Cerenia Ntsiav Tshuaj

Cerenia Ntsiav TshuajNplooj ntawv no muaj cov ntaub ntawv ntawm Cerenia Tablets rau siv tsiaj .
Cov ntaub ntawv muab feem ntau suav nrog cov hauv qab no:
  • Cerenia Tablets Indications
  • Lus ceeb toom thiab ceeb toom rau cov ntsiav tshuaj Cerenia
  • Cov lus qhia thiab ntau npaum li cas rau Cerenia Tablets

Cerenia Ntsiav Tshuaj

Qhov kev kho mob no siv rau cov tsiaj hauv qab no:
Tuam txhab: Zoetis

(maropitant citrate)

Ntsiav tshuaj



Antiemetic



Rau qhov ncauj siv hauv dev nkaus xwb

Cerenia Tablets Ceev faj

Tsoomfwv txoj cai txwv tsis pub siv cov tshuaj no los ntawm lossis txiav txim ntawm tus kws kho tsiaj muaj ntawv tso cai.



Nqe lus piav qhia

Maropitant yog neurokinin (NK1) receptor antagonist uas thaiv kev ua tshuaj ntawm cov tshuaj P hauv lub hauv paus paj hlwb (CNS). Maropitant yog qhov tsis yog tus tswv rau kev hloov pauv quinuclidine. Cov qauv ua piv txwv yog C.32H40N2O C6H8LOS YOG7H2O thiab lub cev hnyav 678.81. Lub npe tshuaj yog (2 S , 3 S -2-benzhydryl- N- (5- tert- cov butyl-2-methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Txhua lub ntsiav tshuaj uas muaj xim txiv kab ntxwv tau qhab nia thiab muaj 16, 24, 60 lossis 160 mg ntawm maropitant li maropitant citrate ib ntsiav tshuaj.

Cov qauv tshuaj lom neeg ntawm maropitant citrate yog:

Cerenia Tablets Indications

CERENIA (maropitant citrate) Cov ntsiav tshuaj tau qhia rau kev tiv thaiv kev ntuav ntuav thiab tiv thaiv ntuav vim mob plab hauv dev.



Dosage thiab Administration

Rau Kev Tiv Thaiv Kev Mob Ncauj

Rau Kev Tiv Thaiv Kev Mob Ncauj Qab Zib hauv dev 2-7 lub hlis ntawm hnub nyoog: CERENIA Tablets hais lus ntawm qhov tsawg kawg ntawm 2 mg/kg (0.9 mg/lb) lub cev hnyav ib hnub ib zaug txog li 5 hnub sib law liag (saib Cov Lus Ceeb Toom thiab Kev Nyab Xeeb Kev Nyab Xeeb).

Rau Kev Tiv Thaiv Kev Mob Ncauj Qab Zib hauv cov dev 7 hli hnub nyoog thiab laus dua: CERENIA Tablets hais lus ntawm qhov tsawg kawg ntawm 2 mg/kg (0.9 mg/lb) lub cev hnyav ib hnub ib hnub kom txog thaum daws qhov ntuav hnyav.

Yog tias ntuav tseem tab tom kho, rooj plaub yuav tsum rov tshuaj xyuas dua. CERENIA yog qhov muaj txiaj ntsig tshaj plaws hauv kev tiv thaiv ntuav ntuav nrog rau kev siv tshuaj kho mob yog tias ua ntej ua ntej tus kws khomob kho mob.

Txog kev tiv thaiv ntuav ntuav, faib tag nrho lossis ib nrab ntsiav tshuaj hauv qhov muaj zog uas ze tshaj ua rau 2 mg/kg koob tshuaj:

Aub lub cev hnyav

Cov Ntsiav Tshuaj

Phaus

Kilograms

16mg: ua

24mg ua

60 mg

8

4

1/2

kaum tsib

8

1

25

12

1

tsib caug

24

2

65

30

1

130

60

2

Kev sib pauv hloov nrog CERENIA Txhaj Tshuaj Tiv Thaiv Kev Tiv Thaiv Kev Mob Ncauj:

Hauv cov dev uas nquag ntuav, kom ntseeg tau tias tau txhaj tshuaj thawj zaug, CERENIA Txhaj Tshuaj tau pom zoo ntawm koob tshuaj 1 mg/kg ib hnub ib zaug. (Saib pob ntxig ntxig rau CERENIA txhaj tshuaj.) Tom qab ntawd, txhawm rau tiv thaiv ntuav ntuav, CERENIA Tablets ntawm koob tshuaj 2 mg/kg ib hnub ib zaug tej zaum yuav siv sib pauv nrog CERENIA Txhaj Tshuaj rau txog 5 hnub.

Rau Kev Tiv Thaiv Vomiting vim Mob Mob hauv cov dev 4 hlis thiab laus dua

CERENIA Tablets hais lus ntawm qhov tsawg kawg ntawm 8 mg/kg (3.6 mg/lb) lub cev hnyav ib hnub ib hnub txog li 2 hnub sib law liag (saib Cov Lus Ceeb Toom thiab Kev Nyab Xeeb Kev Nyab Xeeb).

Muab cov ntsiav tshuaj CERENIA yam tsawg kawg yog ob teev ua ntej yuav mus nrog zaub mov me me los txo qhov ntuav uas cuam tshuam nrog kev noj cov tshuaj ntawm lub plab khoob; txawm li cas los xij, txwv tsis pub noj mov puv ntoob ua ntej mus ncig.

Kev tiv thaiv ntawm ntuav vim mob mob hauv cov dev 4 lub hlis ntawm hnub nyoog thiab laus dua:

Muab cov ntsiav tshuaj tag nrho lossis ib nrab hauv qhov ua tau zoo tshaj plaws uas ua rau 8 mg/kg koob tshuaj ib hnub ib zaug txog li 2 hnub sib law liag:

Aub lub cev hnyav

Cov Ntsiav Tshuaj

Phaus

Kilograms

16mg: ua

24mg ua

60 mg

160 mg ntawm cov tshuaj

2

1

1/2

3

1.5

1/2

4

2

1

6

3

1

8

4

2

13

6

2

16

7.5

1

22

10

1/2

33

kaum tsib

2

44

nees nkaum

1

66

30

1 1/2

88

40

2

132

60

3

CERENIA txhaj tshuaj yuav tsum tsis txhob siv sib pauv nrog CERENIA cov ntsiav tshuaj rau kev tiv thaiv ntuav vim mob plab (8mg/kg).

Lus ceeb toom

Tsis siv rau tib neeg. Tsis txhob ncav cuag cov menyuam. Yog tias tau txais kev yuam kev, nrhiav kev pab kho mob. Kev nthuav tawm cov tshuaj tuaj yeem ua rau muaj kev tsis haum ntawm cov tawv nqaij hauv qee tus neeg. Kev rov ua dua los yog ncua ntev tuaj yeem ua rau daim tawv nqaij ua kom tawv nqaij. Ntxuav tes nrog xab npum thiab dej tom qab muab tshuaj. CERENIA kuj yog qhov khaus qhov muag. Thaum raug qhov muag raug qhov muag, yaug nrog dej li 15 feeb thiab nrhiav kev kho mob.

Hauv cov menyuam yaus hnub nyoog qis dua 11 lub lis piam, cov pov thawj keeb kwm ntawm cov pob txha pob txha hypocellularity tau pom ntawm qhov ntau dua thiab qhov hnyav dua hauv cov menyuam dev kho nrog CERENIA piv rau tswj cov menyuam dev. Hauv menyuam dev 16 lub lis piam thiab laus dua, cov pob txha pob txha hypocellularity tsis tau pom (saib LUS QHUAB QHIA ).

Cov kev ceev faj

Kev nyab xeeb siv CERENIA Tablets tsis tau tshuaj xyuas hauv cov dev siv rau kev yug me nyuam, lossis thaum cev xeeb tub lossis pub niam mis.

Kev nyab xeeb siv CERENIA tsis tau tshuaj xyuas hauv cov dev uas muaj kab mob hauv lub plab, lossis cov dev uas tau noj cov tshuaj lom.

Siv nrog ceev faj hauv cov dev nrog lub siab ua haujlwm vim CERENIA tau hloov pauv los ntawm CYP3A enzymes (saib Pharmacokinetics ). Siv nrog ceev faj nrog lwm cov tshuaj uas muaj cov protein ntau. Kev siv CERENIA nrog lwm cov tshuaj muaj protein ntau tsis tau kawm hauv dev. Feem ntau siv cov tshuaj tiv thaiv kab mob suav nrog NSAIDs, mob plawv, anticonvulsant, thiab tshuaj coj tus cwj pwm. Kev cuam tshuam ntawm cov tshuaj sib xws uas tuaj yeem cuam tshuam cov metabolism hauv CERENIA tsis tau tshuaj xyuas. Kev sib xyaw tshuaj yuav tsum tau saib xyuas hauv cov neeg mob uas xav tau kev kho mob ntxiv.

CERENIA ua rau muaj feem cuam tshuam txog kev txo qis hauv qab los noj mov thiab lub cev hnyav (saib LUS QHUAB QHIA ). Txhawm rau kom muaj peev xwm kho tau zoo tshaj plaws ntawm CERENIA, lub hauv paus ua rau ntuav yuav tsum tau txheeb xyuas thiab hais hauv cov dev uas tau txais CERENIA.

Cov Teeb Meem Tsis Zoo

Tiv thaiv kom txhob ntuav (yam tsawg 2 mg/kg)

Cov xwm txheej tsis zoo hauv qab no tau tshaj tawm thaum kawm Asmeskas kev tshawb fawb txog kev tiv thaiv kev ntuav hnyav hauv cov dev kho nrog CERENIA Tablets yam tsawg kawg ntawm 2 mg/kg qhov ncauj thiab/lossis Tshuaj Txhaj Tshuaj ntawm 1 mg/kg subcutaneously ib hnub ib hnub rau rau 5 hnub sib law liag:

Zaus ntawm Cov Teeb Meem Tsis Zoo los ntawm Kev Kho Mob

Teeb meem tsis haum

Cov placebo (n = 69)

CERENIA (n = 206)

# dev

tshwm sim %

# dev

tshwm sim %

Kev tuag thaum kawm

4

5.8

10

4.9

Euthanized thaum kawm

0

0

2

1

Raws plab

6

8.7

8

3.9

Hematochezia/cov quav ntshav

5

7.2

4

1.9

Anorexy

2

2.9

3

1.5

Otitis/mob ntsws

0

0

3

1.5

Endotoxic Shock

1

1.4

2

1

Hematuria

0

0

2

1

Kev nthuav tawm

0

0

2

1

Lwm cov tsos mob tau tshaj tawm tab sis yog<0.5% of dogs.

Kev tiv thaiv ntawm ntuav vim Mob Mob (yam tsawg kawg ntawm 8 mg/kg)

Cov xwm txheej tsis zoo hauv qab no tau tshaj tawm thaum Asmeskas tshawb fawb txog kev tiv thaiv ntuav vim mob plab hauv cov dev kho nrog CERENIA Tablets yam tsawg kawg ntawm 8 mg/kg hais lus ib zaug. Cov dev tej zaum yuav tau ntsib ntau dua ib qho ntawm qhov tshwm sim tsis zoo.

Zaus ntawm Cov Teeb Meem Tsis Zoo los ntawm Kev Kho Mob

Teeb meem tsis haum

Cov placebo (n = 195)

CERENIA (n = 208)

# dev

tshwm sim %

# dev

tshwm sim %

Hypersalivation

19

9.7

26

12.5

Ntuav1

0

0

kaum ib

5.3

Cov leeg nqaij

1

0.5

2

1

Sedation/Kev nyuaj siab

3

1.5

2

1

Retching

3

1.5

1

0.5

Flatulence

0

0

1

0.5

1Tsis cuam tshuam nrog kev mob plab

Cov xwm txheej tsis zoo hauv qab no tau tshaj tawm thaum kawm European thaj tsam rau kev tiv thaiv ntuav vim mob plab hauv cov dev kho nrog CERENIA Tablets yam tsawg kawg ntawm 8 mg/kg hais lus ib hnub ib hnub rau 2 hnub sib law. Cov dev tej zaum yuav tau ntsib ntau dua ib qho ntawm qhov tshwm sim tsis zoo.

Zaus ntawm Cov Teeb Meem Tsis Zoo los ntawm Kev Kho Mob

Teeb meem tsis haum

Cov placebo (n = 106)

CERENIA (n = 107)

# dev

tshwm sim %

# dev

tshwm sim %

Ntuav

4

4

10

9

Kev tsaug zog/Ua tsis taus pa/Tsis meej pem

1

1

8

8

Hypersalivation

2

2

5

5

Kev txhawj xeeb

0

0

2

2

Tshee/tshee

0

0

2

2

Tsis txaus siab

0

0

2

2

Cov hnoos qeev hauv cov quav

0

0

1

1

Cov Kev Tsis Txaus Siab hauv qab no tau tshaj tawm thaum lub sijhawm coj los ntawm Asmeskas kev sim tshuaj kho mob qhov chaw uas CERENIA Ntsiav Tshuaj tau siv ib zaug ib hnub rau 28 hnub sib law liag rau 32 tus dev: ua tsis taus pa, ntuav, tsis txaus siab, txhaws qhov muag, thiab cov qog ntshav loj.

Kev Pom Zoo Tom Qab Kev Pom Zoo (Hloov kho lub Tsib Hlis 2019)

Cov xwm txheej tsis zoo hauv qab no yog raws li kev pom zoo tom qab pom zoo qhia txog kev siv yeeb tshuaj. Tsis yog txhua qhov xwm txheej tsis zoo raug tshaj tawm rau FDA CVM. Nws tsis yog ib txwm ua tau los ntseeg tau kwv yees qhov xwm txheej tsis zoo lossis tsim kom muaj kev sib raug zoo nrog cov khoom lag luam raug siv cov ntaub ntawv no.

Cov xwm txheej tsis zoo hauv qab no tau tshaj tawm rau cov dev tau teev tseg hauv qhov kev txiav txim tsawg zaus:

anorexia, kev nyuaj siab/qaug zog, ua rau lub cev tsis muaj zog, ntuav, raws plab, tshee, ataxia, ua xua, poob phaus, qaug dab peg, ua tsis taus pa, thiab hnoos.

Cov xwm txheej ntawm kev tsis muaj txiaj ntsig tau tshaj tawm.

Cov xwm txheej ntawm kev tuag (suav nrog euthanasia) tau tshaj tawm.

Txhawm rau tshaj tawm cov xwm txheej tsis txaus ntseeg, rau kev pabcuam lossis kom tau txais daim ntawv theej ntawm SDS, hu rau Zoetis Inc. ntawm 1-888-963-8471 lossis www.zoetis.com.

Yog xav paub ntxiv txog kev siv tshuaj tsis zoo qhia txog tshuaj rau tsiaj, hu rau FDA ntawm 1-888-FDA-VETS lossis online ntawm http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Clinical Pharmacology

Pharmacokinetics

Txhais (± SD) Plasma Pharmacokinetic Parameters rau Maropitant hauv Beagle Dogs tom qab txhaj ib zaug thiab rov hais dua qhov ncauj ntawm Maropitant:

PK Parameter

2 mg/kg Dose Ib Leeg

2 mg/kg rov ua dua 1

8 mg/kg Ib zaug xwb

8 mg/kg Doses rov ua dua 1

T max max ua2 (teev)

2.0 (1.5 - 3.0)

1.5 (1.0 - 3.0)

1.5 (1.0 - 3.0)

2.5 (1.5 - 7.0)

C max max ua (ng/ml)

154 (111) Cov

304 (165) Cov

588 (416) Cov

1409 (516) Cov

AUC (0-24) (ng*teev/ml)

1440 (982)

3890 (3030) Cov

6730 (5030) Cov

26600 (9200)

T 1/22 (teev)

NCO

7.69 (6.21 - 17.8)

NCO

25.4 (6.06 - 30.0)

Kev Sib Piv (R thiab ) 3

NA

2.46 (1.68, 3.61)

NA

4.81 (3.28, 7.05)

1Ua raws ib zaug ib hnub ib koob tshuaj tiv thaiv kab mob rau 14 hnub.

2Nruab Nrab (Ntau Yam)

3Piv = Ntau Dos AUC(0-24)/Ib koob tshuaj AUC(0-24), Qhov tsawg tshaj plaws square txhais tau tias (95% Kev Ntseeg Siab)

NA = Tsis siv tau

NC = Tsis suav

Ua raws li kev tswj hwm qhov ncauj, lub sijhawm nruab nrab kom mus txog Cmax tsis pub dhau 2.5 teev. Kev noj qab haus huv tsis txaus ntseeg ntawm maropitant tau qis (24%) tom qab kev tswj hwm qhov ncauj ntawm 2 mg/kg maropitant. Tom qab txhaj tshuaj ntawm qhov ncauj, qhov xwm txheej ua ntej tsis cuam tshuam loj npaum li cas ntawm qhov ncauj bioavailability. Qhov siab tshaj qhov koob tshuaj sib piv tuaj yeem cia siab nrog kev nce koob tshuaj (1-16 mg/kg PO). Txawm li cas los xij raws li koob tshuaj nce (20-50 mg/kg PO), qhov koob tshuaj sib npaug tau rov tsim dua. Raws li hauv vitro enzyme kinetics, kev koom tes ntawm lub peev xwm muaj zog enzyme (CYP3A12) tuaj yeem pab txhawb qhov no rov qab rau koob tshuaj. Vim tias qhov tshuaj nyob ntawm cov tshuaj pharmacokinetics, cov tshuaj tiv thaiv kab mob tau nce mus txog qhov xwm txheej kwv yees tom qab 4 thiab 8 hnub tom qab 2 thiab 8 mg/kg, feem. Qhov ntsuas pom cov tshuaj sib piv yog 2.46 thiab 4.81, tom qab kev tswj hwm qhov ncauj ntawm 2 thiab 8 mg/kg, feem. Qhov tshwm sim ntawm 10 lub lis piam qub menyuam dev rau kev ua tub sab tau qis dua qhov pom hauv cov neeg laus dev, tshwj xeeb yog tom qab rov ua dua 1 lossis 2 mg/kg. Kev tshem tawm txoj cai ntawm tub sab tom qab IV kev tswj hwm yog 970, 995, thiab 533 mL/hr/kg ntawm koob tshuaj 1, 2 thiab 8 mg/kg, feem.

Kev rov qab tso zis ntawm maropitant thiab nws cov metabolite loj tau tsawg (<1% each). The hepatic metabolism of maropitant involves two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. In hauv vitro enzyme kinetics cov ntaub ntawv qhia tias cov tsis-linear kinetics tej zaum yuav yog ib feem cuam tshuam nrog saturation ntawm lub peev xwm qis enzyme (CYP2D15). Plasma protein khi ntawm maropitant tau siab (99.5%).

Pharmacodynamics

Kev ntuav yog txheej txheem nyuaj ua ke ua ke hauv nruab nrab los ntawm qhov chaw nruab nrab uas muaj ntau lub paj hlwb (thaj tsam postrema, nucleus tractus solitarius, dorsal motor nucleus ntawm vagus) uas tau txais thiab koom ua ke cov kev xav ntawm lub hauv paus thiab ib puag ncig qhov chaw thiab tshuaj lom los ntawm kev ncig thiab cerebro-spinal kua. Maropitant yog neurokininn 1 (NK1) receptor antagonist uas ua los ntawm inhibiting kev khi ntawm cov khoom P, neuropeptide ntawm tachykinin tsev neeg. Cov tshuaj P tau pom nyob rau hauv cov ntsiab lus tseem ceeb hauv cov nuclei suav nrog qhov chaw emetic thiab suav tias yog qhov tseem ceeb neurotransmitter koom nrog hauv emesis.1Los ntawm kev txwv qhov kev khi ntawm cov tshuaj P hauv qhov chaw emetic, maropitant muab cov txiaj ntsig dav dav tiv thaiv neural (central) thiab humoral (peripheral) ua rau ntuav.

Hauv vivo cov qauv kev tshawb fawb hauv dev tau qhia tias maropitant muaj antiemetic zoo tiv thaiv ob qho tib si hauv nruab nrab thiab ib puag ncig emetogens suav nrog apomorphine, thiab phoov ntawm ipecac.

1Diemunsch P, Grelot L. Muaj peev xwm ntawm cov tshuaj P antagonists li antiemetics. [Txheeb xyuas] [60 refs]. Tshuaj. 2000; 60: 533-46.

Ua tau zoo

Tiv thaiv kom txhob ntuav ntuav

Hauv kev sim tshuaj ntsuam xyuas, CERENIA Cov ntsiav tshuaj doses yam tsawg kawg ntawm 2 mg/kg BW txo tus naj npawb ntawm cov xwm txheej tshwm sim cuam tshuam nrog kev tsim neural (nruab nrab) thiab kev tso dag (peripheral) stimuli. Tom qab kev tswj hwm ntawm apomorphine (lub hauv nruab nrab emetic stimuli), ntuav tau pom hauv 33% (4 ntawm 12) ntawm Beagle dev kho nrog CERENIA Tablets thiab 100% (12 ntawm 12) ntawm Beagle dev kho nrog cov tshuaj placebo. Tom qab kev tswj hwm cov kua paug ntawm ipecac (peripheral emetic stimuli) ntuav tau pom hauv 33% (4 ntawm 12) ntawm Beagle dev kho nrog CERENIA Tablets thiab hauv 83% (10 ntawm 12) ntawm Beagle dev kho nrog cov tshuaj placebo.

Hauv kev tshawb fawb ntawm 275 tus neeg mob canine nthuav tawm rau tsev kho mob tsiaj nrog keeb kwm ntawm ntuav ntuav, dev tau pib tswj hwm CERENIA Txhaj Tshuaj los yog cov placebo rau Hnub 0. Tom qab thawj zaug txhaj tshuaj, cov dev faib rau CERENIA pab pawg tau kho nrog CERENIA Tablets ntawm yam tsawg 2 mg/kg qhov ncauj lossis Txhaj Tshuaj ntawm 1 mg/kg subcutaneously ib hnub ib zaug raws li kev txiav txim siab ntawm kws kho mob. Cov dev tau faib rau cov pab pawg placebo raug kho los ntawm kev siv cov tshuaj placebo los yog cov tshuaj placebo ib hnub ib zaug raws li kev txiav txim siab ntawm kws kho mob. Ntawm 199 tus dev suav nrog hauv kev tshuaj xyuas kom ua tau zoo, 27 ntawm 54 tus dev (50%) hauv pawg placebo pom ntuav qee lub sijhawm thaum kawm thiab 31 ntawm 145 tus dev (21.4%) hauv pab pawg kho mob tau ntuav thaum lub sijhawm kawm .

Feem pua ​​ntawm ntuav rau Txhua Hnub Kawm, Raws Li Kev Kho Mob thiab Txoj Kev Tswj.

Hnub

Kev kho mob

Txoj kev

# dev

# ntuav

% ntuav

Hnub 0

Cov placebo (54)

SC

54

kaum tsib

28%

CERENIA (145)

SC

145 (143 *) cov

14

10%

Hnub 1

Cov placebo (45)

PO

22

3

kuv lub mis mob heev

14%

SC

2.3

16

70%

CERENIA (108) Cov

PO

67

2

3%

SC

41

16

39%

Hnub 2

Cov placebo (16)

PO

7

2

29%

SC

9

6

67%

CERENIA (37) Cov

PO

24

0

0%

SC

13

8

62%

Hnub 3

Cov placebo (6)

PO

2

0

0%

SC

4

1

25%

CERENIA (21) Cov

PO

14

0

0%

SC

7

5

71%

Hnub 4

Cov placebo (2)

PO

1

0

0%

SC

1

1

100%

CERENIA (7)

PO

5

0

0%

SC

2

1

tsib caug%

Hnub 5

CERENIA (1)

SC

1

0

0%

*2 tus dev tswj hwm CERENIA tsis pom nyob rau Hnub 0. Lawv ntuav xwm txheej tsis paub. 143 tau siv hauv qhov sib piv rau % ntuav.

Hauv Asmeskas kev tshawb fawb thaj chaw hauv cov neeg mob kho tsiaj, CERENIA Tablets thiab Kev Txhaj Tshuaj tau ua zoo rau cov dev uas nthuav tawm nrog ntau yam mob xws li parvovirus, mob plab hnyuv, thiab mob raum. Tsis muaj qhov sib txawv tseem ceeb hauv kev ntsuas ntsuas nruab nrab ntawm CERENIA kho thiab cov neeg mob kho cov tshuaj placebo.

CERENIA Cov ntsiav tshuaj tau siv nyab xeeb hauv cov dev tau txais lwm yam khoom siv kho tsiaj uas nquag siv xws li cov kua dej thiab cov tshuaj hloov hluav taws xob, cov tshuaj tua kab mob, tshuaj tiv thaiv kab mob, tshuaj tua kab mob, thiab cov tshuaj tua kab mob.

Kev tiv thaiv ntawm ntuav vim Mob Mob

Hauv txoj kev tshawb fawb ntawm cov neeg mob cov tsiaj ua dog dig noj ib teev hauv tsheb thiab kho nrog CERENIA Tablets ntawm qhov tsawg kawg ntawm 8 mg/kg BW lossis cov tshuaj placebo 2 teev ua ntej kev mus, 67 ntawm 122 (55%) ntawm cov dev ntuav thaum taug kev thaum kho nrog cov placebo thaum 8 ntawm 122 (7%) ntuav thaum taug kev tom qab kho nrog CERENIA Tablets. Qhov tshwm sim uas tus dev hauv txoj kev tshawb fawb no, nquag ua rau mob hnyav yuav tsis ntuav thaum taug kev yog tias kho nrog CERENIA Tablets yog 93%, thaum qhov tshwm sim yog 48% yog kho nrog cov placebo.

TSHAJ TSHUAJ TIV THAIV: Laboratory thiab kev tshawb fawb thaj chaw tau pom tias CERENIA Cov ntsiav tshuaj tau ua zoo rau cov dev tom qab kev tswj hwm qhov ncauj.

Lub Hom Phiaj Kev Nyab Xeeb Kev Nyab Xeeb rau Kev Mob Ncauj

Tsib caug rau Beagle dev (28 tus txiv neej thiab 28 tus poj niam) kwv yees li 16 lub lis piam muaj hnub nyoog tau muab CERENIA Ntsiav tshuaj hais lus ib zaug ib hnub rau 15 hnub ntawm 0, 2, 6, thiab 10 mg/kg. Muaj 8 tus dev (4 tus txiv neej thiab 4 tus poj niam) hauv pawg 2 mg/kg thiab 16 tus dev (8 tus txiv neej thiab 8 tus poj niam) hauv txhua pab pawg. CERENIA Cov ntsiav tshuaj ua rau txo qis kev noj zaub mov thiab lub cev hnyav uas tsis tau txhaj tshuaj thiab tsis mob ntxiv tom qab txiav kev kho mob.

Beagle dev kwv yees li 8 lub lis piam muaj hnub nyoog tau muab CERENIA ntsiav tshuaj hais lus ib hnub ib zaug rau 15 hnub ntawm 0, 2, 6, thiab 10 mg/kg siv cov txheej txheem zoo ib yam li kev tshawb fawb dhau los. Ib koob tshuaj nce ntxiv hauv qhov hnyav ntawm pob txha pob txha hypoplasia tau pom keeb kwm. Kev txhais lus ntawm cov txiaj ntsig kev kawm no nyuaj los ntawm kev noj qab haus huv ntawm kev kawm tsiaj. Cov dev siv hauv txoj kev tshawb fawb tau txiav tawm thaum ntxov, tsawg kawg rau qhov chaw sim, ntau tus dev hauv txoj kev tshawb fawb tau kuaj pom tus kab mob coccidia zoo thiab qee qhov tau kuaj pom tus kab mob canine parvovirus.

Beagle dev kwv yees kwv yees li 10 lub hlis ntawm hnub nyoog tau muab cov tshuaj placebo rau 2 hnub, CERENIA Tablets ntawm 8 mg/kg rau 2 hnub, cov placebo (saline) subcutaneously (SC) rau 5 hnub, CERENIA Txhaj Tshuaj ntawm 1 mg/kg SC rau 5 hnub, lossis CERENIA Tablets ntawm 2 mg/kg rau 5 hnub (8 tus dev hauv txhua pawg tshuaj). Qhov mob me me cuam tshuam nrog kev txhaj tshuaj tau sau tseg hauv cov dev ntau dua thiab nyob ntev dua hauv cov dev uas tau txais kev txhaj tshuaj tiv thaiv kab mob piv rau ntsev. Cov txiv neej tau tswj CERENIA ntawm 8 mg/kg qhov ncauj rau 2 hnub tau txo qis hauv kev noj zaub mov. Lub cev hnyav thiab kev noj zaub mov tau hloov pauv thoob plaws 4 lub lim tiam lub sijhawm ua haujlwm. Ob tug dev uas tau txais 8 mg/kg maropitant hais lus rau 2 hnub tau qis dua qhov siv rau kev suav reticulocyte. Kev txo qis hauv cov lej reticulocyte kuj tau pom hauv 4 (ntawm 8) cov tshuaj placebo kho dev (SC ntsev rau 5 hnub). Hypocellular femoral pob txha pob txha piav raws li tsawg tau pom hauv 1 tus txiv neej uas tau txais 1 mg/kg maropitant SC rau 5 hnub; suav reticulocyte tsis muaj rau tus dev no.

Nees nkaum plaub Beagle aub (12 tus txiv neej thiab 12 tus poj niam) 7 lub hlis ntawm hnub nyoog tau txais kev tswj hwm tus kab mob ntawm koob ntawm 0, 1, 5, thiab 20 mg/kg hais lus ib hnub ib hnub rau 93 hnub sib law. Maropitant tsim cov cim kev kuaj mob ib ntus (salivation, emesis), lub cev poob phaus, thiab qis dua cov ntshav cov ntshav albumin ntawm 20 mg/kg/hnub. Maropitant nce PR ncua sijhawm, P nthwv dej ntev, thiab QRS qhov dav hauv 20 mg /kg /hnub koob tshuaj. Ib tus poj niam hauv 20 mg/kg/hnub pab pawg tau nce cellularity ntawm cov pob txha pob txha. Tus poj niam no tau sau tseg kom qis qis qis qis qis (tsis suav cov qe ntshav liab, hemoglobin, hematocrit) thiab suav cov platelet ntau dua thiab reticulocytes.

Lub Hom Phiaj Kev Nyab Xeeb Kev Nyab Xeeb rau Mob Mob

Plaub caug Beagle dev (20 tus txiv neej thiab 20 tus poj niam) thaum muaj hnub nyoog 16 - 18 lub lis piam tau muab CERENIA Ntsiav tshuaj hais lus ib zaug ib hnub rau 6 hnub ntawm 0, 8 thiab 24 mg/kg. Muaj 16 tus dev (8 tus txiv neej thiab 8 tus poj niam) hauv pawg 0 thiab 24 mg/kg thiab 8 tus dev (4 tus txiv neej thiab 4 tus poj niam) hauv pab pawg 8 mg/kg. Ntawm 24 mg/kg, CERENIA Cov ntsiav tshuaj ua rau txo qis kev noj zaub mov, nrog rau lub cev hnyav, daim siab thiab qhov hnyav ntawm qhov hnyav; thiab nce ntxiv hauv RBC suav qhia hemoconcentration, tab sis cuam tshuam rau kev noj zaub mov noj, lub cev hnyav, thiab RBCs tsis nyob hauv lub sijhawm rov kho tom qab lub sijhawm (dhau Hnub 5).

Beagle dev kwv yees li 8 lub lis piam muaj hnub nyoog tau muab CERENIA Tablets hais lus ib hnub ib zaug rau 6 hnub ntawm 0, 8, thiab 24 mg/kg siv cov txheej txheem zoo ib yam li kev tshawb fawb dhau los. Ib tus dev hauv 24 mg/kg/hnub pab pawg neeg tuag vim tsis paub ua rau hnub kawm 2 thiab ib koob tshuaj nyob ntawm qhov tshwm sim thiab qhov hnyav ntawm cov pob txha pob txha hypoplasia thiab lymphoid depletion tau pom keeb kwm. Kev txhais lus ntawm cov txiaj ntsig kev kawm no nyuaj los ntawm kev noj qab haus huv ntawm kev kawm tsiaj. Cov dev siv hauv txoj kev tshawb fawb tau txiav tawm thaum ntxov, tsawg kawg rau qhov chaw sim, thiab ntau tus dev hauv txoj kev tshawb fawb tau kuaj pom zoo rau coccidia. Ib qho ntxiv, qee tus dev hauv txoj kev tshawb fawb tau kuaj pom tus kab mob parvovirus zoo, txawm li cas los xij, kab mob hauv tsev kho mob parvoviral tsis tau kuaj pom tseeb.

Kev Ntseeg Siab

Nees nkaum plaub Beagle dev (14 tus txiv neej thiab 10 tus poj niam) nruab nrab ntawm 11 thiab 25 lub lim tiam ntawm hnub nyoog tau muab CERENIA ntsiav tshuaj hauv 2 theem nrog 8 tus dev ib pab pawg. Hauv thawj theem cov dev tau muab 0, 20 lossis 30 mg/kg hais lus ib hnub ib zaug rau 7 hnub thiab hauv theem ob 0, 40, lossis 50 mg/kg ib hnub ib zaug rau 7 hnub. CERENIA Tablets tswj hwm ntawm 20 thiab 30 mg/kg ua rau ntuav qee zaum. CERENIA Cov ntsiav tshuaj tau tswj hwm ntawm 40 mg/kg thiab 50 mg/kg ua rau muaj teeb meem tshwm sim hauv tsev kho mob ntawm kev poob phaus, ntuav, quav quav, tsis muaj zog, qaug zog, ua kom lub cev tsis muaj dej thiab tsis muaj ntshav qab zib. Ib qho ntxiv, leukopenia tus yam ntxwv los ntawm neutropenia thiab kev hloov pauv kom txo cov ntshav phosphorus qhov txiaj ntsig tau pom. Kev txo qis lub plawv dhia thiab kho qhov QT ncua ntev tau pom nyob hauv txhua pab pawg kho mob raws li kev noj tshuaj.

Nees nkaum-plaub Beagle dev (12 tus txiv neej thiab 12 tus poj niam) kwv yees li 28 lub lis piam muaj hnub nyoog tau tswj hwm maropitant (mesylate ntsev) hais ib zaug ib hnub rau 90 hnub ntawm 0, 1, 5, thiab 20 mg/kg. Qhov kawg ntawm kev kawm lub cev hnyav hauv 20 mg/kg pab pawg tau qis 8-15% qis dua qhov hnyav ntawm lub cev.

Cov ntaub ntawv khaws cia: CERENIA Cov ntsiav tshuaj yuav tsum tau khaws cia ntawm chav sov tswj 20 ° -25 ° C (68 ° -77 ° F) nrog kev mus ncig ntawm 15 ° -30 ° C (59 ° -86 ° F).

Yuav Muab Li Cas

CERENIA cov txiv kab ntxwv-xim xim tau qhab nia nrog kab tawg, thiab muaj 16, 24, 60 lossis 160 mg ntawm maropitant li maropitant citrate ib ntsiav tshuaj. Txhua lub ntsiav tshuaj tau cim nrog MPT thiab lub zog ntawm lub ntsiav tshuaj. Txhua lub ntsiav tshuaj loj tau ntim rau hauv lub raj mis uas muaj 60 ntsiav tshuaj thiab ntim rau hauv cov hlwv ntim uas muaj 4 ntsiav tshuaj rau ib daim ntawv perforated.

Pom zoo los ntawm FDA raws li NADA # 141-262

Faib los ntawm: Zoetis Inc., Kalamazoo, MI 49007

Hloov kho: Tsib Hlis 2019

8834091

8836751

CPN: 3690240.7

ZOETIS INC Dr.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Xov tooj: 269-359-4414
Kev Pabcuam Cov Neeg Siv Khoom: 888-963-8471
Lub Vev Xaib: www.zoetis.com
Txhua qhov kev mob siab tau ua kom ntseeg tau qhov tseeb ntawm Cerenia Tablets cov ntaub ntawv tshaj tawm saum toj no. Txawm li cas los xij, nws tseem yog lub luag haujlwm ntawm cov neeg nyeem kom paub lawv tus kheej nrog cov ntaub ntawv khoom lag luam muaj nyob hauv Asmeskas cov khoom lag luam daim ntawv lo lossis pob ntim.

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