthesia
Anesthesia can be maintained by slow infusion, i.e., 10 to 40 micrograms/kg body weight/min (approximately 1 to 3 mg/min).
The infusion rate depends on the patient's response and reaction to anesthesia. The dose may be reduced when a long-acting neuromuscular blocking agent is used.
Dosage in obstetrics
In obstetrics, during 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 use of Ketalar 50 administered intramuscularly and on the maintenance dose administered intravenously, 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 produce 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 surgery.
Dosage 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 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.
The higher the total dose of Ketalar 50 administered, the longer the recovery time from anesthesia.

B. Ketalar 50 used as an induction agent before the use of other general anesthetics.

Induction of anesthesia is achieved by intravenous or intramuscular administration of the full dose of ketamine 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 50 used in combination with other anesthetic agents.

Ketamine can be combined with commonly used general anesthetic agents, provided that adequate respiratory exchange 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, however, sometimes allow for a reduction in the ketamine dose.

Procedure during emergence from anesthesia

After the procedure, the patient should be monitored and kept calm. This does not exclude monitoring of vital parameters. If the patient experiences any emergence reactions during recovery, the doctor may consider administering diazepam (5 to 10 mg IV in adults). To interrupt severe reactions during emergence, a hypnotic dose of thiobarbital (50 to 100 mg IV) can be administered. If either of these medicines is used, the recovery time may be prolonged.

Use in patients with liver function disorders

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