PATIENT INFORMATION LEAFLET

KETALAR™

10 mg/ml,

50 mg/ml &

100 mg/ml

Injection

Ketamine (as hydrochloride)

What is in the pack?

Ketalar is an injection which can be given directly into a muscle, into a vein or in an infusion (drip). It contains the active ingredient ketamine hydrochloride and is available in three strengths:

Vials containing 20 ml of a 10 mg per ml solution of ketamine base

Vials containing 10 ml of a 50 mg per ml solution of ketamine base

Vials containing 10 ml of a 100 mg per ml solution of ketamine base

The Ketalar 10 mg/ml vials also contain sodium chloride (salt), water for injections and a preservative (benzethonium chloride).

The Ketalar 50 mg/ml and 100 mg/ml vials also contain water for injections and a preservative (benzethonium chloride).

What does the active ingredient in Ketalar do?

Ketamine is an anaesthetic. It may be used in emergencies or for routine operations, in children as well as adults and the elderly.

Before being given Ketalar

If the answer to any of the following questions is 'yes' you should talk to your doctor or anaesthetist before being given Ketalar as it may not be suitable for you. You may have been given Ketalar for an emergency operation. In this case, you will only be able to read this leaflet after you have had Ketalar given to you. The questions below will have been considered by your doctor or anaesthetist before you were given Ketalar, but the urgent need for treatment may have been more important than some of the normal precautions. Check them now, in case you need to be given Ketalar again.

• Have you ever had a reaction to Ketalar or any of its ingredients?
• Are you pregnant, trying to become pregnant, or breast feeding?
• Do you have heart disease or high blood pressure?
• Have you recently had a stroke or an injury to your head or brain?
• Do you drink large amounts of alcohol?
• Do you have a history of drug abuse or addiction?

If you answer yes to any of these questions, tell your doctor or anaesthetist at once.

It is normal to stop eating or drinking for at least six hours before an operation. If, in an emergency, this is not possible and the stomach is full, Ketalar may still be used.

If before your operation the pressure inside your spinal cord is raised, your anaesthetist will pay special attention to this during the operation.

Ketalar and other medicines, anaesthetics and alcohol

Before your operation it is usual to give a medicine such as atropine or hyoscine to dry up your secretions (body fluids like saliva and tears) and another medicine called a benzodiazepine. The benzodiazepine will help you to relax and help to prevent a side-effect known as "emergence reaction", although it should not be given in the same syringe with Ketalar (see the section Side-effects).

When used for an operation on the chest or abdominal organs, Ketalar is usually combined with a pain-killer.

Ketalar must be used with particular care in anyone who is a chronic alcoholic, who is intoxicated (drunk) or who has a history of drug abuse or dependence.

Using Ketalar with barbiturates and narcotics (morphine-like drugs) may slow your recovery from anaesthesia. Otherwise, Ketalar may be used with all other general and local anaesthetics.

How Ketalar is used

Except in an emergency, Ketalar should only be used in hospitals by experienced anaesthetists with resuscitation equipment available.

The dose of Ketalar depends on its use and varies from person to person. When injected directly into a vein at a dose of 2 mg for every kg of your bodyweight, Ketalar produces unconsciousness within 30 seconds and this lasts for 5 to 10 minutes. Because it works so quickly, it is important to be lying down, or supported in some other way when the drug is given. When Ketalar is injected into your muscle, at a dose of 10 mg for every kg of bodyweight, it takes longer to work (three or four minutes) but lasts 12 to 25 minutes.

Your anaesthetist will then keep you anaesthetised with either:

• a) another anaesthetic
• b) more Ketalar given by injection into your muscle or vein, or in a drip
• c) Ketalar with another anaesthetic.

When it is injected directly into a vein, Ketalar is given over at least a minute so that it does not slow your breathing too much. If breathing is slowed, it can be helped mechanically.

While you are anaesthetised, your anaesthetist will watch over you constantly paying particular attention to your breathing, airways, reflexes, degree of anaesthesia and the condition of your heart.

 

After Ketalar has been used

You should not be released from hospital until you have completely recovered from the anaesthetic. If you are released on the same day as the operation, you should be accompanied by another adult. Do not drive a car, operate hazardous machinery, or engage in any hazardous activity for at least 24 hours after you were given the anaesthetic.

Side-effects

Ketalar can sometimes cause side-effects.

There have been reports of effects such as flashbacks, hallucinations, feeling ill at ease, anxiety, sleeplessness and disorientation.

Some people have vivid dreams, feel confused or behave irrationally while recovering from anaesthesia with Ketalar. This is called an "emergence reaction". You will be allowed to recover from the anaesthetic in a quiet place and this helps to prevent the reaction. Medicines known as benzodiazepines, which are given before your operation, also help to prevent this reaction (see the section Ketalar and other medicines, anaesthetics and alcohol). Emergence reactions occur less often in the young and in the elderly. No permanent psychological effects are known to have resulted from the use of Ketalar.

Sometimes Ketalar may temporarily raise blood pressure and increase pulse rate. However, it may also lower blood pressure and slow the heart rate or bring about changes in heart rhythm. Ketalar may slow your breathing (see the section How Ketalar is used) and/or affect the reflexes which keep your airways clear. Your anaesthetist will give you appropriate treatment if this happens to you.

Occasionally, some people may get double vision, unusual eye movements (nystagmus), or slightly raised pressure in their eyes.

Muscle twitches may sometimes occur during anaesthesia, but this does not mean the anaesthetic is not working.

After the operation, some people lose their appetite or feel sick. These feelings are usually mild and short lived, you should be able to drink liquid soon after regaining consciousness.

There have been reports of serious allergic reactions to Ketalar. A temporary rash and an increase in salivation have also been reported. You may have been given a medicine to prevent problems which may be caused by increased saliva. On rare occasions, some people notice pain or a rash at the injection site.

If you get these, or any other unusual effects, please tell your doctor or anaesthetist.

How to store Ketalar

Do not use Ketalar after the last day of the month shown in the expiry date. This will be printed on the outside of the pack.

Remember, as with all medicines, keep Ketalar out of the reach and sight of children.

Do not store Ketalar above 25°C. Do not freeze. Store in the original container. Keep the vial in the outer carton in order to protect from light.