natgillin/translations-raw huggingface dataset:
Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Efter absorption fordeles praziquantel i alle organer.
After absorption, the drug is distributed to all organs.
Må ikke anvendes samtidigt med produkter, der indeholder piperazin.
Do not use simultaneously with piperazine compounds.
Pyrantel i form af pamoatsalt har lav opløselighed, hvilket reducerer absorption i mave-tarmkanalen og medfører, at lægemidlet effektivt kan nå parasitter i tyktarmen.
The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine.
Det berørte produkt kan derfor næppe antages at frembyde større risiko end referenceproduktet for måldyrearten.
Therefore, it can be assumed that the concerned product is unlikely to present any greater risk to the target animal relative to that posed by the reference product.
Bilag I
ANNEX I:
Hageorm: Uncinaria stenocephala, Ancylostoma caninum (voksne).
Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).
Uanset indgivelsesvej og formulering viste praziquantel sig i en dosis på 5 mg/kg kropsvægt konsekvent 100 % effektivt mod umodne og modne former E. granulosus og E. multilocularis.
Regardless of the administration route and the formulation, praziquantel at a dose of 5 mg/kg bw was consistently shown to be up to 100% effective against immature and mature forms of E. granulosus and E. multilocularis.
Produktet bør derfor kun bruges under drægtighed, efter den af dyrlægen foretagne analyse af risiko og fordele.
Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian.
Febantel absorberes relativt hurtigt og omdannes til blandt andet fenbendazol og oxfendazol, som udøver anthelmintisk effekt
Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.
Til yderligere støtte for produktets sikkerhed og virkning fremlagde Chanelle Pharmaceuticals Manufacturing Ltd. lægemiddelovervågningsdata for Prazitel Plus og relaterede kopiprodukter, i hvis produktresumé der påberåbes virkning over for Echinococcus.
In further support of the safety and efficacy of the product, Chanelle Pharmaceuticals Manufacturing Ltd.provided pharmacovigilance data for Prazitel Plus and related duplicate products which include in the SPC the claim for efficacy against Echinococcus.
In vivo-dataene støttes desuden af en sammenligning af opløsningsprofilerne af det berørte produkt og af referenceproduktet Drontal Plus tabletter.
The in vivo data are further supported by the results of the comparative dissolution profiles of the concerned product with the reference product Drontal Plus tablets.
Angreb med bændelorm kan indtræffe igen, medmindre der foretages kontrol af mellemværter såsom lopper, mus etc.
Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
En sikkerhedsundersøgelse i måldyrearten viste, at det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne) er veltolereret hos hvalpe (9 uger gamle) ved administration af en dosis op til fem gange den anbefalede behandlingsdosis samt ved administration af den anbefalede behandlingsdosis i op til tre dage.
A target animal safety study confirmed that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names) is well tolerated when administered to pups (9 weeks of age) at doses up to five times the recommended treatment dose or when administered at the recommended treatment dose for up to three days.
Udfyldes nationalt Praziquantel, Pyrantel, Febantel
Praziquantel, Febantel, Pyrantel.
Praziquantel er aktivt over for alle udviklingsstadier i disse parasitter.
Praziquantel acts against all adult and immature forms of these parasites.
• CVMP gennemgik det primære formål med henvisningen vedrørende virkningen mod Echinococcus granulosus og Echinococcus multilocularis,
• the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Praziquantels maksimale plasma koncentration i hund blev opnået ca. 2,5 time efter administration.
Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.
Kun til dyr.
For Animal Treatment Only.
Praziquantel omdannes til inaktive metabolitter i leveren og udskilles i galden.
Praziquantel is metabolized into inactive forms in the liver and secreted in bile.
Ikke relevant
Not Applicable
Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.
Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Det er ikke nødvendigt at ændre markedsføringstilladelserne for Prazitel Plus, Exitel Plus, Cazitel Plus og relaterede navne, der er godkendt ved MRP IE/V/0241-0243/001/MR (se bilag I).
The marketing authorisations for Prazitel Plus, Exitel Plus, Cazitel Plus and associated names, authorised by MRP IE/V/0241-0243/001/MR (see Annex I) do not need to be amended.
Den maksimale plasmakoncentration for fenbendazol og oxbendazol i hund, blev opnået ca. 7-9 timer efter administration.
Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.
106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 eller 1000 tabletter.
106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets.
Der er tale om syv kopiprodukter med identiske hybride ansøgningsdossierer, der har Drontal Plus (Bayer Animal Health) som referenceprodukt.
The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Særlige forsigtighedsregler for dyret
Special precautions for use in animals
Der er tale om syv ens produkter med identiske hybride ansøgningsdossierer, som Drontal Plus er referenceprodukt for.
The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Produkterne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel.
The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Cestoder:
Cestodes:
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel.
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
CVMP anmodede Chanelle Pharmaceuticals Manufacturing Ltd. om at dokumentere virkningen mod Echinococcus og fremlægge alle de relevante data, der underbygger virkningen mod Echinococcus og tidligere var fremlagt i dossierer til støtte for markedsføringsgodkendelsen.
The CVMP requested Chanelle Pharmaceuticals Manufacturing Ltd.to justify the claim for efficacy against Echinococcus species and to provide all relevant data in support of the Echinococcus claim, which were presented previously in the dossiers submitted for marketing authorisation, together with comments on the suitability of the documentation to support the extrapolation of efficacy from the reference product to the hybrid product.
Samlet resumé af den videnskabelige vurdering af Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
INN/Særnavn
INN/Strength
Spolorm: Toxocara canis, Toxascaris leonina (modne og sene umodne former).
Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Produktinformationen indeholder passende sikkerhedsanvisninger til brugeren.
Appropriate user safety advice is included in the product literature.
140, 150, 180, 200, 204, 206, 250, 280, 300, 500 og 1000 tabletter.
150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Æske med 10 tabletter og derover
{CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}
50 mg (svarende til 144 mg pyrantelembonat)
50mg (equivalent to 144 mg pyrantel embonate)
Som konklusion godtages det på grundlag af en samlet vurdering af de fremlagte data, at det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne) er effektivt (op til 100 %) til behandling af umodne og modne former af E. granulosus og E. multilocularis hos hunde.
In conclusion, based on the totality of data presented, it is accepted that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog.
konkluderede CVMP, at det overordnede benefit/risk-forhold for disse produkter fortsat er positivt, forudsat at der foretages de anbefalede ændringer i produktinformationen for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og relaterede navne, som er godkendt ved MRP IE/V/0272-0275/001/MR med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat.
the CVMP, concluded that the overall benefit/risk balance for these products remains positive subject to the recommended changes in the product information for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State.
Vurdering af benefit/risk-forholdet
Evaluation of the benefit - risk balance
Produktresuméerne for disse fire produkter omfatter ikke indikationer mod Echinococcus granulosus og Echinococcus multilocularis.
The SPCs for these four products does not include indications against Echinococcus granulosus and Echinococcus multilocularis.
4.1 Dyrearter
4.1 Target species
Dette svarer til 1 tablet/10 kg (22 lbs) legemsvægt.
This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.
Milaxyn Plus, Strantel Plus, Prazical Plus og Voxical Plus blev efterfølgende godkendt ved den gensidige anerkendelsesprocedure MRP IE/V/0272-0275/001/MR som hybride ansøgninger i henhold til artikel i 13, stk. 3, i direktiv 2001/82/EF som ændret, med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat.
Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus were authorised subsequently by MRP IE/V/0272-0275/001/MR as hybrid applications under Article 13(3) of Directive 2001/82/EC, as amended involving Ireland as reference Member State and France as concerned Member State.
Desuden anses der i anbefalingerne i produktoplysningerne for at være taget tilstrækkeligt hensyn til risikoen ved produktets anvendelse.
Further, it is considered that use of this product, in accordance with label recommendations in the product literature, sufficiently manages the risk associated with its use.
CVMP anbefalede derfor ændring af de markedsføringstilladelser, for hvilke produktresuméerne, etiketteringen og indlægssedlen fremgår af bilag III, for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus og relaterede navne, som er godkendt ved MRP IE/V/0272-0275/001/MR med Irland som referencemedlemsstat og Frankrig som berørt medlemsstat (se bilag I).
Therefore the CVMP has recommended the variation of the marketing authorisations for which the summaries of product characteristics, labelling and package leaflet are set out in Annex III for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, and associated names, authorised by MRP IE/V/0272-0275/001/MR involving Ireland as reference Member State and France as concerned Member State (see Annex I).
Produktresuméet for disse tre produkter omfatter indikationer mod Echinococcus granulosus og Echinococcus multilocularis.
The SPC for these three products includes indications against Echinococcus granulosus and Echinococcus multilocularis.
Indikationen behandling af infestation med umodne og modne former af E. granulosus og E. multilocularis kan godtages for det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne).
The indication for the treatment of immature and mature forms of E. granulosus and E. multilocularis can be accepted for the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Pyrantel virker som en kolinerg agonist, der stimulerer parasittens nikotine kolinerge receptorer og dermed inducerer spastisk paralyse af nematoderne, hvilket medfører parasittens udstødning fra mave-tarmkanalen.
Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Praziquantel absorberes næsten fuldstændigt fra mave-tarmkanalen efter oral indgift.
Perorally administered praziquantel is absorbed almost completely from the intestinal tract.
Til oral administration
ADVICE ON CORRECT ADMINISTRATION
Må ikke anvendes samtidigt med piperazinforbindelser som anthelmintiske virkninger af pyrantel og piperazin kan modvirkes.
Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized.
Produkterne Prazitel Plus, Exitel Plus, Cazitel Plus og relaterede navne er i mange EU- og EØSmedlemsstater godkendt ved den gensidige anerkendelsesprocedure (MRP) IE/V/0241-0243/001/MR efter enslydende hybride ansøgninger i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF, som ændret.
The marketing authorisation holder for the concerned product is Chanelle Pharmaceuticals Manufacturing Ltd. Prazitel Plus, Exitel Plus, Cazitel Plus and associated names were authorised in many Member States (EU/EEA) by mutual recognition procedure (MRP) IE/V/0241-0243/001/MR as duplicate hybrid applications under Article 13(3) of Directive 2001/82/EC as amended.
Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år
6.3 Shelf life of the veterinary medicinal product as packaged for sale
Dataene er fyldestgørende som bro mellem den dokumenterede virkning af referenceproduktet (Drontal Plus) og af det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne).
These data are adequate as a bridge between the documented efficacy of the reference product (Drontal Plus) and the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names).
Når produkternes svarer til hinanden med hensyn til systemisk tilgængelighed (absorptionsgrad), antages de imidlertid også at svare til hinanden med hensyn til deres optræden lokalt i mave-tarmkanalen efter administration.
While plasma concentrations are not a direct measure of the concentrations of active available locally in the gastro intestinal tract, it is considered that similar systemic availability (similar extent of absorption) is indicative of similar behaviour locally in the gastro intestinal tract following product administration.
Pyrantelembonat, et tetrahydropyrimidinderivat.
Pyrantel acts as a cholinergic agonist.
På grundlag af sikkerhedsundersøgelsen i måldyrearten fandt udvalget det usandsynligt, at anvendelse til hvalpe under 9 uger og hunde under 2,5 kg vil medføre sikkerhedsmæssige betænkeligheder.
The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary.
I pattedyr, konverteres febantel til fenbendazol og oxfendazol ved ringslutning.
Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole.
En del vedrørte dog virkningen af praziquantel dispenseret som andre lægemiddelformer (injektionspræparat, pasta, pulver) og/eller administreret ad andre indgivelsesveje (intramuskulært, subkutant) og/eller kombineret med andre aktive indholdsstoffer (f.eks. Drontal Plus, Bayer Animal Health).
While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health).
Bændelorme: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (voksne og umodne stadier).
Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).
1 tablet/10 kg (22 lbs) legemsvægt.
1 tablet per 10 kg (22 lbs) bodyweight.
Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
This veterinary medicinal product does not require any special storage conditions Keep out of the reach and sight of children.
50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg/tablet Febantel
50 mg/tablet Praziquantel, 50 mg/tablet Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg/tablet Febantel.
Chanelle Pharmaceuticals Manufacturing Ltd. har ekstrapoleret de offentligt tilgængelige data vedrørende virkning for produkter fra Bayer Animal Health (Droncit og Drontal Plus) til det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus og Prazitel Plus og relaterede navne).
Chanelle Pharmaceuticals Manufacturing Ltd.has extrapolated the efficacy data available in the public domain for the Bayer Animal Health products (Droncit and Drontal Plus) to the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names) by presenting a comparative pharmacokinetic study conducted with the concerned product and Drontal Plus (Bayer Aniamal Health).
Æske med 2, 4, 6 og 8 tabletter
{CARTON FOR PACK SIZES OF 2, 4, 6 AND 8 TABLETS}
Hos hund: behandling af infestationer hos hund med rundorm og bændelorm
In dogs: Treatment of mixed infections by nematodes and cestodes.
På grundlag af denne undersøgelse kan testog referenceprodukterne anses for at være ækvivalente med hensyn til AUCinf for praziquantel, hvorfor produkternes systemiske tilgængelighed kan antages at være ens. Plasmakoncentrationen er ikke et direkte mål for den koncentration af det aktive indholdsstof, der lokalt er tilgængelig i mave-tarmkanalen.
Based on the findings of this study, the test and reference products can be considered equivalent with respect to AUCinf of praziquantel; therefore similar systemic availability can be assumed.
1 tablet med smag af svinekød, indeholder 50 mg praziquantel, 50 mg pyrantel (svarende til 144 mg pyrantelembonat) og 150 mg febantel.
1 pork flavoured tablet contains 50 mg Praziquantel, 50 mg Pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg Febantel.
Legemsvægt (kg)
Dosage table: Bodyweight (kg)
Nematoder:
Nematodes:
Laboratorieundersøgelser af får og rotter har afsløret teratogene virkninger ved høj dosis febantel.
Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats.
Vurdering af fordele
Benefit assessment
Prazitel Plus tabletter Praziquantel 50 mg Pyrantel 50 mg (svarende til 144 mg pyrantel embonate)
Praziquantel 50 mg Pyrantel 50 mg (equivalent to 144 mg pyrantel embonate)
DATO FOR SENESTE REVISION AF INDLÆGSSEDLEN
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
6.5 Emballage
6.5 Nature and composition of immediate packaging
Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel (svarende til 14,4 mg/kg pyrantelembonat) og 5 mg/kg praziquantel.
The recommended dose rates are: 15 mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Hos hund: behandling af infestationer hos hund med rundorm og bændelorm af følgende arter:
In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes:
Den anbefalede dosis er: 15 mg/kg febantel, 5 mg/kg pyrantel(svarende til 14,4 mg /kg pyrantelembonat) og 5 mg/kg praziquantel.
The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel.
10. UDLØBSDATO
WITHDRAWAL PERIOD
Indehaver af markedsføring stilladelse
Marketing authorisation holder
Særlige forsigtighedsregler for personer, der administrerer lægemidlet I tilfælde af indtagelse af tabletterne ved hændeligt uheld, skal der straks søges lægehjælp, og indlægssedlen vises til lægen.
In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Hjælpestoffer:
User Precautions:
Produktets sikkerhed hos yngre hvalpe underbygges således af omfattende litteraturdata for hvert af de aktive indholdsstoffer og for kombinationen.
There is extensive literature for the individual active substances and the combination which supports the safety of this product in younger puppies.
Tabletter med smag af svinekød
Pork flavoured tablets.
Luxembo urg
Prazitel Plus
Spolorm: Toxocara canis, Toxascaris leonine (Voksne og næsten modne stadier) Hageorm: Uncinaria stenocephala, Ancylostoma caninum(voksne stadier) Piskeorm: Trichuris vulpis (voksne stadier).
In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.
Til oral administration 1 tablet pr. 10 kg legemsvægt
1 tablet per 10 kg bodyweight.
Sverige Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Sweden Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Lægemiddelform Dyreart
Pharmaceutical form
Norge Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Norway Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Ungarn Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Hungary Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
I denne kombination virker pyrantel og febantel imod alle relevante rundorme (spolorm, hageorme og piskeorme) i hunde, dog særligt imod Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum og Trichuris vulpis.
Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs.
Slovakiet Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Slovakia Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Holland Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea
Netherlands Chanelle Pharmaceuticals Manufacturing Ltd. IE-Loughrea