Patient leaflet - KETAMINE G.L. PHARMA 50 MG / ML SOLUTION FOR INJECTION/INFUSION IN VIALS
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.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor.
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– 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
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1. What Ketamine G.L. Pharma is and what it is used for
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2. What you need to know before you are given Ketamine G.L. Pharma
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3. How Ketamine G.L. Pharma is given
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4. Possible side effects
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5. How to store Ketamine G.L. Pharma
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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- if you are allergic to ketamine or any of the other ingredients of this medicine (listed in section 6)
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– 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
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– 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
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– if you have recently suffered a stroke or serious head or brain injury
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– if you have severe heart disease
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– Ketamine G.L. Pharma in vials (because of the content of an excipient in the vials,
named ‘benzethonium chloride’):
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– if you are a child or an adolescent
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– for infusion (in all patient populations)
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– 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
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– have a history of drug abuse or addiction
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– have a history of or have current mental health problems
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– have a chest infection or problems breathing
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– have problems with your liver
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– have an inherited disease that affects the blood (porphyria)
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– have had any injury to your head or abnormal growth in the brain
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– have increased pressure in your eye (glaucoma)
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– drink large amounts of alcohol
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– are receiving treatment for your thyroid gland
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– 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.
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– When used for an operation on the chest or abdominal organs, ketamine is usually combined with a pain-killer.
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– Tell your doctor if you are taking
o barbiturates (a certain type of sleeping pills, e.g. thiopental)
o 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.
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– Diazepam can increase the effects of Ketamine G.L. Pharma so dose adjustments may be needed.
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– 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.
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– Using Ketamine G.L. Pharma with ergometrine may lead to an increase in blood pressure.
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– 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:
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– The medicine has been prescribed to treat a medical or dental problem and
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– You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
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– 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:
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– another anaesthetic
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– more ketamine given to you by injection into a muscle or vein, or in a drip (infusion)
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– 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)
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– 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
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– Unusual eye movements
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– Increased muscle tone and muscle twitches (which may resemble ‘fits’ or convulsions)
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– Double vision
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– Increased pulse rate, increased blood pressure
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– Breathing more quickly
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– Nausea, vomiting
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– Skin inflammation/rash
Uncommon (may affect up to 1 in 100 people)
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– Loss of appetite, feeling anxious
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– Slowing of heart rate, changes in heart rhythm
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– Lowering of blood pressure
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– Breathing more slowly, narrowing of the voice-box leading to difficulty in breathing
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– Pain or rash at the injection site
Rare (may affect up to 1 in 1 000 people)
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– Allergic symptoms (‘anaphylaxis’) such as breathing problems, swelling and rash
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– Drifting in and out of consciousness (with feeling of confusion and hallucinations),
flashbacks, feeling ill at ease, sleeplessness, feeling disorientated
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– Effect on the reflexes which keep your airways clear, resulting in temporary inability to breathe
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– Increase in salivation
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– Inflammation of the bladder and/or pain when urinating (‘cystitis’), blood in the urine
Not known (frequency cannot be estimated from the available data)
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– Raised pressure in the eyes
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– Abnormal results to liver function tests
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– 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:
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- the active substance is: ketamine. each ml of solution contains ketamine hydrochloride equivalent to 50 mg ketamine.
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– 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.
The following information is intended for healthcare professionals only:
Note
All doses are given in terms of ketamine base.
Preoperative preparations
Ketamine has been safely used alone when the stomach was not empty. However, since the need for supplemental agents and muscle relaxants cannot be predicted, when preparing for elective surgery it is advisable that nothing be given by mouth for at least six hours prior to anaesthesia.
Premedication with an anticholinergic agent (e.g. atropine, hyoscine or glycopyrrolate) or another drying agent should be given at an appropriate interval prior to induction to reduce ketamine-induced hypersalivation.
Midazolam, diazepam, lorazepam, or flunitrazepam used as a premedicant or as an adjunct to ketamine, have been effective in reducing the incidence of emergence reactions.
Onset and duration
As with other general anaesthetic agents, the individual response to ketamine is somewhat varied depending on the dose, route of administration, age of patient, and concomitant use of other agents, so that dosage recommendation cannot be absolutely fixed. The dose should be titrated against the patient's requirements.
Because of rapid induction following i.v. injection, the patient should be in a supported position during administration. An i.v. dose of 2 mg/kg of bodyweight usually produces surgical anaesthesia within 30 seconds after injection and the anaesthetic effect usually lasts 5–10 minutes. An i.m. dose of 10 mg/kg of bodyweight usually produces surgical anaesthesia within 3–4 minutes following injection and the anaesthetic effect usually lasts 12–25 minutes. Return to consciousness is gradual.
A. Ketamine G.L. Pharma as the sole anaesthetic agent
Intravenous infusion
The use of Ketamine G.L. Pharma by continuous infusion enables the dose to be titrated more closely, thereby reducing the amount of drug administered compared with intermittent administration. This results in a shorter recovery time and better stability of vital signs.
A solution containing 1 mg/mL of ketamine is suitable for administration by infusion.
For the preparation of an infusion the following solutions are suitable:
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– sodium chloride 0.9% solution for injection
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– sodium chloride and dextrose solution for injection (sodium chloride 0.18% w/v and dextrose 4% w/v)
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– Ringer’s solution for injection
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– Lactated Ringer’s solution for injection
General anaesthesia induction
An infusion corresponding to 0.5–2 mg/kg as total induction dose.
Maintenance of anaesthesia
Anaesthesia may be maintained using a microdrip infusion of 10–45 microgram/kg/min (approximately 1–3 mg/min). The rate of infusion will depend on the patient's reaction and response to anaesthesia. The dosage required may be reduced when a long acting neuromuscular blocking agent is used.
Intermittent injection
Induction
lntravenous route
The initial dose of ketamine administered i.v. may range from 1–4.5 mg/kg body weight (in terms of ketamine base). The average amount required to produce 5–10 minutes of surgical anaesthesia has been 2.0 mg/kg. It is recommended that i.v. administration be accomplished slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.
Dosage in obstetrics
In obstetrics, for vaginal delivery or in caesarean section, i.v. doses ranging from 0.21.0 mg/kg are recommended.
Intramuscular route
The initial dose of Ketamine G.L. Pharma administered intramuscularly may range from 6.513 mg/kg (in terms of ketamine base). A low initial intramuscular dose of 4 mg/kg has been used in diagnostic manoeuvres and procedures not involving intensely painful stimuli. A dose of 10 mg/kg will usually produce 12–25 minutes of surgical anaesthesia.
Dosage in obstetrics
Data are lacking for intramuscular injection and maintenance infusion of ketamine in the parturient population, and recommendations cannot be made.
Maintenance of generaI anaesthesia
Lightening of anaesthesia may be indicated by nystagmus, movements in response to stimulation, and vocalization. Anaesthesia is maintained by the administration of additional doses of Ketamine G.L. Pharma by either the intravenous or intramuscular route.
Each additional dose is from % to the full induction dose recommended above for the route selected for maintenance, regardless of the route used for induction.
The larger the total amount of ketamine administered, the longer will be the time to complete recovery. Purposeless and tonic-clonic movements of extremities may occur during the course of anaesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anaesthetic.
B. Ketamine G.L. Pharma as induction agent prior to the use of other general anaesthetics
lnduction is accomplished by a full intravenous or intramuscular dose of ketamine as defined above. If Ketamine G.L. Pharma has been administered intravenously and the principal anaesthetic is slow-acting, a second dose of Ketamine G.L. Pharma may be required 5–8 minutes following the initial dose. If Ketamine G.L. Pharma has been administered intramuscularly and the principal anaesthetic is rapid-acting, administration of the principal anaesthetic may be delayed up to 15 minutes following the injection of Ketamine G.L. Pharma.
C. Ketamine G.L. Pharma as supplement to anaesthetic agents
Ketamine G.L. Pharma is clinically compatible with the commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained. The dose of Ketamine G.L. Pharma for use in conjunction with other anaesthetic agents is usually in the same range as the dosage stated above; however, the use of another anaesthetic agent may allow a reduction in the dose of ketamine.
D. Management of patients in recovery
Following the procedure the patient should be observed but left undisturbed. This does not preclude the monitoring of vital signs. lf, during the recovery, the patient shows any indication of emergence delirium, consideration may be given to the use of diazepam (5–10 mg i.v. in an adult). A hypnotic dose of a thiobarbiturate (50–100 mg i.v.) may be used to terminate severe emergence reactions. If any one of these agents is employed, the patient may experience a longer recovery period.
Special populations
Paediatric population
Ketamine G.L. Pharma in vials must not be used in the paediatric population.
Elderly (over 65 years)
For surgery in elderly patients ketamine has been shown to be suitable either alone or supplemented with other anaesthetic agents.
Hepatic impairment
Dose reductions should be considered in patients with cirrhosis or other types of liver impairment.
Method of administration
Intravenous or intramuscular use.
Intravenous infusion after dilution.
For instructions on dilution of the medicinal product before administration as an infusion, see below.
For special restrictions for vials in the paediatric population, for intravenous infusion and for volumes larger than 15 ml, see section 2, ‘You should not be given Ketamine G.L. Pharma’.
Instructions for handling
Use only if the solution is clear and colourless and without precipitation.
Ketamine must not be mixed with barbiturates and diazepam in the same syringe or infusion solution since it is chemically incompatible because of formation of precipitate.
No evidence of incompatibility was observed between Ketamine G.L. Pharma and representative brands of injectable forms of the following drugs when stored over a 48 hour period at ambient temperature using sodium chloride 0.9% solution for injection as diluent – morphine hydrochloride
oxycodone hydrochloride hydromorphone hydrochloride
For the preparation of an infusion the following solutions are suitable:
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– sodium chloride 0.9% solution for injection
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– sodium chloride and dextrose solution for injection (sodium chloride 0.18% w/v and dextrose 4% w/v)
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– Ringer’s solution for injection
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– Lactated Ringer’s solution for injection
Overdose
Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of ketamine (up to 10 times that usually required) have been followed by prolonged but complete recovery.
Symptoms
Respiratory depression can result from an overdosage of ketamine.
Management
Supportive ventilation should be employed. Mechanical support of respiration that will maintain adequate blood oxygen saturation and carbon dioxide elimination is preferred to administration of analeptics.