Lepitil 60 mg Chewable Tablets

Main information

  • Trade name:
  • Lepitil 60 mg Chewable Tablets for Dogs
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lepitil 60 mg Chewable Tablets for Dogs
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Phenobarbital
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0439/001
  • Authorization date:
  • 24-04-2013
  • EU code:
  • UK/V/0439/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2013

AN.01712/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Lepitil60mgFlavouredTabletsforDogs

Lepitilvet60mgTabletsforDogs(SE)

Phenobarbital

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredient:

Eachtabletcontains:

Phenobarbital60mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Tablet

White,circulartabletwithcrossbreaklineononeside.

Thetabletscanbedividedintoequalhalvesorquarters.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dog

4.2 Indicationsforuse,specifyingthetargetspecies

Phenobarbitalisanantiepilepticagentforthepreventionofseizuresduetogeneralized

epilepsyindogs.

4.3 Contra-indications

Donotuseincaseofhypersensitivitytobarbituates.

Donotuseinanimalswithseriousimpairedhepaticfunction.

Donotuseinanimalswithseriousrenalorcardiovasculardisorders.

Donotuseindogsweighinglessthan6kgbodyweight.

4.4 Specialwarningsforeachtargetspecies

ThedecisiontostartantiepilepticdrugtherapywithPhenobarbitalshouldbeevaluated

foreachindividualcaseanddependsonnumber,frequency,durationandseverityof

seizuresindogs.

Administrationoftabletsshouldoccuratthesametime(s)eachday,andshouldbeco-

ordinatedwithfeedingtimesinaconsistentmanner.Withdrawalortransitionfromother

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AN.01712/2011

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typesofantieleptictherapyshouldbemadegraduallytoavoidprecipitatinganincrease

inthefrequencyofseizures.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Cautionisrecommendedinanimalswithimpairedhepaticandrenalfunction,

hypovolemia,anemiaandcardiacorrespiratorydysfunction.Thechanceofhepatotoxic

sideeffectscanbediminishedordelayedusinganeffectivedosethatisaslowas

possible.Monitoringofhepaticparametersisrecommendedincaseofaprolonged

therapy.

Itisrecommendedtoassesstheclinicalpathologyofthepatient2-3weeksafterstartof

treatmentandafterwardsevery4-6months,e.g.measurementofhepaticenzymesand

serumbileacids.Itisimportanttoknowthattheeffectsofhypoxiaetc.docause

increasedlevelsofhepaticenzymesafteraseizure.Phenobarbitalmayincreasethe

activityofserumalkalinephosphataseandtransaminases.Thesemaydemonstrate

non-pathologicalchanges,butcouldalsorepresenthepatotoxicity,liverfunctiontests

arerecommended.Increasedliverenzymevaluesmaynotalwaysrequireadose

reductionofPhenobarbitaliftheserumbileacidsareinthenormalrange.

Instabilizedepilepticpatients,itisnotrecommendedtoswitchfromotherPhenobarbital

formulatorstoEpityl60mgtablets.However,ifthiscannotbeavoidedthenadditional

cautionshouldbetaken.Thisincludesmorefrequentplasmaconcentrationsamplingto

ensurethattherapeuticlevelsaremaintained.Monitoringforincreasedsideeffectsand

forhepaticdysfunctionshouldbeconductedmoreregularlyuntilstabilisationis

confirmed.WithdrawaloftherapywithPhenobarbitalformulationsshouldbemade

graduallytoavoidprecipitatinganincreaseinthefrequencyofseizures.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytobarbituratesshouldavoidcontactwiththe

veterinarymedicinalproduct.Washhandsthoroughlyafteruse.

Takeutmostcarethatchildrendonotcomeincontactwiththeproduct.Childrenare

particularlyatriskofintoxicationwhichmayprovefatal.Incaseofaccidentalingestion,

seekmedicalattentionimmediatelyandshowthepackageleafletorthelabeltothe

physician.Ifpossible,thephysicianshouldbeinformedaboutthetimeandamountof

ingestion,asthisinformationmayhelptoensurethatappropriatetreatmentisgiven.

Eachtimeanunusedpart-tabletisstoreduntilnextuse,itshouldbereturnedeitherto

theopenblisterspaceandinsertedbackintothecardboardboxorplacedbackintothe

containerandkeptinasafeplaceoutofthereachandsightofchildrenasitposesa

healthrisktosmallchildrenduetoaccidentalingestion.

4.6 Adversereactions(frequencyandseriousness)

Duringstartoftherapyataxia,andsedationcanoccurbuttheseeffectsareusually

transitoryanddisappearinmost,butnotall,patientswithcontinuedmedication.Some

Issued:August2013

AN.01712/2011

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animalscandemonstrateaparadoxicalhyperexcitability,particularlyafterfirststarting

therapy.Asthishyperexcitabilityisnotlinkedtooverdosage,noreductionofdosageis

needed.Polyuria,polydipsiaandpolyphagiacanoccurataverageorhighertherapeutic

activeserumconcentrations;theseeffectscanbediminishedbylimitingintakeoffood.

Sedationandataxiaoftenbecomesignificantconcernsasserumlevelsreachthehigher

endsofthetherapeuticrange.Highplasmaconcentrationsmaybeassociatedwith

hepatotoxicity.Phenobarbitalcanhavedeleteriouseffectsonstemcellsfrombone

marrow.Consequencesareimmunotoxicpancytopeniaand/orneutropenia.These

reactionsdisapp earafterthetreatment’swithdrawal.Treatingdogswithphenobarbital

maylowertheirTT4orFT4serumlevels,howeverthismaynotbeanindicationof

hypothyroidism.Treatmentwiththyroidhormonereplacementshouldonlybestartedif

thereareclinicalsignsofthedisease.

Ifadverseeffectsaresevere,thedecreaseintheadministereddoseisrecommended.

4.7 Useduringpregnancy,lactationorlay

Phenobarbitalcrossestheplacentalbarrierandathigherdoses(reversible)withdrawal

symptomsinnewbornscannotbeexcluded.Studiesinlaboratoryanimalshaveshown

evidenceofactionofphenobarbitalonprenatalgrowth,especiallyconcerningsexual

development.Neonatalbleedingtendencieshavebeenassociatedwithphenobarbital

treatmentduringpregnancy.AdministrationofVitaminKtothedamfor10daysbefore

parturitionmayhelptominimizetheseeffectsonthefetus.

Thesafetyoftheproducthasnotbeenestablishedduringpregnancyofdogs.The

benefitsoftreatmentmaybegreaterthanthepotentialrisksassociatedwithepileptic

seizuresonthefetus(hypoxiaandacidosis).Therefore,incaseofpregnancy,

terminationofantiepileptictreatmentisnotrecommended;however,thedoseshouldbe

aslowaspossible.

Phenobarbitalisexcretedinsmallamountsinbreastmilkandduringnursing,pups

shouldbemonitoredcarefullyforundesiredsedativeeffects.Weaningearlymaybean

option.Ifsomnolence/sedativeeffects(thatcouldinterferewithsuckling)appearin

nursingnewborns,anartificialsucklingmethodshouldbechosen.

Useduringpregnancyandlactationonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Atherapeuticdoseofphenobarbitalforantiepileptictherapycansignificantlyinduce

plasmaproteins,(suchas α1acidglycoprotein,AGP),whichbinddrugs.Phenobarbital

mayreducetheactivityofsomedrugsbyincreasingtherateofmetabolismthrough

inductionofdrug-metabolisingenzymesinlivermicrosomes.Thereforespecial

attentionmustbepaidtothepharmacokineticsanddosesofdrugssimultaneously

administered.Theplasmaticconcentrationofarangeofdrugs(forexample

cyclosporine,thyroidhormonesandtheophylline)isdecreasedinthecaseofconcurrent

administrationofPhenobarbital.Concurrentusewithotherdrugshavingacentral

depressiveaction(likenarcoticanalgesics,morphinicderivates,phenothiazines,

antihistamines,clomipramineandchloramphenicol)canincreasetheeffectof

Phenobarbital.

Cimetidineandketoconazoleareinhibitorsofhepaticenzymes:concurrentusewith

phenobarbitalcaninduceanincreaseofserumconcentrationofphenobarbital.

Phenobarbitalmaydecreasetheabsorptionofgriseofulvin.Concurrentusewith

potassiumbromideincreasestheriskofpancreatitis.Useofphenobarbitaltabletsin

Issued:August2013

AN.01712/2011

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conjunctionwithprimidoneisnotrecommendedasprimidoneispredominantly

metabolizedtoPhenobarbital.

Thefollowingdrugscandecreasetheconvulsivethreshold:quinolones,highdosesof β-

lactamantibiotic,theophyllin,aminophyllin,cyclosporineandpropofolforexample).

Medicationswhichmayaltertheseizurethresholdshouldonlybeusedifreally

necessaryandwhennosaferalternativeexists.

Thefollowingdrugscandecreasetheco nvulsivethreshold:quinolones,highdosesofβ-

lactamantibiotic,theophyllin,aminophyllin,cyclosporineandpropofolforexample).

Medicationswhichmayaltertheseizurethresholdshouldonlybeusedifreally

necessaryandwhennosaferalternativeexists

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.Therequireddosagewilldiffertosomeextentbetween

individualsandwiththenatureandseverityofthedisorder.

Dogsshouldbedosedorally,startingwithadoseof2-5mgperkgbodyweightperday.

Thedoseshouldbedividedandadministeredtwicedaily.

Steadystateserumconcentrationsarenotreacheduntil1-2weeksaftertreatmentis

initiated.Thefulleffectofthemedicationdoesnotappearfortwoweeksanddoses

shouldnotbeincreasedduringthistime.

Tabletsmustbegivenatthesametimeeachdaytooptimizetreatmentsuccess.

Ifseizuresarenotbeingcontrolled,thedosagemaybeincreasedby20%atatime,with

associatedmonitoringofserumphenobarbitallevels.Thephenobarbitalserum

concentrationmaybecheckedaftersteadystatehasbeenachieved,andifitisless

than15µg/mlthedosemaybeadjustedaccordingly.Ifseizuresrecurthedosemaybe

raiseduptoamaximumserumconcentrationof45µg/ml.Highplasmaconcentrations

maybeassociatedwithhepatotoxicity.Bloodsamplescouldbetakenatthesametime

toallowplasmaphenobarbitalconcentrationtobedeterminedpreferablyduringtrough

levels,shortlybeforethenextdoseofphenobarbitalisdue.

Plasmaconcentrationsshouldbeinterpretedinconjunctionwiththeobservedresponse

totherapyandafullclinicalassessmentincludingmonitoringforevidenceoftoxic

effectsineachanimal.

Clinicaldatasuggeststhatconsiderablevariationinplasmaconcentrationsof

phenobarbitalmaybeobservedinsomeanimals.Thisvariationmayresultinananimal

withatroughplasmaconcentrationofphenobarbitalbelowthetypicalminimum

therapeuticlevel(15µg/ml)andapeakplasmaconcentrationapproachingthe

maximumlevel(45µg/ml).Iftheseizurecontrolisinadequateinsuchanimals,care

shouldbetakenwhenincreasingthedoseastoxiclevelsmaybereachedor

exceeded.Peakandtroughplasmaconcentrationsofphenobarbitalmayneedtobe

measuredinsuchanimals.(Peakplasmaconcentrationsarereachedwithin

approximately3hoursafteradministration).

Iftheseizuresarenotbeingsatisfactorilycontrolledandifthemaximumplasma

concentrationofphenobarbitalisabout40µg/ml,thenthediagnosisshouldbe

Issued:August2013

AN.01712/2011

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reconsideredand/orasecondantiepilepticproduct(suchasbromides)shouldbe

addedtothetreatmentprotocol.

Tabletscanbedividedintoequalhalvesorquarterstoensureaccuratedosing.

Tobreakacrossscoredtabletintoquarters,placethetabletonanevensurfacewiththe

scoredsideupandapplypressureonthemiddlewithyourthumb.

Tobreakatabletintotwohalves,placethetabletonanevensurfacewiththescored

sideup,holdonehalfofthetabletandpressdownontheotherhalf.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Symptomsofoverdoseare:

-depressionofthecentralnervoussystemdemonstratedbysignsrangingfromsleepto

coma,

-respiratoryproblems,

-cardiovascularproblems,hypotensionandshockleadingtorenalfailureanddeath.

Incaseofoverdoseremoveingestedproductfromthestomach,andgiverespiratory

andcardiovascularsupportasnecessary.

Thereisnospecificantidote,butCNSstimulants,(likeDoxapram)maystimulatethe

respiratorycentre.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiepileptics/barbituratesandderivates

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ATCVetCodeQN03AA02.

5.1 Pharmacodynamicproperties

Theantiepilepticeffectsofphenobarbitalareprobablytheresultofatleasttwo

mechanisms:Decreasedmonosynaptictransmission,whichpresumablyresultsin

reducedneuronalexcitabilityandanincreaseinthemotorcortex'sthresholdfor

electricalstimulation.

5.2 Pharmacokineticparticulars

Afteroraladministrationofphenobarbitaltodogs,thedrugisrapidlyabsorbedand

maximalplasmaconcentrationsarereachedwithin3hours.Bioavailabilityisbetween

86%-96%.About45%oftheplasmaconcentrationisproteinbound.Metabolismisby

aromatichydroxylationofthephenylgroupintheparaposition,andaboutonethirdof

thedrugisexcretedunchangedintheurine.Eliminationhalf-livesvaryconsiderably

betweenindividualsandrangefromabout40-90hours.Steadystateserum

concentrationsarenotreacheduntil1-2weeksaftertreatmentisinitiated.

Afteroraladministrationoftheproductto16beagledogstwicedaily,at12hours

intervals,for14days,atadoserateof0.5tabletperdog,whichequatedto4-5mg/kg

bodyweight,maximumplasmaconcentrationsreachedwithin3hoursvariedfrom32.30

to47.64µg/mlandminimumplasmaconcentrationsvariedfrom12.94to21.05µg/ml.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Magnesiumstearate

Maizestarch

Talc

Grilledmeatflavour

6.2 Incompatibilities

Noneknown

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 3years

Shelflifeofdividedtablets: 2day

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Dividedtabletsshouldbestoredintheoriginalpack.Anydividedtabletportions

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remainingafter2daysshouldbediscarded.Keeptheblisterintheoutercarton.

6.5 Natureandcompositionofimmediatepackaging

Blisterstrips(PVC/Aluminium)containing10tabletsincartonsof10,20,30,40,50,60,

70,80,90,100,500and1000tablets.

WhiteHDPEcontainerswithapolypropylenechildresistantcapcontaining100or500

tablets.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

ChanellePharmaceuticalsManufacturingLtd

Loughrea

Co.Galway

Ireland

8. MARKETINGAUTHORISATIONNUMBER

Vm08749/4033

9. DATEOFFIRSTAUTHORISATION

16August2013

10. DATEOFREVISIONOFTHETEXT

August2013

Approved: 16/08/2013

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Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

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

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

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

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

5-6-2018

Valpam 5 (diazepam) 5 mg tablets

Valpam 5 (diazepam) 5 mg tablets

Product defect alert - potential for blister strip to contain lower strength tablets

Therapeutic Goods Administration - Australia

10-4-2018

Stree Overlord Strong tablets (pills)

Stree Overlord Strong tablets (pills)

Safety alert - stree overlord tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

9-4-2018

Black Ant King tablets

Black Ant King tablets

Safety advisory

Therapeutic Goods Administration - Australia

6-4-2018

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risks

Health Canada is advising Canadians that AA Pharma Inc. is voluntarily recalling two lots of Primidone tablets because they contain high levels of lead. The company has indicated that only the lots identified below are affected by this issue.

Health Canada

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

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

4-7-2012

Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

25-9-2018

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

The #FDA is extending the comment period by 60 days for the Pediatric Device Development Public Meeting docket.

FDA - U.S. Food and Drug Administration

17-8-2018

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here:  https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

FDA - U.S. Food and Drug Administration

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

24-5-2018

Xarelto (Bayer AG)

Xarelto (Bayer AG)

Xarelto (Active substance: rivaroxaban) - Centralised - Renewal - Commission Decision (2018)3264 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/944/R/60

Europe -DG Health and Food Safety

3-5-2018

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety