FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of this veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Dette veterinærlægemiddels sikkerhed er ikke fastlagt under drægtighed og laktation for katte.
English: Due to the lack of data, pradofloxacin should not be used in kittens aged less than 6 weeks.
Danish: På grund af manglende data, bør pradofloxacin ikke anvendes til killinger under 6 uger.
English: • superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius),
Danish: • overfladiske og dybe pyodermier forårsaget af følsomme stammer af Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius),
English: Due to potential harmful effects, the bottle and the filled syringes must be kept out of the sight and reach of children.
Danish: På grund af eventuel skadelig virkning, skal flasken og fyldte sprøjter opbevares utilgængeligt for børn.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (120 mg)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Aluminium blister á 7 tabletter (120 mg)
English: Ask your veterinarian for advice if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Danish: Spørg dyrlægen tid råds, hvis der ikke ses en forbedring af den kliniske tilstand inden 3 dage efter behandlingens start.
English: The treatment should be re-considered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Danish: Behandlingen bør revurderes hvis der ikke ses en forbedring af den kliniske tilstand inden 3 dage efter behandlingens start.
English: Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases.
Danish: Milde forbigående gastrointestinale forstyrrelser inklusiv opkastning er i sjældne tilfælde set.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label (30 ml oral suspension)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaskeetikette (30 ml oral suspension)
English: Brownish single-scored tablets with “P15” on one side Brownish single-scored tablets with “P60” on one side Brownish single-scored tablets with “P120” on one side The tablet can be divided into equal doses.
Danish: Brunlige tabletter med en enkelt delekærv mærket ”P15” på den ene side Brunlige tabletter med en enkelt delekærv mærket ”P60” på den ene side Brunlige tabletter med en enkelt delekærv mærket ”P120” på den ene side Tabletten kan deles i to lige store doser.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 120 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 120 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 120 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 120 mg)
Danish: Æsker indeholdende 1 blisterkort (1 x 7 tabletter à 120 mg) Æsker indeholdende 3 blisterkort (3 x 7 tabletter à 120 mg) Æsker indeholdende 10 blisterkort (10 x 7 tabletter à 120 mg) Æsker indeholdende 20 blisterkort (20 x 7 tabletter à 120 mg)
English: Do not use in cats during pregnancy and lactation (see section “Special Warnings”).
Danish: Må ikke anvendes til katte under drægtighed og laktation (se afsnit ”Særlige advarsler”).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (15 mg)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Aluminium blister á 7 tabletter (15 mg)
English: In cats, absorption of orally administered pradofloxacin at the therapeutic dose is rapid reaching peak concentrations of 1.2 mg/l within 0.5 hours.
Danish: Hos katte absorberes pradofloxacin hurtigt efter oral administration af terapeutiske doser, maksimal plasmakoncentration på 1,2 mg/l nås inden ½ time.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label (15 ml oral suspension)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaskeetikette (15 ml oral suspension)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 60 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 60 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 60 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 60 mg)
Danish: Æsker indeholdende 1 blisterkort (1 x 7 tabletter à 60 mg) Æsker indeholdende 3 blisterkort (3 x 7 tabletter à 60 mg) Æsker indeholdende 10 blisterkort (10 x 7 tabletter à 60 mg) Æsker indeholdende 20 blisterkort (20 x 7 tabletter à 60 mg)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (60 mg)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Aluminium blister á 7 tabletter (60 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 15 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 15 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 15 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 15 mg)
Danish: Æsker indeholdende 1 blisterkort (1 x 7 tabletter à 15 mg) Æsker indeholdende 3 blisterkort (3 x 7 tabletter à 15 mg) Æsker indeholdende 10 blisterkort (10 x 7 tabletter à 15 mg) Æsker indeholdende 20 blisterkort (20 x 7 tabletter à 15 mg)
English: PACKAGE LEAFLET: Veraflox 25 mg/ml oral suspension for cats
Danish: INDLÆGSSEDDEL Veraflox 25 mg/ml oral suspension til kat
English: Staphylococcus intermedius group (including S. pseudintermedius) Escherichia coli
Danish: Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius) Escherichia coli
English: Acute infections of the upper respiratory tract
Danish: Akutte infektioner i de øvre luftveje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats Veraflox 60 mg tablets for dogs Veraflox 120 mg tablets for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 15 mg tabletter til hund og kat Veraflox 60 mg tabletter til hund Veraflox 120 mg tabletter til hund
English: However the product should not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Danish: Produktet bør dog ikke bruges til katte med vedvarende skader i ledbrusken, da skaderne kan forværres under behandling med fluoroquinoloner.
English: Use of the veterinary medicinal product deviating from instructions given in the summary of product characteristics (SPC) may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for crossresistance.
Danish: Afvigende brug af veterinærlægemidlet fra det som er beskrevet i produktresumeet (SPC'et) kan øge forekomsten af resistente bakterier over for flouroquinoloner og kan muligvis nedsætte effekten af behandling med andre fluoroquinoloner grundet mulig kryds-resistens.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 25 mg/ml oral suspension til kat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats pradofloxacin
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 25 mg/ml oral suspension til kat pradofloxacin
English: Use of the veterinary medicinal product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.
Danish: Afvigende brug af veterinærlægemidlet fra det som er beskrevet i SPCet kan øge forekomsten af resistente bakterier overfor flouroquinoloner og kan muligvis nedsætte effekten af behandling med andre fluoroquinoloner grundet mulig kryds-resistens.
English: Hrvatska Bayer d.o.o.
Danish: Slovenija Bayer d.o.o.
English: Treatment of: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Danish: Behandling af akutte infektioner i de øvre luftveje forårsaget af følsomme stammer af Pasteurella multocida, Escherichia coli og Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pradofloxacin.
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 15 mg pradofloxacin.
English: Do not use in dogs with persisting articular cartilage lesions, since lesions may worsen during treatment with fluoroquinolones.
Danish: Må ikke bruges til hunde med vedvarende skader i ledbrusken, da skaderne kan forværres under behandling med fluoroquinoloner.
English: Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.
Danish: Afvigende brug af produktet fra det som er beskrevet i SPCet kan øge forekomsten af resistente bakterier overfor flouroquinoloner og kan muligvis nedsætte effekten af behandling med andre fluoroquinoloner grundet mulig kryds-resistens.
English: EXPIRY DATE EXP {month/year} Once opened, use by ________
Danish: UDLØBSDATO EXP {måneder/år} Efter anbrud anvendes senest
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg pradofloxacin.
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 60 mg pradofloxacin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 120 mg pradofloxacin.
Danish: ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 120 mg Pradofloxacin.
English: TARGET SPECIES Dogs and cats
Danish: Hund og kat
English: Infections of the skin:
Danish: Hudinfektioner:
English: However, the product must not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Danish: Produktet må ikke bruges til katte med vedvarende skader i ledbrusken, da skaderne kan forværres under behandling med fluoroquinoloner.
English: Reading RG2 6AD-UK Tel: +44 (0)118 206 3000
Danish: Tel: +44 (0)118 206 3000
English: Bacterial species
Danish: Bakteriearter
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER ELLERBEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: Lot {number}
Danish: EXP {måneder/år}
English: The duration of treatment depends on the severity of the infection and how well the medicine works in your pet. For most infections the following durations of treatment are recommended:
Danish: Behandlingsvarigheden afhænger af sværhedsgraden af infektionen samt af hvor godt lægemidlet virker i kæledyret.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets for dogs Veraflox 120 mg tablets for dogs pradofloxacin
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 60 mg tabletter til hund Veraflox 120 mg tabletter til hund pradofloxacin
English: Staphylococcus intermedius group (including S. pseudintermedius) and
Danish: Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius) og
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/001-012
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/107/001-012
English: Excipients: Preservative: Sorbic acid (E200)
Danish: Konserveringsmiddel: Sorbinsyre (E200) 2 mg/ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets pradofloxacin
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 15 mg tabletter pradofloxacin
English: Staphylococcus intermedius group (including S. pseudintermedius).
Danish: Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius).
English: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Danish: • sårinfektioner og abscesser (bylder) forårsaget af følsomme stammer af Pasteurella multocida og Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/013-014
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/107/013-014
English: Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Danish: Escherichia coli og Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius).
English: Staphylococcus intermedius group (including S. pseudintermedius)
Danish: Staphylococcus intermedius-gruppen (inklusiv S. pseudintermedius)
English: Wound infections Acute infections of the urinary tract
Danish: Akutte infektioner i urinvejene
English: Česká republika Bayer s.r.o., Animal Health
Danish: Česká republika Bayer s.r.o.,
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets pradofloxacin
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 120 mg tabletter pradofloxacin
English: Shelf life after first opening the container: 3 months.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og æsken efter EXP. Opbevaringstid efter første åbning af beholderen: 3 måneder.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets pradofloxacin
Danish: VETERINÆRLÆGEMIDLETS NAVN Veraflox 60 mg tabletter pradofloxacin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats pradofloxacin
Danish: Veraflox 15 mg tabletter til hund og kat pradofloxacin
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/014
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/107/014
English: Treatment of acute infections of the upper respiratory tract caused by susceptible strains of
Danish: Behandling af: • akutte infektioner i de øvre luftveje forårsaget af følsomme stammer af Pasteurella multocida,
English: TARGET SPECIES Dogs, cats
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Hund, kat
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/013
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/107/013
English: EXPIRY DATE EXP {month/year} Once opened, use within 3 months.
Danish: Efter anbrud anvendes inden 3 måneder.
English: Magyarország Bayer Hungária Kft. HU-1123 Budapest
Danish: Magyarország Bayer Hungária Kft.
English: Dosages
Danish: Laktation
English: For animal treatment only - To be supplied only on veterinary prescription.
Danish: Til dyr - kræver recept.
English: United Kingdom Bayer plc, ,
Danish: Ireland Bayer Limited,
English: used with pain, fever or inflammation) in animals with a history of seizures because of potential higher sensitivity to seizure formation.
Danish: Veraflox ikke bruges i kombination med non-steroide anti-inflammatoriske lægemidler (NSAID, anvendes mod smerter, feber eller betændelse) hos dyr med en forhistorie med krampeanfald, fordi de kan have en højere følsomhed for at udvikle krampeanfald.
English: The variation procedure started on 16 May 2012.
Danish: Ændringsproceduren blev indledt den 16. maj 2012.
English: The results showed efficacy above 95% except on day 7 (94.5%) and day 28 (87.5%).
Danish: Resultaterne viste en virkning på over 95 % undtagen på dag 7 (94,5 %) og dag 28 (87,5 %).
English: The application was submitted to France as reference Member State and to Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom as concerned Member States.
Danish: Ansøgningen blev indgivet til Frankrig som referencemedlemsstat og til Østrig, Belgien, Danmark, Tyskland, Grækenland, Irland, Italien, Luxembourg, Portugal, Slovenien, Spanien og Det Forenede Kongerige som berørte medlemsstater.
English: 6-8 weeks immatures
Danish: 6-8 ugers umodne
English: In absence of a strong signal, these data can be considered supportive data of the clinical data analysed below.
Danish: I mangel af et stærkt signal kan disse data betragtes som understøttende data for de nedenfor analyserede kliniske data.
English: The data did not show any strong signal that any interaction between the active substances that might be present would lead to significantly lower efficacy.
Danish: Dataene viste ikke noget stærk signal på, at en interaktion mellem de eventuelt tilstedeværende aktive stoffer ville kunne føre til en betydeligt lavere virkning.
English: For the time point prior to day 28 and the only immediately after that, efficacy was complete for this animal, indicating no apparent lack of efficacy.
Danish: På tidspunktet forud for dag 28 og den umiddelbart derefter var virkningen fuldstændig for dette dyr, hvilket ikke tydede på nogen tilsyneladende manglende virkning.
English: de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Danish: de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spanien
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 3 April 2013, Belgium initiated a referral procedure under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Danish: Eftersom referencemedlemsstaterne og de berørte medlemsstater ikke kunne nå til enighed med hensyn til ændringen, indledte Belgien den 3. april 2013 en indbringelsesprocedure i henhold til artikel 13, stk. 2, i Europa-Kommissionens forordning (EF) nr. 1234/2008.
English: Efficacy was also observed in respect to Bovicola bovis, however due to the lower infestation inconsistency of findings on some days, the data can only be used as supportive information.
Danish: Virkningen var også observeret i forbindelse med Bovicola bovis, men på grund af den manglende sammenhæng med lavere angreb på nogle dage kan dataene kun anvendes som understøttende information.
English: F - 75668 Paris Cedex 14 France
Danish: F - 75668 Paris Cedex 14 Frankrig
English: This issue remained unsolved and therefore a CMD(v) procedure under Article 13 of Commission Regulation (EC) No 1234/2008 started on 14 January 2013.
Danish: Dette spørgsmål forblev uafklaret, hvorfor der den 14. januar 2013 blev iværksat en CMD(v)procedure i henhold til artikel 13 i Europa-Kommissionens forordning (EF) nr. 1234/2008.
English: Via Isonzo 71 04100 Latina Italy
Danish: Via Isonzo 71 04100 Latina Italien
English: The latter lower efficacy coincided with an apparent egg hatch on one treated animal where 50 lice were detected.
Danish: Sidstnævnte lavere virkning var sammenfaldende med en faktisk udklækning af æg på ét behandlet dyr, hvor 50 lus blev fundet.
English: The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
Danish: Produktet administreres topikalt på dyrets ryg og er beregnet til behandling af blandet nematode- og ikteinfektioner hos kvæg.
English: This was not an unusual finding as egg hatch is rapid and can result in a high lice count.
Danish: Dette var ikke et usædvanligt fund, idet udklækning af æg forekommer hurtigt og kan føre til et højt antal lus.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Danish: En potentiel alvorlig risiko for dyresundheden blev i løbet af ændringsproceduren identificeret af Belgien, navnlig at virkningen mod lusearter ikke var tilstrækkeligt begrundet.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Danish: Liste over det veterinærlægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesvej, indehaver av markedføringstilladelsen i medlemsstaterne
English: ECTOPARASITES Linognathus vituli Bovicola bovis Solenopotes capillatus
Danish: EKTOPARASITTER Linognathus vituli Bovicola bovis Solenopotes capillatus
English: Parasite
Danish: Parasit
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelserne
English: Gastro-intestinal nematodes: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Respiratory tract nematode: Dictyocaulus viviparus TREMATODES
Danish: Gastro-intestinale nematoder: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Luftvejsnematode: Dictyocaulus viviparus TREMATODER Leverikter:
English: Adult stage
Danish: Voksenstadie
English: Animal species
Danish: Indgivelsesvej Dyrearter
English: Efficacy against lice
Danish: Virkning mod lus
English: Pfizer Luxembourg SARL 51, Avenue J.F.Kennedy L-1855 Luxembourg Luksemburg
Danish: Slovenien Pfizer Luxembourg SARL 51, Avenue J.F.Kennedy L-1855 Luxembourg
English: 4.2 Indications for use, specifying the target species In cattle:
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Danish: Tilføjelser til relevante afsnit i produktresuméet, etikettering og indlægsseddel
English: Grounds for the variation to the terms of the marketing authorisations
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelserne
English: The CVMP concluded that a second dose confirmatory study for Linognatus vituli or the other lice species was deemed not to be necessary based on the data from the confirmatory study and moxidectin's efficacy demonstrated on all other lice species as well as in the literature, even if Linognatus vituli is not considered as being the dose-limiting species.
Danish: CVMP konkluderede, at en anden dosisbekræftende undersøgelse af Linognatus vituli eller af de øvrige lusearter ikke blev anset for nødvendig baseret på data fra den bekræftende undersøgelse og moxidectins virkning, som er dokumenteret for alle andre lusearter samt i litteraturen, selv om Linognatus vituli ikke betragtes som dosisbegrænsende arter.
English: Ramsgate Road Sandwich CT13 9NJ United Kingdom
Danish: Storbritannien Pfizer Ltd Ramsgate Road Sandwich CT13 9NJ Storbritannien
English: The comparable efficacy of the moxidectin/triclabendazole pour-on combination product (Cydectin TriclaMox) compared to moxidectin alone in the same vehicle was studied in a pharmacokinetics trial.
Danish: Den sammenlignelige virkning af pour-on-kombinationsproduktet moxidectin/triclabendazol (Cydectin TriclaMox), sammenlignet med moxidectin alene i samme medie, var genstand for en farmakokinetisk undersøgelse.
English: Inhibited stages
Danish: Hæmmet stadie
English: • the CVMP reviewed all available data submitted by the marketing authorisation holder, to support the indication for treatment of lice infestations caused by Linognatus vituli, Bovicola bovis and Solenopotes capillatus;
Danish: • CVMP gennemgik alle tilgængelige data fremlagt af indehaveren af markedsføringstilladelsen til støtte for indikationen behandling af lus forårsaget af Linognatus vituli, Bovicola bovis og Solenopotes capillatus
English: Pfizer Animal Health submitted an application for a type II variation to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) and reference was made to the monoproduct, Cydectin pour-on containing moxidectin alone and for which the claim against lice was already granted.
Danish: Pfizer Animal Health indgav en ansøgning for en type II-ændring med henblik på at tilføje en ny indikation mod lusearter (Linognatus vituli, Bovicola bovis og Solenopotes capillatus), og der blev henvist til pour-on-monoproduktet Cydectin, der indeholder moxidectin alene, for hvilket den påståede virkning mod lus allerede var bevilliget.