Equizol 400 mg Gastro-resistant Granules for Horses

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Omeprazole

Saadav alates:

CP Pharma Handelsgesellschaft mbH

ATC kood:

QA02BC01

INN (Rahvusvaheline Nimetus):

Omeprazole

Ravimvorm:

Gastro-resistant granules

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Horses

Terapeutiline ala:

Gastrointestinal

Volitamisolek:

Authorized

Loa andmise kuupäev:

2018-07-17

Toote omadused

Unlimited renewal: August 2022
AN: 01221/2022
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equizol 400 mg gastro-resistant granules for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of 5 g contains:
ACTIVE SUBSTANCE:
Omeprazole 400 mg.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Gastro-resistant granules
White to beige spherical granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of gastric ulcers in horses.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or any of the
excipients.
See section 4.5.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As the safety of the product has not been assessed in foals under 8
months of age or
weighing less than 125 kg bodyweight, the use of the product is not
recommended in
these animals.
Stress (including high performance training and competition), feeding,
management
and husbandry practices may be associated with the development of
gastric
ulceration in horses. Individuals responsible for the well-being of
horses should
consider reducing the ulcerogenic challenge by modifying husbandry
practices to
Unlimited renewal: August 2022
AN: 01221/2022
Page 2 of 5
achieve one or more of the following: reduced stress, reduced fasting,
increased
intake of roughage and access to grazing.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This product may cause adverse gastrointestinal effects or
hypersensitivity (allergic)
reactions if accidentally ingested, particularly by children.
Do not eat or drink whilst handling or administering the product.
Wash hands or any exposed skin after use.
Any part-used sachets should be returned to the original carton and
suitably stored to
prevent access by children.
In case of accidental ingestion, especially by a child