natgillin/translations-raw huggingface dataset:
The primary mode of action of the fluoroquinolones involves interaction with enzymes essential for major DNA functions such as replication, transcription and recombination. 
Primarno delovanje flourokinolonov temelji na interakciji z encimi, ki sodelujejo pri podvojevanju, obnovi in prepisu deoksiribonukleinske kisline (DNK) v bakterijski celici.
Do not use in dogs during pregnancy and lactation (see section 4.7). 
Ne uporabite pri psih v obdobju brejosti in laktacije, glejte poglavje 4.7.
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) 
Zloženka s pretisnim omotom ( 1 x 7 tablet po 60 mg) Zloženka s pretisnim omotom ( 3 x 7 tablet po 60 mg) Zloženka s pretisnim omotom ( 10 x 7 tablet po 60 mg) Zloženka s pretisnim omotom ( 20 x 7 tablet po 60 mg)
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) 
Zloženka s pretisnim omotom ( 1 x 7 tablet po 120 mg) Zloženka s pretisnim omotom ( 3 x 7 tablet po 120 mg) Zloženka s pretisnim omotom ( 10 x 7 tablet po 120 mg) Zloženka s pretisnim omotom ( 20 x 7 tablet po 120 mg)
Staphylococcus intermedius group (including S. pseudintermedius) Escherichia coli 
Skupina Staphylococcus intermedius (vključno s S.pseudintermedius) Escherichia coli
For dogs over 15 kg, use 60 mg or 120 mg pradofloxacin tablets. 
dajemo 60 mg ali 120 mg tablete pradofloksacina.
Intermittent vomiting was observed after repeated oral administration of 1.6 times the maximum recommended dose. 
Pri ponavljajočem peroralnem dajanju 1,6- kratnega maksimalnega terapevtskega odmerka se je pojavilo občasno bruhanje.
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) 
Zloženka s pretisnim omotom ( 1 x 7 tablet po 15 mg) Zloženka s pretisnim omotom ( 3 x 7 tablet po 15 mg) Zloženka s pretisnim omotom ( 10 x 7 tablet po 15 mg) Zloženka s pretisnim omotom ( 20 x 7 tablet po 15 mg)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (120 mg) 
Pretisni omot iz aluminijaste folije po 7 tablet (120 mg)
Pradofloxacin is cleared from the body at 0.24 l/h/kg. 
Pradofloksacin se izloči iz telesa z očistkom, ki znaša 0,24 l/h/kg.
Therefore, Veraflox should not be administered concurrently with antacids, sucralfate, multivitamins or dairy products, as absorption of Veraflox may be decreased. 
Zaradi zmanjšane absorpcije Verafloxa ne dajemo sočasno z antacidi, sukralfati, multivitaminskimi pripravki ter mlečnimi izdelki.
• superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius), 
• površinskih in globokih piodermij, ki jih povzročajo občutljivi sevi skupine Staphylococcus intermedius (vključno s S. pseudintermedius),
The recommended dose is 5 mg/kg bodyweight of pradofloxacin once daily. 
Priporočeni dnevni odmerek je 5 mg pradofloksacina na kg telesne mase.
2 mg For the full list of excipients, see section 6.1. 
Konzervans: sorbinska kislina (E200) 2 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
4.2 Indications for use, specifying the target species Dogs: 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
Bodyweight of Dog (kg) 
Telesna masa mačk (kg)
PACKAGE LEAFLET: Veraflox 25 mg/ml oral suspension for cats 
NAVODILO ZA UPORABO Veraflox 25 mg/ml peroralna suspenzija za mačke
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing a HDPE bottle (30 ml oral suspension) 
PODATKI NA ZUNANJI OVOJNINI Zloženka s HDPE plastenko (30 ml peroralne suspenzije)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 120 mg pradofloxacin. 
NAVEDBA UČINKOVIN(E) Vsaka tableta vsebuje 120 mg pradofloksacina.
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in cats and dogs. 
Varnost zdravila v obdobju brejosti in laktacije pri psih in mačkah ni bila ugotovljena.
However, the product must not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones. 
Zdravilo se ne sme uporabiti pri mačkah s trdovratnimi lezijami sklepnega hrustanca, ker se lahko stanje lezij poslabša med zdravljenjem s fluorokinoloni.
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. 
Uporaba zdravila, ki ni v skladu z navodili, ki so navedeni v Povzetku glavnih značilnosti zdravila, lahko vpliva na povečanje prevalence bakterij, ki so odporne proti fluorokinolonom ter zmanjša učinke zdravljenja z drugimi fluorokinoloni zaradi možne navzkrižne rezistence.
Due to potential harmful effects, the bottle and the filled syringes must be kept out of the sight and reach of children. 
Zaradi morebitnih škodljivih učinkov, plastenko in polne brizge shranjujte nedosegljivo otrokom.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 
Ne uporabite v primeru preobčutljivosti na flourokinolone ali na katero koli pomožno snov.
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 25 mg/ml peroralna suspenzija za mačke pradofloksacin
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 25 mg/ml peroralna suspenzija za mačke
Do not use in cats during pregnancy and lactation (see section 4.7). 
Ne uporabite pri mačkah v obdobju brejosti in laktacije, glejte poglavje 4.7. 4.4.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (60 mg) 
Pretisni omot iz aluminijaste folije po 7 tablet (60 mg)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pradofloxacin. 
NAVEDBA UČINKOVIN(E) Vsaka tableta vsebuje 15 mg pradofloksacina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing a HDPE bottle (15 ml oral suspension) 
PODATKI NA ZUNANJI OVOJNINI Zloženka s HDPE plastenko (15 ml peroralne suspenzije)
Fluoroquinolones are known to cross the placenta and to be distributed into milk. 
Fluorokinoloni prehajajo skozi placento v materino mleko.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg pradofloxacin. 
NAVEDBA UČINKOVIN(E) Vsaka tableta vsebuje 60 mg pradofloksacina.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (15 mg) 
Pretisni omot iz aluminijaste folije po 7 tablet (15 mg)
After administration the syringe should be cleaned with tap water and stored with the bottle in the carton box. 
Po dajanju brizgo speremo pod tekočo vodo in spravimo v škatlo skupaj z zdravilom.
Pradofloxacin is cleared from the body at 0.28 l/h/kg. 
Pradofloksacin se izloči iz telesa z očistkom, ki znaša 0,28 l/h/kg.
Yellowish to beige suspension. 
Suspenzija rumenkaste do bež barve.
• acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius). 
• akutnih okužb gornjih dihalnih poti, ki jih povzročajo občutljivi sevi Pasteurellae multocidae, Escherichia coli in skupine Staphylococcus intermediusa (vključno S.pseudintermedius).
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. 
Rjavkaste tablete z razdelilno zarezo in »P120« na eni strani.
Do not use during lactation. 
Uporaba ni priporočljiva v obdobju brejosti.
MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/001-012 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/107/001-012
Brownish single-scored tablets with “P15” on one side The tablet can be divided into equal doses. 
Rjavkaste tablete z razdelilno zarezo in »P15« na eni strani.
Infrequent vomiting was observed in cats after repeated oral administration of 2.7 times the maximum recommended dose. 
Pri ponavljajočem peroralnem dajanju 2,7- kratnega maksimalnega terapevtskega odmerka se je pri mačkah pojavilo občasno bruhanje.
Vomiting may be a symptom of overdose. 
Pri prekomernem odmerjanju se lahko pojavi bruhanje.
Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius). 
Pasteurella multocida Escherichia coli Skupina Staphylococcus intermedius (vključno s S.pseudintermedius)
Marketing authorisation holder : Bayer Animal Health GmbH D-51368 Leverkusen Germany 
Imetnik dovoljenja za promet z zdravilom: Bayer Animal Health GmbH D-51368 Leverkusen Nemčija
Staphylococcus intermedius group (including S. pseudintermedius). 
Staphylococcus intermedius (vključno S.pseudintermedius).
Wound infections Acute infections of the urinary tract 
Akutne urinarne okužbe
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the bottle: 3 months 
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece
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). 
Zdravljenje akutnih okužb gornjih dihalnih poti, ki jih povzročajo občutljivi sevi Pasteurelle multocida, Escherichie coli in skupine Staphylococcus intermedius (vključno S.pseudintermedius).
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 15 mg tablete za pse in mačke pradofloksacin
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 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 15 mg tablete za pse in mačke Veraflox 60 mg tablete za pse
The recommended dose is 3 mg/kg bodyweight of pradofloxacin once daily according to the following tables. 
Priporočeni dnevni odmerek je 3 mg pradofloksacina na kg telesne mase.
Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases. 
V redkih primerih se lahko pojavijo lažje prehodne želodčno-črevesne motnje tudi bruhanje.
The treatment should be re-considered if no improvement of the clinical condition is observed within 3 days after starting the treatment. 
Če se klinično stanje ne izboljša v 3 dneh po začetnem zdravljenju, je potrebno o zdravljenju ponovno razmisliti.
Pradofloxacin is eliminated from serum with a terminal half-life of 9 hours. 
Končna razpolovna doba izločanja pradofloksacina iz plazme je 9 ur.
ATCvet code: QJ01MA97 
Farmakoterapevtska skupina: sistemsko protimikrobno zdravilo, flourokinoloni Oznaka ATC vet:QJ 01 MA97
MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/013-014 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/107/013-014
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 15 mg tablete pradofloksacin
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. 
Rjavkaste tablete z razdelilno zarezo in »P60« na eni strani.
Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases in dogs and cats. 
V redkih primerih se lahko pri psih in mačkah pojavijo lažje prehodne želodčno-črevesne motnje tudi bruhanje.
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 120 mg tablete pradofloksacin
Intermittent vomiting and soft faeces were observed in dogs after repeated oral administration of 2.7 times the maximum recommended dose. 
Pri ponavljajočem peroralnem dajanju 2,7- kratnega maksimalnega terapevtskega odmerka se je pri psih v presledkih pojavilo bruhanje in mehko blato.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Oral suspension containing 25 mg/ml pradofloxacin Preservative: Sorbic acid (E200) 2 mg/ml 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Peroralna suspenzija vsebuje 25 mg/ml pradofloksacina.
MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH D-51368 Leverkusen 
IMETNIK(I) DOVOLJENJ(A) ZA PROMET Bayer Animal Health GmbH D-51368 Leverkusen
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets for dogs pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 120 mg tablete za pse pradofloksacin
Excretion via kidneys is an important elimination route for pradofloxacin in dogs. 
Pradofloksacin se pri psih v glavnem izloča preko ledvic.
Pradofloxacin is eliminated from serum with a terminal half-life of 7 hours. 
Končna razpolovna doba izločanja pradofloksacina iz plazme je 7 ur.
- 15 ml bottle and a 3ml oral dosing syringe - 30 ml bottle 
Veraflox peroralna suspenzija je v dveh različnih pakiranjih: - 15 ml plastenka in 3 ml odmerna brizga - 30 ml plastenka
MARKETING AUTHORISATION NUMBER EU/2/10/107/014 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/107/014
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 60 mg tablete pradofloksacin
NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets for dogs pradofloxacin 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Veraflox 60 mg tablete za pse pradofloksacin
Fertility: 
Brejost:
MARKETING AUTHORISATION NUMBER EU/2/10/107/013 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/107/013
• acute urinary tract infections caused by susceptible strains of Escherichia coli and the 
• akutnih okužb gornjih dihalnih poti, ki jih povzročajo občutljivi sevi Pasteurelle multocida,
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
The variation procedure started on 16 May 2012. 
Postopek za spremembo se je začel 16. maja 2012.
The results showed efficacy above 95% except on day 7 (94.5%) and day 28 (87.5%). 
Rezultati so pokazali več kot 95-odstotno učinkovitost, razen 7. dan (94,5 %) in 28. dan (87,5 %).
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. 
Vloga je bila predložena Franciji kot referenčni državi članici ter Avstriji, Belgiji, Danski, Grčiji, Irski, Italiji, Luksemburgu, Nemčiji, Portugalski, Sloveniji, Španiji in Združenemu kraljestvu kot zadevnim državam članicam.
In absence of a strong signal, these data can be considered supportive data of the clinical data analysed below. 
Ker teh znakov ni, je mogoče te podatke šteti za podporne podatke kliničnim podatkom, analiziranim spodaj.
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. 
Ker referenčna in zadevne države niso mogle doseči soglasja glede spremembe, je Belgija 3. aprila 2013 začela postopek napotitve v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
Efficacy against lice 
Učinkovitost proti ušem
de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain 
de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španija
In cattle: 
Pri govedu:
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. 
Podatki niso pokazali bistvenih znakov, da bi morebitno navzkrižno delovanje med aktivnima snovema povzročilo bistveno slabšo učinkovitost.
Inhibited stages 
Inhibirane stopnje
Via Isonzo 71 04100 Latina Italy 
Via Isonzo 71 04100 Latina Italija
F - 75668 Paris Cedex 14 France 
F - 75668 Paris Cedex 14 Francija
6-8 weeks immatures 
nezrele oblike (6-8 tednov)
4.2 Indications for use, specifying the target species In cattle: 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Pri govedu:
The latter lower efficacy coincided with an apparent egg hatch on one treated animal where 50 lice were detected. 
Druga slabša učinkovitost je sovpadla z očitnim leženjem jajčec na eni zdravljeni živali, pri kateri je bilo odkritih 50 uši.
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. 
V času pred 28. dnevom in tik po njem je bilo zdravilo za to žival v celoti učinkovito in ni kazalo očitnega slabega delovanja.
Ramsgate Road Sandwich CT13 9NJ United Kingdom 
Ramsgate Road Sandwich CT13 9NJ Združeno Kraljestvo
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. 
Med postopkom spremembe je Belgija ugotovila možnost resnega tveganja za zdravje živali in zlasti, da učinkovitost zdravila proti vrstam uši ni ustrezno utemeljena.
This was not an unusual finding as egg hatch is rapid and can result in a high lice count. 
To ni neobičajna ugotovitev, saj se jajčeca ležejo zelo hitro, kar lahko vpliva na večje število uši.
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, predlagateljev/imetnikov dovoljenja za promet v državah članicah
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. 
Učinkovitost je bila ugotovljena tudi v zvezi z vrsto Bovicola bovis, vendar pa se lahko podatki zaradi slabše napadenosti živali in nedoslednosti ugotovitev v nekaterih dnevih uporabljajo le kot podporna informacija.
the CVMP recommended the granting of the variation to the terms of the marketing authorisations for the veterinary medicinal products referred to in annex I. The recommended changes in the relevant sections of the product information are set out in annex III. 
priporočil odobritev spremembe pogojev za dovoljenja za promet z zdravilom za uporabo v veterinarski medicini iz Priloge I. Priporočene spremembe v ustreznih oddelkih informacij o zdravilu so določene v Prilogi III.
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 
Gastro-intestinalni nematodi: Haemonchus placei Ostertagia ostertagi Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata Oesophagostomum radiatum Bunostomum phlebotomum Nematodi respiratornega trakta: Dictyocaulus viviparus TREMATODI Metljaj:
ECTOPARASITES Linognathus vituli Bovicola bovis Solenopotes capillatus 
Fasciola hepatica ZUNANJI ZAJEDALCI Linognathus vituli Bovicola bovis Solenopotes capillatus
Pfizer GmbH Linkstraße 10 10785 Berlin Germany 
Pfizer GmbH Linkstraße 10 10785 Berlin Nemčija
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations 
Znanstvene ugotovitve in razlogi za spremembo pogojev dovoljenj za promet z zdravili
1 CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf 
1 Smernica odbora za zdravila za uporabo v veterinarski medicini o posebnih zahtevah glede učinkovitosti za sredstva proti zunanjim zajedalcem pri govedu (EMEA/CVMP/625/03) - na voljo na naslovu:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004643.pdf.
Benefit-risk assessment 
Ocenjevanje razmerja med tveganjem in koristmi
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet 
Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
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. 
To vprašanje je ostalo nerešeno, zato se je v skladu s členom 13 Uredbe Komisije (ES) št. 1234/2008 14. januarja 2013 začel postopek usklajevalne skupine za postopek z medsebojnim priznavanjem in decentralizirani postopek (v nadaljnjem besedilu: CMD(v).
Adult stage 
Odrasla oblika
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. 
Zdravilo se nanese lokalno na hrbet živali in je potrebno za zdravljenje okužb goveda z različni,i vrstami glist in metljajem .
Marketing authorisation holder 
Predlagatelj/ Imetnik dovoljenja za promet
While acknowledging the absence of commingling of the animals which is a worst-case-scenario according to the CVMP guideline on specific efficacy requirements for ectoparasiticides in cattle (EMEA/CVMP/625/03)1, as a limitation in the study, the CVMP considered the study well conducted. 
Čeprav je priznan omejitev pri študiji, ker se živali niso mešale, kar je v skladu s smernico odbora za zdravila za uporabo v veterinarski medicini (CVMP) o posebni učinkovitosti zahtev za zatiranje zunanjih zajedavcev pri govedu najslabši mogoči scenarij (EMEA/CVMP/625/03)1, pa je odbor CVMP menil, da je bila študija dobro izvedena.
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. 
Primerljiva učinkovitost kombiniranega zdravila moksidektina/triklabendazola (Cydectin TriclaMox), ki se uporablja kot kožno poliv, v primerjavi z moksidektimom samim v isti nosilni raztopini se je preučila s farmakokinetičnim preskusom.
• 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; 
• pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v podporo indikaciji za zdravljenje napadov uši, ki jih povzročijo vrste Linognatus vituli, Bovicola bovis in Solenopotes capillatus;
Grounds for the variation to the terms of the marketing authorisations 
Razlogi za spremembo pogojev za dovoljenja za promet z zdravili
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. 
Proizvajalec Pfizer Animal Health je predložil vlogo za spremembo tipa II, da bi dodal novo indikacijo proti vrstam uši (Linognatus vituli, Bovicola bovis in Solenopotes capillatus), skliceval pa se je le na eno učinkovino zdravila, kožni poliv Cydectin, ki vsebuje le moksidektin in za katerega je bila zahteva za delovanje proti ušem že odobrena.