Cronyxin 50 mg/g Oral paste for horses

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Flunixin

Διαθέσιμο από:

Bimeda Animal Health Limited

Φαρμακολογική κατηγορία (ATC):

QM01AG90

INN (Διεθνής Όνομα):

Flunixin

Δοσολογία:

50 milligram(s)/gram

Φαρμακοτεχνική μορφή:

Oral paste

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

flunixin

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-11-16

Αρχείο Π.Χ.Π.

1
_[Version 9,03/2022] corr. 11/2022_
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cronyxin 50 mg/g Oral paste for horses (DE, AT, BE, EE, ES, FR, IE,
IT, NL, PL, UK(NI))
Cronyxin vet 50 mg/g Oral paste for horses (SE)
Cronyxin vet (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of paste contains:
ACTIVE SUBSTANCE:
Flunixin
50 mg
(as Flunixin meglumine
83 mg)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Silica, colloidal anhydrous
Propylene glycol
Titanium dioxide (E171)
Xanthan gum
Aluminium magnesium silicate
Sorbitol, liquid (crystallising)
Apple flavour FL02791
Purified water
White to off-white paste
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Horses
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of acute inflammatory musculoskeletal disorders in horses.
3.3
CONTRAINDICATIONS
Do not exceed the stated dose or duration of treatment.
Do not administer other NSAIDs or glucocorticosteroids concurrently or
within 24 hours of each
other.
Do not use in animals suffering from cardiac, hepatic or renal
disease.
Do not use in animals suspected of having gastrointestinal ulceration
or bleeding.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dehydrated or hypovolaemic animals, except in the case
of endotoxaemia or septic
shock, as there is a potential risk of increased renal toxicity.
Do not use in animals suffering from chronic musculoskeletal
disorders.
See also section 3.7.
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3.4
SPECIAL WARNINGS
Use of the veterinary medicinal product may lead to temporary relief
due to its ameliorating effects on
inflammatory signs. This may appear as effective treatment of the
underlying disease.
The cause of the underlying inflammatory condition should be
determined and treated with
appropriate concomitant therapy.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
Animals should be rested and a sufficient supply of drinking water has
to be ensured duri