Ketamina Biowet Puławy

Ketamina 10%

100 mg/ml, injection solution for anaesthesia in surgery for dogs and cats

 

Active substance and excipient content

1 ml contains:

 

Active substance:

Ketamine 100 mg

(in the form of ketamine hydrochloride 115.34 mg))

 

Excipient:

Chlorobutanol hemihydrate         3 mg

 

Therapeutic indications

Short-lasting general anaesthesia for minor procedures requiring analgesia such as: removal of tartar, removal of foreign bodies from the oral cavity and the oesophagus, incision of abscesses, dressing change, x-ray examinations, clinical examinations of aggressive and excitable animals.
Full anaesthesia with premedication using anaesthetics to achieve general anaesthesia, for example in operations of fractures, reduction of dislocation, castration, amputation, caesarean section, laparotomy.

 

Contraindications

Do not use in animals with circulatory insufficiency, hypertension, hepatic or renal damage.
Do not use in animals with epilepsy, ocular hypertension, open-globe injuries and head injuries.
Do not use in the case of hypersensitivity to ketamine or chlorobutanol.

 

Adverse reactions

Ketamine causes hypertension, tachycardia, moderate respiratory depression, may cause a cardiac arrest.
Ketamine administration might be followed by: increased salvation, increased muscle tone, possible vomiting, convulsions, spastic movements and tonic spasms, nystagmus and pupil dilation as well as pulmonary oedema.
Disappearance of blink reflexes after ketamine administration may lead to corneal dryness. Vocalisation may occur during recovery.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).

 

Posology for each species, routes and methods of administration

Ketamine is administered intravenously or intramuscularly. Before administration of ketamine, perform premedication using atropine in the dose of 0.05 mg/kg b.w. intramuscularly or subcutaneously.

 

Dosage for dogs:
2-5 mg of ketamine/kg b.w. intravenously

5-15 mg of ketamine/kg b.w. intramuscularly

 

Dosage for cats:
5-15 mg of ketamine/kg b.w. intramuscularly

Administration of ketamine in combination with other anaesthetics and premedication drugs before general anaesthesia:

Cats: administer atropine intramuscularly in the dose of 0.05 mg/kg b.w., then xylazine or diazepam and after several minutes administer ketamine in the dose of 5-15 mg/kg b.w.

 

Dogs: administer atropine intramuscularly in the dose of 0.05 mg/kg b.w., then a neuroleptic agent (diazepam, medetomidine or xylazine) and after 5-10 minutes administer 3 mg of ketamine/kg b.w. intravenously or 10 mg of ketamine/kg b.w. intramuscularly.

After intramuscular administration, full anaesthesia is achieved within 3-5 minutes. Normally, the duration of ketamine effect is 20-45 minutes. The higher the dose, the longer the duration of anaesthesia. The dose size has no effect on the depth of anaesthesia.
After approx. two hours, most animals are able to stand up.

 

Recommendations for proper administration

In the case of intravenous administration, the preparation should be warmed to body temperature and injected slowly.

 

Withdrawal period

Not applicable

 

Special precautions for storage

Keep out of the reach and sight of children.
Store below 25°C. Protect from light. Do not freeze.
The durability period after the first opening of the immediate container: 28 days.
Do not use the veterinary medicinal product after the expiry date stated on the label.

 

Special warnings

Special warnings concerning each of the target animal species:

Animals should not be fed any food within 12 hours before application of the product.
Abdominal surgeries require administration of the appropriate analgesic because ketamine does not eliminate enteroception.
Because ketamine does not remove laryngeal reflex, increases salivation and production of tracheal and bronchial secretion in procedures on the rhinopharynx, larynx, trachea and bronchi as well as in endoscopy, the drug should be used in combination with agents removing the aforementioned effects of ketamine.

 

Special precautions for use in animals:

Ketamine may increase salivation and secretion in the respiratory tract, which may lead to choking and obstruction of the respiratory tract.

During anaesthesia, one must remember to secure the eye against corneal dryness.

During the recovery of animals anaesthetised using ketamine, the following symptoms might occur: hallucinations, delirium, motor ataxia, hypersensitivity to touch, overreactivity, aggression. During recovery, animals should be provided with peace and quiet and protection against self-mutilation.

In the case of excessive blood loss, the ketamine dose should be reduced.

Since ketamine increases the heart rate and the heart’s demand for oxygen, it must be used with caution in patients with myocardial disease.

Ketamine causes moderate respiratory depression, frequently reduces the respiratory rate and respiratory volume. After ketamine administration, a characteristic type of respiration occurs, that is long periods of apnoea after inspiration. Therefore, during anaesthesia, the cardiac and pulmonary functions should be monitored.

Special precautions for persons administering the veterinary medicinal product to animals:

Ketamina Biowet Puławy is a product with a very potent effect. Particular caution should be taken to avoid self-injection. In the case of accidental self-injection by a person administering the product, anaesthesia might occur and after approx. 10 minutes loss of consciousness for 10 to 15 minutes. Amnesia and hallucination might occur on recovery. In the case of accidental self-injection, immediately seek medical advice and show the package leaflet or the label to the physician. Do not drive any vehicles. After an accidental contact with skin or mucosa, immediately wash the site with water.

Pregnancy:

Do not use in pregnant animals, excluding a caesarean section.

Lactation:

Do not use in lactation.

 

Interaction with other medicinal products and other forms of interaction

Xylazine, detomidine, medetomidine, acepromazine prevent the occurrence of convulsions which may accompany ketamine anaesthesia.

Ketamine effect is intensified by other agents that weaken the function of the central nervous system.
Narcotic agents, barbiturates, diazepam may prolong recovery.
Chloramphenicol may prolong the anaesthetic effect of ketamine.
Neuromuscular blockers, e.g. succinylcholine and tubocurarine, may intensify or prolong respiratory depression.
Thiopental prevents ketamine-induced stimulation of cerebral metabolism and dilation of cerebral vessels. Atropine prevents excessive salivation occurring after administration of ketamine.

 

Overdose (symptoms, procedures concerning immediate help and antidotes):

Exceeding the recommended doses leads to respiratory depression. A dose that is eight times higher than the recommended one causes paralysis of the respiratory system whereas a dose that is twelve times higher leads to circulatory arrest.
Administration of too high doses of the drug might induce vomiting and muscle tremor.
In the case of an overdose, mechanical resuscitation methods should be considered – respiration must be maintained and cardiac massage must be applied.

 

Pharmaceutical incompatibilities:

Ketamine should not be used with barbiturates due to their chemical incompatibility.

 

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 applicable regulations.

 

Shelf life

2 years

 

For animal treatment only.

Subject to medical prescription – prescription drug.

To be administered under veterinary supervision.

 

Possession and sales of the product are regulated by regulations concerning products containing narcotic drugs or psychotropic substances.

 

Available containers

50 ml and 10 ml

 

Shelf life

2 years

 

Other information

For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.

 

Biowet Puławy Sp z o. o.
Arciucha 2, 24-100 Puławy
Tel./fax: (81) 886 33 53, Tel: (81) 888 91 00
e-mail:sekretariat@biowet.pl

 

2016-02-09  SPC

2016-05-16 decision

31.08.2017 r.