Zimeta (dipyrone injection) - 500 mg/ml (100 mL Vial)

Zimeta is indicated for the control of pyrexia in horses.

• In clinical studies, Zimeta™ demonstrated rapid and effective control of fever in horses.^1,2*
• Dipyrone, the active ingredient in Zimeta, is a member of the non-steroidal anti-inflammatory drug (NSAID) class and has a centrally acting mechanism of action on the hypothalamus where fever originates and is regulated.**
• In a field study, clinical signs associated with adverse events were reported in less than 2% of Zimeta treated horses.²
• This is the first-time dipyrone has been FDA-approved for veterinary use in the United States. Dipyrone, also known as metamizole, is approved and widely used in many other countries.

Administer Zimeta by intravenous injection, 1 to 2 times daily, at 12 hour intervals, for up to 2 daysm at a dosage of 20 mg/kg (13.6 mg/lb). The overall number of doses and duration of treatment with Zimeta is dependent on the response observed (fever reduction). Zimeta may be re-administered based on recurrence of fever for up to 3 days. Zimeta is provided in a multi-dose vial and contains a preservative.

Warnings

For use in horses only. Do not use in horses intended for human consumption. Do not use in any food producintg animals. Not for use in humans. Keep this and all drugs out of reach of children. In case of accidental exposure, contact a physician immediately.

Contraindications

Horses with hypersensitivity to dipyrone should not receive Zimeta. Due to the prolongation of prothrombin time (PT) and associated clinical signs of coagulopathy, dipyrone should not be given more frequently than every 12 hours.

Human Warnings

Care should be taken to ensure that dipyrone is not accidentally injected into humans as studies have indicated that dipyrone can cause agranulocytosis in humans.

Not for use in humans. Keep this and all drugs out of reach of children. In case of accidental exposure, contact a physician immediately. Direct contact with the skin should be avoided. If contact occurs, the skin should be washed immediately with soap and water. As with all injectable drugs causing profound physiological effects, routine precautions should be employed by practitioners when handling and using loaded syringes to prevent accidental self-injection.

Information for Owners or Person Treating Horse: A Client Information Sheet should be provided to the person treating the horse. Treatment administrators and caretakers should be aware of the potential for adverse reactions and the clinical signs associated with NSAID intolerance. Adverse reactions may include colic, diarrhea, and decreased appetite. Serious adverse reactions can occur without warning and, in some situations, result in death. Clients should be advised to discontinue NSAID therapy and contact their veterinarian immediately if any signs of intolerance are observed.

WHAT IS ZIMETA? Zimeta is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) of the pyrazolone class used to control fever in horses by veterinary prescription only. Fever is an elevation in body temperature due to a variety of infectious and inflammatory conditions in the horse.

HOW TO GIVE ZIMETA TO YOUR HORSE Zimeta should be given according to your veterinarian’s instructions. Do not change the way you give Zimeta to your horse without first speaking with your veterinarian.

WHAT KIND OF RESULTS CAN I EXPECT WHEN MY HORSE IS BEING TREATED WITH ZIMETA FOR A FEVER? Zimeta can control fever that is a result of infection or inflammation; however, it is not a cure for the underlying disease. Consult your veterinarian to identify the underlying cause of your horse’s elevated body temperature. Response to Zimeta varies from horse to horse.

WHICH HORSES SHOULD NOT RECEIVE ZIMETA?

Your horse should not be given Zimeta if he/she:

• Has an allergic reaction to dipyrone, the active ingredient in Zimeta
• Has previously had an allergic reaction to other NSAIDs
• Is presently taking other NSAIDS or corticosteroids including but not limited to aspirin, phenylbutazone, flunixin meglumine, diclofenac, ketoprofen, firocoxib
• The safety of Zimeta has not been determined in horses less than three years of age or in breeding horses, pregnant or lactating mares.

ZIMETA SHOULD BE GIVEN INTRAVENOUSLY TO HORSES ONLY Zimeta is not for use in horses intended for human food consumption. Do not use in any food producing animals, including lactating dairy animals. People should not take Zimeta. Keep Zimeta and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans or accidental injection into humans.

WHAT TO TELL/ASK YOUR VETERINARIAN BEFORE GIVING ZIMETA

Talk to your veterinarian about:

• The signs of infection or inflammation you have observed in your horse, such as nasal discharge or coughing
• If any tests, such as bloodwork, will be done before Zimeta is prescribed
• How often your horse may need to be examined by your veterinarian
• The risks and benefits of using Zimeta
• Other medical problems or allergies that your horse has now, or has had in the past
• All medications that you are giving or plan to give to your horse, including those you can get without a prescription and any dietary supplements
• Any recent surgeries

Tell your veterinarian if your horse has ever had the following medical problems:

• Any side effects from taking Zimeta™ (dipyrone injection) or other NSAIDs
• Any increased drinking, increased urination, or known kidney disease
• Any known liver disease
• Any known stomach or gastrointestinal ulcers

Tell your veterinarian if you plan to breed your horse, or if your mare is pregnant or nursing a foal.

WHAT ARE THE POSSIBLE SIDE EFFECTS THAT MAY OCCUR IN MY HORSE DURING ZIMETA THERAPY? Zimeta, like other NSAIDs, may cause some side effects in individual horses. Serious side effects associated with NSAID therapy can occur with or without warning. Look for the following side effects that may indicate your horse is having a problem with Zimeta or may have another medical problem:

• Change in eating or drinking habits (frequency or amount consumed)
• Change in urination
• Unexpected weight loss
• Change in behavior, such as depression
• Change in manure, such as diarrhea
• Unexplained bleeding

It is important to stop therapy and contact your veterinarian if you think your horse has a medical problem or side effect while taking Zimeta. If you have additional questions about possible side effects, talk with your veterinarian or call KindredBio at 1-888-608-2542.

CAN ZIMETA BE GIVEN WITH OTHER MEDICATIONS? Zimeta should not be given at the same time as with other NSAIDS (for example, aspirin, phenylbutazone, diclofenac, ketoprofen, flunixin, or firocoxib) or systemic corticosteroids (for example, prednisolone, dexamethasone, or triamcinolone).

WHAT DO I DO IN CASE MY HORSE RECEIVES MORE THAN THE PRESCRIBED AMOUNT OF ZIMETA? Consult your veterinarian if your horse receives more than the prescribed amount of Zimeta.

WHAT ELSE SHOULD I KNOW ABOUT ZIMETA? This sheet provides a summary of information about Zimeta (dipyrone injection) and general information about NSAIDs. If you have any questions or concerns about Zimeta or fever talk with your veterinarian.

As with all prescribed medicines, Zimeta should only be given to the horse for which it is prescribed. It should be given to your horse only for the condition for which it is prescribed, at the prescribed dose and duration.

It is important to periodically discuss your horse’s response to Zimeta with your veterinarian. Your veterinarian will determine if your horse is responding as expected and if your horse should continue receiving Zimeta.