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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 less than 3 kg bodyweight.
Lokivetmab may induce transient or persistent anti-drug antibodies. The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.
Special precautions for the use in animals
Avoidance or elimination of the allergen is an important consideration in the successful treatment of allergic dermatitis. When treating pruritus associated with allergic dermatitis with lokivetmab, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity); this product is not intended to be used as a long-term maintenance therapy if the offending allergen(s) can be successfully avoided or eliminated. Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.
Accidental self-injection may result in an immune response to lokivetmab. It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.
Do not use in breeding animals
No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, anti-inflammatories and vaccines.
If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab.
Do not mix with any other veterinary medicinal product.
(1 to 10 animals / 10,000 animals treated):
Hypersensitivity reaction1 (anaphylaxis, facial oedema, urticaria)
Vomiting2, diarrhoea2
Neurological signs (ataxia, convulsion, seizure)
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Injection site pain, injection site swelling
Clinical signs of immune mediated diseases (e.g. immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia)
1 In case of such reactions, appropriate treatment should be administered immediately.
2 May occur in connection with hypersensitivity reactions. Treatment should be administered as needed.
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 also the last section of the package leaflet for contact details.