Trankvilin Oral gel for dogs 10 ml

Trankvilin Oral gel for dogs 10 ml

NAME OF THE VETERINARY MEDICINAL PRODUCT

Транквилин  (Trankvilin) Oral gel for dogs

QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each ml contains

Active substance:

Acepromazine 35.0mg (as Acepromazine Maleate 47.5mg)

List of Excipients:

Methyl-4-hydroxybenzoate 0.65 mg and Propyl-4-hydroxybenzoate 0.35 mg, as preservatives

PHARMACEUTICAL FORM: Oral gel

Target species: dogs

Indications for use, specifying the target species: For sedation of dogs, Pre-anesthetic, Mild tranquilizer

Contra-indications: Not for use in animals in shock or post traumatically, or with existing severe emotional excitation or epilepsy.

Do not administer to dogs of Collie, Shelti and Bobtail breeds, as well as to puppies below 6 weeks of age.

AFFECTED BREEDS

Approximately three of every four Collies in the United States have the mutant MDR1 gene. The frequency is about the same in France and Australia, so it is likely that most Collies worldwide have the mutation. The MDR1 mutation has also been found in Shetland Sheepdogs (Shelties). Australian Shepherds, Old English Sheepdogs, English Shepherds, German Shepherds, Long-haired Whippets, Silken Windhounds, and a variety of mixed breed dogs.

The only way to know if an individual dog has the mutant MDR1 gene is to have the dog tested. As more dogs are tested, more breeds will probably be added to the list of affected breeds.

Breeds affected by the MDR1 mutation (frequency %)

Breed Approximate Frequency

Australian Shepherd 50%, Australian Shepherd, Mini 50%, Border Collie < 5%, Collie 70 %, English Shepherd 15 %, German Shepherd 10 %, Herding Breed Cross 10 %, Long-haired Whippet 65 %, McNab 30 %, Mixed Breed 5 %, Old English Sheepdog 5 %, Shetland Sheepdog 15 %, Silken Windhound 30 %

 Special warnings for each target species: Sedation lasts for approximately six hours, although the actual time and depth of sedation are very dependent on the status of the individual animal. Increasing the dosage results in prolonged action and side effects but no greater sedation.

Special precautions for use:

Special precautions for use in animals - Do not use in cases of post traumatic hypovolemia

Special precautions to be taken by the person administering the veterinary medicinal product to animals - In case of accidental ingestion contact a physician showing the pack insert or product label to the physician. Wash hands and exposed skin thoroughly after use. Persons with sensitive skin or in continuous contact are advised to wear impermeable gloves. Avoid contact with eyes. If accidental eye contact occurs, flush gently with running water for 15 minutes and seek medical advice if any irritation persists.

Use during pregnancy or  lactation: Acepromazine should not be used in pregnant or lactating dogs.

Interaction with other medicinal products and other forms of interaction: Acepromazine potentiates the action of centrally depressant drugs.

 The simultaneous use of organic phosphate esters increases the toxicity of acepromazine.

Since acepromazine decreases sympathetic nervous system tone, it should not be given at the same time as blood pressure reducing drugs.

 Dosage: 1 ml per 17.5kg body weight

Overdose (symptoms, emergency procedures, antidotes), if necessary: Overdosage results in an earlier onset of the sedative symptoms and in a prolonged effect.

 Toxic effects are: ataxia, hypotensia, hypothermia, extrapyramidal effects.

 Noradrenaline can be used to counteract the cardiovascular effects.

PHARMACOLOGICAL PROPERTIES

 Acepromazine is a phenothiazine derivate. This group of molecules belongs to the neuroleptica: they depress the central nervous system and exert associated effects on the autonomic system. These effects are due to their interference with different neurotransmitter receptors (dopaminergic, adrenergic) and to their interference with hypothalamic performance. The desired effects observed after treatment with acepromazine include a general tranquillizing effect, anti-emetic effect and a slight antihistaminic effect. There is no analgesic action. The neuroleptical effects are variable between individual animals. Acepromazine is partly absorbed from the gastrointestinal tract. It binds extremely well to plasma proteins and is extensively distributed over the body tissues. Plasma levels are usually low. Acepromazine is highly metabolized and excreted in urine. The sedative activity starts within 15-30 minutes and lasts up to 6-7 hours.