Target species
Dogs.
Indications for use for each target species
For the evaluation of adrenocortical function in dogs.
Contraindications
Do not use in pregnant animals, see Use during pregnancy, lactation or lay.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
None.
Special precautions for safe use in the target species
The safety of the veterinary medicinal product has not been established in dogs under 5 months of age or weighing less than 4.5 kg.
Safety of the veterinary medicinal product has not been established in dogs with diabetes mellitus or hypothyroidism.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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 veterinary medicinal 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 the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Dogs:
Common (1 to 10 animals / 100 animals treated): | Vomiting |
Uncommon (1 to 10 animals / 1,000 animals treated): | Injection site bruising a, Injection site haematoma b Depression Diarrhoea Lameness Nervousness |
a After intramuscular administration.
b After intravenous administration.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Tetracosactide affects the hypothalamic-pituitary-adrenal (HPA) axis, which can be detrimental to the foetus.
Do not use (during the whole or part of the pregnancy).
The safety of the veterinary medicinal product has not been established during lactation.
The use is not recommended during lactation.
Interaction with other medicinal products and other forms of interaction
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.
Amounts to be administered and administration route
Intravenous or intramuscular use.
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 veterinary medicinal product, and take the second blood sample between 60 and 90 minutes after administration of the veterinary medicinal product, to assess the cortisol response.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.