FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Furosemide Vitabalans.
Slovenian: Evropska agencija za zdravila je dne 18. oktobra 2012 zaključila arbitražni postopek po nestrinjanju med državami članicami Evropske unije (EU) glede odobritve zdravila Furosemide Vitabalans.
English: • mild to moderate hypertension (high blood pressure).
Slovenian: • blaga do zmerna hipertenzija (visok krvni tlak).
English: However, the Member States were not able to reach an agreement and the Polish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Slovenian: Ker pa omenjene države članice niso dosegle soglasja, je poljska regulativna agencija za zdravila dne 30. maja 2011 zadevo napotila na CHMP v arbitražo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Furosemide Vitabalans do not outweigh its risks, and the marketing authorisation cannot be granted in Estonia and in the following Member States of the EU: Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Slovakia, Slovenia and Sweden, as well as Norway.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je ugotovil, da koristi zdravila Furosemide Vitabalans niso večje od z njim povezanih tveganj ter da dovoljenja za promet ni mogoče odobriti v Estoniji in naslednjih državah članicah EU: v Češki republiki, na Danskem, Finskem, Madžarskem, v Latviji, Litvi, na Poljskem, Slovaškem, v Sloveniji ter na Švedskem in Norveškem.
English: The CHMP confirmed the above conclusions after re-examining its opinion.
Slovenian: Po ponovnem pregledu svojega mnenja je CHMP potrdil zgornje zaključke.
English: The application was supported by published literature rather than studies carried out with Furosemide Vitabalans, because furosemide has a history of well-established use in the EU for at least 10 years.
Slovenian: Vloga je bila podprta z objavljeno literaturo namesto s študijami, izvedenimi z zdravilom Furosemide Vitabalans, ker je uporaba furosemida v EU dobro uveljavljena že vsaj 10 let.
English: • oedema (swelling) associated with congestive heart failure (a type of heart disease);
Slovenian: • edem (otekanje), povezan s kongestivnim srčnim popuščanjem (vrsta srčnega obolenja);
English: • cirrhosis of the liver (a type of liver disease) and renal disease, including nephrotic syndrome;
Slovenian: • ciroza jeter (vrsta obolenja jeter) in obolenje ledvic, vključno z nefrotskim sindromom;
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Furosemide Vitabalans (tablete, 40 mg)
English: Vitabalans Oy submitted an application for Furosemide Vitabalans to the Estonian medicines regulatory agency for a decentralised procedure.
Slovenian: Družba Vitabalans Oy je zdravilo Furosemide Vitabalans predložila estonski regulativni agenciji za zdravila v decentraliziran postopek.
English: The Polish and Lithuanian agencies were of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Furosemide Vitabalans.
Slovenian: Poljska in litovska agencija sta menili, da podatki, predloženi v podporo vlogi, ne zagotavljajo zadostnega dokaza za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
English: Why was Furosemide Vitabalans reviewed?
Slovenian: Zakaj je bilo zdravilo Furosemide Vitabalans pregledano?
English: The CHMP concluded that the balance of the benefits and risks of Furosemide Vitabalans could not be established, and therefore the marketing authorisation for Furosemide Vitabalans should not be granted in all concerned Member States.
Slovenian: CHMP je zaključil, da razmerja med tveganji in koristmi zdravila Furosemide Vitabalans ni mogoče določiti, zato se dovoljenja za promet z zdravilom Furosemide Vitabalans ne sme odobriti v vseh zadevnih državah članicah.
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg) EMA/423459/2013
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Furosemide Vitabalans (tablete, 40 mg) EMA/107842/2013
English: Furosemide Vitabalans was intended to be used to treat the following conditions:
Slovenian: Zdravilo Furosemide Vitabalans je bilo namenjeno uporabi za zdravljenje naslednjih stanj:
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted were not sufficient to show that Furosemide Vitabalans could be used safely and effectively based on the well established use of furosemide.
Slovenian: Na osnovi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je ta zaključil, da predloženi podatki ne zadostujejo za prikaz varne in učinkovite uporabe zdravila Furosemide Vitabalans na osnovi dobro uveljavljene uporabe furosemida.
English: Furosemide Vitabalans is a medicine that contains the active substance furosemide.
Slovenian: Furosemide Vitabalans je zdravilo, ki vsebuje zdravilno učinkovino furosemid.
English: The active substance in Furosemide Vitabalans, furosemide, belongs to a group of medicines known as diuretics.
Slovenian: Zdravilna učinkovina v zdravilu Furosemide Vitabalans, furosemid, spada v skupino zdravil, znanih kot diuretiki.
English: The grounds for the referral were that the data from the literature submitted to support this application could not be applied to Furosemide Vitabalans and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of Furosemide Vitabalans.
Slovenian: Razlogi za napotitev so bili, da podatkov iz literature, predloženih v podporo tej vlogi, ni mogoče uporabiti za zdravilo Furosemide Vitabalans in da predloženi premostitveni podatki niso bili ocenjeni kot zadostni za sklep o razmerju med tveganji in koristmi zdravila Furosemide Vitabalans.
English: What is Furosemide Vitabalans?
Slovenian: Kaj je zdravilo Furosemide Vitabalans?
English: The results of the three studies after 12 weeks of treatment are as follows:
Slovenian: Rezultati treh študij po 12 tednih zdravljenja so naslednji:
English: Further information on Olumiant can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Slovenian: Nadaljnje informacije o zdravilu Olumiant so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/olumiant.
English: Olumiant must not be used during pregnancy.
Slovenian: Zdravilo Olumiant se ne sme uporabljati med nosečnostjo.
English: The usual dose is 4 mg once a day but this can be reduced to 2 mg once a day when the disease is under control.
Slovenian: Običajni odmerek je 4 mg enkrat dnevno, a ga je mogoče, ko je bolezen pod nadzorom, zmanjšati na 2 mg enkrat dnevno.
English: Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017.
Slovenian: Za zdravilo Olumiant je bilo 13. februarja 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Olumiant?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Olumiant?
English: It works by blocking the action of enzymes known as Janus kinases.
Slovenian: Deluje tako, da zavira delovanje encimov, znanih kot Janus kinaze.
English: Other information about Olumiant
Slovenian: Druge informacije o zdravilu Olumiant
English: Patients will be given a special alert card that summarises the safety information about the medicine.
Slovenian: Bolniki bodo prejeli posebno opozorilno izkaznico, ki povzema varnostne podatke o zdravilu.
English: In one study involving 584 patients, Olumiant was more effective than methotrexate.
Slovenian: V eni od študij, v katero je bilo vključenih 584 bolnikov, je bilo zdravilo Olumiant učinkovitejše od metotreksata.
English: What is Olumiant and what is it used for?
Slovenian: Kaj je zdravilo Olumiant in za kaj se uporablja?
English: However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.
Slovenian: Vendar dolgoročnih podatkov o varnosti ni, zato samo ti podatki ne zadoščajo za podporo uporabi zdravila Olumiant pri bolnikih, ki še niso bili zdravljeni.
English: Why is Olumiant authorised in the EU?
Slovenian: Zakaj je zdravilo Olumiant odobreno v EU?
English: What benefits of Olumiant have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Olumiant izkazalo v študijah?
English: The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Slovenian: Odmerek bo morda treba zmanjšati tudi pri bolnikih z motenim delovanjem ledvic, pri katerih je tveganje za okužbo povečano, in pri bolnikih, starejših od 75 let, ki jemljejo določena druga zdravila.
English: As for all medicines, data on the use of Olumiant is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Olumiant stalno spremljajo.
English: An overview of Olumiant and why it is authorised in the EU
Slovenian: Pregled zdravila Olumiant in zakaj je odobreno v EU
English: What are the risks associated with Olumiant?
Slovenian: Kakšna tveganja so povezana z zdravilom Olumiant?
English: The European Medicines Agency decided that Olumiant'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 Olumiant večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients.
Slovenian: Družba, ki trži zdravilo Olumiant, bo zagotovila, da bodo zdravniki, ki naj bi predpisovali zdravilo, prejeli informativno gradivo o tveganju, povezanem z zdravilom Olumiant, še posebej tveganju okužb, in o spremljanju, ki ga je treba izvajati pri bolnikih.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olumiant 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 Olumiant upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Olumiant glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Slovenian: Baricitinib z zaviranjem encimov zmanjša vnetje in blaži druge simptome bolezni.
English: Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Olumiant, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Slovenian: Ti encimi imajo pomembno vlogo pri procesu vnetja in poškodbi sklepov, do katerih pride pri revmatoidnem artritisu.
English: Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Slovenian: Zdravljenje z zdravilom Olumiant sme uvesti le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
English: In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given.
Slovenian: Ker je zdravljenje peroralno, z vidika varnosti to pomeni, da tveganja pri zdravilu Olumiant niso enaka tveganjem pri drugih zdravilih iz skupine DMARD, ki so dana z injiciranjem, kot so alergijske reakcije, povezane z načinom dajanja zdravila.
English: It is used in patients with moderate to severe arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs') has not worked well enough or if patients cannot tolerate them.
Slovenian: Uporablja se pri bolnikih z zmernim do hudim artritisom, pri katerih standardno zdravljenje z imunomodulirajočimi protirevmatičnimi zdravili (znanimi tudi kot zdravila skupine DMARD), ni bilo dovolj uspešno ali pa ga bolniki ne prenašajo.
English: Olumiant has also been studied in patients who had not received previous treatment.
Slovenian: Zdravilo Olumiant so proučevali tudi pri bolnikih, ki še niso bili zdravljeni.
English: Olumiant can be used either alone or in combination with the DMARD methotrexate.
Slovenian: Zdravilo Olumiant je mogoče uporabljati kot samostojno zdravilo ali v kombinaciji z zdravilom iz skupine DMARD, metotreksatom.
English: The Agency also took into account the lack of treatment options for these patients and the fact that Olumiant can be given by mouth is convenient for patients.
Slovenian: Agencija je upoštevala tudi pomanjkanje možnosti zdravljenja za te bolnike in dejstvo, da je peroralna uporaba zdravila Olumiant za bolnike priročna.
English: The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).
Slovenian: Najpogostejši neželeni učinki zdravila Olumiant, uporabljenega samostojno ali v kombinaciji z metotreksatom (ki lahko prizadenejo vsaj 2 osebi od 100), so povečane ravni holesterola v krvi, okužbe nosu in žrela ter navzeja (slabost).
English: Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).
Slovenian: Olumiant je zdravilo za zdravljenje revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov).
English: The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Slovenian: Učinkovina zdravila Olumiant, baricitinib, je imunosupresiv (zdravilo za zaviranje delovanja imunskega sistema).
English: How is Olumiant used?
Slovenian: Kako se zdravilo Olumiant uporablja?
English: The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them.
Slovenian: Agencija je menila, da je zdravilo Olumiant dokazano učinkovito za blaženje simptomov revmatoidnega artritisa pri bolnikih, pri katerih predhodno zdravljenje z zdravili iz skupine DMARD ni bilo dovolj uspešno, ali pri bolnikih, ki teh zdravil ne prenašajo.
English: Infections reported with Olumiant treatment also included herpes zoster (shingles).
Slovenian: Med okužbami, o katerih so poročali pri zdravljenju z zdravilom Olumiant, je bila tudi okužba z virusom, ki povzroča herpes zoster (pasovec).
English: Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.
Slovenian: vzpostavljenih pa je tudi več ukrepov za zmanjševanje tveganj, povezanih s tem zdravilom, še posebej tveganj za okužbo.
English: For the full list of side effects reported with Olumiant, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Olumiant, glejte navodilo za uporabo.
English: In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo.
Slovenian: V teh študijah je bilo število bolnikov, pri katerih je zaradi zdravila Olumiant (danega samostojno ali v kombinaciji z metotreksatom iz skupine DMARD) prišlo do vsaj 20-odstotnega izboljšanja po standardni lestvici za oceno simptomov (ACR 20), večje od števila bolnikov s takim izboljšanjem simptomov, ki so jemali primerjalna zdravila in placebo.
English: • In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.
Slovenian: • pri bolnikih, ki so bili predhodno zdravljeni z zdravili iz skupine DMARD, imenovanimi zaviralci TNF, je vsaj 20-odstotno izboljšanje doseglo 55 % (98 od 177) bolnikov, ki so prejemali zdravilo Olumiant, v primerjavi s 27 % (48 od 176) bolnikov, ki so prejemali placebo.
English: • In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.
Slovenian: • pri bolnikih, ki so bili predhodno zdravljeni z metotreksatom, je vsaj 20-odstotno izboljšanje na lestvici za oceno simptomov doseglo 70 % (339 od 487) bolnikov, ki so prejemali zdravilo Olumiant, v primerjavi z 61 % (202 od 330) bolnikov, ki so prejemali adalimumab (drugo zdravilo iz skupine DMARD), in 40 % (196 od 488) bolnikov, ki so prejemali placebo;
English: • In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
Slovenian: • pri bolnikih, ki so bili predhodno zdravljeni z običajnimi zdravili iz skupine DMARD, je vsaj 20-odstotno izboljšanje doseglo 62 % (140 od 227) bolnikov, ki so prejemali zdravilo Olumiant, v primerjavi s 40 % (90 od 228) bolnikov, ki so prejemali placebo;
English: Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough.
Slovenian: Tri študije, v katere je bilo vključenih približno 2 500 bolnikov, so pokazale, da zdravilo Olumiant pri bolnikih, pri katerih predhodno zdravljenje z zdravili iz skupine DMARD ni bilo uspešno, blaži simptome, kot sta občutljivost in zatekanje sklepov.
English: How does Olumiant work?
Slovenian: Kako zdravilo Olumiant deluje?
English: EMA/CHMP/138741/2015 EMEA/H/C/000563
Slovenian: EMA/101950/2015 EMEA/H/C/000563
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Aloxi, veljavno po vsej Evropski uniji, izdala 22. marca 2005.
English: The full EPAR for Aloxi 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 Aloxi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Aloxi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aloxi?
English: This is a summary of the European public assessment report (EPAR) for Aloxi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aloxi.
English: The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache.
Slovenian: Najpogostejši neželeni učinek zdravila Aloxi (opažen pri 1 od 10 bolnikov od 100) je glavobol.
English: The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Aloxi večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: A risk management plan has been developed to ensure that Aloxi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Aloxi je bil pripravljen načrt obvladovanja tveganj.
English: All of the studies measured the number of patients who did not vomit after receiving chemotherapy.
Slovenian: V vseh študijah so beležili število bolnikov, ki po kemoterapiji niso bruhali.
English: Other information about Aloxi
Slovenian: Druge informacije o zdravilu Aloxi
English: Aloxi is a medicine that contains the active substance palonosetron.
Slovenian: Aloxi je zdravilo, ki vsebuje zdravilno učinkovino palonosetron.
English: For more information about treatment with Aloxi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Aloxi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Aloxi.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What benefit has Aloxi shown during the studies?
Slovenian: Kakšne koristi je zdravilo Aloxi izkazalo med študijami?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aloxi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Slovenian: Na voljo je v obliki raztopine za injiciranje (250 mikrogramov na 5 ml) in kapsul (500 mikrogramov).
English: In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.
Slovenian: Odrasli, ki jemljejo kapsule, morajo vzeti eno kapsulo eno uro pred začetkom kemoterapije.
English: Aloxi solution for injection was as effective as the comparator medicines.
Slovenian: Zdravilo Aloxi v obliki raztopine za injiciranje je bilo enako učinkovito kot primerjalna zdravila.
English: For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Aloxi glejte navodilo za uporabo.
English: Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Slovenian: Zdravilo v dveh različnih odmerkih so primerjali z ondansetronom in dolasetronom (drugima zdraviloma iste vrste).
English: However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Slovenian: Vendar je v prvih petih dneh po kemoterapiji samo 500-mikrogramski odmerek ostal tako učinkovit kot raztopina za injiciranje: približno 59 % bolnikov, ki so prejeli 500-mikrogramsko kapsulo ali injekcijo, v tem obdobju ni bruhalo.
English: The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Slovenian: Zdravstveni delavec mora raztopino injicirati približno 30 minut pred začetkom kemoterapije.