FrancophonIA/ELRC3.0 huggingface dataset:
English: • producing more tears, tear duct problems, inflamed eye (conjunctivitis)
Slovenian: omotica ali občutek tesnobe, močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis), zvonjenje v ušesih, bolečine v ušesu,
English: Radiographic response Structural joint damage was assessed radiographically and expressed as change in modified
Slovenian: Radiološka ocena Strukturno okvaro sklepov so ocenili radiološko in jo izrazili kot spremembo ocene po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
English: 3infusion-related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Slovenian: 3reakcije, povezane z infuzijo (hipertenzija, navzea, kožni izpuščaj, pireksija,
English: Please talk to your doctor or nurse if you have any questions about the information in this card.
Slovenian: Če imate kakršna koli vprašanja o tej kartici, se posvetujte z zdravnikom ali medicinsko sestro.
English: This is a type of protein called a “monoclonal antibody”.
Slovenian: Zdravilo Ritemvia vsebuje učinkovino rituksimab, ki je vrsta beljkovine, imenovana monoklonsko protitelo.
English: Adverse drug reaction1
Slovenian: Neželeni učinek1
English: (n=268) or R-FCM (n=44), according to the investigators' choice.
Slovenian: R-FC (n = 408) Vrednost p v testu log-rang
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: LogRank p
Slovenian: Vrednost p v testu lograng
English: Muscle spasms Arthralgia
Slovenian: hipoksija intersticijska bolezen pljuč7
English: Bronchitis Rhinitis
Slovenian: Bolezni prebavil driska
English: Please see cytokine release syndrome above for severe reactions.
Slovenian: V zvezi s hudimi neželenimi učinki glejte zgornji opis sindroma sproščanja citokinov.
English: Similarly, in all studies a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Slovenian: Podobno je v vseh študijah dober do zmeren odziv po klasifikaciji Evropske lige za boj proti revmatizmu (EULAR, European League Against Rheumatism)
English: The European Commission issued a decision on 17 February 2012.
Slovenian: Evropska komisija je odločbo izdala dne 17. februarja 2012.
English: 17 February 2012
Slovenian: 17. februar 2012
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Slovenian: Rezultat postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
English: At the time of the review, pholcodine-containing medicines had been withdrawn from the markets in Sweden (in the 1980s) and Norway (in 2007).
Slovenian: V času pregleda so zdravila, ki vsebujejo folkodin, umaknili s trga na Švedskem (v osemdesetih letih prejšnjega stoletja) in Norveškem (leta 2007).
English: Pholcodine-containing medicines are currently approved in the EU in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and the United Kingdom, either subject to medical prescription or as over-the-counter medicines.
Slovenian: Zdravila, ki vsebujejo folkodin, so trenutno odobrena v EU v Belgiji, Franciji, na Irskem, v Litvi, Luksemburgu, na Malti, v Sloveniji, Španiji in Združenem kraljestvu, kjer so bodisi na recept ali v prosti prodaji.
English: A group of experts in immunology and anaesthesia was also convened to provide advice.
Slovenian: Za nasvet je zaprosil tudi skupino strokovnjakov za imunologijo in anestezijo.
English: Therefore, it recommended that all marketing authorisations for medicines containing pholcodine should be maintained throughout the European Union (EU).
Slovenian: Zato je priporočil, da se v vsej Evropski uniji (EU) ohranijo vsa dovoljenja za promet z zdravili, ki vsebujejo folkodin.
English: Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults.
Slovenian: Folkodin je opioidno zdravilo, ki se uporablja za zdravljenje neproduktivnega (suhega) kašlja pri otrocih in odraslih.
English: To assess its safety, the Committee reviewed the results from preclinical and clinical studies, postmarketing data, epidemiological studies and data from the published literature.
Slovenian: Za oceno varnosti je Odbor pregledal rezultate predkliničnih in kliničnih študij, podatke iz obdobja trženja, epidemiološke študije in podatke iz objavljene literature.
English: Why was pholcodine reviewed?
Slovenian: Zakaj je bil folkodin pregledan?
English: They may be available as syrups, oral solutions, suppositories, tablets and capsules under various trade names and as generics.
Slovenian: Kot sirupi, peroralne raztopine, svečke, tablete in kapsule so na voljo pod različnimi tržnimi imeni in kot generična zdravila.
English: • Patients and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough.
Slovenian: • Bolnike in zdravstvene delavce je treba opomniti, da koristi uporabe folkodina še naprej odtehtajo tveganja pri zdravljenju neproduktivnega kašlja.
English: What is pholcodine?
Slovenian: Kaj je folkodin?
English: It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
Slovenian: Deluje neposredno v možganih, kjer zavre refleks kašlja z zmanjšanjem živčnih signalov, ki se pošiljajo mišicam, ki sodelujejo pri kašlju.
English: Cross-sensitisation has also been observed in countries where pholcodine is not on the market, suggesting that other substances may also trigger cross-sensitisation and that the observed changes in reporting rates may be explained by other factors.
Slovenian: Križno senzibilizacijo so opazili tudi v državah, v katerih folkodina ni na trgu, kar kaže na to, da lahko križno senzibilizacijo sprožijo tudi druge snovi in da je mogoče opažene spremembe v stopnjah poročanja razložiti z drugimi dejavniki.
English: No new risks have been identified with pholcodine.
Slovenian: Novih tveganj zaradi uporabe folkodina niso opredelili.
English: Pholcodine has been used as a cough suppressant since the 1950s.
Slovenian: Folkodin se uporablja kot zdravilo za pomirjanje kašlja od petdesetih let prejšnjega stoletja.
English: Consequently, the French medicines regulatory agency changed the prescription status for these medicines in France from over-the-counter to prescription-only, and asked the CHMP to carry out a full assessment of the benefit-risk balance of pholcodine and to issue an opinion on whether the marketing authorisations for pholcodine-containing products should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Posledično je francoska regulativna agencija za zdravila spremenila status predpisovanja za ta zdravila v Franciji iz zdravil, na voljo brez recepta, na zdravila na zdravniški recept, in zaprosila CHMP, da opravi popolno oceno razmerja med tveganji in koristmi za folkodin ter izda mnenje, ali naj se dovoljenje za promet z zdravili, ki vsebujejo folkodin, v EU ohrani, spremeni, začasno odvzame ali umakne.
English: Regarding pholcodine's benefits, the CHMP noted that there is a large body of data demonstrating the effectiveness of opioids in the management of non-productive cough and that pholcodine has been in use for several decades.
Slovenian: V zvezi s koristmi folkodina je CHMP navedel, da obstajajo številni podatki, ki dokazujejo učinkovitost opioidov pri obvladovanju neproduktivnega kašlja, in da se folkodin uporablja že več desetletij.
English: NMBAs are used in emergency hospital procedures to prevent spontaneous muscle movements during surgery.
Slovenian: Blokatorji živčnomišičnega prenosa se uporabljajo v urgentnih bolnišničnih postopkih za preprečevanje spontanih mišičnih gibov med operacijo.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of pholcodine-containing medicines continue to outweigh their risks, and therefore recommended that all marketing authorisations for these medicines should be maintained.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo folkodin, še naprej odtehtajo tveganja, in zato priporočil, da se vsa dovoljenja za promet s temi zdravili ohranijo.
English: The CHMP considered that, although this is biologically plausible, the available data are weak and not fully consistent.
Slovenian: Čeprav je to biološko verjetno, CHMP meni, da so razpoložljivi podatki neprepričljivi in ne povsem dosledni.
English: In 2009, a study was published indicating that the reduction in pholcodine consumption in these countries was associated with a decrease in reports of anaphylactic reactions to neuromuscular blocking agents (NMBAs).
Slovenian: Leta 2009 je bila objavljena študija, ki nakazuje, da je bilo zmanjšanje porabe folkodina v teh državah povezano z manjšim številom poročil o anafilaktičnih reakcijah na blokatorje živčnomišičnega prenosa.
English: Further publications in 2010 and 2011 from the same authors supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA.
Slovenian: Nadaljnje objave istih avtorjev iz let 2010 in 2011 so podprle hipotezo, da lahko uporaba folkodina poveča verjetnost anafilaktične reakcije pri bolnikih, izpostavljenih blokatorjem živčnomišičnega prenosa.
English: The CHMP reviewed all the available data on the effects of pholcodine as a cough suppressant.
Slovenian: CHMP je pregledal vse razpoložljive podatke o učinkih folkodina kot sredstva za pomirjanje kašlja.
English: The Committee noted that the study in Sweden and Norway looked at changes in reporting rates of adverse reactions to NMBAs following the withdrawal of these medicines, without convincingly establishing a causal link with pholcodine use.
Slovenian: Odbor je opozoril, da obravnavajo študije na Švedskem in Norveškem spremembe v stopnji poročanja neželenih učinkov na blokatorje živčnomišičnega prenosa po ukinitvi uporabe teh zdravil, vendar prepričljive vzročne zveze z uporabo folkodina ne vzpostavijo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the existing evidence of the risk is weak, and that the benefits of pholcodine continue to outweigh its risks.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so obstoječi dokazi o tveganju neprepričljivi in da koristi uporabe folkodina še naprej odtehtajo njegova tveganja.
English: Regarding pholcodine's safety, the majority of adverse effects reported with pholcodine are those commonly seen with opioid medicines.
Slovenian: V zvezi z varnostjo folkodina je večina neželenih učinkov, o katerih poročajo pri uporabi folkodina, enaka kot pri drugih opioidnih zdravilih.
English: The European Medicines Agency has completed a review of the safety and effectiveness of pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery.
Slovenian: Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti folkodina, saj je bila izražena skrb, da se lahko zaradi njegove uporabe pri bolnikih pojavi tveganje za razvoj anafilaktičnih (hudih alergijskih) reakcij na blokatorje živčnomišičnega prenosa, ki se uporabljajo med operacijami.
English: from spontaneous reports also suggested a 25% increase in anaphylactic reactions to NMBAs coinciding with a 9% increase in pholcodine use.
Slovenian: Franciji podatki iz spontanih poročil kažejo na 25-odstotno povečanje anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa, kar sovpada z 9-odstotnim povečanjem uporabe folkodina.
English: Therefore, the CHMP concluded that the existing evidence does not support the conclusion that the use of pholcodine-containing medicines presents a risk of developing anaphylactic reactions to NMBAs.
Slovenian: Zato je CHMP zaključil, da obstoječi dokazi ne podpirajo sklepa, da predstavlja uporaba zdravil, ki vsebujejo folkodin, tveganje za razvoj anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa.
English: The hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (‘crosssensitisation').
Slovenian: Hipoteza, da lahko uporaba folkodina sproži anafilaktične reakcije na blokatorje živčnomišičnega prenosa, temelji na tem, da v telesu nastajajo protitelesa proti folkodinu, ki sčasoma sprožijo reakcijo na blokatorje živčnomišičnega prenosa („križna senzibilizacija“).
English: The Committee nevertheless recommended that a new post-marketing study investigating the possibility of an association between pholcodine and anaphylactic reactions to NMBAs should be carried out.
Slovenian: Odbor je kljub temu priporočil izvedbo nove študije v obdobju trženja, ki naj prouči možno povezavo med folkodinom in anafilaktičnimi reakcijami na blokatorje živčnomišičnega prenosa.
English: • Patients taking pholcodine-containing medicines can continue to do so, and should contact their doctor or pharmacist if they have any questions about their treatment.
Slovenian: Če imajo kakršna koli vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
English: In France, data
Slovenian: V
English: Overall Survival was the key secondary study endpoint.
Slovenian: Celokupno preživetje je bil ključni sekundarni cilj študije.
English: Take the medicine pack with you.
Slovenian: Škatlo zdravila vzemite s seboj.
English: • you have ever had blood clots in the past.
Slovenian: • ste kadar koli v preteklosti imeli krvne strdke.
English: Carcinogenicity studies have not been conducted.
Slovenian: Študij kancerogenosti niso izvajali.
English: 31 August 2023
Slovenian: 31. avgust 2023
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Slovenian: Nacionalno nadzorovani sistem razdeljevanja je bil uveden v sodelovanju z vsakim pristojnim nacionalnim organom.
English: When this happens, it is called ‘response'.
Slovenian: Pojav takega stanja se imenuje "odziv".
English: However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time.
Slovenian: Vendar lahko zdravljenje zmanjša znake in simptome bolezni ali povzroči, da za nekaj časa izginejo.
English: CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O ODSTOPANJU ZAHTEVKU ZA ENOLETNO TRŽNO ZAŠČITO KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: Children and adolescents Imnovid is not recommended for use in children and young people under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Imnovid ni priporočeno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
English: Overall Survival: ITT Population
Slovenian: Celokupno preživetje: populacija ITT
English: Final clinical study report:
Slovenian: Končno poročilo o klinični študiji:
English: Day (of 21-day cycle)
Slovenian: Dan (21-dnevnega cikla)
English: See also section 4 “Possible side effects”).
Slovenian: Glejte tudi poglavje 4 "Možni neželeni učinki").
English: Your partner should also tell her doctor straight away.
Slovenian: Tudi vaša partnerica mora o tem takoj obvestiti svojega zdravnika.
English: Patients should be advised to report febrile episodes promptly.
Slovenian: Bolnikom je treba svetovati, da o febrilnih epizodah poročajo takoj.
English: Allergic reactions and severe skin reactions
Slovenian: Alergijske reakcije in hude kožne reakcije
English: If this happens to you, do not drive or operate tools or machinery.
Slovenian: Če se vam to zgodi, ne vozite avtomobila in ne upravljajte orodja ali strojev.
English: Blood donation and blood tests
Slovenian: Darovanje krvi in krvne preiskave
English: WARNING: Risk of severe birth defects.
Slovenian: OPOZORILO: Tveganje hudih prirojenih okvar.
English: *In case of neutropenia, the physician should consider the use of growth factors.
Slovenian: *V primeru nevtropenije naj zdravnik razmisli o uporabi rastnih faktorjev.
English: Pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks.
Slovenian: Pomalidomid smemo spet začeti dajati šele po temeljiti oceni koristi in tveganj.
English: • Increased blood pressure.
Slovenian: • zvišan krvni tlak,
English: Based on these results, the observed effects were attributed to the treatment of females.
Slovenian: Na podlagi teh rezultatov so opazovane učinke pripisali zdravljenju samic.
English: Patients may require use of blood product support and /or growth factors.
Slovenian: Bolniki bodo morda potrebovali podporo v obliki krvnih izdelkov in/ali rastnih faktorjev.
English: The systemic exposure (AUC) of pomalidomide increases in an approximately linear and dose proportional manner.
Slovenian: Sistemska izpostavljenost (AUC) pomalidomidu se zvišuje približno linearno in sorazmerno z odmerkom.
English: These patients should be monitored closely and appropriate precautions taken.
Slovenian: Te bolnike je treba skrbno spremljati in ustrezno ukrepati.
English: Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable.
Slovenian: Opomba: IZ = interval zaupanja; IRAC = Neodvisni presojevalni odbor (Independent Review Adjudication Committee); NE = ni mogoče oceniti.
English: Your doctor should check whether you have ever had hepatitis B infection.
Slovenian: Vaš zdravnik mora preveri, ali ste kadar koli prej imeli okužbo s hepatitisom B.
English: You may feel tired and weak, and short of breath and you are also more likely to get infections.
Slovenian: Mogoče boste utrujeni in šibki in boste imeli kratko sapo in boste bolj dovzetni tudi za okužbe,
English: • You must follow the contraception advice described in this leaflet.
Slovenian: Upoštevati morate nasvete o kontracepciji, opisane v tem navodilu.
English: Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected.
Slovenian: Pomalidomida se ne sme jemati med nosečnostjo, ker se pričakuje teratogeni učinek.
English: System Organ Class/ Preferred Term
Slovenian: Organski sistem/preferenčni izraz
English: Treatment continued until patients had disease progression.
Slovenian: Zdravljenje se je nadaljevalo do napredovanja bolezni.
English: Each cycle lasts 28 days (4 weeks).
Slovenian: Vsak cikel traja 28 dni (4 tedne).
English: In case of permanent discontinuation of any component of the treatment regimen, continuation of the remaining medicinal products is at the physician's discretion.
Slovenian: V primeru trajne ukinitve katere koli sestavine režima zdravljenja je nadaljnje dajanje preostalih zdravil prepuščeno zdravnikovi presoji.
English: • A spinning feeling in your head, making it difficult to stand up and move normally.
Slovenian: • občutek vrtenja v glavi, zaradi katerega težko stojite in se normalno premikate,
English: Based on Cox proportional hazards model.
Slovenian: Na podlagi Coxovega modela proporcionalnih tveganj.
English: The capsules should not be opened, broken or chewed (see section 6.6).
Slovenian: Kapsul ni dovoljeno odpirati, zdrobiti ali žvečiti (glejte poglavje 6.6).
English: Imnovid hard capsules should be taken orally at the same time each day.
Slovenian: Zdravilo Imnovid trde kapsule je treba jemati peroralno vsak dan ob istem času.
English: • if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na pomalidomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In the event of overdose, supportive care is advised.
Slovenian: V primeru prevelikega odmerka se svetuje podporna nega.
English: The PFS advantage was more pronounced in patients who received only one prior line of therapy.
Slovenian: Korist za PFS je bila izrazitejša pri bolnikih, ki so prejeli samo eno vrsto predhodnega zdravljenja.
English: Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.
Slovenian: Pred začetkom zdravljenja povejte zdravniku, da lahko zanosite, tudi če mislite, da to ni verjetno.
English: Pomalidomide has minor or moderate influence on the ability to drive and use machines.
Slovenian: Pomalidomid ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body's natural defences).
Slovenian: To zdravilo je sorodno talidomidu in spada v skupino zdravil, ki vplivajo na delovanje imunskega sistema (naravna obramba telesa).
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for both treatment groups.
Slovenian: Ne glede na ocenjene podskupine je bila PFS na splošno v skladu z opazovano v populaciji ITT za obe skupini zdravljenja.
English: A decision to take prophylactic measures should be made after a careful assessment of the individual patient's underlying risk factors.
Slovenian: Odločitev o uporabi profilaktičnih ukrepov je treba sprejeti po skrbni oceni obstoječih dejavnikov tveganja pri posameznem bolniku.
English: • Guidance on handling pomalidomide for patients, caregivers and family members
Slovenian: • smernice za ravnanje z pomalidomidom za bolnike, skrbnike in družinske člane;
English: If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
Slovenian: Če se neželeni učinki pojavijo po znižanju odmerka na 1 mg, je treba zdravilo ukiniti.
English: In these studies, monkeys exhibited greater sensitivity to pomalidomide effects than rats.
Slovenian: V teh študijah so bile opice bolj občutljive na učinke pomalidomida kot podgane.
English: • After completing each 3-week cycle, start a new one.
Slovenian: • Po dokončanju vsakega 3-tedenskega cikla začnite z novim.
English: The difference in OS between the two treatment arms was statistically significant (p < 0.001).
Slovenian: Razlika v celokupnem preživetju med obema skupinama zdravljenja je bila statistično značilna (p < 0,001).
English: Staphylococcal infection was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without treatment.
Slovenian: Stafilokokno okužbo so opazili pri 4 opicah; 3 med njimi so se odzvale na zdravljenje z antibiotikom, 1 pa je umrla brez zdravljenja.
English: Neutropenia did not lead to pomalidomide discontinuation in any patient and was infrequently serious.
Slovenian: Nevtropenija ni povzročila ukinitve pomalidomida pri nobenem bolniku in je bila redko resna.
English: Dizziness and confusion
Slovenian: Omotičnost in zmedenost
English: Do not use while pregnant or breast-feeding.
Slovenian: Ne uporabljajte med nosečnostjo ali dojenjem.
English: If you forget to take Imnovid on a day when you should, take your next capsule as normal the next day.
Slovenian: Če ste pozabili vzeti zdravilo Imnovid na tisti dan, ko bi morali, vzemite naslednjo kapsulo naslednji dan kot običajno.
English: • You can take the capsules either with or without food.
Slovenian: • Kapsule se lahko jemljejo s hrano ali brez nje.
English: Each cycle lasts 21 days (3 weeks).
Slovenian: Vsak cikel traja 21 dni (3 tedne).
English: • Take Imnovid at about the same time each day.
Slovenian: • Zdravilo Imnovid jemljite vsak dan približno ob istem času.