Peptaleve 370 mg/g Oral Paste for Horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QA02BC01

INN (International Name):

Omeprazole

Dosage:

370 milligram(s)/gram

Pharmaceutical form:

Oral paste

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

omeprazole

Authorization status:

Authorised

Authorization date:

2020-05-29

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
OF THE VETERINARY MEDICINAL PRODUCT
Peptaleve 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.
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 and prevention of gastric ulcers in horses.
4.3.
CONTRAINDICATIONS
See section 4.5
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
4.4.
SPECIAL WARNINGS FOR TARGET SPECIES
The veterinarian should consider the need for performing relevant
diagnostic tests before
selection of the treatment dose rate.
2
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 wellbeing 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. 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 seek medical advice and avoid
handling the product in
future.
4.6.
ADVERSE REACTIONS (FREQUEN