Medesedan

1 x 5 ml

Liquid for injection, solution

Active substance

Detomidine (Detomidine hydrochloride) : 10 mg/ml

ATC code

QN05CM90 Detomidine

QN05CM Other hypnotics and sedatives

QN05C Hypnotics and sedatives

QN05 Psycholeptics

QN Nervous system

Species

Horses and cattle.

Indications

Sedation and analgesia in horses and cattle during various examinations and treatments, and in situations where handling of animals will be facilitated by administration of the veterinary medicinal product. For premedication before administration of injectable or inhalation anaesthetics.

Dose to be administered and administration route

Intramuscular or intravenous use.

To be administered intramuscularly or by slow intravenous injection of detomidine hydrochloride at a dose of 10 - 80 μg/kg depending on the degree and duration of sedation and analgesia required. The effect is more rapid after intravenous administration. To ensure a correct dosage, body weight should be determined as accurately as possible.

Single use (horses and cattle)

Dose		Effect	Duration of effect (h)	Other effects
ml/100 kg	µg/kg	Effect	Duration of effect (h)	Other effects
0.1 - 0.2	10 - 20	Sedation	0.5 - 1
0.2 - 0.4	20 - 40	Sedation and analgesia	0.5 - 1	Slight staggering
0.4 - 0.8	40 - 80	Deeper sedation and better analgesia	0.5 - 2	Staggering, sweating, piloerection, muscular tremors

The onset of action occurs 2 - 5 min after i.v. injection. The full effect is seen 10 - 15 min after i.v. injection. If necessary, detomidine hydrochloride can be administered up to a total dose of 80 μg/kg.

The following dosing instructions show different possibilities for the combination of detomidine hydrochloride. However, the simultaneous administration with other drugs should always be based on a benefit/risk assessment by the responsible veterinarian and it must be done taking into account the SPC of the relevant products.

Combinations with detomidine to increase sedation or analgesia in a standing horse

Detomidine hydrochloride 10 - 30 µg/kg IV in combination with either

•	butorphanol	0.025 - 0.05 mg/kg IV	or
•	levomethadone	0.05 - 0.1 mg/kg IV	or
•	acepromazine	0.02 - 0.05 mg/kg IV

Combinations with detomidine to increase sedation or analgesia in cattle

Detomidine hydrochloride 10 - 30 μg/kg IV in combination with

• butorphanol 0.05 mg/kg IV

Combinations with detomidine for preanaesthetic sedation in the horse

The following anaesthetics can be used after detomidine hydrochloride premedication (10- 20 µg/kg) to achieve lateral recumbency and general anaesthesia:

• ketamine 2.2 mg/kg IV or

• thiopental 3 - 6 mg/kg IV or

• guaifenesin IV (to effect) followed by ketamine 2.2 mg/kg IV

Administer the veterinary medicinal products prior to ketamine and allow sufficient time for sedation to develop (5 minutes). Ketamine and the veterinary medicinal product must therefore never be administered simultaneously in the same syringe.

Combinations with detomidine and inhalation anaesthetics in the horse

Detomidine hydrochloride can be used as sedative premedicant (10 - 30 μg/kg) before induction and maintenance of inhalation anaesthesia. Inhalation anaesthetic is given to effect. The amount of inhalation anaesthetics required is significantly reduced by premedication with detomidine.

Combination with detomidine to maintain injection anaesthesia (total intravenous anaesthesia TIVA) in the horse

Detomidine can be used in combination with ketamine and guaifenesin for maintaining total intravenous anaesthesia (TIVA).

The best-documented solution contains guaifenesin 50 - 100 mg/ml, detomidine hydrochloride 20 μg/ml and ketamine 2 mg/ml. 1 g ketamine and 10 mg detomidine hydrochloride are added to 500 ml of 5 - 10 % guaifenesin; anaesthesia is maintained by an infusion of 1 ml/kg/h.

Combinations with detomidine for induction and maintenance of general anaesthesia in cattle

Detomidine hydrochloride 20 μg/kg (0.2 ml/100 kg) with

• ketamine 0.5 - 1 mg/kg IV, IM or

• thiopental 6 - 10 mg/kg IV

The effect of detomidine-ketamine lasts for 20 - 30 minutes, and the effect of detomidine- thiopental for 10 - 20 minutes.

Adverse reactions

Cattle

Very common

(> 1 animal / 10 animals treated):

Bradycardia, Hypertension (transient), Hypotension

(transient) Hyperglycaemia

Urination^¹

Penile prolapse (transient)^²

Common

(1 to 10 animals / 100 animals treated):

Ruminal tympany^³, Hypersalivation (transient)

Ataxia, Muscle tremor

Uterine contraction

Nasal discharge^⁴, Respiratory depression (slight)^⁵

Hyperthermia, Hypothermia

Rare

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

Arrhythmia^⁶

Increased sweating (transient)

Very rare

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

Excitation

Heart block⁷

Hyperventilation (slight)⁸

¹ A diuretic effect may be observed 45 to 60 minutes after treatment.

²A partial, penis prolapse can occur.

³Substances of this class inhibit ruminal and intestinal motility. Can cause a mild bloat in cattle.

⁴ Mucus discharge from the nose may be seen because of continued lowering of the head during sedation.

^{5, 8}Causes changes in the respiratory rate.

^{6, 7} Causes changes in the conductivity of cardiac muscle as evidenced by partial atrioventricular and sinoatrial blocks.

Horses

Very common

(> 1 animal / 10 animals treated):

Arrhythmia¹, Bradycardia, Heart block², Hypertension

(transient), Hypotension (transient)

Hyperglycaemia

Ataxia, Muscle tremor

Urination³

Penile prolapse (transient)⁴, Uterine contraction

Increased sweating (transient), Piloerection

Hyperthermia, Hypothermia

Common

(1 to 10 animals / 100 animals treated):

Hypersalivation (transient)

Nasal discharge⁵

Skin swelling⁶

Rare

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

Colic⁷

Urticaria

Hyperventilation, Respiratory depression

Very rare

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

Excitation

Hypersensitivity reaction

^{1, 2} Causes changes in the conductivity of cardiac muscle as evidenced by partial atrioventricular and sinoatrial blocks.

³ A diuretic effect may be observed 45 to 60 minutes after treatment.

⁴ A partial penis prolapse can occur in stallions and geldings.

^{5, 6} Mucus discharges from the nose and oedema of the head and face may be seen because of continued lowering of the head during sedation.

⁷ Substances of this class inhibit intestinal motility.

Mild adverse reactions have reportedly resolved uneventfully without treatment. Adverse reactions should be treated symptomatically.

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.