Buprelieve Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses

None

Special precautions for use in animals
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 product. The benefit-risk assessment for
using the product should be made by the attending vet. 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
seven-weeks of age, therefore, use in such animals should be based on the
benefit-risk assessment of the responsible veterinarian.
Repeat administration earlier than the recommended repeat interval suggested
in Section 4.9 is not recommended.
Long-term safety of buprenorphine has not been investigated beyond five
consecutive days of administration in cats or four separate administrations on
three consecutive days in horses.
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 responsible veterinarian.
Safety has not been evaluated in clinically-compromised horses. In horses, use
of opioids has been associated with excitation, but effects with buprenorphine
are minimal when administered in conjunction with sedatives and tranquilisers
such as detomidine, romifidine, xylazine and acepromazine. The safety of
buprenorphine has not been demonstrated in horses younger than 10 months
old and weighing less than 150kg; therefore, use in such animals should be
based on the benefit: risk assessment of the responsible veterinarian.
Ataxia is a known effect of detomidine and similar agents; consequently it may
be seen after administration of buprenorphine with such substances.
Occasionally, ataxia may be marked.
To ensure ataxic horses sedated with detomidine/buprenorphine do not lose
their balance, they should not be moved or otherwise handled in any way that
would compromise their stability.

Revised: November 2025
MA split from NI Expiry following AN: 02842/2025Page 3 of 9
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
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.
Naloxone should be available in case of accidental self-injection.
Buprenorphine may be absorbed systemically on exposure to mucous
membranes. The product may cause skin or eye irritation if contact occurs.
Avoid contact with skin and eyes. In case of accidental spillage onto the skin or
eyes, wash the affected area thoroughly with running water. Seek medical
advice if irritation persists.
Other precautions
None