Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUNIXIN MEGLUMINE
Bimeda Chemicals
QM01AG90
FLUNIXIN MEGLUMINE
50 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food
Flunixin
N.S.A.I.D
Authorised
1996-02-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cronyxin Injection 50 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM A clear, colourless solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: For the control of acute inflammation associated with respiratory disease. Cronyxin Injection may be used as adjunctive therapy in the treatment of acute mastitis. HORSES: For the alleviation of inflammation and pain associated with musculoskeletal disorders. It is also indicated for the alleviation of visceral pain associated with colic. 4.3 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 product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity. Each ml contains: ACTIVE SUBSTANCE: Flunixin (as Flunixin Meglumine) 50.0 mg EXCIPIENTS: Phenol Ph.Eur. 5.0 mg Sodium formaldehyde sulfoxylate 2.2 mg HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 07/01/2016_ _CRN 7022590_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 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 Read the complete document