SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pig

Main information

  • Trade name:
  • SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pig
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SODIUM SALICYL 80% WSP, powder for oral solution for cattle (calves) and pig
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • sodium salicylate
  • Therapeutic area:
  • Cattle Food, Pigs Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0133/001
  • Authorization date:
  • 27-05-2011
  • EU code:
  • NL/V/0133/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs(BE,BG,DE,EE,

EL,HU,IT,LT,LV,NL,PT,RO).

SODIUMSALICYL80%,powderfororalsolutionforcattle(calves)andpigs(IE,UK).

SALIMED80%,powderfororalsolutionforcattle(calves)andpigs(PL).

SALIVET80%,powderfororalsolutionforcattle(calves)andpigs(FR).

SINTEM800mg/g,powderfororalsolutionforcattle(calves)andpigs(ES).

SODILIN,800mg/g,powderfororalsolutionforcattle(calves)andpigs(DK).

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Pergram:

Activesubstance:

Sodiumsalicylate:800mg

(equivalentto690mgofsalicylicacidassodiumsalt)

Excipient:

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Powderfororalsolution.

Whiteoralmost-whitepowder.

4.CLINICALPARTICULARS

4.1 Targetspecies

Cattle(calves)andpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate

(anti-infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

4.3 Contraindications

Donotadministertoanimalswithsevereliverandkidneyaffections.

Donotadministerincaseofgastrointestinalulcerationsandchronicgastrointestinaldisorders.

Donotadministerincaseofmalfunctionofthehematopoeticsystem,coagulopathies,

haemorrhagicdiathesis.

Donotusesodiumsalicylatesinneonatesorcalveslessthan2weeksofage.

Donotuseinpigletslessthan4weeksofage.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Giventhatsodiumsalicylatemayinhibitclottingofblood,itisrecommendedthatelective

surgeryshouldnotbeperformedonanimalswithin7daysaftertheendoftreatment.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytosodiumsalicylateorcorrelatedpharmaceuticals(e.g.

aspirin)orexcipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Irritationoftheskin,eye,andrespiratorytractmightoccur.Duringpreparationandmixingofthe

product,directcontactwiththeskinandeyes,anddirectinhalationofthepowdershouldbe

avoided.Itisrecommendedtoweargloves,safetyglasses,andadustmask.Particularattention

shouldbetakenwhenopeningthebucket.

Washaccidentalexposuretoskinimmediatelywithwater.

Intheeventofaccidentaleyecontact,theuserisadvisedtowashtheeyewithplentyofwaterfor

15minutes,andseekmedicaladviceifirritationpersists.

Duringadministrationofthemedicineasreconstitutedproductindrinkingwaterormilk

(replacer)totheanimalsskincontactshouldbepreventedbywearinggloves.Washaccidentally

exposedskinimmediatelywithwater.

4.6 Adversereactions(frequencyandseriousness)

Gastrointestinalirritationmayoccurespeciallyinanimalswithpre-existinggastrointestinal

disease.Suchirritationmayclinicallybemanifestedbyproductionofblackmanureduetoblood

lossinthegastrointestinaltract.

Inhibitionofnormalbloodclottingmayoccurincidentally.Ifthiseffectoccursitwillbe

reversibleandeffectswilldiminishwithinapproximately7days.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratshaveshownevidenceofteratogenicandfoetotoxiceffects.

Salicylicacidcrossestheplacentaandisexcretedwiththemilk.Half-lifeinthenew-bornis

longerandthustoxicitysymptomsmayoccurmuchsooner.Furthermoreplateletaggregationis

inhibitedandbleedingtimeisincreased,asituationwhichisnotfavourableduringharddelivery/

caesareansection.Finallysomestudiesindicatethatdeliveryispostponed.

Theproductshouldnotbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminoglycosides)shouldbe

avoided.

Salicylicacidishighlyplasma(albumin)boundandcompeteswithavarietyofcompoundsfor

plasmaproteinbindingsites(e.g.ketoprofen).

Plasmaclearanceofsalicylicacidhasbeenreportedtoincreaseincombinationwith

corticosteroids,possiblyduetoinductionofmetabolismofsalicylicacid.

ConcurrentusewithotherNSAIDsisnotrecommended,becauseofincreasedriskofgastro-

intestinalulcers.

Donotuseincombinationwithdrugsknowntohaveanticoagulantproperties.

4.9 Amountstobeadministeredandadministrationroute

Cattle: 40mgsodiumsalicylateperkgofbodyweightoncedaily,

(equivalentto50mgproductperkgBWperday),

for1-3days.

Pigs: 35mgsodiumsalicylateperkgofbodyweightperday,

(equivalentto43.75mgproductperkgBWperday),

for3-5days.

SodiumSalicyl80%WSPcanbeadministeredorallythroughthemilk-replacerand/orthe

drinkingwater.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Calvestoleratedosagesupto80mg/kgfor5daysor40mg/kgfor10dayswithoutanyadverse

effects.

Pigstoleratedosagesupto175mg/kgforupto10dayswithoutanysignificantadverseeffects.

Incaseofanacuteoverdoseintravenousbicarbonateinfusionresultsinahigherclearanceof

salicylicacidbyalkalisationoftheurineandmaybebeneficialincorrecting(secondary

metabolic)acidosis.

4.11Withdrawalperiod(s)

Cattleandpigs:

Meatandoffal:zerodays.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:NSAID

ATCvet-code:QN02BA04

5.1 Pharmacodynamicproperties

Sodiumsalicylateisanon-steroidalanti-inflammatorydrug(NSAID)andexertsananti-

inflammatory,analgesicandanti-pyreticeffect.Theeffectsarelinkedtotheinhibitionofthe

enzymecyclo-oxygenasebywhichthesynthesisofprostaglandin(mediatorforinflammation)

decreases.

5.2 Pharmacokineticproperties

Orallyingestedsalicylatesareabsorbedrapidlybypassivediffusion,partlyfromthestomachbut

mostlyfromtheuppersmallintestine.

Afterabsorption,salicylateisdistributedthroughoutmostbodytissues.Valuesofvolumeof

distribution(Vd)arehigherinthenewborns.Halflivesarelongerintheveryyoungresultingin

slowereliminationofthesubstance.Thisismostprominentinanimalsupto7-14daysofage.

Themetabolismofsalicylatetakesmainlyplaceinhepaticendoplasmicreticulumand

mitochondria.

ExcretionismainlyviatheurineandisapH-dependentprocess.

6.PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Lactosemonohydrate

6.2 Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:36months.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

6.4.Specialprecautionsforstorage

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

6.5 Natureandcompositionofimmediatepackaging

-Compositecan:containerconsistingofPET/aluminium/adhesive/paper,withaPET/aluminium

tear-offmembraneandaHDPElid.

Thecompositecancontains1kgofproduct.

-Bucket:polypropylenebucketprovidedwithapolypropylenelid.

Thebucketcontains1,2.5or5kgofproduct.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

research@dopharma.com

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Supplyonveterinaryprescription.

APPENDIXB:

LABELLINGANDPACKAGELEAFLET

I.LABELLING

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

-Compositecan

-Bucket

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs

2. STATEMENTOFTHEACTIVEANDOTHERSUBSTANCES

Sodiumsalicylate 800mg/g

(equivalentto690mgofsalicylicacidassodiumsalt)

3. PHARMACEUTICALFORM

Powderfororalsolution.

4. PACKAGESIZE

1,2.5or5kg.

5. TARGETSPECIES

Cattle(calves)andpigs.

6. INDICATION(S)

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate(anti-

infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

7. METHODANDROUTE(S)OFADMINISTRATION

Oraluse,afterdissolutionindrinkingwater/milkreplacer.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Cattleandpigs:

Meatandoffal:zerodays.

9. SPECIALWARNING(S)

Readthepackageleafletbeforeuse.

10. EXPIRYDATE

Exp<<EXPmonth/year>>

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

Onceopened,useby:

11. SPECIALSTORAGECONDITIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

12. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

13. THEWORDS"FORANIMALTREATMENTONLY"ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly-tobesuppliedonlyonveterinaryprescription.

14. THEWORDS"KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN"

Keepoutofthereachandsightofchildren.

15. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

16. MARKETINGAUTHORISATIONNUMBER(S)

17. MANUFACTURER'SBATCHNUMBER

Batch<<partijnummer>>

II.PACKAGELEAFLET

PACKAGELEAFLET

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs.

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOFTHE

MANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCHRELEASE,

IFDIFFERENT

Marketingauthorisationholder:

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

Manufacturerresponsibleforthebatchrelease:

DopharmaB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SODIUMSALICYL80%WSP,powderfororalsolutionforcattle(calves)andpigs.

3. STATEMENTOFTHEACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Activesubstance:

Sodiumsalicylate 800mg/g

(equivalentto690mgofsalicylicacidassodiumsalt)

Whiteoralmost-whitepowder.

4. INDICATION(S)

Cattle:

Forsupportivetreatmentofpyrexiainacuterespiratorydisease,incombinationwithappropriate(anti-

infective)therapyifnecessary.

Pigs:

Forthetreatmentofinflammation,incombinationwithconcurrentantibiotictherapy.

5. CONTRAINDICATIONS

Donotadministertoanimalswithsevereliverandkidneyaffections.

Donotadministerincaseofgastrointestinalulcerationsandchronicgastrointestinaldisorders.

Donotadministerincaseofmalfunctionofthehematopoeticsystem,coagulopathies,haemorrhagic

diathesis.

Donotusesodiumsalicylatesinneonatesorcalveslessthan2weeksofage.

Donotuseinpigletslessthan4weeksofage.

6. ADVERSEREACTIONS

Gastrointestinalirritationmayoccurespeciallyinanimalswithpre-existinggastrointestinaldisease.Such

irritationmayclinicallybemanifestedbyproductionofblackmanureduetobloodlossinthegastrointestinal

tract.

Inhibitionofnormalbloodclottingmayoccurincidentally.Ifthiseffectoccursitwillbereversibleand

effectswilldiminishwithinapproximately7days.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Cattle(calves)andpigs

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

Cattle: 40mgsodiumsalicylateperkgofbodyweightoncedaily,

(equivalentto50mgproductperkgBWperday),

for1-3days.

Pigs: 35mgsodiumsalicylateperkgofbodyweightperday,

(equivalentto43.75mgproductperkgBWperday),

for3-5days.

SodiumSalicyl80%WSPcanbeadministeredorallythroughthemilk-replacerand/orthedrinkingwater.

9. ADVICEONCORRECTADMINISTRATION

None.

10. WITHDRAWALPERIOD

Cattleandpigs:

Meatandoffal:zerodays.

11. SPECIALSTORAGEPRECAUTIONS

Storebelow25ºC.

Donotrefrigerateorfreeze.

Protectfromfrost.

Shelflifeafterfirstopeningtheimmediatepackaging:3months.

Shelflifeafterreconstitutionindrinkingwater:24hours.

Shelflifeafterreconstitutioninmilkreplacer:4hours.

Keepoutofthereachandsightofchildren.

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Giventhatsodiumsalicylatemayinhibitclottingofblood,itisrecommendedthatelectivesurgeryshould

notbeperformedonanimalswithin7daysaftertheendoftreatment.

Userwarnings

Peoplewithknownhypersensitivitytosodiumsalicylateorcorrelatedpharmaceuticals(e.g.aspirin)or

excipientsshouldavoidcontactwiththeveterinarymedicinalproduct.

Irritationoftheskin,eye,andrespiratorytractmightoccur.Duringpreparationandmixingoftheproduct,

directcontactwiththeskinandeyes,anddirectinhalationofthepowdershouldbeavoided.Itis

recommendedtoweargloves,safetyglasses,andadustmask.Particularattentionshouldbetakenwhen

openingthebucket.

Washaccidentalexposuretoskinimmediatelywithwater.

Intheeventofaccidentaleyecontact,theuserisadvisedtowashtheeyewithplentyofwaterfor15

minutes,andseekmedicaladviceifirritationpersists.

Duringadministrationofthemedicineasreconstitutedproductindrinkingwaterormilk(replacer)tothe

animalsskincontactshouldbepreventedbywearinggloves.Washaccidentallyexposedskinimmediately

withwater.

Useduringpregnancy,lactationorlay

Laboratorystudiesinratshaveshownevidenceofteratogenicandfoetotoxiceffects.

Salicylicacidcrossestheplacentaandisexcretedwiththemilk.Half-lifeinthenew-bornislongerandthus

toxicitysymptomsmayoccurmuchsooner.Furthermoreplateletaggregationisinhibitedandbleedingtime

isincreased,asituationwhichisnotfavourableduringharddelivery/caesareansection.Finallysome

studiesindicatethatdeliveryispostponed.

Theproductshouldnotbeusedduringpregnancyandlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofpotentiallynephrotoxicdrugs(e.g.aminoglycosides)shouldbeavoided.

Salicylicacidishighlyplasma(albumin)boundandcompeteswithavarietyofcompoundsforplasma

proteinbindingsites(e.g.ketoprofen).

Plasmaclearanceofsalicylicacidhasbeenreportedtoincreaseincombinationwithcorticosteroids,possibly

duetoinductionofmetabolismofsalicylicacid.

ConcurrentusewithotherNSAIDsisnotrecommended,becauseofincreasedriskofgastro-intestinalulcers.

Donotuseincombinationwithdrugsknowntohaveanticoagulantproperties.

Overdose(symptoms,emergencyprocedures,antidotes)

Calvestoleratedosagesupto80mg/kgfor5daysor40mg/kgfor10dayswithoutanyadverseeffects.

Pigstoleratedosagesupto175mg/kgforupto10dayswithoutanysignificantadverseeffects.

Incaseofanacuteoverdoseintravenousbicarbonateinfusionresultsinahigherclearanceofsalicylicacid

byalkalisationoftheurineandmaybebeneficialincorrecting(secondarymetabolic)acidosis.

Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocal/nationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Listofpacksizes:

-Compositecan:containerconsistingofPET/aluminium/adhesive/paper,withaPET/aluminiumtear-off

membraneandaHDPElid.

Thecompositecancontains1kgofproduct.

-Bucket:polypropylenebucketprovidedwithapolypropylenelid.Thebucketcontains1,2.5or5kgof

product.

Notallpacksizesmaybemarketed.

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