DEXIVET 0,5 mg/ml solution for injection

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Conclusion

Dexmedetomidini hydrochloridum 0,5 mg

Solution for injection.

Clear colourless solution with no visible particles.

Target animal species

 Dogs and cats.

Indications with specification for the target animal species

Non-invasive, mildly or moderately painful procedures and examinations requiring sedation, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs when co-administered with butorphanol for examination and minor surgical procedures. Premedication of dogs and cats prior to induction of general anaesthesia and maintenance of anaesthesia.

Contraindications

Do not use in animals with diseases of the cardiovascular system.

Do not use in animals with severe systemic diseases or in animals that are dying.

Do not use in case of hypersensitivity to the medicinal substance or to any of the excipients.

Special warnings for each target species

The administration of dexmedetomidine to puppies less than 16 weeks of age and kittens less than 12 weeks of age has not been investigated. The safety of dexmedetomidine has not been established in breeding males. Corneal opacity may occur in cats during sedation. Protect the eyes with a suitable eye lubricant.

Special precautions for use

Keep the treated animals in a warm environment at a constant temperature both during the procedure itself and during the awakening period.

It is recommended that animals be fasted for 12 hours before administration of dexmedetomidine. Water may be administered.

After treatment, do not give the animal water or food until it is able to swallow. Protect the eyes with a suitable lubricant. Use extra caution with older animals.

Allow nervous, aggressive or agitated animals to calm down before treatment.

Frequent and regular monitoring of respiratory and cardiac function should be carried out. Pulse oximetry may be useful but is not essential for adequate monitoring. A manual ventilation device should be available in the event of respiratory depression or apnoea during the subsequent use of dexmedetomidine and ketamine to induce anaesthesia in cats. It is also advisable to have oxygen readily available in case of hypoxaemia or suspected hypoxaemia.

Premedicate sick and emaciated dogs and cats with dexmedetomidine prior to induction and administration of general anaesthesia only according to an assessment of the therapeutic benefit/risk ratio.

The use of dexmedetomidine to premedicate dogs and cats significantly reduces the amount of drug used to induce anaesthesia. Careful attention should be paid to the effect of the drug used to induce anaesthesia during its intravenous administration.

Side effects (frequency and severity)

Due to its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.  Some dogs and cats may experience a decrease in respiratory rate. Rare cases of pulmonary oedema have been reported. Blood pressure will initially increase, then fall to normal or below. Due to peripheral vasoconstriction and venous desaturation with normal arterial oxygenation, mucous membranes may be blue tinged or pale.  Vomiting may occur 5-10 minutes after injection. Some dogs and cats may also vomit during waking. Muscle tremors may occur during sedation.

Use during pregnancy and lactation

The safety of dexmedetomidine for use during pregnancy and lactation in the target animal species has not been established. Therefore, use during pregnancy and lactation is not recommended.

Interactions with other medicinal products and other forms of interaction

Potentiation of the effect of dexmedetomidine can be expected with the use of other central nervous system depressants and therefore the dose should be adjusted accordingly. Use anticholinergics with dexmedetomidine with caution.

Administration of atipamezole after dexmedetomidine rapidly abolishes its effect and thus shortens the wake-up time. Dogs and cats wake and rise within 15 minutes.

Cats: After intramuscular administration of 40 micrograms of dexmedetomidine/kg bw concomitantly with 5 mg ketamine/kg bw, there is a twofold increase in dexmedetomidine concentration in cats, but Tmax is not affected. The mean biological half-life of dexmedetomidine is increased to 1.6 h and the overall action time (AUC) is increased by 50%.

A dose of 10 mg ketamine/kg given concomitantly with 40 micrograms dexmedetomidine/kg may cause tachycardia.

Amount administered and method of administration

The preparation is intended for:

• Dogs: intravenous or intramuscular administration
• Cats: intramuscular administration

The product is intended for single injection only.

Dosage: the following doses are recommended:

Dogs

Dose determination for dogs is based on body surface area size.

Intravenous: up to 375 micrograms/square meter of body surface area.

Intramuscular: up to 500 micrograms/square meter of body surface area

When administered concomitantly with butorphanol (0.1 mg/kg) to induce deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre of body surface area. The premedication dose of dexmedetomidine is 125-375 micrograms/square metre of body surface area, administered 20 minutes before the start of the procedures required for anaesthesia. The dose should be tailored to the type of surgical procedure, the length of the procedure, and the temperament of the patient.

Co-administration of dexmedetomidine and butorphanol produces sedative and analgesic effects occurring no later than 15 minutes after administration. The maximum sedative and analgesic effect is achieved 30 minutes after administration. Sedation lasts at least 120 minutes after administration, analgesia at least 90 minutes after administration. Spontaneous recovery occurs within 3 hours.

Body weight (kg)	Dexmedetomidin 125 µg/m2		Dexmedetomidin 375 µg/m2		Dexmedetomidin 500 µg/m2
	µg/kg	ml	µg/kg	ml	µg/kg	ml
2-3	9,4	0,04	28,1	0,12	40	0,15
3-4	8,3	0,05	25	0,17	35	0,2
4-5	7,7	0,07	23	0,2	30	0,3
5-10	6,5	0,1	19,6	0,29	25	0,4
10-13	5,6	0,13	16,8	0,38	23	0,5
13-15	5,2	0,15	15,7	0,44	21	0,6
15-20	4,9	0,17	14,6	0,51	20	0,7
20-25	4,5	0,2	13,4	0,6	18	0,8
25-30	4,2	0,23	12,6	0,69	17	0,9
30-33	4	0,25	12	0,75	16	1,0
33-37	3,9	0,27	11,6	0,81	15	1,1
37-45	3,7	0,3	11	0,9	14,5	1,2
45-50	3,5	0,33	10,5	0,99	14	1,3
50-55	3,4	0,35	10,1	1,06	13,5	1,4
55-60	3,3	0,38	9,8	1,13	13	1,5
60-65	3,2	0,4	9,5	1,19	12,8	1,6
65-70	3,1	0,42	9,3	1,26	12,5	1,7
70-80	3	0,45	9	1,35	12,3	1,8
˃80	2,9	0,47	8,7	1,42	12	1,9

 

Deep sedation and analgesia,  combination with butorphanol
Body weight dogs (kg)	Dexmedetomidin 300 µg/m2 i.m.
	µg/kg	ml
2-3	24	0,12
3-4	23	0,16
4-5	22,2	0,2
5-10	16,7	0,25
10-13	13	0,3
13-15	12,5	0,35
15-20	11,4	0,4
20-25	11,1	0,5
25-30	10	0,55
30-33	9,5	0,6
33-37	9,3	0,65
37-45	8,5	0,7
45-50	8,4	0,8
50-55	8,1	0,85
55-60	7,8	0,9
60-65	7,6	0,95
65-70	7,4	1
70-80	7,3	1,1
˃80	7	1,2

Premedication with dexmedetomidine significantly reduces the dose of anaesthetic inducing drug required and also reduces the requirement for volatile anaesthetic required to maintain anaesthesia. In a clinical study, the requirements for propofol and thiopental were reduced by 30% and 60%, respectively. All agents used to induce or maintain anaesthesia should be administered until their effect is achieved. In a clinical study, dexmedetomidine contributed to postoperative analgesia in the range of 0.5 to 4 hours. However, its duration is dependent on many factors and additional analgesia should be given in accordance with clinical judgement.

CATS:

The dosage for cats when used prior to non-invasive, mild to moderate pain procedures requiring sedation, sedation and analgesia is 40 micrograms dexmedetomidine hydrochloride/kg b.w., which corresponds to a volumetric dose of 0.08 mL DEXIVET/kg b.w. The same dose of dexmedetomidine is used for premedication of cats. Premedication with dexmedetomidine will significantly reduce the dose of induction agent required and reduce the requirement for inhalational anaesthetic to maintain anaesthesia. In clinical trials, propofol requirements were reduced by 50%. All anaesthetic agents used to induce or maintain anaesthesia should be administered until effect is achieved.

Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of ketamine at a target dose of 5 mg/kg b.w.

Body weight cats (kg)	Dexmedetomidin 40 µg/m2 i.m.
	µg/kg	ml
1-2	40	0,1
2-3	40	0,2
3-4	40	0,3
4-6	40	0,4
6-7	40	0,5
7-8	40	0,6
8-10	40	0,7

The expected sedative and analgesic effect is achieved within 15 minutes of application and lasts about 60 minutes. Sedation can be reversed with atipamezole. Atipamezole should not be administered earlier than 30 minutes after ketamine administration.

DEXIVET is compatible with butorphanol and ketamine in the same syringe for a minimum of two hours.

Shelf life

Shelf life of the veterinary medicinal product in intact packaging: 2 years.

Shelf life after first opening of the inner packaging: 28 days.

Packaging

10 ml