FrancophonIA/ELRC3.0 huggingface dataset:
English: 751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of lowering blood pressure.
Slovenian: Namen študije je bil poleg koristi za znižanje krvnega tlaka pokazati še zaščitni učinek kalijevega losartanata na ledvice.
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem P.O.
Slovenian: Waarderweg 39, 2031 BN Haarlem
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET POWDER LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: General disorders and administration site conditions: common: asthenia/fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije: pogoste: astenija/utrujenost
English: • One 10 ml oral dosing syringe
Slovenian: • 10 ml brizgo za peroralno odmerjanje
English: The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Slovenian: Običajni začetni odmerek losartana pri bolnikih s srčnim popuščanjem je 12,5 mg enkrat na dan. Odmerek je običajno treba titrirati tedensko (to je 12,5 mg na dan, 25 mg na dan, 50 mg na dan) do običajnega vzdrževalnega odmerka 50 mg enkrat na dan, glede na to, kako bolnik zdravilo prenaša.
English: COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium
Slovenian: COZAAR in povezana imena (glejte Dodatek I) 2,5 mg/ml prašek in vehikel za peroralno suspenzijo Kalijev losartanat
English: Renal and urinary disorders: not known: urinary tract infections
Slovenian: Bolezni sečil: pogostnost ni znana: okužbe urinarnega trakta
English: Add 200 ml of solvent to the 240 ml amber polyethylene terephthalate (PET) bottle provided.
Slovenian: 200 ml vehikla dodajte v 240 ml rumeno-rjavo priloženo PET plastenko.
English: It is important to tell your doctor before taking COZAAR:
Slovenian: Preden vzamete zdravilo COZAAR, se posvetujte z zdravnikom:
English: See package leaflet for instructions on how to prepare COZAAR 2.5 mg/ml oral suspension.
Slovenian: Za navodila, kako pripraviti COZAAR 2,5 mg/ml peroralno suspenzijo, glejte Navodilo za uporabo.
English: Remove the dispenser and administer the medication.
Slovenian: Odstranite brizgo in aplicirajte zdravilo.
English: After reconstitution, losartan suspension is an off-white liquid.
Slovenian: Po pripravi je suspenzija losartana sivo-bela tekočina.
English: Gastrointestinal disorders: not known: diarrhoea
Slovenian: Bolezni prebavil: pogostnost ni znana: diareja
English: With the syringe, adapter, and bottle attached, turn the entire assembly upside down.
Slovenian: Brizgo, nastavek in plastenko skupaj obrnite na glavo.
English: COZAAR is used
Slovenian: Zdravilo COZAAR se uporablja:
English: Hertfordshire EN11 9BU United Kingdom
Slovenian: Hertford Road, Hoddesdon, Herts EN11 9BU, Velika Britanija
English: Each sachet of powder for oral suspension contains 500 mg of losartan potassium.
Slovenian: Ena vrečka s praškom za peroralno suspenzijo vsebuje 500 mg kalijevega losartanata.
English: Cozaar 12,5 mg + 50 mg filmdragerade tabletter
Slovenian: Cozaar 12,5 mg + 50 mg filmdragerade tabletter mg
English: Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.
Slovenian: Iz ene vrečke s praškom za peroralno suspenzijo dobimo 500 mg kalijevega losartanata.
English: Take special care with COZAAR:
Slovenian: Bodite posebno pozorni pri jemanju zdravila COZAAR
English: One ml solvent contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, and 50.6 mg sorbitol.
Slovenian: En ml vehikla vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata in 50,6 mg sorbitola.
English: Neither Losartan nor the active metabolite can be removed by haemodialysis.
Slovenian: S hemodializo ne moremo odstraniti niti losartana niti njegovega aktivnega presnovka.
English: affects 1 to 10 users I 10000
Slovenian: se pojavijo pri 1 do 10 od 10.000 uporabnikov zelo redki:
English: Nervous system disorders: common: dizziness
Slovenian: Bolezni živčevja: pogoste: omotica
English: One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol,.and 1.275 mg lactose.
Slovenian: En ml suspenzije vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata, 50,6 mg sorbitola in 1,275 mg laktoze.
English: LOORTAN 12,50 mg12,5mg Film-coated tabletOral use
Slovenian: LOORTAN 12,50 mg12,5mg Filmsko obložena tableta
English: One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol and 1.275 mg lactose.
Slovenian: En ml raztopine vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata, 50,6 mg sorbitola in 1,275 mg laktoze.
English: Heart Failure
Slovenian: Ledvična okvara
English: (It is also better to avoid COZAAR in early pregnancy
Slovenian: • če ste noseči več kot tri mesece (Zdravilu COZAAR se je bolje izogibati tudi v zgodnji nosečnosti - glejte poglavje "Nosečnost in dojenje"),
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml suspension contains 2.5 mg of losartan potassium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml suspenzije vsebuje 2,5 mg kalijevega losartanata.
English: After reconstitution, each ml suspension contains 2.5 mg of losartan potassium.
Slovenian: Po pripravi en ml suspenzije vsebuje 2,5 mg kalijevega losartanata.
English: • Severe hepatic impairment.
Slovenian: • Huda okvara jeter.
English: • One foil sachet filled with 500 mg losartan potassium powder
Slovenian: • Vrečko iz folije s 500 mg praška kalijevega losartanata.
English: Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Slovenian: Bolezni prebavil: občasne: diareja, navzea, bruhanje
English: LORTAAN IC 12,5 mg Film-coated tabletOral use
Slovenian: LORTAAN IC 12,5 mg Filmsko obložena tableta
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR AMBER BOTTLE FOR ORAL SUSPENSION
Slovenian: NALEPKA ZA RUMENO-RJAVO PLASTENKO ZA PERORALNO SUSPENZIJO
English: LOORTAN 100 mg 100 mg Film-coated tabletOral use
Slovenian: LOORTAN 100 mg 100 mg Filmsko obložena tableta
English: General disorders and administration site conditions: Uncommon: asthenia, fatigue, oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije: občasne: astenija, utrujenost, edem
English: Ear and labyrinth disorders: common: vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: pogoste: vrtoglavica
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem The Netherlands
Slovenian: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem
English: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Slovenian: Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem,
English: Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, The Netherlands
Slovenian: Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, Nizozemska
English: Powder
Slovenian: Ciper
English: Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, The Netherlands
Slovenian: Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, Nizozemska
English: Cozaar 12,5 mg Inicio 12,5 mg Film-coated tabletOral use
Slovenian: Cozaar 12,5 mg Inicio 12,5 mg Filmsko obložena tableta
English: With the dispenser, adapter, and bottle attached, turn the entire assembly upside down.
Slovenian: Celotno pripravo (brizgo, nastavek in plastenko) obrnite na glavo.
English: LORTAAN 100mg 100 mg Film-coated tabletOral use
Slovenian: LORTAAN 100mg 100 mg Filmsko obložena tableta
English: Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblikaPot uporabe zdravila
English: Losartan suspension is a white to off-white liquid when reconstituted with the supplied solution.
Slovenian: Po pripravi s priloženo raztopino je suspenzija losartana bela do sivo bela raztopina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium.
Slovenian: Vehikel za Cozaar in povezana imena (glejte Dodatek I) 2,5 mg/ml prašek in vehikel za peroralno suspenzijo
English: • One foil sachet filled with powder equal to 500 mg losartan potassium
Slovenian: • vrečka iz aluminijaste folije s praškom, ki vsebuje 500 mg kalijevega losartanata.
English: Insert the syringe into the adaptor on the medicine bottle until a tight seal is made.
Slovenian: Brizgo dobro namestite v nastavek na plastenko z zdravilom.
English: COZAAR 12,5 mg 12,5 mg Film-coated tabletOral use
Slovenian: COZAAR 12,5 mg 12,5 mg Filmsko obložena tableta
English: Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasne: dispneja
English: 100 mg Film-coated tablets
Slovenian: 100 mg Filmsko obložene tablete
English: Cozaar 12,5 mg 12,5mg Film-coated tabletOral use
Slovenian: Cozaar 12,5 mg 12,5mg Filmsko obložena tableta
English: Excipient:
Slovenian: Serija:
English: COZAAR 12,5mg 12,5 mg Film-coated tabletOral use
Slovenian: COZAAR 12,5mg 12,5 mg Filmsko obložena tableta
English: BEFORE YOU TAKE COZAAR
Slovenian: SHRANJEVANJE ZDRAVILA COZAAR
English: RP*>-1 (Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep)
Slovenian: * Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
English: 240ml doses)
Slovenian: 100 ml (50 odmerkov)
English: Type I glass vials with chlorobutyl stopper and aluminium seal
Slovenian: Viala iz stekla tipa I s klorobutilnim zamaškom in aluminijasto kapico
English: Pharma ceutical Form
Slovenian: Farmacevtska oblika
English: Further information on Extavia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/extavia.
Slovenian: Nadaljnje informacije za zdravilo Extavia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/extavia.
English: In the second study, no delay in the time to disability progression was seen.
Slovenian: V drugi študiji niso opazili odloga napredovanja invalidnosti.
English: Extavia received a marketing authorisation valid throughout the EU on 20 May 2008.
Slovenian: Za zdravilo Extavia je bilo 20. maja 2008 izdano dovoljenje za promet, veljavno po vsej EU.
English: Other information about Extavia
Slovenian: Druge informacije o zdravilu Extavia
English: What measures are being taken to ensure the safe and effective use of Extavia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Extavia?
English: The European Medicines Agency decided that Extavia's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Extavia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: This medicine is the same as Betaferon, which is already authorised in the EU.
Slovenian: To zdravilo je enako zdravilu Betaferon, ki je že odobreno v EU.
English: What is Extavia and what is it used for?
Slovenian: Kaj je zdravilo Extavia in za kaj se uporablja?
English: As for all medicines, data on the use of Extavia are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Extavia stalno spremljajo.
English: What benefits of Extavia have been shown in studies?
Slovenian: Kakšne koristi zdravila Extavia so se pokazale v študijah?
English: • who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Slovenian: • so prvikrat doživeli znake multiple skleroze in so ti dovolj resni, da upravičujejo zdravljenje z injiciranjem kortikosteroidov (protivnetnih zdravil).
English: Side effects are common at the beginning of treatment but usually decrease with further treatment.
Slovenian: Neželeni učinki so pogosti na začetku zdravljenja, a z nadaljnjim zdravljenjem običajno izzvenijo.
English: Extavia must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Slovenian: Ne smejo ga uporabljati bolniki z dekompenzirano boleznijo jeter (kadar so jetra okvarjena in ne morejo več ustrezno delovati).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Extavia have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Extavia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Extavia must not be used in patients who have severe depression or have thoughts of suicide.
Slovenian: Zdravila Extavia ne smejo uporabljati bolniki s hudimi depresivnimi motnjami ali samomorilnimi mislimi.
English: Side effects reported with Extavia are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Extavia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Extavia authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Extavia odobreno v EU?
English: What are the risks associated with Extavia?
Slovenian: Kakšna tveganja so povezana z zdravilom Extavia?
English: • who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), and with at least two relapses within the last two years;
Slovenian: • imajo vrsto multiple skleroze, imenovano „recidivno-remitentna“ multipla skleroza, pri kateri bolnik doživlja napade (recidive) med obdobji brez simptomov (remisije), in sicer vsaj dva recidiva v zadnjih dveh letih;
English: For more information about using Extavia, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Extavia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Extavia is used in patients:
Slovenian: Zdravilo Extavia se uporablja pri bolnikih, ki:
English: The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Slovenian: Podjetje, ki proizvaja zdravilo Betaferon, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Extavia.
English: An overview of Extavia and why it is authorised in the EU
Slovenian: Pregled zdravila Extavia in zakaj je odobreno v EU
English: In both studies, Extavia showed a reduction in the number (30%) of clinical relapses.
Slovenian: V obeh študijah so pri uporabi zdravila Extavia ugotovili zmanjšanje števila (30 %) kliničnih recidivov.
English: The active substance in Extavia is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Slovenian: Učinkovina v zdravilu Extavia je beljakovina interferon beta-1b, eden od skupine interferonov, ki jih telo lahko po naravni poti proizvaja za obrambo pred okužbami, ki jih povzročajo virusi, in drugimi napadi.
English: Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Slovenian: Zdravilo Extavia je na voljo v obliki praška in vehikla za pripravo raztopine, ki vsebuje odmerek 250 mikrogramov.
English: Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
Slovenian: Zdravilo Extavia je bilo pri zmanjševanju števila letnih recidivov učinkovitejše od placeba: bolniki, ki so prejemali zdravilo, so v povprečju doživeli 0,84 recidiva letno, bolniki, zdravljeni s placebom, pa 1,27.
English: The most frequent side effects with Extavia are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Slovenian: Najpogostejši neželeni učinki zdravila Extavia so gripi podobni simptomi (vključno s povišano telesno temperaturo, mrzlico, bolečinami v sklepih, splošnim slabim počutjem, potenjem, glavobolom in bolečinami v mišicah) in reakcije na mestu injiciranja.
English: The exact way that Extavia works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Slovenian: Natančen način delovanja zdravila Extavia pri multipli sklerozi še ni znan, vendar se zdi, da učinkovina, interferon beta-1b, pomirja imunski sistem in preprečuje redicive multiple skleroze.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Slovenian: • imajo sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki nastopi po recidivnoremitentni multipli sklerozi), pri katerih je bolezen aktivna.
English: Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Slovenian: Zdravljenje se začne z 62,5 mikrograma (četrtino odmerka), ki se injicira vsak drugi dan, ta odmerek pa se v naslednjih 19 dneh postopoma povečuje do priporočenega odmerka 250 mikrogramov, ki se daje vsak drugi dan. Bolniki lahko zdravilo Extavia injicirajo sami, če so bili za to ustrezno usposobljeni.
English: In a study involving 487 patients with a single demyelinating event, treatment with Extavia for two years was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, compared with 45% of those who received placebo.
Slovenian: V študiji, ki je vključevala 487 bolnikov z enkratnim demielinizacijskim dogodkom, so ugotovili, da se je v dveh letih zdravljenja z zdravilom Extavia zmanjšalo tveganje za razvoj klinično dokončne multiple skleroze: ta se je razvila pri 28 % bolnikov, ki so prejemali zdravilo Extavia, v primerjavi s 45 % tistih, ki so prejemali placebo.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Slovenian: Multipla skleroza je obolenje živcev, pri kateri vnetje poškoduje zaščitno ovojnico okrog njih (demielinizacija) in tudi same živce.
English: One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Slovenian: Ena od obeh študij je pokazala pomemben odlog napredovanja invalidnosti (31-odstotno zmanjšanje tveganja zaradi zdravila Extavia) in nastopa stopnje invalidnosti, pri kateri je bolnik priklenjen na voziček (39 %).
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Slovenian: Pri multipli sklerozi se imunski sistem (naravna obramba telesa) ne odziva normalno in napada dele osrednjega živčevja (možgane, hrbtenjačo in optični živec [živec, ki pošilja signale iz očesa v možgane]) ter povzroča vnetje, ki poškoduje živce in zaščitno ovojnico okrog njih.
English: Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Slovenian: Predpisovanje in izdaja zdravila Extavia je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: Extavia contains the active substance interferon beta-1b.
Slovenian: Zdravilo Extavia vsebuje učinkovino interferon beta-1b.
English: For the full list of side effects and restrictions with Extavia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Extavia glejte navodilo za uporabo.
English: Extavia has also been studied in 1,657 patients in two studies involving secondary progressive MS patients who were able to walk, where it was compared with placebo.
Slovenian: Zdravilo Extavia so proučevali tudi v okviru dveh študij, ki sta vključevali 1 657 bolnikov s sekundarno progresivno multiplo sklerozo, sposobnih hoje, pri čemer so ga primerjali s placebom.
English: Extavia treatment should be stopped in patients whose condition does not improve.
Slovenian: Pri bolnikih, pri katerih se stanje ne izboljša, je treba zdravljenje prekiniti.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
Slovenian: Pred njegovo uporabo morajo zdravniki izključiti druge možne vzroke simptomov;
English: Extavia was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Extavia so proučevali dve leti pri 338 bolnikih z recidivno-remitentno multiplo sklerozo, sposobnih hoje brez pomoči, pri čemer so učinkovitost zdravila primerjali z učinkovitostjo placeba (zdravila brez učinkovine).
English: Extavia is a medicine used to treat adults who have multiple sclerosis (MS).
Slovenian: Zdravilo Extavia je namenjeno za zdravljenje odraslih bolnikov z multiplo sklerozo.
English: How is Extavia used?
Slovenian: Kako se zdravilo Extavia uporablja?
English: How does Extavia work?
Slovenian: Kako zdravilo Extavia deluje?
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 March 2017
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati dne 22. marca 2017.
English: Some infections were unusual or opportunistic infections due to reduced white blood cell levels.
Slovenian: Nekatere okužbe so bile nenavadne ali oportunistične zaradi znižanih ravni belih krvnih celic.
English: − familial mediterranean fever (FMF);
Slovenian: − družinske mediteranske vročice (FMF);
English: Periodic fever syndromes
Slovenian: Periodični vročični sindromi
English: Ilaris was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Slovenian: Zdravilo Ilaris je prvotno pridobilo dovoljenje v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ilaris, veljavno po vsej Evropski uniji, izdala 23. oktobra 2009.
English: The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.
Slovenian: Delež bolnikov, pri katerih ni prišlo do zagona, je bil nižji (okoli 57 %) pri otrocih, starih od dveh do štirih let.
English: What measures are being taken to ensure the safe and effective use of Ilaris?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ilaris?
English: The full EPAR for Ilaris 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) za zdravilo Ilaris je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common infections were of the nose and throat.
Slovenian: Najpogostejše okužbe so bile okužbe nosu in grla.
English: This is a summary of the European public assessment report (EPAR) for Ilaris.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ilaris.