Vidalta 10 mg tablets for Oral Use for Cats

Main information

  • Trade name:
  • Vidalta 10 mg Tabletten zum Eingeben für Katzen
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vidalta 10 mg Tabletten zum Eingeben für Katzen
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • carbimazole
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0408/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0408/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:January2012

AN:02006/2010

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vidalta10mgprolonged-releasetabletsforcats

BE,NO:VidaltaVet10mgprolonged-releasetabletsforcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolonged-releasetabletcontains:

Activesubstance:

Carbimazole 10.00mg

Excipients:

Redferricoxide(E172) 0.25mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Prolonged-releasetablet

Roundpinktabletwithlittlespots

4. CLINICALPARTICULARS

4.1 Targetspecies

Cat

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofhyperthyroidismandhyperthyroidism-associatedclinicalsignsincats

4.3 Contraindications

Donotuseincatssufferingfromconcurrentsystemicdiseases,suchassevereprimary

liverdiseaseordiabetesmellitus.

Donotuseincatsshowingsignsofauto-immunediseasesand/oralteredredorwhite

bloodcellcounts,suchasanaemia,neutropaeniaorlymphopaenia.

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Page2of8

Donotuseincatswithplateletdisorders(particularlythrombocytopaenia)or

coagulopathies.

Donotuseincatswithhypersensitivitytomercaptoimidazoles(carbimazoleor

thiamazole(methimazole))

Pleaserefertosection4.7.

4.4 Specialwarningsforthetargetspecies

Thiamazole(methimazole),theactivemetaboliteofcarbimazole,inhibitsthyroid

hormoneproductionandthereforecessationoftreatmentwithcarbimazolewillresultin

arapid(within48hours)returntopre-treatmentthyroidhormonelevels.Chronic

administrationisthereforenecessaryunlesssurgicalorradiation-inducedthyroidectomy

isperformed.

Asmallproportionofcatswiththyroidadenomamayfailtorespondorhaveapoor

responsetotreatment.

Thyroidcarcinomaisararecauseofhyperthyroidisminthecatandmedical

managementaloneisnotrecommendedinsuchcasesasitisnotcurative.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Treatmentshouldbeadjustedaccordingtotherisk:benefitassessmentfortheindividual

case.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Thiscanleadtounmaskingofpre-existentrenaldysfunction.Treatmentof

hyperthyroidismmayalsoinduceanelevationofliverenzymesoraworseningofpre-

existinghepaticdisorders.Renalandliverfunctionshouldthereforebemonitored

beforeandduringtreatment

Duetoriskofleucopeniaorhaemolyticanaemia,haematologyparametersshouldbe

monitoredonaregularbasisbeforeandduringtreatment,preferablyateachvisitofthe

doseadjustmentphaseandmaintenancephase(seesection4.9).

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbetreatedprophylactically

withbactericidalantibioticsandsupportivetherapy.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcats.Therefore,

carefulmonitoringisrecommendedandthedoseshouldbeadjustedaccordingtothe

risk:benefitassessmentfortheindividualcase.

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Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandswithsoapandwaterafteruseandwhenhandlinglitterusedbytreated

animals.

Donothandlethisproductifyouareallergictoantithyroidproducts.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageinsertorthelabeltothephysician.Carbimazole,asaprodrugofthiamazole

(methimazole),maycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Ascarbimazoleisasuspectedhumanteratogen,womenofchild-bearingageshould

weargloveswhenhandlinglitterorvomitoftreatedcats.

4.6Adversereactions(frequencyandseriousness)

Mostfrequentcommonadversereactionsencompassvomiting,diarrhoea,reduced

appetite,lossofcondition,lethargy,tachycardia,polydipsia,dehydration,andpolyuria.

Dermatologicalsigns(pruritus,moistdermatitis,erythema,alopecia)havealsobeen

reported.Theseclinicalsignsareusuallymild,adequatelycontrolledbysymptomatic

therapyanddonotrequiretreatmentdiscontinuation.However,ifmoresevereclinical

signsoccurthatdonotrespondtosymptomatictherapy,thedoseshouldbereducedor

treatmentstoppedaccordingtorisk:benefitevaluation.Incasesofseriousadverse

reactions,mortality,possiblyduetotheproduct,mightoccuriftreatmentisnot

discontinued.

Insomecases,signsofgastrointestinalbleedingsuchasbloodyvomit,oral

haemorrhageordarkfecescanbeobserved.Thesesignsshouldbeconsideredas

seriousandrequireimmediateaction(dosereductionortreatmentdiscontinuation).

Weightloss,dyspnoea,aggressiveness,disorientation,ataxiaorpyrexiahavealso

beenreportedinrarecases.

Treatmentofhyperthyroidismmayresultinareductionintheglomerularfiltrationrate.

Inseverecases,whereazotaemiadevelops,temporaryorpermanenttreatment

discontinuationmayberequired.

Thetreatmentmayinduceincreaseofliverenzymes.Severecasesmayrequire

temporaryorpermanenttreatmentdiscontinuation.However,theseelevationsare

usuallyreversiblefollowingdrugdiscontinuation,althoughsymptomatictherapy

(nutritionalandfluidsupport)mayberequired.

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Page4of8

Anaemia, increase or decrease in white blood cell count, neutrophilia,

thrombocytopaenia,eosinophiliaand/orlymphopaeniamayalsooccur,inparticular

duringthefirst4-6weeksoftreatment.Treatmentdiscontinuationmayberequiredin

caseofpersistentandmarkeddisorder.Inmostofthecases,theabnormalitywill

resolvespontaneouslywithin1monthaftertreatmentdiscontinuation.

Positiveantinuclearantibodytitreshavealsobeenreported.

Itappearsthatadversereactionsarereversibleoncessationoftreatment.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Furthermore,thiamazolecrossestheplacenta,distributes

intomilkandreachesapproximatelythesameconcentrationasinmaternalserum.

Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

carbimazole.

Theconcomitantuseofbenzimidazoleanthelmintics(fenbendazoleormebendazole)

hasbeenshowntoreducethehepaticoxidationofthistherapeuticclassandmay

thereforeinduceanincreaseoftheircirculatingrates.Accordingly,co-administrationof

carbimazolewithabenzimidazoleisnotrecommended.

Thiamazolemaydisplayimmunomodulatingproperties.Thisshouldbetakeninto

accountwhenconsideringvaccinationofthecat.

4.9 Amountstobeadministeredandadministrationroute

Fororaluseonly.

Administrationwithfoodenhancesbioavailability.Thetimingoftreatmentandits

relationtofeedingshouldbekeptconsistentfromdaytoday.

DonotbreakorcrushVidaltatabletsasthiswillaffectthesustainedreleaseproperty.

Theaimoftreatmentistomaintaintotalthyroxinconcentrations(TT4)inthelowerend

ofthereferencerange.Accordingly,thefollowingdoserecommendationsfordosing

duringadjustmentandmaintenancephasesaresuggested.Howeverdosingadjustment

shouldbeprimarilybasedupontheclinicalassessmentoftheindividualcat.Monitoring

ofTT4,fullhaematologyandliverandkidneyparametersisadvisedateach

recommendedfollowupvisit(seesections4.5iand4.6).

Revised:January2012

AN:02006/2010

Page5of8

Adjustmentphase

Thestartingdoseisasingledailyoraladministrationofonetabletof15mgcarbimazole

percat.ConsiderationcouldbegiventoastartingdoseofVidalta10mgdailywherethe

TT4concentrationisonlymildlyincreased,e.g.between50nmol/Land100nmol/L.

WiththerecommendedstartingdoseofoneVidalta15mgtabletoncedaily,total

thyroxinconcentration(TT4)maydecreasetowithintheeuthyroidrange(TT4<50

nmol/L)shortlyaftertreatmentinitiation.Adoseadjustmentmayberequiredasearlyas

10daysoftreatment.

Doseadjustmentshouldbealsoperformed3,5and8weeksafterinitiationof

treatment,dependingonbothclinicalandhormonalresponsestotreatment.

Maintenancephase

Follow-upvisitsevery3to6monthsarerecommended.Thedoseshouldbeadjusted

individuallybasedonclinicalsignsandtotalthyroxinconcentration(TT4).Itisadvisable

tocheckTT410-14daysafterdoseadjustment.

ThetherapeuticdoseofVidaltarangesbetween10mg(one10mgtablet)and25mg

(one10mgtabletandone15mgtablet)oncedaily.

Somecatsrequiredosesoflessthan10mgcarbimazoledaily.Everyotherdaydosing

with10mgor15mgofcarbimazolemaybesufficienttocontrolthedisease.

Doseincreasesshouldnotbemadeinincrementsofgreaterthan5mg.

Dosesabove20mghaveonlybeentrialledinasmallnumberofcatsandshouldbe

usedwithcaution.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdosage,adverseeffectsthatmayappearinclude,butarenotlimitedto,

weightloss,inappetence,vomiting,lethargyandlessfrequentlysignsofgastrointestinal

bleedingsuchashaematemesis,oralhaemorrhage,orhaemorrhageoftheintestinal

tract.Coatandskinabnormalities(erythema,alopecia),aswellasas

haematological/biochemical changes (eosinophilia, lymphocytosis, neutropaenia,

lymphopaenia,slightleucopaenia,agranulocytosis,thrombocytopaeniaorhaemolytic

anaemia)mayalsoappear.Hepatitisandnephritishavebeenreported.Theseadverse

effectsmaybecomesevereincaseofchronicoverdosing.Inmostcases,adverse

effectsarereversibleupontreatmentdiscontinuationandappropriateveterinarycare.

Totalthyroxinconcentrations(TT4)belowthelowerlimitofthereferencerangemaybe

observedduringtreatmentalthoughthisisrarelylinkedtoovertclinicalsigns.

DecreasingthedosewillleadtoanincreaseoftheTT4.Doseadjustmentshouldnotbe

madebasedonTT4only(seesection4.9).

Pleasealsorefertosection4.6

Revised:January2012

AN:02006/2010

Page6of8

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Activeingredient:carbimazole

Pharmacotherapeuticgroup:sulphur-containingimidazolederivatives

ATCvetcode:QH03BB01

5.1 Pharmacodynamicproperties

Carbimazoleistheprodrugofthiamazole(methimazole).Althoughcarbimazolehas

inherentantithyroidactivity,itisalmosttotallyconvertedtothiamazolesoonafteritsoral

administrationinvivoinhumansandcats.

Thiamazoleresultsindose-dependentinhibitionofthethyroidperoxidase-catalysed

reactionsinvolvedinthyroidhormonesynthesis,includingoxidationofiodideand

iodinationoftyrosylresiduesinthyroglobulin,therebyinhibitingneosynthesisofthyroid

hormones.Thiamazolealsointerfereswiththecouplingofiodotyrosinesto

iodothyroninesviainhibitionofthyroidperoxidaseorbybindingandalteringthe

structureofthyroglobulin,thisreactionbeingmoresensitivetoinhibitionthanthe

formationofiodotyrosines.Theinhibitoryactionofthiamazoleisreversible.

Thiamazoledoesnotinhibittheactionofthyroidhormonesalreadyformedandpresent

inthethyroidglandsorbloodstream,orinterferewiththeeffectivenessofadministered

exogenousthyroidhormone(iatrogenichyperthyroidism).Thisexplainswhythelength

ofthelatencyperioduntilnormalisationofserumconcentrationsofthyroxineand

triiodothyronine,andthustoclinicalimprovement,differsbetweenindividuals.

5.2 Pharmacokineticparticulars

Carbimazoleisrapidlyabsorbedfromthegastrointestinaltractafteroraladministration

andhydrolysedinthegastrointestinaltract(orimmediatelyafterenteringintothe

circulation)totheactivemetabolitethiamazole.Theabsolutebioavailabilityof

thiamazolefromcarbimazoleinVidalta15mgtabletsis88%.

FollowingoraladministrationofonetabletofVidalta10mgtohealthyfastedcats,

maximumthiamazoleconcentrationsareobserved3-4hoursafteradministration,witha

meanpeakconcentrationofthiamazoleof0.54-0.87µg/mL.Followingoral

administrationofonetabletofVidalta15mgtohealthyfastedcats,maximum

thiamazoleconcentrationsareobserved5-7hoursafteradministration,withamean

peakconcentrationofthiamazoleof0.72-1.13µg/mL.Forbothstrengths,the

thiamazoleconcentration/timeprofileisdevoidofpronouncedpeakandthiamazole

persistsinthecirculationatleast20and24hoursforVidalta10mgandVidalta15mg,

respectively.

Revised:January2012

AN:02006/2010

Page7of8

Thepresenceoffoodinthegastrointestinaltractatthetimeofadministrationhasbeen

showntoincreasethebioavailabilityofthiamazole.Whentabletsareadministeredwith

food,bothC

andAUC

last maybeincreasedwhereast

isnotexpectedtochange.

Nocumulativeeffectsareobserveduponrepeatedadministration.

Thetissuedistributionofmercaptoimidazoleshasnotbeenspecificallystudiedincats

buthasbeenfullydescribedinrodents.Thiamazoleismainlyconcentratedinthe

thyroidandadrenalglands,andcanbefoundtoalesserextentinthethymus,

diaphragm,kidneys,brain,liver,colon,testes,smallintestine,stomachandplasma.

Mercaptoimidazoleshavealsobeenshowntocrosstheplacentalbarrier.

Inrats,thiamazoleisexcretedmainlyviatheurine,andtoalesserextentinthefaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

-Hypromellose

-Microcrystallinecellulose

-Redferricoxide(E172)

-Silica,colloidalanhydrous

-Magnesiumstearate

-Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductsaspackagedforsale:

18months.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

Keepthecontainertightlyclosedtoprotectfrommoisture.

Donotremovethedessicant.

Revised:January2012

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Page8of8

6.5Natureandcompositionofimmediatepackaging

Highdensitypolyethylenecontainerof30or100tabletsclosedwithpolypropylene

tamper-evident,child-resistant,screwcapbearingadesiccant.

Packsof1or6containers.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

IntervetUKLtd

WaltonManor

Walton

MiltonKeynes

Buckinghamshire

MK77AJ

8. MARKETINGAUTHORISATIONNUMBER

Vm01708/4529

9. DATEOFFIRSTAUTHORISATION

21December2007

10. DATEOFREVISIONOFTHETEXT

January2012

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Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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 of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

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

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

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

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

12-7-2018

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

6-6-2018

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

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

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

14-5-2018

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

FDA has approved Mirataz (mirtazapine transdermal ointment), a new animal drug to manage undesired weight loss in cats. Mirataz is the first transdermal product to receive FDA approval for use in cats. FDA-approved drugs have been demonstrated to be safe and effective for their intended use.

FDA - U.S. Food and Drug Administration

11-5-2018

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

23-2-2018

Bella all Natural Issues Voluntary Nationwide Recall of Diet Capsules Labeled as Bella, Due to Presence of Sibutramine

Bella all Natural Issues Voluntary Nationwide Recall of Diet Capsules Labeled as Bella, Due to Presence of Sibutramine

Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level.

FDA - U.S. Food and Drug Administration

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

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

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (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)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (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)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety