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Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs under 12 months.
The veterinary medicinal product may induce transient or persistent anti-drug antibodies. The induction of such antibodies is uncommon and may have no effect or may result in a decrease in efficacy in animals that responded to treatment previously.
If no or limited response is observed within one month after initial dosing, an improvement in response may be observed after administration of a second dose one month later. However, if the animal does not show a better response after the second dose, the veterinary surgeon should consider alternative treatments.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. Laboratory studies with anti-NGF antibodies in cynomolgus monkeys have shown evidence of teratogenic and foetotoxic effects.
Pregnancy and lactation
Do not use in pregnant or lactating animals.
Do not use in breeding animals.
In a laboratory study over a 2-week period in young, healthy dogs without osteoarthritis, this veterinary medicinal product had no adverse effect when concomitantly administered with a non-steroidal anti-inflammatory product (carprofen).
There are no safety data on the concurrent long-term use of NSAIDs and bedinvetmab in dogs. In clinical trials in humans, rapidly progressive osteoarthritis has been reported in patients receiving humanised anti-NGF monoclonal antibody therapy. The incidence of these events increased with high doses and in those human patients that received long-term (more than 90 days) non-steroidal anti-inflammatory drugs (NSAIDs) concomitantly with an anti-NGF monoclonal antibody.
Dogs have no reported equivalent of human rapidly progressive osteoarthritis.
No other laboratory studies on the safety of concomitant administration of this veterinary medicinal product with other veterinary medicinal products have been conducted. No interactions were observed in field studies where this veterinary medicinal product was administered concomitantly with veterinary medicinal products containing parasiticides, antimicrobials, topical antiseptics with or without corticosteroids, antihistamines and vaccines.
If a vaccine(s) is to be administered at the same time as treatment with this veterinary medicinal product, the vaccine(s) should be administered at a different site to that of Librela’s administration, to reduce any potential impact on immunogenicity of the vaccine.
Do not mix with any other veterinary medicinal product.
(1 to 10 animals / 1,000 animals treated):
Injection site reaction (e.g. injection site swelling, injection site warmth)1.
(1 to 10 animals / 10,000 animals treated):
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Hypersensitivity reaction (anaphylaxis, facial swelling, pruritus)2, immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia.
1 Mild
2 In case of such reactions, appropriate symptomatic treatment should be administered.
Reporting adverse events is important. It allows the 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 also section 16 of the package leaflet for respective contact details.
No adverse reactions, except mild reactions at the injection site, were observed in a laboratory overdose study when Librela was administered for 7 consecutive monthly doses at10 times the maximum recommended dose.
In case of adverse clinical signs after an overdose the dog should be treated symptomatically.
User warnings
Where a dog has not been able to properly exercise prior to treatment due to its clinical condition, it is recommended that the dog is gradually (over a few weeks) allowed to increase the amount of exercise they take (to prevent overexercise by some dogs).
Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. Repeated self-administration may increase the risk of hypersensitivity reactions.
The importance of Nerve Growth Factor (NGF) in ensuring normal foetal nervous system development is well-established and laboratory studies conducted on non-human primates with human anti-NGF antibodies have shown evidence of reproductive and developmental toxicity. Pregnant women, women trying to conceive and breastfeeding women should take extreme care to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.