Tranquigel 35 mg/g Oral Gel for Dogs and Horses

Excipients:.
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Methyl parahydroxybenzoate (E 218)1.04 mgPropyl parahydroxybenzoate0.104 mgHydroxyethylcelluloseEthanol 96%Maleic acid (for pH adjustment)Sodium hydroxide (for pH adjustment)Water, purified.
Clear, viscous, orange-yellow gel.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and horses.
3.2 Indications for use for each target species
For sedation of dogs and horses.
3.3 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.
AN: 01358/2024 & 01360/2024
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.
3.4 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.
3.5 Special precautions for use
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.
AN: 01358/2024 & 01360/2024
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.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
HypotensionUndetermined frequency
(cannot be estimated from
the available data)
Tachycardia, arrhythmia
Increased respiratory rate
Miosis, ataxia, central nervous system stimulation
(generalised)
a
Lacrimation
Aggression
a

a
Contradictory clinical signs
Horses:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hyperthermia/hypothermia
a
Undetermined frequency
(cannot be estimated from the
available data)
Hypotension
b
Decreased red blood cell count
c
, decreased
haemoglobin
c
, thrombocytopenia
c
, leucopenia
c
Fertility disorder
d
, penile prolapse
e
, paraphimosis
f
,
priapism
g
AN: 01358/2024 & 01360/2024
Aggression
h
Central nervous system stimulation (generalised)
h
Prolapse of the nictating membrane
i
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.
3.7 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.
3.8 Interaction with other medicinal products and other forms of interaction
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.
3.9 Administration routes and 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)
AN: 01358/2024 & 01360/2024
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.
Dogs TranquigelLight Sedation
0.5 - 1.0 mg/kg body weight
Deeper Sedation
1.0 - 2.0 mg/kg body weight
Body
weight
Dose
of gel
(gram)
Acepromazine
(mg)
Dose
range
(mg/kg)
Dose
of gel
(gram)
Acepromazine
(mg)
Dose
range
(mg/kg)
10 kg –
17.5 kg
0.258.75
0.88 –
0.50
0.5017.50
1.75 –
1.00
>17.5 kg –
20 kg
0.5017.50
1.00 –
0.88
0.752