natgillin/translations-raw huggingface dataset:
One treatment kills ticks for up to one month. 
Eno zdravljenje ubija klope do 1 mesec.
Most reported adverse reactions were self-limiting and of short duration. 
Večina neželenih učinkov o katerih so poročali je minila sama od sebe in so bili kratkotrajni.
Wash hands after handling the product. 
Po rokovanju z zdravilom si umijte roke.
The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu). 
Zdravilo za uporabo v veterinarski medicini je posamično pakirano v toplotno oblikovane laminirane PVC pretisne omote s hrbtom iz aluminiranega papirja(Aclar/PVC/Alu).
For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/same strengths. 
Za pse nad 50 kg telesne mase uporabite ustrezno kombinacijo žvečljivih tablet iste ali različne jakosti.
The terminal plasma half-life is approximately 2 weeks in most dogs; however, half-life of afoxolaner can differ between dogs (e.g. in one study, t½ in Collies at 25 mg/kg bodyweight was up to 47.7 days) with no effect on safety. 
Končni razpolovni čas v plazmi je pri večini psov približno 2 tedna; vendar pa razpolovni čas lahko variira med posameznimi psi (na primer, v eni študiji je bil pri psih pasem coli pri 25 mg/kg telesne mase ugotovljen razpolovni čas do 47,7 dni) brez vpliva na varnost.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian. 
Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in/ali psov, lažjih od 2 kg temeljiti na oceni razmerja korist-tveganje odgovornega veterinarja.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. 
Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni učinki ali drugi neželeni učinki na reproduktivno sposobnost samcev in samic.
Strength and number of chewable tablets to be administered 
Jakost in število žvečljivih tablet za dajanje
In-vitro experiments demonstrated that P-glycoprotein efflux does not occur, confirming that afoxolaner is not a substrate for the P-glycoprotein transporters. 
In-vitro študije so dokazale, da ne pride do iztoka P-glikoproteinov, kar potrjuje, da afoksolaner ni substrat za P-glikoproteinski transport.
common (more than 1 but less than 10 animals in 100 animals treated) uncommon (more than 1 but less than 10 animals in 1,000 animals treated) rare (more than 1 but less than 10 animals in 10,000 animals treated) very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Severe cases may require prolonged monthly treatments. 
hujših primerih bolezni je lahko potrebnih več mesečnih zdravljenj.
Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks. 
Zdravljenje infestacije z bolhami pri psih (Ctenocephalides felis and C. canis) vsaj 5 tednov.
Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated. 
Afoksolaner se pri psih metabolizira v bolj hidrofilne komponente in se nato izloči.
Afoxolaner MERIAL kills fleas within 8 hours and ticks within 48h. 
Zdravilo Afoxolaner MERIAL ubije bolhe v največ 8 urah in klope najkasneje v 48 urah.
The product should be administered at a dose of 2.7-7 mg/kg bodyweight in accordance with the following table: 
Zdravilo uporabljajte v odmerku 2,7-7 mg/kg telesne mase, glede na spodnjo tabelo:
If the dog does not accept the tablets directly they may be administered with food. 
Če pes ne sprejme samih tablet, mu jih ponudite v hrani.
Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded. 
Paraziti se morajo začeti hraniti, da pridejo v stik z afoksolanerom, zato prenosa s paraziti prenosljivih bolezni ni mogoče izključiti.
The mean maximum concentration (Cmax) was 1,655 ± 332 ng/ml in plasma at 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose. 
Srednja maksimalna koncentracija v plazmi (Cmax) je 1,655 ± 332 ng/ml 2-4 ure (Tmax) po dajanju odmerka 2,5 mg/kg afoksolanera.
Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. 
Afoksolaner deluje na od ligandov odvisne klorove kanalčke, predvsem tiste, ki so pod vplivom nevrotransmiterja gamaaminobutirične kisline (GABA), s čimer zavirajo pre- in post-sinaptični prehod kloridnih ionov skozi celično membrano.
The tablets are chewable and palatable to most dogs. 
Tablete so žvečljive in okusne večini psov.
Monthly administration of the product until two negative skin scrapings are obtained one month apart. 
Zdravilo se daje enkrat mesečno do dveh negativnih ostružkov kože, vzetih v razmiku 1 meseca.
Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family. 
Afoksolaner je insekticid in akaricid iz skupine isoksazolinov.
Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg. 
Afoksolaner se v tkiva prerazporedi z volumnom distribucije 2.6 ± 0,6 l/kg in sistemskim clearance 5,0 ± 1,2 ml/uro/kg.
After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration. 
Po peroralnem dajanju pri psih ima afoksolaner visoko sistemsko absorbcijo.
Each chewable tablet contains: Afoxolaner MERIAL 
Vsaka tableta vsebuje: Afoxolaner MERIAL
For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet. 
Za vsako jakost so žvečljive tablete pakirane v naslednjih velikostih pakiranja: Škatlica z 1 pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z 1 žvečljivo tableto.
Monthly administration of the product for two consecutive months. 
Dajanje enkrat mesečno dva zaporedna meseca.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs. 
Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti in laktacije ali razploda ni bila ugotovljena.
Monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations. 
Zdravite v mesečnih intervali skozi vso sezono bolh/klopov, na podlagi lokalnih epidemioloških razmer.
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
Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely. 
Zelo redko so se pojavili blagi gastrointestinalni učinki (bruhanje, driska), pruritus, letargija, anoreksija in nevrološki znaki (konvulzije, ataksija in mišični tremor).
Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus). 
Zdravljenje infestacije s klopi pri psih (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 
Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Treatment of demodicosis (caused by Demodex canis): 
Zdravljenje demodikoze (ki jo povzroča Demodex canis):
Bodyweight of dog (kg) 
Telesna masa psa (kg)
Treatment of demodicosis (caused by Demodex canis). 
Zdravljenje demodikoze (ki jo povzroča Demodex canis).
The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines' GABA receptors versus mammalian receptors. 
Sklepa se, da je selektivna toksičnost afoksolanera drugačna pri insektih/pršicah in sesalcih zaradi razlike v občutljivosti GABA receptorjev.
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). 
Zdravilo je lahko del strategije zdravljenja in preprečevanja alergijskih dermatitisov, ki jih povzroča bolhavost
One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet. 
Ena škatla z enim pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z
Afoxolaner (mg) 
afoksolaner (mg)
The product kills fleas before egg production and therefore prevents household contamination. 
Zdravilo ubije bolhe preden lahko izležejo jajčeca, zato preprečuje kontaminacijo okolice z razvojnimi oblikami.
Further monthly administration of the product may be required based on clinical assessment and skin scrapings. 
Na podlagi klinične ocene in kožnega ostružka je lahko potrebno z mesečnim zdravljenjem še nadaljevati.
Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis. 
Afoksolaner učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so Dermacentor reticulatus in D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, in Haemaphysalis longicornis.
Treatment of flea and tick infestations: 
Razpored zdravljenja: Zdravljenje infestacij z bolhami in klopi:
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli po EXP. Za shranjevanje zdravila niso potrebna posebna navodila.
Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg 
Psi 2 4 kg Psi >4-10 kg Psi >10-25 kg Psi >25-50 kg
Chewable tablets 
Žvečljive tablete
Name and address of the manufacturer responsible for batch release 
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij MERIAL
The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile. 
Metaboliti in izhodiščna snov se izločilo iz telesa preko ledvic in jeter, večinoma preko žolča.
For oral use. 
Peroralno dajanje.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. 
Da pride do izpostavljenosti učinkovini, se morajo bolhe in klopi pritrditi na gostitelja in pričeti s hranjenjem.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis): 
Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis):
{DD/MM/YYYY} 
DD/MM/LLLL
Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob proteini soje okus govedine povidon (E1201) makrogol 400 makrogol 4000 makrogol 15 hidroksistearat glicerol (E422)
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis). 
Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis).
MERIAL 
KARENCA
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton 
PODATKI NA ZUNANJI OVOJNINI Škatla
chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg 
Žvečljive tablete za pse 2 4 kg Žvečljive tablete za pse >4 10 kg Žvečljive tablete za pse >10 25 kg Žvečljive tablete za pse >25 50 kg
Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister. 
Iz omota odstranite le eno tableto naenkrat, da bi preprečili otrokom morebiten dostop do zdravila za uporabo v veterinarski medicini.
Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg). 
Lisaste rdeče ali rdeče-rjave, okrogle (tablete za pse 2-4 kg) ali pravokotne tablete (tablete za pse >4-10 kg, tablete za pse >10-25 kg in tablete za pse >25-50 kg).
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks. 
6-kratnim zdravljenjem s 5-kratnikom največjega odmerka v dvotedenskih do štiritedenskih intervalih.
No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2-4 weeks. 
Pri zdravih mladičih pasme beagle, starih 8 tednov in več niso opazili nobenih neželenih učinkov med
Afoxolaner MERIAL tablets are chewable and palatable to most dogs. 
Zdravilo Afoxolaner MERIAL učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so
Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner 
Afoxolaner MERIAL 11 mg psi 2-4 kg Afoxolaner MERIAL 28 mg psi >4-10 kg Afoxolaner MERIAL 68 mg psi >10-25 kg Afoxolaner MERIAL 136 mg psi >25-50 kg
To be supplied only on veterinary prescription. 
Pretisni omot IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg 
Afoxolaner MERIAL 11 mg žvečljive tablete za pse 2-4 kg Afoxolaner MERIAL 28 mg žvečljive tablete za pse >4-10 kg Afoxolaner MERIAL 68 mg žvečljive tablete za pse >10-25 kg Afoxolaner MERIAL 136 mg žvečljive tablete za pse >25-50 kg
EMEA/H/C/product number 
EMEA/H/C/številka zdravila
The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment. 
Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, ki so se na zdravljenje v celoti odzvali.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you. 
Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
In particular, the Committee could not conclude on the clinical benefit of the medicine. 
Odbor zlasti ni mogel podati sklepa o klinični koristi zdravila.
The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Istodax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012. 
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 15. novembra 2012 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012 
Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin) EMA/725439/2012
The effects of Istodax were first tested in experimental models before being studied in humans. 
Učinki zdravila Istodax so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In the study, Istodax was not compared with any other treatment. 
V študiji zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja.
The company that applied for authorisation is Celgene Europe Ltd. 
Vlogo za dovoljenje je predložila družba Celgene Europe Ltd.
However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse). 
Vendar zaradi dejstva, da zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja, Odbor ni mogel oceniti kliničnih koristi zdravila v smislu celokupnega preživetja (kako dolgo so bolniki živeli) ali preživetja brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala).
Istodax is a medicine that contains the active substance romidepsin. 
Istodax je zdravilo, ki vsebuje zdravilno učinkovino romidepsin.
As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study. 
Ker ga niso primerjali z nobeno drugo obliko zdravljenja, ni bilo mogoče ugotoviti, ali so bili opaženi učinki povezani z zdravilom ali z značilnostmi bolezni bolnikov, zajetih v študiji.
Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system. 
Periferni T-celični limfom je rak vrste krvnih celic, imenovanih T-celice, ki so del imunskega sistema.
What is Istodax? 
Kaj je zdravilo Istodax?
The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required. 
CHMP je ugotovil tudi, da družba pomotoma ni predložila ustreznega zakonsko predpisanega potrdila o dobri proizvodni praksi za prostor, kjer poteka proizvodnja zdravila.
Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion. 
Posledično CHMP ni mogel oceniti, ali koristi zdravila odtehtajo z njim povezana tveganja, zato je potrdil svoje prvotno negativno mnenje.
Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies. 
Zdravilo Istodax naj bi se uporabljalo za zdravljenje odraslih bolnikov s perifernim T-celičnim limfomom, ki se ne odziva več na terapije ali pa se je ponovno pojavil po vsaj dveh predhodnih terapijah.
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je 19. julija 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Istodax, namenjenim za zdravljenje perifernega T-celičnega limfoma.
Refusal of the marketing authorisation for Istodax (romidepsin) 
Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin)
It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein). 
Zdravilo naj bi bilo na voljo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns. 
Novembra 2012 je CHMP po ponovnem pregledu ugotovil, da ni več zadržka glede potrdila o dobri proizvodni praksi, drugi pomisleki pa še vedno ostajajo.
Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated). 
Zdravilo Istodax je bilo dne 28. oktobra 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje perifernega T-celičnega limfoma (nodalni, ekstranodalni in levkemični/diseminirani).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax. 
Družba je CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Istodax.
The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells. 
Natančen mehanizem delovanja romidepsina pri zdravljenju T celičnega limfoma ni znan, vendar naj bi njegovo delovanje na gene, ki uravnavajo proliferacijo in odmiranje celic, upočasnilo rast in delitev rakavih celic.
The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment. 
Družba je predložila rezultate ene glavne študije, v kateri je 131 bolnikov s perifernim T-celičnim limfomom, ki so predhodno že bili zdravljeni, prejemalo zdravilo Istodax.
What was Istodax expected to be used for? 
Za kaj naj bi se zdravilo Istodax uporabljalo?
The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells. 
Zdravilna učinkovina v zdravilu Istodax, romidepsin, naj bi zavirala delovanje beljakovin, imenovanih histonske deacetilaze, ki sodelujejo v procesu aktiviranja in deaktiviranja genov v celicah.
How is Istodax expected to work? 
Kako naj bi zdravilo Istodax delovalo?
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment. 
Julija 2012 je CHMP na podlagi odziva bolnikov na zdravljenje zaključil, da je študija pokazala, da je imelo zdravilo Istodax protitumorske učinke.
In both studies there were no cases of resistance to treatment after 48 weeks. 
V obeh študijah po 48 tednih ni bilo nobenih primerov odpornosti na zdravljenje.
What measures are being taken to ensure the safe and effective use of Dovato? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dovato?
An overview of Dovato and why it is authorised in the EU 
Pregled zdravila Dovato in zakaj je odobreno v EU
As for all medicines, data on the use of Dovato are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dovato stalno spremljajo.
Other information about Dovato 
Druge informacije o zdravilu Dovato
Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996. 
Obe učinkovini sta v Evropski uniji že pridobili dovoljenje za promet v obliki ločenih tablet: dolutegravir leta 2014 in lamivudin leta 1996.
What benefits of Dovato have been shown in studies? 
Kakšne koristi je zdravilo Dovato izkazalo v študijah?
Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine. 
Zdravilo Dovato je na voljo v obliki tablet, ki vsebujejo 50 mg dolutegravirja in 300 mg lamivudina.
Why is Dovato authorised in the EU? 
Zakaj je bilo zdravilo Dovato odobreno v EU?
Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Dovato, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.