SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses.

FI, SE and NO: Nimatek vet 100 mg/ml, Solution for injection for dogs, cats and horses.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml solution contains:

Active substance:

Ketamine 100 mg

(corresponding to ketamine hydrochloride 115.4 mg)

Excipient(s):

Chlorocresol (preservative) 1 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless liquid free from visible evidence of contamination.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs, cats and horses

4.2 Indications for use, specifying the target species

The product may be used to induce anaesthesia:

Based on a benefit/risk assessment performed by the veterinarian the 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.

4.3 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 any of the excipients.

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 anaestheticsis necessary. As muscle relaxation required for surgical procedures cannot be achieved with ketamine alone, additional muscle-relaxants should be used concomitantly. For improvement of anaesthesiaor prolongation of effect ketamine can be combined with α₂-receptor-agonists, anaesthetics, neuroleptanalgesics, tranquilizers and inhalational anaestheticagents. It should be noted that time-to-full-effect may be prolonged when using the subcutaneous administration route in cats.

4.5 Special precautions for use

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 for all anaestheticsanimals should be fasted for 12 hours before 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 orusingappropriateointments.

Ketamine mayexhibitpro-convulsantandanti-convulsant properties, andthereforeshouldbeusedwithcarein patientswithseizuredisorders.

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.

People with known hypersensitivity to ketamine or any of the excipients should avoid contact with the 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 product.

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.

4.6 Adverse reactions (frequency and seriousness)

Ketamine may cause salivation in cats. Ketamine causes an increased tonus of skeletal muscles. Muscular twitching and mild tonic convulsions have been reported in the cat at recommended dose rates.

Ketamine causes a dose-related respiratory depression, which may lead to respiratory arrest particularly in cats. Combination with respiratory depressant products may increase this respiratory effect.

Ketamine increases the heart rate and increases arterial blood pressure with concurrent increased bleeding tendency.

In cats and dogs eyes remain opened with mydriasis and nystagmus.

Emergence reactions - ataxia, hypersensitivity to stimuli, excitation – may occur during recovery

There may be some pain on intramuscular injection.

4.7 Use during pregnancy and lactation

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

The use of the product has not been assessed during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

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.

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 dogs (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 bodyweight

** based on a dose rate of 15 mg ketamine/kg bodyweight

Medetomidine/ketamine

Administer medetomidine at a dose rate of 40 µg/kg (corresponding to 0.40 ml/10 kg bodyweight of medetomidine 1 mg/ml solution) and ketamineat 5.0-7.5 mg/kg (corresponding to 0.5-0.75 ml/10 kg bodyweight), 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 dogs (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 bodyweight

** based on a dose rate of 5 mg ketamine/kg bodyweight

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

Weight of dogs (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 bodyweight

** based on a dose rate of 7.5 mg ketamine/kg bodyweight

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 bodyweight).

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 dogs (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 bodyweight

** based on a dose rate of 25 µg medetomidine/kg bodyweight

*** based on a dose rate of 5 mg ketamine/kg bodyweight

CAT:

Ketamine as a sole agent

Mono-anaesthetic use of ketamine is possible, but to avoid undesired psycomotoric 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) 22-33 (0.22-0.33 ml/kg)	Minor restraint Minor surgery and restraint of fractious cats

Duration of ketamine anaesthesia is 20-40 minutes and recovery takes place over an 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 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 bodyweightof 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 bodyweight) 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 bodyweight

** based on a dose rate of 22 mg ketamine/kg bodyweight

Medetomidine/ketamine

Administer medetomidine at a dose rate of 80 µg/kg by intramuscular injection. This should be followed immediately by the intramuscular injection of ketamine a dose rate of 2.5-7.5 mg/kg (corresponding to 0.12-0.38 ml/5 kg bodyweight).

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 bodyweight

** based on a dose rate of 5 mg ketamine/kg bodyweight

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 bodyweight

** based on a dose rate of 1.25 mg ketamine/kg bodyweight

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

Butorphanol/medetomidine/ketamine

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 bodyweight) 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 bodyweight

** based on a dose rate of 80 µg medetomidine/kg bodyweight

*** based on a dose rate of 5 mg ketamine/kg bodyweight

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 bodyweight) 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 bodyweight

** based on a dose rate of 40 µg medetomidine/kg bodyweight

*** based on a dose rate of 2.5 mg ketamine/kg bodyweight

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 the 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 bodyweight of xylazine 10% solution). The horse should appear sedated by 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 bodyweight).

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 10-30 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 bodyweight

** based on a dose rate of 2.2 mg ketamine/kg bodyweight

Detomidine/ketamine

Detomidine should be administered by intravenous injection at a dose rate of 20 µg/kg. The horse should appear sedated by 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 bodyweight) 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:

Thiopental sodium may be administered intravenously to prolong anaesthesia.

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 bodyweight

** based on a dose rate of 2.2 mg ketamine/kg bodyweight

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 bodyweight

** based on a dose rate of 1.1 mg ketamine/kg bodyweight

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:

Thiopental sodium may be administered intravenously to prolong anaesthesia.

Depending on depth and duration of anaesthesia required, administer romifidine intravenously within the dose range of 25-50 µg/kg bodyweight, i.e. ¼-½ the initial premedication dose followed immediately by ketamine intravenously at a dose rate of 1.1 mg/kg bodyweight, 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 bodyweight

** based on a dose rate of 2.2 mg ketamine/kg bodyweight

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 bodyweight

** based on a dose rate of 1.1 mg ketamine/kg bodyweight

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

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.

4.11 Withdrawal period

Horse

Meat and offal: 1 day

Milk: 1 day

5. 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 properties

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

6.2 Incompatibilities

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

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 vial in the outer carton in order to protect from light

6.5 Nature and composition of 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.

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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 16849/4049

9. DATE OF FIRST AUTHORISATION

16 April 2014

10. DATE OF REVISION OF THE TEXT

April 2014

Approved: 16/04/2014