Target species
Dogs and cats.
Indications for use for each target species
Post-operative analgesia in dogs and cats.
Potentiation of the sedative effects of centrally acting agents in dogs.
Contraindications
Do not administer by the intrathecal or peridural route.
Do not use pre-operatively for Caesarean section (see section: Pregnancy, lactation or lay).
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Buprenorphine may cause respiratory depression and as with other opioid drugs, care should be taken when treating animals with impaired respiratory function or animals that are receiving drugs that can cause respiratory depression.
In case of renal, cardiac or hepatic dysfunction or shock, there may be greater risk associated with the use of the veterinary medicinal product. Safety has not been fully evaluated in clinically compromised cats.
Buprenorphine should be used with caution in animals with impaired liver function, especially biliary tract disease, as the substance is metabolised by the liver and its intensity and duration of action may be affected in such animals.
The safety of buprenorphine has not been demonstrated in animals less than 7 weeks of age.
Repeat administration earlier than the recommended repeat interval suggested in section "Administration route and dosage" is not recommended.
Long-term safety of buprenorphine in cats has not been investigated beyond 5 consecutive days of administration.
The effect of an opioid on head injury is dependent on the type and severity of the injury and the respiratory support supplied.
Use of the veterinary medicinal product in the above circumstances should only be in accordance with the benefit-risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
As buprenorphine has opioid-like activity, care should be taken to avoid self-injection. In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Following eye contamination or skin contact, wash thoroughly with cold running water. Seek medical advice if irritation persists.
Naloxone should be available in case of accidental self-injection.
People with known hypersensitivity to the active substance or to any of the excipients should avoid contact with the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs
Rare (1 to 10 animals / 10 000 animals treated): | Hypertension, tachycardia Sedation a |
Very rare (<1 animals / 10 000 animals treated, including isolated reports): | Hypersalivation Bradycardia Hypothermia Agitation Respiratory depressionb |
Undetermined frequency (cannot be estimated from the available data) | Dehydration Miosis |
a When used to provide analgesia. May occur at dose levels higher than those recommended.
b See also Section "Special precautions for use"
Cats:
Common (1 to 10 animals / 100 animals treated): | Mydriasis a Euphoria (excessive purring, pacing, rubbing) a |
Rare (1 to 10 animals / 10 000 animals treated): | Sedation b |
Very rare (<1 animals / 10 000 animals treated, including isolated reports): | Respiratory depression c |
a Usually resolves within 24 hours.
b When used to provide analgesia. May occur at dose levels higher than those recommended.
c See also Section "Special precautions for use"
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Laboratory studies in rats have not produced any evidence of a teratogenic effect. However, these studies have shown post-implantation losses and early foetal deaths. These may have resulted from a reduction in parental body condition during gestation and in post-natal care owing to sedation of the mothers.
As reproductive toxicity studies have not been conducted in the target species, use only according to the benefit-risk assessment by the responsible veterinarian.
The veterinary medicinal product should not be used pre-operatively in cases of Caesarean section, due to the risk of respiratory depression in the offspring periparturiently, and should only be used post-operatively with special care (see below).
Lactation:
Studies in lactating rats have shown that, after intramuscular administration of buprenorphine, concentrations of unchanged buprenorphine in the milk equalled or exceeded that in the plasma. As it is likely that buprenorphine will be excreted in the milk of other species, use is not recommended during lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Buprenorphine may cause some drowsiness, which may be potentiated by other centrally acting agents, including tranquillisers, sedatives and hypnotics.
There is evidence in humans to indicate that therapeutic doses of buprenorphine do not reduce the analgesic efficacy of standard doses of an opioid agonist, and that when buprenorphine is employed within the normal therapeutic range, standard doses of opioid agonist may be administered before the effects of the former have ended without compromising analgesia. However, it is recommended that buprenorphine is not used in conjunction with morphine or other opioid-type analgesics, e.g. etorphine, fentanyl, pethidine, methadone, papaveretum or butorphanol.
Buprenorphine has been used with acepromazine, alphaxalone/alphadalone, atropine, dexmedetomidine, halothane, isoflurane, ketamine, medetomidine, propofol, sevoflurane, thiopental and xylazine. When used in combination with sedatives, depressive effects on heart rate and respiration may be augmented.
Administration routes and dosage
Intramuscular or intravenous use.
Dogs: Post-operative analgesia, potentiation of the sedation.
10 - 20 µg/kg (0.3 - 0.6 ml per 10 kg)
Cats: Post-operative analgesia.
10 - 20 µg/kg (0.3 - 0.6 ml per 10 kg)
For further pain relief the dose may be repeated if necessary:
Dogs: either after 3 – 4 hours with 10 µg/kg (0.3 ml per 10 kg)
or after 5 – 6 hours with 20 µg/kg (0.6 ml per 10 kg)
Cats: Once, after 1 – 2 hours with 10 - 20 µg/kg (0.3 - 0.6 ml per 10 kg)
While sedative effects are present by 15 minutes after administration, analgesic activity becomes apparent after approximately 30 minutes. To ensure that analgesia is present during surgery and immediately on recovery, the veterinary medicinal product should be administered preoperatively as part of premedication.
When administered for potentiation of sedation or as part of premedication, the dose of other centrally-acting agents, such as acepromazine or medetomidine, should be reduced. The reduction will depend on the degree of sedation required, the individual animal, the type of other agents included in premedication and how anaesthesia is to be induced and maintained. It may also be possible to reduce the amount of inhalational anaesthetic used.
Animals administered opioids possessing sedative and analgesic properties may show variable responses. Therefore, the response of individual animals should be monitored and subsequent doses should be adjusted accordingly. In some cases, repeat doses may fail to provide additional analgesia. In these cases, consideration should be given to using a suitable injectable NSAID.
An appropriately graduated syringe must be used to allow accurate dosing. The closure must not be punctured more than 100 times (with a 21G or 23G needle).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In cases of overdosage, supportive measures should be instituted, and, if appropriate, naloxone or respiratory stimulants may be used.
When administered at overdose to dogs, buprenorphine may cause lethargy. At very high doses, bradycardia and miosis may be observed.
Naloxone may be of benefit in reversing reduced respiratory rate and respiratory stimulants such as doxapram are also effective in man. Because of the prolonged duration of effect of buprenorphine in comparison to such drugs, they may need to be administered repeatedly or by continuous infusion. Volunteer studies in man have indicated that opiate antagonists may not fully reverse the effects of buprenorphine.
In toxicological studies of buprenorphine hydrochloride in dogs, biliary hyperplasia was observed after oral administration for one year at dose levels of 3.5 mg/kg/day and above. Biliary hyperplasia was not observed following daily intramuscular injection of dose levels up to 2.5 mg/kg/day for 3 months. This is well in excess of any clinical dose regimen in dogs.
Please also refer to sections "Special precautions for use" and "Adverse events"
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.