Relaquine

1 x 10 ml

Oral gel

Active substance

Acepromazine (Acepromazine maleate) : 35 mg/ml

ATC code

QN05AA04 Acepromazine

QN05AA Phenothiazines with aliphatic side-chain

QN05A Antipsychotics

QN05 Psycholeptics

QN Nervous system

Species

Horses.

Indications

For sedation of horses.

Dose to be administered and administration route

For oral administration.

Prefilled syringe

The veterinary medicinal 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 anti-clockwise 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 veterinary medicinal 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 bodyweight Dosage guidelines:

Bodyweight (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.

Adverse reactions

Horse:

Rare

(1 to 10 animals / 10,000 animals treated):

Excitation¹

Very rare

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

Low blood pressure²,

Hypothermia³, Hyperthermia³

Decreased red blood cell count⁴, Decreased haemoglobin⁴, Low platelet count⁴, Leucopenia⁴

Infertility⁵, Penile prolapse⁶, Paraphimosis⁷, Priapism⁷ Aggression⁸, Generalized central nervous system stimulation⁸

Prolapse of the nictitating membrane

¹ Paradoxical reaction

² Since acepromazine decreases sympathetic nervous system tone, a transient drop in blood pressure may occur after administration.

³ Inhibition of temperature regulation.

⁴ Transient.

⁵ Because it increases prolactin secretion, the administration of acepromazine may lead to disturbances in fertility.

⁶ 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.

⁷ Acepromazine has caused paraphimosis sometimes in sequel to priapism.⁸ Contradictory clinical signs

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.