Label: information for the user

Ketolar 50 mg/ml injectable solution

Ketamine hydrochloride

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this label. See section 4.

Contents of the package and additional information.

Ketolar belongs to a group of medications called anesthetics, which are used to put someone to sleep during an operation. The active ingredient is ketamine. Ketolar can be used alone or in combination with other anesthetics.

No use Ketolar

• If you are allergic to ketamine or any of the other components of this medication (listed in section 6)
• If you are in a situation or have a condition where a rise in blood pressure could pose a serious danger
• If you have a severe complication of pregnancy called pre-eclampsia, characterized by an increase in blood pressure, edema (swelling due to fluid retention), and loss of proteins in the urine, or if you have seizures or coma during pregnancy, during delivery, or shortly after giving birth (eclampsia)

Advertencias y precauciones

Consult your doctor or pharmacist before starting to useKetolar

• If you habitually consume excessive amounts of alcohol or are intoxicated
• If you have any liver disease
• If you have high blood pressure within the skull
• If you have high blood pressure within the eye (elevated intraocular pressure)
• If you have any mental illness
• If you have a hereditary metabolic disease called acute intermittent porphyria
• If you have had previous seizures
• If you have hyperthyroidism (an excess of hormones produced by the thyroid gland) or are receiving thyroid hormones (see Use of other medications)
• If you have an infection in the lungs or upper respiratory tract
• If you have any head injury or head or eye trauma
• If you are dehydrated or have adecrease in the amount of circulating blood (hypovolemia)
• If you have any heart disease, especially if your heart does not receive enough oxygen (coronary disease), if your heart is not able to pump blood adequately 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 abusing drugs or developing addiction or dependence on drugs

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

Uso a largo plazo

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

There have been reports of urinary tract infections, sometimes accompanied by bleeding, and liver problems, particularly with long-term use (>3days) or drug abuse. See section 4 Possible adverse effects.

Abuso y dependencia de drogas

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

Uso de Ketolar con otros medicamentos

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

Certain medications may interact with each other. It is especially important to inform your doctor if you are taking any of the following medications:

• Barbiturates and/or opioid agonists
• Diazepam (a medication withsedative, tranquilizing, muscle-relaxing, and anticonvulsant effects)
• Neuromuscular blockers such as atracurium and tubocurarine
• Central nervous system depressants, such as ethanol, phenothiazines, H1 receptor antagonists, and muscle relaxants
• Medications for the treatment of anxiety and insomnia
• Halogenated anesthetics, thiopental (medications used for anesthesia)
• Thyroid hormones (medications used when the thyroid gland is not able to produce hormones in sufficient quantities)
• Antihypertensives (medications used in the treatment of high blood pressure)
• Sympathomimetics and vasopressin
• Ergometrine (vasoconstrictor)
• Theophylline and aminophylline(a medication used to dilate the bronchi)

Uso de Ketolar con los alimentos y bebidas

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, in an emergency, this is not possible.

Embarazo, lactancia y fertilidad

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consultyour doctor or pharmacist before this medication is administered.

Embarazo

Ketamine easily crosses the placental barrier. There have been reports of newborns who, after receiving ketamine during delivery, have experienced respiratory problems and a low Apgar score, requiring resuscitation.

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

Lactancia

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

Conducción y uso de máquinas

Do not drive or operate machinery after receiving Ketolar, as this medication may affect your reaction time. Your doctor will indicate how long you should wait before driving or using machinery (usually 24 hours).

This medication will only be administered to you in a hospital by an anesthesiologist or an intensive care physician.

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

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

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 your body weight, Ketolar produces a state of unconsciousness in 30 seconds and the effect lasts 5 to 10 minutes. As it acts very quickly, it is essential to be lying down at the time of administration.

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

You should 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 Use of Machines).

Use in children and adolescents

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

Form of use and route of administration

Ketolarcan 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 also before administering other general anesthetics.

If more Ketolar than necessary is used

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

Ketolarhas a wide margin of safety. Several cases of accidental administration of up to 10 times the normally required dose have fully recovered, although it took them a long time to do so.

In case of Ketolaroverdose, or too rapid administration, respiratory depression may occur, requiring assisted ventilation, with mechanical ventilation being preferred.

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

Like all medicines, Ketolar can cause side effects, although not everyone will experience them.

Frequent side effects(that may affect fewer than 1 in 10 patients)

-hallucinations, abnormal dreams, nightmares, confusion, agitation, abnormal behavior

-involuntary and uncontrollable eye movements (nystagmus), double vision (diplopia)

-increased muscle tone (hypertonia), involuntary movements similar to seizures (tonic clonic movements)

-nausea, vomiting

-skin redness (erythema), skin rash similar to measles

-increased blood pressure, increased heart rate, increased respiratory rate

Less frequent side effects(that may affect fewer than 1 in 100 patients)

-respiratory depression, laryngeal spasm

-low blood pressure (hypotension), slow heart rate (bradycardia), irregular heart rhythm (arrhythmia)

-loss of appetite (anorexia), anxiety

-pain and/or rash at the injection site

Rare side effects(that may affect fewer than 1 in 1,000 patients)

-severe allergic reaction throughout the body (anaphylactic reaction)

-obstruction of the airways, interruption of breathing (apnea)

-delirium, recurring hallucinations (flashbacks), emotional or mood alteration (dysphoria), difficulty sleeping (insomnia), disorientation

-excessive salivation

-inflammation of the bladder (cystitis), inflammation of the bladder with blood in the urine (hemorrhagic cystitis)

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

-increased intraocular pressure

-abnormal results in liver function tests, liver damage in cases of prolonged use (more than 3 days) or abuse of the medication

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication 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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.

Disposal of unused medication and all materials

Ketolar 50 mg/ml CompositionInjectable Solution

-The active ingredient is ketamine. Each vial, which contains 10 ml of solution, contains 500 mg of ketamine (50 mg of ketamine per each ml of solution).

-The other components are benzethonium chloride and water forparenteral preparations.

Product Appearance and Packaging Contents

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

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Pfizer, s.l

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid).

Responsible Manufacturer:

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln, Germany

Last Review Date of thisProspect:November 2023

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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Instructions for Use and Handling for Healthcare Professionals

Ketolar should only be used in hospitals by, or under the supervision of, experienced or qualified medical doctors in the administration of general anesthetics as well as in the maintenance of respiratory pathways and in the control of respiration.

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

It is recommended to administer the intravenous dose of ketamine over a period of about 60 seconds. A faster administration may cause respiratory depression or apnea and an increase in blood pressure response.

Single-dose packaging. 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 medications should be visually inspected to detect particles and discoloration before administration whenever the solution and packaging permit.

Keep 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 for a long time to the action of light. Although the darkening of the solution does not affect the potency of the medication, it should not be used if precipitation signs are observed.

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

Ketamine should not be mixed with diazepam in the same syringe or infusion bottle. If it is desired to supplement the ketamine dose with diazepam, the two medications should be administered separately.