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Date: Saturday, May 18, 2024 14:20

Release 2.114
Relaquine® 35 mg/ml Oral Gel for Horses
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Neurological preparations: Tranquilisers
Active ingredient: Acepromazine Maleate
Product:Relaquine® 35 mg/ml Oral Gel for Horses
Product index: Relaquine 35 mg/ml Oral Gel for Horses
Withdrawal notes: Not authorised for use in horses intended for human consumption.
Incorporating:
Qualitative and quantitative composition
Each ml contains: Active substance:
Acepromazine 35.00 mg (as acepromazine maleate 47.50 mg)
Excipients:
Methyl parahydroxybenzoate (E218) 0.65 mg
Propyl parahydroxybenzoate 0.35 mg
Pharmaceutical form
Oral gel. Clear yellow gel for oral administration.
Clinical particulars
Target species
Horse.
Indications for use
For sedation of horses.
Contraindications
Do not use in cases of post-traumatic shock or hypovolaemia.
Do not use in animals in a state of severe emotional excitation.
Do not use in animals with epilepsy.
Do not use in pregnant or lactating mares.
Do not use in animals with heart failure.
Do not use in animals with haematological disorders/coagulopathies.
Do not use in animals suffering from hypothermia.
Do not use in the case of known hypersensitivity to the active substance or any of the excipients of the product.
Do not use in neonates.
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 above that recommended results in prolonged action and side effects but no greater sedation.
Special precautions for use in animals
In stallions, the lowest dose range is indicated to minimise prolapse of the penis.
The product should be used with caution and with reduced dosage in the case of cardiac or hepatic disease or in debilitated, hypovolemic or anaemic animals.
Acepromazine has negligible analgesic effects. Painful activities should be avoided when handling tranquilised animals.
Tranquilised horses should be kept in a calm place and sensorial stimuli should be avoided as far as possible.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands and exposed skin thoroughly after use. Persons with sensitive skin or in continuous contact with the 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.
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.
Adverse reactions
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common ( more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Since acepromazine decreases sympathetic nervous system tone, a transient drop in blood pressure may occur after administration.
Inhibition of temperature regulation.
The following reversible changes are possible in the haemogram:
- transient decrease in erythrocyte count and haemoglobin concentration;
- transient decrease in thrombocyte and leukocyte counts.
Because it increases prolactin secretion, the administration of acepromazine may lead to disturbances in fertility.
Penile prolapse may occur due to the relaxation of the retractor penis muscles. Retraction of the penis should 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. Acepromazine has caused paraphimosis sometimes in sequel to priaprism.
In rare cases paradoxical excitation reactions can develop.
Contradictory clinical signs of aggressiveness and generalised CNS stimulation may occur.
Prolapse of the nictitating membrane has also been cited as a possible adverse effect in horses.
Use during pregnancy and lactation
Acepromazine should not be used in pregnant or lactating mares.
Acepromazine has the potential to induce hypotension in newborns when administered as a premedication for caesarean section in the mare.
Please see also Adverse reactions relating to disturbances in fertility.
Interactions
Acepromazine potentiates the action of centrally depressant drugs.
Simultaneous administration, or administration to horses recently treated with organophosphates 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 may enhance the hypotensive effects of acepromazine.
Amounts to be administered and administration route
For oral administration.
Prefilled syringe
The product is contained within a 10 ml or 15 ml polyethylene syringe. The plunger has a locking ring which should be adjusted to provide the volume required in accordance with the dosage guidelines. 1.0 ml intervals are printed on the syringe plunger, but it is also possible to dose at 0.5 ml intervals.
Before first use of the syringe, turn the locking ring clockwise until aligned with the 0.0 ml mark (side of the ring facing the barrel). Turn the locking ring anticlockwise will move the ring backwards. Turn the locking ring backwards until the left side of the locking ring lines up with the volume of the oral gel to be administered.
Place the syringe in the animal's mouth and expel the required dose into the cheek pouch. The gel may also be mixed with food.
Glass bottle
The product is filled into 10, 15, 20, 30 and 50 ml glass bottles with CRC closure and supplied with a 5 ml syringe with a dose graduation allowing accurate dosing of 0.1 or 0.2 ml. Withdraw the appropriate dose from the bottle using the supplied syringe. The syringe is brought into the animal's mouth and the appropriate dose is expelled into the animal's cheek.
The gel may also be mixed with food.
Amount(s) to be administered:
Moderate sedation: 0.15 mg acepromazine per kg body weight.
Dosage guidelines:
Body weight (kg)
200
300
400
450
500
600
Dose (ml)
1.0
1.5
1.5
2.0
2.5
2.5
The above dosage information is provided as a guideline. The dose may be varied to administer between 0.5 and 1.5 times the above recommendation depending on the level of sedation required, i.e. for mild sedation, administer half the recommended dose and for deeper sedation, administer 1½ times the recommended dose.
Overdose
Overdosage 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.
Withdrawal period
Not authorised for use in horses intended for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Nervous system.
ATCvet code: QN05AA04
Pharmacodynamic properties
Acepromazine is a phenothiazine derivative. This group of molecules belongs to the neuroleptics: 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 sedative activity starts within 15-30 minutes of treatment and lasts for 6-7 hours.
The desired effects observed after treatment with acepromazine include a general tranquilising effect, anti-emetic effect and a slight anti-histaminic effect. There is no analgesic action. The neuroleptic effects are variable between individual animals.
Pharmacokinetic properties
Acepromazine is partly absorbed from the gastrointestinal tract. Plasma protein binding is high and it is extensively distributed throughout the body tissues. Plasma levels are usually low. Acepromazine is highly metabolised, with the urine as the main route of excretion.
Pharmaceutical particulars
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 90 days.
Special precautions for storage
Do not store above 25°C. Protect from frost. Protect from light. After use, replace cap on syringe. Keep the broached syringe in the original carton and store in a dry place.
Immediate packaging
Prefilled syringes:
Container: White, high-density polyethylene syringe barrel and a white, low-density polyethylene syringe plunger closed with a white, high-density polyethylene, push-fit cap.
Or
White, linear low-density polyethylene syringe closed with a linear low-density polyethylene, push-fit cap.
Fill volume: 10 ml / 15 ml
Dosing device: The product is presented in an oral dosing syringe which is graduated at 1 ml intervals.
Glass bottles
Container: Amber Type III glass bottles of 10, 15, 20, 30 and 50 ml, fitted with syringe adaptors and HDPE/LDPE CRC closures containing 9 ml, 14 ml, 18 ml, 28 ml and 48 ml product, respectively.
Dosing device: The product is presented with an oral dosing syringe of 5 ml which is graduated at 0.1 or 0.2 ml intervals.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
GB: Floris Animal Health Limited, Bath House 6-8, Bath Street, Bristol, BS1 6HL, United Kingdom.
NI: Floris Holding BV, Kempenlandstraat 33/35, 5262 GK Vught, The Netherlands.
Marketing Authorisation Number
GB: Vm 52764/5002
NI: Vm 56190/3001
Significant changes
Date of the first authorisation or date of renewal
10 March 2011
Date of revision of the text
February 2022
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Relaquine 35 mg/ml Oral Gel for Horses 10 ml:
GTIN:08714225153626