Cronyxin Injection 50 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flunixin meglumine

Available from:

Bimeda Animal Health Limited

ATC code:

QM01AG90

INN (International Name):

Flunixin meglumine

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

flunixin

Authorization status:

Authorised

Authorization date:

1996-02-20

Summary of Product characteristics

_[Version 9,03/2022]_
ANNEX
I
SUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cronyxin Injection 50 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Flunixin (as Flunixin Meglumine)
50.0 mg/ml
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Propylene glycol
Phenol
5.0 mg/ml
Disodium edetate
Sodium formaldehyde sulfoxylate
2.2 mg/ml
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection
Clear, colourless to light yellow solution, free of foreign matter.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
Horses
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle: For the control of acute inflammation associated with
respiratory disease. The veterinary
medicinal product may be used as adjunctive therapy in the treatment
of acute mastitis.
Horses: For the alleviation of inflammation and pain associated with
musculoskeletal disorders. The
veterinary medicinal product is also indicated for the alleviation of
visceral pain associated with colic.
3.3
CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is the possibility of
gastro-intestinal ulceration or bleeding, where there is evidence of a
blood dyscrasia or
hypersensitivity
to the veterinary medicinal product.
3.4
SPECIAL WARNINGS
Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there
is a potential risk of
increased renal toxicity.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
NSAIDs can cause inhibition of phagocytosis and hence in the treatment
of inflammatory conditions
associated with bacterial infections, appropriate concurrent
antimicrobial therapy should be instigated.
Avoid intra-arterial injection.
Some NSAIDs may be highly bound to plasma proteins and compete with
other highly bound drugs to
pro