Equinor 370 mg/g Oral Paste for Horses

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Omeprazole

Prieinama:

Norbrook Laboratories (Ireland) Limited

ATC kodas:

QA02BC01

INN (Tarptautinis Pavadinimas):

Omeprazole

Dozė:

370 milligram(s)/gram

Vaisto forma:

Oral paste

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Gydymo sritis:

omeprazole

Autorizacija statusas:

Authorised

Leidimo data:

2013-07-26

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
OF THE VETERINARY MEDICINAL PRODUCT
Equinor 370 mg/g Oral Paste for Horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Omeprazole:
370 mg
EXCIPIENTS:
Yellow Iron Oxide (E 172): 2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
A yellow to tan oily paste
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Horses
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and prevention of gastric ulcers in horses.
4.3.
CONTRAINDICATIONS
See section 4.5
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
4.4.
SPECIAL WARNINGS FOR TARGET SPECIES
The veterinarian should consider the need for performing relevant
diagnostic tests before
selection of the treatment dose rate.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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Not recommended for animals under 4 weeks of age or weighing less than
70 kg
bodyweight.
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 wellbeing 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
As this product may cause irritant and hypersensitivity reactions,
avoid direct contact with
skin and eyes. Use impervious gloves and do not eat or drink when
handling and
administering the product. Wash hands or any exposed skin after use.
In case of contact
with eyes, wash immediately with clean running water and seek medical
advice. Persons
developing a reaction after contact with the product should seek
medical advice and avoid
handling the product in future.
4.6.
ADVERSE RE