Dexdomitor (dexmedetomidine hydrochloride) – Package leaflet - QN05CM18

Updated on site: 21-Sep-2017

Medication name: Dexdomitor
ATC: QN05CM18
Substance: dexmedetomidine hydrochloride
Manufacturer: Orion Corporation

PACKAGE LEAFLET

DEXDOMITOR 0.1 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 0.1 mg/ml solution for injection

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substance:

One ml contains 0.1 mg dexmedetomidine hydrochloride

 

equivalent to 0.08 mg dexmedetomidine.

List of excipients:

Methyl parahydroxybenzoate (E 218) 2.0 mg/ml

 

Propyl parahydroxybenzoate (E 216) 0.2 mg/ml

4.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.

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 α2-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.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Dogs and cats

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

Dexmedetomidine

 

Dexmedetomidine

Dexmedetomidine

Weight

125 micrograms/m2

 

375 micrograms/m2

500 micrograms/m2

(kg)

(mcg/kg)

(ml)

 

(mcg/kg)

(ml)

(mcg/kg)

(ml)

9.4

0.2

 

28.1

0.6

0.75

8.3

0.25

 

0.85

7.7

0.35

 

1.5

5.1-10

6.5

0.5

 

19.6

1.45

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

 

 

 

Dexmedetomidine

 

 

Weight

 

 

300 micrograms/m2 intramuscularly

 

(kg)

 

(mcg/kg)

 

 

 

(ml)

 

 

 

 

 

0.6

 

 

 

 

 

0.8

 

 

22.2

 

 

 

 

5.1-10

 

16.7

 

 

 

1.25

 

10.1-13

 

 

 

 

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

Dexmedetomidine 40 micrograms/kg intramuscularly

(kg)

(mcg/kg)

(ml)

0.5

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.

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

Not applicable

11.SPECIAL STORAGE PRECAUTIONS

Do not freeze.

After withdrawal of the first dose, the product may be stored for 3 months at 25ºC. Keep out of the sight and reach of children.

Do not use after the expiry date stated on the label and carton after EXP.

12.SPECIAL WARNINGS

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 increased twofold 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 doctors: Dexdomitor is an α2-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 α2- 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.

13.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15.OTHER INFORMATION

Package size: 15 ml, 10 x 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.

België/Belgique/Belgien

VETOQUINOL SA/NV

Kontichsesteenweg 42

BE-2630 Aartselaar

Deutschland

VETOQUINOL GmbH

Parkstrasse 10

D-88212 Ravensburg

Ελλάδα ΕΛΑΝΚΟ ΕΛΛΑΣ Α.Ε.Β.Ε

335 Μεσογείων,15231

Χαλάνδρι,Αττική-Ελλάς

España

Ecuphar Veterinaria S.L.U.

Avenida Río de Janeiro, 60 – 66, planta 13 08016 Barcelona (España)

France

VETOQUINOL SA

Magny-Vernois

70200 Lure

Ireland

VETOQUINOL UK LIMITED

Vétoquinol House

Great Slade, Buckingham Industrial Park

Buckingham, MK18 1PA, UK

Italia

VETOQUINOL Italia S.r.l

Via Piana, 265

47032 Bertinoro (FC)

Κύπρος

Lifepharma (Z.A.M.) Ltd,

Αγίου Νικολάου 8, 1055 Λευκωσία,

Κύπρος, τηλ. 00357 22056300

Luxembourg/Luxemburg

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Nederland

VETOQUINOL BV

Postbus 3191, 5203

DD‘s Hertogenbosch

Österreich

Bayer Austria Ges.m.b.H Herbststrasse 6-10 A-1160 Wien

Portugal

Belphar LDA

Edifício Amoreiras Square

Rua Carlos Alberto da Mota Pinto, 17, 3º A 1070-313 Lisboa (Portugal)

Suomi/Finland

Orion Oyj ORION PHARMA

Eläinlääkkeet

Tengströminkatu 8, 20360 Turku

Sverige

Orion Pharma Animal Health

Box 520, 19205 Sollentuna

United Kingdom

VETOQUINOL UK LIMITED

Vétoquinol House

Great Slade, Buckingham Industrial Park

Buckingham, MK18 1PA, UK

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

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Active substance:

One ml contains 0.5 mg dexmedetomidine hydrochloride

 

equivalent to 0.42 mg dexmedetomidine.

List of excipients:

Methyl parahydroxybenzoate (E 218) 1.6 mg/ml

 

Propyl parahydroxybenzoate (E 216) 0.2 mg/ml

4.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.

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 α2-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.

If you notice any serious effects or other effects not mentioned in this leaflet, 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

Dexmedetomidine

Dexmedetomidine

Dexmedetomidine

Weight

125 mcg/m2

375 mcg/m2

500 mcg/m2

(kg)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

(mcg/kg)

(ml)

9.4

0.04

28.1

0.12

0.15

8.3

0.05

0.17

0.2

7.7

0.07

0.2

0.3

5-10

6.5

0.1

19.6

0.29

0.4

10-13

5.6

0.13

16.8

0.38

0.5

13-15

5.2

0.15

15.7

0.44

0.6

15-20

4.9

0.17

14.6

0.51

0.7

20-25

4.5

0.2

13.4

0.6

0.8

25-30

4.2

0.23

12.6

0.69

0.9

30-33

0.25

0.75

1.0

33-37

3.9

0.27

11.6

0.81

1.1

37-45

3.7

0.3

0.9

14.5

1.2

45-50

3.5

0.33

10.5

0.99

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

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

0.45

1.35

12.3

1.8

>80

2.9

0.47

8.7

1.42

1.9

For deep sedation and analgesia with butorphanol

Dog

 

Dexmedetomidine

Weight

 

300 mcg/m2 intramuscularly

(kg)

(mcg/kg)

(ml)

0.12

0.16

22.2

0.2

5-10

16.7

0.25

10-13

0.3

13-15

12.5

0.35

15-20

11.4

0.4

20-25

11.1

0.5

25-30

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

70-80

7.3

1.1

>80

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

Dexmedetomidine 40 mcg/kg intramuscularly

(kg)

(mcg/kg)

(ml)

0.1

0.2

0.3

0.4

0.5

0.6

8-10

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

Not applicable

11.SPECIAL STORAGE PRECAUTIONS

Do not freeze.

After withdrawal of the first dose, the product may be stored for 3 months at 25ºC. Keep out of the sight and reach of children.

12.SPECIAL WARNINGS

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 increased twofold 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 doctors: Dexdomitor is an α2-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 α2- 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.

13.SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15.OTHER INFORMATION

Package size: 10 ml, 10 x10 ml.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

VETOQUINOL SA/NV

Kontichsesteenweg 42

BE-2630 Aartselaar

Deutschland

VETOQUINOL GmbH

Parkstrasse 10

D-88212 Ravensburg

Ελλάδα ΕΛΑΝΚΟ ΕΛΛΑΣ Α.Ε.Β.Ε

335 Μεσογείων,15231

Χαλάνδρι,Αττική-Ελλάς

España

Ecuphar Veterinaria S.L.U.

Avenida Río de Janeiro, 60 – 66, planta 13 08016 Barcelona (España)

France

VETOQUINOL SA

Magny-Vernois

70200 Lure

Ireland

VETOQUINOL UK LIMITED

Vétoquinol House

Great Slade, Buckingham Industrial Park

Buckingham, MK18 1PA, UK

Italia

VETOQUINOL Italia S.r.l

Via Piana, 265

47032 Bertinoro (FC)

Κύπρος

Lifepharma (Z.A.M.) Ltd,

Αγίου Νικολάου 8, 1055 Λευκωσία,

Κύπρος, τηλ. 00357 22056300

Luxembourg/Luxemburg

VETOQUINOL SA

Magny-Vernois

70200 Lure

France

Nederland

VETOQUINOL BV

Postbus 3191, 5203

DD‘s Hertogenbosch

Österreich

Bayer Austria Ges.m.b.H Herbststrasse 6-10 A-1160 Wien

Portugal

Belphar LDA

Edifício Amoreiras Square

Rua Carlos Alberto da Mota Pinto, 17, 3º A 1070-313 Lisboa (Portugal)

Suomi/Finland

Orion Oyj ORION PHARMA

Eläinlääkkeet

Tengströminkatu 8, 20360 Turku

Sverige

Orion Pharma Animal Health

Box 520, 19205 Sollentuna

United Kingdom

VETOQUINOL UK LIMITED

Vétoquinol House

Great Slade, Buckingham Industrial Park

Buckingham, MK18 1PA, UK

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