Equizol 400 mg gastro-resistant granules for horses

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Omeprazole

Boleh didapati daripada:

CP-Pharma Handelsgesellschaft mbH

Kod ATC:

QA02BC01

INN (Nama Antarabangsa):

Omeprazole

Dos:

400 mg/sachet

Borang farmaseutikal:

Gastro-resistant granules

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kawasan terapeutik:

omeprazole

Status kebenaran:

Authorised

Tarikh kebenaran:

2018-07-20

Ciri produk

Health Products Regulatory Authority
20 July 2018
CRN000TW2
Page 1 of 6
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.
Health Products Regulatory Authority
20 July 2018
CRN000TW2
Page 2 of 6
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
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 accid