natgillin/translations-raw huggingface dataset:
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/ES za zdravilo Losec in povezana imena (EMEA/H/A-30/1001) usklajene indikacije za zdravila, ki vsebujejo omeprazol, vključujejo preprečevanje z NSAID povezanih želodčnih in duodenalnih ulkusov pri ogroženih bolnikih z vsakodnevnim 20-miligramskim odmerkom omeprazola.
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. 
Odbor CHMP je zato presodil, da sta glede na usklajeno indikacijo zdravil za zaščito želodca, ki vsebujejo omeprazol, v Evropski uniji, vse podatke, ki jih je predstavil predlagatelj, ter dobro poznani profil varnosti in učinkovitosti omeprazola in diklofenaka terapevtska učinkovitost in varnost zdravila Diotop 75 mg/20 mg zadovoljivo utemeljeni.
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. 
Obvestilo predlagateljem, zvezek 2A, poglavje 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf zdravila za uporabo v humani medicini (CHMP).
• The Committee considered the totality of the data submitted by the applicant in support of Diotop 75 mg / 20 mg modified-release capsules, hard; 
• odbor je upošteval vse podatke, ki jih je v podporo zdravilu Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem predložil predlagatelj,
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. 
Predlagatelj, podjetje Temmler Pharma GmbH, je v Nemčiji v skladu s členom 10b Direktive 2001/83/ES vložil vlogo za pridobitev dovoljenja za promet z zdravilom Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem.
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. 
Poleg tega so v literaturi na voljo podatki iz več randomiziranih kliničnih preskušanj, ki podpirajo varnost in učinkovitost vsakodnevnega jemanja 20 mg omeprazola za zdravljenje, obvladovanje in/ali preprečevanje z NSAID povezanih želodčnih in duodenalnih ulkusov pri bolnikih z 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. 
Referenčna država članica Združeno kraljestvo meni, da predloženi dokazi v zadostni meri podpirajo profil varnosti in učinkovitosti zdravila Diotop 75 mg/20 mg.
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 podlagi pregleda vseh razpoložljivih podatkov odbor CHMP meni, da je razmerje med koristmi in tveganji zdravila Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem in povezanih imen ugodno in zato priporoča izdajo dovoljenja za promet.
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. 
Nemčija je menila, da se sklepanje na podlagi drugih snovi, odmerkov in študij ne šteje za sprejemljiv pristop, zaradi česar varnost in učinkovitost zdravila Diotop 75 mg/20 mg nista bili zadovoljivo dokazani.
The 75 mg daily dose of diclofenac is approved for other diclofenac products in the EU for the symptomatic treatment of rheumatic disease. 
Dnevni odmerek 75 mg diklofenaka je v Evropski uniji odobren za druga zdravila, ki vsebujejo diklofenak in se uporabljajo za simptomatsko zdravljenje revmatskih bolezni.
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 bil ustrezen prispevek omeprazola k želenemu terapevtskemu učinku zdravila; dodatek zaviralca protonske črpalke pri bolnikih, ki potrebujejo dolgotrajno zdravljenje z NSAID in pri katerih obstaja tveganje za nastanek želodčnih in duodenalnih ulkusov, je predhodno priporočil Odbor za
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). 
Ena kapsula s prirejenim sproščanjem vsebuje 75 mg natrijevega diklofenakata (25 mg v obliki gastrorezistentnih pelet in 50 mg v obliki pelet s podaljšanim sproščanjem) in 20 mg omeprazola (gastrorezistentne pelete).
The DCP application was withdrawn from EE, LT, MT and LV during the national phase. 
Vloga za pridobitev dovoljenja za promet po decentraliziranem postopku je bila v Estoniji, Litvi, na Malti in v Latviji umaknjena v nacionalni fazi.
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. 
Predlagana indikacija je: simptomatsko zdravljenje revmatoidnega artritisa, osteoartritisa in ankilozirajočega spondilitisa pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek z nesteroidnimi protivnetnimi zdravili (NSAID) povezanih želodčnih in/ali duodenalnih ulkusov, ki se zadovoljivo obvladujejo z diklofenakom in omeprazolom.
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. 
Zdravilo Diotop 75 mg/20 mg je namenjeno za simptomatsko zdravljenje revmatoidnega artritisa, osteoartritisa in ankilozirajočega spondilitisa pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek z NSAID povezanih želodčnih in/ali duodenalnih ulkusov, ki se zadovoljivo obvladujejo z diklofenakom in omeprazolom.
CHMP also noted that there is a risk of GI complications with diclofenac 75 mg QD based on epidemiological data. 
Odbor CHMP je poudaril tudi, da tveganje za zaplete v prebavilih pri vsakodnevnem jemanju diklofenaka v odmerku 75 mg izražajo tudi epidemiološki podatki.
The CHMP acknowledged that there is no literature data regarding the specific free combination of diclofenac 75 mg QD and omeprazole 20 mg QD. 
Odbor CHMP je potrdil, da v literaturi ni podatkov o vsakodnevnem jemanju te točno določene proste kombinacije diklofenaka v odmerku 75 mg in omeprazola v odmerku 20 mg.
Diotop 75 mg / 20 mg is a fixed dose combination product consisting of diclofenac sodium and omeprazole. 
Diotop 75 mg/20 mg je zdravilo s fiksno kombinacijo odmerkov, ki vsebuje natrijev diklofenakat in omeprazol.
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. 
• odbor je menil, da predloženi bibliografski podatki zadovoljivo dokazujejo varnost in učinkovitost predlaganega zdravila s fiksno kombinacijo odmerkov odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem in povezanih imen ugodno in zato priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA
EU/1/97/037/001 Vistide 75 mg/ml 
EU/1/97/037/001 Vistide 75 mg/ml intravenska uporaba viala (steklena) 5 ml
5 ml 
1 viala
Strength Pharmaceutical Form Route of administration 
Zdravilo nima veā dovoljenja za promet
Packaging Content (concentration) 
Številka EU izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
(In these studies efficacy was not investigated). 
(Pri tem učinkovitost ni bila raziskana).
All dogs recovered without treatment. 
Vsi psi so okrevali brez zdravljenja.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. 
Priporoča se veterinarski pregled 30 dni po zdravljenju, ker je lahko pri nekaterih živalih potrebno zdravljenje ponoviti.
The prandial state of the dog does not significantly affect the extent of its absorption. 
Hranjenje psa ne vpliva občutno na obseg absorbcije.
The tablets should not be divided. 
Tablet ne smete deliti.
Interactions with other medicinal products and other forms of interactions: None known. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso znane.
Date of first authorisation: 31/01/2018. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 31/01/2018.
The bioavailability of sarolaner following oral dosing was high at >85%. 
Biološka razpoložljivost sarolanerja po peroralnem dajanju je visoka >85%.
A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues. 
Raziskave porazdelitve so določile, da so ostanki povezani z 14C-sarolanerjem široko porazdeljeni v tkivih.
Tablets can be administered with or without food. 
Tablete se lahko daje s hrano ali brez.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz tega zdravila, je treba odstraniti v skladu z lokalnimi zahtevami.
Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart. 
Zdravljenje je treba nadaljevati, dokler kožni ostružki niso negativni, najmanj dva zaporedna odvzema, v razmaku enega meseca.
For the treatment of demodicosis (Demodex canis). 
Za zdravljenje demodikoze (Demodex canis).
These signs typically resolve without treatment. 
Ti znaki navadno minejo brez zdravljenja.
The depletion from tissues was consistent with the plasma half-life. 
Izločanje iz tkiv je bilo skladno z razpolovno dobo v plazmi.
Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg). 
Sarolaner ima nizek renalni očistek (0.12 ml/min/kg) in zmeren volumen porazdelitve (2.81 l/kg).
As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately. 
Ker je demodikoza večplastna bolezen, je priporočljivo, da obenem ustrezno zdravite tudi osnovno bolezen.
Ticks on the animal prior to administration are killed within 24 hours. 
Klopi, ki so že na živali pred dajanjem zdravila, so ubiti znotraj 24 ur.
For each strength, the chewable tablets are available in a carton with 1 blister of 3 tablets. 
Za vsako jakost so žvečljive tablete na voljo v kartonski škatli z 1 pretisnim omotom s po 3 tabletami.
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. 
Da bi preprečili otrokom dostop do zdravila, se mora iz pretisnega omota vzeti le posamezna tableta naenkrat in samo kadar je to potrebno.
For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs. 
Za zdravljenje demodikoze (ki jo povzroča Demodex canis) je uporaba enkratnega odmerka, enkrat mesečno, tri zaporedne mesece, učinkovita in vodi do izrazitega izboljšanja kliničnih znakov.
No treatment-related clinical signs were observed. 
Pri tem niso opazili nobenih kliničnih znakov povezanih z zdravljenjem.
Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects. 
Z laboratorijskimi študijami na kuncih in podganah teratogeni učinki niso bili dokazani.
Mild and transient gastrointestinal signs such as vomiting and diarrhoea, transient neurological disorders such as tremor, ataxia or convulsion and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases. 
Blagi in prehodni gastrointestinalni znaki, kot so bruhanje in driska, prehodne nevrološke motnje, kot so tremor, ataksija ali konvulzije in sistemske motnje kot so letargija, anoreksija/inapetenca se lahko pojavijo v zelo redkih primerih.
The number embossed on one side refers to the strength (mg) of the tablets: “5”, “10”, ”20”, “40”, “80” or “120”. 
Številka vtisnjena na eni strani žvečljive tablete se nanaša na jakost (v mg) tablet: "5", “10”, ”20”, “40”, “80” or “120”.
Parasites need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded. 
Paraziti se morajo začeti hraniti na gostitelju, da so izpostavljeni sarolanerju, zato tveganja prenašanja infekcijskih bolezni, ki jih prenašajo paraziti, ni mogoče izključiti.
The veterinary medicinal product should be administered at a dose of 2-4 mg/kg bodyweight in accordance with the following table: 
Zdravilo je treba dajati v odmerku 2 do 4 mg/kg telesne teže, v skladu z naslednjo preglednico:
One carton contains one blister of 3 tablets. 
En karton vsebuje 1 pretisni omot z 3 tabletami.
Aluminium foil/foil blister package. 
Aluminijev folija/folija pretisni omot.
One 
Ena
ATC vet code: QP53BE03. 
Farmakoterapevtska skupina: Ektoparazitiki za sistemsko uporabo Oznaka ATCvet: QP53BE03.
Number of tablets to be administered 
Število tablet, ki jih je treba dati
Sarolaner is well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 5 times the recommended dose. 
Sarolaner so dobro prenašali koliji z nezadostnim MDR 1-/- (multidrug-resistance-protein 1) po enkratnem peroralnem dajanju 5krat večjega odmerka od priporočenega.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). 
Zdravilo se lahko uporablja kot del strategije zdravljenja dermatitisa zaradi alergije na bolhe (Flea Allergy Dermatitis - FAD).
Sarolaner was dose proportional in Beagle dogs when dosed from the intended use dose of 2-4 mg/kg, to 20 mg/kg. 
Sarolaner je bil sorazmeren odmerku pri psih pasme Beagle pri odmerjanju od predpisanega odmerka 2 do 4mg/kg do odmerka 20 mg/kg.
Tablet strength (mg sarolaner) 
Jakost tablete (mg sarolanerja)
The primary route of elimination is biliary excretion of parent molecule, with elimination through the faeces. 
Glavna pot izločanja je izločanje matične molekule z žolčem v blato.
The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access. 
To zdravilo ubije bolhe, ki pridejo na psa po dajanju zdravila, preden bi lahko izlegle jajčeca in tako prepreči onesnaženje okolja z bolhami na področjih, do katerih ima pes dostop.
Use appropriate combination of available strengths to achieve the recommended dose of 2-4 mg/kg. 
Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočen odmerek 2 do 4 mg/kg telesne teže.
For ticks (I. ricinus), the onset of efficacy is within 12 hours of attachment during the 28 day period after product administration. 
Pri klopih (I. ricinus) je začetek delovanja zdravila znotraj 12 ur po pritrditvi v obdobju 28 dni po dajanju zdravila.
Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes. 
Sarolaner ne deluje medsebojno z znanimi mesti vezave nikotinskih in drugih GABAergičnih insekticidov kot so neonikotinoidi, fiproli, milbemicini, avermektini in ciklodieni.
Special warnings for each target species: 
Posebni previdnostni ukrepi za vsako ciljno žival:
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). 
Zdravljenje infestacij z bolhami (Ctenocephalides felis in Ctenocephalides canis).
In the overdose groups, transient and self-limiting neurological signs were observed in some animals: mild tremors at 3 times the maximum exposure dose and convulsions at 5 times the maximum exposure dose. 
V skupinah psov s prekomernim odmerjanjem, so pri nekaterih živalih opazili naslednje prehodne in samoomejujoče nevrološke znake: blago tresenje pri 3krat večjem odmerku od največjega priporočenega in krče pri 5-krat večjem odmerku od največjega priporočenega.
MiPet Easecto tablets are chewable and palatable and readily consumed by dogs when offered by the owner. 
Tablete MiPet Easecto so žvečljive in okusne, zato jih psi radi sprejmejo od lastnika.
For the treatment of sarcoptic mange (Sarcoptes scabiei). 
Za zdravljenje garjavosti (Sarcoptes scabiei).
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. 
V primeru nenamernega zaužitja, se takoj posvetujete z zdravnikom in mu pokažite zdravniku navodilo za uporabo ali ovojnino.
During clinical field trials, no interactions between MiPet Easecto chewable tablets for dogs and routinely used veterinary medicinal products were observed. 
Med terenskimi kliničnimi testiranji niso opazili nobenih interakcij z rutinsko uporabljenimi zdravili za uporabo v veterinarski medicini.
For the treatment of ear mite infestations (Otodectes cynotis). 
Za zdravljenje ušesne garjavosti (Otodectes cynotis).
In laboratory safety studies, no interactions were observed when sarolaner was co-administered with milbemycin oxime, moxidectin and pyrantel pamoate. 
Med laboratorijskimi varnostnimi testiranji niso opazili nobenih interakcij med sarolanerjem in sočasnim dajanjem milbemicin oksima, moksidektina ali pirantel pamoata.
Sarolaner is highly bound to plasma proteins and might compete with other highly bound drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and the cumarin derivative warfarin. 
Sarolaner se močno veže na plazemske beljakovine in se lahko kosa z drugimi močno vezanimi zdravili, kot so nesteroidna protivnetna zdravila (NSAID) in kumarinski derivat varfarin.
MiPet Easecto chewable tablets sarolaner (mg) 
MiPet Easecto žvečljive tablete sarolaner (mg)
For the treatment of ear mite infestations (Otodectes cynotis) a single dose should be administered. 
Za zdravljenje ušesne garjavosti (ki jo povzroča Otodectes cynotis), je treba dati enkratni odmerek zdravila.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding. 
Varnost zdravila v obdobju brejosti, laktacije in pri psih za vzrejo ni bila ugotovljena.
For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continue throughout the flea and/or tick season based on local epidemiological situations. 
Za optimalni nadzor infestacije s klopi in bolhami, je treba zdravilo dajati v mesečnih razmikih in nadaljevati z dajanjem skozi celotno sezono bolh in/ali klopov glede na krajevne epidemiološke situacije.
In a margin of safety study, the veterinary medicinal product was administered orally to 8 week old Beagle puppies at doses of 0, 1, 3, and 5 times the maximum exposure dose of 4 mg/kg at 28 day intervals for 10 doses. 
V mejni varnostni študiji so zdravilo dajali peroralno 8 tednov starim psičkom pasme Beagle, v odmerkih, ki so bili 0, 1, 3 in 5 krat večji od največjega priporočenega odmerka 4 mg/kg telesne teže, po 10 odmerkov v 28 dnevnih presledkih,.
PSUR submissions for MiPet Easecto shall be synchronised and submitted at the same frequency as for Simparica. 
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Vloge PSUR za MiPet Easecto se sinhronizirajo in pošiljajo enako pogosto kot pri Simparici.
PACKAGE LEAFLET: MiPet Easecto chewable tablets for dogs 
NAVODILO ZA UPORABO MiPet Easecto žvečljive tablete za pse
Pregnancy and lactation: 
Uporaba v obdobju brejosti in laktacije:
For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) a single dose should be administered at monthly intervals for two consecutive months. 
Za zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis), je treba dajati enkratni odmerek zdravila enkrat mesečno, dva meseca zapored.
Plasma protein binding was determined in vitro and calculated at ≥99.9%. 
Razpolovna doba je bila primerljiva pri intravenozni in peroralni poti 12 in 11 dan. Vezava na plazemske proteine je bila določena in vitro in je izračunana pri ≥99.9%.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN učinkovina:
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration. 
Pri bolhah je začetek delovanja zdravila znotraj 8 ur po pritrditvi v obdobju 28 dni po dajanju zdravila.
Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines. 
Sarolaner inhibira GABA- in glutamat- odvisne kloridne kanale v centralnem živčnem sistemu insektov in pršic.
3 tablets 
VELIKOST PAKIRANJA 3 tablete
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.3 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian. 
Zaradi pomanjkanja podatkov, se to zdravilo za uporabo v veterinarski medicini sme uporabljati za mladiče do 8 tednov starosti oziroma pri psih, ki tehtajo manj kot 1,3 kg le v skladu z oceno razmerja med koristjoin tveganjem, ki jo opravi odgovorni veterinar.
Mottled brown coloured, square shaped chewable tablets with rounded edges. 
Lisasto rjavo obarvana žvečljiva tableta kvadratne oblike z zaobljenimi robovi.
Chewable tablets. 
Žvečljiva tableta.
Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus and the mites Demodex canis, Otodectes cynotis and Sarcoptes scabiei. 
(Ctenocephalides felis and Ctenocephalides canis) kot tudi na številne vrste klopov (Dermacentor reticulatus, , Ixodes hexagonus, , Ixodes ricinus, Rhipicephalus sanguineus) in garjavce: Demodex canis, Otodectes cynotis inSarcoptes scabiei.
No adverse effects were observed at the maximum exposure dose of 4 mg/kg. 
Pri največjem priporočenem odmerku 4 mg/kg telesne teže ni bilo opaziti nobenih stranskih učinkov.
Read the package leaflet before use. 
POSEBNA NAVODILA ZA SHRANJEVANJE Pred uporabo preberite navodilo za uporabo.