Dogs and cats

Dog ; Post-operative analgesia. Potentiation of the sedative effects of centrally-acting agents.

Cat; Post-operative analgesia.

The product should not be used pre-operatively for caesarean section.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not administer Buprecare Multidose 0.3 mg/ml Solution by the intrathecal or peridural route.

None.

Use of the veterinary medicinal product in the below circumstances should only be in accordance with the benefit/risk assessment by the responsible veterinarian. Buprenorphine may occasionally cause significant 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. 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 some animals. In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk associated with the use of the product. The benefit:risk ratio for using the product should be made by the attending vet. Safety has not been fully evaluated in clinically compromised cats. The safety of buprenorphine has not been demonstrated in animals less than 7 weeks of age, therefore use in such animals should be based on the benefit:risk assessment by the veterinarian. Repeated administration earlier than the recommended repeat interval is not recommended. The effect of an opioid on head injury is dependent on the type and severity of the injury and the respiratory support supplied. The product should be used in accordance with the benefit:risk assessment of the attending veterinarian. Long-term safety of buprenorphine in cats has not been investigated beyond 5 consecutive days of administration.

Wash hands/affected area thoroughly after any accidental spillage. As buprenorphine has opioid-like activity care should be taken to avoid accidental 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. Naloxone should be available in case of accidental parenteral exposure. Following eye contamination or skin contact, wash thoroughly with cold running water, seek medical advice if irritation persists.

Salivation, bradycardia, hypothermia, agitation, dehydration and miosis can occur in the dog, and rarely hypertension and tachycardia.

Mydriasis and signs of euphoria (excessive purring, pacing, rubbing) commonly occur in cats, and will usually resolve within 24 hours.

Buprenorphine may occasionally cause significant respiratory depression.

When used to provide analgesia, sedation is rarely seen, but may occur at dose levels higher than those recommended.

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. 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 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 section on lactation 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 accordingly to benefit:risk assessment by the responsible veterinarian.

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, thiopentone and xylazine. When used in combination with sedatives, depressive effects on heart rate and respiration may be augmented.

For intramuscular use.

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 product should be administered pre-operatively 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 responses 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.

Administration:

Dog: Intramuscular or intravenous injection

Cat: Intramuscular or intravenous injection

Before administration, the weight of the animal should be accurately determined.

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 product should be administered pre-operatively 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 responses 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 administration of the required dose volume. This is particularly important when injecting small volumes.

The vial seal may be punctured up to a maximum of 30 times.

In case of over dosage, 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.

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 the dog.

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.

Not applicable.