Tranquigel 35 mg/g Oral Gel for Dogs and Horses

Composition

Each gram contains:

Active substances:

Acepromazine (as acepromazine maleate) 35.0 mg

Excipients:.

Clear, viscous, orange-yellow gel.

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Pharmacological properties

4.1 ATCvet code:

QN05AA04.

4.2 Pharmacodynamics

Acepromazine is a phenothiazine derivative with neuroleptic activity. Phenothiazines inhibit the post-synaptic dopamine receptors in the central nervous system and can inhibit the dopamine release.

Besides this, phenothiazines have an anticholinergic effect and they can antagonise the alpha-adrenergic receptors and thus decrease the tone of the sympathetic nervous system.

4.3 Pharmacokinetics

In dogs the bioavailability after oral administration is approximately 20%. Sedation usually sets in after 1 hour and lasts up to 8-12 hours. As the gastro-intestinal absorption is variable, dose adjustment is necessary per patient.

In horses bioavailability after oral administration is approximately 20-50%. Sedation usually sets in after 15-20 minutes after administration with a peak effect after 30-60 minutes and lasts up to 6-7 hours.

In both target species acepromazine is extensively distributed throughout the body tissues and the plasma protein binding is more than 99%. Acepromazine is metabolised in the liver, with urine as the main route of excretion of unconjugated and conjugated metabolites.

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Target species

Dogs and horses.

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Indications

For sedation of dogs and horses.

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Dosage

Oral use.

Dogs

Light sedation: 0.5 – 1.0 mg acepromazine / kg body weight (corresponding to 0.14 – 0.29 g of veterinary medicinal product per 10 kg bodyweight)

Deeper sedation: 1.0 – 2.0 mg acepromazine /kg body weight (corresponding to 0.29 – 0.57 g of veterinary medicinal product per 10 kg bodyweight)

Horses

Moderate sedation: 0.150 mg acepromazine / kg body weight (corresponding to 0.43 g of veterinary medicinal product per 100 kg bodyweight)

Deeper sedation: 0.225 mg acepromazine / kg body weight (corresponding to 0.64 g of veterinary medicinal product per 100 kg bodyweight)

The above dosage information is provided as a guideline and should be adapted to each patient, taking into account the various factors (e.g. temperament, breed, nervousness etc.) that may affect the sensitivity to sedatives.

Use of this veterinary medicinal product for light sedation in dogs weighing less than 17.5 kg should be based on a careful benefit: risk assessment by the responsible veterinarian. See section 3.5.

The 3 and 6 gram syringes have a dosage ring graduated every 0.25 gram.

The 10 and 12 gram syringes have a dosage ring graduated every 0.5 gram. The most appropriate syringe should be chosen to ensure accurate dosing.

The following tables are intended as a guide to dispensing this veterinary medicinal product at the recommended dose rates. Turn the dial ring anti-clockwise until the left side of the ring lines up with the weight of the oral gel to be administered. Place the pre-filled oral syringe in the animal's mouth and expel the required dose on the back of the tongue of dogs or into the cheek pouch of horses.

In dogs sedation usually sets in after 1 hour and lasts 8-12 hours, in horses sedations sets in after 15-20 minutes and lasts for 6-7 hours. For longer use in dogs these doses may be repeated once after 12 hours.

To ensure a correct dosage, body weight should be determined as accurately as possible.

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Contraindications

Do not use in cases of hypotension, post-traumatic shock or hypovolemia.

Do not use in animals in a state of severe emotional excitation.

Do not use in animals suffering from hypothermia.

Do not use in animals with haematological disorders/coagulopathies or anaemia. Do not use in animals with heart and or lung failure.

Do not use in animals with epilepsy.

Do not use in neonates.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Hypotension

Undetermined frequency (cannot be estimated from the available data): Tachycardia, arrhythmia; Increased respiratory rate; Miosis, ataxia, central nervous system stimulation (generalised)a; Lacrimation; Aggressiona

a Contradictory clinical signs

Horses:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Hyperthermia/hypothermiaa

Undetermined frequency (cannot be estimated from the available data): Hypotensionb; Decreased red blood cell countc, decreased haemoglobinc, thrombocytopeniac, leucopeniac; Fertility disorderd, penile prolapsee, paraphimosisf, priapismg; Aggressionh; Central nervous system stimulation (generalised)h; Prolapse of the nictating membranei

a Inhibition of temperature regulation.

b Due to a decrease of the sympathetic nervous system tone. Transient.

c Transient and reversible.

d Due to increased prolactin secretion which may lead to disturbances in fertility.

e Due to relaxation of the retractor penis muscles. Retraction of the penis must be visible within two to three hours. If this does not take place, it is advised to contact a veterinary surgeon. Lack of retraction is of particular concern in breeding stallions.

f The foreskin does not return to the normal position. May occur in sequal to priapism.

g Persistent erection.

h Contradictory clinical signs.

i Third eyelid.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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.

Dogs

Use of this veterinary medicinal product in dogs less than 17.5 kg bodyweight should be based on a careful benefit: risk assessment by the responsible veterinarian. Owing to limitations of the dosing- device in delivering small doses use in small (less than 17,5 kg) dogs is not recommended for light sedation in sensitive individuals and breeds. 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.

Horses

In stallions, the lowest dose range is indicated to minimise prolapse of the penis. Use of this veterinary medicinal product in horses less than 100 kg bodyweight should be based on a careful benefit: risk assessment by the responsible veterinarian.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

The safety of this veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy and lactation:

Use only according to the benefit-risk assessment by the responsible veterinarian. Please see also Section 3.6 relating to disturbances in fertility in mares.

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Interactions

Acepromazine potentiates the action of centrally depressant drugs.

Simultaneous administration, or administration to animals recently treated with organophosphates or procaine hydrochloride (a local anaesthetic) should be avoided, since these molecules enhance the toxic effects of acepromazine.

Since acepromazine decreases sympathetic nervous system tone, simultaneous treatment with blood pressure lowering products should not take place.

Antacids may cause a decrease in the gastrointestinal absorption of acepromazine after oral administration.

Opiates and adrenaline may enhance the hypotensive effects of acepromazine.

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Overdose

Overdose results in an earlier onset of the sedative symptoms and in a prolonged effect. Toxic effects are ataxia, hypotension, hypothermia and central nervous system (extrapyramidal) effects. Noradrenaline, but not adrenaline, can be used to counteract the cardiovascular effects.

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Special warnings

Dogs

None

Horses

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 above that recommended results in prolonged action and side effects but no greater sedation.

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Withdrawal period

Not authorised for use in horses intended for human consumption.

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Special precautions for the person administering

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. Replace cap immediately after use. While replacing the cap a “click” must be heard to ensure proper closure. Keep the broached oral syringe in the original carton and make sure that the carton is closed properly. Keep the package out of sight and reach of children at all times. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician but DO NOT DRIVE as sedation can occur.

Wash hands and exposed skin thoroughly after use.

People with sensitive skin or in continuous contact with the veterinary medicinal product 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.

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Incompatibilities

Not applicable.

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Immediate packaging

White LLDPE (linear low-density polyethylene) pre-filled oral syringe of different sizes: 4 ml containing 3 gram, 8 ml containing 6 gram, 14 ml containing 10 gram and 14 ml containing 12 gram. The 3 and 6 gram syringes have a dosage ring graduated every 0.25, 0.5 and 1 gram. The 10 and 12 gram syringes have a dosage ring graduated every 0.5 and 1 gram. The syringes are tightly closed with a LLDPE cap. Each pre-filled oral syringe is packed in a cardboard box.

Pack sizes:

Box with 1 pre-filled oral syringe of 3 gram

Box with 1 pre-filled oral syringe of 6 gram

Box with 1 pre-filled oral syringe of 10 gram

Box with 1 pre-filled oral syringe of 12 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 3 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 6 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 10 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 12 gram

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf-life after first opening the immediate packaging: 56 days (8 weeks).

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 41821/4044

8 DATE OF FIRST AUTHORISATION

21 November 2017

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Le Vet Beheer B.V.

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