Introduction

Company name: Bimeda

Address: A division of Cross Vetpharm Group UK Limited

Bryn Cefni Industrial Park,

Llangefni,

Anglesey LL77 7XA.

Telephone: 0800 526769

Fax: 01248 725416

Email: sales@bimeda.co.uk

Presentation

Cronyxin Injection is a clear, sterile, aqueous solution for slow intravenous injection in cattle and horses.

Each ml contains: Flunixin 50 mg (as Flunixin Meglumine) and Phenol 5 mg (Preservative).

Uses

Cattle

For the control of acute inflammation associated with respiratory disease. It has also been shown to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever).

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.

Dosage and administration

The dose is administered by intravenous injection.

Cattle: The recommended dose is 2 ml Cronyxin Injection per 45 kg bodyweight (equivalent to 2.2 mg Flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days. The cause of the acute inflammatory condition should be determined and treated with concomitant therapy.

Horses: For use in equine musculoskeletal disorders, the recommended dose in 1 ml Cronyxin Injection per 45 kg bodyweight (equivalent to 1.1 mg Flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days according to clinical response.

For use in equine colic, the recommended dose is 1 ml Cronyxin Injection per 45 kg bodyweight (equivalent to 1.1 mg Flunixin per kg) injected intravenously and repeated once or twice if signs of colic recur. The cause of colic should be determined and treated with concomitant therapy.

Contra-indications, warnings, etc

For animal treatment only.

Do not exceed the stated dose or duration of treatment.

Do not administer other NSAIDs concurrently or within 24 hours of each other.

Avoid intra-arterial injection.

Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.

Do not administer to pregnant mares. Studies to demonstrate safety in pregnant mares have not been conducted.

Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Monitor drug compatibility closely where adjunctive therapy is required. As with other NSAIDs, Cronyxin may potentiate the effects of Warfarin and other drugs.

Due to their common mode of action, Flunixin may potentiate and be potentiated by other NSAIDs, which act by interfering with prostaglandin synthesis.

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.

Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.

It is preferable that Flunixin is not administered to animals undergoing general anaesthesia until fully recovered.

Concurrent administration of potentially nephrotoxic drugs should be avoided.

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.

Prolonged use of NSAIDs, including Flunixin, may predispose or lead to gastrointestinal irritation or in severe cases, ulceration.

Do not exceed the recommended dose or treat animals for more than 5 consecutive days. Tolerance trials in cattle and horses confirmed excellent tolerance to Cronyxin at twice the recommended dose.

Do not administer to racehorses within 8 days of racing.

Withdrawal Periods

Calves: Milk from lactating cows should be discarded during treatment. Milk from cows should only be taken for human consumption from 12 hours following cessation of treatment. Animals may not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 8 days from the last treatment.

Horses: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national Horse Passport Legislation.

User Warnings

Avoid eye contact and direct contact with skin.

Gloves should be worn during application.

Wash hands after use.

In case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.

The product may cause reactions in sensitive individuals.

Avoid accidental self-injection.

Pharmaceutical precautions

Keep out of reach and sight of children. Do not mix Cronyxin with other medicaments prior to administration. Do not store above 25°C. Following withdrawal of the first dose, use the product within 28 days.

Legal category

POM-V

Packaging Quantities

50 ml and 100 ml clear glass multi dose vials.

Further information

Nil.

Marketing authorisation number

VM 12597/4014.