Cosacthen 0.25 mg/ml Solution for Injection for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tetracosactide

Available from:

Dechra Limited

ATC code:

QH01AA02

INN (International Name):

Tetracosactide

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Hormone

Authorization status:

Authorized

Authorization date:

2019-12-16

Summary of Product characteristics

Amended pages: July 2021
AN: 00761/2020
Page 1 of 5
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
1 ml contains:
Active substance:
Tetracosactide
0.25 mg
(equivalent to 0.28 mg tetracosactide hexaacetate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the evaluation of adrenocortical function in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant animals, see section 4.7.
Do not use in cases of hypersensitivity to the active substances, or
to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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.
Amended pages: July 2021
AN: 00761/2020
Page 2 of 5
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 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-pitui