COMPOSITION
1 ml of the product contains butorphanol 10 mg
(as Butorphanol tartrate 14.58 mg)
Solution for injection.
Clear colourless solution.
Target species
Horses, dogs, cats.
Indications for use, specifying the target species
The product is indicated for the management of analgesia and sedation in horses; for the management of analgesia, sedation and preanaesthesia in dogs and cats.
HORSE:
Analgesic: To alleviate mild to severe abdominal pain of gastrointestinal origin including a colic. The product alleviates pain related to a colic or labour and delivery conditions.
Sedative: For sedation after administration of determined alpha2-adrenoceptor agonists (detomidine hydrochloride, romifidine).
Sedation in therapeutic and diagnostic procedures in standing animals.
DOG:
Analgesic: Alleviation of mild to severe pain associated with postoperative procedures, especially after orthopaedic surgery or soft tissue surgery.
Sedative: In combination with medetomidine hydrochloride.
Preanaesthetic: Preanaesthetic administration of the product reduces the dose of general anaesthetic, especially sodium thiopental. The product is administered as a part of the anaesthesia protocol in combination with medetomidine hydrochloride and ketamine.
CAT:
Analgesic: Alleviation of mild to severe pain associate with surgery procedures, especially with castration, orthopaedic surgery or soft tissue surgery.
Sedative: In combination with medetomidine hydrochloride.
Preanaesthetic: Preanaesthetic administration of the product reduces the dose of general anaesthetic, especially sodium thiopental. The product is administered as a part of the anaesthesia protocol in combination with medetomidine hydrochloride and ketamine.
Contraindications
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
HORSE:
Do not use in animals with known alteration of the liver function.
Butorphanol / detomidine hydrochloride combination:
Do not use the combination in animals with known cardiac arrhythmia or bradycardia.
Do not use the combination in animals with known alteration of the liver function.
DOG, CAT:
Do not use the combination in animals with known alteration of the liver function.
Special warnings (for each target species)
No distinct sedation occurs in cats when butorphanol alone is administered.
Special precautions for use
Special precautions for use in animals
Before using the product in combination with any other medicines, the contraindications and warnings stated in SPC documents for the respective medicines should be taken into account.
Butorphanol is a morphine derivative and thus it shows opiate activity. Safety of the product in puppies, kittens and foals has not been established. Use of the product in these groups should be based on an assessment of the therapeutic benefit and risk by the responsible veterinary physician.
HORSE:
Butorphanol / detomidine hydrochloride combination: Routine cardiac auscultation should be performed prior to using the combination.
DOG:
Before administering the product as a preanaesthetic, using an anticholinergic drug (e.g. atropine) is recommended to prevent bradycardia during the narcosis.
Intravenous application should be slow, not a rapid bolus.
Naloxone can be used as an antidote in case of respiratory depression.
CAT:
Observe accurate dosing. The dose should be administered based on accurately established live weight of the animal. A syringe with an appropriate scale (e.g. an insulin syringe) should be used for accurate dosing.
Naloxone can be used as an antidote in case of respiratory depression.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prevent accidental self-administration. Protect the needle till the moment of product administration. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the general practitioner.
AVOID DRIVING as sedation, dizziness and disorientation may occur. An opioid antagonist may be used as an antidote.
Avoid direct contact with skin and eyes. In case of accidental spillage on the skin or when in contact with the eyes, rinse immediately with plenty of water.
Pregnant and breastfeeding women should take great care when administering the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
Mild pain may be observed at the puncture site after intramuscular application.
HORSE:
Mild ataxia is the most common adverse effect, which may persist for 3–10 minutes. Mild to moderate ataxia may occur after application of butorphanol in combination with detomidine hydrochloride. These reactions are unlikely to cause the animal to lie down. Common precautions should be taken to prevent an injury of the horse.
Mild sedation may occur after application of butorphanol alone.
DOG:
Butorphanol may cause respiratory depression.
Butorphanol may reduce motility of the gastrointestinal tract. Rarely, anorexia, diarrhoea or transient ataxia may occur.
CAT:
Pain upon intramuscular application was observed in a study. The frequency was very common.
Butorphanol may cause respiratory depression.
Mydriasis may occur after application of the product.
Use during pregnancy and lactation
HORSE:
Butorphanol / detomidine hydrochloride combination: Do not use during pregnancy.
Butorphanol / romifidine combination: Avoid using in the last month of pregnancy.
DOG, CAT:
Safety of the product during pregnancy and lactation has not been established. Use of the product should be based on an assessment of the therapeutic benefit and risk by the responsible veterinary physician.
Interactions with other medicinal products and other forms of interaction
Butorphanol may be used in combination with other sedatives such as alpha2-adrenoceptor agonists (e.g. romifidine or detomidine in horses; medetomidine in dogs and cats) if synergistic effects can be expected. An appropriate dose reduction is necessary when used concomitantly with such agents (see section 4.9).
Posology and method of administration
HORSE: Only for intravenous administration (i.v.)
DOG, CAT: Intravenous (i.v.), subcutaneous (s.c.) or intramuscular (i.m.) administration
Avoid bolus application where i.v. administration is used. Avoid an excessively rapid i.v. administration. Different application sites should be used for repeated s.c. or i.m. administration.
HORSE
When used as an analgesic:
Butorphanol alone:
To be applied in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight, i.e. 1 ml/100 kg of live weight i.v.
The dosing can be repeated as needed. The analgesic effect develops in 15 minutes from application.
As a sedative:
Butorphanol in combination with detomidine:
Detomidine hydrochloride should be applied in the dose of 0.012 mg/kg of live weight i.v. Subsequently, 5 minutes later butorphanol should be applied in the dose of 0.025 mg/kg of live weight, which is equivalent to 0.0025 ml of the product/kg of live weight, i.e. 0.25 ml of the product/100 kg of live weight i.v.
Butorphanol in combination with romifidine:
Romifidine should be applied in the dose of 0.04–0.12 mg/kg of live weight i.v. Subsequently, 5 minutes later butorphanol should be applied in the dose of 0.02 mg/kg of live weight, which is equivalent to 0.002 ml of the product/kg of live weight, i.e. 0.2 ml of the product/100 kg of live weight i.v.
DOG
As an analgesic:
Butorphanol alone:
To be applied in the dose of 0.2–0.3 mg/kg of live weight, which is equivalent to 0.02–0.03 ml of the product/kg of live weight, i.e. 0.2–0.3 ml of the product/10 kg of live weight i.v., i.m. or s.c.
The product should be applied 15 minutes before the end of anaesthesia to provide an analgesic effect in the recovery phase. The analgesic effect can be observed in 15 minutes. For continuous analgesia, product dosing can be repeated as needed.
As a sedative:
Butorphanol in combination with medetomidine:
Butorphanol should be applied in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight i.v. or i.m. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.01–0.025 mg/kg of live weight i.v. or i.m. Both agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities).
Before initiating the therapeutic procedure, wait for 20 minutes after the application for sufficient sedation.
Atipamezole should be applied in the dose of 0.05–0.125 mg/kg of live weight to return from anaesthesia. The patient assumes the sternal position approximately in 5 minutes and stands up after additional 2 minutes.
As a preanaesthetic:
Butorphanol alone:
To be applied in the dose of 0.1–0.2 mg/kg of live weight, which is equivalent to 0.01–0.02 ml of the product/kg of live weight i.v., i.m. or s.c.
To be applied 15 minutes before inducing anaesthesia.
As a sedative and preanaesthetic – premedication of barbiturate anaesthesia:
Butorphanol in combination with medetomidine:
Butorphanol should be applied in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight i.v. or i.m. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.01 mg/kg of live weight i.v. or i.m. Both agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities).
As a part of the anaesthesia protocol:
Butorphanol in combination with medetomidine and ketamine:
Butorphanol should be applied in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight i.m. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.025 mg/kg of live weight i.m. Both agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities). After 15 minutes, ketamine should be applied in the dose of 5 mg/kg of live weight i.m.
Sedation and the onset of anaesthesia develop approximately in 6 minutes from the first application. Extinction of the pedal reflex occurs approximately in 14 minutes. Anaesthesia subsides approximately in 53 minutes from ketamine application – the pedal reflex returns. The patient assumes the sternal position approximately in 35 minutes and stands up after additional 36 minutes.
Atipamezole is not recommended to be used to remove anaesthesia when butorphanol is used in combination with medetomidine / ketamine.
CAT
As a preoperative analgesic:
Butorphanol alone:
To be applied in the dose of 0.4 mg/kg of live weight, which is equivalent to 0.04 ml of the product/kg of live weight, i.e. 0.2 ml/5 kg of live weight i.m. or s.c.
When intravenous induction of anaesthesia is used, butorphanol should be applied 15–30 minutes before administering the anaesthetic.
When intramuscular induction of anaesthesia is used (acepromazine/ketamine or xylazine/ketamine), butorphanol should be applied 5 minutes before administering the anaesthetic. The use of butorphanol has no distinct effect on the awakening period.
As a postoperative analgesic:
- Intramuscular; subcutaneous administration: Butorphanol should be applied separately in the dose of 0.4 mg/kg of live weight, which is equivalent to 0.04 ml of the product/kg of live weight, i.e. 0.2 ml/5 kg of live weight s.c. or i.m.
- Intravenous administration: Butorphanol should be applied separately in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight, i.e. 0.05 ml/5 kg of live weight i.v.
To be applied 15 minutes before awakening from anaesthesia.
As a sedative:
Butorphanol in combination with medetomidine:
Butorphanol should be applied in the dose of 0.4 mg/kg of live weight, which is equivalent to 0.04 ml of the product/kg of live weight i.m. or s.c. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.05 mg/kg of live weight s.c. or i.m. Both agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities).
Local anaesthesia should be used for surgical suturing of wounds.
Atipamezole should be applied in the dose of 0.125 mg/kg of live weight to return from anaesthesia. The patient assumes the sternal position approximately in 4 minutes and stands up after an additional 1 minute.
As a part of the anaesthesia protocol:
Butorphanol in combination with medetomidine and ketamine:
- Intravenous administration:
Butorphanol should be applied in the dose of 0.1 mg/kg of live weight, which is equivalent to 0.01 ml of the product/kg of live weight i.v. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.04 mg/kg of live weight i.v. and ketamine in the dose of 1.25–2.5 mg/kg of live weight i.v.; ketamine should be dosed based on the required depth of anaesthesia. The agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities).
The patient lies down in 2–3 minutes from the application. Extinction of the pedal reflex occurs approximately in 3 minutes from the application. Atipamezole should be applied in the dose of 0.2 mg/kg of live weight to return from anaesthesia. The pedal reflex returns approximately in 2 minutes; the patient assumes the sternal position approximately in 6 minutes and stands up after additional 18 minutes.
- Intramuscular administration:
Butorphanol should be applied in the dose of 0.4 mg/kg of live weight, which is equivalent to 0.04 ml of the product/kg of live weight i.m. Medetomidine hydrochloride should be applied immediately thereafter in the dose of 0.08 mg/kg of live weight i.m. and ketamine in the dose of 5 mg/kg of live weight i.m. The agents should be administered separately, not in a single syringe (see section 6.2 Incompatibilities).
The onset of the effect and its subsiding depend on the administered dose of ketamine. The patient lies down in 1 minute including the pedal reflex loss. The anaesthesia lasts up to 60 minutes without any additional medication (sternal position resumed) and the patient stands up in 70–83 minutes. Atipamezole should be applied in the dose of 0.1 mg/kg of live weight to return from anaesthesia. The pedal reflex returns approximately in 4 minutes; the patient assumes the sternal position approximately in 7 minutes and stands up after additional 18 minutes.
The stopper can be punctured up to 50 times.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Respiratory depression is the most important consequence of overdose. Opioid receptor antagonists (e.g. naloxone) are suitable antidotes.
Atipamazole is a suitable antidote in case of overdose of butorphanol in combination with medetomidine hydrochloride or ketamine, with the exception of intramuscular administration of the butorphanol/medetomidine/ketamine combination in dogs.
Withdrawal periods
Horse:
Meat: No withdrawal periods.
Milk: No withdrawal periods.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Protect from light.
Package size:
1 x 10 ml
