Buprecare 0.3 mg/ml Solution for Injection for Dogs and Cats

When used to provide analgesia, sedation is rarely seen, but may occur at dose
levels higher than those recommended.
4.7 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.

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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.
4.8 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, thiopentone and xylazine. When used in combination with sedatives,
depressive effects on heart rate and respiration may be augmented.
4.9 Amounts to be administered and administration route
For intramuscular use.
SpeciesPost-Operative AnalgesiaSedation
Dog
10–20 microgram per kg (0.3–0.6 ml per 10 kg)
repeated if necessary after 3–4 hours with 10
microgram or 5–6 hours with 20 microgram doses.
10–20 microgram per
kg (0.3–0.6 ml per 10
kg).
Cat
10–20 microgram per kg (0.3–0.6 ml per 10 kg),
repeated if necessary, once, after 2 hours.
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 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

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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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
In case of overdosage, supportive measures should be instituted and if appropriate,
naloxone or respiratory stimulants may be used. However, dose levels many times
higher than those indicated above have been used without serious side effects.
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.
Please also refer to sections 4.5 and 4.6 of this SPC.
4.11 Withdrawal period(s)
Not applicable.
5.