Hexasol LA Solution for Injection for Cattle

Presentation:
Hexasol LA is a clear dark amber solution for parenteral administration containing:

Oxytetracycline as Oxytetracycline Dihydrate 300mg/ml
Flunixin, as Flunixin Meglumine 20mg/ml
Sodium Formaldehyde Sulphoxylate is also included as a chemical preservative.

Uses:
Oxytetracycline is a member of the tetracycline family of broad-spectrum antibiotics that inhibit proteinsynthesis in susceptible microorganisms.

Flunixin meglumine is a relatively potent non-narcotic, nonsteroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties.

Hexasol LA is specifically formulated to provide initial antiinflammatory activity for 24-36 hours and sustained antibacterial activity for 5-6 days following a single administration.

Hexasol LA is indicated primarily for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, where an anti-inflammatory and anti-pyretic effect is required.

In addition a wide range of organisms including Pasteurella spp, Arcanobacterium pyogenes, Staphylococcus aureus and certain mycoplasmas are known to be sensitive in vitro to oxytetracycline.

Hexasol LA may, therefore, be of use in the treatment of disease in cattle caused by such organisms where both antiinflammatory and anti-pyretic effect is required.

Dosage & Administration:
For deep intramuscular injection to cattle.

The recommended dosage is 1ml per 10kg bodyweight (equivalent to 30mg/kg oxytetracycline and 2mg/kg flunixin) on a single occasion.

Maximum volume per injection site: 15ml. If concurrent treatment is administered, use a separate injection site.

Withdrawal Period:
Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 35 days from the last treatment. Not for use in cattle producing milk for human consumption.

Contraindictions, Warnings etc:
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding or where there is hypersensitivity to the product.

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

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

Concurrent use of potentially nephrotoxic drugs should be avoided. Do not exceed the stated dose or duration of treatment.

Adverse Reactions:
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Special Warnings:
Avoid intra-arterial injection. Use in any animals 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.

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

Although Hexasol LA is well tolerated, occasionally a local reaction of a transient nature may be observed.

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

If concurrent treatment is administered, use a separate injection site. It is preferable that prostaglandin-inhibiting drugs are not administrated to animals undergoing general anaesthesia until fully recovered.

Operator Warnings:
Avoid eye contact and direct contact with skin. To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during application. 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 antiinflammatory products, do not handle the product. Reactions may be serious. Avoid accidental self-injection.

Pharmaceutical Precautions:
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Store upright only. Keep the container in the outer carton.
Do not store above 25°C.
Following withdrawal of the first dose, use the product within 28 days.

When the container is broached for the first time, using the in-use shelf-life which is specified on the package, insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Further Information
Clinically beneficial anti-inflammatory activity has been demonstrated following the single administration of flunixin in Hexasol LA. However, additional NSAID therapy may be administered after 24 hours if desired. Following intramuscular injection of Hexasol LA at the recommended dose rate effective oxytetracycline blood levels persist for 5-6 days