Doxylin 50% WSP

Main information

  • Trade name:
  • Doxylin 50% WSP
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Doxylin 50% WSP
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0171/001
  • Authorization date:
  • 19-01-2012
  • EU code:
  • NL/V/0171/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

LABELLINGANDPACKAGELEAFLET

A.LABELLING

<PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE>

Securitainerandbucket

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Doxylin50%WSP,powderfororalsolutioninpre-ruminantcalves,pigsandchickens

Doxycyclinehyclate

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Doxycyclinehyclate500mg/g

(equivalenttodoxycycline433mg/g)

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

1kg,2.5kg,5kg.

5. TARGETSPECIES

Pre-ruminantcalves,pigsandchickens

6. INDICATION

Treatmentofthefollowingspecifiedinfectionsoftherespiratorytractandthealimentarytractcausedby

micro-organismssusceptibletodoxycycline.

Pre-ruminantcalves:

-BronchopneumoniaandpleuropneumoniacausedbyPasteurellaspp.,Streptococcusspp.,Arcanobacterium

pyogenes,HistophilussomniandMycoplasmaspp..

Pigs:

-AtrophicrhinitiscausedbyPasteurellamultocidaandBordetellabronchiseptica;

-BronchopneumoniacausedbyPasteurellamultocida,StreptococcussuisandMycoplasmahyorhinis;

-PleuropneumoniacausedbyActinobacilluspleuropneumoniae.

Chickens:

-InfectionsoftherespiratorytractcausedbyMycoplasmaspp.,Escherichiacoli,Haemophilus

paragallinarumandBordetellaavium;

-EnteritiscausedbyClostridiumperfringensandClostridiumcolinum.

7. METHODANDROUTEOFADMINISTRATION

Oraluse,afterdissolutionindrinkingwater/milkreplacer.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Meatandoffal:

Calves:7days

Pigs:8days

Chickens:5days

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

Notpermittedforuseincattleproducingmilkforhumanconsumption.

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse.

10.EXPIRYDATE

Exp<<EXPmonth/year>>

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:useimmediately.

Onceopened,useby:

11.SPECIALSTORAGECONDITIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

13.THEWORDS"FORANIMALTREATMENTONLY"ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14.THEWORDS"KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN"

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveer

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

Tobecompletednationally

17.MANUFACTURER'SBATCHNUMBER

Batch<<number>>

B.PACKAGELEAFLET

PACKAGELEAFLET

Doxylin50%WSP,powderfororalsolutioninpre-ruminantcalves,pigsandchickens

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveer

TheNetherlands

Manufacturerresponsibleforthebatchrelease:

DopharmaB.V.

Zalmweg24

4941VXRaamsdonksveer

TheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Doxylin50%WSP,powderfororalsolutioninpre-ruminantcalves,pigsandchickens

Doxycyclinehyclate

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance:

Doxycyclinehyclate500mg/g

(equivalenttodoxycycline433mg/g)

Slightlyyellowishpowder.

4. INDICATION

Treatmentofthefollowingspecifiedinfectionsoftherespiratorytractandthealimentarytractcausedby

micro-organismssusceptibletodoxycycline.

Pre-ruminantcalves:

-BronchopneumoniaandpleuropneumoniacausedbyPasteurellaspp.,Streptococcusspp.,Arcanobacterium

pyogenes,HistophilussomniandMycoplasmaspp..

Pigs:

-AtrophicrhinitiscausedbyPasteurellamultocidaandBordetellabronchiseptica;

-BronchopneumoniacausedbyPasteurellamultocida,StreptococcussuisandMycoplasmahyorhinis;

-PleuropneumoniacausedbyActinobacilluspleuropneumoniae.

Chickens:

-InfectionsoftherespiratorytractcausedbyMycoplasmaspp.,Escherichiacoli,Haemophilus

paragallinarumandBordetellaavium;

-EnteritiscausedbyClostridiumperfringensandClostridiumcolinum.

5. CONTRAINDICATIONS

Donotuseincaseofhypersensitivitytotetracyclinesoranyoftheexcipients.

Donotadministertoanimalswithsevereliver-orkidneyinsufficiency.

6. ADVERSEREACTIONS

Noneknown.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Pre-ruminantcalves,pigs,chickens

8. DOSAGEFOREACHSPECIES,ROUTE(S)ANDMETHOD(S)OFADMINISTRATION

Pre-ruminantcalves: 10mgdoxycyclinehyclate/kgbodyweight/day,

correspondingto20mgofproductperkgbodyweight,

for3-5consecutivedays,dividedover2administrations.

Pigs:

10mgdoxycyclinehyclate/kgbodyweight/day,

correspondingto20mgofproductperkgbodyweight,

for3-5consecutivedays.

Chickens:

25mgdoxycyclinehyclate/kgbodyweight/day,

correspondingto50mgofproductperkgbodyweight,

for3-5consecutivedays.

Tobeadministeredorallythroughthemilk-replacerand/orthedrinkingwater.

9. ADVICEONCORRECTADMINISTRATION

Fortheadministrationthroughthedrinkingwater,theexactdailyamountofproductshouldbecalculated,

basedontherecommendeddose,andthenumberandweightoftheanimalstobetreated,accordingtothe

followingformula:

mgproduct/kgbodyweight/day x Meanbodyweight(kg)of

animalstobetreated

=....mgproductper

litredrinkingwater Meandailywaterconsumption(litre)peranimal

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible.

Theuptakeofmedicatedwaterisdependantontheclinicalconditionsoftheanimals.Inordertoobtainthe

correctdosage,theconcentrationindrinkingwatermayhavetobeadjusted.

Theuseofsuitablycalibratedweighingequipmentisrecommendedifpartpacksareused.Thedailyamount

istobeaddedtothedrinkingwatersuchthatallmedicationwillbeconsumedin24hours.Medicated

drinkingwatershouldbefreshlypreparedevery24hours.Itisrecommendedtoprepareaconcentratedpre-

solution-approximately100gramsproductperlitredrinkingwater-andtodilutethisfurthertotherapeutic

concentrationsifrequired.Alternatively,theconcentratedsolutioncanbeusedinaproportionalwater

medicator.

Themedicatedmilkreplacershouldbeusedimmediately.

10. WITHDRAWALPERIOD

Meatandoffal:

Calves:7days

Pigs:8days

Chickens:5days

Notpermittedforuseinlayingbirdsproducingeggsforhumanconsumption.

Notpermittedforuseincattleproducingmilkforhumanconsumption.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Donotuseaftertheexpirydatestatedonthelabelafterexp.

Shelflifeafterfirstopeningthecontainer:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:useimmediately.

12. SPECIALWARNINGS

Specialprecautionsforuseinanimals

Duetovariability(time,geographical)insusceptibilityofbacteriafordoxycycline,bacteriologicalsampling

andsusceptibilitytestingofmicro-organismsfromdiseasedanimalsonfarmarehighlyrecommended.

AhighresistancerateofE.coli,isolatedfromchickens,againsttetracyclineshasbeendocumented.

ThereforetheproductshouldbeusedforthetreatmentofinfectionscausedbyE.colionlyafter

susceptibilitytestinghasbeencarriedout.Resistancetotetracyclineshasalsobeenreportedinpig

respiratorypathogens(A.pleuropneumoniae,S.suis,)andcalfpathogens(Pasteurellaspp)insomeEU

countries.

Aseradicationofthetargetpathogensmaynotbeachieved,medicationshouldthereforebecombinedwith

goodmanagementpractices,e.g.goodhygiene,properventilation,nooverstocking.

Userwarnings

Duringthehandlingoftheproduct,skincontactandinhalationhastobeavoided,takingintoaccounttherisk

ofsensitizationandcontactdermatitis.Forthatpurposewearglovesandadustmask.

Useduringpregnancy,lactationorlay

Duetodepositofdoxycyclineinyoungbonetissue,useoftheproductshouldbelimitedduringpregnancy

andlactation.

Interactionswithothermedicinalproductsandotherformsofinteraction

Donotuseinconjunctionwithbactericidalantibiotics,suchaspenicillinsandcephalosporins.

Tetracyclinescanchelatecations(e.g.Mg,Mn,FeandAl)andthismayleadtodecreasedbioavailability.

Overdose(symptoms,emergencyprocedures,antidotes)

Incalvesacute,sometimesfatalmyocardialdegenerationcanoccurfollowingsingleormultipledosages.

Sincemostlythisiscausedbyoverdosage,itisimportanttomeasurethedosageaccurately.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

Tobecompletednationally

15. OTHERINFORMATION

Tobecompletednationally

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FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

18-4-2018

ViaGro 500mg Male Enhancement capsules

ViaGro 500mg Male Enhancement capsules

Safety advisory

Therapeutic Goods Administration - Australia

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

28-3-2018

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

Public Notification: Rhino 69 Extreme 50000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

25-9-2017

Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.

Danish Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety