Isoflurane 100% Inhalation Vapour, Liquid

Main information

  • Trade name:
  • Isoflurane 100% Inhalation Vapour, Liquid
  • Pharmaceutical form:
  • Inhalation vapour, liquid
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Isoflurane 100% Inhalation Vapour, Liquid
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • isoflurane
  • Therapeutic area:
  • Cats, Dogs, Horses, Other, Other Birds

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0300/001
  • Authorization date:
  • 01-12-2012
  • EU code:
  • UK/V/0300/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:January2012

AN:01444/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Iso-Vet

Isoflurane1000mg/gInhalationVapour,liquid(AllCMSexceptSpain,

PortugalSweden,Denmark,Finland&Iceland)

IsoVet

IsoVet1000mg/gInhalationVapour,liquid(Spain&Portugal)

Attanevet

Isoflurane1000mg/gInhalationVapour,liquid(Denmark,Sweden,

Finland&Iceland)

ForuseinHorses,Dogs,Cats,OrnamentalBirds,Reptiles,Rats,Mice,

Hamsters,Chinchillas,Gerbils,GuineaPigsandFerrets.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

Isoflurane1000mg/g

Theveterinarymedicinalproductcontainsnoexcipients.

3. PHARMACEUTICALFORM

Inhalationvapour,Liquid.

Clear,colourless,mobile,heavyliquid

4. CLINICALPARTICULARS

4.1 TargetSpecies

Horses,dogs,cats,ornamentalbirds,reptiles,rats,mice,hamsters,

chinchillas,gerbils,guineapigsandferrets.

4.2 Indicationsforuse,specifyingthetargetspecies

Inductionandmaintenanceofgeneralanaesthesia.

4.3 Contra-indications

Donotuseincaseofknownsusceptibilitytomalignanthyperthermia.Do

notuseincaseofhypersensitivitytoisofluraneortootherhalogenated

agents.

Revised:January2012

AN:01444/2011

4.4 Specialwarningsforeachtargetspecies

Themetabolismofbirds,andtoanextentsmallmammals,isaffected

moreprofoundlybydecreasesinbodytemperature,duetohighsurface

areatobodyweightratio.Drugmetabolisminreptilesisslowandhighly

dependentuponenvironmentaltemperature.

Theeaseandrapidityofalterationofthedepthofanaesthesiawith

Isofluraneanditslowmetabolism,maybeconsideredadvantageousfor

itsuseinspecialgroupsofpatientssuchastheoldoryoung,andthose

withimpairedhepatic,renalorcardiacfunction.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Isofluranehaslittleornoanalgesicproperties.Adequateanalgesiashould

alwaysbegivenbeforesurgery.Theanalgesicrequirementsofthepatient

shouldbeconsideredbeforegeneralanaesthesiaisended.

Theuseoftheproductinpatientswithcardiacdiseaseshouldbe

consideredonlyafterarisk/benefitassessmentbytheveterinarian.

Itisimportanttomonitorbreathingandpulseforthefrequencyandits

features.Respiratoryarrestshouldbetreatedbyassistedventilation.Itis

importanttomaintainairwaysfreeandproperlyoxygenatetissuesduring

themaintenanceofanaesthesia.Inthecaseofcardiacarrest,performa

completecardiopulmonaryresuscitation.

ii. Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals

Donotbreathethevapour.UsersshouldconsulttheirNationalAuthority

foradviceonOccupationalExposureStandardsforisoflurane.

Operatingroomsandrecoveryareasshouldbeprovidedwithadequate

ventilationorscavengingsystemstopreventtheaccumulationof

anaestheticvapour.

Allscavenging/extractionsystemsmustbeadequatelymaintained.

Pregnantandbreast-feedingwomenshouldavoidcontactwiththe

productandshouldavoidoperatingroomsandanimalrecoveryareas.

Avoidusingmaskingproceduresforprolongedinductionandmaintenance

ofgeneralanaesthesia.Usecuffedendotrachealintubationwhenpossible

fortheadministrationofisofluraneduringmaintenanceofgeneral

anaesthesia.

Toprotecttheenvironment,itisconsideredgoodpracticetousecharcoal

filterswithscavengingequipment.

Careshouldbetakenwhendispensingisoflurane,withanyspillage

removedimmediatelyusinganinertandabsorbentmateriale.g.sawdust.

Revised:January2012

AN:01444/2011

Washanysplashesfromskinandeyes,andavoidcontactwiththemouth.

Ifsevereaccidentalexposureoccursremovetheoperatorfromthesource

ofexposure,seekurgentmedicalassistanceandshowthislabel.

Halogenatedanaestheticagentsmayinduceliverdamage.Incaseof

isofluranethisisanidiosyncraticresponseveryrarelyseenafterrepeated

exposure.

AdvicetoDoctors:Ensureapatentairwayandgivesymptomaticand

supportivetreatment.Notethatadrenalineandcatecholaminesmaycause

cardiacdysrhythmias.

4.6 Adversereactions(frequencyandseriousness)

Isofluraneproduceshypotensionandrespiratorydepressioninadose-

relatedmanner.Cardiacarrhythmiasandtransientbradycardiahavebeen

reportedonlyrarely.Malignanthyperthermiahasbeenreportedveryrarely

insusceptibleanimals.

WhenusingIsofluranetoanaesthetiseananimalwithaheadinjury,

considerationshouldbegivenastowhetherartificialventilationis

appropriatetomaintainnormalCO

levels,sothatcerebralbloodflow

doesnotincrease.

4.7 Useduringpregnancyandlactationorlay

Pregnancy:

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.Isofluranehasbeensafelyusedforanaesthesiaduring

caesareansectioninthedogandcat.

Lactation:

Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicamentsandotherformsofinteraction

Theactionofmusclerelaxantsinman,especiallythoseofthe

nondepolarising(competitive)typesuchasatracurium,pancuroniumor

vecuronium,isenhancedbyisoflurane.Similarpotentiationmightbe

expectedtooccurinthetargetspecies,althoughthereislittledirect

evidencetothiseffect.Concurrentinhalationofnitrousoxideenhances

theeffectofisofluraneinmanandsimilarpotentiationmightbeexpected

inanimals.

Theconcurrentuseofsedativeoranalgesicdrugsislikelytoreducethe

levelofisofluranerequiredtoproduceandmaintainanaesthesia.

Someexamplesaregivenin4.9.

Revised:January2012

AN:01444/2011

Isofluranehasaweakersensitisingactiononthemyocardium,tothe

effectsofcirculatingdysrhythmogeniccatecholamines,thanhalothane.

Isofluranemaybedegradedtocarbonmonoxidebydriedcarbondioxide

absorbents.

Forreptilesandsmallmammals,therearenodataavailable.

4.9Amount(s)tobeadministeredandadministrationroute

Isofluraneshouldbeadministeredusinganaccuratelycalibratedvaporiser

inanappropriateanaestheticcircuit,sincelevelsofanaesthesiamaybe

alteredrapidlyandeasily.

Isofluranemaybeadministeredinoxygenoroxygen/nitrousoxide

mixtures.

TheMAC(minimalalveolarconcentrationinoxygen)oreffectivedose

valuesandsuggestedconcentrationsgivenbelowforthetarget

speciesshouldbeusedasaguideorstartingpointonly.Theactual

concentrationsrequiredinpracticewilldependonmanyvariables,

includingtheconcomitantuseofotherdrugsduringtheanaesthetic

procedureandtheclinicalstatusofthepatient.

Isofluranemaybeusedinconjunctionwithotherdrugscommonlyusedin

veterinaryanaestheticregimesforpremedication,inductionandanalgesia.

Somespecificexamplesaregivenintheindividualspeciesinformation.

Theuseofanalgesiaforpainfulproceduresisconsistentwithgood

veterinarypractice.

RecoveryfromIsofluraneanaesthesiaisusuallysmoothandrapid.The

analgesicrequirementsofthepatientshouldbeconsideredbeforethe

terminationofgeneralanaesthesia.

Althoughanaestheticshavealowpotentialfordamagetotheatmosphere,

itisgoodpracticetousecharcoalfilterswithscavengingequipment,

ratherthantodischargethemintotheair.

HORSE

TheMACforisofluraneinthehorseisapproximately1.31%

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatible with isoflurane: acepromazine, alfentanil, atracurium,

Revised:January2012

AN:01444/2011

butorphanol, detomidine, diazepam, dobutamine, dopamine,

guaiphenesin,ketamine,morphine,pentazocine,pethidine,thiamylal,

thiopentoneandxylazine.Drugsusedforpremedicationshouldbe

selectedfortheindividualpatient.However,thepotentialinteractions

belowshouldbenoted.

Interactions:

DetomidineandxylazinehavebeenreportedtoreducetheMACfor

Isofluraneinhorses.

Induction

Asitisnotnormallypracticabletoinduceanaesthesiainadulthorses

usingisoflurane,inductionshouldbebytheuseofashortacting

barbituratesuchasthiopentonesodium,ketamineorguaiphenesin.

Concentrationsof3to5%isofluranemaythenbeusedtoachievethe

desireddepthofanaesthesiain5to10minutes

Isofluraneataconcentrationof3to5%inahighflowoxygenmaybe

usedforinductioninfoals.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to2.5%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

DOG

TheMACforisofluraneinthedogisapproximately1.28%.

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatible with isoflurane: acepromazine, atropine, butorphanol,

buprenorphine, bupivacaine, diazepam, dobutamine, ephedrine,

epinephrine, etomidate, glycopyrrolate, ketamine, medetomidine,

midazolam,methoxamine,oxymorphone,propofol,thiamylal,thiopentone

andxylazine.Drugsusedforpremedicationshouldbeselectedforthe

individualpatient.However,thepotentialinteractionsbelowshouldbe

noted.

Revised:January2012

AN:01444/2011

Interactions:

Morphine,oxymorphone,acepromazine,medetomidine,medetomidine

plusmidazolamhavebeenreportedtoreducetheMACforisofluranein

dogs.

Theconcomitantadministrationofmidazolam/ketamineduringisoflurane

anaesthesiamayresultinmarkedcardiovasculareffects,particularly

arterialhypotension.

Thedepressanteffectsofpropanololonmyocardialcontractilityare

reducedduringisofluraneanaesthesia,indicatingamoderatedegreeofβ-

receptoractivity.

Induction

Inductionispossiblebyfacemaskusingupto5%isoflurane,withor

withoutpremedication.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to2.5%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

CAT

TheMACforisofluraneinthecatisapproximately1.63%.

Premedication

Isofluranemaybeusedwithotherdrugscommonlyusedinveterinary

anaestheticregimes.Thefollowingdrugshavebeenfoundtobe

compatiblewithisoflurane:acepromazine,atracurium,atropine,diazepam,

ketamine,andoxymorphone.Drugsusedforpremedicationshouldbe

selectedfortheindividualpatient.However,thepotentialinteractions

belowshouldbenoted.

Interactions:

Intravenousadministrationofmidazolam-butorphanolhasbeenreported

toalterseveralcardio-respiratoryparametersinisoflurane-inducedcats

ashasepiduralfentanylandmedetomidine.Isofluranehasbeenshownto

reducethesensitivityofthehearttoadrenaline(epinephrine).

Revised:January2012

AN:01444/2011

Induction

Inductionispossiblebyfacemaskusingupto4%isoflurane,withor

withoutpremedication.

Maintenance

Anaesthesiamaybemaintainedusing1.5%to3%isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

ORNAMENTALBIRDS

FewMAC/ED

valueshavebeenrecorded.Examplesare1.34%forthe

Sandhillcrane,1.45%fortheracingpigeon,reducedto0.89%bythe

administrationofmidazolam,and1.44%forcockatoos,reducedto1.08%

bytheadministrationofbutorphanolanalgesic.

Theuseofisofluraneanaesthesiahasbeenreportedformanyspecies,

fromsmallbirdssuchaszebrafinches,tolargebirdssuchasvultures,

eaglesandswans.

Druginteractions/compatibilities

Propofolhasbeendemonstratedintheliteraturetobecompatiblewith

isofluraneanaesthesiainswans.

Interactions:

ButorphanolhasbeenreportedtoreducetheMACforisofluranein

cockatoos.MidazolamhasbeenreportedtoreducetheMACfor

isofluraneinpigeons.

Induction

Inductionwith3to5%isofluraneisnormallyrapid.Inductionof

anaesthesiawithpropofol,followedbyisofluranemaintenance,hasbeen

reportedforswans.

Revised:January2012

AN:01444/2011

Maintenance

Themaintenancedosedependsonthespeciesandindividual.Generally,

2to3%issuitableandsafe.

Only0.6to1%maybeneededforsomestorkandheronspecies.

Upto4to5%maybeneededforsomevulturesandeagles.

3.5to4%maybeneededforsomeducksandgeese.

Generally,birdsrespondveryrapidlytochangesinconcentrationof

isoflurane.

Recovery

Recoveryisusuallysmoothandrapid.

REPTILES

Isofluraneisconsideredbyseveralauthorstobetheanaestheticofchoice

formanyspecies.Theliteraturerecordsitsuseonawidevarietyof

reptiles(eg.variousspeciesoflizard,tortoise,iguanas,chameleonand

snakes).

TheED

wasdeterminedinthedesertiguanatobe3.14%at35˚Cand

2.83%at20˚C.

Druginteractions/compatibilities

Nospecificpublicationsonreptileshavereviewedcompatibilitiesor

interactionsofotherdrugswithisofluraneanaesthesia.

Induction

Inductionisusuallyrapidat2to4%isoflurane.

Maintenance

1to3%isausefulconcentration

Recovery

Recoveryisusuallysmoothandrapid

RATS,MICE,HAMSTERS,CHINCHILLAS,GERBILS,GUINEAPIGS

ANDFERRETS

Isofluranehasbeenrecommendedforanaesthesiaofawidevarietyof

‘smallmammals’(eg.rats,mouse,hamster,chinchilla,gerbil,guineapig

andferret).

Revised:January2012

AN:01444/2011

TheMACformicehasbeencitedas1.34%,andfortheratas1.38%,

1.46%and2.4%.

Druginteractions/compatibilities

Nospecificpublicationsonsmallmammalshavereviewedcompatibilities

orinteractionsofotherdrugswithisofluraneanaesthesia.

Induction

Isofluraneconcentration2to3%.

Maintenance

Isofluraneconcentration0.25to2%.

Recovery

Recoveryisusuallysmoothandrapid.

Species MAC(%) Induction(%) Maintenance

(%) Recovery

Horse 1.31 3.0 –5.0

(foals) 1.5 –2.5 Smoothand

rapid

Dog 1.28 Upto5.0 1.5 –2.5 Smoothand

rapid

Cat 1.63 Upto4.0 1.5 –3.0 Smoothand

rapid

Ornamental

birds Seeposology 3.0 –5.0 Seeposology Smoothand

rapid

Reptiles Seeposology 2.0 –4.0

1.0 –3.0

Smoothand

rapid

Rats,mice,

hamsters,

chinchillas,

gerbils,guinea

pigsand

ferrets 1.34(mouse)

1.38/1.46/2.40

(rat)

2.0 –3.0

0.25 –2.0 Smoothand

rapid

4.10Overdose (symptoms, emergency procedures, antidotes) if

necessary

Isofluraneoverdosemayresultinprofoundrespiratorydepression.

Therefore,respirationmustbemonitoredcloselyandsupportedwhen

necessarywithsupplementaryoxygenand/orassistedventilation.

Incasesofseverecardiopulmonarydepression,administrationof

isofluraneshouldbediscontinued,thebreathingcircuitshouldbeflushed

Revised:January2012

AN:01444/2011

withoxygen,theexistenceofapatentairwayensured,andassistedor

controlled ventilation with pure oxygen initiated. Cardiovascular

depressionshouldbetreatedwithplasmaexpanders,pressoragents,

antiarrhythmicagentsorotherappropriatetechniques.

4.11Withdrawalperiod(s)

Horses:meat2days

“Notauthorisedforuseinlactatinganimalsproducingmilkforhuman

consumption”

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anaesthetic,general-halogenated

hydrocarbons

ATCvetcode:QN01AB06

5.1 Pharmacodynamicproperties

Isofluraneproducesunconsciousnessbyitsactiononthecentralnervous

system.Ithaslittleornoanalgesicproperties.

Likeotherinhalationanaestheticsofthistype,isofluranedepressesthe

respiratoryandcardiovascularsystems.

5.2 PharmacokineticParticulars

sofluraneisabsorbedoninhalationandisrapidldistributediathe

bloodstreamtoothertissues,includingthebrain.tsbloodgaspartition

coefficientat3 Cis1.4.TheabsorptionanddistributionofIsofluraneand

theeliminationofnon-metabolisedisofluranebythelungsareallrapid,

withtheclinicalconsequencesofrapidinductionandrecoveryandeasy

andrapidcontrolofthedepthofanaesthesia.

Metabolismofisofluraneisminimal(about0.2%,mainlytoinorganic

fluoride)andalmostalloftheadministeredisofluraneisexcreted

unchangedbythelungs.

6. PHARMACEUTICALPARTICULARS

6.1 ListandExcipients

None

Revised:January2012

AN:01444/2011

6.2 Incompatibilities

Isofluranehasbeenreportedtointeractwithdrycarbondioxide

absorbentstoformcarbonmonoxide.Inordertominimisetheriskof

formationofcarbonmonoxideinrebreathingcircuitsandthepossibilityof

elevatedcarboxyhaemoglobinlevels,carbondioxideabsorbentsshould

notbeallowedtodryout.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.Protectfromdirectsunlight&directheat.

Storeintightlyclosedoriginalcontainer.

6.5 Natureandcompositionofimmediatepackaging

TypeIIIamberglassbottlescontaining100mlor250mlofIsoflurane,

fittedwithablackphenolic/ureascrewcapwithalow-densitypolyethylene

coneinsert.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PiramalHealthcareUKLimited

WhaltonRoad,

Morpeth,

NorthumberlandNE613YA,

UnitedKingdom

Tel:00441670562400

Fax:00441670562543

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 29595/4001

Revised:January2012

AN:01444/2011

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:12 th August2009

10. DATEOFREVISIONOFTHETEXT

Date:January2012

Conditionofsupply:PrescriptionOnlyMedicine

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

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

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

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

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

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

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

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

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