For:

For The Treatment Of Equine Protozoal Myeloencephalitis (EPM) In Horses

DESCRIPTION:

Marquis® (15% w/w ponazuril) Antiprotozoal Oral Paste is supplied in ready-to-use syringes containing 127 grams of paste. Each gram of paste contains 150 mg of ponazuril (15% w/w). Marquis (ponazuril) is designed to be delivered as an orally administered paste. Each syringe barrel of Marquis (ponazuril) contains enough paste to treat one (1) 1,200 lb (544 kg) horse for seven (7) days, at a dose rate of 5 mg/kg (2.27 mg/lb) body weight. The plunger contains a dosage ring calibrated for a dose rate of 5 mg/kg (2.27 mg/lb) body weight and marked for horse weight from 600 to 1,200 lbs (272 to 544 kg). The syringe barrels are packaged in units of four with four reusable plungers. This package provides sufficient paste to treat one 1,200 lb (544 kg) horse for 28 days at a dose rate of 5 mg/kg (2.27 mg/lb) body weight.

INGREDIENT(S):

15% w/w ponazuril

CLINICAL PHARMACOLOGY:

The activity of ponazuril has been demonstrated in several Apicomplexans1-6. Lindsay, Dubey and Kennedy7 showed that the concentration of ponazuril necessary to kill Sarcocystis neurona in vitro was 0.1 to 1.0 �g/mL. Furr and Kennedy8 evaluated the pharmacokinetics of ponazuril in serum and CSF in normal horses treated daily at 5 mg/kg for 28 days. The time to peak serum concentration (Tmax) was 18.20 (�5.9) days and the maximum serum concentration (Cmax) was 5.59 (�0.92) �g/mL. The terminal elimination half-life for serum (calculated using Day 28 to 42 data) was 4.50 (�0.57) days. In CSF, Tmax was 15.40 (�7.9) days and Cmax was 0.21 (�0.072) �g/mL.

USES AND INDICATIONS:

Marquis (ponazuril) is indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

CONTRAINDICATIONS AND PRECAUTION:

Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Prior to treatment, EPM should be distinguished from other diseases that may cause ataxia in horses. Injuries or lameness may also complicate the evaluation of an animal with EPM. In most instances, ataxia due to EPM is asymmetrical and affects the hind limbs. Clinicians should recognize that clearance of the parasite by ponazuril may not completely resolve the clinical signs attributed to the natural progression of the disease. The prognosis for animals treated for EPM may be dependent upon the severity of disease and the duration of the infection prior to treatment. The safe use of Marquis (ponazuril) in horses used for breeding purposes, during pregnancy, or in lactating mares, has not been evaluated. The safety of Marquis (ponazuril) with concomitant therapies in horses has not been evaluated.

ADVERSE EFFECTS AND WARNINGS:

In the field study, eight animals were noted to have unusual daily observations. Two horses exhibited blisters on the nose and mouth at some point in the field study, three animals showed a skin rash or hives for up to 18 days, one animal had loose stools throughout the treatment period, one had a mild colic on one day and one animal had a seizure while on medication. The association of these reactions to treatment was not established. For use in animals only. Not for use in horses intended for food. Not for human use. Keep out of the reach of children.

DOSAGE AND ADMINISTRATION:

Paste syringe assembly: Before administration, the syringe barrel and plunger require assembly. Ensure plunger is clean and dry. Step 1. End cap must be on syringe barrel when inserting plunger. Step 2. Carefully insert reusable plunger into base of syringe barrel until it snaps into place, then remove end cap and gently apply pressure to the plunger until paste is seen at the tip of the syringe barrel. Step 3. Return end cap to tip of paste syringe. Administering Marquis (ponazuril) to the horse: NOTE: The paste syringe is a multi-dose package. Ensure that the correct dose is administered with each use. Step 1. Remove end cap and gently apply pressure to the plunger until paste is seen at the tip of the syringe barrel. Return end cap to tip of paste syringe. Step 2. Determine weight of horse and insure the horse's mouth contains no feed. Step 3. To measure dose, dosage ring collar and barrel collar should be flush. Hold plunger and rotate dosage ring with the other hand to the weight of the horse. Step 4. Remove end cap from tip of syringe barrel. Step 5. The selected dose of paste should be deposited onto the back and top of the horse's tongue. Introduce tip of paste syringe into the side of the horse's mouth at the space between the front (incisor) and back (molar) teeth. Deposit paste on the horse's tongue by depressing the plunger of the syringe as far as the dose ring permits. Remove tip of syringe from horse's mouth. Step 6. To aid swallowing of paste, immediately raise horse's head for a few seconds after dosing. Step 7. Clean the tip of the syringe with a clean disposable towel and return end cap to tip of syringe barrel. Step 8. For the next daily dose, repeat steps 1-7. NOTE: At the end of the prescribed treatment period, partially used syringes should be discarded.

STORAGE:

Store at Controlled Room Temperature 15-30° C (59-86° F).

MANUFACTURER:

Bayer HealthCare LLC