SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AT, BE, CZ, DE, EE, EL, ES, FR,HU,IE, NL, PL, PT, SI, UK:

Ketamidor 100 mg/ml solution for injection

DK, IS, SE, FI:

Ketador vet. 100 mg/ml solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Ketamine (as hydrochloride) 100 mg

Excipient:

Benzethonium chloride 0.1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless to nearly colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Horse, cattle, pig, dog, cat.

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with severe cardiac de-compensation, apparent high blood pressure, cerebrovascular insults and disorders in liver- and kidney function.

Do not use in eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g. epilepsy). Not recommended for surgical intervention on pharynx, larynx, trachea or bronchial tree, if sufficient relaxation is not ensured by administration of a muscle relaxant (intubation obligatory).

Not recommended in animals undergoing a myelogram procedure.

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

4.4 Special warnings for each target species

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.

Use of the intramuscular route of administration may be associated with pain.

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

4.5 Special precautions for use

Special precautions for use in animals

When using the product in combination with other products, the SPCs should be read carefully and all warnings and contraindications observed.

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

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

In cases of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. Do not drive.

Wash splashes from skin and eyes immediately.

Advice to doctor:

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

4.6 Adverse reactions (frequency and seriousness)

Increased muscle tonus (due to disinhibition of the extra pyramidal system), rarely tachycardia and increase of blood pressure, salivation (due to brainstem stimulation). When no concomitant muscle relaxant is administered the increased muscle tonus may cause tremors or tonic-clonic convulsions.

Concomitant effects of ketamine use may be motoric excitations, opened eyes, nystagmus (rhythmic eye movement), mydriasis (dilation of pupil) as well as increased sensibility especially against acoustic stimuli during anaesthesia and in the recovery period.

4.7 Use during pregnancy, lactation or lay

Pregnancy:

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

Lactation:

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

4.8 Interaction with other medicinal products and other forms of interaction

Neuroleptanalgesics, tranquilizers 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.

4.9 Amounts to be administered and administration route

Ketamine can show large inter-individual variation in effect, and therefore dose rates administered should be tailored to the individual animal, dependant 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.

Administration is possible intravenously (horse and cattle), intramuscularly (pig, dog and cat) or in cats also subcutaneously.

In adult farm animals intravenous application is recommended.

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

HORSE

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

To induce anaesthesia

With detomidine:

Detomidine 20 µg/kg IV,

after 5 minutes

Ketamine 2.2 mg/kg fast IV (2.2 ml/100 kg)

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

With xylazine:

Xylazine 1.1 mg/kg IV, followed by

Ketamine 2.2 mg/kg IV (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 IV/IM, followed by

Ketamine 2 - 5 mg/kg IV (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.

PIG

To induce anaesthesia

With azaperone

Ketamine 15 - 20 mg/kg IM (1.5 - 2 ml/10 kg)

and 2 mg/kg azaperone IM.

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

DOG

Ketamine can not 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 IM, followed by

Ketamine 5 - 7.5 mg/kg IM (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 IM,

after 10 minutes

Ketamine 10 mg/kg IM (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.

CAT

Mono-anaesthetic use of ketamine is possible, but to avoid undesired psychomotoric effects combined anaesthesia is recommended.

As a sole agent

11 mg/kg ketamine IM for minor restraint,

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

Onset of action is usually within 5 minutes of ketamine administration and duration of effect lasts for approximately 30 - 45 minutes.

To induce anaesthesia (anaesthesia < 1 hour)

With medetomidine

Medetomidine 80 µg/kg IM, followed by

Ketamine 5 – 7.5 mg/kg IM (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 IM/SC and

Ketamine 10 - 20 mg/kg IM/SC (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, it is recommended to use an insulin type syringe to accurately measure dosages.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case 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.

4.11 Withdrawal period(s)

Horse and cattle:

Meat and offal: zero days

Milk: zero hours

Pig:

Meat and offal: zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: General anaesthetics. ATC-vet Code: QN01AX03.

5.1 Pharmacodynamic properties

The product is a potent dissociative anaesthetic agent. The 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 product is used in combination with other agents.

5.2 Pharmacokinetic particulars

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 metabolisation differs between individual animal species. Excretion is mainly renal.

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

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

• Benzethonium chloride

• Water for injections

6.2 Incompatibilities

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

6.3 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

6.4. Special precautions for storage

Keep the container in the outer carton in order to protect from light.

After first opening do not store above 25 °C.

6.5 Nature and composition of immediate packaging

Clear glass vial, type I (Ph. Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap.

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

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

8. MARKETING AUTHORISATION NUMBER

Vm 22080/4004

9. DATE OF FIRST AUTHORISATION

07 February 2013

10. DATE OF REVISION OF THE TEXT

April 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Only on veterinary prescription.

Approved: 04/04/2016