Prasequine 1 mg tablets for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pergolide mesilate

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QN04BC02

INN (International Name):

Pergolide mesilate

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

pergolide

Authorization date:

2023-07-14

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prasequine 1 mg tablets for horses (AT, BE, DE, EE, EL, ES, FR, HU,
IE, IT, LT, LV, NL, PT, SK,
UK-NI)
Prasequin vet. 1 mg tablets for horses (DK, FI, NO, PL, SE)
Pras-equine 1 mg tablets for horses (CZ)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Pergolide
1.0 mg
equivalent to 1.31 mg pergolide mesilate
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Lactose monohydrate
Croscarmellose sodium
Povidone
Magnesium stearate
Iron oxide yellow (E172)
Off-white round and convex tablet with a cross-shaped break line on
one side.
Tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses (non food-producing)
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Symptomatic treatment of clinical signs associated with Pituitary Pars
Intermedia Dysfunction (PPID)
(Equine Cushing’s Disease).
3.3
CONTRAINDICATIONS
Do not use in horses with known hypersensitivity to pergolide mesilate
or other ergot derivatives or to
any of the excipients.
Do not use in horses less than 2 years of age.
3.4
SPECIAL WARNINGS
Appropriate endocrinologic laboratory tests should be conducted as
well as evaluation of clinical signs
in order to establish a diagnosis of PPID.
3.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for safe use in the target species:
As the majority of cases of PPID are diagnosed in aged horses, other
pathological processes are
frequently present. For monitoring and frequency of testing, see
section 3.9.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
This veterinary medicinal product may cause eye irritation, an
irritating smell, or headache after
dividing the tablets. Avoid contact with the eyes and inhalation when
handling the tablets. Minimise
exposure risks when dividing or dissolving tablets, e.g. tablets
should not be crushed.
In case of contact with skin, wash exposed skin with water. In the
event of eye exposure, f