Protazil (1.56% diclazuril) Antiprotozoal Pellets

Nplooj ntawv no muaj cov ntaub ntawv hais txog Protazil (1.56% diclazuril) Antiprotozoal Pellets rau kev siv kws kho tsiaj .
Cov ntaub ntawv muab feem ntau suav nrog cov hauv qab no:
  • Protazil (1.56% diclazuril) Antiprotozoal Pellets Indications
  • Cov lus ceeb toom thiab ceeb toom rau Protazil (1.56% diclazuril) Antiprotozoal Pellets
  • Cov lus qhia thiab ntau npaum li cas rau Protazil (1.56% diclazuril) Antiprotozoal Pellets

Protazil (1.56% diclazuril) Antiprotozoal Pellets

Txoj kev kho no siv rau cov hom hauv qab no:
Lub tuam txhab: Intervet / Merck Animal Health

ANTIPROTOZOAL PELLETS

(1.56% diclazuril)



Rau qhov ncauj siv hauv horses nkaus xwb



Protazil (1.56% diclazuril) Antiprotozoal Pellets Ceev faj

Tsoom Fwv Teb Chaws (U.S.A.) txoj cai txwv tsis pub cov tshuaj no siv los ntawm lossis raws li kev txiav txim ntawm tus kws kho tsiaj muaj ntawv tso cai.

NADA #141-268 Pom zoo los ntawm FDA



Kev piav qhia

Diclazuril, (±)-2,6-dichloro-α-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-2(3H)-yl) benzeneacetonitrile, muaj cov qauv molecular ntawm C17H9TAM SIM NO3N4LUBobQhov hnyav molecular ntawm 407.64, thiab cov qauv molecular raws li hauv qab no:

Diclazuril yog ib qho tshuaj tiv thaiv kab mob anticoccidial (antiprotozoal) nrog kev ua haujlwm tawm tsam ntau yam ntawm phylum Apicomplexa. PROTAZIL®(diclazuril) yog muab los ua lub qhov ncauj pellets uas muaj 1.56% diclazuril yuav tsum tau muab sib xyaw ua cov khaub ncaws saum toj kawg nkaus hauv pub. Inert cov khoom xyaw suav nrog lub cev qhuav dej alfalfa pluas mov, nplej middlings, cane molasses thiab propionic acid (preservative).

Protazil (1.56% diclazuril) Antiprotozoal Pellets Indications

PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets yog qhia rau kev kho mob ntawm equine protozoal myeloencephalitis (EPM) tshwm sim los ntawm Sarcocystis neurona hauv nees.



vit d2 1.25 mg 50 000 units

KEV PAB CUAM THIAB KEV PAB CUAM

Dosage: PROTAZIL®(1.56% diclazuril) yog siv los ua ib qho hnav khaub ncaws saum toj kawg nkaus hauv tus nees cov khoom noj txhua hnub ntawm tus nqi ntawm 1 mg diclazuril ib kg (0.45 mg diclazuril / lb) ntawm lub cev hnyav rau 28 hnub. Qhov ntau ntawm PROTAZIL®Qhov tsim nyog kom xa cov koob tshuaj no yog 64 mg pellets ib kg (29 mg pellets / lb) ntawm lub cev hnyav.

Kev tswj hwm: Txhawm rau ua tiav qhov koob tshuaj no, ntsuas tus nees (lossis siv daim nplaum hnyav). Scoop up PROTAZIL®mus rau qib (khob kos) sib raug rau cov koob tshuaj rau tus nees lub cev hnyav siv cov ntawv hauv qab no:

Qhov hnyav ntawm Nees (lb)

mLs ntawm pellets

275-524 : kuv

nees nkaum

525-774 : kuv

30

775-1024 : kuv

40

1025-1274 : kuv

tsib caug

1275-1524 : kuv

60

1525-1774 Ib

70

1775-2074 : kuv

80

Ib 2.4-lb thoob ntawm PROTAZIL®yuav kho ib tus nees 1274-lb rau 28 hnub. Ib 10-lb thoob ntawm PROTAZIL®yuav kho tsib 1100-lb nees rau 28 hnub.

Contraindications

Kev siv PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets yog contraindicated nyob rau hauv nees nrog paub hypersensitivity rau diclazuril.

Ceeb toom

Siv rau hauv nees nkaus xwb. Tsis txhob siv rau hauv nees npaj rau tib neeg noj. Tsis yog siv rau tib neeg. Khaws kom deb ntawm cov menyuam yaus.

Cov kev ceev faj

Kev nyab xeeb siv PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets hauv nees siv rau kev yug me nyuam, thaum cev xeeb tub, lossis hauv lactating mares tsis tau soj ntsuam. Kev nyab xeeb ntawm PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets nrog concomitant kho nyob rau hauv nees tsis tau raug soj ntsuam.

Kev Phem Tsis Zoo

Tsis muaj qhov cuam tshuam tsis zoo uas tau sau tseg hauv kev tshawb fawb teb uas tuaj yeem ua rau diclazuril. Txhawm rau tshaj tawm cov kev xav tsis zoo, kom tau txais MSDS, lossis hu rau kev pab cuam 1-800-224-5318 ib .

Clinical Pharmacology

Cov txiaj ntsig ntawm diclazuril hauv inhibiting merozoite ntau lawm Sarcocystis neurona thiab S. falcatula nyob rau hauv bovine turbinate cell kab lis kev cai tau kawm los ntawm Lindsay thiab Dubey (2000).ibDiclazuril inhibited merozoite ntau lawm ntau dua 80% hauv kab lis kev cai ntawm S. neuron los yog S. falcatula kho nrog 0.1 ng / mL diclazuril thiab ntau dua 95% inhibition ntawm merozoite ntau lawm (IC95) tau pom thaum kab lis kev cai raug kho nrog 1.0 ng / mL diclazuril. Qhov tseem ceeb ntawm kev kho mob hauv vitro cov ntaub ntawv kab lis kev cai ntawm tes tsis tau txiav txim siab.

Pharmacokinetics Hauv Nees

Qhov ncauj bioavailability ntawm diclazuril los ntawm PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets ntawm 5 mg / kg koob tshuaj yog kwv yees li 5%. Cov ntsiab lus ntawm diclazuril concentrations nyob rau hauv lub cerebrospinal kua (CSF) nyob nruab nrab ntawm 1% thiab 5% ntawm cov concentrations pom nyob rau hauv plasma. Txawm li cas los xij, raws li equine pilot kawm cov ntaub ntawv, CSF concentrations cia siab tias yuav muaj ntau tshaj qhov hauv vitro IC95kev kwv yees rau merozoite ntau lawm ( Dirikolu et al. Ib., 1999)ob. Vim nws qhov ntev lub davhlau ya nyob twg tshem tawm ib nrab-lub neej hauv nees (kwv yees li 43-65 teev), diclazuril tsub zuj zuj tshwm sim nrog kev noj ib zaug ib hnub. Cov ntshav hauv lub xeev khov kho tau ua tiav los ntawm kwv yees li Hnub 10 ntawm kev tswj hwm.

Kev ua tau zoo

Ob puas thiab kaum plaub mares, stallions, thiab geldings ntawm ntau hom tsiaj, xws li hnub nyoog ntawm 9.6 lub hlis mus rau 30 xyoo, tau cuv npe kawm hauv ntau qhov chaw kawm. Tag nrho cov nees tau lees paub EPM-zoo raws li cov txiaj ntsig ntawm kev kuaj mob thiab kev sim kuaj, suav nrog CSF Western Blot analyses. Nees tau tswj hwm PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets ntawm koob tshuaj 1, 5, lossis 10 mg diclazuril / kg lub cev qhov hnyav raws li hnav khaub ncaws saum toj kawg nkaus ntawm lawv cov khoom noj txhua hnub rau 28 hnub. Cov nees tau raug soj ntsuam rau kev hloov kho mob los ntawm kev hloov kho Mayhew neurological scale rau Hnub 48 raws li hauv qab no:

0. Ib txwm, tsis pom kev tsis txaus ntawm lub paj hlwb.

1. Neurological deficits yuav kuaj tau ntawm ib txwm gaits; cov paib exacerbated nrog cov txheej txheem manipulative (xws li, thim rov qab, tig hauv lub voj voog nruj, taug kev nrog lub taub hau nce, truncal swaying, thiab lwm yam).

2. Neurological deficit pom tseeb ntawm ib txwm gaits lossis posture; cov paib exacerbated nrog cov txheej txheem manipulative.

3. Neurological deficit tseem ceeb heev ntawm ib txwm gaits: nees muab lub tswv yim lawv yuav poob (tab sis tsis ua) thiab buckle los yog poob nrog manipulative txheej txheem.

4. Neurological deficit muaj ntau heev ntawm ib txwm gait: nees nquag stumbles los yog mus txawv tebchaws thiab tej zaum yuav poob ntawm ib txwm gaits los yog thaum manipulative txheej txheem tau siv.

5. Nees yog recumbent, sawv tsis tau.

Txhua tus nees cov lus teb rau kev kho mob tau muab piv rau nws cov nqi kho mob ua ntej. Kev ua tiav cov lus teb rau kev kho mob tau txhais tias yog kev txhim kho kev kho mob tsawg kawg ib qib los ntawm Hnub 48 ± hloov pauv ntawm CSF rau Western Blot-negative xwm txheej rau S. neuron los yog ua tiav ntawm Western Blot-negative CSF raws li txoj cai yam tsis tau txhim kho qib 1 ataxia.

Plaub caug-ob tus nees tau pib ntsuas qhov ua tau zoo thiab 214 tus nees tau raug tshuaj xyuas kom nyab xeeb. Kev kho mob tau soj ntsuam los ntawm tus kws tshawb fawb soj ntsuam cov ntsiab lus ntawm cov qhab nia thiab tom qab ntawd txheeb xyuas los ntawm kev ntsuam xyuas cov kab mob neurological kuaj videotapes los ntawm lub npog ntsej muag ntawm peb tus kws kho tsiaj equine. Txawm hais tias 42 tus nees tau raug ntsuas rau kev kho mob tau zoo, kev lees paub ntawm kev kho mob tau zoo los ntawm kev ntsuam xyuas video tsis tuaj yeem ua tau rau ib tus nees vim tias tsis muaj cov ntaub ntawv kuaj mob neurologic. Yog li ntawd, tus nees no tsis tau suav nrog hauv kev suav ua tiav. Raws li cov naj npawb ntawm cov nees uas seroconverted rau qhov tsis zoo Western Blot xwm txheej, thiab cov naj npawb ntawm cov nees cais raws li kev ua tiav los ntawm cov kws tshawb fawb soj ntsuam, 28 ntawm 42 tus nees (67%) ntawm 1 mg / kg tau suav hais tias ua tiav. Hais txog kev ywj pheej ntawm cov kws tshaj lij npog cov duab thaij duab, 10 ntawm 24 tus nees (42%) ntawm 1 mg / kg tau suav hais tias ua tiav. Tsis muaj qhov sib txawv ntawm kev kho mob hauv kev ua tau zoo ntawm 1, 5, thiab 10 mg / kg cov txiaj ntsig kho mob. Cov xwm txheej tsis zoo tau tshaj tawm rau ob ntawm 214 tus nees tau soj ntsuam kev nyab xeeb. Nyob rau hauv thawj rooj plaub, ib tug nees tau cuv npe uas qhia cov tsos mob hnyav heev. Hauv 24 teev tom qab noj tshuaj, tus nees tau rov qab, tom, thiab pom cov tsos mob ntawm dementia. Tus nees tuag, thiab tsis pom qhov ua rau tuag. Hauv qhov thib ob, tus nees pib taug kev nruj li 13 hnub tom qab pib noj tshuaj. Tus kws kho tsiaj xa mus tau tshaj tawm tias tus nees tau noj nyom clippings thiab tej zaum muaj laminitis.

Kev Nyab Xeeb Tsiaj

PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets tau muab rau 30 tus nees (15 txiv neej thiab 15 tus poj niam, txij li 5 txog 9 lub hlis) hauv kev tshawb fawb txog kev nyab xeeb tsiaj. Tsib pawg ntawm 6 tus nees txhua tus (3 txiv neej thiab 3 tus poj niam) tau txais 0, 5 (5X), 15 (15X), 25 (25X) lossis 50 (50X) mg diclazuril / kg (2.27mg / lb) lub cev hnyav / hnub rau 42 hnub sib law liag raws li hnav khaub ncaws saum toj kawg nkaus ntawm cov qoob loo ntawm tus nees. Cov kev hloov pauv tau ntsuas thaum lub sijhawm kawm suav nrog: kev soj ntsuam thiab kev soj ntsuam lub cev, lub cev qhov hnyav, kev noj zaub mov thiab dej, hematology, serum chemistry, urinalysis, fecal analysis, necropsy, organ weights, tag nrho thiab histopathologic exams. Kev nyab xeeb ntawm diclazuril cov khaub ncaws saum toj kawg nkaus muab rau cov nees ntawm 1 mg / kg ib zaug ib hnub tsis tuaj yeem txiav txim siab raws li txoj kev tshawb no vim tias tsis muaj pab pawg tswj hwm txaus (tswj cov nees tau kuaj pom zoo rau cov tshuaj hauv ntshav thiab CSF). Txawm li cas los xij, kev tshawb pom muaj peev xwm cuam tshuam nrog cov tshuaj tau txwv rau qhov nce hauv BUN, creatinine, thiab SDH thiab tsawg dua li qhov xav tau qhov hnyav. Cov ntsiab lus tseem ceeb ntawm cov ntsiab lus cuam tshuam tau txo qis cov qoob loo / hnav khaub ncaws sab saum toj hauv cov nees hauv 50 mg / kg pawg.

Hauv kev tshawb fawb thib ob hom tsiaj kev nyab xeeb, PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets tau muab rau 24 nees (12 tus txiv neej thiab 12 tus poj niam, txij li 2 txog 8 xyoos). Peb pawg ntawm 4 tus nees / poj niam / pab pawg tau txais 0, 1, lossis 5 mg diclazuril / kg lub cev hnyav / hnub rau 42 hnub raws li cov khaub ncaws saum toj kawg nkaus ntawm cov qoob loo ntawm tus nees. Cov kev hloov pauv tau ntsuas thaum lub sijhawm kawm suav nrog kev kuaj lub cev, qhov hnyav ntawm lub cev, kev noj zaub mov thiab dej, hematology, thiab ntshav chemistry. Tsis muaj cov ntawv xeem hais txog kev tshawb pom pom thaum kawm.

Cov ntaub ntawv khaws cia

Khaws ntawm 15 ° C txog 30 ° C (59 ° F txog 86 ° F).

YUAV UA LI CAS

PROTAZIL®(1.56% diclazuril) Antiprotozoal Pellets yog muab rau hauv 2.4-lb (1.1 kg) thoob.

REFERENCES

ntsuab tshuaj m 51

1. Lindsay, D. S., thiab Dubey, J. P. 2000. Kev txiav txim siab ntawm kev ua ntawm diclazuril tawm tsam Sarcocystis neurona thiab Sarcocystis falcatula hauv kab lis kev cai ntawm tes. J. Parasitology, 86(1):164-166.

2. Dirikolu, L., Lehner, F., Nattrass, C., Bentz, B. G., Woods, W. E., Carter, W. E., Karpiesiuk, W. G., Jacobs, J., Boyles, J., Harkins, J. D., Granstrom, D. E. thiab Tobin, T. 1999. Diclazuril nyob rau hauv tus nees: Nws txheeb xyuas thiab nrhiav kom tau thiab ua ntej pharmacokinetics. J. Vet. Pharmacol. Kev kho mob. 22:374-379.

Intervet Inc d/b/a Merck Animal Health, 556 Morris Avenue, Summit, NJ 07901

Copyright © 2014 Intervet Inc., ib lub koom haum ntawm Merck & Co. Inc.

Tag nrho cov cai.

2.4 lbs (1.1 kg) hnyav

07-2014

CPN: 1047490.3

MERCK ANIMAL HEALTH
Intervet Inc.

2 GIRALDA FARMS, MADISON, NJ, 07940
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Fax: 973-937-5557 Ib
Lub Vev Xaib: www.merck-animal-health-usa.com
Txhua qhov kev siv zog tau ua los xyuas kom meej qhov tseeb ntawm Protazil (1.56% diclazuril) Antiprotozoal Pellets cov ntaub ntawv luam tawm saum toj no. Txawm li cas los xij, nws tseem yog lub luag haujlwm ntawm cov neeg nyeem kom paub txog lawv tus kheej nrog cov ntaub ntawv cov khoom lag luam uas muaj nyob rau hauv Teb Chaws Asmeskas cov khoom lag luam lossis cov pob ntxig.

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