Powdox 100 mg/ml Oral Solution for Use in Drinking Water for Chickens and Pigs

Main information

  • Trade name:
  • Powdox 100 mg/ml Oral Solution for Use in Drinking Water for Chickens and Pigs
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Powdox 100 mg/ml Oral Solution for Use in Drinking Water for Chickens and Pigs
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • doxycycline
  • Therapeutic area:
  • Chicken Broilers, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0249/001
  • Authorization date:
  • 02-09-2012
  • EU code:
  • UK/V/0249/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2013

AN:00843/2012

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SOLDOXIN100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [ES,FR,IT]

ORIDOX100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [HU]

POWDOX100mg/mloralsolutionforuseindrinkingwaterforchickens

andpigs [UK]

FLUID-DOX100mg/mloralsolutionforuseindrinkingwaterfor

chickensandpigs [DK]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionperml:

Doxycycline.......................................................100mg

(equivalenttoDoxycyclinehyclate116.0mg)

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Oralsolutionforuseindrinkingwater.

Clear,dense,brownish-yellowsolution.

4. CLINICALPARTICULARS

4.1.Targetspecies

Chicken(broilers)andpigs.

4.2. Indicationsforuse,specifyingthetargetspecies

CHICKENS(BROILERS)

Preventionandtreatmentofchronicrespiratorydisease(CRD)and

mycoplasmosiscausedbymicroorganismssensitivetodoxycycline.

Revised:September2013

AN:00843/2012

Page2of8

PIGS

PreventionofclinicalrespiratorydiseaseduetoPasteurellamultocida

andMycoplasmahyopneumoniaesensitivetodoxycycline.

Thepresenceofthediseaseintheherdshouldbeestablishedbefore

treatment.

4.3.Contraindications

Donotuseincaseofhypersensitivitytotetracyclines.

Donotuseincasesofresistancetotetracyclines.

Donotuseinanimalswithhepaticdysfunction.

4.4. Specialwarningsforeachtargetspecies

Sickanimalsmayhaveareducedappetiteandaltereddrinkingpatterns

andshould,ifnecessary,bemedicatedparenterally.

Incasesofalteredfoodordrinkingwateruptake,theconcentrations

shouldbeadjustedinsuchawaythattherecommendeddosageis

achieved.

Donotadministertolayinghens.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Prolongedorrepeateduseofthisveterinarymedicinalproductis

discouraged.Attentionshouldbepaidtoavoidanceofstressful

conditionsandimprovementofmanagementpracticesandhygiene

standards.

Avoidadministrationinoxidiseddrinkingequipment.

Useoftheproductshouldbebasedonsusceptibilitytestingofthe

bacteriaisolatedfromtheanimal.Ifthisisnotpossible,therapyshould

bebasedonlocal(regionalandfarmlevel)epidemiologicalinformation

aboutsusceptibilityofthetargetbacteria,takingintoaccountofficial

nationalantimicrobialpolicies.Inappropriateuseoftheproductmay

increasetheprevalenceofbacteriaresistanttodoxycyclineandmay

decreasetheeffectivenessoftreatmentwithtetracyclines,duetothe

potentialforcross-resistance.

Duetovariability(time,geographical)insusceptibilityofbacteriafor

doxycycline,bacteriologicalsamplingandsusceptibilitytestingofmicro-

organismsfromdiseasedbirdsonfarmarehighlyrecommended.

AhighresistancerateofE.coli,isolatedfromchickens,against

tetracyclineshasbeendocumented.Thereforetheproductshouldbe

usedforthetreatmentofinfectionscausedbyE.colionlyafter

susceptibilitytestinghasbeencarriedout.

Revised:September2013

AN:00843/2012

Page3of8

Aseradicationofthetargetpathogensmaynotbeachieved,medication

shouldthereforebecombinedwithgoodmanagementpractices,e.g.

goodhygiene,properventilation,nooverstocking.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Tetracyclinesmay –inveryrarecases–inducephotosensitivityand

allergicreactions.

Donothandletheproductifyouarehypersensitivetotetracyclines.

Weargloves,workoverallandapprovedsafetyglasses.

Thisproductisacidandlikelytobeirritant.Avoidcontactwithskinand

eyes.Incaseofcontactwithskin,rinseimmediatelywithplentyofwater.

Incaseofcontactwitheyes,rinseimmediatelywithcopiousamountsof

waterandseekmedicaladvice.

Donotsmoke,eatordrinkwhilehandlingthisproduct.

Theproductcanbeharmfulbyskincontactandinhalationandmay

causeeyeirritation.

Incaseofaccidentalingestionseekmedicaladviseandshowthelabelto

thedoctor.

Ifanysymptomshouldappear,suchasacutaneouseruption,seek

promptmedicaladvice.Swellingoftheface,lipsoreyesorrespiratory

difficultiesarethemostserioussignswhichrequireurgentmedical

attention.

4.6. Adversereactions(frequencyandseriousness)

Allergicandphotosensitivityreactionscanoccur.Intestinalfloramaybe

affectediftreatmentisveryprolonged,andthismayresultindigestive

disturbance.

Ifsuspectedadversereactionsoccur,treatmentshouldbediscontinued.

4.7. Useduringpregnancy,lactationorlay

Theproductshouldnotbeusedduringpregnancyorlactation

4.8.Interactionwithothermedicinalproductsandotherformsof

interaction

Doxycyclineabsorptionmaybereducedbythepresenceofhigh

quantitiesofcalcium,iron,magnesiumoraluminiuminthediet.Donot

administertogetherwithantacids,kaolinandironpreparations.

Donotadministertogetherwithbactericidalantibiotics.

ThesolubilityoftheproductispHdependentandwillprecipitateifmixed

inalkalinesolution

Donotadministerwithmilkreplacers

Revised:September2013

AN:00843/2012

Page4of8

4.9. Amountstobeadministeredandadministrationroute

Tobeadministeredindrinkingwater

-CHICKEN(broilers):11.5 –23mgdoxycyclinehyclate/kgbody

weight/day,correspondingto0.1-0.2mlofPOWDOXperkgbody

weight,for3-5consecutivedays.

-PIGS:11.5mgdoxycyclinehyclate/kgbodyweight/day,

correspondingto0.1mlofPOWDOXperkgbodyweight,for5

consecutivedays.

Basedontherecommendeddose,andthenumberandweightofthe

animalstobetreated,theexactdailyamountofPOWDOXshouldbe

calculatedaccordingtothefollowingformula:

XmlPOWDOX/kg

b.w./day

x Meanbody

weight(kg)of

animalstobe

treated

= XmlPOWDOX

perldrinking

water

Meandailywaterconsumption(l)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.Theuptakeofmedicated

waterisdependantontheclinicalconditionoftheanimals.Inorderto

obtainthecorrectdosage,theconcentrationindrinkingwatermayhave

tobeadjusted.

Theuseofsuitablycalibratedweighingequipmentisrecommendedif

partpacksareused.Thedailyamountistobeaddedtothedrinking

watersuchthatallmedicationwillbeconsumedin24hours.Medicated

drinkingwatershouldbefreshlypreparedevery24hours.Itis

recommendedtoprepareaconcentratedpre-solution –approximately

100gramsproductperlitredrinkingwater –andtodilutethisfurtherto

therapeuticconcentrationsifrequired.Alternatively,theconcentrated

solutioncanbeusedinaproportionalwatermedicator.

Medicatedwatershouldbetheonlydrinkingsource.

Theremainingmedicatedwatershouldbedisposedofinaccordance

withlocalrequirements.

Ifnoimprovementinclinicalsignsisseenwithinthetreatmentduration,

thediagnosisshouldbereviewedandtreatmentchanged.

4.10.Overdose(symptoms,emergencyprocedures,antidotes)

Nodataavailable.

Revised:September2013

AN:00843/2012

Page5of8

4.11.Withdrawalperiod

Meat&offal:

Chickens(broilers):7days

Pigs:7days.

Eggs:Notpermittedforuseinlayingbirdsproducingeggsforhuman

consumption

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibiotic,Tetracyclines

ATCvetcode:QJ01AA02

5.1. Pharmacodynamicproperties

Doxycyclineisabacteriostaticagentthatactsbyinterferingwiththe

bacterialproteinsyntesisofsensitivespecies.

Doxycyclineisasemi-synthetictetracyclinederivedfromoxytetracicline.

Itactsonthesubunit30Softhebacterialribosome,towhichislinked

reversibly,blockingtheunionbetweenaminoacyl-tRNA(transferRNA)to

themRNA-ribosomecomplex,preventingtheadditionofnewaminoacids

intothegrowingpeptidechainandthusinterferingwithproteinsynthesis.

DoxycyclineisactiveagainstGram-positiveandGram-negativebacteria.

Spectrumofactivity:

Streptococcusspp.

Staphylococcusaureus

Chlamydiaspp.

Mycoplasmaspp.

Salmonellaspp.

Pasteurellamultocida

InvitrosensitivityofdoxycyclineagainstPasteurellamultocidaand

Bordetellabronchisepticastrainsisolatedfrompigshasbeendetermined

bymeansofaplatediffusionmethod,andagainstMycoplasma

hyopneumoniaebyadilutionmethod,withMIC

valuesof0.517

AccordingtotheNCCLSstandard,strainssensitivetodoxycyclinehave

Thereareatleasttwomechanismsofresistancetotetracyclines.The

mostimportantmechanismisduetodecreasedcellularaccumulationof

thedrug.Thisisduetotheestablishmentofeitherapumpelimination

pathoranalterationinthetransportsystemthatlimitstheuptakeof

tetracycline.Thealterationinthetransportsystemisproducedby

inducibleproteinscodifiedinplasmidsandtransposons.Theother

mechanismisevidencedbydecreasedribosomeaffinitiyforthe

Revised:September2013

AN:00843/2012

Page6of8

Tetracycline-Mg 2+ complex owing to chromosomal mutations.

Resistancetotetracyclinesmaynotonlybetheresultoftherapywith

tetracyclines,butmayalsobecausedbytherapywithotherantibiotics

leadingtoselectionofmulti-resistantstrainsincludingtetracyclines.

Althoughminimalinhibitoryconcentrations(MIC)tendtobelowerfor

doxycyclinethanforoldergenerationtetracyclines,pathogensresistant

toonetetracyclinearegenerallyalsoresistanttodoxycycline(cross

resistance).Bothlongtermtreatmentandtreatingforaninsufficient

lengthoftimeand/orsub-therapeuticdosagescanselectfor

antimicrobialresistanceandshouldbeavoided.

5.2. Pharmacokineticparticulars

Doxycyclineisbioavailableafteroraladministration.Whenorally

administered,itreachesvaluesgreaterthan70%inmostspecies.

Feedingcanmodifytheoralbioavailabilityofdoxycycline.Infasting

conditionsbioavailabilityisaround10-15%greaterthanwhentheanimal

isfed.

Doxycyclineiswelldistributedthroughthebodyasitishighlylipid

soluble.Itaccumulatedinliver,kidney,bonesandintestine;

enterohepaticrecyclingoccurs.Inlungs,italwaysreacheshigher

concentrationsthaninplasma.Therapeuticconcentrationshavebeen

detectedinaqueoushumour,myocardium,reproductivetissues,brain

andmammarygland.Plasmaproteinbindingis90-92%.

40%ofthedrugismetabolizedandlargelyexcretedthroughfaeces

(biliaryandintestinalroute),mainlyasmicrobiologicallyinactive

conjugates.

CHICKENS(broilers)

Afteroraladministration,doxycyclineisrapidlyabsorbedreaching

maximumconcentrations(C

)around1.5h.Bioavailabilitywasabout

75%.Thepresenceoffoodinthegastrointestinaltractreducesits

absorption,reachingabioavailabilityaround60%andextending

considerablythetimeatwhichitreachesthemaximumpeak

concentration,(t

)3.3h.

PIGS

Afteranoraldoseof10mg/kg/day,theconcentrationatsteadystate

(Css)wasaround1.30µg/mLandplasmaeliminationhalf-life(t1/2)was

7.01h.

6. PHARMACEUTICALPARTICULARS

6.1.Listofexcipients

Pyrrolidone

Propyleneglycol

Revised:September2013

AN:00843/2012

Page7of8

6.2.Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

6.3.Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:15

months

Shelflifeafterdilutionaccordingtodirections:24hours

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Donotstoreabove25ºC.

Protectfromlight.

6.5.Natureandcompositionofimmediatepackaging

Theproductispackagedinwhitehigh-densitypolyethylenecontainersof

1Land5L.Containersareclosedwithascrewcapofthesamematerial

withinductionsealing.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordance

withlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETPHARMAANIMALHEALTH,S.L.

LesCorts,23

08028Barcelona

SPAIN

8. MARKETINGAUTHORISATIONNUMBER

Vm32509/4006

9. DATEOFFIRSTAUTHORISATION

20August2008

10. DATEOFREVISIONOFTHETEXT

September2013

APPROVED 20/09/13

Revised:September2013

AN:00843/2012

Page8of8

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

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

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

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

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration