FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Simparica Trio can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
Slovenian: Nadaljnje informacije o zdravilu Simparica Trio so na voljo na spletni strani agencije: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
English: The tablets should be kept in the original packaging until use in order to prevent children directly accessing the medicine.
Slovenian: Tablete je treba do uporabe hraniti v originalni embalaži, da bi preprečili neposreden dostop otrok do njih.
English: Sarolaner acts as an ‘ectoparasiticide'.
Slovenian: Sarolaner deluje kot „ektoparaziticid“.
English: Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog's environment.
Slovenian: Sarolaner uniči bolhe, preden te lahko izležejo jajčeca, in tako pomaga zmanjšati kontaminacijo okolja psa.
English: The European Medicines Agency decided that Simparica Trio's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila Simparica Trio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni učinkovini, se morajo prisesati na kožo in se začeti hraniti s krvjo psa.
English: Two studies conducted in Australia and one in Japan that followed a similar design to the US study also showed 100% effectiveness against naturally occurring heartworm infection.
Slovenian: Dve študiji, izvedeni v Avstraliji, in ena študija, opravljena na Japonskem, ki so imele podobno zasnovo kot ameriška študija, so prav tako potrdile 100 % učinkovitost zdravila proti naravnim infestacijam s srčno glisto.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites).
Slovenian: Uporablja se lahko tudi kot del zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
English: This results in uncontrolled activity of the nervous system and thus the paralysis and death of the parasites.
Slovenian: S tem povzroči nenadzorovano delovanje živčnega sistema in posledično paralizo in pogin zajedavcev.
English: Sarolaner kills these parasites that have ingested the dog's blood by acting on their nervous system.
Slovenian: Sarolaner uniči zajedavce, ki so zaužili kri psa, tako da deluje na njihov živčni sistem.
English: Other information about Simparica Trio
Slovenian: Druge informacije o zdravilu Simparica Trio
English: To prevent lungworm and heartworm disease for one month, a single treatment is required.
Slovenian: Za preprečevanje okužbe s pljučnimi in srčnimi glistami za obdobje enega meseca je potrebno eno samo zdravljenje.
English: Why is Simparica Trio authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Simparica Trio odobreno v EU?
English: Simparica Trio (sarolaner / moxidectin / pyrantel)
Slovenian: Simparica Trio (sarolaner/moksidektin/pirantel)
English: What benefits of Simparica Trio have been shown in studies?
Slovenian: Kakšne koristi zdravila Simparica Trio so se pokazale v študijah?
English: An overview of Simparica Trio and why it is authorised in the EU
Slovenian: Pregled zdravila Simparica Trio in zakaj je odobreno v EU
English: The appropriate tablet strength should be used according to the dog's weight.
Slovenian: Ustrezna jakost tablete se določi glede na telesno maso psa.
English: In areas where lungworm and heartworm are present, treatments are required at monthly intervals.
Slovenian: Na območjih, kjer so prisotne pljučne in srčne gliste, so zdravljenja potrebna v enomesečnih intervalih.
English: What is Simparica Trio and what is it used for?
Slovenian: Kaj je zdravilo Simparica Trio in za kaj se uporablja?
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey signals between nerves (neurotransmitters).
Slovenian: Zavira normalno prehajanje nabitih kloridnih delcev (ionov) v živčne celice in iz njih, in sicer zlasti tistih, ki so povezani z gamaaminomasleno kislino (GABA) in glutamatom, tj. dvema snovema, ki prenašata signale med živci (živčna prenašalca).
English: What are the risks associated with Simparica Trio?
Slovenian: Kakšna tveganja so povezana z zdravilom Simparica Trio?
English: This means that it kills parasites present on the skin or in the fur of animals, such as fleas and ticks.
Slovenian: To pomeni, da uniči parazite na koži ali v dlaki živali, kot so bolhe in klopi.
English: It acts by blocking signals, normally associated with the neurotransmitter acetylcholine, from their nerves to their muscles, causing sudden contraction followed by paralysis and death.
Slovenian: Deluje tako, da zavira signale, ki so običajno povezani z živčnim prenašalcem acetilholinom in ki potujejo od živcev do mišic, s čimer povzroči nenadno krčenje, ki mu sledita paraliza in smrt.
English: For the list of restrictions, see the package leaflet.
Slovenian: Znanih neželenih učinkov ni. Za celoten seznam omejitev glejte navodilo za uporabo.
English: Roundworms and hookworms
Slovenian: Valjasti in kavljasti črvi
English: Moxidectin causes paralysis and death of these parasites by interfering in a different way to sarolaner with the flow of chloride ions in nerve cells associated with GABA and glutamate.
Slovenian: Moksidektin povzroči paralizo in pogin teh parazitov tako, da na drugačen način kot sarolaner onemogoči pretok kloridnih ionov v živčnih celicah, povezanih z GABA in glutamatom.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by the percentage reduction in live tick counts on day 7, 14, 21 and 30 after treatment.
Slovenian: Študija je pokazala, da je zdravilo Simparica Trio primerljivo s primerjalnim zdravilom, merjeno z odstotkom zmanjšanja števila živih klopov na 7., 14., 21. in 30. dan po zdravljenju.
English: In a field study involving 622 dogs in an area of Denmark and Italy known to be affected by lungworm disease, dogs treated with Simparica Trio every 30 days until day 270 did not test positive for lungworm until day 300 after first treatment and therefore the effectiveness was 100% with some dogs testing positive in the control group which was given a dummy treatment.
Slovenian: V terenski študiji, v katero je bilo vključenih 622 psov na Danskem in v Italiji, za katere je bilo znano, da so bili infestirani s pljučnimi glistami, so bili psi, ki so bili vsakih 30 dni do 270. dne zdravljeni z zdravilom Simparica Trio, do 300. dne po prvem zdravljenju negativni na prisotnost pljučnih glist, zaradi česar se učinkovitost tega zdravila šteje za 100 %, medtem ko bili nekateri psi v kontrolni skupini, zdravljeni s placebom, pri testiranju pozitivni.
English: Pyrantel also kills roundworms and hookworms present in the gut but acts differently to moxidectin.
Slovenian: Pirantel prav tako uniči valjaste in kavljaste črve v črevesju, vendar na drugačen način kot moksidektin.
English: For flea or tick infestations, one treatment with Simparica Trio is effective for up to 5 weeks.
Slovenian: Za zdravljenje infestacij z bolhami ali klopi zadostuje eno zdravljenje z zdravilom Simparica Trio, ki učinkuje do pet tednov.
English: For gut worms only a single treatment is required.
Slovenian: Pri črevesnih črvih je potrebno samo eno zdravljenje.
English: Further flea or tick treatment should be continued using a different veterinary medicine with a narrower range of action.
Slovenian: Za nadaljnje zdravljenje infestacij z bolhami ali klopi je treba uporabiti druga zdravila za uporabo v veterinarski medicini z ožjim spektrom delovanja.
English: For more information about using Simparica Trio, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Simparica Trio glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: In a US study of 410 dogs in an area affected by heartworm disease, dogs treated with Simparica Trio every 30 days until day 300 showed 100% effectiveness based on blood tests at days 120, 240 and 330 after first treatment.
Slovenian: V ameriški študiji s 410 psi z območja, kjer razsajajo srčne gliste, so bili psi, ki so bili vsakih 30 dni do 300. dne zdravljeni z zdravilom Simparica Trio, so na podlagi krvnih preiskav na 120., 240. in 330. dan po prvem zdravljenju potrdili 100 % učinkovitost zdravila.
English: Simparica Trio is a veterinary medicine used to treat dogs with flea or tick infestations and roundworm or hookworm infections in the gut.
Slovenian: Simparica Trio je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih za zdravljenje infestacij z bolhami ali klopi ter okužb z valjastimi ali kavljastimi črvi.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Simparica Trio, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila Simparica Trio in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: Fleas
Slovenian: Bolhe
English: Effectiveness, based on faecal egg counts on day 7 after treatment, for dogs treated with Simparica Trio was comparable to the comparator medicine.
Slovenian: Učinkovitost zdravljenja, ki je bila izmerjena s številom jajčec v blatu na sedmi dan po zdravljenju, je bila pri psih, ki so bili zdravljeni z zdravilom Simparica Trio, primerljiva s primerjalnim zdravilom.
English: At the same time, Simparica Trio is used to prevent heartworm and lungworm disease (both caused by blood worms that infect the heart and blood vessels supplying the lungs).
Slovenian: Prav tako se uporablja za preprečevanje obolenj, ki jih povzročajo srčne in pljučne gliste (gliste v krvi, ki se naselijo v srcu in žilah, ki oskrbujejo pljuča).
English: Simparica Trio must only be used when there is a need to treat both fleas or ticks and worms in the gut.
Slovenian: Zdravilo Simparica Trio se lahko uporablja le, kadar je treba istočasno zdraviti bolhe ali klope in črevesne črve.
English: Simparica Trio is available as chewable tablets and can only be obtained with a prescription.
Slovenian: Zdravilo Simparica Trio je na voljo v obliki žvečljivih tablet, predpisovanje in izdaja zdravila pa je le na recept.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by flea counts on day 14 and 30 after treatment.
Slovenian: Študija je pokazala, da je zdravilo Simparica Trio primerljivo s primerjalnim zdravilom, merjeno s številom bolh na 14. in 30. dan po zdravljenju.
English: Simparica Trio received a marketing authorisation valid throughout the EU on 17 September 2019.
Slovenian: Zdravilo Simparica Trio je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, dne
English: Heartworms
Slovenian: Klopi
English: In a field study in dogs infested with at least 5 live fleas, 297 dogs were treated with Simparica Trio and 164 dogs with afoxolaner and milbemycin oxime (an authorised treatment for fleas and ticks).
Slovenian: V terenski študiji pri psih, ki so bili infestirani z vsaj petimi živimi bolhami, je bilo 297 psov zdravljenih z zdravilom Simparica Trio, 164 psov pa z afoksolanerjem in milbemicin oksimom (odobrenima zdraviloma proti bolham in klopom).
English: How does Simparica Trio work?
Slovenian: Kako zdravilo Simparica Trio deluje?
English: In a field study involving dogs infected with roundworms or hookworms, 194 dogs were treated with Simparica Trio and 97 dogs with afoxolaner and milbemycin oxime.
Slovenian: V terenski študiji pri psih, ki so bili infestirani z valjastimi ali kavljastimi črvi, je bilo 194 psov zdravljenih z zdravilom Simparica Trio, 97 psov pa z afoksolanerjem in milbemicin oksimom.
English: In a further field study in dogs infested with at least 3 live ticks, 189 dogs were treated with Simparica Trio and 91 dogs with afoxolaner and milbemycin oxime.
Slovenian: V dodatni terenski študiji pri psih, ki so bili infestirani z vsaj tremi živimi klopi, je bilo 189 psov zdravljenih z zdravilom Simparica Trio, 91 psov pa z afoksolanerjem in milbemicin oksimom.
English: Moxidectin kills parasites present inside the body of animals, such as roundworms, hookworms, lungworm and heartworm.
Slovenian: Moksidektin uniči parazite v telesu živali, kot so valjasti in kavljasti črvi ter pljučne in srčne gliste.
English: Simparica Trio contains the active substances sarolaner, moxidectin and pyrantel.
Slovenian: Zdravilo Simparica Trio vsebuje učinkovine sarolaner, moksidektin in pirantel.
English: How is Simparica Trio used?
Slovenian: Kako se zdravilo Simparica Trio uporablja?
English: Simparica contains three active substances: sarolaner, moxidectin and pyrantel.
Slovenian: Zdravilo Simparica Trio vsebuje tri učinkovine: sarolaner, moksidektin in pirantel.
English: Lungworms
Slovenian: Pljučne gliste
English: EPAR summary for the public telmisartan
Slovenian: Povzetek EPAR za javnost telmisartan
English: Page 2/2
Slovenian: Če želena vrednost krvnega stran 2/2
English: It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).
Slovenian: Na voljo je v obliki belih tablet (okroglih: 20 mg; ovalnih: 40 mg; v obliki kapsule: 80 mg).
English: Other information about Tolura:
Slovenian: Druge informacije o zdravilu Tolura:
English: The European Commission granted a marketing authorisation valid throughout the EU for Tolura to Krka, d.d., Novo mesto on 4 June 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tolura, veljavno po vsej Evropski uniji, odobrila družbi Krka, d.d., Novo mesto, dne 4. junija 2010.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Slovenian: Uporablja se pri bolnikih, ki so imeli težave zaradi krvnih strdkov v preteklosti (kot so srčno obolenje, možganska kap ali arterijska bolezen) ali ki imajo sladkorno bolezen tipa 2, ki je poškodovala določen organ (npr. oči, srce ali ledvice).
English: Tolura is used to treat essential hypertension (high blood pressure) in adults.
Slovenian: Zdravilo Tolura se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: This document is a summary of the European Public Assessment Report (EPAR) for Tolura.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tolura.
English: This means that Tolura is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Micardis.
English: For more information about treatment with Tolura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tolura preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: What are the benefit and risk of Tolura?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Tolura?
English: The doctor should monitor the patient's blood pressure closely when starting Tolura, and may decide to adjust the patient's blood pressure-lowering medication.
Slovenian: Zdravnik mora skrbno spremljati bolnikov krvni tlak ob začetku zdravljenja z zdravilom Tolura in se lahko odloči za prilagoditev zdravila za zniževanje bolnikovega krvnega tlaka.
English: The full EPAR for Tolura can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tolura je na voljo na spletni strani agencije: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tolura.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Tolura, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The Committee recommended that Tolura be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Tolura odobri dovoljenje za promet.
English: Because Tolura is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Tolura generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Tolura is a ‘generic medicine'.
Slovenian: Zdravilo Tolura je „generično zdravilo“.
English: Tolura is a medicine that contains the active substance telmisartan.
Slovenian: Tolura je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
English: For the treatment of essential hypertension, the recommended dose of Tolura is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Slovenian: Za zdravljenje esencialne hipertenzije znaša priporočeni odmerek zdravila Tolura 40 mg enkrat dnevno, toda za nekatere bolnike zadostuje že 20-miligramski odmerek.
English: The active substance in Tolura, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Tolura, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Slovenian: tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, kot je hidroklorotiazid.
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Micardis, odtehtajo znana tveganja.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack.
Slovenian: Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganja, povezana s previsokim krvnim tlakom, kot sta na primer srčni napad ali možganska kap.
English: Tolura is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks.
Slovenian: Zdravilo Tolura se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni infarkt ali možganska kap.
English: Because Tolura is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Slovenian: Ker je zdravilo Tolura generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Micardis.
English: The CHMP concluded that, in accordance with EU requirements, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Tolura primerljivo raven kakovosti kot zdravilo Micardis ter da mu je biološko enakovredno.
English: Why has Tolura been approved?
Slovenian: Zakaj je bilo zdravilo Tolura odobreno?
English: How has Tolura been studied?
Slovenian: Kako je bilo zdravilo Tolura raziskano?
English: What is Tolura used for?
Slovenian: Za kaj se zdravilo Tolura uporablja?
English: How does Tolura work?
Slovenian: Kako zdravilo Tolura deluje?
English: What is Tolura?
Slovenian: Kaj je zdravilo Tolura?
English: How is Tolura used?
Slovenian: Kako se zdravilo Tolura uporablja?
English: Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.
Slovenian: Pri približno 99 % bolnikov, okuženih z genotipom 1 (125 od 126), 96 % bolnikov, okuženih z genotipom 2 (25 od 26), in 89 % bolnikov, okuženih z genotipom 3 (16 od 18), 12 tednov po koncu načrtovanega zdravljenja niso odkrili nobenih znakov virusa v krvi.
English: The usual dose is 60 mg once a day for 12 or 24 weeks.
Slovenian: Običajni odmerek je 60 mg enkrat na dan, tablete pa je treba jemati dvanajst ali 24 tednov.
English: This is a summary of the European public assessment report (EPAR) for Daklinza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Daklinza.
English: The full EPAR and risk management plan summary for Daklinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Daklinza sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks.
Slovenian: Bolniki v študiji so bili okuženi z genotipom 1, 2 ali 3 in so zdravljenje prejemali 12 ali 24 tednov.
English: Daklinza is available as 30, 60, and 90 mg tablets.
Slovenian: Zdravilo Daklinza je na voljo v obliki 30, 60 in 90-miligramskih tablet.
English: The dose may have to be raised or lowered if the patient is taking other medicines that decrease or increase Daklinza's effects.
Slovenian: Odmerek se lahko poveča ali zmanjša, če bolnik jemlje druga zdravila, ki povečujejo ali zmanjšujejo učinke zdravila Daklinza.
English: What is Daklinza and what is it used for?
Slovenian: Kaj je zdravilo Daklinza in za kaj se uporablja?
English: What benefits of Daklinza have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Daklinza izkazalo v študijah?
English: What are the risks associated with Daklinza?
Slovenian: Kakšna tveganja so povezana z zdravilom Daklinza?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daklinza have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Daklinza upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in
English: By blocking this protein, the medicine stops the hepatitis C virus from multiplying.
Slovenian: Z zaviranjem te beljakovine zdravilo prepreči razmnoževanje virusa hepatitisa C.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Slovenian: Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, ki se zdravijo s temi zdravili in so preboleli raka jeter, obstaja tveganje njegove zgodnje ponovitve.
English: For more information about treatment with Daklinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Daklinza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali