Isoflurane

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
    Ireland
  • 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

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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

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

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

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

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

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

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

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

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

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

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

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety