FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - alergijske reakcije (preobčutljivost) - alergijska reakcija z izpuščajem, otekanjem obraza, s težavnim dihanjem (bronhialni krč) ali z anafilaktičnim šokom - medikamentna reakcija s sistemskimi simptomi (medikamentna reakcija z eozinofilijo in sistemskimi simptomi) - nenadno in hudo vnetje jeter (fulminantni hepatitis) - hudi in življenjsko nevarni kožni izpuščaji (Stevens Johnsonov sindrom/toksična epidermalna nekroliza) - zmanjšanje števila rdečih krvničk (anemija)
English: Raltegravir and Viramune can be coadministered without dose adjustments.
Slovenian: Raltegravir in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: It is not recommended to coadminister fosamprenavir and Viramune if fosamprenavir is not coadministered with ritonavir (see section 4.4).
Slovenian: Če fosamprenavirja ne dajemo hkrati z ritonavirjem, sočasne uporabe fosamprenavirja in zdravila Viramune ne priporočamo (glejte poglavje 4.4).
English: Telbivudine and Viramune may be coadministered without dose adjustments.
Slovenian: Telbivudin in Viramune lahko dajemo sočasno, brez prilagajanja odmerkov.
English: Saquinavir/ritonavir and Viramune can be co-administered without dose adjustments.
Slovenian: Sakvinavir z ritonavirjem in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/055/002
English: Common (may affect up to 1 in 10 people): - rash - fever - headache - abdominal pain - feeling sick (nausea) - loose stools (diarrhoea) - feeling tired (fatigue)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - izpuščaj - povišana telesna temperatura - glavobol - trebušna bolečina - siljenje na bruhanje (navzea) - mehko blato (driska) - utrujenost.
English: Approximately half of the patients had at least 3 years of prior exposure to Viramune immediate-release prior to entering study
Slovenian: Približno polovica bolnikov je pred sprejemom v študijo 1100.1526 že najmanj 3 leta prejemala zdravilo Viramune.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/055/004
English: Lopinavir/ritonavir (capsules) 400/100 mg BID
Slovenian: Lopinavir/ritonavir (kapsule)
English: Adefovir and Viramune may be coadministered without dose adjustments.
Slovenian: Adefovir in Viramune lahko dajemo sočasno, brez prilagajanja odmerkov.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 100 mg of nevirapine (as anhydrous)
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s podaljšanim sproščanjem vsebuje 100 mg nevirapina (v brezvodni obliki).
English: Liver test monitoring should be performed if the patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity.
Slovenian: Če se pri bolniku pojavijo znaki ali simptomi, ki kažejo na hepatitis ali preobčutljivost ali oboje, moramo pregledati delovanje jeter.
English: Paediatric patients:
Slovenian: Pakiranja za vzdrževalno zdravljenje:
English: Compounds using this metabolic pathway may have decreased plasma concentrations when coadministered with nevirapine.
Slovenian: Pri sočasnem dajanju z nevirapinom se lahko v plazmi zmanjša koncentracija spojin z isto potjo presnavljanja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/97/055/007
English: Didanosine and Viramune can be coadministered without dose adjustments.
Slovenian: Didanozin in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Slovenian: Poročajo o primerih Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize in reakcije na zdravilo z eozinofijo in sistemskimi simptomi s smrtnim izidom.
English: Fluconazole AUC  0.94 (0.88
Slovenian: AUC klaritromicina  0,69 (0,62
English: Lamivudine and Viramune can be coadministered without dose adjustments.
Slovenian: Lamivudin in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: Investigations
Slovenian: vrednostmi
English: You should stop breast-feeding if you are taking Viramune.
Slovenian: Če jemljete tablete Viramune, morate dojenje prekiniti.
English: Stavudine and Viramune can be coadministered without dose adjustments.
Slovenian: Stavudin in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: Cimetidine and Viramune can be coadministered without dose adjustments.
Slovenian: Cimetidin in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: - if you have taken Viramune before and had to stop the treatment because you suffered from: - severe skin rash - skin rash with other symptoms for example: - fever - blistering - mouth sores - inflammation of the eye - swelling of the face
Slovenian: Ne jemljite zdravila Viramune: - če ste alergični na nevirapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če ste že prej jemali zdravilo Viramune in ste morali zdravljenje prekiniti, ker ste dobili: - hud kožni izpuščaj - kožni izpuščaj in druge simptome, na primer: - vročino - mehurje - bolečine v ustih - očesno vnetje
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 400 mg of nevirapine (as anhydrous)
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s podaljšanim sproščanjem vsebuje 400 mg nevirapina (v brezvodni obliki).
English: In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Slovenian: Farmakokinetično študijo z enkratnim 200 mg odmerkom nevirapina so izvedli pri bolnikih z negativnim izvidom za HIV in z blago ali zmerno jetrno okvaro (Child-Pugh A, n = 6; Child-Pugh B, n = 4).
English: Rapid emergence of HIV-strains which are cross-resistant to NNRTIs has been observed in vitro.
Slovenian: In vitro so ugotovili hiter pojav sevov HIV, ki so navzkrižno odporni proti nenukleozidnim zaviralcem reverzne transkriptaze.
English: The medicinal product should be used within 6 months of opening.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika je 6 mesecev.
English: These adverse reactions are commonly associated with other antiretroviral agents and may be expected to occur when nevirapine is used in combination with other agents; however it is unlikely that these adverse reactions are due to nevirapine treatment.
Slovenian: Običajno so bili povezani z drugimi protiretrovirusnimi zdravili in se lahko pojavijo, če uporabljamo nevirapin v kombinaciji z drugimi zdravili.
English: Maraviroc and Viramune can be coadministered without dose adjustments.
Slovenian: Maravirok in zdravilo Viramune lahko dajemo sočadno brez prilagajanja odmerkov.
English: Darunavir and Viramune can be coadministered without dose adjustments.
Slovenian: Darunavir in zdravilo Viramune lahko dajemo sočasno brez prilagajanja odmerkov.
English: Dose management considerations
Slovenian: v primerjavi s prejšnjimi, kontrolnimi vrednostmi
English: 24 July 2014 EMA/444346/2014
Slovenian: 24. julij 2014 EMA/444346/2014
English: Oral solutions have been authorised in Denmark, Finland, Malta, Norway, Sweden and the United Kingdom; oral tablets have been authorised in Denmark, Finland, Hungary, Iceland, Norway, Romania, Spain and Sweden.
Slovenian: Peroralne raztopine so bile odobrene na Danskem, Finskem, Malti, Norveškem, Švedskem in v Združenem kraljestvu; peroralne tablete so bile odobrene na Danskem, Finskem, Madžarskem, Islandiji, Norveškem, v Romuniji, Španiji in na Švedskem.
English: • Patients who have questions or concerns should consult their doctor or another healthcare professional.
Slovenian: • Bolniki, ki imajo vprašanja ali pomisleke, naj se posvetujejo z zdravnikom ali drugim zdravstvenim delavcem.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: The review of oral methadone medicines containing povidone was initiated on 10 April 2014 under Article 107i of Directive 2001/83/EC, also known as the ‘urgent Union procedure'.
Slovenian: Pregled peroralnih zdravil, ki vsebujejo metadon in povidon, se je začel 10. aprila 2014 v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot „nujni postopek Unije“.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Slovenian: CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU).
English: Methadone is also used in the treatment of severe pain.
Slovenian: Metadon se uporablja tudi za zdravljenje hude bolečine.
English: Methadone is a synthetic opioid (a morphine-like substance).
Slovenian: Metadon je sintetični opioid (morfinu podobna snov).
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Slovenian: Tel.: +44 (0)20 7418 8427 E-pošta: 1
English: The efficacy of methadone in opioid substitution therapy was acknowledged and was not questioned in this review.
Slovenian: Učinkovitost metadona pri nadomestnem zdravljenju z opioidi je bila potrjena in v tem pregledu ni bila obravnavana.
English: Methadone medicines containing povidone have been authorised via national procedures in several European countries.
Slovenian: Zdravila, ki vsebujejo metadon in povidon, so bila po nacionalnih postopkih odobrena v več evropskih državah.
English: Treatment with methadone should be given in the context of a wider rehabilitation program.
Slovenian: Zdravljenje z metadonom se mora uvesti v okviru širšega programa za zdravljenje odvisnosti.
English: The PRAC recommendation was sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Priporočilo odbora PRAC je bilo posredovano Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
English: They will need to be appropriately reformulated before being reintroduced on the European market.
Slovenian: Preden bodo ponovno dana na evropski trg, jih bo treba ustrezno reformulirati.
English: Povidone is available in different molecular weights.
Slovenian: Povidon je na voljo v različnih relativnih molekulskih masah.
English: The above recommendations are based on available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone.
Slovenian: Zgoraj navedena priporočila temeljijo na razpoložljivih podatkih o varnosti, ki se nanašajo na tveganja, povezana z napačno uporabo zdravil, ki vsebujejo metadon in povidon, z injiciranjem.
English: Different types of povidone are available, which vary in their molecular weight (a measure of the size of the molecule).
Slovenian: Na voljo so različne vrste povidona, ki se razlikujejo po relativni molekulski masi (merilo za velikost molekule).
English: • Methadone tablets containing povidone of lower molecular weight can continue to be used, but patients are reminded that they should only be taken by mouth.
Slovenian: • Tablete metadona, ki vsebujejo povidon z manjšo relativno molekulsko maso, se lahko še naprej uporabljajo, vendar je treba bolnike opozoriti, da se lahko jemljejo samo skozi usta.
English: They will need to be reformulated before being reintroduced on the market.
Slovenian: Preden bodo ponovno dane na trg, jih bo treba reformulirati.
English: The PRAC assessed the available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone from post-marketing reports and the published literature, and a group of experts (which included pathologists and addiction experts) was consulted for advice.
Slovenian: Odbor PRAC je ocenil razpoložljive podatke o varnosti, ki se nanašajo na tveganja, povezana z napačno uporabo zdravil, ki vsebujejo metadon in povidon, z injiciranjem, iz poročil iz obdobja trženja in objavljene literature ter se posvetoval s skupino strokovnjakov (v kateri so bili tudi patologi in strokovnjaki za odvisnosti).
English: Because the CMDh reached an agreement by consensus, it will be implemented by the Member States where the medicines are authorised according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno dosegla sporazum, ga bodo izvajale države članice, v katerih so ta zdravila odobrena, v skladu z dogovorjenim časovnim razporedom.
English: Additionally, the CMDh agreed that methadone tablets that contain low molecular weight povidone should remain on the market with changes to the product information.
Slovenian: Poleg tega se je skupina CMDh strinjala, da morajo tablete metadona, ki vsebujejo povidon z majhno relativno molekulsko maso, ostati na trgu, vendar s spremenjenimi informacijami o zdravilu.
English: These products will remain suspended until they have been reformulated.
Slovenian: Zdravila bodo s trgov umaknjena, dokler ne bodo reformulirana.
English: • Some methadone oral solutions contain an additive, povidone.
Slovenian: • Nekatere peroralne raztopine metadona vsebujejo dodatek, imenovan povidon.
English: Methadone-containing medicines are used to treat drug addiction in patients dependent on opioids (such as heroin); methadone prevents or reduces opiate withdrawal symptoms.
Slovenian: Zdravila, ki vsebujejo metadon, se uporabljajo za zdravljenje odvisnosti od drog pri bolnikih, ki so odvisni od opioidov (kot je na primer heroin); metadon preprečuje ali zmanjša simptome odtegnitve opiatov.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented in all EU Member States where these medicines are marketed, according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej izvajale vse države članice EU, v katerih se tržijo ta zdravila, v skladu z dogovorjenim časovnim razporedom.
English: • While these medicines are suspended, healthcare professionals should switch their patients to alternative methadone products.
Slovenian: • V času, ko bodo ta zdravila začasno umaknjena s trga, morajo zdravstveni delavci bolnikom predpisati druga zdravila, ki vsebujejo metadon.
English: Methadone is used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids such as heroin.
Slovenian: Metadon se uporablja v programih za zdravljenje odvisnosti za preprečevanje ali zmanjšanje odtegnitvenih simptomov pri bolnikih, ki so odvisni od opioidov, kot je na primer heroin.
English: The PRAC concluded that risk minimisation measures would be insufficient to mitigate the risks with oral solutions containing high molecular weight povidone, and therefore recommended that these products should be suspended.
Slovenian: Odbor PRAC je zaključil, da ukrepi za zmanjšanje tveganja ne bi zadostovali za zmanjšanje tveganj, povezanih s peroralnimi raztopinami, ki vsebujejo povidon z veliko relativno molekulsko maso, in zato priporočil, da se ta zdravila začasno umaknejo s trga.
English: While these medicines are intended for oral use only, some patients may misuse oral methadone formulations by injecting them into a vein.
Slovenian: Zdravila so namenjena samo za peroralno uporabo, vendar lahko nekateri bolniki peroralne farmacevtske oblike metadona napačno uporabljajo, tako da jih injicirajo v veno.
English: • Methadone is used to treat drug addiction in patients depending on opioids (such as heroin).
Slovenian: • Metadon se uporablja za zdravljenje odvisnosti od drog pri bolnikih, ki so odvisni od opioidov (kot je na primer heroin).
English: The source of povidone could not be confirmed, but is likely to be methadone oral solution containing high molecular weight povidone following misuse by injection.
Slovenian: Vira povidona ni bilo mogoče potrditi, vendar je verjetno, da je bila to peroralna raztopina metadona, ki je vsebovala povidon z veliko relativno molekulsko maso in je bila napačno uporabljena z injiciranjem.
English: • Because of the potential harm that could derive from such a misuse (injection into a vein), methadone solutions containing povidone K90 will be suspended.
Slovenian: • Zaradi možnih okvar, ki jih lahko povzroči tovrstna napačna uporaba (injiciranje v veno), bodo raztopine metadona, ki vsebujejo povidon K90, začasno umaknjene s trga.
English: • Since no measures could be identified to minimise the potential harm with methadone oral solutions containing high molecular weight povidone, these solutions will be suspended.
Slovenian: • Ker ni bilo mogoče opredeliti nobenih ukrepov za zmanjšanje možnih okvar, povezanih s peroralnimi raztopinami metadona, ki vsebujejo povidon z veliko relativno molekulsko maso, bodo te raztopine začasno umaknjene s trga.
English: The safety of oral methadone medicines containing povidone was reviewed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
Slovenian: Varnost peroralnih zdravil, ki vsebujejo metadon in povidon, je ocenil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, potem ko so se na Norveškem pojavila poročila o resnih neželenih dogodkih pri nekdanjih ali trenutnih uporabnikih drog, zaradi česar so bile peroralne raztopine metadona, ki vsebujejo povidon K90, začasno umaknjene z norveškega trga.
English: Methadone tablets containing low molecular weight povidone remain on the market, but their product information will be amended to reinforce the recommendation that these medicines are for oral administration only and must not be used in any other way.
Slovenian: Tablete metadona, ki vsebujejo povidon z majhno relativno molekulsko maso, ostajajo na trgu, vendar bodo informacije o zdravilu za ta zdravila spremenjene tako, da se bo okrepilo opozorilo, da so ta zdravila namenjena samo za peroralno uporabo in se ne smejo uporabljati na noben drug način.
English: • Some oral methadone solutions contain high molecular weight povidone (K90), which can be harmful if injected as it is retained in the body and may cause tissue damage.
Slovenian: • Nekatere peroralne raztopine metadona vsebujejo povidon z veliko relativno molekulsko maso (K90), ki je lahko škodljiv, če se injicira, saj se ohrani v telesu in lahko povzroči poškodbe tkiv.
English: • Patients taking methadone oral solutions with povidone K90 as part of their rehabilitation program will be switched to other methadone medicines, which do not pose the same risk of povidone accumulating inside vital organs.
Slovenian: • Bolnikom, ki uporabljajo peroralne raztopine metadona, ki vsebujejo povidon K90, v okviru programa za zdravljenje odvisnosti, bodo predpisana druga zdravila, ki vsebujejo metadon in ne predstavljajo tveganja, da bi se povidon kopičil v vitalnih organih.
English: Oral methadone medicines are available as solutions or tablets, and should only be taken by mouth.
Slovenian: Peroralna zdravila, ki vsebujejo metadon, so na voljo v obliki raztopin ali tablet in se lahko jemljejo samo skozi usta.
English: Povidone is used in oral solutions as a suspending and dispersing agent, or as a binding agent for tablets.
Slovenian: Povidon se v peroralnih raztopinah uporablja kot suspendirajoče sredstvo in dispergent, v tabletah pa kot vezivno sredstvo.
English: Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights.
Slovenian: Nekatere peroralne farmacevtske oblike metadona vsebujejo tudi dodatek povidon z različnimi relativnimi molekulskimi masami.
English: The povidone contained in oral methadone solutions has a high molecular weight (known as K90), while the povidone used in methadone tablets has a low molecular weight (e.g. K25 and K30).
Slovenian: Povidon, ki ga vsebujejo peroralne raztopine metadona, ima veliko relativno molekulsko maso (imenujemo ga K90), medtem ko ima povidon v tabletah metadona majhno relativno molekulsko maso (npr. K25 in K30).
English: For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does.
Slovenian: Za tablete metadona, ki vsebujejo povidon z manjšo relativno molekulsko maso (npr. K25 in K30), so razpoložljivi podatki pokazali, da se ta vrsta povidona izloči iz telesa in se v nasprotju s povidonom z veliko relativno molekulsko maso ne kopiči v celicah.
English: • The risk of harm is reduced with low molecular weight povidone since it is expected to be readily excreted and not to accumulate inside cells.
Slovenian: • Pri povidonu z majhno relativno molekulsko maso je tveganje za okvare manjše, saj naj bi se hitro izločil in naj se ne bi kopičil v celicah.
English: If methadone oral solutions containing high molecular weight povidone (K90) are misused by injection instead of being taken by mouth as they are intended, the povidone accumulates inside vital organs and may cause serious harm, with possible fatal consequences.
Slovenian: Če se peroralne raztopine metadona, ki vsebujejo povidon z veliko relativno molekulsko maso (K90), napačno uporabijo z injiciranjem, namesto da bi se dale skozi usta, kot je predvideno, se povidon kopiči v vitalnih organih in lahko povzroči resne okvare, ki imajo lahko usodne posledice.
English: Oral methadone medicines are available as solutions or tablets; only oral methadone products containing povidone were concerned by this review.
Slovenian: Peroralna zdravila, ki vsebujejo metadon, so na voljo v obliki raztopin ali tablet; v tem pregledu so bila obravnavana samo peroralna zdravila, ki vsebujejo metadon in povidon.
English: • Cases of povidone deposits and serious adverse reactions (e.g. anaemia and pathological fractures) have been reported in intravenous drug abusers.
Slovenian: • Pri uporabnikih intravenskih drog so poročali o primerih nalaganja povidona in resnih neželenih učinkih (npr. anemija in patološki zlomi).
English: market and changes will be made to the product information (SmPC and package leaflet) to reinforce the message that tablets are for oral administration only and must not be taken in any other way.
Slovenian: Ta zdravila bodo zato ostala na trgu, informacije o zdravilu (povzetek glavnih značilnosti zdravila in navodilo za uporabo) pa bodo spremenjene tako, da se bo okrepilo opozorilo, da so tablete namenjene samo za peroralno uporabo in se ne smejo dajati na noben drug način.
English: If a medicine containing high molecular weight povidone (known as K90) is misused in this way, the povidone is not excreted from the body and accumulates inside the cells of vital organs, which may cause serious harm.
Slovenian: Če se na ta način napačno uporabi zdravilo, ki vsebuje povidon z veliko relativno molekulsko maso (imenovan K90), se povidon ne izloči iz telesa, temveč se kopiči v celicah vitalnih organov, s čimer lahko povzroči resne okvare.