Ceftiosan,

Main information

  • Trade name:
  • Alfacef RTU 50 mg/ml, suspension for injection for cattle and pigs
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Alfacef RTU 50 mg/ml, suspension for injection for cattle and pigs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Ceftiofur
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0148/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • NL/V/0148/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:.

Activesubstance:

Ceftiofur(ashydrochloride)50.0mg

Excipients:

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsweighingupto125kg.

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

-TreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Thisproductisnottobeusedinpigswithabodyweightmorethan125kg.

Incattle:

-TreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica,Pasteurella

multocidaandHaemophilussomnus.

-Treatmentofacuteinterdigitalnecrobacillosis(panaritium,foulinthefoot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

-Treatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum,sensitivetoceftiofur.Theindicationisrestrictedtocaseswheretreatmentwithanother

antimicrobialhasfailed

4.3 Contraindications

Donotinjectintravenously.

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandotherb-lactam

antibioticsortoanyoftheexcipients.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

4.4 Specialwarningsforeachtargetspecies

Donotuseincaseofknownresistancetotheactivesubstance.

Crossresistancetootherlactamantibioticscanbepresent.Donotuseincasessuchcross-resistanceis

known.

4.5 Specialprecautionsforuse

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Specialprecautionsforuseinanimals

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Ceftiosanselectsforresistantstrainssuchasbacteriacarryingextendedspectrumbetalactamases

(ESBL)andmayconstitutearisktohumanhealthifthesestrainsdisseminatetohumanse.g.viafood.

Forthisreason,Ceftiosanshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly(referstoveryacutecaseswhentreatmentmustbeinitiated

withoutbacteriologicaldiagnosis)tofirstlinetreatment.Official,nationalandregionalantimicrobialpolicies

shouldbetakenintoaccountwhentheproductisused.Increaseduse,includinguseoftheproduct

deviatingfromtheinstructionsgivenintheSPC,mayincreasetheprevalenceofsuchresistance.

Wheneverpossible,Ceftiosanshouldonlybeusedbasedonsusceptibilitytesting.

Ceftiosanisintendedfortreatmentofindividualanimals.Donotusefordiseasepreventionorasapartof

heardhealthprogrammes.Treatmentofgroupsofanimalsshouldbestrictlyrestrictedtoongoingdisease

outbreaksaccordingtotheapprovedconditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,inhalation,ingestion

orskincontact.Hypersensitivitytopenicillinsmayleadtocrossreactionstocephalosporinsandvice

versa.Allergicreactionstothesesubstancesmayoccasionallybeserious.

Donothandlethisproductifyouknowyouaresensitised,orifyouhavebeenadvisednottoworkwith

suchpreparations.Handlethisproductwithgreatcaretoavoidexposure,takingallrecommended

precautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,aremore

serioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,anaphylaxia)

mayoccasionallyoccur.Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobservedin

someanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaanddiscolorationofthe

subcutaneoustissueand/orfascialsurfaceofthemusclemaybeobserved.Clinicalresolutionisreachedin

mostanimalsby10daysafterinjectionalthoughslighttissuediscolorationmaypersistfor28daysormore.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffects.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinthetargetspeciesduring

pregnancyandlactation.

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Thebactericidalpropertiesofcephalosporinsareantagonizedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

4.9 Amountstobeadministeredandadministrationroute

Pigs:

Bacterialrespiratorydisease:3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kg

bwateachinjection.

Themaximuminjectionvolumemustnotexceed4mlperinjectionsite.Eachinjectionmustbegivenat

separatesites,withnooverlapofsubsequentinjections.Thisproductisnottobeusedinpigswitha

bodyweightmorethan125kg.

Cattle:

Bacterialrespiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1

ml/50kgbwateachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50kgbw

ateachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysby

subcutaneousinjection,i.e.1ml/50kgbwateachinjection.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Eachinjectionmustbegivenatseparatesites,withnooverlapofsubsequentinjections.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.Beforeuseshakethebottlefor15secondsor

untiltheproductappearsadequatelyresuspended.

Asthevialcannotbebroachedmorethan40times,theusershouldchoosethemoreappropriatevialsize.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof8

timestherecommendeddailydoseofceftiofuradministeredintramuscularlyfor15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteraloverdosages.

4.11Withdrawalperiod(s)

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCvetcode:QJ01DD90

5.1 Pharmacodynamicproperties

Ceftiofurisalategenerationcephalosporin,whichisactiveagainstmanyGram-positiveandGram-

negativebacteria.Ceftiofurinhibitsthebacterialcellwallsynthesis,therebyexertingbactericidal

properties.

Beta-lactamsactbyinterferingwithsynthesisofthebacterialcellwall.Cellwallsynthesisisdependenton

enzymesthatarecalledpenicillin-bindingproteins(PBP's).Bacteriadevelopresistancetocephalosporins

byfourbasicmechanisms:1)alteringoracquiringpenicillinbindingproteinsinsensitivetoanotherwise

effective 

-lactam;2)alteringthepermeabilityofthecellto 

-lactams;3)producingb-lactamasesthat

cleavethe 

-lactamringofthemolecule,or4)activeefflux.

Some 

-lactamases,documentedinGram-negativeentericorganisms,mayconferelevatedMICsto

varyingdegreestothirdandfourthgenerationcephalosporins,aswellaspenicillins,ampicillins, 

-lactam

inhibitorcombinations,andfirstandsecondgenerationcephalosporins.

Ceftiofurisactiveagainstthefollowingmicroorganismswhichareinvolvedinrespiratorydiseasesinpigs:

Pasteurellamultocida,ActinobacilluspleuropneumoniaeandStreptococcussuis.Bordetella

bronchisepticaisintrinsicallynon-susceptibletoceftiofur.

Itisalsoactiveagainstbacteriainvolvedinrespiratorydiseaseincattle:Pasteurellamultocida,

Mannheimiahaemolytica,Haemophilussomnus.;bacteriainvolvedinacutebovinefoulinthefoot

(interdigitalnecrobacillosis)incattle:Fusobacteriumnecrophorum,Bacteroidesmelaninogenicus

(Porphyromonasasaccharolytica);andbacteriaassociatedwithacutepost-partum(puerperal)metritisin

cattle:Escherichiacoli,ArcanobacteriumpyogenesandFusobacteriumnecrophorum.

ThefollowingMinimumInhibitoryConcentrations(MIC)havebeendeterminedforceftiofurinEuropean

isolatesoftargetbacteria,isolatedfromdiseasedanimals:

Pigs

Organism(numberofisolates) MICrange(µg/mL) MIC

90 (µg/mL)

A.pleuropneumoniae(28)

0.03 *

0.03

Pasteurellamultocida(37)

0.03-0.13

0.03

Streptococcussuis(495)

0.03-0.25

0.03

Cattle

Organism(numberofisolates) MICrange(µg/mL) MIC

(µg/mL

Mannheimiahaemolytica(87)

0.03 *

0.03

P.multocida(42)

0.03-0.12

0.03

H.somnus(24)

0.03 *

0.03

Arcanobacteriumpyogenes(123)

0.03-0.5 0.25

Escherichiacoli(188) 0.13->32.0 0.5

Fusobacteriumnecrophorum

(67)(isolatesfromcasesoffoot

rot)

0.06-0.13 ND

Fusobacteriumnecrophorum

(2)(isolatesfromcasesofacute

metritis)

0.03-0.06 ND

*Norange;allisolatesyieldedthesamevalue.ND:notdetermined.Thefollowingbreakpointsare

recommendedbyNCCLSforbovineandporcinerespiratorypathogens:

ZoneDiameter(mm) MIC(μg/mL)

Interpretation

≥21 ≤2.0 (S)Susceptible

18-20 4.0 (I)Intermediate

≤17 ≥8.0

(R)Resistant

Nobreakpointshavebeendeterminedtodateforthepathogensassociatedwithfoulinthefootoracute

post-partummetritisincows.

5.2 Pharmacokineticparticulars

Afteradministration,ceftiofurisquicklymetabolisedtodesfuroylceftiofur,theprincipalactivemetabolite.

Desfuroylceftiofurhasanequivalentanti-microbialactivitytoceftiofuragainstthebacteriainvolvedin

respiratorydiseaseinanimals.Theactivemetaboliteisreversiblyboundtoplasmaproteins.Dueto

transportationwiththeseproteins,themetaboliteconcentratesatasiteofinfection,isactiveandremains

activeinthepresenceofnecrotictissueanddebris.

Inpigsgivenasingleintramusculardoseof3mg/kgbodyweight(bw),maximumplasmaconcentrationsof

7.34µg/mLwerereachedafter1.33hours;theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurwas

10,9hours.Noaccumulationofdesfuroylceftiofurhasbeenobservedafteradoseof3mgceftiofur/kg

bw/dayadministereddailyover3days.

Theeliminationoccursmainlyviatheurineandpartlyinthefaeces.Ceftiofuriscompletelybioavailable

followingintramuscularadministration.

Afterasingle1mg/kgdosegivensubcutaneouslytocattle,maximumplasmalevelsof2.87µg/mLare

reachedat4hoursafteradministration.Theterminaleliminationhalf-life(t½)ofdesfuroylceftiofurin

cattleis10.0hours.Noaccumulationwasobservedafteradailytreatmentover5days.Eliminationoccurs

mainlyviatheurineandpartlyinthefaeces.

Ceftiofuriscompletelybioavailablefollowingsubcutaneousadministration.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydrogenatedsoyalecithin

Sorbitanoleate

Cottonseedoil

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:100and250ml:3years;50ml:18months.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

6.4.Specialprecautionsforstorage

Donotrefrigerateorfreeze.Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

Cartonboxcontainingoneglassvial,typeII50ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining15glassvials,typeII50ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII100ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining12glassvials,typeII100ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII250ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining6glassvials,typeII250ml,sealedwithbromobutylrubberstopperandaluminium

overseal.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements

7. MARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

23-02-2011

10 DATEOFREVISIONOFTHETEXT

31august2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobesuppliedonlyonveterinaryprescription.

ANNEXII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Polystyrenebox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. PACKAGESIZE

15x50ml

12x100ml

6x250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Cartonbox

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

Whitetooffwhitecolouredsuspension.

4. PACKAGESIZE

50ml

100ml

250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

VialstypeII

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachmlcontains:Ceftiofur(ashydrochloride)50.0mg

3. PHARMACEUTICALFORM

Suspensionforinjection.

4. PACKAGESIZE

50ml

100ml

250ml

5. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

6. INDICATION(S)

Pigs,Cattle:

Readthepackageleafletbeforeuse.

7. METHODANDROUTE(S)OFADMINISTRATION

Pigs:intramuscularinjection

Cattle:subcutaneousinjection

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

9. SPECIALWARNING(S),IFNECESSARY

Penicillinsandcephalosporinsmayoccasionallycausesevereallergicreactions.Seepackageleafletfor

userwarnings.

10. EXPIRYDATE

EXP:MM/YY

Oncebroached,useby….

Shelflifeafterfirstopeningtheimmediatepackaging:28days

11. SPECIALSTORAGECONDITIONS

Donotrefrigerateorfreeze.Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

13. THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14. THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER’SBATCHNUMBER

B.PACKAGELEAFLET

PACKAGELEAFLET

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

ceftiofur(asceftiofurhydrochloride)

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE(EUbatchrelease)

AlfasanNederlandBV

Kuipersweg9

3449JAWoerden

TheNetherlands

Tel.:++31348416945

Fax:++31348483676

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ceftiosan,50mg/ml,suspensionforinjectionforpigsandcattle

Ceftiofur(asceftiofurhydrochloride)

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Eachmlwhitetooffwhitecolouredsuspensioncontains:

Ceftiofur(ashydrochloride)50.0mg

4. INDICATION(S)

Infectionsassociatedwithbacteriasensitivetoceftiofur:

Inpigs:

-TreatmentofbacterialrespiratorydiseaseassociatedwithPasteurellamultocida,Actinobacillus

pleuropneumoniaeandStreptococcussuis.

Thisproductisnottobeusedinpigswithabodyweightmorethan125kg.

Incattle:

-TreatmentofbacterialrespiratorydiseaseassociatedwithMannheimiahaemolytica,Pasteurella

multocidaandHaemophilussomnus.

-Treatmentofacuteinterdigitalnecrobacillosis(panaritium,foulinthefoot),associatedwith

FusobacteriumnecrophorumandBacteroidesmelaninogenicus(Porphyromonasasaccharolytica).

-Treatmentofthebacterialcomponentofacutepost-partum(puerperal)metritiswithin10daysafter

calvingassociatedwithEscherichiacoli,ArcanobacteriumpyogenesandFusobacterium

necrophorum,sensitivetoceftiofur.Theindicationisrestrictedtocaseswheretreatmentwithanother

antimicrobialhasfailed

5. CONTRAINDICATIONS

Donotinjectintravenously.

Donotadministertoananimalpreviouslyfoundtobehypersensitivetoceftiofurandotherb-lactam

antibioticsortoanyoftheexcipients.

Donotuseinpoultry(includingeggs)duetoriskofspreadofantimicrobialresistancetohumans.

6. ADVERSEREACTIONS

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyour

veterinarysurgeon.

Hypersensitivityreactionsunrelatedtodosecanoccur.Allergicreactions(e.g.skinreactions,anaphylaxia)

mayoccasionallyoccur.Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Inpigs,mildreactionsattheinjectionsite,suchasdiscolorationofthefasciaorfat,havebeenobservedin

someanimalsforupto20daysafterinjection.

Incattle,mildinflammatoryreactionsattheinjectionsite,suchastissueoedemaanddiscolorationofthe

subcutaneoustissueand/orfascialsurfaceofthemusclemaybeobserved.Clinicalresolutionisreachedin

mostanimalsby10daysafterinjectionalthoughslighttissuediscolorationmaypersistfor28daysormore.

7. TARGETSPECIES

Pigsweighingupto125kg.

Cattle.

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Pigs:

Bacterialrespiratorydisease:3mgceftiofur/kgbw/dayfor3daysviaintramuscularroute,i.e.1ml/16kg

bwateachinjection.

Themaximuminjectionvolumemustnotexceed4mlperinjectionsite.Eachinjectionmustbegivenat

separatesites,withnooverlapofsubsequentinjections.Thisproductisnottobeusedinpigswitha

bodyweightmorethan125kg.

Cattle:

Bacterialrespiratorydisease:1mgceftiofur/kgbw/dayfor3to5daysbysubcutaneousinjection,i.e.1

ml/50kgbwateachinjection.

Acuteinterdigitalnecrobacillosis:1mg/kgbw/dayfor3daysbysubcutaneousinjection,i.e.1ml/50kgbw

ateachinjection.

Acutepost-partummetritiswithin10daysaftercalving:1mg/kgbw/dayfor5consecutivedaysby

subcutaneousinjection,i.e.1ml/50kgbwateachinjection.

Incaseofacutepost-partummetritis,additionalsupportivetherapymightberequiredinsomecases.

Eachinjectionmustbegivenatseparatesites,withnooverlapofsubsequentinjections.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Asthevialcannotbebroachedmorethan40times,theusershouldchoosethemoreappropriatevialsize.

9. ADVICEONCORRECTADMINISTRATION

Shakebeforeusetobringproductbackintosuspension.

10. WITHDRAWALPERIOD

Pigs:

Meatandoffal:8days.

Cattle:

Meatandoffal:8days.

Milk:zerohours.

11. SPECIALSTORAGEPRECAUTIONS

Donotrefrigerateorfreeze.Protectfromfrost.

Shelf-lifeafterfirstbroachingofthecontainer:28days.

Donotuseaftertheexpirydatestatedonthelabel/cartonafterEXP:

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Specialwarningsforeachtargetspecies

Donotuseincaseofknownresistancetotheactivesubstance.

Crossresistancetootherlactamantibioticscanbepresent.Donotuseincasessuchcross-resistanceis

known.

Specialprecautionsforuse

Shakethebottlewellbeforeusetobringtheproductbackintosuspension.

Specialprecautionsforuseinanimals

Incaseoftheoccurrenceofallergicreactionthetreatmentshouldbewithdrawn.

Ceftiosanisintendedfortreatmentofindividualanimals.Donotusefordiseasepreventionorasapartof

heardhealthprogrammes.Treatmentofgroupsofanimalsshouldbestrictlyrestrictedtoongoingdisease

outbreaksaccordingtotheapprovedconditionsofuse.

Donotuseasprophylaxisincaseofretainedplacenta.

UseofCeftiosanmayconstitutearisktopublichealthduetospreadofantimicrobial

resistance.

Ceftiosanshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly(referstoveryacutecaseswhentreatmentmustbe

initiatedwithoutbacteriologicaldiagnosis)tofirstlinetreatment.Official,nationaland

regionalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Increaseduse,includinguseoftheproductdeviatingfromtheinstructionsgiven,may

increasetheprevalenceofresistance.Wheneverpossible,Ceftiosanshouldonlybeused

basedonsusceptibilitytesting.

Userwarnings

Penicillinsandcephalosporinsmaycausehypersensitivity(allergy)followinginjection,

inhalation,ingestionorskincontact.Hypersensitivitytopenicillinsmayleadtocross

reactionstocephalosporinsandviceversa.Allergicreactionstothesesubstancesmay

occasionallybeserious.Donothandlethisproductifyouknowyouaresensitised,orif

youhavebeenadvisednottoworkwithsuchpreparations.Handlethisproductwith

greatcaretoavoidexposure,takingallrecommendedprecautions.

Ifyoudevelopsymptomsfollowingexposuresuchasaskinrash,youshouldseekmedicaladviceand

showthedoctorthiswarning.Swellingoftheface,lipsoreyesordifficultywithbreathing,aremore

serioussymptomsandrequireurgentmedicalattention.

Washhandsafteruse.

Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxicormaternotoxiceffects.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinthetargetspeciesduring

pregnancyandlactation.

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

Interactionwithothermedicinalproductsandotherformsofinteraction.

Thebactericidalpropertiesofcephalosporinsareantagonizedbysimultaneoususeofbacteriostatic

antibiotics(macrolides,sulfonamidesandtetracyclines).

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Thelowtoxicityofceftiofurhasbeendemonstratedinpigsusingceftiofursodiumatdosesinexcessof8

timestherecommendeddailydoseofceftiofuradministeredintramuscularly.for15consecutivedays.

Incattle,nosignsofsystemictoxicityhavebeenobservedfollowingsubstantialparenteraloverdosages.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithnationlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

31August2012

15. OTHERINFORMATION

Cartonboxcontainingoneglassvial,typeII50ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining15glassvials,typeII50ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII100ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining12glassvials,typeII100ml,sealedwithabromobutylrubberstopperand

aluminiumoverseal.

Cartonboxcontainingoneglassvial,typeII250ml,sealedwithabromobutylrubberstopperandaluminium

overseal.

Polystyreneboxcontaining6glassvials,typeII250ml,sealedwithbromobutylrubberstopperandaluminium

overseal.

Notallpacksizesmaybemarketed.

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

29-11-2018

ANSES Newsletter in English - N°50 - November 2018

ANSES Newsletter in English - N°50 - November 2018

France - Agence Nationale du Médicament Vétérinaire

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

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

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

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

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

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

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety