KETOLAR 50 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Ketolar 50 mg/ml Solution for Injection

Do not use Ketolar

• If you are allergic to ketamine or any of the other ingredients of this medicine (listed in section 6)
• If you are in a situation or have a disease in which an increase in blood pressure can pose a serious danger
• If you have a severe complication of pregnancy called pre-eclampsia, characterized by high blood pressure, edema (swelling due to fluid retention), and protein loss in the urine, or if you have convulsions or coma during pregnancy, childbirth, or shortly after giving birth (eclampsia)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ketolar

• If you regularly consume excessive amounts of alcohol or are intoxicated
• If you have liver disease
• If you have high blood pressure inside the skull
• If you have high blood pressure inside the eye (increased intraocular pressure)
• If you have a mental illness
• If you have a hereditary metabolic disorder called acute intermittent porphyria
• If you have had seizures before
• If you have hyperthyroidism (an excess of hormones produced by the thyroid) or are receiving thyroid hormones (see Use with other medicines)
• If you have a lung or upper respiratory tract infection
• If you have a head or eye injury or trauma
• If you are dehydrated or have a decrease in blood volume (hypovolemia)
• If you have heart disease, especially if your heart does not receive enough oxygen (coronary artery disease), if your heart is not able to pump blood properly to the rest of the body (heart failure), if your heart beats irregularly (arrhythmias), or if you have high blood pressure
• If you have a history of drug abuse or have developed dependence on drugs

You should be aware that some patients, during recovery from anesthesia, may have some type of reaction that can vary in severity between pleasant states similar to sleep, vivid images, hallucinations, nightmares, and delirium (often with a feeling of being outside the body or floating). Sometimes, it can be accompanied by confusion, excitement, and irrational behavior, being remembered by some patients as an unpleasant experience. Normally, it only lasts a few hours, although in some cases, it has recurred up to 24 hours after the operation has finished. It is not known that the use of ketamine causes psychological sequelae. If necessary, your doctor will take the appropriate measures to reduce these reactions.

Long-term use

Ketolar is not indicated or recommended for long-term use.

Urinary tract infection, sometimes accompanied by bleeding, and liver problems, particularly with long-term use (>3 days) or drug abuse, have been reported. See section 4 Possible side effects.

Drug abuse and dependence

If used daily for several weeks, dependence and tolerance can develop, particularly in people with a history of drug abuse and dependence. Other side effects have also been reported: see "Long-term use".

Using Ketolar with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicine.

Certain medicines can interact with each other. It is especially important that you inform your doctor if you are taking any of the following medicines:

• Barbiturates and/or opioid agonists
• Diazepam (a medicine with tranquilizing, sedating, muscle-relaxing, and anticonvulsant effects)
• Neuromuscular blockers such as atracurium and tubocurarine
• Central nervous system depressant medicines, such as ethanol, phenothiazines, sedating H1 receptor antagonists, and muscle relaxants
• Medicines for the treatment of anxiety and insomnia
• Halogenated anesthetics, thiopental (medicines used for anesthesia)
• Thyroid hormones (medicines used when the thyroid is not able to produce hormones in sufficient quantity)
• Antihypertensive medicines (medicines used in the treatment of high blood pressure)
• Sympathomimetic medicines and vasopressin
• Ergometrine (vasoconstrictor)
• Theophylline and aminophylline (medicine used to dilate the bronchi)

Using Ketolar with food and drinks

It is recommended that you do not eat or drink for at least 6 hours before anesthesia. Ketolar will normally be administered when your stomach is empty. However, Ketolar can still be used if this is not possible in an emergency.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before you are given this medicine.

Pregnancy

Ketamine crosses the placental barrier easily. Cases have been reported of newborns who, after receiving ketamine from their mother during childbirth, have presented respiratory problems and a low score on the Apgar test, requiring resuscitation.

High doses of ketamine have caused increases in blood pressure and uterine tone in the mother. The safety of ketamine during pregnancy has not been established, so its use is not recommended.

Breastfeeding

The safe use of ketamine during breastfeeding has not been established, so its use is not recommended.

Driving and using machines

Do not drive or use tools or machines after receiving Ketolar, as this medicine can affect your reaction ability. Your doctor will tell you how long you should wait before driving or using machines (usually 24 hours).

3. How to use Ketolar 50 mg/ml Solution for Injection

This medicine will only be administered in hospitals by an anesthesiologist or by an intensive care physician.

Ketolar is not indicated or recommended for long-term use.

Before the operation, you may be given other medicines (to reduce saliva secretion or to reduce the risk of reactions during recovery from anesthesia).

The dose you receive will depend on the type of intervention you are undergoing and varies from person to person.

When injected directly into a vein at a dose of 2 mg per kilogram of body weight, Ketolar produces a state of unconsciousness in 30 seconds, and the effect lasts from 5 to 10 minutes. As it acts very quickly, it is essential to be lying down at the time of administration.

When administered into a muscle, at a dose of 10 mg per kilogram of body weight, the anesthetic effect takes longer to appear (3-4 minutes), but lasts from 12 to 25 minutes. Recovery of consciousness occurs gradually.

Do not leave the healthcare facility until you have fully recovered from the anesthesia. If you are discharged on the same day as the operation, you must be accompanied by another adult (see Driving and using machines).

Use in children and adolescents

Intramuscular doses of 9-13 mg/kg usually produce a state of unconsciousness in 3-4 minutes after injection, and the effect lasts from 12 to 25 minutes.

Method of use and route of administration

Ketolar can be administered by intramuscular or intravenous route.

Ketolar can be administered as a single anesthetic, as a complement to other general or local anesthetics, or before administering other general anesthetics.

If you use more Ketolar than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist or the emergency service of your hospital immediately. You can also contact the Toxicology Information Service. Telephone 91 562 04 20.

Ketolar has a wide safety margin. Several cases of accidental administration of up to 10 times the normally required dose have been reported, and they recovered completely, although it took them a long time to do so.

In case of Ketolar overdose, or too rapid administration, respiratory depression can occur, requiring assisted ventilation, and mechanical ventilation is preferred.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketolar can cause side effects, although not everybody gets them.

Common side effects(may affect up to 1 in 10 people)

• hallucinations, abnormal dreams, nightmares, confusion, agitation, abnormal behavior
• involuntary and uncontrolled eye movements (nystagmus), double vision (diplopia)
• increased muscle tone (hypertonia), involuntary movements similar to convulsions (clonic-tonic movements)
• nausea, vomiting
• redness of the skin (erythema), rash similar to measles
• increased blood pressure, increased heart rate, increased respiratory rate

Uncommon side effects(may affect up to 1 in 100 people)

• respiratory depression, laryngospasm
• low blood pressure (hypotension), slow heart rate (bradycardia), irregular heart rate (arrhythmia)
• loss of appetite (anorexia), anxiety
• pain and/or rash at the injection site

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

• severe allergic reaction throughout the body (anaphylactic reaction)
• obstruction of the airways, interruption of breathing (apnea)
• delirium, repeated hallucinations (flashbacks), emotional or mood changes (dysphoria), difficulty sleeping (insomnia), disorientation
• excessive salivation
• bladder inflammation (cystitis), bladder inflammation with blood in the urine (hemorrhagic cystitis)

Side effects of unknown frequency(cannot be estimated from the available data)

• increased pressure inside the eye
• abnormal liver function test results, liver damage in cases of prolonged use (more than 3 days) or drug abuse

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketolar 50 mg/ml Solution for Injection

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature. Store in the original packaging. Store the vial in the outer packaging to protect it from light. Do not freeze.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste.

The disposal of unused medicine and all materials

6. Contents of the pack and further information

Composition of Ketolar 50 mg/ml Solution for Injection

• The active ingredient is ketamine. Each vial, which contains 10 ml of solution, contains 500 mg of ketamine (50 mg of ketamine per ml of solution).
• The other ingredients are benzethonium chloride and water for injections.

Appearance and packaging

Ketolar is presented in transparent glass vials, with 10 ml of solution. Each vial is closed with a bromobutyl stopper and an aluminum seal. Each pack contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid).

Manufacturer:

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln, Germany

Date of last revision of this leaflet:November 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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Instructions for use and handling directed to the healthcare professional

Ketolar should only be used in hospitals by, or under the supervision of, medical experts or qualified professionals in the administration of general anesthetics, as well as in the maintenance of airways and control of respiration.

It is recommended to have a resuscitation equipment ready for use.

It is recommended to administer the intravenous dose of ketamine over a period of about 60 seconds. Faster administration can cause respiratory depression or apnea and an increase in pressor response.

Single-dose container. After opening: From a microbiological point of view, the product should be used immediately, unless the opening method prevents the risk of microbial contamination. Discard the unused product after opening.

Parenteral medicines should be inspected visually for particles and discoloration before administration, whenever the solution and container allow.

Store the vial in the outer packaging to protect it from light. The color of the solution may vary from colorless to very slightly yellowish and may darken if exposed to light for a long time. Although darkening of the solution does not affect the potency of the medicine, it should not be used if signs of precipitation are observed.

Ketamine and barbiturates should not be mixed in the same syringe, as their chemical incompatibility leads to the formation of precipitates.

Ketamine and diazepam should not be mixed in the same syringe or infusion bottle. If you want to supplement the dose of ketamine with diazepam, the two medicines should be administered separately.