Linco-Sol 400 mg/g powder for oral solution

Main information

  • Trade name:
  • Linco-Sol 400 mg/g powder for oral solution
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Linco-Sol 400 mg/g powder for oral solution
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • lincomycin
  • Therapeutic area:
  • Chicken, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • HU/V/0111/001
  • Authorization date:
  • 24-11-2010
  • EU code:
  • HU/V/0111/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Sol400mg/gpowderforuseindrinkingwaterforpigsandchickens

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Lincomycin(ashydrochloride)400mg/g

Excipients:

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Powderforuseindrinkingwater.

Whiteoralmostwhitepowder.

4.CLINICALPARTICULARS

4.1Targetspecies

Swineandchicken(broiler)

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectioncausedbymycoplasmaandbacteriasusceptibletolincomycinforexample:

Pigs:swinedysenterycausedbyBrachyspirahyodysenteriaeandmycoplasmapneumoniaassociatedwith

Mycoplasmahyopneumoniae.

Chicken:necroticenteritiscausedbyClostridiumperfringens.

4.3Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstanceortotheexcipient.

Donotuseifresistancetolincosamideshasbeendetected.

Donotadministertohorses,ruminants,guineapigs,hamsters,chinchillaandrabbits.Ingestionbythese

speciesmayresultinseveregastrointestinaleffects.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Medicateddrinkingwateruptakecanbeaffectedbytheseverityofthedisease.Incaseofinsufficient

uptakeofwater,animalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialandlocal

antimicrobialpolicies.UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistanttolincomycinandmaydecreasetheeffectivenessoftreatmentwith

otherlincosamides,macrolidesorstreptograminsduetopotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Careshouldbetakennottoinhaleanydust.Thewearingofapproveddustmasks(eitheradisposablehalf-

maskrespiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143),glovesandsafetyglassesisrecommendedwhilstreconstituting

oradministeringthesolution.

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Incaseofaccidentalexposurerinseabundantlywithwater.Incaseofallergicreaction(inflammationof

theface,lipsoreyesorrespiratorydifficulties)duringreconstitutingoradministeringoftheproduct,seek

medicaladviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Donotsmoke,eatordrinkwhenhandlingtheproduct.

Washhandsandanyexposedskinwithsoapandwaterimmediatelyafteruse.

Otherprecautions

Whenspreadingthemanureofweanerpigstreatedwiththeveterinarymedicinalproductatadoseof10

mg/kgfor21days,aminimumdistancetosurfacewaterof10mshouldbeapplied.

4.6Adversereactions(frequencyandseriousness)

Lincomycinmayoccasionallycausetransientsoftstoolsand/ormildswellingoftheanuswithinthefirst

twodaysoftreatment.Veryrarelysomepigsmayshowreddeningofskinandmildirritablebehaviour.

Theseconditionsareusuallyself-correctingwithin5-8dayswithoutdiscontinuinglincomycintreatment.

4.7Useduringpregnancy,lactation,egglaying

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantorlactatingsows.Use

onlyinaccordancewithbenefit/riskassessmentbytheresponsibleveterinarian.Donotuseinbirdsinlay

orwithin4weeksbeforetheonsetofthelayingperiod.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusetogetherwithmacrolideantibiotics.

4.9Amountstobeadministeredandadministrationroute

Dosage:

Swine:

Swinedysentery:thedailydoseis10mglincomycinperkgofbodyweightfor10days“oratleast5days

afterclinicalsignsdisappear”.

Mycoplasmapneumonia:10mglincomycinperkgofbodyweightfor21days.

Chicken(boiler)

NecroticenteritiscausedbyClostridiumperfringens:thedailydoseis5mglincomycinperkgofbody

weightfor7days.

Administration:

Tobeadministeredorally,inthedrinkingwater.

Swine:

Theproductshouldbeadministeredcontinuouslyinthedrinkingwater.Inpigs,administrationof33mg

lincomycinperlitrecontainingtothecompletionofdrinkingwaterbydissolving100gofproductin1200

litresofwater.Whenusingawaterproportioner,prepareastocksolutionbydissolving100gofproduct

in12litresofwater.Settheproportionertodeliver10mlofstocksolutionperlitreofdrinkingwater.

Chicken(broiler):

Theconcentrationtobeuseddependsontheactualbodyweightandthewaterconsumptionoftheanimals

andcanbecalculatedasfollows:

.....mgproduct

perkgbodyweightandday

x Averagechicken

bodyweight(kg)

=....mgproductperlitreof

drinkingwater

Averagedailywaterintake(litre/animal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theintakeof

medicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrectdosagethe

concentrationofLincomycinhastobeadjustedaccordingly.

Themedicatedwatershouldbetheonlysourceofdrinkingwater,throughoutthetreatmentperiod.

Medicatedwatershouldberefreshedevery24hours.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Lincomycinhasagoodmarginofsafety,buthigherlevelsofdosagethanrecommendedmaycause

diarrhoeaandloosestoolsinpigs.

4.11Withdrawalperiod(s)

Meatandoffalofswine:0day

Meatandoffalofchicken(broiler):5days

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:lincosamideantibiotic,ATCvetcode:QJ01FF02

5.1Pharmacodynamicproperties

LincomycinisalincosamideantibioticproducedbyStreptomyceslincolensis.Lincomycinisbacteriostatic

inactioninhibitingtheproteinsynthesispredominantlybybindingtothe50Sribosomalsubunitsof

bacteria.

Dependingonthesensitivityofmicro-organisms,andontheconcentrationoftheactivesubstancethe

proteinsynthesisinhibitionantibacterialactioncaneitherbebacteriostaticorbactericide.

LincomycinisactiveagainstawiderangeofGram-positivemicro-organisms,includingalsoanaerobic

bacteriasuchasclostridiaandBrachyspiraspp.,aswellasMycoplasmaspp.

LincomycinhasnoactivityagainstGram-negativebacteria,suchasKlebsiellaspp.,Pasteurellaspp.and

Salmonellaspp.

Theresistancerateagainstlincomycinisslow,multiple-steptype.Plasmidmediatedinfectiousresistance

isalsodescribed.

Nocross-resistancehasbeendescribedwithpenicillin,ampicillin,cephalosporins,tetracyclines,or

novobiocin.

LincomycinMIC

(µg/ml)valuesarethefollowings:

Mycoplasmahyopneumoniae:MIC

(µg/ml)=0.25

Brachyspirahyodysenteriae:MIC

(µg/ml)=100

5.2Pharmacokineticparticulars

Systemicbioavailabilityoflincomycinisapproximately53%afteroraladministrationinpigs

Lincomycinisrapidlyabsorbedorallyandreachestherapeuticplasmaconcentration.

Afterasingle,oraladministrationofapproximately4.4mg/kgand11mg/kglincomycintopigs

resultedtherapeuticplasmaconcentrationfor12-16hours,reachingpeakplasmaconcentrationafter4

hours.Afterasingle,oraldoseof10mg/kglincomycintopigsthemaximumplasmaconcentration

)of1.45mg/kgwasreachedat3.6hours(T

).Theeliminationhalflife(T

1/2β )isabout3.36

hours.Theoraladministrationof22mg/kglincomycinfor3daystopigsdidnotresultindrug

accumulationafter24hoursofadministrationandtherewasnotherapeuticplasmaconcentration.

Afteroraladministrationtheabsorbedlincomyciniseliminatedthroughthebileandfaecesinactive

formorasmetabolites.

Lincomycinisalsoexcretedinthemilk.

Lincomycinreachestheinflammationsitebypolymorfneutrophilgranulocytesthatexplainsitsfast

absorptionanddistribution,efficientpenetrationandtargetedactivityindifficulttoreachtissues.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate.

6.2Incompatibilities

Inabsenceofcompatibilitystudiesthisproductmustnotbemixedwithotherveterinaryproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Storeintheoriginalcontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcompositionofimmediatepackaging

150gpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

1.5kgpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

5kgpolypropylenecontainerwithpolypropylenelidandinnerbagofLDPE.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalsLtd.

1161Budapest

Ottóu.14.

Hungary

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

A.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

150gpolypropylenecontainerwithinnerbagofLDPE.

1.5kgpolypropylenecontainerwithinnerbagofLDPE.

5kgpolypropylenecontainerwithinnerbagofLDPE.

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Sol400mg/gpowderforuseindrinkingwaterforpigsandchickens

Lincomycin(ashydrochloride)

2.STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Lincomycin(ashydrochloride)400mg/g

3.PHARMACEUTICALFORM

Powderforuseindrinkingwater

4.PACKAGESIZE

150g

1.5kg

5kg

5.TARGETSPECIES

Swineandchicken(broiler)

6.INDICATION(S)

Treatmentofinfectioncausedbymycoplasmaandbacteriasusceptibletolincomycinforexample:

Pigs:swinedysenterycausedbyBrachyspirahyodysenteriae,mycoplasmapneumoniaassociatedwith

Mycoplasmahyopneumoniae.

Chicken:necroticenteritiscausedbyClostridiumperfringens.

7.METHODANDROUTE(S)OFADMINISTRATION

Tobeadministeredorally,inoralsolution.

Averagedose:10mglincomycinperkgofbodyweightinpigsand5mglincomycinperkgofbody

weightinchicken.

Readthepackageleafletbeforeuse.

8.WITHDRAWALPERIOD

Withdrawalperiod:

Meatandoffalofswine:0day

Meatandoffalofchicken(broiler):5day

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

9.SPECIALWARNING(S),IFNECESSARY

Userwarnings:

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Wearprotectivegloves,safetyglassesanddustmaskwhenreconstitutingoradministeringthesolution.

Readpackageleafletforfulluserwarnings.

10.EXPIRYDATE

EXP{month/year}

Shelf-lifeafterfirstopeningofcontainer:3months.

Shelf-lifeafterreconstitutionindrinkingwater:24hours.

Oncebroached,useby:

11.SPECIALSTORAGECONDITIONS

Donotstoreabove25°C.

Storeintheoriginalcontainerinordertoprotectfrommoisture.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Disposeofwastematerialinaccordancewithlocalrequirements.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthesightandreachofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LavetPharmaceuticalLtd.

1161Budapest

Ottóu.14.

Hungary

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

Batch:{number}

B.PACKAGELEAFLETFOR:

Linco-Sol400mg/gpowderforuseindrinkingwaterforpigsandchickens

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE

Marketingauthorisationholder:

LavetPharmaceuticalsLtd.,1161Budapest,Ottóu.14,Hungary

Manufacturerforbatchrelease:

LavetPharmaceuticalsLtd.,2143Kistarcsa,Batthyányu.6,Hungary

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Linco-Sol400mg/gpowderforuseindrinkingwaterforpigsandchickens

Lincomycin(ashydrochloride)

3.STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Each1gramcontains:

Activesubstance:

Lincomycin(ashydrochloride)400mg

Whiteoralmostwhitepowder.

4.INDICATION(S)

Treatmentofinfectioncausedbymycoplasmaandbacteriasusceptibletolincomycinforexample:

Pigs:swinedysenterycausedbyBrachyspirahyodysenteriae,mycoplasmapneumoniaassociatedwith

Mycoplasmahyopneumoniae.

Chicken:necroticenteritiscausedbyClostridiumperfringens.

5.CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstanceortotheexcipient.

Donotuseifresistancetolincosamideshasbeendetected.

Donotadministertohorses,ruminants,guineapigs,hamsters,chinchillaandrabbits.Ingestionbythese

speciesmayresultinseveregastrointestinaleffects.

6.ADVERSEREACTIONS

Lincomycinmayoccasionallycausetransientsoftstoolsand/ormildswellingoftheanuswithinthefirst

twodaysoftreatment.Veryrarelysomepigsmayshowreddeningofskinandmildirritablebehaviour.

Theseconditionsareusuallyself-correctingwithin5-8dayswithoutdiscontinuinglincomycintreatment.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,pleaseinformyour

veterinarysurgeon.

7.TARGETSPECIES

Swineandchicken(broiler)

8.DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHODOFADMINISTRATION

Tobeadministeredorally,inthedrinkingwater.

Dosage:

Swine:

Swinedysentery:thedailydoseis10mglincomycinperkgofbodyweightfor10days“oratleast5days

afterclinicalsignsdisappear”.

Mycoplasmapneumonia:10mglincomycinperkgofbodyweightfor21days.

Chicken(broiler)

NecroticenteritiscausedbyClostridiumperfringens:thedailydoseis5mglincomycinperkgofbody

weightfor7days.

9.ADVICEONCORRECTADMINISTRATION

Swine:

Theproductshouldbeadministeredcontinuouslyinthedrinkingwater.Inpigs,administrationof33mg

lincomycinperlitrecontainingtothecompletionofdrinkingwaterbydissolving100gofproductin1200

litresofwater.Whenusingawaterproportioner,prepareastocksolutionbydissolving100gofproduct

in12litresofwater.Settheproportionertodeliver10mlofstocksolutionperlitreofdrinkingwater.

Chicken(broiler):

Theconcentrationtobeuseddependsontheactualbodyweightandthewaterconsumptionoftheanimals

andcanbecalculatedasfollows:

.....mgproduct

perkgbodyweightandday

x Averagechicken

bodyweight(kg)

=....mgproductperlitreof

drinkingwater

Averagedailywaterintake(litre/animal)

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.Theintakeof

medicatedwaterdependsontheclinicalconditionoftheanimals.Inordertoobtainthecorrectdosagethe

concentrationofLincomycinhastobeadjustedaccordingly.

Themedicatedwatershouldbetheonlysourceofdrinkingwater,throughoutthetreatmentperiod.

Medicatedwatershouldberefreshedevery24hours.

10.WITHDRAWALPERIOD

Meatandoffalofswine:0day

Meatandoffalofchicken(broiler):5day

Notauthorisedforuseinlayingbirdsproducingeggsforhumanconsumption.

11.SPECIALSTORAGEPRECAUTIONS

Donotstoreabove25

C.

Storeintheoriginalcontainerinordertoprotectfrommoisture.

Keepoutofthereachandsightofchildren.

Donotuseaftertheexpirydatestatedonthelabel.

Shelf-lifeafterfirstopeningthecontainer:3months.

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours.

12.SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Medicateddrinkingwateruptakecanbeaffectedbytheseverityofthedisease.Incaseofinsufficient

uptakeofwater,animalsshouldbetreatedparenterally.

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccountofficialandlocal

antimicrobialpolicies.UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistanttolincomycinandmaydecreasetheeffectivenessoftreatmentwith

otherlincosamides,macrolidesorstreptograminsduetopotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals:

Peoplewithknownhypersensitivitytolincomycinshouldavoidcontactwiththeveterinarymedicinal

product.

Careshouldbetakennottoinhaleanydust.Thewearingofapproveddustmasks(eitheradisposablehalf-

maskrespiratorconformingtoEuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143),glovesandsafetyglassesisrecommendedwhilstreconstituting

oradministeringthesolution.

Directcontactoftheproductwiththeskin,eyesandmucousmembranesshouldbeavoided.

Incaseofaccidentalexposurerinseabundantlywithwater.Incaseofallergicreaction(inflammationof

theface,lipsoreyesorrespiratorydifficulties)duringreconstitutingoradministeringoftheproduct,seek

medicaladviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Donotsmoke,eatordrinkwhenhandlingtheproduct.

Washhandsandanyexposedskinwithsoapandwaterimmediatelyafteruse.

Pregnancy,lactation,egglaying

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinpregnantorlactatingsows.Use

onlyinaccordancewithbenefit/riskassessmentbytheresponsibleveterinarian.Donotuseinbirdsinlay

orwithin4weeksbeforetheonsetofthelayingperiod.

Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusetogetherwithmacrolideantibiotics.Inabsenceofcompatibilitystudiesthisproductmust

notbemixedwithotherveterinaryproducts.

Overdose(symptoms,emergencyprocedures,antidotes)

Lincomycinhasagoodmarginofsafety,buthigherlevelsofdosagethanrecommendedmaycause

diarrhoeaandloosestoolsinpigs.

Otherprecautions

Whenspreadingthemanureofweanerpigstreatedwiththeveterinarymedicinalproductatadoseof10

mg/kgfor21days,aminimumdistancetosurfacewaterof10mshouldbeapplied.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTORWASTE

MATERIALS,IFANY

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.Thesemeasuresshouldhelp

toprotecttheenvironment.

14.DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15.OTHERINFORMATION

Natureandcompositionofimmediatepackaging

150gpolypropylenecontainerwithinnerbagofLDPE.

1.5kgpolypropylenecontainerwithinnerbagofLDPE.

5kgpolypropylenecontainerwithinnerbagofLDPE.

InItaly:

Pharmacotherapeuticgroup:lincosamideantibiotic,ATCvetcode:QJ01FF02

IntheUnitedKingdom:

Whenthecontainerisopenedforthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthis

packageleaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshouldbe

workedout.Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

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Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety