Dogs.

For the evaluation of adrenocortical function in dogs.

Do not use in pregnant animals, see Use during pregnancy and lactation.

Do not use in cases of hypersensitivity to the active substances, or to any of the excipients.

The safety of the product has not been established in dogs under 5 months of age, or weighing less than 4.5 kg.

Safety of the product has not been established in dogs with diabetes mellitus or hypothyroidism.

Use only according to the benefit /risk assessment by the responsible veterinarian.

Tetracosactide can cause hypersensitivity in people, particularly those with existing allergic disorders, such as asthma. People with such allergic disorders, or a known hypersensitivity to tetracosactide, ACTH or any of the excipients, should avoid contact with the product. If you develop clinical symptoms following exposure, such as skin reactions, nausea, vomiting, oedema and dizziness, or any signs of anaphylactic shock, you should seek medical advice immediately and show the package leaflet or label to the physician.

Wash hands after use.

Tetracosactide has not been tested in reproductive or developmental toxicity studies, but the pharmacological effects on the hypothalamic-pituitary-adrenal axis can have adverse effects in pregnancy. Therefore, the veterinary medicinal product should not be administered by pregnant women. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.

Vomiting was observed commonly during clinical studies.

Application site bruising (IM route of administration), injection site haematoma (IV route of administration), depression, diarrhoea, lameness, and nervousness occurred uncommonly during clinical studies.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s)

- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

Do not use during pregnancy. Tetracosactide affects the hypothalamic-pituitary-adrenal (HPA) axis, which can be detrimental to the foetus.

The safety of the veterinary medicinal product has not been established during lactation. The use of the product is not recommended during lactation.

Before performing an ACTH stimulation test, ensure that a sufficient wash-out period has elapsed since the administration of any medicinal product which may either cross-react with the cortisol assay, or have an effect on the hypothalamic-pituitary-adrenal (HPA) axis.

The HPA axis may be affected by medicinal products which either interact with glucocorticoid receptors, or which affect the pathways involved in the synthesis and release of cortisol from the adrenal gland.

Administer 5 µg/kg (0.02 mL/kg) by intravenous or intramuscular injection, with the purpose of performing the ACTH stimulation test. Take the first blood sample immediately prior to administering the product, and take the second blood sample between 60 and 90 minutes after administration of the product, to assess the cortisol response.

In a tolerance study where eight dogs were administered 280 µg/kg tetracosactide (56 times the recommended dose) intravenously once weekly for three weeks, hypersalivation occurred on eight of 24 dosing occasions (33% incidence). In the same study, injected mucous membranes, inguinal erythema, facial oedema, and tachycardia, characteristic of a hypersensitivity reaction was observed in one dog following administration of the third dose.