Omeproshield 370 mg/g Oral Paste for Horses

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Omeprazole

Saadav alates:

Boehringer Ingelheim Animal Health UK Ltd

ATC kood:

QA02BC01

INN (Rahvusvaheline Nimetus):

Omeprazole

Ravimvorm:

Oral paste

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Horses

Terapeutiline ala:

Gastrointestinal

Volitamisolek:

Authorized

Loa andmise kuupäev:

2015-02-17

Toote omadused

Revised: March 2020
AN: 00719/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Omeproshield 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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
Smooth homogeneous yellow to yellow-tan 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.
4.3
CONTRAINDICATIONS
Do not use in mares producing milk for human consumption
See section 4.5..
4.4
SPECIAL WARNINGS FOR TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not recommended for animals under 4 weeks of age or weighing less than
70 kg
bodyweight.
Revised: March 2020
AN: 00719/2019
Page 2 of 5
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
As this product may cause hypersensitivity, 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 avoid
handling the
product in future.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The