Ketolar 50 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ketolar 50 mg/ml injection solution

Ketamine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Ketolar 50 mg/ml injection solution is and what it is used for.
2. What you need to know before using Ketolar 50 mg/ml injection solution.
3. How to use Ketolar 50 mg/ml injection solution.
4. Possible side effects.
5. How to store Ketolar 50 mg/ml injection solution.

Pack contents and other information.

1. What Ketolar 50 mg/ml injectable solution is and what it is used for

Ketolar belongs to a group of medicines called anaesthetics, which are used to render you unconscious during surgery. The active substance is ketamine. Ketolar may be used alone or in combination with other anaesthetics.

2. What you need to know before using Ketolar 50 mg/ml injection solution

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 condition or suffer from a disease where an increase in blood pressure could pose a serious risk
• 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 experience seizures or coma during pregnancy, childbirth, or shortly after delivery (eclampsia)

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Ketolar

• If you regularly consume excessive amounts of alcohol or are intoxicated
• If you have a liver disease
• If you have increased pressure inside the skull
• If you have high pressure inside the eye (elevated intraocular pressure)
• If you have a mental illness
• If you have a hereditary metabolic disorder called acute intermittent porphyria
• If you have previously had seizures
• If you have hyperthyroidism (excess thyroid hormones) or are receiving thyroid hormone therapy (see Other medicines)
• If you have a lung infection or upper respiratory tract infection
• If you have an injury inside the skull or trauma to the head or eye
• If you are dehydrated or have reduced circulating blood volume (hypovolemia)
• If you have a heart disease, especially if your heart does not receive enough oxygen (coronary artery disease), if your heart cannot 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 previously abused drugs or developed drug addiction or dependence

Please be aware that some patients, during recovery from anesthesia, may experience reactions ranging in severity from pleasant, dream-like states, vivid imagery, hallucinations, nightmares, and delirium (often with a sensation of being outside the body or floating). Sometimes, these may be accompanied by confusion, excitement, and irrational behavior, which some patients may recall as an unpleasant experience. These effects usually last only a few hours, although in some cases they have recurred up to 24 hours after the procedure has ended. There is no known evidence that ketamine use causes long-term psychological sequelae. If necessary, your doctor will take appropriate measures to minimize these reactions.

Long-term use

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

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

Drug abuse and dependence

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

Using Ketolar with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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

• Barbiturates and/or opioid agonists
• Diazepam (a medicine with tranquilizing, sedative, muscle-relaxant, and anticonvulsant effects)
• Neuromuscular blockers such as atracurium and tubocurarine
• Central nervous system depressants, 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 gland cannot produce sufficient hormones)
• Antihypertensives (medicines used to treat high blood pressure)
• Sympathomimetic drugs and vasopressin
• Ergometrine (a vasoconstrictor)
• Theophylline and aminophylline (medicines 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 is usually administered when your stomach is empty. However, Ketolar may still be used in emergency situations where this is not possible.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Ketamine crosses the placental barrier easily. Cases have been reported of newborns whose mothers received ketamine during childbirth, who experienced respiratory problems and low Apgar scores, requiring resuscitation.

High doses of ketamine have caused increased 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 operate tools or machinery after receiving Ketolar, as this medicine may affect your reaction ability. Your doctor will advise you how long you should wait before driving or using machines (usually 24 hours).

3. How to use Ketolar 50 mg/ml injectable solution

This medicine will only be administered to you in hospitals by an anaesthetist or an intensive care physician.

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

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

The dose you receive will depend on the type of procedure 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 induces unconsciousness within 30 seconds, and the effect lasts from 5 to 10 minutes. Because it acts very rapidly, it is important to be lying down at the time of administration.

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

You must not leave the healthcare facility until you have fully recovered from anaesthesia. If you are discharged on the same day as your 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 usually produce unconsciousness within 3–4 minutes after injection, and the effect lasts from 12 to 25 minutes.

Method and route of administration

Ketolar can be administered by intramuscular or intravenous route.

Ketolar may be used as the sole anaesthetic agent, as an adjunct to other general or local anaesthetics, or prior to administration of other general anaesthetics.

If you use more Ketolar than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or hospital emergency service immediately. You may 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 resulted in complete recovery, although recovery took a considerably long time.

In cases of Ketolar overdose or excessively rapid administration, respiratory depression may occur, in which case assisted ventilation is required, preferably mechanical ventilation.

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

4. Possible adverse effects

Like all medicines, Ketolar can cause adverse effects, although not everyone experiences them.

Frequent adverse effects (may affect less 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 seizure-like movements (tonic-clonic movements)
• nausea, vomiting
• skin redness (erythema), measles-like skin rash
• increased blood pressure, increased heart rate, increased respiratory rate

Uncommon adverse effects (may affect less than 1 in 100 patients)

• respiratory depression, laryngeal spasm
• low blood pressure (hypotension), slower heartbeat (bradycardia), irregular heartbeat (arrhythmia)
• loss of appetite (anorexia), anxiety
• pain and/or rash at the injection site

Rare adverse effects (may affect less than 1 in 1,000 patients)

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ketolar 50 mg/ml injection solution

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. Keep the vial in the outer packaging to protect it from light. Do not freeze.

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

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

Disposal of unused medicine and all associated materials

6. Contents of the pack and other information

Composition of Ketolar 50 mg/ml injectable solution

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

Appearance of the product and contents of the pack

Ketolar is presented in clear glass vials containing 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 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 the most recent review of this summary: November 2023

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

Instructions for use and handling for healthcare professionals

Ketolar should only be used in hospitals by, or under the supervision of, physicians experienced or qualified in the administration of general anesthetics, as well as in airway management and respiratory control.

It is recommended that resuscitation equipment be readily available.

The intravenous dose of ketamine should be administered over a period of approximately 60 seconds. More rapid administration may cause respiratory depression or apnea and an increase in pressor response.

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

Parenteral medicines should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

Store the vial in the outer packaging to protect from light. The solution may range from colorless to very slightly yellowish and may darken upon prolonged exposure to light. Although darkening of the solution does not affect the potency of the medicine, the product should not be used if precipitation is observed.

Ketamine and barbiturates must not be mixed in the same syringe, as their chemical incompatibility leads to precipitate formation.

Ketamine and diazepam must not be mixed in the same syringe or infusion bottle. If supplementation of the ketamine dose with diazepam is desired, the two drugs should be administered separately.