SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cosacthen 0.25 mg/ml solution for injection for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Tetracosactide 0.25 mg

(equivalent to 0.28 mg tetracosactide hexaacetate) Excipients:

Qualitative composition of excipients and other constituents

Acetic acid, glacial

Sodium acetate trihydrate

Sodium chloride

Water for injections

Clear, colourless solution.

3. CLINICAL INFORMATION

3.1 Target species

Dogs.

3.2 Indications for use for each target species

For the evaluation of adrenocortical function in dogs.

3.3 Contraindications

Do not use in pregnant animals, see section 3.7.

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

3.4 Special warnings

None.

3.5 Special precautions for use

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.

3.6 Adverse events Dogs:

Common (1 to 10 animals / 100 animals treated):	Vomiting
Uncommon (1 to 10 animals / 1,000 animals treated):	Injection site bruisinga, Injection site haematomab Depression Diarrhoea Lameness Nervousness

^aAfter intramuscular administration. ^bAfter 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.

3.7 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.

3.8 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-pituitaryadrenal (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.

3.9 Administration routes and dosage

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.

3.10 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.

3.11 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.

3.12 Withdrawal periods Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QH01AA02

4.2 Pharmacodynamics

Tetracosactide is a synthetic polypeptide, which consists of the first 24 amino acids of adrenocorticotropic hormone (ACTH). The administration of tetracosactide results in cortisol concentrations that are significantly elevated compared to baseline values. Administration of tetracosactide at a dose of 5 µg/kg, either by intravenous or intramuscular administration, leads to a maximum concentration of cortisol at 60 to 90 minutes after administration. Doses lower than 5 µg/kg result in a shorter duration of maximal cortisol secretion than a dose of 5 µg/kg. Doses higher than 5 µg/kg do not cause higher peak cortisol concentrations.

4.3 Pharmacokinetics

Compared to intramuscular administration, intravenous administration of tetracosactide results in a higher maximum plasma concentration (Cmax) of immunoreactive (IR)-ACTH, a measurement which includes both endogenous ACTH and tetracosactide. By either route of administration, the time of peak concentration (Tmax) of IR-ACTH occurs at or before 30 minutes following administration. Peptidases rapidly break tetracosactide down into smaller peptides, with a return to baseline IR-ACTH concentrations attained by 120 minutes post-dosing.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. For single use only, any veterinary medicinal product remaining after first use must be discarded.

5.3 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Keep the vial in the outer carton in order to protect from light.

5.4 Nature and composition of immediate packaging

Type I clear glass vial with a coated rubber stopper and aluminium seal packed in a cardboard box.

Pack size: 1 ml vial per box.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Dechra Regulatory B.V.

7. MARKETING AUTHORISATION NUMBER

Vm 50406/5034

8. DATE OF FIRST AUTHORISATION

16 December 2019

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

April 2025

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk. Gavin Hall

Approved: 25 April 2025