Cosacthen 0.25 mg/ml solution for injection for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tetracosactide hexaacetate

Available from:

Dechra Regulatory B.V.

ATC code:

QH01AA02

INN (International Name):

Tetracosactide hexaacetate

Dosage:

0.25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tetracosactide

Authorization status:

Authorised

Authorization date:

2020-02-14

Summary of Product characteristics

Health Products Regulatory Authority
19 February 2020
CRN008PYK
Page 1 of 4
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.
Special precautions to be taken by theperson 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-pituita