Vitamine K1 laboratoire TVM 50 mg tablets for dogs

Main information

  • Trade name:
  • Vitamine K1 laboratoire TVM 50 mg tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vitamine K1 laboratoire TVM 50 mg tablets for dogs
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • phytomenadione
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0208/002
  • Authorization date:
  • 20-09-2012
  • EU code:
  • FR/V/0208/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

LaboratoireTVM

57ruedesBardines

63370LEMPDES

FRANCE

VITAMINK

1 LABORATOIRETVM

50 mg

Tabletfordogs

MutualRecognitionProcedure

Volume2/5

PartI

ADMINISTRATIVEDATA

ANDSUMMARYOFTHEDOSSIER

Part 1b: SPC, labelandpackageinsert

D90early

RevisedVersion

September2012

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

TABLEOFCONTENTS

PART 1b: SPC, labeland packageinsert

1.b.1

S UMMARYOFPRODUCTCHARACTERISTICS (SPC) ............................ 5

1.b.2

P ROPOSALFORPACKAGING , LABELLINGANDPACKAGEINSERT .......13

1.b.3

SPC SAPPROVEDINMEMBERSTATES ................................................21

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

4

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

Part1.b.1

S UMMARYOFPRODUCTCHARACTERISTICS

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

P ROPOSALFOR SPC

1)Nameoftheveterinarymedicinalproduct

<fantasyname/strength/pharmaceuticalform>

<VitamineK1comprimésTVM>(FR)

<VitaminK1

LaboratoireTVM , 50mg , film-coated tabletsfordogs> (UK)

<VitaminK1

LaboratoireTVM , 50mg , filmomhuldetablettabletten voorhonden> (NL)

<VitaminK1

LaboratoireTVM , 50mg , filmtabletteTabletten fürHunde> (DE, AT)

<VitaminaK1

LaboratoireTVM , 50mg , comprimidorecubiertoconpelículacomprimidos para

perros> (ES)

<VitaminaK1

LaboratoireTVM , 50mg , compressafilm-rivestitapercanicompressepercani >

(IT)

[NB:Uppercaseletteringhavebeen removed.]

2)QualitativeandQuantitativeComposition

Forafilm-coatedtabletof1025mgwith3scoredlines

Eachdivisibletabletcontains :

Activesubstance:

Phytomenadione..............................50.0mg

Excipients..........................................to1tablet

Forfulllistofexcipients, seesection6.1 “listofexcipients” .

3)Pharmaceuticalform

Film-coatedtablet.

Oblongtablet, slightyellowwith3scoredlines.

Thetabletcanbedividedintoequalhalvesandquarters.

4)Clinicalparticulars

4.1-Targetspecies

Dogs.

4.2-Indicationsforuse, specifyingthetargetspecies

Indogs:

Treatmentofanticoagulantpoisoning, followingparenteraltreatment.

4.3-Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.Noneknown.

Formatiert:Französisch(Frankreich),

NichtHochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Englisch

(Großbritannien),NichtHochgestellt/

Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

Astheanticoagulanteffectsofrodenticidesareknowntobelonglastingitis

recommendedto bringadminister vitaminK1withanoralformulation duringfor 3

weeks,andtoevaluatethecoagulationstatus(viaonestageprothrombintimes)48hours

afterthelastadministration.Ifitisprolonged,thetreatmentismaintaineduntilthe Quick

clotting timeis returned normal48hoursaftercessationoftreatmenttoavoidrelapse.

Thedurationoftreatmentcanbeextendedaslongastheanticoagulantpersistsinthe

body.

4.5-Specialprecautionsforuse

i.Specialprecautionsforusein animals

Theformationofprothrombinmaybeinadequatewhendealingwithpatientswith

severeliverdysfunction.Therefore requiresa carefulmonitoringofcoagulation

parametersafteradministrationofvitaminK1 isrequired .

ii.Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Keepoutofreachandsightofchildren.

Peoplewithknownhypersensitivitytophytomenadioneshouldavoidcontactwiththe

veterinarymedicinalproduct.

Washhandsafteruse.

iii.Otherprecautions

None.

4.6-Adversereactions(frequencyandseriousness)

Noneknown.

4.7-Useduringpregnancy, lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinbitch es during

pregnancyandlactation.

Studiesconductedinlaboratoryanimalshaveshownnoteratogenicorfoetotoxiceffects.

VitaminK1

crossestheplacentalbarrier.

Useonlyaccording ly tothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8-Interactionwithothermedicinalproductsandotherformsofinteraction

Salicylates(NSAID)andcephalosporinspresentingtheN-methyl-thiotetrazolemoiety

mayreducetheeffectofvitaminK1,byinhibitionofthevitaminK1recycling.None

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

4.9-Amountstobeadministeredandadministrationroute

Fororaluse.

5mgphytomenadioneperkgbodyweightperday, correspondingto1tabletper10kg

bodyweightperday,onceaday, duringfor 21days, inaccordancewiththefollowing

table:

Bodyweight(kg) Numberoftablets

<2.5 ¼ tablet

from2.5to 5 ½ tablet

from5 to 7.5 ¾ tablet

from7.5to 10* 1 tablet

*Dog>10kg:¼tabletper2.5kg

Preferablyuseinnon-fastedanimals.

TheOral treatment byoralroutewillshould beundertakenwithin12hoursaftertheend

oftheemergencytreatmentbytheintravenousroute(2intravenousinjectionsof5mg

vitaminK1perkgbodyweightgiven12hoursapart).

Seesection4.4.

Returnanydividedtablettotheblisterpackandusewithin3days.Theblisterpack

shouldbeinsertedbackintothecardboardcarton.

4.10-Overdose(symptoms, emergencyprocedures, antidotes), ifnecessary

No signsof intolerance sign weredisplayedat3timesthetherapeuticdose, administered

duringfor 3weeks.

4.11-Withdrawalperiod

Notapplicable.

5)PharmacologicalProperties:

ATC-vetcode:QB02BA01

Pharmacotherapeuticclassification:antih a emorrhagic

5.1-Pharmacodynamicproperties

VitaminK1isacofactornecessaryforthesynthesisofK-dependentcoagulationfactors

(factorsII,VII,IXandX).Duringthissynthesis,vitaminK1isconvertedintovitamin

K1hydroquinone(activeformofvitaminK1)andthenintovitaminK1epoxide.Itis

thenrecycledbackintovitaminK1. AntivitaminKrodenticidesinhibittherecyclingof

vitaminK1epoxide,causingariskofuncontrolledbleedingthroughtheabsenceof

functionalfactorsII,VII,IXandXsynthesis.ThesupplyofvitaminK1mustbe

sufficientlylargetoactivatethealternativehydrogenaseenzymepathwaythatconvertsit

toitsactive(hydroquinone)form.

5.2-Pharmacokineticsparticulars

Afteroraladministration, vitaminK1israpidlyabsorbedinthedog.

SomeofthevitaminK1iseliminatedwiththebileintheintestinaltractaftermetabolism

intheliver,andsomeiseliminatedinurine(intheformofglucuronoconjugated

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

Formatiert:Schriftart:12Pt.,

Schriftartfarbe:Automatisch,Nicht

Hochgestellt/Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

6)Pharmaceuticalparticulars

6.1-Listofexcipients

Tabletcore:

Silica,colloidalanhydrous

Calciumhydrogenphosphatedihydrate

Glyceroldibehenate

Magnesiumstearate

Lactosemonohydrate

Croscarmellosesodium

Coating:

Hypromellose

Polydextrose

Talc

Maltodextrine

MediumChainTriglycerides

6.2-Incompatibilities

Noneknown.

6.3-Shelf-life

Shelf-lifeoftheveterinarymedicinalproduct as pack ageded forsale:3years.

Shelf-life afterfirstopeningofonealveolusofdividedtablets :3days.

6.4-Specialprecautionsforstorage

Storeinthe outer originalpackaging, awayprotect fromlight.

Afteropeningtheblisterpocket, replacetheremainingportion(s)oftabletintheblister

pocketandreturntheblisterstriptothecardboardcarton.

Afteropeningofonealveolus:replacetheremaining¼,½and¾ofthetabletinthe

alveolus.

6.5-Natureandcompositionofimmediatepackaging

BoxcontainingwhitePVC/Aluminiumthermosealedblisterof7tabletseach.

Boxof1thermosealedblistersof7tablets

Boxof2thermosealedblistersof7tablets

Boxof3thermosealedblistersof7tablets

Boxof4thermosealedblistersof7tablets

Boxof5thermosealedblistersof7tablets

Boxof12thermosealedblistersof7tablets

Notallpacksizesmaybemarketed.PVC/Aluminiumthermosealedblister.

6.6-Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts, ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.Dispose

ofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocal

Formatiert:Schriftart:Fett

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

7)Marketingauthorizationholder

LaboratoireTVM

57ruedesBardines

63370LEMPDES

FRANCE

8)Marketingauthorizationnumber(s)

FRANCE:

FR/V/92492996/1996

Boxof1thermosealedblistersof7tablets

Boxof2thermosealedblistersof7tablets

Boxof3thermosealedblistersof7tablets

Boxof4thermosealedblistersof7tablets

Boxof5thermosealedblistersof7tablets

Boxof12thermosealedblistersof7tablets

Notallpacksizesmaybemarketed.NB:fortheothercountries,inafirsttime,onlythe

followingpackagesizeswillberegistered:

Boxof2 thermosealedblistersof7 tablets

Boxof12thermosealedblistersof7 tablets

9)DateoffirstMarketingAuthorization/renewaloftheauthorisation

20.03.1996–20.03.2011

10)Dateofrevisionofthetext

20/09/201214/05/2012

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

PartI.B.2

P ROPOSALFORPACKAGING , LABELLINGAND

P ACKAGEINSERT

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

OUTER PACKAGING: CASE

Nameoftheveterinarymedicinalproduct

VitaminK1LaboratoireTVM

50mg , film-coated tablet s fordogs

Statementofactivesubstanceandothersubstances:

Eachdivisibletabletcontains:Forafilm-coatedtabletof1025mgwith3scoredlines:

Activesubstance:

Phytomenadione.................50.0mg

Activesubstance:

Phytomenadione....................................50.0mg

Excipients................................................to1tablet

Pharmaceuticalform

Film-coatedtT ablet.

Packagesize

Boxof1thermosealedblistersof7tablets

or

Boxof2thermosealedblistersof7tablets

or

Boxof3thermosealedblistersof7tablets

or

Boxof4thermosealedblistersof7tablets

or

Boxof5thermosealedblistersof7tablets

or

Boxof12thermosealedblistersof7tablets

Boxof2thermosealedblistersof7tablets

Boxof12thermosealedblistersof7tablets

Targetspecies

Dogs

Indications

Formatiert:NichtHochgestellt/

Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

Methodandrouteofadministration

Fororaluse.

5mgphytomenadioneperkgbodyweightperday,correspondingto1tabletper10kgbodyweight

perday,onceaday, duringfor 21days, inaccordancewiththefollowingtable:

Bodyweight(kg) Numberoftablets

<2.5 ¼ tablet

from2.5to 5 ½ tablet

from5 to 7.5 ¾ tablet

from7.5to 10* 1 tablet

*Dog>10kg:¼tabletper2.5kg

Preferablyuseinnon-fastedanimals.

Forfurtherinformationreadthepackageleafletenclosed.

Specialwarningsandotherinformation

Readthepackageleafletbeforeuse.

Specialstorageconditionsandshelf-life

Storeinthe outeroriginal packaging, awayprotect fromlight.

Afteropeningtheblisterpocket,replacetheremainingportion(s)oftabletintheblisterpocketand

returntheblisterstriptothecardboardcarton.

Afterfirstopeningofonealveolus:replacetheremaining¼,½and¾ofthetabletinthealveolus.

Shelf-lifeofdividedtablets:3days.

Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

Disposeofanyunusedproductandemptycontainersinaccordancewithguidancefromyourlocal

wasteregulationauthority.

Classificationofthemedicinalproductintermsofdispensing

Foranimaltreatmentonly.

Keepoutofthereachandsightofchildren.

Marketingauthorizationholder

LaboratoireTVM

57ruedesBardines

63370Lempdes

France

Marketingauthorizationnumber(s):

XXX

Manufacturer’sBatchNumber/ExpiryDate

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

IMMEDIATE PACKAGING: ALUMINIUM FLAT PLATE

VitaminK1LaboratoireTVM

50mg , film-coated tablet s fordogs

Foranimaltreatmentonly

Oraluse

Batchnumber(“LOT XXXXX”)

Expirydate(“EXP:MM/YYYY”)

Formatiert:NichtHochgestellt/

Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

PACKAGE LEAFLET

Vitamin e K1LaboratoireTVM

50mg , film-coated tablet s fordogs

1)Marketingauthorizationholder/Manufacturerforthebatchrelease

LABORATOIRETVM

57ruedesBardines

63370Lempdes

France

2)Nameoftheveterinarymedicinalproduct

VitaminK1LaboratoireTVM

50mg , film-coated tablet s fordogs

3)Statementofactivesubstanceandotheringredients:

Eachdivisibletabletcontains:

Forafilm-coatedtabletof1025mgwith3scoredlines:

Activesubstance:

Phytomenadione..............................50.0mg

Excipients..........................................to1tablet

4)Indications

Indogs:treatmentofanticoagulantpoisoning, followingparenteraltreatment.

5)Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.Noneknown.

6)Adversereactions

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.Noneknown.

7)Targetspecies

Formatiert:Französisch(Frankreich),

NichtHochgestellt/Tiefgestellt

Formatiert:NichtHochgestellt/

Tiefgestellt

Formatiert:Schriftart:NichtKursiv,

Punktiertunterstreichen

Formatiert:Schriftart:NichtKursiv

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

8)Dosage, routeandmethodofadministration

Fororaluse.

5mgphytomenadioneperkgbodyweightperday,correspondingto1tabletper10kg

bodyweightperday,onceaday, duringfor 21days, inaccordancewiththefollowingtable:

Bodyweight(kg) Numberoftablets

<2.5 ¼ tablet

from2.5to 5 ½ tablet

from5 to 7.5 ¾ tablet

from7.5to 10* 1 tablet

*Dog>10kg:¼tabletper2.5kg

Preferablyuseinnon-fastedanimals.

TheOral treatment byoralroutewillshould beundertakenwithin12hoursaftertheendofthe

emergencytreatmentbytheintravenousroute(2intravenousinjectionsof5mgvitaminK1per

kgbodyweightgiven12hoursapart).

Seesection“Specialwarningsforeachtargetspecies”.

Returnanydividedtablettotheblisterpackandusewithin3days. Theblisterpackshouldbe

insertedbackintothecardboardcarton.

9)Adviceoncorrectadministration

Specialprecautionsforusein animals

Theformationofprothrombinmaybeinadequatewhendealingwithpatientswithsevereliver

dysfunction.Therefore requiresa carefulmonitoringofcoagulationparametersafter

administrationofvitaminK1 isrequired .

Useduringpregnancy, lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinbitch es during

pregnancyandlactation.

Studiesconductedinlaboratoryanimalshaveshownnoteratogenicorfoetotoxiceffects.

VitaminK1crossestheplacentalbarrier.

Useonlyaccording ly tothebenefit/riskassessmentbytheresponsibleveterinarian.

Interactionwith othermedicinalproductsand otherformsofinteraction

Salicylates(NSAID)andcephalosporinspresentingtheN-methyl-thiotetrazolemoietymay

reducetheeffectofvitaminK1, byinhibitionofthevitaminK1recycling.

Noneknown.

Overdose(symptoms,emergencyprocedures,antidotes), ifnecessary

No signsof intolerance sign weredisplayedat3timesthetherapeuticdose,administered during

for 3weeks.

10)Withdrawalperiod

Formatiert:NichtHochgestellt/

Tiefgestellt

Formatiert:NichtHochgestellt/

Tiefgestellt

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

11)Specialstorageconditions

Storeinthe outeroriginal packaging, awayprotect fromlight.

Afteropeningtheblisterpocket, replacetheremainingportion(s)oftabletintheblisterpocket

andreturntheblisterstriptothecardboardcarton.

Afterfirstopeningofonealveolus:replacetheremaining¼,½and¾ofthetabletinthe

alveolus.

12)Shelf-life

Shelf-lifeofdividedtablets:3days.Afteropeningofonealveolus:3days.

13)Specialwarnings

Specialprecautionsforeach targetspecies:

Astheanticoagulanteffectsofrodenticidesareknowntobelonglastingitisrecommendedto

bringadminister vitaminK1withanoralformulation duringfor 3weeks,andtoevaluatethe

coagulationstatus(viaonestageprothrombintimes)48hoursafterthelastadministration. Ifit

isprolonged,thetreatmentismaintaineduntilthe Quickclotting timeis returned normal48

hoursaftercessationoftreatmenttoavoidrelapse.Thedurationoftreatmentcanbeextendedas

longastheanticoagulantpersistsinthebody.

Specialprecautionsto betaken bythepersonadministeringthemedicinalproductto animals:

Keepoutofthereachandsightofchildren.

Peoplewithknownhypersensitivitytophytomenadioneshouldavoidcontactwiththeveterinary

medicinalproduct.

Washhandsafteruse.

14)Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.Disposeofany

unusedproductandemptycontainersinaccordancewithguidancefromyourlocalwaste

regulationauthority.

15)Dateonwhichthepackageleafletwaslastapproved

XX14 / 05XX /2012.

16)Otherinformation

Package s size:

Boxof1thermosealedblistersof7tablets

Boxof2thermosealedblistersof7tablets

Boxof3thermosealedblistersof7tablets

Boxof4thermosealedblistersof7tablets

Boxof5thermosealedblistersof7tablets

Boxof12thermosealedblistersof7tablets

[Onlythemarketed packagessizeswillbementioned on thefinalnationalartworks].

Marketingauthorizationnumber:

XXX

Classificationofthemedicinalproductin termsofdispensing

Foranimaltreatmentonly.

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

PartI.B.3

SPC

SAPPROVEDINMEMBERSTATES

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

TheoriginalFrenchversionofSPC(May2012)ispresentedinthefollowingpages.

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

LaboratoireTVM

VITAMINK1LABORATOIRETVM,50mg,tabletfordogs

Mutualrecognitionprocedure/D90early/September2012 Part1b–SPC,labeland

packageinsert

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration