APIGUARD

Main information

  • Trade name:
  • APIGUARD
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APIGUARD
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • thymol
  • Therapeutic area:
  • Bees

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0132/001
  • Authorization date:
  • 17-10-2011
  • EU code:
  • FR/V/0132/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

11767APIGUARDRENEWALSPCfinalversion

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Formatiert:Englisch(USA)

SUMMARYOFPRODUCTCHARACTERISTICS

1. Nameoftheveterinarymedicinalproduct

APIGUARDgel(25%thymol)forbeehiveuse

2. Qualitativeandquantitativecomposition

Thymol…………………………………………12.5g

Forafulllistofexcipients,seesection6.1

3. Pharmaceuticalform

Gel

Slightlyopalescent,colourlesstopinkgranulargel.

4. Clinicalparticulars

4.1.Targetspecies

Honeybees (Apismellifera).

4.2.Indicationsforuse,specifyingthetargetspecies

TreatmentofvarroosisduetoVarroadestructor

4.3.Contraindications

Noneknown.

4.4.Specialwarningsforeachtargetspecies

Careshouldbetakentoensurethattheauthoriseddosagescheduleisadheredtoasimproperdosing

coulddeleteriouslyaffectthecolony.

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Donottreatduringhoneyflowtoavoidpotentialtastetainting.

Thetreatmentcanbeperformedimmediatelyaftertheremovalofthesupers.

Donotusetheproductwhenthemaximumdailytemperatureexpectedduringthetreatmentislower

than15°Corwhenthecolonyactivityisveryloworwhentemperatureisabove40°C.

Combineweakcoloniesbeforetreatment.

Allcoloniesofanapiaryshouldbetreatedsimultaneously

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductsto

animals

Becauseofpossiblecontactdermatitisandirritationoftheskinandeyes,directskinandeyecontact

shouldbeavoided.

Whenhandlingtheproduct,wearimpermeableglovesaswellastheusualprotectionequipment.

Afterapplication,washhandsandthematerialbeingincontactwiththegelwithsoapandwater.

11767APIGUARDRENEWALSPCfinalversion

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Formatiert:Englisch(USA)

Incaseofskincontact,washthoroughlytheaffectedareawithsoapandwater.

Incaseofeyecontact,washtheeyesthoroughlywithcopiousamountsofcleanrunningwaterand

seekmedicaladvice.

Donotinhale.

iii)Otherprecautions

4.6.Adversereactions(frequencyandseriousness)

Aslightagitationofthecolonyduringthetreatmentispossible.

Occasionallyathightemperaturesomeslightreductioninyoungbroodcanoccurduringthetreatment

period;thisistransientandhasnoeffectonthedevelopmentofthecolony.

4.7.Useduringpregnancy,lactationorlay

Notapplicable

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9.Amount(s)tobeadministeredandadministrationroute

Treatmentinthehive:twoapplicationsof50gofgelpercolonyata2weekinterval.

Maximumoftwotreatmentsperyear.

Methodofadministration

Openthehive.Peelbackthefoillidofthetrayleavingonecornerofthelidattachedtothetray.Place

theopentraycentrallyonthetopoftheframes,gelsideup.

Ensurethatthereisafreespaceofatleast0.5cmbetweenthetopofthetrayandthehivecover

board.Closethehive.Aftertwoweeksreplacethefirsttraywithanewoneaccordingtothesame

instruction.Leavetheproductinthecolonyuntilthetrayisempty.Removetheproductwheninstalling

thesupersonthecolony.

Theefficacyoftheproductismaximisediftheproductisusedinlatesummerafterthehoneyharvest

(whentheamountofbeebroodpresentisdiminishing).However,inthecaseofsevereinfestations,

theproductcanalsobeusedduringspringtime,whentemperaturesareabove15°C.

Efficacymayvarybetweencoloniesduetothenatureoftheapplication.Therefore,Theproduct

shouldbeusedasonetreatmentamongotherswithinanIntegratedPestManagementprogramme,

andmitefallregularlymonitored.IffurthersignificantmitefallisobservedduringthefollowingWinteror

Spring,itisrecommendedtouseanadditionalsecondaryWinterorSpringtreatmentforvarroa.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theuseofadosehigherthantherecommended(50ggelperapplicationcorrespondingto12.5gof

thymol)couldcausedisturbancesinthebehaviourofthecolony(agitation,absconding,orincreased

mortality).Incaseofoverdose,removetheexcessproductfromthecolony.

4.11.Withdrawalperiod(s)

Honey:Zerodays.

Donotuseduringhoneyflow.

11767APIGUARDRENEWALSPCfinalversion

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Formatiert:Englisch(USA)

5. Pharmacologicalproperties

Pharmacotherapeuticgroup:ectoparasiticidesfortopicaluse,includinginsecticides

ATCVetCode:QP53AX22

5.1.Pharmacodynamicproperties

Thymolhasacaricidalaction.However,itsexactmodeofactionisnotfullyunderstood.Itactsdirectly

onthemitesthroughinhalationandcontact.

Proteindenaturisationisoneoftheprobablemodesofactioninmites.

5.2.Pharmacokineticparticulars

Itisthoughtthat2/3oftheactioniselicitedbyinhalationand1/3bydirectcontactthroughhoneybees.

However,therelativeproportionofeachroutemayvarywithtemperatureandhoneybeeactivity.

Environmentalproperties

6. Pharmaceuticalparticulars

6.1.Listofexcipients

Carbomer

Triethanolamine

Water,purified

6.2.Incompatibilities

Notapplicable.

6.3.Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

6.4.Specialprecautionsforstorage

Donotstoreabove30°C.

Donotfreeze.

Keepunopenedinoriginalpackaging.

Protectfromdirectsunlight.

Donotstoretheproductnearpesticidesorotherchemicalsubstanceswhichcouldcontaminatethe

product.

Storeawayfromfoodstuffs.

6.5.Natureandcompositionofimmediatepackaging

Natureoftheimmediatepackaging:

Aluminiumtray.

Aluminiumlid.

Model(s)forsale:

Boxof10traysof50gofgel.

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

11767APIGUARDRENEWALSPCfinalversion

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Formatiert:Englisch(USA)

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7. Marketingauthorisationholder

VITA(EUROPE)LIMITED

21/23WOTESTREET

BASINGSTOKE

HAMPSHIRERG217NE

UNITEDKINGDOM

8. Marketingauthorisationnumber(s)

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14-12-2018


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14-12-2018


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14-12-2018


Summary of opinion: Rubraca,rucaparib,  13/12/2018,  Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Zirabev,bevacizumab,  13/12/2018,  Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004,  06/12/2018,  Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Summary of opinion: Evant,eimeria acervulina, strain 003 / eimeria maxima, strain 013 / eimeria mitis, live / eimeria praecox, live / eimeria tenella, strain 004, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Kriptazen,halofuginone,  06/12/2018,  Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Summary of opinion: Kriptazen,halofuginone, 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated),  06/12/2018,  Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Summary of opinion: Zulvac BTV Ovis,bluetongue vaccine (inactivated), 06/12/2018, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

22-11-2018


Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety