Hipnoton 10 mg/ml Solution for Injection 10ml for Horses & Cattle

Hipnoton 10 mg/ml Solution for Injection for Horses and Cattle 10ml.

Target species
Horses and cattle.

Indications for use
Horses and Cattle:
- For the sedation and slight analgesia to facilitate physical examinations and treatments such as minor surgical interventions.
- Premedication prior to the administration of injectable or gaseous anaesthetics.
Detomidine can be used in the following cases:
- Medical examinations (such as endoscopy, rectal and reproductive tract examinations, radiography).
- Minor surgical procedures (such as dental or tendinous treatments, excision of skin tumours, treatment of teats or various injuries).
- Before surgery or administration of medication (such as gastric intubation, shoeing).
For premedication prior to administration of injection- or inhalation anaesthetics. See section 'Special precautions for use' before use.

Contra-indications
Do not use in animals with cardiac or respiratory disease.
Do not use in animals with renal or hepatic failure.
Do not use in animals with poor general health (for example in dehydrated animals).
Do not use in combination with butorphanol in horses suffering from colic.
See sections 'Adverse reactions', 'Use during pregnancy', 'Interactions'.

Special warnings for each target species
None.

Special precautions for use
Special precautions for use in animals
To avoid ruminal bloat and aspiration of feed or saliva, cattle should be maintained in sternal recumbency during and following treatment and the head and neck of recumbent cattle should be lowered.
In cases of prolonged sedation it is necessary to monitor and help maintain the animal's normal body temperature.
In horses especially, when sedation begins, animals can slip and lower the head while standing. On the other hand, cattle, especially young cattle, tend to lie down. Therefore, it is necessary to carefully choose the location for treatment to prevent injuries. Moreover, the usual precautionary measures must be taken, particularly when the product has to be administered to horses, to prevent human or animal injury.
Animals in shock or with kidney or liver disease should only be treated after the benefit/risk assessment made by the responsible veterinarian.
It is not recommended to use this product in animals with heart disease (with pre-existing bradycardia or risk of atrioventricular block), respiratory or hepatic or renal failure, shock or under extraordinary stress conditions.
It is not recommended to use the combination detomidine/butorphanol in horses with a history of liver disease or cardiac arrhythmia.
It is not recommended to feed the animals for 12 hours before anaesthesia nor to give water or feed before the drug effect has passed.
In the case of painful procedures, detomidine should be used in combination with an analgesic or local anaesthetics.
While waiting for the sedative to take effect, it is recommended to keep the animals in a quiet environment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental oral intake or self-injection seek medical advice immediately and show the package leaflet to the doctor.
DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of fresh water.
Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.

Advice to doctors:
Detomidine is an alpha2-adrenoreceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.

Other precautions
None.

Adverse reactions
Detomidine injection may cause the following side effects:
- Bradycardia.
- Transient hypotension and/or transient hypertension.
- Respiratory depression, rarely hyperventilation.
- Increased blood glucose.
- As with other sedatives, paradoxical reactions (excitations) may occur in rare cases.
- Ataxia.
- Uterine contractions
- In horses: cardiac arrhythmia, atrioventricular and sino-atrial blocks.
- In cattle: ruminal atony, tympanism, paralysis of the tongue.
At doses above 40 µg of detomidine hydrochloride per kg bodyweight, the following symptoms may also be observed: sweating, piloerection, muscle tremors, transient prolapse of the penis in stallions and geldings, mild and transient ruminal tympanism as well as hypersalivation in cattle.
Due to the temporary inhibition of intestinal motility common to a2-sympathomimetics, in very rare cases, horses may show symptoms of colic following the administration of the product. Detomidine should be prescribed with caution in horses with colic or indigestion signs.
A diuretic effect is usually observed within 45 to 60 minutes after treatment.

Use during pregnancy, lactation or lay
The use is not recommended during the last trimester of pregnancy.
Use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions
Concomitant use with other sedatives should only be done after the consultation of contraindications and precautions of use of these products.
Detomidine should not be used in conjunction with sympathomimetic amines such as adrenaline, dobutamine and ephedrine except as required in anaesthetic emergencies.
Concomitant use with certain potentiated sulphonamides may cause fatal cardiac arrhythmia. Do not use in conjunction with sulphonamides.
Concomitant use of detomidine with other sedatives and anaesthetics requires caution because additive/synergistic effects are possible.
When induction of anaesthesia with detomidine and ketamine has been used prior to maintenance with halothane, the effects of halothane may be delayed. Therefore, special care must be taken to avoid overdose.
When detomidine is used as a premedication prior to general anaesthesia, detomidine may delay onset of induction.

Amounts to be administered and administration route
Administration by intravenous (IV) or intramuscular (IM) route.
The product should be injected slowly.
The onset of the effect is faster after IV administration than through IM.
Dosage in
Dosage in ml of
  
Onset of effect (min)
Duration
µg/kg
solution
Level of
    
of effect
(Detomidine)
per 100kg
sedation
Horses
Cattle
(hours)
10-20
0.1-0.2
Mild
3-5
5-8
0.5-1
20-40
0.2-0.4
Moderate
3-5
5-8
0.5-1
When prolonged sedation and analgesia are required, doses of 40 to 80 µg of detomidine hydrochloride per kg bodyweight may be used. The duration of the effect can reach 3 hours. Doses of 10 to 30 µg of detomidine hydrochloride per kg may be used in association with other products to enhance sedation or in premedication prior to general anaesthesia. It is recommended to wait 15 minutes after the administration of detomidine before starting the therapeutic procedure.
The weight of the animal to be treated should be determined as precisely as possible to avoid overdose.

Overdose
Accidental overdose may cause cardiac arrhythmia, hypotension, delayed recovery, deep depression of the central nervous system and the respiratory system. In cases of overdose or should the effects of detomidine become life-threatening, general measures for circulatory and respiratory stabilization and administration of an alpha2-adrenergic antagonist is recommended.

Withdrawal periods
Horses and cattle
Meat and offal: 2 days
Milk: 12 hours

Pharmacological particulars
Pharmacotherapeutic group: sedative and analgesic. ATC-vet code: QN05CM90.
Detomidine is a sedative with analgesic properties (a2-adrenergic agonist). The duration and intensity of the effect are dose-dependent.
Detomidine is rapidly absorbed after intramuscular injection.

Pharmaceutical particulars
Major incompatibilities
In the absence of compatibility studies, this 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: 28 days
Special precautions for storage
Keep container in the outer carton in order to protect from light.

Immediate packaging
Pack size: 10 ml
Type I clear glass vials which are fitted with a bromobutyl rubber stopper sealed with aluminium caps with plastic flip-off.
[FR]
Type I clear glass vials which are fitted with a bromobutyl rubber stopper sealed with aluminium caps with plastic flip-off.

Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.