What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 21597/0059.


Ketamine G.L. Pharma 50mg/ml Solution for Injection/Infusion in Ampoules

Package leaflet: Information for the patient

Ketamine G.L. Pharma 50 mg/ml Solution for injection/infusion in ampoules

Ketamine G.L. Pharma 50 mg/ml Solution for injection/infusion in vials

Ketamine

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ketamine G.L. Pharma is and what it is used for
2. What you need to know before you are given Ketamine G.L. Pharma
3. How Ketamine G.L. Pharma is given
4. Possible side effects
5. How to store Ketamine G.L. Pharma
6. Contents of the pack and other information

1. What Ketamine G.L. Pharma is and what it is used for

Ketamine G.L. Pharma contains ketamine, which is an anaesthetic (used to put you to sleep during an operation). Ketamine G.L. Pharma may be used in both routine and emergency surgery.

Ketamine G.L. Pharma is used in adults, children and adolescents.

Ketamine G.L. Pharma can be given alone or in combination with other anaesthetic agents.

2. What you need to know before you are given Ketamine G.L. Pharma

You should not be given Ketamine G.L. Pharma

  • if you are allergic to ketamine or any of the other ingredients of this medicine (listed in section 6)
  • if you are suffering from any condition in which an increase in blood pressure may be harmful to you or have suffered in the past from a medical condition which may have been caused/made worse by an increase in blood pressure
  • if you have been pregnant and during your pregnancy you have suffered from a condition called eclampsia or pre-eclampsia which causes an increase in your blood pressure
  • if you have recently suffered a stroke or serious head or brain injury
  • if you have severe heart disease
  • Ketamine G.L. Pharma in vials (because of the content of an excipient in the vials, named ‘benzethonium chloride’):
    • if you are a child or an adolescent
    • for infusion (in all patient populations)
    • in larger volumes than 15 ml in single doses (in all patient populations)

Warnings and precautions

Talk to your doctor if any of the following apply to you, to help them decide if Ketamine G.L. Pharma is suitable for you. If you

  • have a history of drug abuse or addiction
  • have a history of or have current mental health problems
  • have a chest infection or problems breathing
  • have problems with your liver
  • have an inherited disease that affects the blood (porphyria)
  • have had any injury to your head or abnormal growth in the brain
  • have increased pressure in your eye (glaucoma)
  • drink large amounts of alcohol
  • are receiving treatment for your thyroid gland
  • have, or have ever had, seizures (fits)

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

Long-term use

If you receive ketamine for a longer period (more than 3 days) it may have a harmful effect on your liver.

If you receive ketamine for a longer period (one month up to several years) you may develop an inflammation of your bladder (the appearance of blood in the urine may also occur).

These side effects may also occur with the abuse of ketamine.

Drug abuse and dependence

With abuse of ketamine signs and symptoms including flashbacks, hallucinations, depressive mood, anxiety, sleeplessness, disorientation, inflammation of the bladder and liver damage have been reported.

Occurrence of these side effects cannot be ruled out for treatment with ketamine.

If you currently suffer from, or if you have a history of, drug abuse or dependence, you may develop dependence and tolerance of ketamine.

Other medicines and Ketamine G.L. Pharma

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Ketamine G.L. Pharma is usually given together with other medicines during surgery.

  • When used for an operation on the chest or abdominal organs, ketamine is usually combined with a pain-killer.
  • Tell your doctor if you are taking
    • barbiturates (a certain type of sleeping pills, e.g. thiopental)
    • narcotics (morphine-like medicines)
    since use with Ketamine G.L. Pharma may slow your recovery from anaesthesia. Otherwise, ketamine may be used with all other general and local anaesthetics.
  • Diazepam can increase the effects of Ketamine G.L. Pharma so dose adjustments may be needed.
  • Using sympathomimetics (for example adrenaline or noradrenaline) or vasopressin with Ketamine G.L. Pharma may lead to an increase in blood pressure and heart rate.
  • Using Ketamine G.L. Pharma with ergometrine may lead to an increase in blood pressure.
  • Using Ketamine G.L. Pharma with theophylline or aminophylline may lead to an increased likelihood of seizures.

Ketamine G.L. Pharma with food and drink

It is normal not to eat or drink for at least six hours before an operation; therefore Ketamine G.L. Pharma is generally given when your stomach is empty.

If in an emergency this is not possible, Ketamine G.L. Pharma may still be used.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Driving and using machines

Ketamine may reduce your ability to react. This should be considered in situations requiring special alertness like participating in road traffic.

You should not drive, operate machines or work in dangerous situations in the first 24 hours after your anaesthesia.

If you have been treated on an out-patient basis somebody should accompany you on your way home.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine
  • However, you would not be committing an offence (called ‘statutory defence’) if:
    • The medicine has been prescribed to treat a medical or dental problem and
    • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
    • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. How Ketamine G.L. Pharma is given

Except in an emergency, Ketamine G.L. Pharma should only be used in hospitals by experienced anaesthetists with resuscitation equipment available.

How Ketamine G.L. Pharma is given to you

Ketamine G.L. Pharma is administered slowly into a vein or into a muscle.

Information for the physician: Advice for handling is at the end of this leaflet.

Before your operation you will usually be given a medicine such as atropine or hyoscine to dry up your secretions (body fluids like saliva and tears) and additionally another medicine called ‘benzodiazepine’. The benzodiazepine will help you to relax and help to prevent a side effect known as ‘emergence reaction’.

The dose of Ketamine G.L. Pharma depends on its use and varies from person to person.

Your anaesthetist will then keep you anaesthetised with either:

  • another anaesthetic
  • more ketamine given to you by injection into a muscle or vein, or in a drip (infusion)
  • ketamine together with another anaesthetic

When it is injected directly into a vein, Ketamine G.L. Pharma 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 monitor you constantly, paying particular attention to your breathing, airways, reflexes, the degree of anaesthesia and the condition of your heart. You should not be released from the hospital until you have completely recovered from the anaesthesia. If you are released on the day of the operation, you should be accompanied by another adult (see also section 2, ‘Driving and using machines’).

If you are given more Ketamine G.L. Pharma than you should

You may experience breathing difficulties. Your doctor may provide you with equipment to help you breathe.

Information for the physician: Advice for management of overdose is at the end of this leaflet.

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

4. Possible side effects

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

Tell your doctor immediately if you notice pain, inflammation of the skin or rash at the injection site.

Ketamine can sometimes cause allergic symptoms (‘anaphylaxis’) such as breathing problems, swelling and rash. Some people have hallucinations, vivid dreams, nightmares, feel ill at ease, confused, anxious or behave irrationally while recovering from anaesthesia with Ketamine G.L. Pharma. These side effects are collectively known as an ‘emergence reaction’. You will be allowed to recover from the anaesthetic in a quiet place and this helps to prevent the reaction (see section 3 under ‘How Ketamine G.L. Pharma is given’).

The following side effects have been reported:

Common (may affect up to 1 in 10 people)

  • The following, while recovering from anaesthesia (these are collectively known as an ‘emergence reaction’): hallucinations (which may include flashbacks or floating sensation), vivid dreams, nightmares, feeling agitated, confused and irrational behaviour
  • Unusual eye movements
  • Increased muscle tone and muscle twitches (which may resemble ‘fits’ or convulsions)
  • Double vision
  • Increased pulse rate, increased blood pressure
  • Breathing more quickly
  • Nausea, vomiting
  • Skin inflammation/rash

Uncommon (may affect up to 1 in 100 people)

  • Loss of appetite, feeling anxious
  • Slowing of heart rate, changes in heart rhythm
  • Lowering of blood pressure
  • Breathing more slowly, narrowing of the voice-box leading to difficulty in breathing
  • Pain or rash at the injection site

Rare (may affect up to 1 in 1 000 people)

  • Allergic symptoms (‘anaphylaxis’) such as breathing problems, swelling and rash
  • Drifting in and out of consciousness (with feeling of confusion and hallucinations), flashbacks, feeling ill at ease, sleeplessness, feeling disorientated
  • Effect on the reflexes which keep your airways clear, resulting in temporary inability to breathe
  • Increase in salivation
  • Inflammation of the bladder and/or pain when urinating (‘cystitis’), blood in the urine

Not known (frequency cannot be estimated from the available data)

  • Raised pressure in the eyes
  • Abnormal results to liver function tests
  • Drug-induced liver injury (when taken for more than 3 days)

Reporting of side effects

If you get 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 via the national reporting system:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ketamine G.L. Pharma

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

Do not freeze.

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and on the ampoule/vial after ‘EXP’. The expiry date refers to the last day of that month.

Ampoules: For single use only. Remaining solution must be discarded.

Vials: For single use only. Discard any unused product at the end of each operating session.

6. Contents of the pack and other information

What Ketamine G.L. Pharma contains

  • The active substance is: ketamine. Each mL of solution contains ketamine hydrochloride equivalent to 50 mg ketamine.
  • The other ingredients are: benzethonium chloride (vials only), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection.

What Ketamine G.L. Pharma looks like and contents of the pack

Ketamine G.L. Pharma is a clear, colourless solution for Injection/Infusion.

Packs of 2, 5, or 10 mL ampoules as well as 5, 10, or 20 mL vials in boxes of 1, 5, 10, 15, 20, 50, or 100.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

This leaflet was last revised in July 2019.