Phenoxypen

Main information

  • Trade name:
  • Phenoxypen WSP
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Phenoxypen WSP
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • phenoxymethylpenicillin (penicillin V)
  • Therapeutic area:
  • Chicken Other

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0121/001
  • Authorization date:
  • 24-02-2011
  • EU code:
  • NL/V/0121/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PhenoxypenWSP,325mg/gpowderfororalsolutionforchickens.(AT,BE,BG,DE,EL,FR,IT,LT,

NL,RO,SK)

PhenoxypenWSP,325mg/gproszekdosporządzaniaroztworudoustnegodlakurcząt.(PL)

Phenoxypen293mg/gprášekpropřípravuperorálníhoroztokuprokuřata(CZ)

Phenoxylin,325mg/gpowderfororalsolutionforchickens(DK)

PhenoxypenvízoldékonyporházityúkokrészéreA.U.V. (HU)

PhenoxypenWaterSolublePowder,325mg/gpowderfororalsolutionforchickens(IE,UK)

Phenoxypen,325mg/gpowderfororalsolutionforchickens(PT)

Avipen,325mg/gpowderfororalsolutionforchickens(ES)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergram:

Activesubstance:

Phenoxymethylpenicillin 293mg

equivalenttopotassiumphenoxymethylpenicillin325mg

Excipient:

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution.

Whitetooff-whitepowder.

4.CLINICALPARTICULARS

4.1 Targetspecies

Chickens.

4.2 Indicationsforuse,specifyingthetargetspecies

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridium

perfringenssusceptibletophenoxymethylpenicillin.

4.3 Contraindications

Donotuseincaseofhypersensitivitytotheactivesubstance.

4.4 Specialwarningsforeachtargetspecies

Theadministrationoftheproductmayleadtoanincreaseinmedicatedwaterconsumption.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromchickens

thathavealreadydiedonthefarm.

Theproductshouldnotbeusedtocompensateforpoorhygieneandmanagementofthechicken

houses.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Phenoxymethylpenicillinmaycausehypersensitivityreactionsafterinjection,inhalation,oral

ingestion,skinoreyecontact.Hypersensitivitytophenoxymethylpenicillinmayleadtocross-

sensitivitytootherpenicillinsandcephalosporins,andviceversa.Allergicreactionscausedby

thesesubstancescansometimesbeserious.

Incaseofaccidentalingestionorserioussymptomsofhypersensitivityreactionssuchasskinrash

followingexposure,swellingoftheface,lipsoreyesordifficultywithbreathing,seekmedical

adviceimmediatelyandshowthepackageleaflettothephysician.

Peoplewithknownhypersensitivitytopenicillinsorcephalosporinsshouldavoidcontactwiththe

product.Incaseofdevelopmentofhypersensitivitysymptomsfollowingexposuretotheproduct,

allfurthercontactwiththeproduct(andothermedicinescontainingotherpenicillinsor

cephalosporins)shouldbeavoided.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Wear

protectiveclothing,imperviousglovesandeitheradisposablehalfmaskrespiratorconformingto

EuropeanStandardEN149oranon-disposablerespiratorconformingtoEuropeanStandard

EN140withafiltertoEN143whenmixingandhandlingtheproduct.Washhandsimmediately

afterhandlingtheproduct..

4.6 Adversereactions(frequencyandseriousness)

Althoughnoadversereactionshavebeenseenaftertheadministrationoftheproduct,penicillins

maycausevomiting,diarrhoeaandaltergutflorawithselectingresistantbacteria.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalsandhumanshavenotproducedanyevidenceofeffectson

reproductivefunctionorfoetaldevelopment.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithbacteriostaticantibiotics.

4.9 Amountstobeadministeredandadministrationroute

13.5–20mgphenoxymethylpenicillinperkgofbodyweightperday,

correspondingwith,46–68mgoftheproductperkgofbodyweightperday,

for5days.

Methodofadministration:oraluse,dissolveindrinkingwaterandusewithin12hours.

Themaximumsolubilityis250goftheproductperlitreofdrinkingwater.

Thefollowingcalculationshouldbemadetodeterminethequantityingramoftheproducttobe

addedin1000litresofwater:

mgproduct/kgbodyweight/dayxmeanbodyweightofindividualanimals(kg)xnumberofanimals

Totalwaterconsumptionofthehouse(litres)atthepreviousday

=mgproduct/lx1000=gproduct/1000lwater

Indispensingtheweightoftheproducttobeused,theuseofcalibratedweighingequipmentis

recommended.

Takingintoaccountthatsickanimalsmaydrinkless,itisrecommendedtostarttherapywiththe

higherdose,tocompensateforapossiblelowerintakeofmedicatedwater.

Toensurecorrectdosage,thebodyweightoftheanimalsshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Noothersourceofdrinkingwatershouldbeavailableduringthemedicationperiod.

Incasesofaltereddrinkingwaterconsumptioninpoultry,theconcentrationshouldbeadjustedso

thattherecommendeddosageisachieved.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Phenoxymethylpenicillinhasahightherapeuticindex.Theadministrationofthemedicated

drinkingwaterattwoandfivetimestherecommendedtherapeuticdosefortwicethe

recommendeddurationoftreatmentdidnotrevealanyadverseeffects.Insomeindividuals,

administrationoffivetimestherecommendedtherapeuticdosefortwicetherecommended

durationoftreatmentledtoanincreaseinwaterconsumption,adecreaseinfeedintakeand

wateryfaeces.

4.11Withdrawalperiod

Meatandoffal: 2days.

Eggs: zerodays.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Beta-lactamantibacterials,penicillins

ATCvet-code:QJ01CE02

5.1 Pharmacodynamicproperties

Phenoxymethylpenicillinisanarrow-spectrumpenicillinwithactivitymainlyagainstgram-

positivebacteria.

Phenoxymethylpenicillinasallotherpenicillins,exertsabactericidalactiononbacteriaduring

thestageofactivemultiplication.Itformsanirreversiblebindingtopenicillin-binding-proteins

(PBPs),enzymesthatfacilitatetheformationofcross-linksofpeptidoglycanchainsinthe

synthesisofthebacterialcellwall.Thisresultsinabnormalcellgrowthandcytolysisofthecell.

Phenoxymethylpenicillinisanacid-stablederivateofbenzylpenicillinandhasalargely

comparablespectrumofactivity.

Developmentofresistanceismainlybasedontheformationofbeta-lactamase,anenzymethat

breaksopenthebeta-lactamring,renderingtheantibioticineffective.Crossresistanceexists

betweenphenoxymethylpenicillinandotherbeta-lactamantibiotics.

MinimumInhibitoryConcentrations(MICs)ofphenoxymethylpenicillinweredetermined

againstClostridiumperfringensisolatesfromclinicalcasesofnecroticenteritisinchickens

during1998and1999.TheMICforC.perfringensisolatedfromfaeces,liverandcaecum

sampleswere<0.01–0.05μg/ml.

5.2 Pharmacokineticproperties

ThemostimportantadvantageofphenoxymethylpenicillinincomparisonwithpenicillinGis

thatitismorestableinanacidenvironmentanditisthereforebetterabsorbedfromthe

gastrointestinaltract.

Followingoraluse,phenoxymethylpenicillinforthemostpartescapesdecompositionbygastric

juices,asitisstableatalowpH.

Phenoxymethylpenicilliniswelldistributedovermostofthetissues,leadingtoahigh

concentrationinthekidneysandtheliver.Phenoxymethylpenicillinispartiallydecomposedin

thegastrointestinaltract.Asmallportionoftheabsorbedamountismetabolisedinthebody.For

themostpart,phenoxymethylpenicillinisexcretedinunalteredactiveforminurineandfaeces.

Followingasingleadministrationoftheproductinpoultryatadoseof15mgof

phenoxymethylpenicillinpotassium/kgbodyweightbyoralgavage,maximumplasma

concentrationsof0.40±0.15mg/lareachievedwithin1.7±1.0hoursafteradministration.

Phenoxymethylpenicilliniswellabsorbedandhasanabsolutebioavailabilityof69%.

6.PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

6.2 Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

Contactofpenicillincontainingsolutionswithmetalsandtheuseofmetalsystemsfortheir

administrationisknowntoadverselyinfluencepenicillinstability.Thereforesuchsystemsshould

beavoidedandtheyshouldnotbeusedforthestorageofsolutions.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterfirstopeningoftheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

6.4.Specialprecautionsforstorage

Storebelow25°C.

Storeintheoriginalpackage.

Donotrefrigerateorfreeze.

Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

- Securitainer:whitePPcylindricalcontainer,withwhiteHDPE/LDPEclosure,withthumb-

tabforopening.Thistypeofcontainerhastwodifferentsizes(650ml,1875ml)witha

contentof250g,1000gproductrespectively.

- Compositecan:three-layeredrectangularcontainer,whichconsistsofacardboardbasewith

aninnerliningofaluminium-paperandwithlabelontheoutside.Thistypeofcontainerhas

acontentof1kgofproduct.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

research@dopharma.com

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

LABELLINGANDPACKAGELEAFLET

A.LABELLING

<PARTICULARSTOAPPEARONTHEOUTERPACKAGE>

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

Securitainer,Compositecan

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PhenoxypenWSP,325mg/gpowderfororalsolutionforchickens.

Potassiumphenoxymethylpenicillin

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Pergram:

Activesubstance:

Phenoxymethylpenicillin 293mg

equivalenttopotassiumphenoxymethylpenicillin 325mg

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

250gramor1kg.

5. TARGETSPECIES

Chickens

6. INDICATION

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridiumperfringens

susceptibletophenoxymethylpenicillin.

7. METHODANDROUTEOFADMINISTRATION

Oraluse,afterdissolutionindrinkingwater

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:2days.

Eggs: zerodays.

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

Exp<<EXPmonth/year>>

Shelflifeafterfirstopeningofthecontainer:3months

Shelflifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

Onceopened,useby:

11. SPECIALSTORAGECONDITIONS

Storebelow25°C.

Storeintheoriginalpackage.

Donotrefrigerateorfreeze.

Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

13. THEWORDS"FORANIMALTREATMENTONLY"ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS"KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN"

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER'SBATCHNUMBER

Batch<<partijnummer>>

B.PACKAGELEAFLET

PACKAGELEAFLET

PhenoxypenWSP,325mg/gpowderfororalsolutionforchickens.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

Manufacturerresponsibleforthebatchrelease:

DopharmaB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PhenoxypenWSP,325mg/gpowderfororalsolutionforchickens

Potassiumphenoxymethylpenicillin

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Pergram

Activesubstance:

Phenoxymethylpenicillin 293mg

equivalenttopotassiumphenoxymethylpenicillin 325mg

Whitetooff-whitepowder

4. INDICATION

PreventionofmortalityatagrouplevelfromnecroticenteritisinchickenscausedbyClostridiumperfringens

susceptibletophenoxymethylpenicillin.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotheactivesubstance.

6. ADVERSEREACTIONS

Althoughnoadversereactionshavebeenseenaftertheadministrationoftheproduct,penicillinsmaycause

vomiting,diarrhoeaandaltergutflorawithselectingresistantbacteria.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Chickens

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHOD(S)OFADMINISTRATION

13.5–20mgphenoxymethylpenicillinperkgofbodyweightperday,

correspondingwith46–68mgoftheproductperkgofbodyweightperday,for5days

Thisproductisadministeredtothechickensafterdissolutionindrinkingwater.

Thefollowingcalculationshouldbemadetodeterminethequantityingramoftheproducttobeadded

in1000litresofwater:

mgproduct/kgbodyweight/dayxmeanbodyweightofindividualanimals(kg)xnumberofanimals

Totalwaterconsumptionofthehouse(litres)atthepreviousday

=mgproduct/lx1000=gproduct/1000lwater

Indispensingtheweightoftheproducttobeused,theuseofcalibratedweighingequipmentis

recommended.

9. ADVICEONCORRECTADMINISTRATION

Takingintoaccountthatsickanimalsmaydrinkless,itisrecommendedtostarttherapywiththehigherdose,

tocompensateforapossiblelowerintakeofmedicatedwater.

Toensurecorrectdosage,thebodyweightoftheanimalsshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

Themaximalsolubilityis250goftheproductperlitreofdrinkingwater.

Noothersourceofdrinkingwatershouldbeavailableduringthemedicationperiod.

Incasesofaltereddrinkingwaterconsumptioninpoultrytheconcentrationshouldbeadjustedsothatthe

recommendeddosageisachieved.

Onlysufficientmedicateddrinkingwatershouldbepreparedtocoverdailyrequirements

Medicateddrinkingwatershouldberefreshedorreplacedevery12hours.

10. WITHDRAWALPERIOD

Meatandoffal:2days.

Eggs: zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storebelow25ºC.

Storeintheoriginalpackage.

Donotrefrigerateorfreeze.

Protectfromfrost.

Donotuseaftertheexpirydatestatedonthelabelafterexp.

Shelf-lifeafterfirstopeningofthecontainer:3months.

Shelf-lifeafterreconstitutionindrinkingwateraccordingtodirections:12hours.

Whenthecontainerisopenedforthefirsttime,usingthein-useshelf-lifewhichisspecifiedonthispackage

leaflet,thedateonwhichanyproductremaininginthecontainershouldbediscardedshouldbeworkedout.

Thisdiscarddateshouldbewritteninthespaceprovidedonthelabel.

12. SPECIALWARNINGS

Specialwarningsforeachtargetspecies

Theadministrationoftheproductmayleadtoanincreaseinmedicatedwaterconsumption.

Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingofthebacteriaisolatedfromchickensthathave

alreadydiedonthefarm.

Theproductshouldnotbeusedtocompensateforpoorhygieneandmanagementofthechickenhouses.

Operatorwarnings

Phenoxymethylpenicillinmaycausehypersensitivityreactionsafterinjection,inhalation,oralingestion,skin

oreyecontact.Hypersensitivitytophenoxymethylpenicillinmayleadtocross-sensitivitytootherpenicillins

andcephalosporins,andviceversa.Allergicreactionscausedbythesesubstancescansometimesbeserious.

Incaseofaccidentalingestionorserioussymptomsofhypersensitivityreactionssuchasskinrashfollowing

exposure,swellingoftheface,lipsoreyesordifficultywithbreathing,seekmedicaladviceimmediatelyand

showthepackageleaflettothephysician.

Peoplewithknownhypersensitivitytopenicillinsorcephalosporinsshouldavoidcontactwiththeproduct.In

caseofdevelopmentofhypersensitivitysymptomsfollowingexposuretotheproduct,allfurthercontactwith

theproduct(andothermedicinescontainingotherpenicillinsorcephalosporins)shouldbeavoided.

Handlethisproductwithgreatcaretoavoidexposure,takingallrecommendedprecautions.Wearprotective

clothing,imperviousglovesandeitheradisposablehalfmaskrespiratorconformingtoEuropeanStandard

EN149oranon-disposablerespiratorconformingtoEuropeanStandardEN140withafiltertoEN143when

mixingandhandlingtheproduct.Washhandsimmediatelyafterhandlingtheproduct.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalsandhumanshavenotproducedanyevidenceofeffectsonreproductive

functionorfoetaldevelopment.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotusetheproductincombinationwithbacteriostaticantibiotics.

Donotmixtheproductwithotherveterinarymedicinalproducts.

Overdose(symptoms,emergencyprocedures,antidotes)

Phenoxymethylpenicillinhasahightherapeuticindex.Theadministrationofthemedicateddrinkingwater

attwoandfivetimestherecommendedtherapeuticdosefortwicetherecommendeddurationoftreatment

didnotrevealanyadverseeffects.Insomeindividuals,administrationoffivetimestherecommended

therapeuticdosefortwicetherecommendeddurationoftreatmentledtoanincreaseinwaterconsumption,a

decreaseinfeedintakeandwateryfaeces.

Incompatibilities

Contactofpenicillincontainingsolutionswithmetalsandtheuseofmetalsystemsfortheiradministrationis

knowntoadverselyinfluencepenicillinstability.Thereforesuchsystemsshouldbeavoidedandtheyshould

notbeusedforthestorageofsolutions.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproduct

shouldbedisposedofinaccordancewithlocalrequirements.

Askyourveterinarysurgeontodisposeofmedicinalproductsnolongerrequired.Thesemeasuresshould

helptoprotecttheenvironment.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Listofpacksizes:

250gram,1kg.

Notallpacksizesmaybemarketed.

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Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

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

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product 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. 

FDA - U.S. Food and Drug Administration

15-3-2018

Duro-K 600 mg potassium chloride tablets

Duro-K 600 mg potassium chloride tablets

Advisory – lead content may exceed regulatory guidelines

Therapeutic Goods Administration - Australia

26-11-2018

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Active substance: naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7966 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4325/T/04

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

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3259 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2679/R/24

Europe -DG Health and Food Safety

24-5-2018

Ristaben (Merck Sharp and Dohme Limited)

Ristaben (Merck Sharp and Dohme Limited)

Ristaben (Active substance: sitagliptin) - PSUSA - Modification - Commission Decision (2018)3258 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2711/201708

Europe -DG Health and Food Safety

24-5-2018

Tesavel (Merck Sharp and Dohme Limited)

Tesavel (Merck Sharp and Dohme Limited)

Tesavel (Active substance: sitagliptin) - PSUSA - Modification - Commission Decision (2018)3256 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2711/201708

Europe -DG Health and Food Safety

24-5-2018

Pedea (Orphan Europe S.A.R.L.)

Pedea (Orphan Europe S.A.R.L.)

Pedea (Active substance: Ibuprofen) - PSUSA - Modification - Commission Decision (2018)3257 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1712/201707

Europe -DG Health and Food Safety

16-5-2018

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

Europe -DG Health and Food Safety