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

Oxycomplex NS is a clear, sterile, yellow to amber aqueous solution for parenteral administration to cattle.

Each ml contains: Oxytetracycline 100 mg

_(as Oxytetracycline Hydrochloride)

Flunixin 20 mg

_(as Flunixin Meglumine)

Uses

For the control and treatment of infectious diseases of cattle, caused by or associated with organisms sensitive to oxytetracycline, where concurrent analgesic, anti-inflammatory, anti-endotoxic or antipyretic therapy is desired.

This product is especially indicated for the treatment of respiratory disease (particularly that associated with Mannheimia and Pasteuralla infection) and acute mastitis (in conjunction with appropriate intramammary therapy).

Dosage and administration

1 ml per 10 kg bodyweight (equivalent to 10 mg oxytetracycline and 2 mg flunixin per kg bodyweight) daily for up to 5 days.

The first injection should be administered intravenously, slowly, with subsequent injections given intramuscularly. Do not inject more than 20 ml intramuscularly at a single site. Where the dose exceeds 20 ml it should be divided between two or more sites, as appropriate.

Contra-indications, warnings, etc

For animal treatment only.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 31 days following the last treatment.

Do not use in cattle producing milk for human consumption.

Contra-indications

Do not exceed the stated dose or duration of treatment.

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

Use is contra-indicated 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.

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.

Rapid intravenous injection in cattle may occasionally cause cardiovascular collapse.

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.

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

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

Concurrent administration of methoxyflurane anaesthesia or other potentially nephrotoxic drugs should be avoided.

Side effects

Prolonged use of NSAIDs, including flunixin, may predispose or lead to gastrointestinal ulceration.

Overdosing by intramuscular injection may give rise to swellings at the site of injection. Treatment should be symptomatic.

Use during pregnancy or lactation

Reports of teratogenicity, effects on breeding performance, or gestation lengths have not been noted following use of flunixin. Use with care in pregnant animals.

The use of tetracyclines during the period of tooth development, including late pregnancy, may lead to tooth discolouration.

Drug interactions

Oxycomplex NS may potentiate the effects of warfarin and related drugs.

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

Warnings

Avoid eye contact and direct contact with skin.

To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during application. Wash hands after use.

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

The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious.

avoid accidental self-injection.

Pharmaceutical precautions

Keep out of reach and sight of children.

Do not store above 25°C. Protect from light.

Following withdrawal of the first dose, the product should be used within 28 days.

Legal category

POM-V

Packaging Quantities

100 ml vials.

Further information

Nil.

Marketing authorisation number

VM 12597/4007.