SPC Lutalyze

8/18/2019 SPC Lutalyze

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Revised: February 2014 AN: 01388/2013

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Lutalyse 5 mg/ml Solutio !or "#e$tio

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

%a$& ml $otais 5 mg dio'rost (as t&e tromet&amie salt) *it& 1+,5- be.ylal$o&ol as 'reservative+

For t&e !ull list o! all ot&er e$i'iets see se$tio ,+1+

3. PHARMACEUTICAL FORM

Solutio !or "#e$tio+

4. CLINICAL PARTICULARS

4.1 Target se!"es

attle &orses ad 'igs+

4.2 I#$"!at"%#s &%r 'se( se!"&)"#g t*e target se!"es

Lutalyse is idi$ated !or its luteolyti$ ad/or oyto$i$ e!!e$ts i $attle &orses ad'igs+ &e idi$atios !or use are:

Catt+e

1+ o more e!!e$tively $otrol t&e time o! oestrus i $y$lig $o*s+2+ o treat $o*s *&i$& &ave a !u$tioal $or'us luteum but do ote'ress be&avioural oestrus (suboestrus or silet &eat)+

3+ o idu$e abortio+4+ o idu$e 'arturitio+5+ For treatmet o! $&roi$ metritis ad 'yometra+

,+ For $otrolled breedig i ormally$y$lig dairy $o*s: oestrus sy$&roisatio ovulatio sy$&roisatio i $ombiatio *it& R or Raalogues as 'art o! !ied time arti!i$ial isemiatio 'roto$ols+

Mares

1+ o more e!!e$tively $otrol t&e time o! oestrus i $y$lig mares+2+ o treat mares *&i$& &ave a !u$tioal $or'us luteum but do ote'ress be&avioural oestrus+

3+ o idu$e abortio+

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P"gs

1+ "du$tio o! 'arturitio2+ o redu$e t&e *eaig to oestrus iterval (67") ad t&e *eaig to

!ertile servi$e iterval (6FS") i so*s i &erds *it& re'rodu$tive

'roblems+

4.3 C%#tra"#$"!at"%#s

otraidi$ated i aimals su!!erig !rom eit&er a$ute or suba$ute disorderso! t&e vas$ular system gastroitestial tra$t or res'iratory system+ otraidi$ated *&e abortio or 'arturitio is ot iteded+o ot admiister by t&e itraveous route+

4.4 Se!"a+ ,ar#"#gs &%r ea!* target se!"es

Catt+e- Lo$ali.ed 'ost i#e$tio ba$terial i!e$tios t&at may be$omegeerali.ed &ave bee re'orted+ Aggressive atibioti$ t&era'y 'arti$ularly$overig $lostridial s'e$ies s&ould be em'loyed at t&e !irst sig o! i!e$tio+are!ul ase'ti$ te$&i9ues s&ould be em'loyed to de$rease t&e 'ossibility o!'ost i#e$tio ba$terial i!e$tios+

4. Se!"a+ re!a't"%#s &%r 'se

(i) S'e$ial 're$autios !or use i aimals

1+ Lo$ali.ed 'ost i#e$tio ba$terial i!e$tios t&at may be$omegeerali.ed &ave bee re'orted+ Aggressive atibioti$ t&era'y'arti$ularly $overig $lostridial s'e$ies s&ould be em'loyed att&e !irst sig o! i!e$tio+ are!ul ase'ti$ te$&i9ues s&ould beem'loyed to de$rease t&e 'ossibility o! 'ost i#e$tio ba$teriali!e$tios+

2+ Aimals s&ould ot be treated i! t&ey su!!er !rom eit&er a$ute orsuba$ute disorders o! t&e vas$ular system gastroitestialtra$t or res'iratory system+

3+ rega$y status s&ould be determied 'rior to i#e$tio si$eLutalyse &as bee demostrated to result i abortio or

'arturitio idu$tio *&e admiistered at su!!i$ietly &ig& dosesto may aimal s'e$ies+4+ Lutalyse is ie!!e$tive *&e admiistered 'rior to day !ive a!ter

ovulatio+5+ "! 'regat t&e uli;ely 'ossibility o! uterie ru'ture s&ould be

bore i mid es'e$ially i! $ervi$al dilatio does ot o$$ur+,+ "du$tio o! 'arturitio i 'igs earlier t&a


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(ii) S'e$ial 're$autios to be ta;e by t&e 'erso admiisterig t&eveteriary medi$ial 'rodu$t to aimals

1+ rostagladis o! t&e F2α ty'e $a be absorbed t&roug& t&e s;i

ad may $ause bro$&os'asm or mis$arriage+

2+ are s&ould be ta;e *&e &adlig t&e 'rodu$t to A=7"S%LF"N>%"7N or S?"N 7NA+

3+ 6ome o! $&ildbearig age ast&mati$s ad 'ersos *it&bro$&ial or ot&er res'iratory 'roblems s&ould avoid $ota$t*it& or *ear dis'osable 'lasti$ gloves *&e admiisterig t&e'rodu$t+

4+ A$$idetal s'illage o t&e s;i s&ould be *as&ed o!! immediately*it& soa' ad *ater+

5+ 6as& &ads a!ter use+

4./ A$0erse rea!t"%#s &re'e#!) a#$ ser"%'s#ess

Catt+e

&e most !re9uetly observed sidee!!e$t is i$reased re$tal tem'erature at a5 or 10 overdose+ o*ever re$tal tem'erature $&ages &ave beetrasiet i all $ases observed ad &ave ot bee detrimetal to t&e aimal+Limited salivatio &as bee see i some ista$es+

Lo$ali.ed 'ost i#e$tio ba$terial i!e$tios t&at may be$ome geerali.ed &avebee re'orted+ Aggressive atibioti$ t&era'y 'arti$ularly $overig $lostridial

s'e$ies s&ould be em'loyed at t&e !irst sig o! i!e$tio+ are!ul ase'ti$te$&i9ues s&ould be em'loyed to de$rease t&e 'ossibility o! 'ost i#e$tioba$terial i!e$tios+

H%rses

&e most !re9uetly observed sidee!!e$ts are s*eatig ad de$reasedre$tal tem'eratures+ o*ever t&ese &ave bee trasiet i all $asesobserved ad &ave ot bee detrimetal to t&e aimal+ 7t&er rea$tios see&ave bee i$rease i &eart rate i$rease i res'iratio rate some abdomialdis$om!ort lo$omotor i$oordiatio ad lyig do*+ &ese e!!e$ts are usually

see *it&i 15 miutes o! i#e$tio ad disa''ear *it&i oe &our+ @aresusually $otiue to eat durig t&e 'eriod o! e'ressio o! sidee!!e$ts+

P"gs

rasiet sidee!!e$ts $osistig o! i$reased body tem'erature i$reasedres'iratory rate i$reased salivatio stimulatio o! de!ae$atio ad uriatio!lus&ig o! t&e s;i ad restlessess (ar$&ig o! ba$; 'a*ig ad rubbigad ga*ig t&e $rate) o$$ur o$$asioally !ollo*ig t&e admiistratio o!dio'rost i 'regat so*s ad gilts+ &ese e!!e$ts ted to 'arallel t&e sigse&ibited by so*s 'rior to ormal 'arturitio oly t&ey a''ear to be

$odesed i time+ &ese e!!e$ts are usually see *it&i 15 miutes o!i#e$tio ad disa''ear *it&i oe &our+

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4. Use $'r"#g reg#a#!)( +a!tat"%# %r +a)

ermiatio o! 'rega$y is a idi$atio !or use+

4.5 I#tera!t"%# ,"t* %t*er 6e$"!"#a+ r%$'!ts a#$ %t*er &%r6s %& "#tera!t"%#

Noe ;o*+

4.7 A6%'#ts t% 8e a$6"#"stere$ a#$ a$6"#"strat"%# r%'te

A sigle i#e$tio o! t&e re$ommeded dose o! dio'rost a$tivity is luteolyti$'rovided a !u$tioal $or'us luteum is 'reset+

Admiister by itramus$ular i#e$tio+ Full ase'ti$ 're$autios must be ta;e+se a sterile syrige ad eedle ad ma;e t&e i#e$tio t&roug& a area o!

$lea dry s;i+ are s&ould be ta;e to avoid i#e$tio t&roug& *et or dirtyareas o! s;i+

Catt+e

&e dose !or all idi$ated uses i $attle is 5 ml Lutalyse (25 mg dio'rost)

Mares

&e dose !or all idi$ated uses i mares is 1 ml Lutalyse (5 mg dio'rost)

P"gs

"du$tio o! 'arturitio: 2 ml Lutalyse (10 mg dio'rost) *it&i


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2. Treat6e#t %& s'89%estr's #% 0"s"8+e %estr's "# !att+e a#$ *%rses.

"dividual !att+e may &ave ormal $y$li$al ovaria a$tivity *it&out dete$tablebe&avioural oestrusB t&is o$$urs most !re9uetly i t&e *iter mot&s at 'ea;

la$tatio i &ig& 'rodu$ig dairy $o*s ad i su$;ler bee! $o*s+ "! a $or'usluteum is 'reset ad ovulatio &as ot o$$urred i t&e 'revious !our daysadmiistratio o! Lutalyse *ill result i $or'us luteum regressio !ollo*ed byretur to oestrus ad ovulatio+

Creedig o! $attle treated *it& Lutalyse !or t&e above idi$atio may be byatural servi$e arti!i$ial isemiatio at t&e usual time i relatio to observedoestrus or by !ied time isemiatio (


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4. I#$'!t"%# %& art'r"t"%# "# !att+e a#$ "gs.

Catt+e: Lutalyse &as bee used to idu$e 'arturitio o or a!ter day 2


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Programme II

1+ "#e$t 5 ml Lutalyse itramus$ularlyB2+ Re'eat t&e i#e$tio i 11 (10 to 12) daysB t&e3+ "semiate


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• ay < H "#e$t 5 ml Lutalyse itramus$ularly

• Arti!i$ial isemiatio ad i#e$t R or aalogue ,0H


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&e &orse must &ave bee de$lared as otiteded !or &uma $osum'tio uder atioal&orse 'ass'ort legislatio+

. PHARMACOLO;ICAL PROPERTIES

&e t&era'euti$ use o! dio'rost (atural 'rostagladi F2α) i !ood 'rodu$ig

aimals is to idu$e regressio o! $or'ora lutea+ &is res'ose is observed imay aimals+ &e itra$ellular me$&aism by *&i$& dio'rost idu$esluteolysis remais u;o*+ =arious ot&er '&ysiologi$al res'oses todio'rost are ;o*+ &ese i$lude stimulatio o! smoot& mus$le i$ludigvas$ular bro$&ial uterie ad gastroitestial mus$le+

Follo*ig admiistratio dio'rost tromet&amie is ra'idly disso$iated to

dio'rost (F2α)+ &is $om'oud &as a etremely s&ort blood &al!li!e o!

oly a !e* miutes+ Near $om'lete $leara$e o$$urs o oe to t*o 'assagest&roug& t&e liver or lugs+ No a$$umulatio o! dio'rost or residues &ave beeobserved i blood !ollo*ig re'eated daily i#e$tios i $attle+ ig&est tissue$o$etratios o! dio'rost are observed at t&e i#e$tio site *&i$& de'lete toba$;groud $o$etratios by 2448 &r 'osti#e$tio+ Residue $o$etratiosi mil; o! $o*s 'ea; at 2 &r 'osti#e$tio ad de$rease ra'idly t&erea!ter+

ATC Vet C%$e: K02A01

/. PHARMACEUTICAL PARTICULARS

/.1 L"st %& e=!""e#ts

Ce.yl Al$o&olSodium ydroide or ydro$&lori$ A$id6ater !or "#e$tios

/.2 I#!%6at"8"+"t"es

Noe ;o*+

/.3 S*e+& +"&e

S&el!li!e o! t&e veteriary medi$ial 'rodu$t as 'a$;aged !or sale: 2 years+S&el!li!e a!ter !irst o'eig t&e immediate 'a$;agig: 28 days+

/.4 Se!"a+ re!a't"%#s &%r st%rage

o ot store above 25+ Follo*ig *it&dra*al o! t&e !irst dose t&e 'rodu$ts&ould be used *it&i 28 days+ is$ard uused material+ Avoid t&eitrodu$tio o! $otamiatio durig use+

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/. Nat're a#$ !%6%s"t"%# %& "66e$"ate a!>ag"#g

@ultidose glass vials *it& a !luoro$arbo $oated butyl rubber sto''er adalumiium overseal su''lied i a $arto $otaiig 5 10 ml vials or a 30 ml

vial+ Not all 'a$; si.es may be mar;eted+

/./ Se!"a+ re!a't"%#s &%r t*e $"s%sa+ %& '#'se$ 0eter"#ar) 6e$"!"#a+r%$'!t %r ,aste 6ater"a+s $er"0e$ &r%6 t*e 'se %& s'!* r%$'!ts( "&ar%r"ate

Ay uused veteriary medi$ial 'rodu$t or *aste materials derived !rom su$&veteriary medi$ial 'rodu$ts s&ould be dis'osed o! i a$$orda$e *it& lo$alre9uiremets+

. MAR?ETIN; AUTHORISATION HOLDER

Joetis ? Limited5t& Floor , St+ Adre* StreetLodo%4A 3A%

5. MAR?ETIN; AUTHORISATION NUM@ER

V6 42058/4082

7. LAST RENE:AL OF THE AUTHORISATION

Date-


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FERTAGYL®

Intervet/Merck Animal Health

(GONADORELIN)

FOR INJECTION FOR THE TREATMENT OF CYSTIC OVARIES IN CATTLE

ANADA 200-1!" A##r$ve% &' FDA

F(R ANIMAL )*E (NLY

DE*+RI,TI(N

Ferta'l i. a .terile .$lti$n c$ntainin ! /mL $na%$relin GnRH e3ivalent t$

40 /mL $na%$relin %iacetate tetrah'%rate5 .ita&le 6$r intram.clar $r intraven$.

a%mini.trati$n7 G$na%$relin i. a %eca#e#ti%e c$m#$.e% $6 the .e3ence $6 amin$ aci%. -

4-$8$,r$-Hi.-Tr#-*er-T'r-Gl'-Le-Ar-,r$-Gl'-NH2

9ith a m$leclar 9eiht $6 11:272 an% em#irical 6$rmla +44H;4 N1;(17

G$na%$relin i. the h'#$thalamic relea.in 6act$r re.#$n.i&le 6$r the relea.e $6 $na%$tr$#in.

e77" LH" F*H5 6r$m the anteri$r #ititar'7

*'nthetic $na%$relin i. #h'.i$l$icall' an% chemicall' i%entical t$ the en%$en$. &$vine

h'#$thalamic relea.in 6act$r7

,HARMA+(L(GY AND T(0 /k7 In ane.theti=e% %$. it %i% n$t #r$%ce %e#re..i$n $6

m'$car%ial $r .'.temic hem$%'namic. $r a%ver.el' a66ect c$r$nar' $8'en .##l' $r

m'$car%ial $8'en re3irement.7

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The intraven$. a%mini.trati$n $6 >0 /k/%a' $na%$relin %iacetate tetrah'%rate t$ #renant

rat. an% ra&&it. %rin $ran$ene.i. %i% n$t ca.e em&r'$t$8ic $r terat$enic e66ect.7

The intram.clar a%mini.trati$n $6 1000 $na%$relin %iacetate tetrah'%rate t$ n$rmall'

c'clin %air' cattle ha% n$ e66ect $n hemat$l$' $r &l$$% chemi.tr'7

Frther" $na%$relin %iacetate tetrah'%rate %i% n$t ca.e irritati$n at the .ite $6 intram.clar

a%mini.trati$n in %$.7 The %$.ae a%mini.tere% 9a. ;2 /k/%a' 6$r ; %a'.7

INDICATION AND DOSAGE

Ferta'l $na%$relin5 i. in%icate% 6$r the treatment $6 $varian 6$lliclar c'.t. in %air' cattle7

(varian c'.t. are n$n-$vlate% 6$llicle. 9ith inc$m#lete lteini=ati$n 9hich can re.lt in

n'm#h$mania $r irrelar e.tr.7

Hi.t$ricall'" c'.tic $varie. have re.#$n%e% t$ an e8$en$. .$rce $6 lteini=in h$rm$ne

LH5 .ch a. hman ch$ri$nic $na%$tr$#in7

Ferta'l initiate. relea.e $6 en%$en$. LH t$ ca.e $vlati$n an% lteini=ati$n7

The rec$mmen%e% intram.clar $r intraven$. %$.ae $6 Ferta'l i. :> /c$9 2 mL

e3ivalent t$ 100 $na%$relin %iacetate tetrah'%rate/c$957

Each mL $6 Ferta'l c$ntain.@

G$na%$relin !

en='l Alc$h$l B m

*$%im +hl$ri%e ;7!; m

Cater 6$r Inecti$n" ,hEr7 37.7

#H a%.te% 9ith .$%im #h$.#hate m$n$&a.ic an% %i&a.ic57

Keep refrigerate! "# $ %#C (&'# $ '#F)

+A)TI(N

Fe%eral la9 re.trict. thi. %r t$ .e &' $r $n the $r%er $6 a licen.e% veterinarian7

HO* S+,,LIED

Ferta'l i. availa&le in a c$ncentrati$n $6 ! /mL e3ivalent t$ 40 /mL $na%$relin

%iacetate tetrah'%rate5 .ita&le 6$r intram.clar $r intraven$. a%mini.trati$n7

Ferta'l i. .##lie% in mlti%$.e vial. c$ntainin 20 mL $6 .terile .$lti$n +$%e N$7

021B157

012! IN)2!0

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0;;B22E :704

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SPC Lutalyze