Ketamidor 100 mg/ml solution for injection for cattle, horses, sheep, pigs, goats, dogs and cats
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains -
Active substance:
Ketamine (as hydrochloride) 100.0 mg
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to almost colourless solution.
Target species
Horse, cattle, sheep, goat, pig, dog, cat
Indications for use, specifying the target species
- Short anaesthesia for diagnostic and minor surgical interventions and painful therapy
- Pre-medication to general anaesthesia before surgery
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 of liver- and kidney function.
Do not use in eclampsia, pre-eclampsia, glaucoma and epilepsy, for surgical intervention
on pharynx, larynx or bronchial tree, if sufficient relaxation by administration of a muscle
relaxant isn’t ensured (intubation obligatory).
Special warnings for each target species
In dogs ketamine can cause increase of intraocular pressure.
Increased effect:
Can be seen sporadic in young animals due to ontogenetic weakness of enzymes, as full metabolic
activity (normal activity of metabolic enzymes) is inexistent (reached not until an age of 2 – 3
months). Therefore application of only 25 – 50 % of the normal dosage is recommended (especially in
puppies).
Limited activity:
Faster metabolism of ketamine is induced by pesticides, herbicides and other
environmental toxins (chlorated hydrocarbons, hexachlorobenzoles) effected by an
induction of microsomal metabolized enzymes. Cats are likely to absorb a larger amount
of environmental harmful substances than other animals (catching of mice, licking of
coat). Repeated applications in shorter time intervals can induce a faster decomposition of
ketamine.
Special precautions for use
Special precautions for use in animals
Ketamine as a very effective anaesthetic has to be applicated according to the rules and precautions of
anaesthesia. Apnoe can occur in case of relative and absolute over-dosage.
When combined with other drugs, the relevant SPCs have to be read carefully and followed,
especially concerning contraindications, withdrawal periods and side effects.
Pre-surgical preparation:
At least 10 hours before ketamine anaesthesia the animal concerned should be fasted (valid for all
anaesthetics). Secretion inhibiting substances like atropine can be used (especially indicated in dogs
and cats). Adrenergic acting substances have to be discontinued, as an increase in blood pressure is
apparent.
Anaesthetic period:
Under ketamine anaesthesia the eyes of patients are opened. To prevent desiccation in case of longer
lasting procedures they should be protected (by using ointments).
Recovery period:
Smooth recovery, if the animal is not disturbed by noise or sudden movement; Recovery phase
prolonged - complete recovery after 2 hours, sometimes even longer. In dogs states of psychomotor
excitation with howling can rarely be observed.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In cases of accidental self-injection seek medical advice immediately and show the package leaflet or
the label to the physician.
Adverse reactions (frequency and seriousness)
Increased tonicity (due to disinhibition of extra pyramidal system), rarely tachycardia and increase of
blood pressure, salivation (due to brainstem stimulation)
As valid for all anaesthetics and narcotics, with ketamine death, even if very rarely during anaesthesia,
can occur despite correct application.
Concomitant with ketamine effect can be observed motoric excitations, opened eyes, nystagmus
(rhythmic eye movement), mydriasis (dilation of pupil) as well as increased sensibility against
accustic stimuli during anaesthesia and in the recovery period.
Use during pregnancy, lactation or lay
Pregnancy: Ketamine passes the blood-placenta barrier, thus use only accordingly to the benefit/risk
assessment by the responsible veterinarian. Ketamine should not be used in the peripartal period.
Lactation: Ketamine can be used during lactation.
Interaction with other medicinal products and other forms of interaction
Neuroleptanalgesics, tranquilizers and chloramphenicol activate ketamine anaesthesia.
Barbiturates and opiates can prolong the recovery period.
Simultaneously administered intravenous spasmolytics can provoke a collapse.
Amounts to be administered and administration route
Ketamine effect can be species specific individually different (valid for all anaesthetics),
therefore dosage accommodation is recommended. Prolongation of effect is possible by
reapplication of an eventually reduced initial dose.
Administration is possible IM or IV, in cats also SC.
In adult farming animals intravenous application is recommended.
Notice:
For very painful and major surgical interventions, as well as for maintenance of
anaesthesia, a combination with injectable- or inhalation-anaesthetics is necessary.
Necessary muscle relaxation for surgical procedures should be provided by additive use
of muscle-relaxants.
For improvement of anaesthesia or prolongation of effect ketamine can be combined
with α2-receptor-agonists (for example: detomidine, medetomidine), anaesthetics,
neuroleptanalgesics, tranquilizers and inhalation-narcotics.
Horse
A sedative pre-medication is absolute necessary for a sufficient anaesthetic effect:
Detomidine 20 µg/kg IV/IM
After 15 – 30 minutes:
ketamine 1 – 2 mg/kg fast IV (Ketamidor 10% 1 – 2 ml/100 kg)
After injection the horse lays down spontaneously without any help. If a distinct muscle
relaxation is wanted simultaneously, guaifenesin can be administered best to the lying
animal, until the horse shows first symptoms of relaxation.
For short anaesthesia (15 – 20 minutes):
Xylazine 0.6 – 1.1 mg/kg IV
After 5 – 10 minutes:
ketamine 2 mg/kg IV (Ketamidor 10% 2 ml/100 kg)
Cattle
To avoid uncontrolled lying down and possible symptoms of excitation or for potentiation
effect of anaesthesia a sedative premedication is recommended. To avoid hypoxia due to
lateral or dorsal recumbency, oxygen can be administered through a nasal catheter.
Detomidine 10 – 30 µg/kg IV/IM
After 15 – 30 minutes:
ketamine 1 – 2 mg/kg IV (Ketamidor 10% 1 – 2 ml/100 kg)
For minor surgery:
Xylazine: 0.3 mg/kg IV
After 3 – 5 minutes:
ketamine 2 mg/kg IV (Ketamidor 10% 2 ml/100 kg)
Sheep, goat
Mono-Use:
Ketamine 10 – 20 mg/kg IM/IV (Ketamidor 10% 1 – 2 ml/10 kg)
For prolongation of narcotic effect:
Repeated injection of 6 mg/kg Ketamine IM/IV (Ketamidor 10% 0.6 ml/10kg)
Pig
Mono-Use for sedation:
Ketamine 5 – 10 mg/kg IM/IV (Ketamidor 10% 0.5 – 1 ml/10 kg)
Combination-Use:
Ketamine 10 – 15 mg/kg IM/IV (Ketamidor 10% 1 - 1.5ml/10kg)
and 2 mg/kg Azaperon
Dog
Ketamine can not be used as a mono-anaesthetic in dogs, it causes an increased muscle tone and
uncoordinated muscle motions.
Combined-application for short surgical interventions (anaesthesia about 30 – 60 minutes):
Medetomidine 40 – 60 µg/kg IM/IV
After 10 – 20 minutes:
ketamine 2 – 4 mg/kg IM/IV (Ketamidor 10% 0.2 – 0.4 ml/10 kg)
or:
Xylazine 2 mg/kg IM
and ketamine 5 – 10 mg/kg IM (Ketamidor 10% 0.5 – 1 ml/10 kg)
To avoid possible excitations due to xylazine:
approx. 10 minutes before Diazepam 0.1 mg/kg IV can be administered..
Combination-Use for prolonged surgical procedures (anaesthesia > 1 hour):
Medetomidine 20 – 40 µg/kg IM/IV
After 10 – 20 minutes:
ketamine 8 – 10 mg/kg IM/IV (Ketamidor 0.8 - 1 ml/10 kg)
Cat
Mono-anaesthetic use of ketamine is possible, but to avoid undesired psychomotor effects combined
anaesthesia is recommended.
Mono-Use:
For short surgical procedures and little painful surgical procedures:
Ketamine 10 – 20 mg/kg IV/IM (Ketamidor 10% 0.5 – 1 ml/5 kg)
For more painful surgical procedures:
Ketamine 20 – 30 mg/kg IV/IM (Ketamidor 10% 1 – 1.5 ml/5 kg)
For major surgical procedures according to severity and length of surgery:
Ketamine 30 – 40 mg/kg IV/IM (Ketamidor 10% 1.5 – 2 ml/5 kg)
Combination Use (anaesthesia < 1 hour):
Medetomidine 80–100 µg/kg IM
After 10 – 20 minutes:
ketamine 5 – 7.5 mg/kg IM (Ketamidor 10% 0.25 – 0.4 ml/5 kg)
or:
Xylazine 2 mg/kg SC
and ketamine 10 mg/kg SC (Ketamidor 10% 0.5 ml/5 kg)
Overdose (symptoms, emergency procedures, antidotes), if necessary
Dosage recommendation should be followed, despite of relatively broad range of tolerance. In case of
overdosage central excitation, even spasms, respiratory paralysis and cardiac arrhythmia can occur.
Spasms can be blocked with benzodiazepines.
Overdosage can lead to breath-depression – in such case artificial respiration, massage of thorax and
oxygen-shower is superior to application of analeptics.
Withdrawal period(s)
Zero days
Incompatibilities
In the absence of compatibility studies, this veterinary product must not be mixed with other
veterinary medicinal products.
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
Special precautions for storage
This veterinary medicinal product does not require any special temperature storage conditions.
Keep the container in the outer carton in order to protect from light.
After first opening the container store below 25°C.
Nature and composition of immediate packaging
10 ml glass vial, type I (Ph. Eur.) with brombutyl-rubber stopper type I (Ph.Eur.) and aluminium
cap.
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.
