Gastrogard Sport 370 mg/g Oral Paste for Horses

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Omeprazole

Tersedia dari:

Boehringer Ingelheim Animal Health UK Ltd

Kode ATC:

QA02BC01

INN (Nama Internasional):

Omeprazole

Bentuk farmasi:

Oral paste

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Horses

Area terapi:

Gastrointestinal

Status otorisasi:

Expired

Tanggal Otorisasi:

2018-08-09

Karakteristik produk

Issued: August 2018
AN: 01842/2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gastrogard Sport 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.
Issued: August 2018
AN: 01842/2017
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)