FrancophonIA/ELRC3.0 huggingface dataset:
English: Benepali must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.
Slovenian: Zdravila Benepali ne smejo uporabljati bolniki, ki imajo sepso ali pri katerih obstaja nevarnost sepse (kadar bakterije in toksini krožijo v krvi in začnejo povzročati poškodbe organov), ali bolniki z okužbami.
English: • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups:
Slovenian: • določenih oblik juvenilnega idiopatskega artritisa (redke otroške bolezni, ki povzroča vnetje več sklepov) pri naslednjih skupinah:
English: What benefits of Benepali have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Benepali izkazalo v študijah?
English: The active substance in Benepali, etanercept, is a protein designed to block the activity of a protein in the body called tumour necrosis factor (TNF).
Slovenian: Zdravilna učinkovina v zdravilu Benepali, etanercept, je beljakovina, ki je bila zasnovana tako, da v telesu zavre dejavnost beljakovine, imenovane tumorje nekrotizirajoči faktor (TNF).
English: What are the risks associated with Benepali?
Slovenian: Kakšna tveganja so povezana z zdravilom Benepali?
English: What is Benepali and what is it used for?
Slovenian: Kaj je zdravilo Benepali in za kaj se uporablja?
English: The most common side effects with Benepali are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Slovenian: Najpogostejši neželeni učinki zdravila Benepali so reakcije na mestu injiciranja (vključno s krvavitvami, rdečico, srbečico, bolečino in otekanjem) in okužbe (vključno s prehladi ter okužbami pljuč, mehurja in kože).
English: • psoriatic arthritis in adults who have not responded adequately to other treatments;
Slovenian: • psoriatičnega artritisa pri odraslih, ki se niso ustrezno odzvali na druge vrste zdravljenja;
English: Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations.
Slovenian: Zdravilo Benepali ni namenjeno uporabi pri otrocih, ki tehtajo manj kot 62,5 kg, saj ni na voljo v formulacijah z majhnim odmerkom.
English: In addition, a study comparing Benepali to Enbrel in adults with rheumatoid arthritis showed that both medicines are similarly effective.
Slovenian: Poleg tega je študija, v kateri so zdravilo Benepali primerjali z zdravilom Enbrel pri odraslih z revmatoidnim artritisom, pokazala, da sta obe zdravili podobno učinkoviti.
English: The company that makes Benepali will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled syringe/pen correctly).
Slovenian: Družba, ki izdeluje zdravilo Benepali, bo zagotovila izobraževalno gradivo za zdravnike, ki naj bi predpisovali zdravilo (s pomočjo katerega bodo bolnike poučili o pravilni uporabi napolnjene injekcijske brizge/peresnika).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je sklenil, da je v skladu z zahtevami EU glede podobnih bioloških zdravil zdravilo Benepali po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Enbrel in da se po telesu enako prenaša.
English: Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
Slovenian: Zdravilo Benepali se lahko uporablja tudi pri bolnikih s hudim revmatoidnim artritisom, ki pred tem metotreksata niso jemali;
English: Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat.
Slovenian: Zdravljenje z zdravilom Benepali lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se uporablja zdravilo Benepali.
English: Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate.
Slovenian: Zdravilo Benepali so z zdravilom Enbrel primerjali tudi v glavni študiji, ki je vključevala 596 odraslih bolnikov z zmernim do hudim revmatoidnim artritisom kljub zdravljenju z metotreksatom.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease.
Slovenian: • psoriaze v plakih (bolezni, ki povzroča rdeče, luskaste zaplate na koži) pri odraslih z zmernim do hudim obolenjem in bolnikih, starejših od šest let, z dolgotrajno hudo boleznijo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benepali 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 Benepali upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali.
Slovenian: Zdravilo Benepali je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti etanercepta, izvedenih z zdravilom Enbrel, z zdravilom Benepali ni treba ponavljati.
English: For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Benepali preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepali's approved indications.
Slovenian: Vsi ti podatki so zadostovali za sklepanje, da se bo zdravilo Benepali obnašalo enako z vidika učinkovitosti pri odraslih in otrocih, kadar se zdravilo jemlje pri odobrenih indikacijah.
English: Benepali is used in patients who have not responded to or cannot receive other treatments for this disease.
Slovenian: Zdravilo Benepali se uporablja pri bolnikih, ki se niso odzvali na druga zdravila za zdravljenje teh obolenj ali pa jih ne smejo prejemati.
English: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234).
Slovenian: Rezultati te študije so pokazali, da je zdravilo Benepali pri zmanjševanju simptomov revmatoidnega artritisa enako učinkovito kot zdravilo Enbrel: po 24 tednih zdravljenja je prišlo do vsaj 20-odstotnega zmanjšanja vrednosti ACR pri 78 % (193 od 247) bolnikov, ki so prejeli zdravilo Benepali, in pri 80 % (188 od 234) bolnikov, ki so prejeli zdravilo Enbrel.
English: Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient.
Slovenian: Zdravilo Benepali se uporablja bodisi skupaj z metotreksatom (zdravilom, ki učinkuje na imunski sistem) pri odraslih z zmernim do resnim obolenjem, ki so se neustrezno odzvali na druge načine zdravljenja, bodisi kot samostojno zdravilo, če metotreksat za bolnika ni primeren.
English: • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over).
Slovenian: • zmernega do hudega revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča vnetje sklepov) pri odraslih (starejših od 18 let).
English: This protein is found at high levels in patients with the diseases that Benepali is used to treat.
Slovenian: Ta beljakovina je prisotna v visokih koncentracijah pri bolnikih z obolenji, ki se zdravijo z zdravilom Benepali.
English: Therefore, the CHMP's view was that, as for Enbrel, the benefits outweighs the identified risks.
Slovenian: Zato je odbor menil, da njegove koristi enako kot pri zdravilu Enbrel odtehtajo znana tveganja.
English: Patients developing a serious infection should stop Benepali treatment.
Slovenian: Bolniki, pri katerih se pojavi resna okužba, morajo zdravilo Benepali prenehati jemati.
English: Benepali contains the active substance etanercept and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Benepali vsebuje zdravilno učinkovino etanercept in je „podobno biološko zdravilo“.
English: − patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
Slovenian: − bolnikih, starih od dve do 17 let, z obolenjem, ki prizadene več sklepov (poliartritisom s pozitivnim ali negativnim revmatoidnim faktorjem), in obolenjem, ki se začne v določenih sklepih in se nato razširi na več sklepov (oligoartritis), ter tistih, ki se niso ustrezno odzvali na metotreksat ali ga ne morejo jemati;
English: − adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
Slovenian: − mladostnikih, starih od 12 do 17 let, ki imajo artritis, povezan z entezitisom, in se niso ustrezno odzvali na standardno zdravljenje ali ga ne prenašajo;
English: For practical information about using Benepali, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Benepali naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about Benepali
Slovenian: Druge informacije o zdravilu Benepali
English: Benepali is available as pre-filled syringes or pens containing a solution for injecting under the skin.
Slovenian: Zdravilo Benepali je na voljo v napolnjenih injekcijskih brizgah ali peresnikih, ki vsebujejo raztopino za podkožno injiciranje.
English: The Committee recommended that Benepali be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Benepali izda dovoljenje za promet.
English: • severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
Slovenian: • hudega radiografsko nezaznavnega aksialnega spondilartritisa (kroničnega vnetnega obolenja hrbtenice), kadar so stvarni znaki vnetja prisotni, rentgenska slika pa ne kaže nepravilnosti;
English: Why is Benepali approved?
Slovenian: Zakaj je bilo zdravilo Benepali odobreno?
English: How is Benepali used?
Slovenian: Kako se zdravilo Benepali uporablja?
English: − adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
Slovenian: − mladostnikih, starih od 12 do 17 let, ki imajo psoriatični artritis (bolezen, ki povzroča rdeče, luskaste zaplate na koži in vnetje sklepov) in se niso ustrezno odzvali na zdravljenje z metotreksatom ali pa ga ne morejo jemati;
English: Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Benepali primerjali z zdravilom Enbrel, so pokazale, da je zdravilo Benepali po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Enbrel.
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
Slovenian: • hudega ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje v sklepih hrbtenice) pri odraslih, ki so se neustrezno odzvali na druge načine zdravljenja;
English: Benepali is an anti-inflammatory medicine.
Slovenian: Zdravilo Benepali je protivnetno zdravilo.
English: For the full list of all side effects reported with Benepali, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Benepali, glejte navodilo za uporabo.
English: The patient or carer can give the injection after appropriate training.
Slovenian: Zdravilo lahko po ustreznem usposabljanju injicira bolnik sam ali njegov negovalec.
English: The reference medicine for Benepali is Enbrel.
Slovenian: Referenčno zdravilo za zdravilo Benepali je zdravilo Enbrel.
English: Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.
Slovenian: Izobraževalno gradivo vključuje tudi opomnik, da zdravilo Benepali ni namenjeno uporabi pri otrocih in mladostnikih, ki tehtajo manj kot 62,5 kg. Bolniki, ki prejemajo zdravilo Benepali, morajo prejeti posebno opozorilno kartico s povzetkom informacij o varnosti zdravila, tako da lahko prepoznajo morebitne resne neželene učinke in vedo, kdaj naj poiščejo nujno zdravniško pomoč.
English: How does Benepali work?
Slovenian: Kako zdravilo Benepali deluje?
English: A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.
Slovenian: Opravljena je bila študija, ki je pokazala, da je količina zdravilne učinkovine v telesu pri zdravilu Benepali podobna kot pri zdravilu Enbrel.
English: The European Commission issued a decision on:
Slovenian: Evropska komisija je izdala odločbo o:
English: (high blood pressure) and heart failure (when the heart does not work as well as it should);
Slovenian: (visokega krvnega tlaka) in srčnega popuščanja (ko srce ne deluje tako dobro, kot bi moralo);
English: Outcome of four procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended
Slovenian: Izid štirih postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena1
English: 20 February 2013 EMA/796016/2012 rev.1
Slovenian: 20. februar 2013 EMA/796016/2012 rev.1
English: Why were these medicines reviewed?
Slovenian: Zakaj je bil za ta zdravila opravljen pregled?
English: Hence, the results of the studies concerned could not be considered reliable.
Slovenian: Zato rezultatov zadevnih študij ni mogoče upoštevati kot zanesljivih.
English: The CHMP confirmed its previous conclusions on these medicines.
Slovenian: Odbor CHMP je potrdil svoje prejšnje zaključke glede teh zdravil.
English: More information on these medicines can be found on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Več informacij o teh zdravilih je na voljo na spletni strani Evropske agencije za zdravila (EMA): ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Which medicines are affected by the Agency's review?
Slovenian: Na katera zdravila vpliva pregled, ki ga je izvedla agencija?
English: For more information, see: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
Slovenian: Za dodatne informacije glejte: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
English: The CHMP also requested the companies to provide any additional relevant data, which had not been submitted as part of the initial applications.
Slovenian: Družbe je tudi zaprosil, naj predložijo morebitne dodatne pomembne podatke, ki niso bili predloženi kot del prvotnih vlog.
English: • Patients and prescribers should note that there are no safety concerns with any of these medicines currently on the market.
Slovenian: • Bolniki in zdravniki, ki zdravila predpisujejo, naj upoštevajo, da za nobeno od teh zdravil, ki so trenutno na tržišču, ni varnostnih zadržkov.
English: Consequently, the European Commission asked the CHMP to assess whether the identified issues have an impact on the benefit-risk balance of the centrally authorised medicines concerned, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Posledično je Evropska komisija zaprosila odbor CHMP, naj oceni, ali opredeljene težave vplivajo na razmerje med tveganji in koristmi zadevnih centralno odobrenih zdravil, in naj izda mnenje o tem, ali je treba dovoljenja za promet s temi zdravili v EU ohraniti, spremeniti, začasno umakniti ali preklicati.
English: The Committee considered the importance of the data from these studies in the context of the overall data submitted in the applications.
Slovenian: Odbor je upošteval pomen podatkov iz teh študij v okviru skupnih podatkov, predloženih v vlogah.
English: This review was initiated by the European Commission for the centrally authorised medicines and by the UK Medicines Regulatory Agency for the nationally authorised medicines.
Slovenian: Ta pregled sta začeli Evropska komisija za centralno odobrena zdravila in regulativna agencija za zdravila iz Združenega kraljestva za nacionalno odobrena zdravila.
English: One of the studies is a ‘pharmacokinetic' study in children, whose results are included in the product information.
Slovenian: Ena od študij je farmakokinetična študija pri otrocih, katere rezultati so vključeni v informacije o zdravilu.
English: However, as Tygacil is not approved for use in this population, no specific action was considered necessary.
Slovenian: Ker pa zdravilo Tygacil ni odobreno za uporabo pri tej populaciji, je bilo sklenjeno, da posebni ukrepi niso potrebni.
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013
Slovenian: • Fenofibrato Pensa in Fenofibrato Ranbaxy: 20. februarja 2013
English: In addition, the UK Medicines Regulatory Agency requested the CHMP to carry out the same assessment for the concerned nationally authorised medicines.
Slovenian: Poleg tega je regulativna agencija za zdravila iz Združenega kraljestva odbor CHMP zaprosila, naj enako oceno izvede za zadevna nacionalno odobrena zdravila.
English: In July 2012, the CHMP had concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.3
Slovenian: Odbor CHMP je julija 2012 opravil podoben pregled za tri druga zadevna centralno odobrena zdravila: Conbriza, PecFent in Torisel.3
English: At the request of the company that markets Fenofibrato Pensa and Fenofibrato Ranbaxy, the CHMP reexamined the initial opinion for these medicines, and confirmed its previous recommendation on 13 December 2012.
Slovenian: Na zahtevo družbe, ki trži zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy, je Odbor ponovno proučil prvotno mnenje glede teh zdravil in 13. decembra 2012 potrdil svoje prejšnje priporočilo.
English: The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil.
Slovenian: Odbor je ugotovil, da študije, opravljene v tej ustanovi, ne podpirajo nobene indikacije ali priporočila za predpisovanje zdravila Tygacil.
English: During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination.
Slovenian: Med postopkom ponovnega pregleda za zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy je družba predložila nove podatke, kar v okviru ponovnega pregleda ni dovoljeno.
English: The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA.
Slovenian: Vse zadevne študije so bile opravljene v ustanovi Cetero Research v Houstonu, v ameriški državi Teksas.
English: • Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available.
Slovenian: • Bolniki, ki jemljejo katero koli od generičnih zdravil, ki so bila začasno umaknjena, bi morali vedeti,
English: Although the Committee noted that no problems have been identified with the products currently on the market, bioequivalence studies are a mandatory part of the marketing authorisation application for generic medicines.
Slovenian: Čeprav je Odbor ugotovil, da v zvezi z zdravili, ki so trenutno na tržišču, ni nobenih poročil o težavah, so študije biološke enakovrednosti obvezen del vloge za pridobitev dovoljenja za promet z generičnimi zdravili.
English: Nevertheless the CHMP requested the company to update the product information with revised data.
Slovenian: Kljub temu pa je odbor CHMP družbo zaprosil, naj informacije o zdravilu dopolni s pregledanimi in popravljenimi podatki.
English: On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications.
Slovenian: Evropska agencija za zdravila je 20. septembra 2012 zaključila pregled devetih centralno in nacionalno odobrenih zdravil2 po izraženih zadržkih glede izvedbe laboratorijskih analiz pri nekaterih študijah, ki so bile predložene kot del vlog za pridobitev dovoljenj za promet s temi zdravili.
English: In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.
Slovenian: Odbor je julija 2012 že opravil podoben pregled treh drugih zdravil (Conbriza, PecFent in Torisel) ter zaključil, da ni vpliva na razmerje med tveganji in koristmi teh zdravil ter da naj se dovoljenje za promet s temi zdravili ohrani.
English: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.
Slovenian: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva in Ribavirin Teva Pharma B.V.
English: The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010.
Slovenian: Evropska agencija za zdravila je bila obveščena, da so bili med nedavnimi inšpekcijskimi pregledi v ustanovi Cetero Research v Teksasu, ki jih je opravil ameriški urad za hrano in zdravila (FDA), izpostavljeni pomisleki glede tega, kako so bile v obdobju od aprila 2005 do junija 2010 v tej ustanovi izvedene laboratorijske analize nekaterih študij, t. i. „bioanalitičnih“ študij.
English: For Temodal and Tygacil the findings have no impact on the benefit-risk balance of these medicines and no further action is needed.
Slovenian: Za zdravili Temodal in Tygacil te ugotovitve ne vplivajo na njuno razmerje med tveganji in koristmi, zato nadaljnji ukrepi niso potrebni.
English: • Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
Slovenian: 1 Številke postopka: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.