Omeproshield 370 mg/g oral paste for horses

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Omeprazole

Dostopno od:

Boehringer Ingelheim Vetmedica GmbH

Koda artikla:

QA02BC01

INN (mednarodno ime):

Omeprazole

Odmerek:

370 milligram(s)/gram

Farmacevtska oblika:

Oral paste

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

omeprazole

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-03-13

Lastnosti izdelka

Health Products Regulatory Authority
06 March 2020
CRN009673
Page 1 of 4
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 EACH 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.
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.
Health Products Regulatory Authority
06 March 2020
CRN009673
Page 2 of 4
4.6 ADVE