natgillin/translations-raw huggingface dataset:
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy). 
Potrebno je razmotriti mogućnost produljenja trajanja terapije na više od 12 tjedana do najviše 24 tjedna, osobito u podskupina s jednim ili više čimbenika koji se otprije povezuju s nižim stopama odgovora na terapiju na bazi interferona (npr. uznapredovala fibroza/ciroza,
Treated subjects (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA 
Medijan dobi liječenih ispitanika (n = 419) bio je 51 godina (raspon: 19 do 74); 60% ispitanika bili su muškarci; medijan indeksa tjelesne mase iznosio je 25 kg/m2 (raspon: 17 do 44 kg/m2); srednja vrijednost početne razine HCV RNK bila je 6,4 log10 IU/ml; 21% imalo je cirozu; 78% imalo je HCVgenotip 3; 65% je prethodno imalo relaps.
Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms 
mialgija bol u leđima, mišićni grčevi
EXP 
Emtricitabin f
• chest pain, feeling weak 
• bol u leđima, mišićni grčevi • bol u prsnom košu, osjećaj slabosti
and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in subjects <75 kg, 1,200 mg daily in subjects ≥75 kg). 
Ako su se u ispitanika razine hemoglobina održale na ≥ 12 g/dl, doza ribavirina bila je povišena u 2. i 4. tjednu te nakon toga svaka 4 tjedna sve dok nije postignuta odgovarajuća doza prema tjelesnoj težini (1000 mg na dan u ispitanika tjelesne težine < 75 kg, a 1200 mg na dan u ispitanika tjelesne težine ≥ 75 kg).
Overall No cirrhosis Cirrhosis 
Ukupno Bez ciroze
SOF+RBV 12 weeks (n = 73) 
SOF+RBV 12 tjedana (n = 68)
Cirrhosisa 
• omaglica
Cirrhosis No Yes Response to prior HCV treatment Relapser Nonresponder 70% (7/10) 
Bez odgovora 70% (7/10)
Overall No cirrhosis Cirrhosis TN = treatment-naïve; TE = treatment-experienced. 
TN = prethodno nisu liječeni; TE = prethodno liječeni.
Sovaldi is contraindicated with St. John's wort, a potent intestinal P-gp inducer (see section 4.3). 
Sovaldi je kontraindiciran s gospinom travom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
Treated subjects (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6. 
Medijan dobi liječenih ispitanika (n = 327) bio je 54 godine (raspon: 19 do 70); 64% ispitanika bili su muškarci; 79% bili su bijelci, 17% bili su crnci; 14% bili su hispano ili latino-porijekla; srednja vrijednost indeksa tjelesne mase iznosila je 29 kg/m2 (raspon: 18 do 56 kg/m2); 78% imalo je početni
Based on population pharmacokinetic analysis in subjects with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively. 
infekcije (n = 986), AUC0-24 za sofosbuvir u stanju dinamičke ravnoteže bio je 1010 ng•h/ml, a za
Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114) 
Genotip 3 SOF+RBV 12 tjedana (n = 11)
ANTIMYCOBACTERIALS Rifampicinf 
Tenofovir dizoproksil fumaratf
GS-331007 ↔ Cmax 1.23 (1.14, 
GS-331007 7200 ng•h/ml.
--1 Rabies virus, strain SPBN GASGAS, live - 106.8 to 108.1 FFU* per 1.7 ml dose * Focus forming units 
Virus bjesnoće, soj SPBN GASGAS, živo: - 106.8 FFU* - 108.1 FFU* po 1,7 ml doze * Focus Forming Units - jedinice formiranja fokusa
Packaging Content 
Put primjene Pakovanje Sastav
Withdrawal period 
Suspenzija:
• The Committee considered the (Co-)Rapporteur's assessment report; 
• Povjerenstvo je razmotrilo izvješće procjene (su)izvjestitelja;
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC where Germany raised objections as a potential serious risk to public health; 
• Povjerenstvo je razmatralo postupak upućivanja prema članku 29. stavku 4. Direktive 2001/83/EZ u kojem je Njemačka postavila primjedbe u smislu potencijalno ozbiljnog rizika za javno zdravlje;
In addition, the applicant refers to relevant clinical guidelines. 
Osim toga, podnositelj upućuje na relevantne kliničke smjernice.
The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion. 
Informacije o lijeku ostaju u skladu s konačnom verzijom donesenom tijekom postupka Koordinacijske skupine kako je navedeno u Prilogu III. mišljenja CHMP-a.
The DCP application was withdrawn from EE, LT, MT and LV during the national phase. 
Zahtjev za decentraliziranim postupkom povukle su EE, LT, MT i LV za vrijeme nacionalne faze postupka.
According to Article 10b of Directive 2001/83/EC, new clinical or non-clinical trials relating to the combination (although not the individual active substances) should be submitted. 
Prema članku 10.b Direktive 2001/83/EZ, potrebno je dostaviti podatke iz kliničkih ili nekliničkih ispitivanja koji se odnose na ovu kombinaciju (iako ne na pojedinačne djelatne tvari).
This specific dose is also supported by bibliographical evidence submitted by the applicant. 
Specifičnu dozu potkrepljuju i bibliografski dokazi koje je dostavio podnositelj zahtjeva.
However, according to Notice to Applicants Volume 2A Chapter 1 Section 5.51 , a mixed-dossier can be accepted. 
Međutim, prema Uputama za podnositelje zahtjeva, volumen 2A, poglavlje 1 dio 5.51 , može biti prihvaćena kombinirana dokumentacija o lijeku.
A decentralised procedure (DCP) with the UK as reference Member State (RMS) and AT, EE, LT, LV and MT as CMSs, concluded positively on 7 November 2016 (UK/H/6135/001/DC). 
Decentralizirani postupak (DCP) s Ujedinjenom Kraljevinom (UK) kao referentnom državom članicom i Austrijom (AT), Estonijom (EE), Litvom (LT), Latvijom (LV) i Maltom (MT) kao članicama sudionicama, zaključen je pozitivno 7. studenoga 2016. (UK/H/6135/001/DC).
• The Committee was of the view that the submitted bibliographical data demonstrate sufficiently the safety and efficacy of the proposed fixed dose combination product. 
• Povjerenstvo je mišljenja da dostavljeni bibliografski podaci dovoljno dokazuju sigurnost primjene i djelotvornost predložene kombinacije fiksnih doza ovoga lijeka.
Data from studies of higher doses of diclofenac or other NSAIDs can be extrapolated to support the efficacy and safety of the specific combination. 
Podatke iz ispitivanja viših doza diklofenaka ili drugih NSAIL-ova može se ekstrapolirati kako bi se poduprla djelotvornost i sigurnost primjene ove specifične kombinacije.
The applicant has submitted a review of the literature relating to the use of diclofenac and omeprazole in combination. 
Podnositelj zahtjeva dostavio je pregled literature koja se odnosi na primjenu diklofenaka i omeprazola u kombinaciji.
Moreover the mechanisms for both NSAID-associated GI toxicity and the gastro-protective efficacy of omeprazole are not expected to differ across the different non-selective NSAIDs studied, which are all associated with a risk of upper GI complications. 
Nadalje, ne očekuje se da će se mehanizmi gastrointestinalne toksičnosti povezane s NSAIL-ovima i gastroprotektivne djelotvornosti omeprazola razlikovati za različite neselektivne ispitivane NSAIL-ove, što je sve povezano s rizikom od komplikacija gornjeg dijela gastrointestinalnog sustava.
However, the CHMP took into consideration the Guideline on clinical development of fixed combination medicinal products2 and concluded by consensus that the development of Diotop 75 mg/20 mg is in line with it, since the Guideline does not preclude extrapolation from higher doses and different substances if scientifically justified. 
Međutim, CHMP je uzeo u obzir Smjernice o kliničkom razvoju fiksne kombinacije lijekova 2 i konsenzusom zaključio da je razvoj Diotopa 75 mg/20 mg u skladu sa Smjernicama, jer one ne isključuju ekstrapolaciju s višim dozama i različitim tvarima ako je to znanstveno opravdano.
DE is in agreement with the CHMP conclusion. 
Njemačka se slaže sa zaključcima CHMP-a.
The 75 mg daily dose of diclofenac is approved for other diclofenac products in the EU for the symptomatic treatment of rheumatic disease. 
Dnevna doza diklofenaka od 75 mg odobrena je za druge lijekove s diklofenakom u EU-u za simptomatsko liječenje reumatskih bolesti.
It is noted that the bioequivalence has been demonstrated between the free combination of the recognised reference formulations of the individual mono-components and the proposed fixed combination product and there are no outstanding concerns regarding quality and non-clinical issues. 
Napominje se da je između slobodne kombinacije priznatih referentnih formulacija individualnih monokomponenti i fiksne kombinacije predloženog lijeka dokazana bioekvivalentnost te da nema nikakvih neriješenih zabrinutosti u pogledu kakvoće i nekliničkih pitanja.
The applicant Temmler Pharma GmbH submitted in Germany (DE) an application for a Marketing Authorisation (MA) for Diotop 75 mg / 20 mg modified-release hard capsules, under Article 10b of Directive 2001/83/EC. 
Podnositelj zahtjeva, tvrtka Temmler Pharma GmbH dostavila je u Njemačkoj zahtjev za odobrenje za stavljanje u promet lijeka Diotop 75 mg/20 mg tvrde kapsule s prilagođenim otpuštanjem, prema članku 10.b Direktive 2001/83/EZ.
Therefore, the CHMP considered that in the context of the harmonised gastro protection indication for omeprazole products in the European Union, the totality of the data presented by the applicant and the well-known safety and efficacy profile of omeprazole and diclofenac, the therapeutic efficacy and the safety of Diotop 75 mg/20 mg is adequately justified. 
Stoga CHMP smatra da je u kontekstu usklađene gastroprotektivne indikacije lijekova s omeprazolom u Europskoj uniji, s obzirom na ukupnost podataka koje je dostavio podnositelj zahtjeva i dobro poznati profil sigurnost i djelotvornosti omeprazola i diklofenaka, terapijska djelotvornost lijeka Diotop 75 mg/20 mg odgovarajuće opravdana.
However, the position of DE was that this particular combination of diclofenac/omeprazole in the specific doses 75 mg / 20 mg administered once daily has never been tested in any published study and no new clinical data has been generated. 
Njemačke bio je da baš ta kombinacija diklofenaka/omeprazola u specifičnim dozama od 75 mg/20 mg za primjenu jedanput na dan, nikada nije bila ispitana ni u jednom objavljenom ispitivanju te da nisu generirani nikakvi novi klinički podatci.
Bioequivalence has been demonstrated between Diotop 75 mg / 20 mg and the free combination of the recognised reference formulations of the individual mono-components. 
Bioekvivalencija je dokazana između lijeka Diotop 75 mg/20 mg i slobodne kombinacije priznatih referentnih formulacija individualnih monokomponenti.
Moreover, following an Article 30 procedure of Directive 2001/83/EC for Losec and associated names (EMEA/H/A-30/1001), the harmonised indications for omeprazole products include the prevention of NSAID-associated gastric and duodenal ulcers in patients at risk with omeprazole dosed at 20 mg 
Direktive 2001/83/EZ za lijek Losec i pridružena imena (EMEA/H/A-30/1001), usklađene indikacije za lijekove koji sadrže omeprazol uključuju sprječavanje ulkusa želuca i dvanaesnika povezanog s NSAIL-ovima u bolesnika pod rizikom zbog primjene omeprazola u dozi od 20 mg na dan.
In addition, there are literature data from several large RCTs supporting the safety and efficacy of omeprazole 20 mg daily for the treatment, maintenance and/or prevention of NSAID-associated gastroduodenal ulceration in patients with arthritis. 
Nadalje, literaturni podatci iz nekoliko velikih randomiziranih kontroliranih ispitivanja podupiru sigurnost i djelotvornost omeprazola 20 mg na dan za liječenje, terapiju održavanja i/ili sprječavanje ulceracija gastroduodenuma povezanih s primjenom NSAIL-ova u bolesnika s artritisom.
The reference member state (RMS) UK considers that the submitted evidence is adequate to support the safety and efficacy profile of Diotop 75 mg / 20 mg. 
Ujedinjena Kraljevina kao referentna članica (RMS) smatra da je dostavljeni dokaz dovoljan kako bi se potkrijepio profil sigurnosti i djelotvornosti lijeka Diotop 75 mg/20 mg.
DE considered that extrapolation across different substances, doses and studies is not considered to be an acceptable approach and thus the safety and efficacy of Diotop 75 mg / 20 mg has not been sufficiently shown. 
Njemačka je smatrala da se ekstrapolacija na različite tvari, doze i ispitivanja ne smatra prihvatljivim pristupom te stoga sigurnost i djelotvornost lijeka Diotop 75 mg/20 mg nisu dostatno prikazane.
The relevant contribution of omeprazole to the desired therapeutic effect of the product has been demonstrated; the addition of a proton pump inhibitor in patients requiring long-term use of NSAIDs who are at risk of gastroduodenal ulceration has previously been recommended by the CHMP. 
Dokazan je relevantan doprinos omeprazola željenom terapijskom učinku lijeka; dodatak inhibitora protonske pumpe u bolesnika kojima je potrebna dugotrajna primjena NSAIL-ova i koji su pod rizikom
This referral procedure concerns the products in UK, AT and DE. 
Ovaj postupak upućivanja odnosi se na lijekove u UK-u, AT-u i DE-u.
• The Committee considered the totality of the data submitted by the applicant in support of Diotop 75 mg / 20 mg modified-release capsules, hard; 
• Povjerenstvo je uzelo u obzir ukupnost podataka koje je dostavio podnositelj zahtjeva u prilog lijeku Diotop 75 mg/20 mg tvrde kapsule s prilagođenim otpuštanjem;
The CHMP acknowledged that there is no literature data regarding the specific free combination of diclofenac 75 mg QD and omeprazole 20 mg QD. 
CHMP prihvaća da nema podataka iz literature koji se odnose na specifičnu slobodnu kombinaciju diklofenaka 75 mg na dan i omeprazola 20 mg na dan.
The proposed indication is: symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers who are adequately controlled with diclofenac and omeprazole. 
Predložena indikacija je: simptomatsko liječenje reumatoidnog artritisa, osteoartritisa i ankilozantnog spondilitisa u odraslih bolesnika u kojih postoji rizik od razvoja ulkusa želuca i/ili dvanaesnika povezan s primjenom NSAIL-ova, a odgovarajuće su kontrolirani diklofenakom i omeprazolom.
Each modified release capsule contains 75 mg diclofenac sodium (25 mg as gastroresistant pellets and 50 mg as prolonged release pellets) and 20 mg of omeprazole (gastro-resistant pellets). 
Jedna kapsula s prilagođenim otpuštanjem sadrži 75 mg diklofenaknatrija (25 mg u obliku želučanootpornih peleta (zrnaca) i 50 mg u obliku peleta s produljenim otpuštanjem) i 20 mg omeprazola (želučanootporne pelete).
Based on the review of all available data, the CHMP considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation. 
Na temelju pregleda svih dostupnih podataka, CHMP smatra da je omjer rizika i koristi lijeka Diotop 75 mg/20 mg tvrdih kapsula s prilagođenim otpuštanjem te pridruženih imena povoljan te stoga preporučuje davanje odobrenja za stavljanje lijeka u promet.
CHMP also noted that there is a risk of GI complications with diclofenac 75 mg QD based on epidemiological data. 
CHMP je također napomenuo da na temelju epidemioloških podataka postoji rizik od gastrointestinalnih komplikacija uz 75 mg diklofenaka na dan.
Diotop 75 mg / 20 mg is intended for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers, who are adequately controlled with diclofenac and omeprazole. 
Diotop 75 mg/20 mg namijenjen je za simptomatsko liječenje reumatoidnog artritisa, osteoartritisa i ankilozantnog spondilitisa u odraslih bolesnika u kojih postoji rizik od razvoja ulkusa želuca i/ili dvanaesnika povezan s primjenom NSAIL-ova, a odgovarajuće su kontrolirani diklofenakom i omeprazolom.
Notice to Applicants Volume 2A Chapter 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf daily. 
Uputa za podnositelje zahtjeva, volumen 2A, poglavlje 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf od gastroduodenalnih ulceracija prethodno je preporučio CHMP.
Diotop 75 mg / 20 mg is a fixed dose combination product consisting of diclofenac sodium and omeprazole. 
Diotop 75 mg/20 mg lijek je s kombinacijom fiksnih doza koji se sastoji od diklofenaknatrija i omeprazola.
The Committee, as a consequence, considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion. 
Povjerenstvo, posljedično, smatra da je omjer koristi i rizika lijeka Diotop 75 mg/20 mg tvrde kapsule s prilagođenim otpuštanjem i pridruženih imena povoljan te stoga preporučuje davanje odobrenja za stavljanje u promet lijeka navedenog u Prilogu I. mišljenja CHMP-a.
Date of first authorisation: 31/01/2018. 
Datum prvog odobrenja: 31/01/2018.
ATC vet code: QP53BE03. 
ATCvet kod: QP53BE03.
Wash hands after handling the product. 
Oprati ruke nakon primjene proizvoda.
Tablets can be administered with or without food. 
Tablete se mogu primijeniti s ili bez hrane.
All dogs recovered without treatment. 
Svi psi su se oporavili bez liječenja.
Interactions with other medicinal products and other forms of interactions: None known. 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Nisu poznate.
If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. 
Ako pas dobrovoljno ne uzme tabletu, može mu se dati preko hrane ili direktno u usta.
Each tablet contains: 
Svaka tableta sadržava:
Plasma protein binding was determined in vitro and calculated at ≥99.9%. 
Vezanje za proteine u plazmi određeno je in vitro, te se iznosi ≥ 99,9%.
The bioavailability of sarolaner following oral dosing was high at >85%. 
Biološka raspoloživost sarolanera nakon peroralne primjene je visoka, > 85%.
Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects. 
Laboratorijski pokusi na štakorima i kunićima nisu izazvali nikakav teratogeni učinak.
Half-life was comparable for the intravenous and oral routes at 12 and 11 
Poluživot je usporediv s intravenoznom i peroralnom primjenom 11. i 12. dan.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, UKOLIKO JE PRIMJENJIVO
One carton contains one blister of 3 tablets. 
Jedna kartonska kutija sadrži jedan blister s 3 tablete.
For the treatment of demodicosis (Demodex canis). 
Za liječenje demodikoze (Demodex canis).
No treatment-related clinical signs were observed. 
Nisu primijećeni nikakvi klinički znakovi koji bi se morali liječiti.
EU/2/17/220/001 (5 mg, 3 tablets) EU/2/17/220/002 (10 mg, 3 tablets) EU/2/17/220/003 (20 mg, 3 tablets) EU/2/17/220/004 (40 mg, 3 tablets) EU/2/17/220/005 (80 mg, 3 tablets) EU/2/17/220/006 (120 mg, 3 tablets) 
EU/2/17/220/001 (5 mg, 3 tablete) EU/2/17/220/002 (10 mg, 3 tablete) EU/2/17/220/003 (20 mg, 3 tablete) EU/2/17/220/004 (40 mg, 3 tablete) EU/2/17/220/005 (80 mg, 3 tablete) EU/2/17/220/006 (120 mg, 3 tablete)
The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodyweight in accordance with the following table: 
Veterinarsko - medicinski proizvod treba davati u dozi 2 - 4 mg/kg tjelesne težine u skladu sa sljedećom tablicom:
The depletion from tissues was consistent with the plasma half-life. 
Eliminacija iz tkiva je u skladu s polu-životom u plazmi.
To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required. 
Kako biste djeci spriječili pristup proizvodu, iz blistera treba izvaditi samo jednu tabletu za žvakanje i to samo kada je potrebno.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tog veterinarsko-medicinskog proizvoda trebaju se odlagati u skladu s lokalnim propisima.
The prandial state of the dog does not significantly affect the extent of its absorption. 
Hranjenje pasa nema značajan utjecaj na opseg resorpcije.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. 
Buhe i krpelji trebaju se pričvrstiti na domaćina i započeti hranjenje, kako bi mogli biti izloženi djelatnoj tvari.
These signs typically resolve without treatment. 
Ovi simptomi obično prolaze bez liječenja.
A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues. 
Ispitivanja distribucije su utvrdile da su ostaci povezani s 14C-sarolanerom široko rasprostranjeni u tkivima.
As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately. 
S obzirom da je demodikoza multifaktorska bolest, također se preporuča liječiti osnovnu bolest.
The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”. 
Broj utisnut na jednoj strani odnosi se na jačinu (mg) tableta: "5", "10", "20", "40", "80" ili "120".
Pharmacotherapeutic group: Ectoparasiticides for systemic use. 
Farmakoterapijska grupa: ektoparazitici za sustavnu upotrebu.
Ticks on the animal prior to administration are killed within 24 hours. 
Krpelji koji su prilikom liječenja već na životinji, ubijeni su unutar 24 sata.
EU/2/17/220/001-006 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2//17/220/001-006
During clinical field trials, no interactions between MiPet Easecto chewable tablets for dogs and routinely used veterinary medicinal products were observed. 
Tijekom kliničkih terenskih ispitivanja nisu primijećene interakcije između MiPet Easecto tableta za žvakanje za pse i redovito upotrebljenog veterinarsko - medicinskog proizvoda.
For the treatment of sarcoptic mange (Sarcoptes scabiei). 
Za liječenje sarkoptes šuge (Sarcoptes scabiei).
No adverse effects were observed at the maximum exposure dose of 4 mg/kg. 
Nikakvi popratni učinci nisu primijećeni prilikom maksimalne izloženosti dozi 4 mg/kg.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). 
Veterinarsko - medicinski proizvod može se koristiti kao dio strategije liječenja u kontroli alergijskog dermatitisa uzrokovanih buhama.
Tablet strength (mg sarolaner) 
Jačina tablete (mg sarolanera)
Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg. 
Upotrijebite odgovarajuću kombinaciju raspoloživih jačina tableta da bi postigli preporučenu dozu 2 do 4 mg/kg tjelesne težine.
Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg). 
Sarolaner ima niski bubrežni klirens (0,12 ml/min/kg), te umjereni volumen raspodjele (2,81 L/kg).
Number of tablets to be administered 
Broj tableta koje treba primijeniti
Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. 
Liječenje treba nastaviti sve dok testovi struganje kože nisu negativni, najmanje dva uzastopna puta, u roku od mjesec dana.