Phenoleptil 100 mg Tablets for Dogs

Main information

  • Trade name:
  • Phenoleptil 100 mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Phenoleptil 100 mg Tablets for Dogs
    Greece
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0336/004
  • Authorization date:
  • 24-10-2012
  • EU code:
  • UK/V/0336/004
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:January2013

AN:01563/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHENOLEPTIL100mgTabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstance mg

Phenobarbital 100

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Whitetooffwhite,circular,convextabletwithbrownspecklesandacrossedscoreline

ononeside(13mmdiameter).

Thetabletscanbedividedintotwoorfourequalparts.

4. CLINICALPARTICULARS

4.1Targetspecies

Dog.

4.2Indicationsforuse,specifyingthetargetspecies

Preventionofseizuresduetogeneralisedepilepsyindogs.

4.3Contraindications

Donotuseincaseofhypersensivitytotheactivesubstance.

Donotuseinanimalswithseriousimpairedhepaticfunction.

Donotuseinanimalswithseriousrenalorcardiovasculardisorders.

Donotuseindogsweighinglessthan10kgbodyweight.

4.4Specialwarningsforthetargetspecies

Thedecisiontostartantiepilepticdrugtherapywithphenobarbitalshouldbeevaluated

foreachindividualcaseanddependsonnumber,frequency,durationandseverityof

seizuresindogs.

Issued:January2013

AN:01563/2011

Page2of7

Generalrecommendationsforinitiatingtherapyincludeasingleseizureoccurringmore

thanonceevery4-6weeks,clusterseizureactivity(i.e.morethanoneseizurewithin24

h)orstatusepilepticusregardlessoffrequency.

Toachievesuccessfultherapy,administrationoftabletsmustbeatthesametimeeach

day.

Withdrawalortransitionfromothertypesofantiepileptictherapyshouldbemade

graduallytoavoidprecipitatinganincreaseinthefrequencyofseizures.

Someofthedogsarefreeofepilepticseizuresduringthetreatment,butsomeofthe

dogsshowonlyaseizurereduction,andsomeofthedogsareconsideredtobenon-

responders.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Cautionisrecommendedinanimalswithimpairedhepaticandrenalfunction,

hypovolemia,anemiaandcardiacorrespiratorydysfunction.

Theriskofhepatotoxicsideeffectscanbediminishedordelayedusinganeffective

dosethatisaslowaspossible.Monitoringofhepaticparametersisrecommendedin

caseofaprolongedtherapy

Itisrecommendedtoassesstheclinicalpathologyofthepatient2-3weeksafterstartof

treatmentandafterwardsevery4-6months,e.g.measurementofhepaticenzymesand

serumbileacids.Itisimportanttoknowthattheeffectsofhypoxiaetc.docause

increasedlevelsofhepaticenzymesafteraseizure.

Phenobarbitalmayincreasetheactivityofserumalkalinephosphataseand

transaminases.Thesemaydemonstratenon-pathologicalchanges,butcouldalso

representhepatotoxicity.Therefore,inthecaseofsuspectedhepatotoxicity,liver

functiontestsarerecommended.Increasedliverenzymevaluesdonotrequireadose

reductionofPhenobarbitaliftheserumbileacidsareinthenormalrange.

Instabilisedepilepticpatients,itisnotrecommendedtoswitchfromotherphenobarbital

formulationstoPhenoleptilTablets.However,ifthiscannotbeavoidedthenadditional

cautionshouldbetaken.Thisincludesmorefrequentplasmaconcentrationsamplingto

ensurethattherapeuticlevelsaremaintained.Monitoringforincreasedsideeffectsand

forhepaticdysfunctionshouldbeconductedmoreregularlyuntilstabilisationis

confirmed.

WithdrawaloftherapywithPhenobarbitalformulationsshouldbemadegraduallyto

avoidprecipitatinganincreaseinthefrequencyofseizures.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytobarbituratesshouldavoidcontactwiththe

veterinarymedicinalproduct.Washhandsafteruse.

Takeutmostcarethatchildrendonotcomeintoanycontactwiththeproduct.

Childrenareparticularlyatriskofintoxicationwhichmayprovefatal.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.Ifpossible,thephysicianshouldbe

informedaboutthetimeandamountofingestion,asthisinformationmayhelptoensure

thatappropriatetreatmentisgiven.

Issued:January2013

AN:01563/2011

Page3of7

4.6Adversereactions(frequencyandseriousness)

Duringstartoftherapyataxia,sleepiness,slacknessanddizzinesscanoccurbutthese

effectsareusuallytransitoryanddisappearinmost,butnotall,patientswithcontinued

medication.

Someanimalscandemonstrateaparadoxicalhyperexcitability,particularlyafterfirst

startingtherapy.

Asthishyperexcitabilityisnotlinkedtooverdosage,noreductionofdosageisneeded.

Polyuria,polydipsiaandpolyphagiacanoccurataverageorhighertherapeuticactive

serumconcentrations;theseeffectscanbediminishedbylimitingintakeofbothfood

andwater.

Sedationandataxiaoftenbecomesignificantconcernsasserumlevelsreachthehigher

endsofthetherapeuticrange.

Highplasmaconcentrationsmaybeassociatedwithhepatotoxicity.

Phenobarbitalcanhavedeleteriouseffectsonstemcellsfrombonemarrow.

Consequencesareimmunotoxicpancytopeniaand/orneutropenia.Thesereactions

disappearafterthetreatment’swithdrawal.

TreatingdogswithphenobarbitalmaylowertheirTT4orFT4serumlevels,howeverthis

maynotbeanindicationofhypothyroidism.Treatmentwiththyroidhormone

replacementshouldonlybestartedifthereareclinicalsignsofthedisease.

Ifadverseeffectsaresevere,adecreaseintheadministereddoseisrecommended.

4.7Useduringpregnancy,lactationorlay

Phenobarbitalcrossestheplacentalbarrierandathigherdoses(reversible)withdrawal

symptomsinnewbornscannotbeexcluded.Studiesinlaboratoryanimalshaveshown

evidenceofactionofphenobarbitalonprenatalgrowth,especiallyconcerningsexual

development.Neonatalbleedingtendencieshavebeenassociatedwithphenobarbital

treatmentduringpregnancy.AdministrationofVitaminKtothedamfor10daysbefore

parturitionmayhelptominimizetheseeffectsonthefetus.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyofdogs.Thebenefitsoftreatmentmaybegreaterthanthepotentialrisks

associatedwithepilepticseizuresonthefetus(hypoxiaandacidosis).Therefore,in

caseofpregnancy,terminationofantiepileptictreatmentisnotrecommended;however,

thedoseshouldbeaslowaspossible.

Phenobarbitalisexcretedinsmallamountsinbreastmilkandduringnursingpups

shouldbemonitoredcarefullyforundesiredsedativeeffects.Weaningearlymaybean

option.Ifsomnolence/sedativeeffects(thatcouldinterferewithsuckling)appearin

nursingnewborns,anartificialsucklingmethodshouldbechosen.

Useduringpregnancyandlactationonlyaccordinglytothebenefit/riskassessmentby

theresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Atherapeuticdoseofphenobarbitalforantiepileptictherapycansignificantlyinduce

plasmaprotein(suchasα1acidglycoprotein,AGP),whichbinddrugs.Thereforespecial

attentionmustbepaidtothepharmacokineticsanddosesofdrugssimultaneously

administered.

Issued:January2013

AN:01563/2011

Page4of7

Theplasmaticconcentrationofcyclosporine,thyroidhormonesandtheophyllineis

decreasedinthecaseofconcurrentadministrationofphenobarbital.Theeffectiveness

ofthesesubstancesisdiminishedtoo.

Cimetidineandketoconazoleareinhibitorsofhepaticenzymes:concurrentusewith

phenobarbitalcaninduceanincreaseofserumconcentrationofphenobarbital.

Concurrentusewithpotassiumbromideincreasestheriskofpancreatitis.

Concurrentusewithotherdrugshavingacentraldepressiveactionlikenarcotic

analgesics,morphinicderivates,phenothiazines,antihistamines,clomipramineand

chloramphenicolcandecreasetheeffectofphenobarbital.

Phenobarbitalmayenhancethemetabolismof,andthereforedecreasetheeffectof,

antiepileptics,chloramphenicol,corticosteroids,doxycycline,betablockersand

metronidazole.

Thereliabilityoforalcontraceptivesislower.

Phenobarbitalmaydecreasetheabsorptionofgriseofulvin.

Thefollowingdrugscandecreasetheconvulsivethreshold:qu inolones,highdosesofβ-

lactamantibiotic,theophyllin,aminophyllin,cyclosporineandpropofolforexample).

Medicationswhichmayaltertheseizurethresholdshouldonlybeusedifreally

necessaryandwhennosaferalternativeexists.

4.9Amountstobeadministeredandadministrationroute

Administrationroute

Fororaladministration.Amountstobeadministered

Therecommendedinitialdosageis2.5mgphenobarbitalperkgbodyweighttwice

daily.Thecrossedscorelineononesideofthetabletallowsdivisionintotwo(eachpart

of50mgphenobarbital)orfour(eachpartof25mgphenobarbital)equalparts.

Tabletsmustbegivenatthesametimeeachdaytoachievesuccessfultherapy.

Foraccuracyofdosing,dogsunder10kgshouldcommencetherapywithPhenoleptil

12.5mgor25mgTablet.

Eventualadjustmentsofthisdosageshouldbemadeonthebasisofclinicalefficacy,

bloodlevelsandtheoccurrenceofundesirablesideeffects.Alsoseeundersection

4.5i).

Theserumphenobarbitalconcentrationsshouldbemeasuredaftersteadystatehas

beenachieved.Theidealtherapeuticrangeforserumphenobarbitalconcentrationis

between15and40µg/ml.Ifserumphenobarbitalconcentrationislessthan15µg/mlor

theseizuresarenotcontrolledthedosemaybeincreasedby20%atatime,with

associatedmonitoringofserumphenobarbitallevelsuptoamaximumserum

concentration45µg/ml.Theultimatedosesmayvaryconsiderably(rangingfrom1mgto

15mgperkgbodyweighttwicedaily)becauseofthedifferencesinphenobarbital

excretionanddifferencesinsensitivityamongpatients.

Iftheseizuresarenotbeingsatisfactorilycontrolledandifthemaximumlevel

concentrationisabout40µg/ml,thenthediagnosisshouldbereconsideredand/ora

secondantiepilepticproduct(suchasbromides)shouldbeaddedtothetreatment

protocol.

Instabilisedepilepticpatients,itisnotrecommendedtoswitchfromotherphenobarbital

formulationstoPhenoleptilTablets.However,ifthiscannotbeavoidedthenadditional

cautionshouldbetaken.Itisrecommendedtotrytoachieveassimilardosagesas

possiblecomparedwiththepreviousformulationusedtakingintoconsiderationcurrent

plasmaconcentrationmeasurements.Stabilisationprotocolsasforinitiatingtreatments

shouldbefollowed.Alsoseesection4.5i).

Issued:January2013

AN:01563/2011

Page5of7

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Symptomsofoverdoseare:

-depressionofthecentralnervoussystemdemonstratedbysignsrangingfromsleepto

coma,

-respiratoryproblems,

-cardiovascularproblems,hypotensionandshockleadingtorenalfailureanddeath.

Incaseofoverdoseremoveingestedproductfromthestomach,forexamplebylavage.

Activatedcharcoalmaybegiven.Offerrespiratorysupport.

Thereisnospecificantidote,butCNSstimulants(likeDoxapram)maystimulatethe

respiratorycentre.Giveoxygensupport.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiepileptics/barbituratesandderivates

ATCvetcode:QN03AA02.

5.1Pharmacodynamicproperties

Theantiepilepticeffectsofphenobarbitalareprobablytheresultofatleasttwo

mechanisms,beingdecreasedmonosynaptictransmission,whichpresumablyresultsin

reducedneuronalexcitabilityandanincreaseinthemotorcortex'sthresholdfor

electricalstimulation.

5.2Pharmacokineticparticulars

Afteroraladministrationofphenobarbitaltodogs,thedrugisrapidlyabsorbedand

maximalplasmaconcentrationsarereachedwithin4-8hours.Bioavailabilityisbetween

86%-96%,apparentvolumeofdistributionis0,75l/kgandasteadystateserum

concentrationisreached2-3weeksafterstartoftherapy.

About45%oftheplasmaconcentrationisproteinbound.Metabolismisbyaromatic

hydroxylationofthephenylgroupintheparaposition(p-hydroxyphenobarbital),and

about25%ofthedrugisexcretedunchangedintheurine.Eliminationhalf-livesvary

considerablybetweenindividualsandrangefromabout40-90hours.

Environmentalproperties

None.

Issued:January2013

AN:01563/2011

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DryBeefFlavour201627

LactoseMonohydrate

MicrocrystallineCellulose

SodiumStarchGlycolate(TypeA)

Silica,ColloidalAnhydrous

MagnesiumStearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Returnanydividedtabletstotheopenedblisterpackandusewithin48hours.

6.4.Specialprecautionsforstorage

Donotstoreabove30 o

C.

Keepthecontainerintheouterpackageinordertoprotectfromlight.

Dividedtabletsshouldbestoredintheopenblisterpack.

6.5Natureandcompositionofimmediatepackaging

100tabletsinacardboardcartoncontaining10aluminium/pvcblisterstripseachstrip

with10tablets.

500tabletsinacardboardcartoncontaining50aluminium/pvcblisterstripseachstrip

with10tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Issued:January2013

AN:01563/2011

Page7of7

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm19994/4031

9. DATEOFFIRSTAUTHORISATION

28January2013

10.DATEOFREVISIONOFTHETEXT

January2013

Approved: 28/01/2013

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

22-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

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

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety