Cepedex (dexmedetomidine hydrochloride) – Summary of product characteristics - QN05CM18
Updated on site: 08-Feb-2018
Lääkkeen nimi: | Cepedex |
ATC: | QN05CM18 |
Lääkeaine: | dexmedetomidine hydrochloride |
Valmistaja: | CP-Pharma Handelsgesellschaft mbH |
Artikkelin sisältö
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Cepedex 0.1 mg/ml solution for injection for dogs and cats.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: |
|
Active substance: |
|
Dexmedetomidine hydrochloride | 0.1 mg |
(equivalent to dexmedetomidine | 0.08 mg) |
Excipients: |
|
Methyl parahydroxybenzoate (E 218) | 2.0 mg |
Propyl parahydroxybenzoate | 0.2 mg |
For the full list of excipients, see section 6.1. |
|
3. PHARMACEUTICAL FORM |
|
Solution for injection.
Clear, colourless solution.
4.CLINICAL PARTICULARS
4.1Target species
Dogs and cats.
4.2Indications for use, specifying the target species
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.
4.3Contraindications
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.
4.4Special warnings for each target species
The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.
4.5Special precautions for use
Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to Cepedex administration. Water may be given.
After treatment, the animal should not be given water or food before it is able to swallow.
Corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. To be used with precaution in elderly animals.
The safety of dexmedetomidine has not been established in males intended for breeding.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
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
Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction medicinal product required for induction of anaesthesia. Attention should be given during the administration of intravenous induction medicinal products to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Dexmedetomidine is a sedative and sleep inducing drug. Care should be taken to avoid
Pregnant women should administer the product with special caution to avoid
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.
People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Advice to physicians: Cepedex is an
4.6Adverse reactions (frequency and seriousness)
By virtue of its
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
Muscle tremors may occur during sedation.
Corneal opacities may occur during sedation (see also section 4.5).
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience
When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern
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.
4.7Use during pregnancy, lactation or lay
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.
4.8Interaction with other medicinal products and other forms of interaction
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. Anticholinergics should be used with caution with dexmedetomidine.
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.
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 Tmax. The mean
A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Atipamezole does not reverse the effect of ketamine.
4.9Amounts 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
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.

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 | ||||
6.5 | 0.5 | 19.6 | 1.45 | |||
5.6 | 0.65 | 16.8 | 1.9 |
|
| |
5.2 | 0.75 |
|
|
|
| |
4.9 | 0.85 |
|
|
|
| |
*only IM |
|
|
|
|
|
|
|
|
|
| |||
|
| For deep sedation and analgesia with butorphanol |
| |||
|
|
|
|
|
| |
Dog |
|
| Dexmedetomidine |
|
| |
Weight |
| 300 micrograms/m2 intramuscularly |
| |||
(kg) |
| (mcg/kg) |
|
| (ml) |
|
|
|
| 0.6 |
| ||
|
|
| 0.8 |
| ||
| 22.2 |
|
|
| ||
| 16.7 |
|
| 1.25 |
| |
|
|
| 1.5 |
| ||
| 12.5 |
|
| 1.75 |
|
For higher weight ranges, use Cepedex 0.5 mg/ml and its dosing tables.
Cats:
The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Cepedex/kg bw when used for
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 | Dexmedetomidine 40 micrograms/kg intramuscularly | |
Weight |
|
|
(kg) | (mcg/kg) | (ml) |
0.5 | ||
For higher weight ranges, use Cepedex 0.5 mg/ml and its dosing table.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes)
Dogs:
In cases of overdose, 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 Cepedex 0.1 mg/ml that was given to the dog, regardless of route of administration of Cepedex.
Cats:
In cases of overdose, or if the effects of dexmedetomidine become potentially
After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
4.11 Withdrawal period(s)
Not applicable
5.PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives
ATCvet code: QN05CM18
5.1Pharmacodynamic properties
Cepedex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats. The duration and depth of the sedation and analgesia are
Dexmedetomidine is a potent and selective
A slight decrease in temperature may be observed.
5.2Pharmacokinetic particulars
As a lipophilic compound, dexmedetomidine is well absorbed after intramuscular administration. Dexmedetomidine is also rapidly distributed in the body and penetrates the
several times that of the corresponding concentration in plasma. In the circulation, dexmedetomidine is largely bound to plasma proteins (>90%).
Dogs: After an intramuscular dose of 50 micrograms/kg a maximum concentration in plasma of about 12 nanograms/ml is reached after 0.6 hours. The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg. The elimination
Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and N- methylation in the liver. All known metabolites lack pharmacological activity. Metabolites are excreted mainly in the urine and to a lesser extent in the faeces. Dexmedetomidine has a high clearance and its elimination depends on the hepatic blood flow. A prolonged elimination
Cats: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 ng/ml. The maximum plasma concentration is reached about 0.24 h after intramuscular administration. The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination
Biotransformations in the cat occur by hydroxylation in the liver. Metabolites are excreted mainly in the urine (51% of the dose), and to a lesser extent in the faeces. As in dogs dexmedetomidine has a high clearance in cats and its elimination depends on the hepatic blood flow. A prolonged elimination
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Methyl parahydroxybenzoate (E 218)
Propyl parahydroxybenzoate
Sodium chloride
Sodium hydroxide (E 524) (for pH adjustment)
Hydrochloric acid (E507) (for pH adjustment)
Water for injections
6.2Incompatibilities
None known.
Dexmedetomidine is compatible with butorphanol and ketamine in the same syringe at least for two hours.
6.3Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4.Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5Nature and composition of immediate packaging
Colourless Type I glass vials of 5 ml and 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Carton box pack sizes:
1 vial of 5 ml
1 or 5 vials of 10 ml
Not all pack sizes may be marketed.
6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
CP Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf
Germany
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:13/12/2016
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Cepedex 0.5 mg/ml solution for injection for dogs and cats
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: |
|
Active substance: |
|
Dexmedetomidine hydrochloride | 0.5 mg |
(equivalent to dexmedetomidine | 0.42 mg) |
Excipients: |
|
Methyl parahydroxybenzoate (E 218) | 1.6 mg |
Propyl parahydroxybenzoate | 0.2 mg |
For the full list of excipients, see section 6.1. |
|
3. PHARMACEUTICAL FORM |
|
Solution for injection.
Clear, colourless solution.
4.CLINICAL PARTICULARS
4.1Target species
Dogs and cats.
4.2Indications for use, specifying the target species
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.
4.3Contraindications
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.
4.4Special warnings for each target species
The administration of dexmedetomidine to puppies younger than 16 weeks and kittens younger than 12 weeks has not been studied.
4.5Special precautions for use
Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature, both during the procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to Cepedex administration. Water may be given.
After treatment, the animal should not be given water or food before it is able to swallow.
Corneal opacities may occur during sedation. The eyes should be protected by a suitable eye lubricant. To be used with precaution in elderly animals.
The safety of dexmedetomidine has not been established in males intended for breeding.
Nervous, aggressive or excited animals should be given the possibility to calm down before initiation of treatment.
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
Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the amount of induction medicinal product required for induction of anaesthesia. Attention should be given during the administration of intravenous induction medicinal products to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also reduced.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Dexmedetomidine is a sedative and sleep inducing drug. Care should be taken to avoid
Pregnant women should administer the product with special caution to avoid
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.
People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Advice to physicians: Cepedex is an
4.6Adverse reactions (frequency and seriousness)
By virtue of its
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
Muscle tremors may occur during sedation.
Corneal opacities may occur during sedation (see also section 4.5).
When dexmedetomidine and ketamine are used sequentially, with a 10 minute interval, cats may occasionally experience
When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern
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.
4.7Use during pregnancy, lactation or lay
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.
4.8Interaction with other medicinal products and other forms of interaction
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. Anticholinergics should be used with caution with dexmedetomidine.
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.
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 Tmax. The mean
A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Atipamezole does not reverse the effect of ketamine.
4.9Amounts 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.
The stopper may be safely punctured up to 100 times.
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
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.
| 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 | 0.04 |
| 28.1 | 0.12 | 0.15 |
| |||
| 8.3 | 0.05 |
| 0.17 | 0.2 |
| ||||
| 7.7 | 0.07 |
| 0.2 | 0.3 |
| ||||
| 6.5 | 0.1 |
| 19.6 | 0.29 | 0.4 |
| |||
| 5.6 | 0.13 |
| 16.8 | 0.38 | 0.5 |
| |||
| 5.2 | 0.15 |
| 15.7 | 0.44 | 0.6 |
| |||
| 4.9 | 0.17 |
| 14.6 | 0.51 | 0.7 |
| |||
| 4.5 | 0.2 |
| 13.4 | 0.6 | 0.8 |
| |||
| 4.2 | 0.23 |
| 12.6 | 0.69 | 0.9 |
| |||
| 0.25 |
| 0.75 | 1.0 |
| |||||
| 3.9 | 0.27 |
| 11.6 | 0.81 | 1.1 |
| |||
| 3.7 | 0.3 |
| 0.9 | 14.5 | 1.2 |
| |||
| 3.5 | 0.33 |
| 10.5 | 0.99 | 1.3 |
| |||
| 3.4 | 0.35 |
| 10.1 | 1.06 | 13.5 | 1.4 |
| ||
| 3.3 | 0.38 |
| 9.8 | 1.13 | 1.5 |
| |||
| 3.2 | 0.4 |
| 9.5 | 1.19 | 12.8 | 1.6 |
| ||
| 3.1 | 0.42 |
| 9.3 | 1.26 | 12.5 | 1.7 |
| ||
| 0.45 |
| 1.35 | 12.3 | 1.8 |
| ||||
| >80 | 2.9 | 0.47 |
| 8.7 | 1.42 | 1.9 |
| ||
| *only IM |
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| For deep sedation and analgesia with butorphanol |
|
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| |
| Dog |
|
|
|
| Dexmedetomidine |
|
|
| |
| Weight |
|
| 300 micrograms/m2 intramuscularly |
|
| ||||
| (kg) |
|
| (mcg/kg) |
|
| (ml) |
|
| |
|
|
|
|
|
| 0.12 |
|
| ||
|
|
|
|
|
| 0.16 |
|
| ||
|
|
| 22.2 |
|
|
| 0.2 |
|
| |
|
|
| 16.7 |
|
|
| 0.25 |
|
| |
|
|
|
|
|
| 0.3 |
|
| ||
|
|
| 12.5 |
|
|
| 0.35 |
|
| |
|
|
| 11.4 |
|
|
| 0.4 |
|
| |
|
|
| 11.1 |
|
|
| 0.5 |
|
| |
|
|
|
|
|
| 0.55 |
|
| ||
|
|
| 9.5 |
|
|
| 0.6 |
|
| |
|
|
| 9.3 |
|
|
| 0.65 |
|
| |
|
|
| 8.5 |
|
|
| 0.7 |
|
| |
|
|
| 8.4 |
|
|
| 0.8 |
|
| |
|
|
| 8.1 |
|
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| 0.85 |
|
| |
|
|
| 7.8 |
|
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| 0.9 |
|
| |
|
|
| 7.6 |
|
|
| 0.95 |
|
| |
|
|
| 7.4 |
|
|
|
|
| ||
|
|
| 7.3 |
|
|
| 1.1 |
|
| |
| >80 |
|
|
|
|
| 1.2 |
|
|

Cats:
The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Cepedex/kg bw when used for
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 | Dexmedetomidine 40 micrograms/kg intramuscularly | ||
Weight | |||
|
| ||
(kg) | (mcg/kg) | (ml) | |
0.1 | |||
0.2 | |||
0.3 | |||
0.4 | |||
0.5 | |||
0.6 | |||
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.
4.10 Overdose (symptoms, emergency procedures, antidotes)
Dogs:
In cases of overdose, 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 Cepedex 0.5 mg/ml that was given to the dog, regardless of route of administration of Cepedex.
Cats:
In cases of overdose, or if the effects of dexmedetomidine become potentially
4.11 Withdrawal period(s)
Not applicable
5.PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives
ATCvet code: QN05CM18
5.1Pharmacodynamic properties
Cepedex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats. The duration and depth of the sedation and analgesia are
Dexmedetomidine is a potent and selective
A slight decrease in temperature may be observed.
5.2Pharmacokinetic particulars
As a lipophilic compound, dexmedetomidine is well absorbed after intramuscular administration. Dexmedetomidine is also rapidly distributed in the body and penetrates the
Dogs: After an intramuscular dose of 50 micrograms/kg a maximum concentration in plasma of about 12 nanograms/ml is reached after 0.6 hours. The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg. The elimination
Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and N- methylation in the liver. All known metabolites lack pharmacological activity. Metabolites are excreted mainly in the urine and to a lesser extent in the faeces. Dexmedetomidine has a high clearance and its elimination depends on the hepatic blood flow. A prolonged elimination
Cats: After a 40 micrograms/kg bw intramuscular dose the Cmax is 17 ng/ml. The maximum plasma concentration is reached about 0.24 h after intramuscular administration. The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination
Biotransformations in the cat occur by hydroxylation in the liver. Metabolites are excreted mainly in the urine (51% of the dose), and to a lesser extent in the faeces. As in dogs dexmedetomidine has a high clearance in cats and its elimination depends on the hepatic blood flow. A prolonged elimination
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Methyl parahydroxybenzoate (E 218)
Propyl parahydroxybenzoate
Sodium chloride
Sodium hydroxide (E 524) (for pH adjustment)
Hydrochloric acid (E507) (for pH adjustment)
Water for injections
6.2Incompatibilities
None known.
Dexmedetomidine is compatible with butorphanol and ketamine in the same syringe at least for two hours.
6.3Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4.Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5Nature and composition of immediate packaging
Colourless Type I glass vials of 5 ml, 10 ml and 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Carton box pack sizes: 1 vial of 5 ml
1 or 5 vials of 10 ml
1 vial of 20 ml
Not all pack sizes may be marketed.
6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
CP Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf
Germany
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:13/12/2016
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.