Nimatek 100 mg/ml Solution for Injection for Dogs, Cats and Horses

Composition

Each ml contains:

Active substance:

100 mg ketamine equivalent to 115.4 mg ketamine hydrochloride

Excipient:

Chlorocresol 1 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Chlorocresol

Sodium hydroxide

Hydrochloric acid

Water for injections

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Pharmaceutical form

Solution for injection.

Clear, colourless liquid free from visible evidence of contamination.

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Pharmacological properties

Pharmacotherapeutic group: dissociative anaesthetic.

ATCvet code: QN01AX03.

5.1 Pharmacodynamic properties

Ketamine is a dissociative anaesthetic agent. Ketamine 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. Ketamine does not cause significant respiratory depression at usual doses, but at higher doses it can cause respiratory rates to decrease. All these characteristics may be modified if the product is used in combination with other agents.

5.2 Pharmacokinetic particulars

Ketamine undergoes extensive hepatic biotransformation in dogs and horses. Some hepatic metabolism occurs in cats, but normally the majority of the drug is excreted via the kidney. Recovery of ketamine after intravenous bolus is by rapid redistribution from the CNS to other tissues, primarily fat, lung, liver and kidney.

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Target species

Dogs, cats and horses

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Indications

The veterinary medicinal product may be used to induce anaesthesia:

a) in conjunction with butorphanol and medetomidine in the dog and cat,

b) in conjunction with xylazine in the dog, cat and horse,

c) in conjunction with detomidine in the horse,

d) in conjunction with romifidine in the horse.

Based on a benefit/risk assessment performed by the veterinarian the veterinary medicinal product may also be used as a sole agent for restraint and minor surgical procedures where muscle relaxation is not required in the domestic cat.

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Dosage

For use by intramuscular, subcutaneous or intravenous injection.

It should be noted that dosages and routes of administration vary widely between species.

Furthermore, the effect of ketamine may show large inter-individual differences and therefore, individual dosage accommodation is recommended.

To ensure a correct dosage, body weight should be determined as accurately as possible.

DOG:

Xylazine/ketamine

Administer xylazine at a dose rate of 1 mg/kg by intramuscular injection (corresponding to 0.5 ml/10 kg body weight of xylazine 2% solution). Immediately administer ketamine at a dose rate of 15 mg/kg by intramuscular injection (corresponding to 1.5 ml/10 kg body weight).

Dogs become recumbent in approximately 3 minutes and lose their pedal reflex in approximately 7 minutes. Duration of anaesthesia is approximately 24 minutes, the pedal reflex returning about 30 minutes following administration of the ketamine injection.

Table 1: Xylazine and ketamine canine anaesthesia (IM)

Weight of dog (kg) 1 3 5 10 15 20 25 30 40

Xylazine 2% dose (ml)* 0.05 0.15 0.25 0.50 0.75 1.00 1.25 1.50 2.00

Ketamine (100 mg/ml) dose (ml)** 0.15 0.45 0.75 1.50 2.25 3.00 3.75 4.50 6.00

* based on a dose rate of 1 mg xylazine/kg body weight ** based on a dose rate of 15 mg ketamine/kg body weight

Medetomidine/ketamine

Administer medetomidine at a dose rate of 40 µg/kg (corresponding to 0.40 ml/10 kg body weight of medetomidine 1 mg/ml solution) and ketamine at 5.0-7.5 mg/kg (corresponding to 0.5-0.75 ml/10 kg body weight), depending on duration of anaesthesia required, by intramuscular injection.

Loss of pedal reflex occurs approximately 11 minutes following injection at 5 mg ketamine/kg and 7 minutes following injection at 7.5 mg ketamine/kg. Duration of anaesthesia is approximately 30 and 50 minutes respectively.

It is NOT advisable to reverse this combination in the dog with atipamezole.

Table 2: Medetomidine and ketamine canine anaesthesia (IM): Dosage chart for 5 mg ketamine/kg (duration of anaesthesia approximately 30 min)

Weight of dog (kg) 1 3 5 10 15 20 25 30 40

Medetomidine (1 mg/ml) dose (ml)* 0.04 0.12 0.20 0.40 0.60 0.80 1.00 1.20 1.60

Ketamine (100 mg/ml) dose (ml)** 0.05 0.15 0.25 0.50 0.75 1.00 1.25 1.50 2.00

* based on a dose rate of 40 µg medetomidine/kg body weight ** based on a dose rate of 5 mg ketamine/kg body weight

Table 3: Medetomidine and ketamine canine anaesthesia (IM): Dosage chart for 7.5 mg ketamine/kg (duration of anaesthesia approximately 50 min)

Weight of dog (kg) 1 3 5 10 15 20 25 30 40

Medetomidine (1 mg/ml) dose (ml)* 0.04 0.12 0.20 0.40 0.60 0.80 1.00 1.20 1.60

Ketamine (100 mg/ml) dose (ml)** 0.08 0.23 0.38 0.75 1.13 1.50 1.88 2.25 3.00

* based on a dose rate of 40 µg medetomidine/kg body weight ** based on a dose rate of 7.5 mg ketamine/kg body weight

Butorphanol/medetomidine/ketamine

Administer butorphanol at 0.1 mg/kg and medetomidine at 25 µg/kg by intramuscular injection.

Dogs become recumbent in approximately 6 minutes and lose their pedal reflex in approximately 14 minutes.

Ketamine injection should be administered 15 minutes following the first injection at a dose rate of 5 mg/kg by intramuscular injection (corresponding to 0.5 ml/10 kg body weight).

The pedal reflex returns approximately 53 minutes following administration of the ketamine injection. Sternal recumbency is attained approximately 35 minutes later followed by standing a further 36 minutes later.

It is NOT advisable to reverse this combination in the dog with atipamezole.

Table 4: Butorphanol, medetomidine and ketamine canine anaesthesia (IM)

Weight of dog (kg) 1 3 5 10 15 20 25 30 40

Butorphanol (10 mg/ml) dose (ml)* 0.01 0.03 0.05 0.10 0.15 0.20 0.25 0.30 0.40

Medetomidine (1 mg/ml) dose (ml)** 0.03 0.08 0.13 0.25 0.38 0.50 0.63 0.75 1.00

Administer butorphanol and medetomidine by intramuscular injection at the above dose rates

Wait 15 minutes before administering ketamine by intramuscular injection at the dose rates below

Ketamine (100 mg/ml) dose (ml)*** 0.05 0.15 0.25 0.50 0.75 1.00 1.25 1.50 2.00

* based on a dose rate of 0.1 mg butorphanol/kg body weight ** based on a dose rate of 25 µg medetomidine/kg body weight *** based on a dose rate of 5 mg ketamine/kg body weight

CAT:

Ketamine as a sole agent

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 or subcutaneous injection, but intramuscular injection is the recommended route. The dose is 11-33 mg ketamine/kg depending on the degree of restraint or surgical interference that is intended. The following dosages are indicated as a guide but may need to be adjusted depending on the physical condition of the patient and the usage of sedatives and premedicants.

Dose (mg/kg) Clinical procedures

11 (0.11 ml/kg) Minor restraint

22-33 (0.22-0.33 ml/kg) 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.

For major surgery, ketamine should be used in conjunction with supplemental sedatives or anaesthetics. Dosage varies from 1.25-22 mg/kg (0.06-1.1 ml/5 kg) depending on the combination and route of administration used.

Vomiting is unlikely to occur when ketamine is used alone, however, cats should be starved for several hours prior to anaesthesia where possible.

Ketamine supplementary combination in the cat:

Acepromazine can be administered by intramuscular injection, as premedication. Endotracheal intubation can be achieved during ketamine anaesthesia. Inhalation anaesthesia may be maintained by suitable combinations of isoflurane, methoxyflurane, halothane, nitrous oxide and oxygen.

Xylazine/ketamine

Administer xylazine at a dose rate of 1.1 mg/kg (corresponding to 0.28 ml/5 kg body weight of xylazine 2% solution) by intramuscular injection.

Wait 20 minutes and then administer ketamine at a dose rate of 22 mg/kg (corresponding to 1.1 ml/5 kg body weight) by intramuscular injection.

Xylazine may induce vomiting up to 20 minutes after administration. Onset of anaesthesia after intramuscular injection of ketamine takes some 3-6 minutes. A xylazine/ketamine combination produces a deeper anaesthesia with more pronounced respiratory and cardiac effects and a longer recovery period than acepromazine/ketamine combinations.

Table 5: Xylazine and ketamine feline anaesthesia (IM)

Weight of cat (kg) 1.5 2 2.5 3 3.5 4 4.5 5

Xylazine 2% dose (ml)* 0.08 0.11 0.14 0.17 0.19 0.22 0.25 0.28

Wait 20 minutes

Ketamine (100 mg/ml) dose (ml)** 0.33 0.44 0.55 0.66 0.77 0.88 0.99 1.10

* based on a dose rate of 1.1 mg xylazine/kg body weight ** based on a dose rate of 22 mg ketamine/kg body weight

Medetomidine/ketamine

a) intramuscular

Administer medetomidine at a dose rate of 80 µg/kg by intramuscular injection. This should be followed immediately by the intramuscular injection of ketamine at a dose rate of 2.5-7.5 mg/kg (corresponding to 0.12-0.38 ml/5 kg body weight). Onset of anaesthesia is 3-4 minutes. The duration of surgical anaesthesia varies between 30-60 minutes and is related to the dose of ketamine used. If required, anaesthesia may be prolonged with halothane and oxygen with or without nitrous oxide.

Table 6: Medetomidine and ketamine feline anaesthesia (IM)

Weight of cat (kg) 1.5 2 2.5 3 3.5 4 4.5 5

Medetomidine (1 mg/ml) dose (ml)* 0.12 0.16 0.20 0.24 0.28 0.32 0.36 0.40

Ketamine (100 mg/ml) dose (ml)** 0.08 0.10 0.13 0.15 0.18 0.20 0.23 0.25

* based on a dose rate of 80 µg medetomidine/kg body weight ** based on a dose rate of 5 mg ketamine/kg body weight

b) intravenous

Medetomidine and ketamine may be administered together by intravenous injection at the following dose rates: 40 µg medetomidine /kg and 1.25 mg ketamine/kg. Clinical experience has shown that when ketamine and medetomidine have been used intravenously in cats and the need for anaesthesia has passed, administration of 100 µg atipamezole/kg by intramuscular injection results in recovery to sternal recumbency in approximately 10 minutes and to standing in approximately 14 minutes.

Table 7: Medetomidine and ketamine feline anaesthesia (IV)

Weight of cat (kg) 1.5 2 2.5 3 3.5 4 4.5 5

Medetomidine (1 mg/ml) dose (ml)* 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20

Ketamine (100 mg/ml) dose (ml)** 0.02 0.03 0.03 0.04 0.05 0.05 0.06 0.06

* based on a dose rate of 40 µg medetomidine/kg body weight ** based on a dose rate of 1.25 mg ketamine/kg body weight

Use of either insulin syringes or 1 ml graduated syringes is recommended to ensure accurate dosing.

Butorphanol/medetomidine/ketamine

a) intramuscular

Administer butorphanol at a dose rate of 0.4 mg/kg, medetomidine at a dose rate of 80 µg/kg and ketamine at a dose rate of 5 mg/kg (corresponding to 0.25 ml/5 kg body weight) by intramuscular injection.

Cats become recumbent in 2-3 minutes following injection. Loss of pedal reflex occurs 3 minutes post injection. At 45 minutes post induction, reversal with 200 µg atipamezole/kg results in return of pedal reflex 2 minutes later, sternal recumbency 6 minutes later and standing 31 minutes later.

Table 8: Butorphanol, medetomidine and ketamine feline anaesthesia (IM)

Weight of cat (kg) 1.5 2 2.5 3 3.5 4 4.5 5

Butorphanol (10 mg/ml) dose (ml)* 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20

Medetomidine (1 mg/ml) dose (ml)** 0.12 0.16 0.20 0.24 0.28 0.32 0.36 0.40

Ketamine (100 mg/ml) dose (ml)*** 0.08 0.10 0.13 0.15 0.18 0.20 0.23 0.25

* based on a dose rate of 0.4 mg butorphanol/kg body weight ** based on a dose rate of 80 µg medetomidine/kg body weight *** based on a dose rate of 5 mg ketamine/kg body weight

b) intravenous

Administer butorphanol at a dose rate of 0.1 mg/kg, medetomidine at a dose rate of 40 µg/kg and ketamine, depending on depth of anaesthesia required, at a dose rate of 1.25-2.5 mg/kg (corresponding to 0.06-0.13 ml/5 kg body weight) by intravenous injection.

Approximate time scales when using the triple combination intravenously:

Ketamine dose (mg/kg)* Time to recumbency Time to loss of pedal reflex Time to return of pedal reflex Time to sternal recumbency Time to standing

1.25 32 sec 62 sec 26 min 54 min 74 min

2.50 22 sec 39 sec 28 min 62 min 83 min

* in conjunction with butorphanol at 0.1 mg/kg and medetomidine at 40 µg/kg

Clinical experience has shown that reversal, at any stage, with 100 µg atipamezole/kg results in return of the pedal reflex 4 minutes later, sternal recumbency 7 minutes later and standing 18 minutes later.

Table 9: Butorphanol, medetomidine and ketamine feline anaesthesia (IV): Dosage chart for 2.5 mg/kg ketamine (duration of anaesthesia approximately 28 minutes)

Weight of cat (kg) 1.5 2 2.5 3 3.5 4 4.5 5

Butorphanol (10 mg/ml) dose (ml)* 0.02 0.02 0.03 0.03 0.04 0.04 0.05 0.05

Medetomidine (1 mg/ml) dose (ml)** 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20

Ketamine (100 mg/ml) dose (ml)*** 0.04 0.05 0.06 0.08 0.09 0.10 0.11 0.13

* based on a dose rate of 0.1 mg butorphanol/kg body weight ** based on a dose rate of 40 µg medetomidine/kg body weight *** based on a dose rate of 2.5 mg ketamine/kg body weight

HORSE:

For the production of short-term anaesthesia suitable for minor surgical interferences or for induction prior to inhalation anaesthesia. When romifidine or detomidine are used as the premedicant, anaesthesia may also be maintained with a ‘top-up’ combination of either romifidine and ketamine or detomidine and ketamine at regular 8-10 minute intervals. Ketamine should never be used as a sole anaesthetic agent. It is generally accepted as good anaesthetic practice to starve animals for a period prior to anaesthesia where possible.

To achieve the best results, it is important that horses are not stressed before the anaesthetic. It is equally important that the whole procedure, from induction to recovery, should take place in quiet and calm surroundings.

For horses that are stressed before the procedure, the use of acepromazine 45 minutes prior to administration of either detomidine or romifidine facilitates handling and placement of an intravenous catheter.

If the horse fails to become sedated following the injection of either xylazine, detomidine or romifidine, then ketamine should not be injected and the anaesthetic procedure should be abandoned. The situation should be assessed to establish why the horse failed to respond, and then the environment and/or the drugs should be adjusted as necessary, before trying again the following day.

When using a total intravenous technique and for safe and effective use of a top-up regime, the use of an intravenous catheter is strongly advised.

During castration it has been noted that the use of 10 ml lidocaine divided between the testicles eliminates the possible response to ligation of the testicular cord and minimises the number of top-ups required.

Xylazine/ketamine

Xylazine should be administered by slow intravenous injection at a dose rate of 1.1 mg/kg (corresponding to 1.1 ml/100 kg body weight of xylazine 10% solution). The horse should appear sedated within 2 minutes post injection. Injection of ketamine should be administered at this stage. It is recommended not to delay the ketamine injection longer than 5 minutes after xylazine administration. Ketamine should be administered as an intravenous bolus at a dose rate of 2.2 mg/kg (corresponding to 2.2 ml/100 kg body weight).

Induction and recumbency take some 1-2 minutes. Muscle jerking may occur in the first minutes, but this usually subsides.

Anaesthesia is variable in duration, lasting between 10 and 30 minutes, but usually less than 20 minutes. Horses invariably stand 25-45 minutes after induction. Recovery is generally quiet, but may occur suddenly. It is important therefore that short duration interferences only are attempted, or arrangements to prolong anaesthesia are made. For longer periods of anaesthesia, intubation and maintenance by inhalation anaesthesia can be used.

Table 10: Xylazine and ketamine equine anaesthesia (IV)

Weight of horse (kg) 50 100 150 200 250 300 400 500 600

Xylazine 10% dose (ml)* 0.60 1.10 1.70 2.20 2.80 3.30 4.40 5.50 6.60

Wait 2 minutes

Ketamine (100 mg/ml) dose (ml)** 1.10 2.20 3.30 4.40 5.50 6.60 8.80 11.00 13.20

* based on a dose rate of 1.1 mg xylazine/kg body weight ** based on a dose rate of 2.2 mg ketamine/kg body weight

Detomidine/ketamine

Detomidine should be administered by intravenous injection at a dose rate of 20 µg/kg. The horse should appear sedated within five minutes post injection. At this stage ketamine should be administered at a dose rate of 2.2 mg/kg (corresponding to 2.2 ml/100 kg body weight) as an intravenous bolus.

Onset of anaesthesia is gradual; most horses take approximately 1 minute to become recumbent. Large, fit horses may take up to 3 minutes for recumbency. Anaesthesia continues to deepen for a further 1-2 minutes and during this time the horse should be left quietly. Horses regain sternal recumbency approximately 20 minutes post ketamine injection giving a surgical anaesthesia duration of 10-15 minutes.

Maintenance of surgical anaesthesia

Should it become necessary to prolong anaesthesia, either of the following regimes may be used:

a) Thiopental sodium

Thiopental sodium may be administered intravenously to prolong anaesthesia.

b) Detomidine/ketamine

Administer 10 µg detomidine/kg, i.e. ½ the initial premedication dose by intravenous injection, followed immediately by 1.1 mg ketamine/kg, i.e. ½ the initial induction dose by intravenous injection. This will provide approximately 10 minutes additional surgical anaesthesia, which can be repeated at regular 10 minute intervals (up to 5 times) without compromising recovery.

Table 11: Detomidine and ketamine equine anaesthesia (IV): Premedication and induction of anaesthesia

Weight of horse (kg) 50 100 150 200 250 300 400 500 600

Detomidine (10 mg/ml) dose (ml)* 0.10 0.20 0.30 0.40 0.50 0.60 0.80 1.00 1.20

Wait 5 minutes

Ketamine (100 mg/ml) dose (ml)** 1.10 2.20 3.30 4.40 5.50 6.60 8.80 11.00 13.20

* based on a dose rate of 20 µg detomidine/kg body weight ** based on a dose rate of 2.2 mg ketamine/kg body weight

Table 12: Detomidine and ketamine equine anaesthesia (IV): Maintenance (top- up) dose at 10 minute intervals

Weight of horse (kg) 50 100 150 200 250 300 400 500 600

Detomidine (10 mg/ml) dose (ml)* 0.05 0.10 0.15 0.20 0.25 0.30 0.40 0.50 0.60

Ketamine (100 mg/ml) dose (ml)** 0.55 1.10 1.65 2.20 2.75 3.30 4.40 5.50 6.60

* based on a dose rate of 10 µg detomidine/kg body weight ** based on a dose rate of 1.1 mg ketamine/kg body weight

Romifidine/ketamine

Romifidine should be administered by intravenous injection at a dose rate of 100 µg/kg. The horse should appear sedated by five to ten minutes post injection. At this stage ketamine should be administered at a dose rate of 2.2 mg/kg (corresponding to 2.2 ml/100 kg) as an intravenous bolus. Sedation should be apparent before the induction of anaesthesia.

Maintenance of surgical anaesthesia

Should it become necessary to prolong anaesthesia, either of the following regimes may be used:

a) Thiopental sodium

Thiopental sodium may be administered intravenously to prolong anaesthesia.

b) Romifidine/ketamine

Depending on depth and duration of anaesthesia required, administer romifidine intravenously within the dose range of 25-50 µg/kg body weight, i.e. ¼-½ the initial premedication dose followed immediately by ketamine intravenously at a dose rate of 1.1 mg/kg body weight, i.e. ½ the initial induction dose. Each top-up lasts approximately 8-10 minutes and can be repeated at regular 8-10 minute intervals (up to 5 times) without compromising recovery.

Table 13: Romifidine and ketamine equine anaesthesia (IV): Premedication and induction of anaesthesia

Weight of horse (kg) 50 100 150 200 250 300 400 500 600

Romifidine (10 mg/ml) dose (ml)* 0.50 1.00 1.50 2.00 2.50 3.00 4.00 5.00 6.00

Wait 5-10 minutes

Ketamine (100 mg/ml) dose (ml)** 1.10 2.20 3.30 4.40 5.50 6.60 8.80 11.00 13.20

* based on a dose rate of 100 µg romifidine/kg body weight ** based on a dose rate of 2.2 mg ketamine/kg body weight

Table 14: Romifidine and ketamine equine anaesthesia (IV): Maintenance (top- up) dose at 8-10 minute intervals

Weight of horse (kg) 50 100 150 200 250 300 400 500 600

Romifidine (10 mg/ml) dose (ml)* 0.25 0.50 0.75 1.00 1.25 1.50 2.00 2.50 3.00

Ketamine (100 mg/ml) dose (ml)** 0.55 1.10 1.65 2.20 2.75 3.30 4.40 5.50 6.60

* based on a dose rate of 50 µg romifidine/kg body weight ** based on a dose rate of 1.1 mg ketamine/kg body weight

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Contraindications

Do not use in animals with hepatic or renal failure.

Do not use ketamine as a sole agent in the horse or the dog.

Do not use in animals with severe cardiac de-compensation, apparent high blood pressure or glaucoma.

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

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Hypertonia (of skeletal muscles). Ataxia, hyperaesthesia, excitation (as emergence reactions during recovery).

Undetermined frequency (cannot be estimated from the available data): Increased heart rate, increased arterial blood pressure/hypertension (with concurrent increased bleeding tendency). Eyes remain open with mydriasis and nystagmus. Injection site pain (on intramuscular injection). Respiratory depressiona.

Cats:

Rare (1 to 10 animals / 10,000 animals treated): Hypertonia (of skeletal muscles). Ataxia, hyperaesthesia, excitation (as emergence reactions during recovery).

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Hypersalivation.

Undetermined frequency (cannot be estimated from the available data): Increased heart rate, increased arterial blood pressure/hypertension (with concurrent increased bleeding tendency). Eyes remain open with mydriasis and nystagmus. Injection site pain (on intramuscular injection). Respiratory depressiona. Twitching (muscle tremor), tonic seizures (mild)b.

Horses:

Rare (1 to 10 animals / 10,000 animals treated): Hypertonia (of skeletal muscles). Ataxia, hyperaesthesia, excitation (as emergence reactions during recovery).

Undetermined frequency (cannot be estimated from the available data): Increased heart rate, increased arterial blood pressure/hypertension (with concurrent increased bleeding tendency). Injection site pain (on intramuscular injection). Respiratory depressiona.

a Dose-related, may lead to respiratory arrest particularly in cats. Combination with respiratory depressant products may increase this respiratory effect.

b These subside spontaneously but may be prevented by use of acepromazine or xylazine premedication, or controlled by use of acepromazine or ultra-short acting barbiturates in low doses.

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 the national competent authority via the national reporting system. See package leaflet for respective contact details.

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Warnings

Special precautions for use in animals A small proportion of animals have been reported to be unresponsive to ketamine as an anaesthetic agent at normal dosages. Use of premedicants should be followed by a suitable reduction in dosage.

Induction and recovery should be allowed to occur in quiet and calm surroundings. As with all anaesthetics, animals should be fasted for an appropriate duration (as determined by the responsible veterinary surgeon) prior to ketamine anaesthesia.Atropine premedication may reduce salivation in cats. Since use of atropine with alpha-2-agonists, which are often administered with ketamine, may increase arterial blood pressure, heart rate and the incidence of arrhythmias, atropine premedication should only be used according to a benefit:risk assessment by the responsible veterinarian.

Muscular twitching and mild tonic convulsions have been reported in the cat at recommended dose rates. These subside spontaneously but may be prevented by use of acepromazine or xylazine premedication, or controlled by use of acepromazine or ultra-short acting barbiturates in low doses.

In the cat and dog, the eyes remain open and the pupils dilated. The eyes may be protected by covering with a damp gauze swab or using appropriate ointments. Ketamine may exhibit pro-convulsant and anti-convulsant properties, and therefore should be used with care in patients with seizure disorders.

Ketamine may increase intracranial pressure and therefore, may not be suitable for patients with cerebrovascular insults.

When used in combination with other products, consult the contraindications and warnings that appear on the relevant data sheets.

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. Preferably use a guarded needle until the moment of injection. People with known hypersensitivity to ketamine or any of the excipients 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. The veterinary medicinal product should not be administered by pregnant women.

In case 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 doctors:

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

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

Ketamine passes the blood-placenta-barrier very well to enter the foetal blood circulation, in which 75 to 100% of maternal blood levels can be reached. This partially anaesthetises neonates when delivered by Caesarean section.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

Care should be taken when using ketamine-halothane combinations since half-life of ketamine is prolonged. Neuroleptanalgesics, tranquilizers and chloramphenicol potentiate ketamine anaesthesia. Barbiturates and opiates can prolong the recovery period. Ketamine has been reported to enhance the occurrence of tachycardia and hypertension when used in human patients receiving thyroid hormones.

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Overdose

In excessive doses, significant respiratory depression may occur. If necessary, suitable artificial aids to maintain ventilation and cardiac output should be used until sufficient detoxification has taken place to enable a return to adequate spontaneous ventilation and cardiac activity. 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, tranquillisers and inhalational anaesthetic agents. It should be noted that time-to-full-effect may be prolonged when using the subcutaneous administration route in cats.

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Withdrawal period

Horse Meat and offal: 1 day Milk: 24 hours

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Incompatibilities

Do not mix with any other veterinary medicinal product, except the infusion fluids: 0.9% sodium chloride, Ringer’s solution and lactated Ringer’s solution.

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Immediate packaging

Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 5 ml, 10 ml, 20 ml, 25 ml, 30 ml and 50 ml.

1 vial in a cardboard box.

Not all pack sizes may be marketed.

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Storage

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

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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

product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 16849/5001

9 DATE OF FIRST AUTHORISATION

16 April 2014

10 DATE OF REVISION OF THE TEXT

July 2023

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved: 25 July 2023

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Registration holder

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

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