GASTROGARD 37% W/W ORAL PASTE FOR HORSES
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
03-01-2017
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Aktivna sestavina:
OMEPRAZOLE
Dostopno od:
Merial Animal Health Limited
Koda artikla:
QA02BC01
INN (mednarodno ime):
OMEPRAZOLE
Odmerek:
37 Per Cent
Farmacevtska oblika:
Oral Paste
Tip zastaranja:
POM
Terapevtska skupina:
Equine - Food
Terapevtsko območje:
Omeprazole
Terapevtske indikacije:
Alimentary Tract Preparation
Status dovoljenje:
Authorised
Datum dovoljenje:
2004-11-19
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GastroGard 37% w/w 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.
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.i.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/12/2016_
_CRN 7025205_
_page number: 1_
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.
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 administ
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