Hexasol

Hexasol™ Injection is a sterile, pre-constituted solution of the broad-spectrum antibiotic oxytetracycline dihydrate and the non-steroidal anti-inflammatory drug (NSAID) flunixin meglumine. Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline; 20 mg of flunixin base as flunixin meglumine, 40% (v/v) glycerol formal, 10% (v/v) polyethylene glycol 200, 2.7% (w/v) magnesium oxide, 0.4% (w/v) sodium formaldehyde sulphoxylate (as a preservative) and monoethanolamine (as required to adjust pH).

Do not use in animals showing hypersensitivity to either flunixin meglumine or oxytetracycline.

Withdrawal Periods and Residue Warnings

Residue Warnings: Discontinue treatment at least 21 days prior to slaughter of cattle. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause milk residues. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Use of dosages other than those indicated may result in residue violations.

Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in beef cattle and non-lactating dairy cattle may result in antibiotic residues beyond the withdrawal time.

Antibacterial Warnings

Use of antibacterial drugs in the absence of a susceptible bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant pathogenic bacteria.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. The absence of a favorable response following treatment or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Hexasol Injection in conjunction with penicillin.

User Safety Warnings

Not for use in humans. Keep out of reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To obtain an MSDS contact Norbrook at 1-866-591-5777.

Animal Safety Warnings and Precautions

At the first sign of any adverse reaction, discontinue use of the product. Some of the reactions may be attributable either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection, treated animals may have transient hemoglobinuria resulting in darkened urine. Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site.

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of Hexasol Injection with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.

Flunixin is a cyclo-oxygenase inhibitory NSAID, and as with others in this class, adverse effects may occur with its use. The most frequently reported adverse effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported for other drugs in this class.

Not for use in animals intended for breeding purposes. The effects of oxytetracycline and flunixin on bovine reproductive performance, pregnancy, and lactation have not been determined. NSAIDs are known to have potential effects on both parturition and the estrous cycle. There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle. The effects of flunixin on imminent parturition have not been evaluated in a controlled study. NSAIDs are known to have the potential to delay parturition through a tocolytic effect.

Other Warnings

Hexasol Injection, when administered as directed, may induce a transient reaction at the site of injection and underlying tissues that may result in trim loss of edible tissue at slaughter.

A randomized negative-controlled target animal safety study was conducted in 3- to 5-month-old calves to evaluate the effects of Hexasol Injection when administered to cattle intramuscularly at 1X, 3X, and 5X the labeled dose every 3 days for 3 treatments (3X the labeled duration). Hexasol Injection produced no drug-related adverse effects at the labeled dose. In separate injection site studies, intramuscular or subcutaneous injection of Hexasol Injection resulted in transient inflammation, including signs of discomfort, swelling, and/or hardness.

Store at 59° to 86°F (15° to 30°C)

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Restricted Drug (California) - Use Only As Directed.

NADA 141-312, Approved By FDA

Made in the UK.

Norbrook Laboratories Limited
Newry, BT35 6PU, Co. Down, Northern Ireland U.S. Patent No. 6,479,473

™ Hexasol is a registered trademark of Norbrook Laboratories Limited

REVISION DATE - September 2010

012670I01