Patient leaflet - Dexdomitor
B. PACKAGE LEAFLET
PACKAGE LEAFLET
DEXDOMITOR 0.1 mg/ml solution for injection
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXDOMITOR 0.1 mg/ml solution for injection dexmedetomidine hydrochloride
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
List of excipients:
One ml contains 0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine.
Methyl parahydroxybenzoate (E 218) 2.0 mg/ml
Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
4.
INDICATION(S)
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.
-
5. CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that are moribund.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
-
6. ADVERSE REACTIONS
By virtue of its a2-adrenergic activity, dexmedetomidine causes decreases in heart rate and body temperature.
In some dogs and cats a decrease in respiratory rate may occur. Rare instances of pulmonary oedema have been reported. 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.
Vomiting may occur 5–10 minutes after injection.
Some dogs and cats may also vomit at the time of recovery.
Muscle tremors may occur during sedation.
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole. Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea. In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia. Vomiting, hypothermia and nervousness have been reported after such use.
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 have been reported. These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
When dexmedetomidine is used as a premedicant in dogs, bradypnoea, tachypnoea and vomiting may occur. Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.
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 depolarizations, 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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs and cats
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The product is intended for:
-
– Dogs: intravenous or intramuscular use
-
– Cats: intramuscular use
The product is not intended for repeat injections.
Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmacologically compatible.
The following doses are recommended:
DOGS:
Dexdomitor doses are based on body surface area:
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 dosage 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.
| 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 | 0.2 | 28.1 | 0.6 | 40 | 0.75 |
| 3.1–4 | 8.3 | 0.25 | 25 | 0.85 | 35 | 1 |
| 4.1–5 | 7.7 | 0.35 | 23 | 1 | 30 | 1.5 |
| 5.1–10 | 6.5 | 0.5 | 19.6 | 1.45 | 25 | 2 |
| 10.1–13 | 5.6 | 0.65 | 16.8 | 1.9 | ||
| 13.1–15 | 5.2 | 0.75 | ||||
| 15.1–20 | 4.9 | 0.85 | ||||
| For deep sedation and analgesia with butorphanol | |||
| Dog weight (kg) | (mcg/kg) | Dexmedetomidine 300 micrograms/m2 intramuscularly | (ml) |
| 2–3 | 24 | 0.6 | |
| 3.1–4 | 23 | 0.8 | |
| 4.1–5 | 22.2 | 1 | |
| 5.1–10 | 16.7 | 1.25 | |
| 10.1–13 | 13 | 1.5 | |
| 13.1–15 | 12.5 | 1.75 | |
For higher weight ranges, use DEXDOMITOR 0.5 mg/ml and its dosing tables.
CATS:
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.4 ml Dexdomitor/ 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 dosage 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 | 0.5 |
| 2.1–3 | 40 | 1 |
For higher weight ranges, use DEXDOMITOR 0.5 mg/ml and its dosing table.
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.
Atipamezole should not be administered prior to 30 minutes following ketamine administration.
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9. ADVICE ON CORRECT ADMINISTRATION
It is recommended that animals are fasted for 12 hours prior to administration. Water may be given.
After treatment, the animal should not be given water or food before it is able to swallow.
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10. WITHDRAWAL PERIOD(S)
Not applicable
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11. SPECIAL STORAGE PRECAUTIONS
Do not freeze. After withdrawal of the first dose, the product may be stored for 3 months at 25°C. Keep out of the sight and reach of children. Do not use this medicinal product after the expiry date which is stated on the label and carton after EXP.
-
12. SPECIAL WARNINGS(S)
Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species. Therefore the use of the product during pregnancy and lactation is not recommended.
The safety of dexmedetomidine has not been established in males intended for breeding.
To be used with precaution in elderly animals.
The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.
In cats, corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant.
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made. Use of dexmedetomidine as a premedicant in dogs significantly reduces the amount of induction drug required for induction of anaesthesia. Attention should be given during the administration of intravenous induction drugs to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Anticholinergics should be used with caution with dexmedetomidine.
Cats: After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine /kg bw to cats, the maximum concentration of dexmedetomidine increasedtwofold but there was no effect on T max. The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
A dose of 10 mg ketamine/kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period. Within 15 minutes dogs and cats are normally awake and standing
For information on adverse reactions, see section: Adverse reactions.
Frequent and regular monitoring of respiratory and cardiac function should be performed. Pulse oximetry may be useful but is not essential for adequate monitoring.
Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats. It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.
In cases of overdosing the following recommendations should be followed:
DOGS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area). The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Dexdomitor 0.1 mg/ml that was given to the dog, regardless of route of administration of Dexdomitor.
CATS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw. After concurrent exposure to a triple (3X) overdose of dexmedetomidine and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
At high serum concentration of dexmedetomidine sedation is not increased although the level of analgesia does increase with further dose increases.
The dose volume of atipamezole at the concentration of 5 mg/ml equals one- tenth (1/10) the volume of Dexdomitor 0.1 mg/ml that was given to the cat.
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin. In case of eye contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.
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 physicians: Dexdomitor is an a2-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. The specific a2-adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Persons with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( ).
15.
OTHER INFORMATION
Package size: 15 ml, 10 × 15 ml.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
| Belgie/Belgique/Belgien Vetoquinol N.V. Tel: +32 3 877 44 34 | Lietuva UAB Orion Pharma Tel: +370 5 276 9499 |
| PenyönuKa Etnrapua Orion Corporation Ten: +358 10 4261 | Luxembourg/Luxemburg Vetoquinol SA Tel: +33 3 84 62 55 55 |
| Česká republika Orion Pharma s.r.o. Tel: +420 227 027 263 | Magyarország Orion Pharma Kft. Tel.: +36 1 886 3015 |
| Danmark Orion Pharma Animal Health Tlf: 86 14 00 00 | Malta Orion Corporation Tel: + 358 10 4261 |
| Deutschland Vetoquinol GmbH Tel: +49 89 999 79 74–0 | Nederland Vetoquinol B.V. Tel: +31 10 498 00 79 |
| Eesti UAB Orion Pharma Tel: +370 5 276 9499 | Norge Orion Pharma AS Animal Health Tlf: 4000 4190 |
| EZZáSa EAANKO EAAAZ A.E.B.E Tq!.: (+30) 2130065000 | Österreich Richter Pharma AG Tel: 07242–490–0 |
| España Ecuphar Veterinaria S.L.U. Tel: +34 93 595 5000 | Polska Orion Pharma Poland Sp. z o.o. Tel.: +48 22 8333177 |
| France Vetoquinol SA Tél: +33 3 84 62 55 55 | Portugal BELPHAR, Lda Tel: +351 308 808 321 |
| Hrvatska IRIS d.o.o. Tel: +386 1 200 66 50 | Romania Orion Pharma Romania srl Tel: +40 31845 1646 |
| Ireland Vetoquinol Ireland Limited Tel: +44 1280 814500 | Slovenija IRIS d.o.o. Tel: +386 1 200 66 50 |
| Ísland Icepharma hf Simi: 540 8080 | Slovenská republika Orion Pharma s.r.o. Tel: +420 227 027 263 |
| Italia Vetoquinol Italia Tel: +39 05 43 46 24 11 | Suomi/Finland ORION PHARMA Eläinlääkkeet Puh/Tel: 010 4261 |
| Kúnpog Lifepharma (Z.A.M.) Ltd Tn!: +357 22 056 300 | Sverige Orion Pharma AB, Animal Health Tel: +46 8 623 64 40 |
| Latvija UAB Orion Pharma Tel: +370 5 276 9499 | United Kingdom (Northern Ireland) Vetoquinol UK Limited Tel: +44 1280 814500 |
PACKAGE LEAFLET
DEXDOMITOR 0.5 mg/ml solution for injection
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
-
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
DEXDOMITOR 0.5 mg/ml solution for injection dexmedetomidine hydrochloride
-
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
List of excipients:
One ml contains 0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine.
Methyl parahydroxybenzoate (E 218) 1.6 mg/ml
Propyl parahydroxybenzoate (E 216) 0.2 mg/ml
4.
INDICATION(S)
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.
-
5. CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that are moribund.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
-
6. ADVERSE REACTIONS
By virtue of its a2-adrenergic activity, dexmedetomidine causes decreases in heart rate and body temperature.
In some dogs and cats a decrease in respiratory rate may occur. Rare instances of pulmonary oedema have been reported. 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.
Vomiting may occur 5–10 minutes after injection.
Some dogs and cats may also vomit at the time of recovery.
Muscle tremors may occur during sedation.
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience AV-block or extrasystole. Expected respiratory events are bradypnoea, intermittent respiratory patterns, hypoventilation, and apnoea. In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia. Vomiting, hypothermia and nervousness have been reported after such use.
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 have been reported. These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
When dexmedetomidine is used as a premedicant in dogs, bradypnoea, tachypnoea and vomiting may occur. Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases.
When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur. Intramuscular dosing at 40 mcg/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 depolarizations, 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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
-
7. TARGET SPECIES
Dogs and cats
-
8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
The product is intended for:
-
– Dogs: intravenous or intramuscular use
-
– Cats: intramuscular use
The product is not intended for repeat injections.
Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmacologically compatible.
The following doses are recommended:
DOGS:
Dexdomitor doses are based on body surface area:
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 dosage 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.
| Dog weight (kg) | Dexmedetomidine 125 mcg/m2 | Dexmedetomidine 375 mcg/m2 | Dexmedetomidine 500 mcg/m2 | |||
| (mcg/kg) | (ml) | (mcg/kg) | (ml) | (mcg/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 |
| For deep sedation and analgesia with butorphanol | |||
| Dog weight (kg) | (mcg/kg) | Dexmedetomidine 300 mcg/m2 intramuscularly | (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 | |
CATS:
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/ kg bw equal to a dose volume 0.08 ml Dexdomitor/ 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 dosage 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 mcg/kg intramuscularly | |
| (mcg/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 effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration. Sedation may be reversed with atipamezole.
Atipamezole should not be administered prior to 30 minutes following ketamine administration.
-
9. ADVICE ON CORRECT ADMINISTRATION
It is recommended that animals are fasted for 12 hours prior to administration. Water may be given.
After treatment, the animal should not be given water or food before it is able to swallow.
10.
WITHDRAWAL PERIOD(S)
Not applicable
-
11. SPECIAL STORAGE PRECAUTIONS
Do not freeze. After withdrawal of the first dose, the product may be stored for 3 months at 25°C. Keep out of the sight and reach of children. Do not use this medicinal product after the expiry date which is stated on the label and carton after EXP.
-
12. SPECIAL WARNING(S)
Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species. Therefore the use of the product during pregnancy and lactation is not recommended.
The safety of dexmedetomidine has not been established in males intended for breeding.
To be used with precaution in elderly animals.
The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.
In cats, corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant.
The use of other central nervous system depressants is expected to potentiate the effects of dexmedetomidine and therefore an appropriate dose adjustment should be made. Use of dexmedetomidine as a premedicant in dogs significantly reduces the amount of induction drug required for induction of anaesthesia. Attention should be given during the administration of intravenous induction drugs to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Anticholinergics should be used with caution with dexmedetomidine.
Cats: After administration of 40 micrograms dexmedetomidine/ kg bw intramuscularly concurrently with 5 mg ketamine /kg bw to cats, the maximum concentration of dexmedetomidine mcreasedjwofold but there was no effect on T max. The mean half-life of elimination of dexmedetomidine increased to 1.6 h and the total exposure (AUC) increased by 50%.
A dose of 10 mg ketamine/kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Administration of atipamezole after dexmedetomidine rapidly reverses the effects and thus shortens the recovery period. Within 15 minutes dogs and cats are normally awake and standing.
For information on adverse reactions, see section: Adverse reactions.
Frequent and regular monitoring of respiratory and cardiac function should be performed. Pulse oximetry may be useful but is not essential for adequate monitoring.
Equipment for manual ventilation should be available in case of respiratory depression or apnoea when dexmedetomidine and ketamine are used sequentially to induce anaesthesia in cats. It is also advisable to have oxygen readily available, should hypoxaemia be detected or suspected.
Sick and debilitated dogs and cats should only be premedicated with dexmedetomidine before induction and maintenance of general anaesthesia based on a risk-benefit assessment.
In cases of overdosing the following recommendations should be followed:
DOGS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area). The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Dexdomitor that was given to the dog, regardless of route of administration of Dexdomitor.
CATS: In cases of overdosage, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw. After concurrent exposure to a triple (3X) overdose of dexmedetomidine and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
At high serum concentration of dexmedetomidine sedation is not increased although the level of analgesia does increase with further dose increases.
The dose volume of atipamezole at the concentration of 5mg/ml equals one-half the volume of Dexdomitor that was given to the cat.
In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In case of skin or mucosal contact, wash the exposed skin immediately after exposure with large amounts of water and remove contaminated clothes that are in direct contact with skin. In case of eye contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.
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 physicians: Dexdomitor is an a2-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. The specific a2-adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Persons with known hypersensitivity to the active substance or any of the excipients should administer the product with caution.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED