Gastazole 370 mg/g oral paste for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Chanelle Pharmaceuticals Manufacturing 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:

2020-05-15

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gastazole 370 mg/g oral paste for horses AT, CZ, DE, DK, EL, ES, FR,
HU, IE, IT, PL, PT, RO
Gastazole vet 370 mg/g oral paste for horses FI, SE
Gastazole vet NO
Omeprogard 370 mg/g Oral Paste for Horses BE, NL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1g paste contains:
ACTIVE SUBSTANCE:
Omeprazole
370 mg
EXCIPIENTS:
Ferric Oxide Yellow (E172)
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 of gastric ulcers and the prevention of recurrence of
gastric ulcers.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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. The
product should not be used in animals
under 4 weeks of age or weighing less than 70 kg bodyweight. The
veterinarian should consider the need
for performing relevant diagnostic tests before use of the product.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
As this product may cause irritation and hypersensitivity reactions,
avoid direct contact with skin and eyes.
People with known hypersensitivity to omeprazole or any of the
excipients should avoid contact with the
veterinary medicinal product. Personal protective equipment consisting
of imperv