FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the recommendations for patients and prescribers?
Slovenian: Kakšna so priporočila za bolnike in zdravnike, ki predpisujejo zdravilo?
English: What are the risks of exposure to endotoxins?
Slovenian: Kakšna so tveganja zaradi izpostavljenosti endotoksinom?
English: Which products are affected by the review?
Slovenian: Katere izdelke zadeva ta pregled?
English: These include changes to the design of the plant, new cleaning regimens and the introduction of improved testing methods.
Slovenian: Med njimi so spremembe v zasnovi obrata, novi režimi čiščenja in uvajanje izboljšanih načinov testiranja.
English: It also cleaned the other tanks and pipework involved in the production.
Slovenian: Poleg tega je poskrbela za čiščenje drugih posod in cevi, vključenih v proizvodnjo.
English: However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey).
Slovenian: Kljub temu si je prizadeval zmanjšati odvisnost od tega obrata in v januarju 2011 pripravil priporočila za uporabo izdelkov, uvoženih iz štirih proizvodnih obratov zunaj EU (iz Kanade, ZDA, Singapurja in Turčije).
English: The Committee also adopted a strategy to ensure adequate supply of products in the EU should problems reoccur in the future.
Slovenian: Odbor je izdelal tudi strategijo za zagotavljanje zadostne preskrbe z izdelki v EU, če bi se tovrstne težave ponovile.
English: The Irish medicines agency will inspect the plant again in October 2011 after which it will go through a 12-month ‘requalification period' where the plant will be carefully monitored and the products will undergo rigorous testing.
Slovenian: Irska agencija za zdravila bo v oktobru 2011 ponovno pregledala obrat, ki bo nato 12 mesecev v „obdobju ponovnega kvalificiranja“; v tem času bo obrat pod natančnim nadzorom, izdelke pa bodo podrobno testirali.
English: • Patients who have any questions should contact their doctors to discuss their treatment.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se o zdravljenju posvetujejo z zdravnikom.
English: As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar.
Slovenian: V okviru načrta za obvladovanje tveganj v prihodnosti je odbor CHMP sprejel predloge za obdobje intenzivnega spremljanja vseh poročil o aseptičnem peritonitisu v prvih mesecih trženja novih izdelkov iz Castlebara.
English: The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages.
Slovenian: Odbor CHMP je začel sedanji pregled, da bi v celoti raziskal vprašanja glede kontaminacije z endotoksini in pripravil priporočila, ki bi pomagala zaščititi javno zdravje in preprečiti prihodnje pomanjkanje v preskrbi.
English: All affected products from Castlebar were eventually recalled in stages across the EU.
Slovenian: Vsi oporečni izdelki iz Castlebara so bili postopoma odpoklicani po vsej Evropski uniji.
English: The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland.
Slovenian: Evropska agencija za zdravila je zaključila preiskavo proizvodnih postopkov v proizvodnem obratu družbe Baxter v Castlebaru na Irskem.
English: If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body's defence mechanism, will react against the endotoxins and cause inflammation.
Slovenian: Če bolnik dobi zdravilo, ki vsebuje endotoksine, je v nevarnosti, da se bo njegov imunski sistem (tj. obrambni mehanizem telesa) odzval proti endotoksinom z vnetjem.
English: The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread.
Slovenian: Odbor CHMP je zaključil, da je glavni vzrok prisotnosti endotoksinov v oporečnih proizvodnih linijah kombinacija dejavnikov: neodkrite razpoke v opremi so morda omogočile razraščanje bakterij, medtem ko so zasnova obrata in uporabljeni načini čiščenja lahko pripomogli k razširjenju kontaminacije.
English: It was believed that the endotoxins were being produced by ‘biofilms' (layers of bacteria that adhere to each other), which are very resistant to cleaning processes.
Slovenian: Domnevali so, da so endotoksini nastajali v „biofilmih“ (plasti bakterij, ki se sprimejo med seboj), ki so zelo odporni proti postopkom čiščenja.
English: Endotoxins are harmful substances (toxins) released from bacteria after they have died.
Slovenian: Endotoksini so škodljive snovi (toksini), ki se sproščajo iz odmrlih bakterij.
English: In order to facilitate this, the CHMP had earlier during the investigation made recommendations to formally include the production sites in Canada, USA, Turkey and Poland in the products' marketing authorisations in Europe.
Slovenian: Za povečanje preskrbe je odbor CHMP v zgodnjem obdobju preiskave priporočil, da se v dovoljenja za promet z zdravili, ki veljajo v Evropi, uradno vključijo proizvodne lokacije v Kanadi, ZDA, Turčiji in na Poljskem.
English: • Patients who suspect they have aseptic peritonitis or notice any relevant symptoms (cloudy effluent in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and fever) should contact their doctor.
Slovenian: • Bolniki, ki sumijo, da imajo aseptični peritonitis, ali ki opazijo kakršne koli ustrezne simptome (motnost eluata v drenažni vrečki ob koncu dialize, bolečine v trebuhu, navzeja, bruhanje in povišana telesna temperatura), naj se obrnejo na zdravnika.
English: These include: Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; Monosol and a sodium chloride solution for haemodialysis.
Slovenian: Med njimi so raztopine za peritonealno dializo Dianeal, Extraneal in Nutrineal; Monosol in raztopina natrijevega klorida za hemodializo.
English: In particular, endotoxins in solutions used in peritoneal dialysis can cause ‘aseptic peritonitis', an inflammation of the peritoneum that may affect the way it filters the blood.
Slovenian: Zlasti endotoksini v raztopinah, ki se uporabljajo pri peritonealni dializi, lahko povzročijo „aseptični peritonitis“, tj. vnetje trebušne mrene, ki lahko vpliva na način filtriranja krvi.
English: The corrective measures being made at Castlebar will also be applied to Baxter's other manufacturing sites.
Slovenian: Sanacijski ukrepi, ki potekajo v obratu v Castlebaru, bodo uporabljeni tudi na drugih proizvodnih lokacijah družbe Baxter.
English: The Agency was made aware of the presence of endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the Castlebar plant in December 2010.
Slovenian: Agencija je bila obveščena o prisotnosti endotoksinov v serijah raztopin Dianeal, Extraneal in Nutrineal, izdelanih decembra 2010 v obratu v Castlebaru.
English: • Healthcare professionals should continue to monitor dialysis patients for any adverse events including aseptic peritonitis and report any suspected cases to the company using the reporting forms that will be provided by Baxter.
Slovenian: • Zdravstveni delavci naj še naprej spremljajo pojave neželenih učinkov pri dializnih bolnikih, vključno z aseptičnim peritonitisom, in družbi Baxter sporočijo morebitne primere suma nanje na obrazcih, ki jim jih bo predložila.
English: Dialysis solutions are used in patients with kidney problems to help clear waste substances (such as urea) from the blood.
Slovenian: Dializne raztopine se uporabljajo pri bolnikih, ki imajo težave z delovanjem ledvic, kot pripomoček pri odstranjevanju odpadnih snovi (kot je sečnina) iz krvi.
English: Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time.
Slovenian: Odbor CHMP zaradi pomanjkanja drugih zadostnih virov dializnih raztopin takrat ni mogel odpoklicati vseh oporečnih izdelkov iz obrata v Castlebaru.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised recommendations to ensure the adequate supply of these dialysis solutions in the EU while measures are being put in place at Castlebar to enable the production of endotoxin-free solutions.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je pripravil priporočila za zagotavljanje ustrezne preskrbe s temi dializnimi raztopinami v EU, medtem ko se v obratu v Castlebaru izvajajo ukrepi, ki bodo omogočili izdelavo raztopin brez prisotnosti toksinov.
English: Symptoms of aseptic peritonitis include cloudy effluent (the solution in the drainage bag), abdominal pain, nausea (feeling sick), vomiting and sometimes fever.
Slovenian: Med simptomi aseptičnega peritonitisa so motnost eluata (raztopine v drenažni vrečki), bolečina v trebuhu, navzeja (slabost), bruhanje in včasih povišana telesna temperatura.
English: Despite these measures, endotoxins were still detected in new batches of solutions produced at the plant, causing the manufacture of these solutions to be shut down at the plant.
Slovenian: Kljub tem ukrepom so v novih serijah raztopin, izdelanih v obratu, znova odkrili endotoksine, zaradi česar je bila izdelava teh raztopin v obratu ustavljena.
English: The CHMP noted that improvements are being made to Castlebar plant to ensure future production of endotoxin-free dialysis solutions.
Slovenian: Odbor CHMP je zapisal, da v Castlebaru potekajo izboljšave obrata za zagotovitev, da tam izdelane dializne raztopine v prihodnje ne bodo vsebovale endotoksinov.
English: The investigation follows the detection in December 2010 of endotoxins in dialysis solutions produced at the plant.
Slovenian: Preiskava je bila opravljena po tem, ko so v decembru 2010 odkrili endotoksine v dializnih raztopinah, izdelanih v tem proizvodnem obratu.
English: At the time, the company identified endotoxin-producing bacteria in two tanks as the root cause of the problem and removed the tanks from the production line.
Slovenian: Takrat je družba kot glavni vzrok težav navedla prisotnost bakterij, iz katerih so se sproščali endotoksini, v dveh posodah, in zadevni posodi odstranila iz proizvodne linije.
English: Aseptic peritonitis can force the patient to stop dialysis until it is resolved.
Slovenian: Pri bolnikih z aseptičnim peritonitisom bo morda treba prenehati izvajati dializo, dokler ne okrevajo.
English: The products affected by this review are some of the dialysis solutions produced at Baxter's Castlebar plant.
Slovenian: Ta pregled zadeva nekatere dializne raztopine, izdelane v obratu družbe Baxter v Castlebaru.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Slovenian: Podjetje trenutno izvaja tudi opazovalno študijo o dolgoročni varnosti zdravila.
English: The tablets should be taken at the same time each day.
Slovenian: Tablete je treba vzeti vsak dan ob isti uri.
English: Further information on Daxas can be found on the Agency's website: ema.europa/Find medicine/Human medicine/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Daxas so na voljo na spletni strani agencije: ema.europa/Find medicine/Human medicine/European public assessment reports.
English: At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Slovenian: Na začetku študij sta imeli obe skupini bolnikov vrednost FEV1 okoli 1 litra (1 000 ml).
English: Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.
Slovenian: Za zdravilo Daxas je bilo 5. julija 2010 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Daxas?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Daxas?
English: After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Odbor je ob upoštevanju vseh razpoložljivih podatkov o učinkih zdravila zaključil, da so koristi zdravila Daxas večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Daxas are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Daxas stalno spremljajo.
English: Daxas must not be used in patients who have moderate or severe problems with their liver.
Slovenian: Zdravila Daxas ne smejo uporabljati bolniki z zmernimi ali hudimi težavami z jetri.
English: The company will also provide cards for patients, telling them what information about their symptoms and past illnesses they need to give their doctor to help the doctor determine whether Daxas is appropriate for them.
Slovenian: Zagotovilo bo tudi kartice za bolnike, na katerih bodo navedene informacije o simptomih in preteklih boleznih, ki jih morajo sporočiti zdravniku, da bo ta lahko presodil, ali je zdravilo Daxas zanje primerno.
English: The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Slovenian: Učinkovina v zdravilu Daxas, roflumilast, spada v skupino zdravil, ki se imenujejo „zaviralci fosfodiesteraze tipa 4 (PDE4)“.
English: The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Slovenian: Podjetje, ki izdeluje zdravilo Daxas, bo zagotovilo, da bodo v vseh državah članicah Evropske unije (EU) zdravstveni delavci, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo o neželenih učinkih zdravila in njegovi uporabi.
English: An overview of Daxas and why it is authorised in the EU
Slovenian: Pregled zdravila Daxas in zakaj je odobreno v EU
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daxas have also 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 Daxas upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Daxas is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Slovenian: Zdravilo Daxas se ne uporablja samostojno, ampak kot „dodatek“ k zdravljenju z bronhodilatorji (zdravili, ki širijo dihalne poti v pljučih).
English: For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Daxas glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Daxas authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Daxas odobreno v EU?
English: Because patients taking Daxas may lose weight, they are advised to weigh themselves on a regular basis.
Slovenian: Ker lahko bolniki, ki jemljejo zdravilo Daxas, shujšajo, jim je treba svetovati redno tehtanje.
English: These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Slovenian: Ti sta vključevali več kot 3 000 odraslih bolnikov s hudo kronično obstruktivno pljučno boleznijo, ki so imeli najmanj en izbruh bolezni v preteklem letu.
English: The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Slovenian: Najpogostejši neželeni učinki zdravila Daxas (ki so jih opazili pri 1 do 10 od 100 bolnikov) so zmanjšana telesna masa, zmanjšan tek, nespečnost (motnje spanja), glavobol, driska, navzeja (siljenje na bruhanje) in bolečine v trebuhu.
English: Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Daxas, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefit of Daxas have been shown in studies?
Slovenian: Kakšne koristi zdravila Daxas so se pokazale v študijah?
English: In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Slovenian: Poleg tega so imeli bolniki, ki so jemali zdravilo Daxas, v povprečju 1,1 zmernega ali hudega izbruha bolezni v primerjavi z 1,4 izbruha pri bolnikih, ki so jemali placebo.
English: Patients may need to take Daxas 500 micrograms for several weeks before it starts to have an effect.
Slovenian: Bolniki bodo morali morda zdravilo Daxas v odmerku 500 mg jemati več tednov, preden se pokaže njegov učinek.
English: Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing patients from dropping out because of side effects when starting treatment.
Slovenian: Čeprav odmerek 250 mg na dan ne izboljša pljučne funkcije, je bil koristen pri preprečevanju izstopa bolnikov zaradi neželenih učinkov ob začetku zdravljenja.
English: Other information about Daxas:
Slovenian: Druge informacije o zdravilu Daxas
English: Daxas contains the active substance roflumilast.
Slovenian: Zdravilo Daxas vsebuje učinkovino roflumilast.
English: The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.
Slovenian: Koristi izboljšanja FEV1 so bile ob koncu študije podobne pri obeh skupinah, vendar pa pri bolnikih, ki niso mogli jemati 500 mg na dan in so nato prejemali le 250 mg na dan, ni prišlo do izboljšanja pljučne funkcije.
English: What is Daxas and what is it used for?
Slovenian: Kaj je zdravilo Daxas in za kaj se uporablja?
English: Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.
Slovenian: Zdravilo Daxas je na voljo v obliki tablet (250 in 500 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: What are the risks associated with Daxas?
Slovenian: Kakšna tveganja so povezana z zdravilom Daxas?
English: The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment is started with one 250-microgram tablet daily to reduce side effects that might make patients stop taking the medicine.
Slovenian: Priporočeni odmerek zdravila Daxas za zdravljenje je ena 500-mikrogramska tableta enkrat na dan, zdravljenje pa se začne z eno 250-mikrogramsko tableto enkrat na dan, s čimer se zmanjšajo neželeni učinki, zaradi katerih bi bolniki morda prenehali jemati zdravilo.
English: Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily.
Slovenian: Iz študije je izstopilo približno 18 odstotkov (81 bolnikov od 441) tistih, ki so začeli z 250 mg na dan, v primerjavi s 25 odstotki (109 bolnikov od 443) tistih, ki so začeli s 500 mg na dan. Bolniki, ki so začeli z manjšim odmerkom, so imeli manj neželenih učinkov.
English: After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Slovenian: Po enem letu so imeli bolniki, ki so jemali zdravilo Daxas, v povprečju za 40 ml večjo vrednost FEV1, medtem ko se je pri tistih, ki so prejemali placebo, ta vrednost zmanjšala za 9 ml.
English: The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD.
Slovenian: Evropska agencija za zdravila je ugotovila, da obstaja potreba po novih načinih zdravljenja kronične obstruktivne pljučne bolezni in da sta glavni študiji pokazali skromno korist zdravila Daxas v odmerku 500 mg pri bolnikih s hudo kronično obstruktivno pljučno boleznijo.
English: Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose.
Slovenian: V drugi 12-tedenski študiji, v katero je bilo vključenih 1 323 bolnikov, so proučevali učinek štiritedenskega zdravljenja z odmerkom zdravila Daxas 250 mg dnevno pred povečanjem odmerka na 500 mg dnevno v primerjavi z začetkom pri večjem odmerku.
English: Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Slovenian: Zdravilo Daxas se uporablja za zdravljenje hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih, ki imajo kronični bronhitis (dolgotrajno vnetje dihalnih poti) in pri katerih se izbruhi kronične obstruktivne pljučne bolezni pogosto pojavljajo.
English: After taking 250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily.
Slovenian: Po štiritedenskem jemanju 250 mg dnevno se odmerek poveča na 500 mg dnevno.
English: Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies.
Slovenian: 500-mikrogramski odmerek zdravila Daxas se je pri zdravljenju kronične obstruktivne pljučne bolezni izkazal za učinkovitejšega od placeba (zdravila brez učinkovine) v dveh glavnih študijah.
English: For the full list of side effects of Daxas, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Daxas glejte navodilo za uporabo.
English: How does Daxas work?
Slovenian: Kako zdravilo Daxas deluje?
English: How is Daxas used?
Slovenian: Kako se zdravilo Daxas uporablja?
English: The doctor may stop treatment with Daxas if the patient loses too much weight.
Slovenian: Če bolnik izgubi preveč telesne mase, se bo zdravnik morda odločil, da prekine zdravljenje z zdravilom Daxas.
English: The full EPAR and risk management plan summary for Vylaer Spiromax 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 Vylaer Spiromax sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vylaer Spiromax budesonide / formoterol
Slovenian: Vylaer Spiromax budezonid/formoterol
English: Vylaer Spiromax 160/4.5 microgram can be used for the regular treatment of asthma.
Slovenian: Zdravilo Vylaer Spiromax 160/4,5 mikrograma se lahko uporablja za redno zdravljenje astme.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vylaer Spiromax on 19 November 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vylaer Spiromax, veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
English: If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Slovenian: Če bolniki potrebujejo več kot osem vpihov iz inhalatorja z olajševalcem na dan, je priporočljivo, da se posvetujejo z zdravnikom, ki bo ponovno ocenil njihovo zdravljenje astme.