Sedadex
Active substance
ATC code
Species
Dogs and cats.
Indications
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Dose to be administered and administration route
The veterinary medicinal product is intended for:
- Dogs: intravenous or intramuscular use
- Cats: intramuscular use
The veterinary medicinal product is not intended for repeat injections.
Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
The following doses are recommended:
Dogs:
Dexmedetomidine doses are based on body surface area:
For non-invasive, mildly to moderately painful procedures and examinations requiring restraint, sedation and analgesia:
Intravenously: up to 375 micrograms/square metre body surface area.
Intramuscularly: up to 500 micrograms/square metre body surface area.
When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation and analgesia, the intramuscular dose of dexmedetomidine is 300 micrograms/square metre body surface area.
The premedication dose of dexmedetomidine is 125 – 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia. The dose should be adjusted to the type of surgery, length of procedure and patient temperament.
Concomitant use of dexmedetomidine and butorphanol produces sedative and analgesic effects beginning no later than 15 minutes after administration. The peak sedative and analgesic effects are reached within 30 minutes after administration. Sedation lasts for at least 120 minutes post administration and analgesia lasts for at least 90 minutes.
Spontaneous recovery occurs within 3 hours.
Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol and thiopental was reduced by 30% and 60% respectively. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect. In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 – 4 hours. However, this duration is dependent on a number of variables and further analgesia should be administered in accordance with clinical judgement.
The corresponding doses based on body weight are presented in the following tables. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes.
|
For non-invasive, mildly to moderately painful procedures and examinations requiring restraint, sedation and analgesia and for premedication |
||||||
|
Dog Weight (kg) |
Dexmedetomidine 125 micrograms/m2 |
Dexmedetomidine 375 micrograms/m2 |
Dexmedetomidine 500 micrograms/m2* |
|||
|
(mcg/kg) |
(ml) |
(mcg/kg) |
(ml) |
(mcg/kg) |
(ml) |
|
|
2-3 |
9.4 |
0.04 |
28.1 |
0.12 |
40 |
0.15 |
|
3.1-4 |
8.3 |
0.05 |
25 |
0.17 |
35 |
0.2 |
|
4.1-5 |
7.7 |
0.07 |
23 |
0.2 |
30 |
0.3 |
|
5.1-10 |
6.5 |
0.1 |
19.6 |
0.29 |
25 |
0.4 |
|
10.1-13 |
5.6 |
0.13 |
16.8 |
0.38 |
23 |
0.5 |
|
13.1-15 |
5.2 |
0.15 |
15.7 |
0.44 |
21 |
0.6 |
|
15.1-20 |
4.9 |
0.17 |
14.6 |
0.51 |
20 |
0.7 |
|
20.1-25 |
4.5 |
0.2 |
13.4 |
0.6 |
18 |
0.8 |
|
25.1-30 |
4.2 |
0.23 |
12.6 |
0.69 |
17 |
0.9 |
|
30.1-33 |
4 |
0.25 |
12 |
0.75 |
16 |
1.0 |
|
33.1-37 |
3.9 |
0.27 |
11.6 |
0.81 |
15 |
1.1 |
|
37.1-45 |
3.7 |
0.3 |
11 |
0.9 |
14.5 |
1.2 |
|
45.1-50 |
3.5 |
0.33 |
10.5 |
0.99 |
14 |
1.3 |
|
50.1-55 |
3.4 |
0.35 |
10.1 |
1.06 |
13.5 |
1.4 |
|
55.1-60 |
3.3 |
0.38 |
9.8 |
1.13 |
13 |
1.5 |
|
60.1-65 |
3.2 |
0.4 |
9.5 |
1.19 |
12.8 |
1.6 |
|
65.1-70 |
3.1 |
0.42 |
9.3 |
1.26 |
12.5 |
1.7 |
|
70.1-80 |
3 |
0.45 |
9 |
1.35 |
12.3 |
1.8 |
|
>80 |
2.9 |
0.47 |
8.7 |
1.42 |
12 |
1.9 |
*only IM
|
For deep sedation and analgesia with butorphanol |
||
|
Dog Weight (kg) |
Dexmedetomidine 300 micrograms/m2 intramuscularly |
|
|
(mcg/kg) |
(ml) |
|
|
2-3 |
24 |
0.12 |
|
3.1-4 |
23 |
0.16 |
|
4.1-5 |
22.2 |
0.2 |
|
5.1-10 |
16.7 |
0.25 |
|
10.1-13 |
13 |
0.3 |
|
13.1-15 |
12.5 |
0.35 |
|
15.1-20 |
11.4 |
0.4 |
|
20.1-25 |
11.1 |
0.5 |
|
25.1-30 |
10 |
0.55 |
|
30.1-33 |
9.5 |
0.6 |
|
33.1-37 |
9.3 |
0.65 |
|
37.1-45 |
8.5 |
0.7 |
|
45.1-50 |
8.4 |
0.8 |
|
50.1-55 |
8.1 |
0.85 |
|
55.1-60 |
7.8 |
0.9 |
|
60.1-65 |
7.6 |
0.95 |
|
65.1-70 |
7.4 |
1 |
|
70.1-80 |
7.3 |
1.1 |
|
>80 |
7 |
1.2 |
Cats:
The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
When dexmedetomidine is used for premedication in cats, the same dose is used.
Premedication with dexmedetomidine will significantly reduce the dose of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. In a clinical study, the requirement for propofol was reduced by 50%. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect.
Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw or by intravenous administration of propofol to effect. Dosing for cats is presented in the following table.
|
Cat Weight (kg) |
Dexmedetomidine 40 micrograms/kg intramuscularly |
|
|
(mcg/kg) |
(ml) |
|
|
1-2 |
40 |
0.1 |
|
2.1-3 |
40 |
0.2 |
|
3.1-4 |
40 |
0.3 |
|
4.1-6 |
40 |
0.4 |
|
6.1-7 |
40 |
0.5 |
|
7.1-8 |
40 |
0.6 |
|
8.1-10 |
40 |
0.7 |
Dogs and cats
The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration. Sedation may be reversed with atipamezole (see section 4.10). Atipamezole should not be administered prior to 30 minutes following ketamine administration.
Adverse reactions
Adverse reactions in dogs and cats
Pulmonary oedema has been reported rarely
Corneal opacities during sedation may occur (see also section 4.5).
By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature, which has been reported very rarely in spontaneous reports.
Bradypnoea has been reported very rarely in spontaneous reports.
Blood pressure will increase initially and then return to normal or below normal.
Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation, the mucous membranes may appear pale and/or with a blue tinge. Pale mucous membranes have been reported very rarely in spontaneous reports.
Vomiting has been reported very rarely in spontaneous reports. Vomiting may occur 5-10 minutes after injection, some dogs and cats may also vomit at the time of recovery.
Muscle tremors during sedation have been reported very rarely in spontaneous reports.
When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal or prolonged sedation may occur. Brady- and tachyarrhythmias, which may include profound sinus bradycardia, 1st and 2nd degree AV-block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes, have been reported.
When dexmedetomidine is used as a premedicant in dogs, bradypnoea, tachypnoea and vomiting may occur. Brady- and tachyarrhythmias, including profound sinus bradycardia, 1st and 2nd degree AV-block and sinus arrest have been reported. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV-block may be observed in rare cases.
When dexmedetomidine and ketamine are used sequentially, with a 10-minute interval, AV-block or extrasystole may occasionally be experienced by cats. Bradypnoea, intermittent respiratory patterns, hypoventilation, apnoea, vomiting, hypothermia and nervousness have also been reported after such use. Hypoxaemia was commonly reported in clinical trials, especially within the 15 first minutes into dexmedetomidineketamine anaesthesia.
When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur. Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarisations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or escape beats/rhythms.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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|---|---|
| Art. Nr. | 41821/5003 |
| EAN | 8718469445516 |
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