1. Name of the medicinal product
Ketalar 50 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml of solution contains:
ketamine hydrochloride equivalent to 50 mg ketamine base per ml.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Solution for Injection or Infusion
A clear solution for injection or infusion.
pervision of experienced medically qualified anaesthetists except under emergency conditions.
4. Clinical particulars
4.1 Therapeutic indications
Ketamine is indicated in children and in adults.
Ketalar is recommended:
As an anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketalar is best suited for short procedures. With additional doses, or by intravenous infusion, Ketalar can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.
For the induction of anaesthesia prior to the administration of other general anaesthetic agents.
To supplement other anaesthetic agents.
Specific areas of application or types of procedures:
When the intramuscular route of administration is preferred.
Debridement, painful dressings, and skin grafting in burned patients, as well as other superficial surgical procedures.
Neurodiagnostic procedures such as pneumoencephalograms, ventriculograms, myelograms, and lumbar punctures.
Diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions.
Note: Eye movements may persist during ophthalmological procedures.
Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided, if at all possible.
Orthopaedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies.
Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus.
Cardiac catheterization procedures.
Caesarean section; as an induction agent in the absence of elevated blood pressure.
Anaesthesia in the asthmatic patient, either to minimise the risks of an attack of bronchospasm developing, or in the presence of bronchospasm where anaesthesia cannot be delayed.
4.2 Posology and method of administration
For intravenous infusion, intravenous injection or intramuscular injection.
NOTE: All doses are given in terms of ketamine base
Adults, elderly (over 65 years) and children:
For surgery in elderly patients ketamine has been shown to be suitable either alone or supplemented with other anaesthetic agents.
Preoperative preparations
Ketalar 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 glycopyrolate) 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 Ketalar 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 intravenous injection, the patient should be in a supported position during administration. An intravenous dose of 2 mg/kg of bodyweight usually produces surgical anaesthesia within 30 seconds after injection and the anaesthetic effect usually lasts 5 to 10 minutes. An intramuscular dose of 10 mg/kg of bodyweight usually produces surgical anaesthesia within 3 to 4 minutes following injection and the anaesthetic effect usually lasts 12 to 25 minutes. Return to consciousness is gradual.