Horses (non-food producing)

Symptomatic treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease).

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.

Appropriate endocrinologic laboratory tests should be conducted as well as evaluation of clinical signs in order to establish a diagnosis of PPID.

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 Amounts to be administered and administration route.

This product may cause hypersensitivity (allergy) reactions. People with known hypersensitivity to pergolide or other ergot derivatives should avoid contact with the veterinary medicinal product.

This product may cause adverse effects due to decreased prolactin levels, which poses a particular risk to pregnant and lactating women. Pregnant or lactating women should avoid dermal contact or hand-to-mouth contact and wear gloves when administering the product.

Accidental ingestion, especially by children, may cause adverse reactions such as emesis, dizziness, lethargy or low blood pressure. To avoid accidental ingestion, the blister should be replaced into the carton and carefully kept away from children. Avoid hand-to-mouth contact. Do not eat, drink or smoke when using this product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This product may cause eye irritation. Avoid contact with the eyes including hand-to-eye contact when handling the tablets. Minimize exposure risks when dissolving the tablets, e.g. tablets should not be crushed. In case of contact of the dissolved product with skin, wash exposed skin with water. In the event of eye exposure, flush the affected eye immediately with water and seek medical advice.

Wash hands after use.

Horses:

1 transient

2 mild

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 also section ‘contact details’ of the package leaflet for respective contact details.

Pregnancy: Use only according to the benefit/ risk assessment by the responsible veterinarian. The safety of this veterinary medicinal product has not been demonstrated in pregnant mares. Laboratory studies in mice and rabbits have not produced any evidence of teratogenic effects. Reduced fertility was seen in mice at a dose of 5.6 mg/kg body weight per day.

Lactation: The use is not recommended in lactating horses, in which the safety of this veterinary medicinal product has not been demonstrated. In mice, reduced body weights and survival rates in the progeny were attributed to the pharmacological inhibition of prolactin secretion resulting in lactation failure.

Use with caution in case the veterinary medicinal product is co-administered with other drugs known to affect protein binding.

Do not administer concurrently with dopamine antagonists, such as neuroleptics (phenothiazines - e.g. acepromazine), domperidone, or metoclopramide, as these agents may reduce the effectiveness of pergolide.

Oral use, once daily.

To facilitate administration, the required daily dose should be placed in a small amount of water and/or mixed with molasses or other sweetener and agitated until dissolved. In this case, the dissolved tablets should be administered with a syringe.

The whole amount should be administered immediately. Tablets should not be crushed, see Special precautions to be taken by the person administering the veterinary medicinal product to animals.

The starting dose is about 2 µg pergolide/kg (dose range: 1.3-2.5 µg/kg; see table below). The maintenance dose should then be titrated according to the individual response as determined by monitoring (see below), resulting in an average maintenance dose of 2 µg pergolide/kg body weight with a dose range of 0.6-10 µg pergolide/kg body weight.

Starting doses are recommended as follows:

Lifelong treatment is anticipated for this disease.

Most horses respond to therapy and are stabilised at an average dose of 2 µg pergolide/kg body weight. Clinical improvement with pergolide is expected within 6-12 weeks. Horses may respond clinically at lower or varying doses; it is therefore recommended to titrate to the lowest effective dose per individual based on response to therapy, whether it is effectiveness or signs of intolerance. Some horses may require doses as high as 10 µg pergolide/kg body weight per day. In these rare situations, appropriate additional monitoring is advised.

Following initial diagnosis, repeat endocrinologic testing for dose titration and monitoring of treatment at intervals of 4-6 weeks until stabilisation or improvement of clinical signs and/or diagnostic testing occurs.

If clinical signs or diagnostic testing have not yet improved at the first 4-6 week interval, the total daily dose may be increased by 0.50 mg. In case clinical signs have improved but are not yet normalised, the veterinarian may decide to titrate or not to titrate the dose, considering the individual’s response/tolerance to the dose.

In case clinical signs are not adequately controlled (clinical evaluation and/or diagnostic testing) it is recommended to increase the total daily dose by 0.5 mg increments (if the drug is tolerated at that dose) every 4-6 weeks until stabilisation occurs. If signs of dose intolerance develop, treatment should be stopped for 2-3 days and reinstated at one-half of the previous dose. The total daily dose may then be titrated back up to the desired clinical effect by 0.5 mg increments every 2-4 weeks. If a dose is missed, the next scheduled dose should be administered as prescribed.

Following stabilisation, regular clinical assessment and diagnostic testing should be performed every 6 months to monitor treatment and dose. Where there is no apparent response to treatment, the diagnosis should be re-evaluated.

Not authorised for use in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

Not authorised for use in mares producing milk for human consumption.