Pergoquin 1 mg Tablets for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Pergolide

Available from:

VetViva Richter GmbH

ATC code:

QN04BC02

INN (International Name):

Pergolide

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Neurological Agent

Authorization status:

Authorized

Authorization date:

2019-09-17

Summary of Product characteristics

Unlimited renewal: February 2024
AN: 03019/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pergoquin 1 mg tablets for horses
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
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Croscarmellose sodium
Iron oxide red (E172)
0.9 mg
Lactose monohydrate
Magnesium Stearate
Povidone
Pink 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 cases of hypersensitivity to the active substance or
other ergot
derivatives or to any of the excipients.
Do not use in horses less than 2 years of age.
Unlimited renewal: February 2024
AN: 03019/2023
Page 2 of 8
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
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 tablets,
e.g. tablets
should not be crushed.
In case of