FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of ViraferonPeg and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Slovenian: Kombinacijo zdravila ViraferonPeg in ribavirina so proučevali tudi v študiji s 1 354 odraslimi bolniki, pri katerih predhodno zdravljenje ni bilo uspešno, in študiji s 107 otroki in mladostniki, starimi od 3 do 17 let, ki pred tem še niso bili zdravljeni.
English: ViraferonPeg, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Slovenian: Zdravilo ViraferonPeg, uporabljeno sočasno z ribavirinom ali brez njega, so primerjali z interferonom alfa-2b v petih glavnih študijah s skupno več kot 6 000 odraslih bolnikov s hepatitisom C, ki predhodno še niso bili zdravljeni, vključno s 328 bolniki s cirozo in 507 bolniki, ki so bili okuženi tudi z virusom HIV.
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Slovenian: Ostalim odraslim z virusom hepatitisa C v krvi, vključno z bolniki, ki so okuženi tudi z virusom humane imunske pomanjkljivosti (HIV), se ViraferonPeg daje bodisi z ribavirinom (dvotirno zdravljenje) bodisi kot samostojno zdravilo, če bolniki ne morejo jemati ribavirina.
English: ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Slovenian: Zdravilo ViraferonPeg se lahko daje v okivru trotirnega zdravljenja v kombinaciji z ribavirinom in boceprevirjem odraslim bolnikom s hepatitisom C tipa 1, katerih jetra so poškodovana, vendar še vedno normalno delujejo (kompenzirana bolezen jeter).
English: In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Slovenian: Pri otrocih in mladostnikih, ki so prejemali kombinacijo zdravila ViraferonPeg in ribavirina, so bili neželeni učinki podobni kot pri odraslih, čeprav je bila pri več kot 1 bolniku od 10 opažena tudi manjša telesna rast.
English: For the full list of all side effects reported with ViraferonPeg, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ViraferonPeg, glejte navodilo za uporabo.
English: The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Slovenian: Interferon alfa-2b, ki ga vsebuje zdravilo ViraferonPeg, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori interferon alfa-2b.
English: A 40% increase was seen among patients who had been treated before.
Slovenian: Pri predhodno zdravljenih bolnikih je to povečanje znašalo 40 %.
English: What is the risk associated with ViraferonPeg?
Slovenian: Kakšna tveganja so povezana z zdravilom ViraferonPeg?
English: ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b.
Slovenian: ViraferonPeg je zdravilo, ki vsebuje zdravilno učinkovino peginterferon alfa-2b.
English: Triple therapy led to an increase of about 30% in the number of previously early responders who were cured after six months.
Slovenian: Pri trotirnem zdravljenju se je število predhodno nezdravljenih bolnikov, ki so se zgodaj odzvali na zdravljenje in so bili po šestih mesecih ozdravljeni, povečalo za približno 30 %.
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ViraferonPeg in a triple therapy combination with ribavirin and boceprevir compared with ViraferonPeg and ribavirin alone.
Slovenian: V dveh glavnih študijah, v katerih so sodelovali 1 503 odrasli bolniki s hepatitisom C tipa 1 in kompenzirano boleznijo jeter, so preučevali učinek zdravila ViraferonPeg v trotirnem zdravljenju z ribavirinom in boceprevirjem v primerjavi z njegovim učinkom v kombinaciji zgolj z ribavirinom.
English: In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed.
Slovenian: Zdravilo ViraferonPeg se lahko uporablja pri odraslih bolnikih (starih vsaj 18 let), ki še niso bili zdravljeni oziroma pri katerih predhodno zdravljenje ni bilo uspešno.
English: ViraferonPeg is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Slovenian: Zdravilo ViraferonPeg se uporablja za zdravljenje bolnikov, starejših od treh let, z dolgotrajnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
English: In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin.
Slovenian: Pri odraslih bolnikih, ki še niso bili zdravljeni, je bilo zdravilo ViraferonPeg učinkovitejše od interferona alfa-2b, pri čemer se jih je približno četrtina odzvala na zdravilo, vzeto samostojno, približno polovica pa na kombinacijo zdravila ViraferonPeg in ribavirina.
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone.
Slovenian: V študijah trotirnega zdravljenja bolnikov s hepatitisom C tipa 1 in kompenzirano boleznijo jeter se je zdravljenje z zdravilom ViraferonPeg v kombinaciji z ribavirinom in boceprevirjem izkazalo za učinkovitejše od dvotirnega zdravljenja z zdravilom ViraferonPeg in ribavirinom.
English: Why has ViraferonPeg been approved?
Slovenian: Zakaj je bilo zdravilo ViraferonPeg odobreno?
English: In ViraferonPeg, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu ViraferonPeg je interferon alfa-2b „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Slovenian: Opaziti je tudi znatno povečanje deleža ozdravljenih bolnikov z dolgotrajno okužbo s hepatitisom C tipa 1 pri trotirnem zdravljenju z zdravilom ViraferonPeg v kombinaciji z ribavirinom in boceprevirjem.
English: The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons'.
Slovenian: Zdravilna učinkovina zdravila ViraferonPeg, peginterferon alfa-2b, spada v skupino interferonov.
English: How has ViraferonPeg been studied?
Slovenian: Kako je bilo zdravilo ViraferonPeg raziskano?
English: What is ViraferonPeg?
Slovenian: Kaj je zdravilo ViraferonPeg?
English: What is ViraferonPeg used for?
Slovenian: Za kaj se zdravilo ViraferonPeg uporablja?
English: How is ViraferonPeg used?
Slovenian: Kako se zdravilo ViraferonPeg uporablja?
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
Slovenian: Na zdravljenje s kombinacijo zdravila ViraferonPeg in ribavirina se je odzvala približno četrtina odraslih bolnikov, pri katerih predhodno zdravljenje ni bilo uspešno, in okoli dve tretjini otrok in mladostnikov.
English: The doses of ribavirin and ViraferonPeg may need to be adjusted for patients who experience side effects.
Slovenian: Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo odmerek ribavirina in zdravila ViraferonPeg morda treba prilagoditi.
English: How does ViraferonPeg work?
Slovenian: Kako zdravilo ViraferonPeg deluje?
English: Ref. EMEA/266786/2008
Slovenian: EMEA/304454/2008
English: International non-proprietary name (INN): beclomethasone dipropionate
Slovenian: Mednarodno nelastniško ime (INN): beklometazon dipropionat
English: It was to be available as two separate tablets, to be taken together: one immediate-release tablet (immediate-release means that the tablet has been made to allow the active substance to be released immediately) and one gastro-resistant tablet (gastro-resistant means that the tablet's content passes through the stomach without being broken down until it reaches the intestine).
Slovenian: Na voljo naj bi bilo v obliki dveh ločenih tablet, ki bi se naj jemali skupaj: ena tableta s takojšnjim sproščanjem (takojšnje sproščanje pomeni, da je tableta narejena tako, da omogoča takojšnje sproščanje zdravilne učinkovine), druga tableta pa je gastrorezistentna (gastrorezistentnost pomeni, da lahko vsebina tablete preide skozi želodec, ne da bi se pri tem razkrojila, dokler ne doseže črevesja).
English: orBec was designated as an orphan medicinal product on 13 March 2002.
Slovenian: Zdravilo orBec je bilo dne 13. marca 2002 določeno kot zdravilo sirota.
English: It works by dampening down the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell.
Slovenian: Deluje tako, da zavira delovanje imunskega sistema (naravni obrambni mehanizem telesa), in sicer tako, da se veže na receptorje v različnih vrstah imunskih celic.
English: The CHMP had also concerns that most of the patients who took part in the study came from one study centre, and therefore the results were not representative for the overall population.
Slovenian: CHMP je bil zaskrbljen tudi zaradi dejstva, da je bila večina v študiji sodelujočih bolnikov iz enega samega študijskega centra, tako da rezultati niso bili reprezentativni za celotno populacijo.
English: The applicant presented data on experimental models for beclomethasone dipropionate from the scientific literature.
Slovenian: Predlagatelj je predstavil podatke o poskusnih modelih za beklometazon dipropionat iz znanstvene literature.
English: The CHMP was concerned that the single main study did not demonstrate orBec's effectiveness.
Slovenian: CHMP je izrazil zaskrbljenost, da edina glavna študija ni izkazala učinkovitosti zdravila orBec.
English: orBec was not significantly better than placebo in increasing the time until the disease came back during the 50-day treatment period.
Slovenian: Zdravilo orBec ni bilo bistveno učinkovitejše od placeba pri podaljševanju časa do ponovnega pojava bolezni v okviru 50-dnevnega zdravljenja.
English: It was expected to block receptors in the stomach and intestine, reducing locally the production of substances that are involved in recognising foreign cells and in the inflammation process.
Slovenian: Zdravilo naj bi blokiralo receptorje v želodcu in črevesju ter tako zmanjšalo lokalno proizvajanje snovi, ki sodelujejo pri prepoznavanju tujih celic in pri vnetnih procesih.
English: What is orBec?
Slovenian: Kaj je zdravilo orBec?
English: Graft-versus-host disease can occur in patients following tissue or organ transplantation, when the cells in the transplanted tissue or organ recognise the patient as ‘foreign' and attack the body.
Slovenian: Gastrointestinalna bolezen presadka proti gostitelju se lahko pojavi pri bolnikih po presaditvi tkiv ali organov, ko celice v presajenem tkivu ali organu telo bolnika prepoznajo kot „tujek“ in napadejo njegovo telo.
English: On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease.
Slovenian: Družba DOR BIOPHARMA UK Ltd je dne 22. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom orBec, namenjenim zdravljenju gastrointestinalne bolezni presadka proti gostitelju.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ORBEC
Slovenian: VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom ORBEC
English: Patients with gastrointestinal graft-versus-host disease have damage to the stomach and the intestine, which causes severe inflammation of these organs.
Slovenian: Bolniki z gastrointestinalno boleznijo presadka proti gostitelju imajo poškodovan želodec in črevesje, kar lahko povzroči huda vnetja teh organov.
English: This was expected to lead to a reduction in damage to the stomach and intestine.
Slovenian: To naj bi posledično ugodno vplivalo na zmanjševanje poškodb želodca in črevesja.
English: The main measure of effectiveness was how long it took for treatment to fail during the 50 days of treatment.
Slovenian: Glavno merilo učinkovitosti je bil čas v okviru 50-dnevnega zdravljenja, v katerem se je pokazalo, da zdravljenje ni bilo uspešno.
English: The active substance of orBec, beclomethasone dipropionate, is a corticosteroid that has been used in inhaled, nasal and skin medicines since the 1970s.
Slovenian: Zdravilna učinkovina v zdravilu orBec, beklometazon dipropionat, je kortikosteroid, ki se od 1970-ih uporablja v zdravilih za vdihavanje ter zdravilih za nos in kožo.
English: Based on the review of the data and the company's response to the CHMP list of question at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that orBec could not have been approved for the treatment of gastrointestinal graft-versus-host disease.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila orBec ni mogoče odobriti za zdravljenje gastrointestinalne bolezni presadka proti gostitelju.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with orBec?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila orBec?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with orBec.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila orBec.
English: What was orBec expected to be used for?
Slovenian: Za kaj naj bi se zdravilo orBec uporabljalo?
English: In addition, the Committee noted that there was a lack of data to demonstrate how the active substance in orBec works in the stomach and intestine, when used for treatment of gastrointestinal graft-versus-host disease.
Slovenian: Poleg tega je Odbor izpostavil tudi pomanjkanje podatkov o načinu delovanja zdravilne učinkovine zdravila orBec v želodcu in črevesju pri zdravljenju gastrointestinalne bolezni presadka proti gostitelju.
English: In orBec, beclomethasone dipropionate was to be taken orally so that it could act within the stomach and intestine.
Slovenian: Beklometazon dipropionat v zdravilu orBec bi se naj jemal peroralno, tako da bi lahko zdravilna učinkovina delovala v želodcu in črevesju.
English: orBec was expected to be used for the treatment of gastrointestinal graft-versus-host disease.
Slovenian: Zdravilo orBec naj bi se uporabljalo za zdravljenje gastrointestinalne bolezni presadka proti gostitelju.
English: orBec is a medicine containing the active substance beclomethasone dipropionate.
Slovenian: Zdravilo orBec je zdravilo, ki vsebuje zdravilno učinkovino beklometazon dipropionat.
English: The effectiveness of orBec was studied in one main study, in which orBec was compared with placebo (a dummy treatment) in 129 patients with gastrointestinal graft-versus-host disease.
Slovenian: Učinkovitost zdravila orBec so preučevali v eni glavni študiji, v kateri so pri 129 bolnikih z gastrointestinalno boleznijo presadka proti gostitelju zdravilo orBec primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of orBec had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je v času umika menil, da koristi zdravila orBec niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: How is orBec expected to work?
Slovenian: Kako naj bi zdravilo orBec delovalo?
English: This may appear several days after birth.
Slovenian: To se lahko pojavi nekaj dni po rojstvu.
English: This must be for at least 30 days and to be decided by your doctor.
Slovenian: To mora trajati vsaj 30 dni in o tem odloči vaš zdravnik.
English: Patient characteristics in these studies are shown below.
Slovenian: Značilnosti bolnikov v teh študijah so prikazane spodaj.
English: Local representative contact
Slovenian: Kontakt lokalnega predstavnika
English: Patients over 65 years
Slovenian: Bolniki, stari več kot 65 let
English: • social support system
Slovenian: • sistem socialne podpore.
English: Patient name:
Slovenian: Ime bolnika:
English: Do not attempt to remove the implants by yourself as this could be very dangerous.
Slovenian: Implantatov ne poskušajte odstraniti sami, saj je to lahko zelo nevarno.
English: • The patient should be able to lie on their back.
Slovenian: • Bolnik mora biti sposoben ležati na hrbtu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1369/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1369/001
English: 50018 Scandicci (Firenze), Italy
Slovenian: 50018 Scandicci (Firenze), Italija
English: • stability of living environment
Slovenian: • stabilnost življenjskega okolja,
English: The experience of a second treatment cycle is limited.
Slovenian: Izkušnje z drugim ciklom zdravljenja so omejene.
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Slovenian: Zato je treba odmerke omejiti in se izogniti tej kombinaciji v primerih, ko obstaja tveganje za zlorabo.
English: Important aspects to consider during treatment:
Slovenian: Pomembni dejavniki, ki jih je treba upoštevati med zdravljenjem:
English: Percentage of negative results
Slovenian: Odstotek negativnih rezultatov
English: Primary opioid of abuse, n (%)
Slovenian: Primarni zlorabljani opioid, n (%)
English: The nature of the syndrome may vary depending upon the mother's drug use history.
Slovenian: Narava tega sindroma se lahko razlikuje glede na materino zgodovino jemanja drog.
English: Scandicci ITALY
Slovenian: Scandicci ITALIJA
English: • general weakness and poor health, or you are elderly
Slovenian: • splošno šibkost ali slabo zdravje, ali če ste starejši,
English: • Always keep this card with you while on treatment.
Slovenian: • To kartico imejte v času zdravljenja vedno pri sebi.
English: The implant time was 24 weeks.
Slovenian: Čas implantacije je znašal 24 tednov.
English: 747 70 Opava, Komarov CZECH REPUBLIC
Slovenian: 747 70 Opava, Komarov
English: Number (%) of broken implants
Slovenian: Število (%) zlomljenih implantatov
English: Treating doctor (name / contact information):
Slovenian: Lečeči zdravnik (ime/kontaktni podatki):
English: • Drowsiness may occur especially in the first week after insertion.
Slovenian: • Lahko se pojavi zaspanost, zlasti v prvem tednu po vstavitvi.
English: • participation in a structured activity/job
Slovenian: • sodelovanje pri strukturirani aktivnosti/delu,
English: Breakage rates decreased in studies using the current technique and training.
Slovenian: Število zlomov je bilo nižje v študijah, ki so uporabljale trenutno tehniko in usposabljanje.
English: • This medicine can cause dependence, but at a lower level than other substances such as morphine.
Slovenian: • To zdravilo lahko povzroči odvisnost, toda v manjši meri kot druge snovi, na primer morfin.
English: Acute alcoholism or delirium tremens
Slovenian: Akutni alkoholizem ali delirium tremens
English: Frequency categories are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Overdose symptoms include:
Slovenian: Simptomi prevelikega odmerjanja vključujejo:
English: This endpoint was considered to be of clinical relevance in the targeted indication.
Slovenian: Ta opazovani dogodek je veljal za klinično relevantnega pri ciljni indikaciji.
English: • adequate lighting, such as headlamp
Slovenian: • ustrezna osvetlitev, kot je čelna luč,
English: Sixmo with food, drink and alcohol
Slovenian: Zdravilo Sixmo skupaj s hrano, pijačo in alkoholom
English: Weeks 1 to 16
Slovenian: 1. do 16. teden
English: It is used to treat opioid dependence in adults who are also receiving medical, social and psychological support.
Slovenian: Uporablja se za zdravljenje odvisnosti od opiodiov pri odraslih, ki so deležni tudi zdravstvene, socialne in psihološke podpore.
English: The syndrome is generally delayed for several hours to several days after birth.
Slovenian: Sindrom se običajno pojavi nekaj ur ali nekaj dni po rojstvu.
English: • Present this card to your doctor, dentist or surgeon before any medical treatment or surgery.
Slovenian: • To kartico pokažite zdravniku, zobozdravniku ali kirurgu pred vsakim zdravljenjem ali kirurškim posegom.
English: Buprenorphine is approximately 96% protein bound, primarily to alpha and beta globulin.
Slovenian: Buprenorfin je približno 96-odstotno vezan na beljakovine, predvsem na alfa in beta globulin.
English: • period without episodes of hospitalisations (addiction or mental health issues), emergency room visits, or crisis interventions
Slovenian: • obdobje brez epizod hospitalizacije (težav z odvisnostjo ali duševnim zdravjem), nujne zdravniške pomoči ali kriznih posredovanj,
English: The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.
Slovenian: Sindrom je lahko blažji in dolgotrajnejši kot pri kratko delujočih polnih μ-opioidnih agonistih.
English: 4.5 Interaction with other medicinal products and other forms of interaction Buprenorphine should not be administered together with:
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Buprenorfina se ne sme uporabljati skupaj z:
English: In some cases, the dose delivered by the implants might be more than the one you need.
Slovenian: V nekaterih primerih je lahko odmerek, ki ga dovajajo implantati, lahko večji od potrebnega.
English: This product may cause dizziness, somnolence or sedation especially at the start of treatment.
Slovenian: To zdravilo lahko povzroči omotico, zaspanost ali sedacijo, zlasti na začetku zdravljenja.
English: The majority of patients (around 80%) in both studies were adequately treated with 4 implants; around 20% of patients required a dose increase with a fifth implant.
Slovenian: Večina bolnikov (približno 80 %) v obeh študijah je bila ustrezno zdravljena s 4 implantati; približno 20 % bolnikov je potrebovalo povečanje odmerka s petim implantatom.
English: Step 12: Complete the Patient Alert Card and give it to the patient to keep.
Slovenian: 12. korak: Izpolnite opozorilno kartico za bolnika in jo izročite bolniku, ki naj jo shrani.