Peptizole Oral Paste for Horses
Country: Ирска
Језик: Енглески
Извор: HMA (Heads of Medicines Agencies)
Карактеристике производа
(SPC)
14-09-2013
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Активни састојак:
omeprazole 0 0
Доступно од:
Norbrook Laboratories Limited
АТЦ код:
QA02BC01
Фармацеутски облик:
Oral paste
Терапеутска група:
omeprazole
Терапеутска област:
Horses Non Food
Датум одобрења:
2013-06-26
Карактеристике производа
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Peptizole 370 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 of gastric ulcers and the prevention of recurrence 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 EACH TARGET SPECIES
The veterinarian should consider the need for performing relevant diagnostic tests before selection of the treatment
dose rate.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/07/2013_
_CRN 7013030_
_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 irritant and hypersensitivity reactions, avoid direct contact with skin and eyes.
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