Prascend 1 mg Tablets for Horses
Страна: Великобритания
Язык: английский
Источник: VMD (Veterinary Medicines Directorate)
Характеристики продукта
(SPC)
27-10-2015
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Активный ингредиент:
Pergolide
Доступна с:
Boehringer Ingelheim Ltd
код АТС:
QN04BC02
ИНН (Международная Имя):
Pergolide
Фармацевтическая форма:
Tablet
Тип рецепта:
POM-V - Prescription Only Medicine – Veterinarian
Терапевтическая группа:
Horses
Терапевтические области:
Neurological Agent
Статус Авторизация:
Authorized
Дата Авторизация:
2010-03-11
Характеристики продукта
Revised: October 2015
AN: 00495/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prascend 1 mg tablets for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
1.0 mg pergolide (as pergolide mesylate 1.31 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Pink, rectangular scored tablet, engraved on one side with the Boehringer Ingelheim
logo and the letters “PRD”. The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses not intended for human consumption
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment of clinical signs associated with Pituitary Pars Intermedia
Dysfunction (PPID) (Equine Cushing’s Disease).
4.3 CONTRAINDICATIONS
Do not use in horses with known hypersensitivity to pergolide mesylate or other ergot
derivatives or to any of the excipients.
Do not use in horses less than 2 years of age.
4.4 SPECIAL WARNINGS
Appropriate endocrinologic laboratory tests should be conducted as well as evaluation
of clinical signs in order to establish a diagnosis of PPID.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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
4.9.
Special precautions to be taken by the person administering the medicinal product to
animals
Page 1 of 6
Revised: October 2015
AN: 00495/2015
This product may cause eye irritation, an irritating smell, or headache after splitting.
Minimise exposure risks when splitting tablets. Tablets should not be crushed.
Avoid contact with the eyes and inhalation when handling the tablets.
Wash
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