Tranquiline 35 mg/ml Oral Gel for Dogs

None.

Special precautions for safe use in the target species:
The veterinary medicinal product is presented in a 10 ml prefilled syringe and 10 ml
glass bottle with dosing syringe. The accuracy of dosing differs between the two
presentations.
Prefilled syringe
Given the limitations of the prefilled syringe in delivering dose volumes of less than
0.5 ml, its use in animals weighing less than 17.5 kg bodyweight for sedation or in
sensitive individuals and breeds is not recommended and the glass bottle with the 1
ml syringe should be used instead.
Glass bottle
Use of the veterinary medicinal product with the 1 ml dosing syringe in dogs less than
1.75 kg bodyweight should be based on a careful benefit-risk assessment by the
responsible veterinarian (see section 3.9).
This veterinary medicinal product should be used with caution and with reduced
dosage in the case of hepatic disease or in debilitated animals.
Acepromazine has negligible analgesic effects. Painful activities should be avoided
when handling tranquillized animals, unless treated with appropriate analgesics.
After administration of this veterinary medicinal product, animals should be kept in a
calm place and sensorial stimuli should be avoided as far as possible.
In dogs with the ABCB1-1Δ (also called MDR1) mutation, acepromazine tends to
cause more profound and prolonged sedation. In these dogs the dose should be
reduced by 25% - 50%.
In some dogs, particularly Boxers and other short-nosed breeds, spontaneous
fainting or syncope may occur, due to sinoatrial block caused by excessive vagal
tone, and an attack may be precipitated by acepromazine, so a low dose should be
used. Where there is a history of this type of syncope, or if it is suspected because of
excessive sinus arrhythmia, it may be advantageous to control the dysrhythmia with
atropine given just before the acepromazine.
Large breeds: it has been noted that large breeds of dogs are particularly sensitive to
acepromazine and the minimum dose possible should be used in these breeds.
Acepromazine should be used cautiously as a restraining agent in aggressive dogs
as it may make the animal more prone to startle and react to noises or other sensory
inputs.
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Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Acepromazine may cause sedation. Care should be taken to avoid accidental
ingestion.
To avoid accidental ingestion by a child when using the prefilled syringe: replace cap
immediately after use. Keep the broached oral syringe in the original carton and
make sure that the carton is closed properly. To avoid accidental ingestion by a child
when using the glass bottle, do not leave the filled syringe unattended and store the
properly closed bottle and used syringe in the original carton.
This veterinary medicinal product must be used and kept out of sight and reach of
children.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
DO NOT DRIVE as sedation and changes in blood pressure may occur.
People with known hypersensitivity to acepromazine or other phenothiazines or to
any of the excipients should avoid contact with the veterinary medicinal product.
Persons with sensitive skin or in frequent contact with the veterinary medicinal
product are advised to wear impermeable gloves.
Wash hands and exposed skin thoroughly after use.
In case of accidental spillage onto the skin, immediately after exposure wash the
exposed skin with large amounts of water.
This veterinary medicinal product may cause mild eye irritation. 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.
Special precautions for the protection of the environment:
Not applicable.
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