
A HUGE SINCERE THANK YOU !
Our Warmest and Deepest Appreciation -
To BAYER !
Thank
You for Your Efforts Developing Marquis !
On Behalf of Wonderful Horses Like Glacier!
Below, please
find info on the Bayer Corporation
and their successful medication; " Marquis " aka
Ponazuril.
| BAYER CORPORATION Animal Health P.O. BOX 390 SHAWNEE MISSION KS 66201-0390 USA |
Customer Service Tel.: 800-633-3796 Customer Service Fax: 800-344-4219 Website: www.bayer-ah.com |
| The following information is from the most recent U.S.A. product label/insert supplied to us by the Manufacturer/Distributor. | |
MARQUIS™ Rx
(15% w/w ponazuril) Antiprotozoal Oral Paste
Bayer Corporation
Caution: Federal (U.S.A.) Law restricts
this drug to use by or on the order of a licensed veterinarian.
For The Treatment Of Equine Protozoal Myeloencephalitis (EPM)
In Horses
For Oral Use Only
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 one reusable plunger. 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.
Ponazuril is an anticoccidial (antiprotozoal) compound with
activity against several genera of the phylum Apicomplexa.
CHEMICAL NOMENCLATURE AND STRUCTURE:
Ponazuril
1,3,5-Triazine-2,4,6(1H, 3H, 5H)-trione,1-methyl-3-[3-methyl-4-[4-[(trifluoromethyl)sulfonyl]
phenoxy]phenyl]-(9CI)
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 µg/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) µg/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) µg/mL.
INDICATIONS: Marquis (ponazuril) is indicated for the
treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis
neurona.
EFFECTIVENESS SUMMARY: A field study was conducted at six
sites with seven investigators across the United States.9
The study was conducted using historical controls. In this study,
each animal's response to treatment was compared to its pre-treatment
values. The following standardized neurologic scale was used to
grade the horses:
Improvement was defined as a decrease of at
least one grade.
Naturally-occurring clinical cases of EPM, characterized by
signalment and laboratory diagnosis, were randomly allotted to
one of two treatment doses (5 or 10 mg/kg/day for a period of 28
days), then evaluated for clinical changes through 118 days.
Acceptance into the study was based on the results from a
standardized neurological examination including radiography,
serum S. neurona IgG level determination by Western Blot (WB),
and a positive cerebrospinal fluid (CSF) for S. neurona
IgG level by WB.
Response to treatment was determined by the investigator to be
acceptable when a clinical improvement of at least one grade
occurred by no later than 3 months after treatment, regardless of
whether the CSF by WB was positive or negative.
Changes in clinical condition were evaluated first by the
subjective scoring of the investigator, then by masked assessment
of videotapes of the neurological examination. At 5 mg/kg for 28
days, 28 of 47 horses (60%) improved at least one grade by Day
118. Seventy-five percent (75%) of those improved, that had also
been videotaped, were corroborated successes by videotape
assessment. At 10 mg/kg, 32 of 55 animals (58%) improved at least
one grade by Day 118 and 56% of those improved, that had also
been videotaped, were corroborated successes using videotape
assessment. With respect to the clinical investigators' scores
there was no statistical difference between 5 mg/kg and 10 mg/kg
treatment group results (p = 0.8867).
WARNING: For use in animals only. Not for use in horses
intended for food. Not for human use. Keep out of the reach of
children.
PRECAUTIONS: 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 REACTIONS: 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.
ANIMAL SAFETY SUMMARY: Marquis (ponazuril) was
administered to 24 adult horses (12 males and 12 females) in a
target animal safety study. Three groups of 8 horses each
received 0, 10, or 30 mg/kg (water as control, 2X and 6X for a 5
mg/kg [2.27 mg/lb] dose). Horses were dosed after feeding. One
half of each group was treated for 28 days and the other half for
56 days followed by necropsy upon termination of treatment. There
were several instances of loose feces in all animals in the study
irrespective of treatment, sporadic inappetence and one horse at
10 mg/kg (2X) lost weight while on test. Loose feces were
treatment related. Histopathological findings included moderate
edema in the uterine epithelium of three of the four females in
the 6X group (two treated for 28 days and one for 56 days).
For a copy of the Material Safety Data Sheet (MSDS) or to report
Adverse Reactions, call Bayer Customer Service at (800) 633-3796.
DOSAGE: Marquis (ponazuril) is to be used at a dose of 5
mg/kg (2.27 mg/lb) body weight once daily for a period of 28 days.
| 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 ensure 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: | When the paste syringe barrel is empty, remove plunger for re-use and assembly with a new syringe barrel. When removed, the plunger may retain a seal from the empty paste syringe barrel. If this occurs, remove the seal before plunger is inserted into the base of the new paste syringe barrel. 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). | |||
HOW SUPPLIED:
| Code: 045799 | Carton contains four (4) x 127 gram syringe applicators and one (1) reusable syringe plunger |