Ketamidor 100 mg/ml Solution for Injection

Composition

Each ml contains:

Active substances:

Ketamine (as hydrochloride) 100 mg

Excipients:

Clear, colourless to almost colourless solution.

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Pharmacological properties

4.1 ATCvet code: QN01AX03.

4.2 Pharmacodynamics

Ketamine is a potent dissociative anaesthetic agent. The veterinary medicinal product induces a state of catalepsy with amnesia and analgesia: muscle tone is maintained including the pharyngeal and laryngeal reflexes. The heart rate, blood pressure and cardiac output are increased; respiratory depression is not a noticeable feature.

All these characteristics may be modified if the veterinary medicinal product is used in combination with other agents.

4.3 Pharmacokinetics

Ketamine is distributed quickly and completely in the organism. It passes the placenta, but concentrations in the foetus are much lower than blood concentration in the dam. Protein binding in blood is about 50 %. Distribution in tissue is irregular, highest concentrations were found in liver and kidney. It is quickly and completely metabolised, but metabolism differs between individual animal species. Excretion is mainly renal.

In horses (after a single dose of 2.2 mg/kg i.v. ketamine) a Cmax of 685 +/- 147 ng/ml is observed, with Tmax being reached at 2h. In cattle (after a single dose of 5 mg/kg i.v.) Cmax is 18,135 ng/ml, with Tmax = 0.083 h. In pigs a Cmax of 11.6 µg/ml is observed, with Tmax being reached after 5 minutes after a single dose of 15 mg/kg i.m.. In the target animal species dog and cat after administration of 20 mg/kg i.v., peak tissue levels are 42 % of the original dose, with Tmax being reached within 10 minutes.

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Target species

Horses, cattle, pigs, dogs, cats.

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Indications

To be used as a sole agent for restraint and minor surgical procedures in the cat, where muscle relaxation is not required.

To be used to induce anaesthesia:

a) in combination with detomidine in the horse.

b) in combination with xylazine in the horse, in cattle, dog and in the cat.

c) in combination with azaperone in the pig.

d) in combination with medetomidine in the dog and cat.

e) in combination with diazepam in the dog.

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Dosage

For intravenous use (i.v.): horses, cattle, dogs and cats.

For intramuscular use (i.m.): pigs, dogs and cats.

For subcutaneous use (s.c.): cats.

Ketamine can show large inter-individual variation in effect, and therefore dose rates administered should be tailored to the individual animal, dependent on factors such as age, condition, and the depth and duration of anaesthesia required. Prolongation of effect is possible by repeated administration of an optionally reduced initial dose.

For combination use: before ketamine is administered, please ensure that the animals are adequately sedated.

Horses

Pre-medication with a sedative is required for a sufficient anaesthetic effect:

To induce anaesthesia

With detomidine

Detomidine 20 µg/kg i.v., after 5 minutes

Ketamine 2.2 mg/kg fast i.v. (2.2 ml/100 kg)

Onset of action is gradual, taking approximately 1 minute to attain recumbency, with duration of anaesthetic effect lasting approximately 10 - 15 minutes.

With xylazine

Xylazine 1.1 mg/kg i.v., followed by

Ketamine 2.2 mg/kg i.v. (2.2 ml/100 kg)

Onset of action is gradual, taking approximately 1 minute, with duration of anaesthetic effect being variable and lasting 10 - 30 minutes but usually less than 20 minutes.

After injection the horse lays down spontaneously without any further help. If a distinct muscle relaxation is required simultaneously, muscle relaxants can be administered to the recumbent animal, until the horse shows first symptoms of relaxation.

Cattle

To avoid uncontrolled lying down and possible symptoms of excitation or for potentiation of anaesthesia a sedative premedication is recommended. To avoid hypoxia due to lateral or dorsal recumbency, oxygen can be administered through a nasal tube.

To induce anaesthesia

With xylazine

Xylazine 0.14 - 0.22 mg/kg i.v./i.m., followed by

Ketamine 2 - 5 mg/kg i.v. (2 - 5 ml/100 kg)

Onset of action is approximately 1 minute, with duration of anaesthetic effect lasting approximately 30 minutes.

The lower end of the stated dose range should be used when administering xylazine via the intravenous route.

Pigs

To induce anaesthesia

With azaperone

Ketamine 15 - 20 mg/kg i.m. (1.5 - 2 ml/10 kg) and 2 mg/kg azaperone i.m..

In 4 – 5 month old pigs, following administration of 2 mg/kg azaperone and 20 mg/kg ketamine i.m., the onset of anaesthesia took on average 29 minutes and duration of effect lasted about 27 minutes.

Dogs

Ketamine cannot be used as a mono-anaesthetic in dogs, as it causes an increased muscle tone and uncoordinated muscle contractions.

To induce anaesthesia

With medetomidine

Medetomidine 40 µg/kg i.m., followed by

Ketamine 5 - 7.5 mg/kg i.m. (0.5 - 0.75 ml/10 kg)

Duration of effect varies between 30 - 50 minutes and is dose related.

With xylazine

Xylazine 2 mg/kg i.m., after 10 minutes

Ketamine 10 mg/kg i.m. (1 ml/10 kg).

In dogs weighing more than 25 kg bodyweight reduce xylazine dosage to 1.3 mg/kg.

Onset of action is usually within 10 minutes and duration of effect lasts for approximately 30 minutes.

With diazepam

Administer diazepam 0.25 mg/kg i.v., immediately followed by

Ketamine 5 mg/kg i.v. (0.5 ml/10 kg).

Ketamine should be injected slowly and generally administered to effect, when used intravenously.

Appropriate premedication should be used to ensure adequate sedation before administration of the diazepam-ketamine combination and to facilitate intubation. The optimal dosing regimen should be individually based on the pre-medication used.

Average duration of effect is 10-20 minutes.

Cats

Mono-anaesthetic use of ketamine is possible, but to avoid undesired psychomotoric effects combined anaesthesia is recommended. Ketamine on its own may be used by intravenous injection, but intramuscular injection is the recommended route.

Ketamine should be injected slowly when administered intravenously.

As a sole agent

11 mg/kg ketamine i.m./i.v. for minor restraint,

22 - 33 mg/kg ketamine i.m./i.v. for minor surgery and restraint of fractious cats.

Duration of ketamine anaesthesia is 20 – 40 minutes and recovery takes place over a 1 – 4 hour period.

To induce anaesthesia (anaesthesia < 1 hour)

With medetomidine

Medetomidine 80 µg/kg i.m., followed by

Ketamine 5 – 7.5 mg/kg i.m. (0.25 - 0.4 ml/5 kg)

Onset of action is usually 3 - 4 minutes and duration of effect varies between 30 - 60 minutes and is dose related.

With xylazine

Xylazine 1 - 2 mg/kg i.m./s.c. and

Ketamine 10 - 20 mg/kg i.m./s.c. (0.5 - 1 ml/5 kg)

The lowest dose of xylazine (1 mg/kg) should be used, if ketamine is used at the highest dose (20 mg/kg).

Onset of action is usually within 5 minutes of ketamine administration and duration of effect lasts for at least 30 minutes.

Due to low dose volumes, the use of suitably calibrated measuring equipment, e.g. an insulin type syringe, is recommended.

The rubber stopper can be punctured safely a maximum of 25 times.

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Contraindications

Do not use:

- in animals with severe cardiac de-compensation, suspected pulmonary disease, apparent high blood pressure, or cerebrovascular insults.

- in animals with pre-existing liver and kidney pathology.

- in eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g. epilepsy).

- for surgical intervention on pharynx, larynx, trachea or bronchial tree, if sufficient relaxation is not ensured by administration of a muscle relaxant (intubation obligatory).

- in animals undergoing a myelogram procedure.

Do not use in cases of hypersensitivity to the active substance or to the excipient.

Do not use the veterinary medicinal product as a sole anaesthetic agent in any other species apart from the cat.

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Adverse reactions

Horses, cattle, pigs, dogs, cats:

Rare (1 to 10 animals / 10 000 animals treated):

Tachycardia, Hypertension, Increased salivation1

Undetermined frequency (cannot be estimated from the available data):

Immediate pain upon injection2, Muscular hypertonicity3, Muscle tremor4, Convulsion4,5, Nystagmus6, Mydriasis6, Hyperaesthesia, Increased sensitivity to sound7, Excitation8, Respiratory depression9, Respiratory arrest10

1 Due to brainstem stimulation.

2 During intramuscular injection.

3 Due to disinhibition of the extra pyramidal system.

4 When no concomitant muscle relaxant is administered.

5 Tonic-clonic.

6 The eyes remain open.

7 During anaesthesia and in the recovery period.

8 Motoric.

9 Dose-related. Combination with respiratory depressant products may increase this respiratory effect.

10 Particularly in cats.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Do not reverse ketamine-medetomidine combinations in dogs and cats with atipamezole until 45 minutes after ketamine administration, when ketamine action has ceased.

Pre-surgical preparation:

As for all anaesthetics animals should be fasted for 12 hours before ketamine anaesthesia.

Anaesthetic period:

Under ketamine anaesthesia the eyes of treated animals remain open, therefore to prevent desiccation in case of longer lasting procedures they should be protected accordingly (by use of appropriate ointments).

Recovery period:

It is important that both premedication and recovery should occur in quiet and calm surroundings. Recovery usually is complete after 2 hours but may occasionally take longer. In dogs, states of psychomotoric excitation with howling can rarely be observed.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

People with known hypersensitivity to ketamine or to the excipient should avoid contact with the veterinary medicinal product.

Avoid contact with the skin and eyes. Wash any splashes from skin and eyes immediately with large amounts of water.

Adverse effects on the foetus cannot be excluded. Pregnant women should avoid handling the veterinary medicinal product.

This is a potent drug - particular care should be taken to avoid accidental self-administration.

In cases of accidental self-injection or if symptoms occur after ocular/oral contact, seek medical advice immediately and show the package leaflet or the label to the physician, but DO NOT DRIVE.

Advice to doctor:

Do not leave patient unattended. Maintain airways and give symptomatic and supportive treatment.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy:

Ketamine crosses the placental barrier. Use only according to the benefit-risk assessment by the responsible veterinarian. Ketamine should not be used in the periparturient period.

Lactation:

Use during lactation only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Neuroleptanalgesics, tranquilizers, morphine analogues, cimetidine and chloramphenicol potentiate ketamine anaesthesia.

Barbiturates and opiates or diazepam can prolong the recovery period. Effects may be additive; dosage reduction of one or both agents may be required. Potential for increased risk for arrhythmias when used in combination with thiopental or halothane. Halothane prolongs the half-life of ketamine. Simultaneously administered intravenous spasmolytics can provoke a collapse.

Theophylline with ketamine can cause an increased incidence of seizures.

The use of detomidine in combination with ketamine gives a slow recuperation.

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Overdose

In cases of overdose cardiac arrhythmia and respiratory depression up to paralysis may occur. If necessary, suitable artificial aids to maintain ventilation and cardiac output should be used until sufficient detoxification has taken place. Pharmacological cardiac stimulants are not recommended, unless no other supportive measures are available.

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Special warnings

For very painful and major surgical interventions, as well as for maintenance of anaesthesia, a combination with injectable- or inhalation-anaesthetics is necessary.

As muscle relaxation required for surgical procedures cannot be achieved with ketamine alone, additional muscle-relaxants should be used concomitantly. For improvement of anaesthesia or prolongation of effect ketamine can be combined with α2-receptor-agonists, anaesthetics, neuroleptanalgesics, tranquilizers and inhalational anaesthetic agents.

A small proportion of animals have been reported to be unresponsive to ketamine as an anaesthetic agent at normal dosages.

It should be noted that time-to-full-effect may be prolonged when using the subcutaneous administration route in cat.

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Withdrawal period

Horses and cattle:

Meat and offal: zero days

Milk: zero hours

Pigs:

Meat and offal: zero days

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Clear glass vial, type I (Ph. Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap, packed in a cardboard box.

Package sizes: 1 x 10 ml, 5 x 10 ml, 1 x 50 ml

Not all pack sizes may be marketed.

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Storage

Keep the container in the outer carton in order to protect from light. After first opening do not store above 25 °C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 28 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 57446/5005

Vm 57446/3005

8 DATE OF FIRST AUTHORISATION

07 February 2013

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

April 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 09 July 2025

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Registration holder

VetViva Richter GmbH

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