DOLPAC 2

Main information

  • Trade name:
  • DOLPAC 2
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOLPAC 2
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • praziquantel, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0183/001
  • Authorization date:
  • 19-05-2011
  • EU code:
  • FR/V/0183/001
  • Last update:
  • 09-08-2016

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

Vetoquinol/DOLPACSmalldogs/EuropeanRenewal June2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Austria

Belgium

Cyprus

Malta

CzechRepublic

Netherlands

Greece

Portugal

Slovakia

Hungary

Slovenia

Germany

Finland Dolpacsmalldogstablets

FranceLuxembourg Dolpac2comprimé

UK-Ireland-Italy DolpacTabletsforSmallDogs

Spain

Poland Dolpacsmalldogstabletsfor1-6

kg

Denmark

Sweden Dolpacvetsmalldogstablets

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains

Activesubstances

Oxantel 40.06mg(equivalentto111.8mgofoxantelembonate)

Pyrantel 9.99mg(equivalentto28.8mgofpyrantelembonate)

Praziquantel 10.00mg

Excipienttoone190mgdivisibletablet

Excipients

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Paleyellowtoyellowoblongtabletwithbreakingline;

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Forcurativetreatmentofdogsharbouringmixedparasiticinfestationswiththefollowingadultstages

ofnematodeandcestodespecies:

Nematodes:

Toxocaracanis

Toxascarisleonina

Ancylostomacaninum

Vetoquinol/DOLPACSmalldogs/EuropeanRenewal June2011

Uncinariastenocephala

Trichurisvulpis

Cestodes:

Dipylidiumcaninum

Taeniaspp

Echinococcusmultilocularis

Echinococcusgranulosus

4.3 Contraindications

Seesection4.8.

4.4 Specialwarningsforeachtargetspecies

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeated

useofananthelminticofthatclass.

Fleasserveasintermediatehostsforoneofthecommontapeworms –Dipylidiumcaninum.

Tapeworminfestationmayreoccurunlesscontrolofintermediatehosts(fleas)isundertaken.

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

RoundwormandHookworminfection:

Insomeanimals,AncylostomacaninumandToxocaracanismaynotbetotallyeradicatedbythe

treatment,resultinginacontinuedriskofeggsheddingintotheenvironment.Follow-upexaminations

ofthefaecesareadvisableandaccordingtotheresultsoftheseexaminations,treatmentwitha

nematodicidalproductmaybecarriedoutifnecessary.

Theproductisnotrecommendedforuseinpupsyoungerthantwomonthsoldorweighinglessthan

1kg.

Indebilitatedorheavilyinfestedanimals,theproductshouldbeusedonlyaccordingtoabenefit/risk

assessmentbytheresponsibleveterinarian

Donotuseinanimalswithknownhypersensitivitytoanyofthecomponentsoftheproduct.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Someconstituentsofthisproductmaycauseallergicreactionsorskinirritation.

Avoidcontactwiththeskin.

Peoplewithknownhypersensitivitytoanyoftheingredientsshouldavoidcontactwiththisproduct.

Washhandsafteruse.

Incaseofaccidentalingestion,seekmedicaladviceandshowthepackageleaflettothephysician.

4.6 Adversereactions(frequencyandseriousness)

Vomitinganddiarrhoeamaybeobservedfollowingthetreatment.

Despitenotbeingobservedinstudiesperformedwiththeproduct,anorexiacanoccurasitisa

commonadverseeffectofproductscontainingpraziquantel.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyand

lactation.Theuseisnotrecommendedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusesimultaneouslywithlevamisole,piperazineorcholineesteraseinhibitors

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddoserateis20mgoxantel/5mgpyrantel/5mgpraziquantelperkgbodyweight,

ieonetabletper2kgbodyweightinasingleintake,byoralroute.

Administertherequirednumberoftablets,accordingtobodyweight,orally,inasingleadministration.

Preferably,dogsshouldbefastedpriortotreatment.Foodmaybegivenonehourormoreafter

treatment.

Vetoquinol/DOLPACSmalldogs/EuropeanRenewal June2011

Weightofdog Numberoftablets

1kg ½

From1.1to2kg 1

From2.1to4kg 2

From4.1to6kg 3

Thetabletcanbedividedintohalves.

Dogskepttogetherorinkennelsshouldbetreatedatthesametime.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Administrationoftheproducttohealthydogsat5timestherecommendeddosagefor6consecutive

weekshadnoadverseconsequences.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Praziquantel,combinations

ATCvetCode:QP52AA51

5.1 Pharmacodynamicproperties

Theproductcontainsthreeactiveingredients,pyrantelembonate,oxantelembonateand

praziquantel.Thespectrumofactivityoftheproductiswide,directedtowardsgastro-intestinal

roundworms(ascaris,whipwormandhookworms)andtapeworms.

Pyrantelhasaparalysingeffectonroundwormmuscles,byactivatingacetylcholinereceptors.Its

activityismoreparticularlydirectedagainstToxocaracanis,Toxascarisleonina,Uncinaria

stenocephalaandAncylostomacaninum.ItsactivityagainstTrichurisvulpisisnegligible.

Oxantelisanm-oxyphenolicderivateofpyrantel,thathasbeendevelopedforitsactivityagainst

whipworms.

Praziquantelleadstomuscularcontractions,paralysisandalteredparasitetegumentintegrity.Itis

activeagainstadultsandlarvalstagesofdogtapeworms,Echinococcus,TaeniaandDipylidium.

5.2 Pharmacokineticparticulars

Afteroraladministration,theabsorptionofoxantelembonateisnegligible.Pyrantelisquickly

absorbedbutinsmallquantities(T

max =1.38h,C

=0.048µg/ml)andisveryquicklyeliminated.

Praziquantelisquicklyabsorbed(T

max =1.28h,C

=0.4µg/ml)andeliminated(eliminationhalf-life

1.5h).

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dextrates

PovidoneK30

SodiumLaurylsulphate

Baconflavour

Crospovidone

Sodiumstearylfumarate

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:threeyears

Discardanyunusedhalftablet

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Vetoquinol/DOLPACSmalldogs/EuropeanRenewal June2011

6.5 Natureandcompositionofimmediatepackaging

Polyamide-aluminium-PVC/aluminiumblisterorpolychlorotrifluoroethylene-PVC/aluminiumblister

stripof10tablets.

Cardboxwith1stripof10tablets

Cardboxwith6stripsof10tablets

Cardboxwith10stripsof10tablets

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Vetoquinol/DOLPACSmalldogs/EuropeanRenewal June2011

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

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