FrancophonIA/ELRC3.0 huggingface dataset:
English: Glimepiride inhibits the hepatic glucose production by increasing the intracellular concentration of fructose-2,6 bisphosphate, which in turn inhibits gluconeogenesis.
Slovenian: Glimepirid poveča znotrajcelično koncentracijo fruktoza-2,6-bisfosfata, ki zavira glukoneogenezo, in zato zavira nastajanje glukoze v jetrih.
English: Your doctor should regularly test your
Slovenian: Redno spremljajte svojo telesno maso.
English: The frequency of glimepiride adverse reactions identified from clinical trial and post
Slovenian: Pogostnost neželenih učinkov glimepirida na osnovi podatkov iz kliničnih preskušanj in podatkov po pridobitvi dovoljenja za promet
English: NAME OF THE MEDICINAL PRODUCT AVAGLIM 8 mg/4 mg film-coated tablets.
Slovenian: IME ZDRAVILA AVAGLIM 8 mg/4 mg filmsko obložene tablete
English: The improved glycaemic control is associated with reductions in both fasting and post
Slovenian: Boljšo urejenost glikemije spremlja znižanje glukoze na tešče in postprandialne glukoze.
English: Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e.g. fluconazole) or inducers (see section 4.5).
Slovenian: Rosiglitazon je treba uporabljati previdno med sočasnim zdravljenjem z zaviralci CYP2C8 (npr. gemfibrozilom) ali njegovimi induktorji (npr. rifampicinom), glimepirid pa med sočasnim zdravljenjem z zaviralci CYP2C9 (npr. flukonazolom) ali njegovimi induktorji (glejte poglavje 4.5).
English: NAME OF THE MEDICINAL PRODUCT AVAGLIM 4 mg/4 mg film-coated tablets.
Slovenian: IME ZDRAVILA AVAGLIM 4 mg/4 mg filmsko obložene tablete
English: These include: y taking other medicines to treat diabetes y stress situations (such as trauma, surgery or infections) Early symptoms of low blood sugar are:
Slovenian: Nizek krvni sladkor (hipoglikemija): Če jemljete zdravilo Avaglim, lahko pomenijo določeni pogoji večjo verjetnost za prekomerno zmanjšanje krvnega sladkorja, kot so: y jemanje drugih zdravil za zdravljenje sladkorne bolezni y stresne okoliščine (npr. poškodba, operacija ali okužba) Zgodnji simptomi nizkega krvnega sladkorja so:
English: CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: Podatki po pridobitvi dovoljenja za promet
English: A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Slovenian: Študija je pokazala, da je bila pri vseh bolnikih, ki so imeli očistek kreatinina manj kot 22 ml/min, koncentracija glukoze ustrezno urejena z odmerjanjem zgolj 1 mg na dan (glejte poglavji 4.2 in 4.4).
English: In the fed state, the rate and extent of absorption of the rosiglitazone-glimepiride 4 mg/4 mg combination were equivalent to concomitant administration of 4 mg rosiglitazone and 4 mg glimepiride.
Slovenian: Na poln želodec sta bila hitrost in obseg absorpcije kombinacije 4 mg/4 mg rosiglitazona in glimepirida enakovredna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
English: To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVAGLIM Pri zdravljenju sladkorne bolezni je pomembno, da natančno upoštevate vsa zdravnikova navodila, tako o dietni prehrani in življenjskem slogu kot jemanju zdravila Avaglim.
English: Pharmacotherapeutic group: Combinations of oral blood glucose lowering drugs, ATC code: A10BD04
Slovenian: Oznaka ATC: A10BD04
English: The ingredients may pass into breast milk and so may harm your baby.
Slovenian: Sestavine zdravila lahko prehajajo v materino
English: Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Slovenian: Med sočasno uporabo katerega od naslednjih zdravil se lahko poveča učinek na znižanje glukoze v krvi, tako da se v nekaterih primerih pojavi hipoglikemija.
English: Always take Avaglim tablets exactly as your doctor has told you.
Slovenian: Pri jemanju Avaglim tablet natančno upoštevajte zdravnikova navodila.
English: Mean doses at the end of randomised treatment are shown in the following table:
Slovenian: Povprečne odmerke na koncu randomiziranega zdravljenja
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Slovenian: Po pridobitvi dovoljenja za promet so, pri uporabi tiazolidindionov, vključno z rosiglitazonom, poročali o primerih na novo nastalega diabetičnega edema makule z zmanjšano ostrino vida ali njegovega poslabšanja.
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Slovenian: Po pridobitvi dovoljenja za promet z rosiglitazonom so poleg neželenih učinkov, odkritih med kliničnimi preskušanji, poročali še o neželenih učinkih, ki so navedeni v preglednici 2.
English: 4.2 Posology and method of administration
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: A more pronounced glucose-lowering effect was observed in obese patients.
Slovenian: Pri debelih bolnikih so opažali izrazitejši učinek na znižanje glukoze.
English: The absorption of rosiglitazone is not affected by increases in gastric pH.
Slovenian: Zvišanje pH v želodcu ne vpliva na absorpcijo
English: The AUC and Cmax of glimepiride increased in a dose-proportional manner following administration of rosiglitazone-glimepiride 4 mg/1 mg, 4 mg/2 mg, and 4 mg/4 mg.
Slovenian: AUC in Cmax glimepirida sta se po uporabi kombinacij 4 mg/1 mg, 4 mg/2 mg in 4 mg/4 mg rosiglitazona in glimepirida povečali sorazmerno odmerku.
English: Glaxo Wellcome, S.A.
Slovenian: Glaxo Wellcome, S.A. Avenida de Extremadura, 3
English: What Avaglim looks like and contents of the pack Avaglim 4 mg/4 mg tablets are pink, rounded triangular-shaped, and marked "gsk" on one side and
Slovenian: Izgled zdravila Avaglim in vsebina pakiranja Avaglim 4 mg/4 mg tablete so rožnate barve, zaokroženo trikotne oblike.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje rosiglitazonijev maleat v količini, ki ustreza 4 mg rosiglitazona, in 4 mg
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje rosiglitazonijev maleat v količini, ki ustreza 8 mg rosiglitazona, in 4 mg
English: In their entirety, the available data on the risk of cardiac ischaemia are
Slovenian: V celoti pa razpoložljivi podatki ne omogočajo dokončnega sklepa o tveganju srčne za srčne ishemije.
English: New or worse cases of macular oedema have occurred on rare occasions in people taking Avaglim and similar medicines.
Slovenian: V redkih primerih so pri bolnikih, ki so se zdravili z zdravilom Avaglim in podobnimi zdravili poročali o novem pojavu ali poslabšanju že obstoječega makularnega edema.
English: No clinically significant reductions in glimepiride AUC and Cmax were observed after repeat doses of rosiglitazone for eight days in healthy adult
Slovenian: Po uporabi večkratnih odmerkov rosiglitazona pri zdravih odraslih preiskovancih v obdobju osmih dni niso ugotovili klinično pomembnega zmanjšanja AUC in Cmax glimepirida.
English: The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM
Slovenian: Začetni odmerek je 4 mg/dan rosiglitazona in 4 mg/dan glimepirida (uporabljenih v obliki ene tablete AVAGLIM 4 mg/4 mg).
English: - contains lactose (approximately 104 mg) For a full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The decision whether to continue the patient on therapy with AVAGLIM should be guided by clinical judgement pending laboratory evaluations.
Slovenian: Dokler nimate laboratorijskih izvidov, se morate o nadaljevanju terapije z AVAGLIMOM odločiti na osnovi klinične presoje.
English: No adequate pharmacokinetic studies of glimepiride have been conducted in subjects with functional hepatic impairment.
Slovenian: Pri preiskovancih s funkcijsko okvaro jeter ustrezne farmakokinetične študije glimepirida niso bile izvedene.
English: Adverse reactions are presented below for each of the component parts of AVAGLIM.
Slovenian: V nadaljevanju so navedeni neželeni učinki vsake od zdravilnih učinkovin zdravila AVAGLIM.
English: Therefore, AVAGLIM should not be used during pregnancy and the use of insulin is recommended.
Slovenian: Zato AVAGLIMA med nosečnostjo ne smete uporabljati.
English: In addition, glimepiride seems to have pronounced extrapancreatic effects, also postulated for other sulphonylureas.
Slovenian: Poleg tega kaže, da ima glimepirid izrazite ekstrapankreatične učinke, ki jih imajo
English: Just take your next dose at the usual time.
Slovenian: Vzemite le naslednji predvideni
English: Contains lactose, see leaflet for further information
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Slovenian: Za režim zdravljenja z rosiglitazonom kot monoterapijo so neželeni učinki v preglednici, znotraj vsakega organskega sistema, navedeni po padajoči pogostnosti.
English: A switch to insulin should be considered in stress situations (e.g. trauma, surgery, infections).
Slovenian: V stresnih okoliščinah (npr. poškodba, operacija, okužbe) pride v poštev prehod na insulin.
English: What Avaglim is and what it is used for
Slovenian: Kaj je zdravilo Avaglim in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Avaglim
English: The frequency of adverse reactions identified from clinical trial data with rosiglitazone
Slovenian: Pogostnost neželenih učinkov na osnovi podatkov iz kliničnih preskušanj z
English: Avaglim 8 mg/4 mg tablets are red, rounded triangular-shaped, and marked "gsk" on one side and
Slovenian: Avaglim 8 mg/4mg tablete so rdeče barve, zaokroženo trikotne oblike.
English: Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
Slovenian: Med sočasno uporabo katerega od naslednjih zdravil se lahko zmanjša učinek na znižanje glukoze v krvi,
English: General disorders and administration site conditions oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: Medicinal product subject to medical prescription.
Slovenian: Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
English: AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba AVAGLIMA pri otrocih mlajših od
English: What Avaglim contains
Slovenian: Vsebuje laktozo.
English: 05 October 2012
Slovenian: 5. oktober 2012
English: The main measure of effectiveness was overall survival (the length of time the patients lived).
Slovenian: Glavno merilo učinkovitosti je bilo celokupno preživetje (koliko časa so bolniki še živeli).
English: The full European Public Assessment Report for Erbitux can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Erbitux je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Erbitux is an anticancer medicine which has been authorised in the European Union (EU) since 29 June 2004.
Slovenian: Zdravilo Erbitux je zdravilo proti raku, ki je v Evropski uniji (EU) odobreno od 29. junija 2004.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.
Slovenian: Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo je bila umaknjena potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: When it attaches to EGFR, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Slovenian: Ko se cetuksimab veže na receptorje za epidermalni rastni faktor, tumorske celice ne morejo več prejemati sporočil, potrebnih za rast, napredovanje in širjenje.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far are not sufficient to address CHMP's concerns and that more data will be needed.
Slovenian: Družba je v uradnem pismu izjavila, da njena odločitev za umik vloge temelji na mnenju CHMP, da podatki, ki so bili zagotovljeni dotlej, niso zadostni za odpravo pomislekov Odbora in da bo potrebnih več podatkov.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: CHMP je ocenil odgovore družbe na vprašanja, a so nekatera vprašanja še vedno ostala nerešena.
English: There are no consequences on the use of Erbitux in its authorised indications.
Slovenian: Umik nima nobenih posledic za uporabo zdravila Erbitux pri njegovih odobrenih indikacijah.
English: It was to be used in combination with platinum-based chemotherapy in patients who had not been treated before.
Slovenian: Uporabljalo naj bi se v kombinaciji s kemoterapijo na osnovi platine, in sicer pri bolnikih, ki predhodno še niso bili zdravljeni.
English: On 17 September 2012, Merck KGaA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Erbitux, to extend its use in the treatment of non-small cell lung cancer.
Slovenian: Družba Merck KGaA je dne 17. septembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Erbitux, katere namen je bil razširiti njegovo uporabo na zdravljenje nedrobnoceličnega pljučnega raka.
English: In non-small cell lung cancer, Erbitux was expected to work in the same way as it does in its existing indications.
Slovenian: Pri nedrobnoceličnem pljučnem raku naj bi zdravilo Erbitux delovalo na enak način, kot deluje pri obstoječih indikacijah.
English: In colorectal cancer it can be used in combination with chemotherapy (medicines to treat cancer) or on its own.
Slovenian: Pri kolorektalnem raku se lahko uporablja v kombinaciji s kemoterapijo (zdravili za zdravljenje raka) ali samostojno.
English: In the study, patients were given cisplatin and vinorelbine (two chemotherapy medicines) with or without Erbitux.
Slovenian: V tej študiji so bolniki prejemali cisplatin in vinorelbin (dve zdravili za kemoterapijo) bodisi skupaj z zdravilom Erbitux bodisi brez njega.
English: In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Slovenian: Pri lokalno napredovalnem raku (kadar je tumor zrasel, vendar se ni razširil) se zdravilo Erbitux uporablja v kombinaciji z radioterapijo (obsevanjem).
English: The applicant presented a re-analysis of the data from one main study involving 1,125 patients with advanced or metastatic non-small cell lung cancer with EGFR.
Slovenian: Predlagatelj je predstavil ponovno analizo podatkov iz ene glavne študije, v kateri je sodelovalo 1 125 bolnikov z napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom z receptorji za epidermalni rastni faktor.
English: Erbitux is also used to treat squamous cell cancers of the head and neck.
Slovenian: Zdravilo Erbitux se uporablja tudi za zdravljenje ploščatoceličnega raka glave in vratu.
English: The study had been previously used to support an application for the use of Erbitux in non-small cell lung cancers, but this application had been refused.
Slovenian: Študija je bila predhodno uporabljena za podporo vlogi za uporabo zdravila Erbitux pri nedrobnoceličnem pljučnem raku, vendar je bila ta vloga zavrnjena.
English: The Committee was concerned that, although the re-analysis of the data indicated that there might be a beneficial effect on survival for patients whose tumour cells had high levels of EGFR, there were some concerns, particularly over the way that patients had been categorised into high or low EGFR level groups in the retrospective analysis, as well as the fact that the effect seen in patients with high EGFR levels in the main study had not been confirmed in another study.
Slovenian: Odbor je bil zaskrbljen nad dejstvom, da so se - čeprav je ponovna analiza podatkov pokazala, da zdravilo lahko ugodno vpliva na preživetje bolnikov, katerih tumorske celice so imele visoke ravni receptorjev za epidermalni rastni faktor - pojavili določeni pomisleki, zlasti v zvezi z načinom, kako so bili bolniki pri retrospektivni analizi razvrščeni v skupini z visokimi ali nizkimi ravnmi receptorjev za epidermalni rastni faktor, ter z dejstvom, da učinki, opaženi pri bolnikih z visokimi ravnmi teh receptorjev v glavni študiji, niso bili potrjeni v nobeni drugi študiji.
English: Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain a ‘wildtype' (non-mutated) gene called ‘KRAS'.
Slovenian: Zdravilo Erbitux se uporablja pri bolnikih, katerih tumorske celice imajo na svoji površini beljakovino, imenovano receptor za epidermalni rastni faktor (RERF), in vsebujejo „divji“ (nemutirani) tip gena, imenovanega „KRAS“.
English: It is used to treat adults with colorectal cancer (a cancer of the large intestine) when the cancer is metastatic (has spread to other parts of the body).
Slovenian: Uporablja se za zdravljenje odraslih s kolorektalnim rakom (rakom debelega črevesa), kadar je rak metastatski, kar pomeni, da se je že razširil na druge dele telesa.
English: Based on the review of the data and the company's response to the questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Erbitux could not have been approved for the treatment of non-small cell lung cancer.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na vprašanja je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Erbitux ni mogoče odobriti za zdravljenje nedrobnoceličnega pljučnega raka.
English: The company presented an analysis of the study data, comparing the survival of patients whose tumour cells had high levels of EGFR on their surface, with the survival of patients whose tumours had low levels of EGFR.
Slovenian: Družba je predstavila analizo podatkov študije, v kateri je primerjala preživetje bolnikov, katerih tumorske celice so imele visoke ravni receptorjev za epidermalni rastni faktor na svoji površini, s preživetjem bolnikov, katerih tumorji so imeli nizke ravni teh receptorjev.
English: Therefore, at the time of the withdrawal, the CHMP concluded that the medicine could not have been approved based on the data presented by the company and that further studies were required to confirm the benefit of Erbitux in patients whose tumour cells have high EGFR levels.
Slovenian: Zato je CHMP v času umika zaključil, da na podlagi podatkov, ki jih je predstavila družba, zdravila ni mogoče odobriti in da so za potrditev koristi zdravila Erbitux pri bolnikih, katerih tumorske celice imajo visoke ravni receptorjev za epidermalni rastni faktor, potrebne nadaljnje študije.
English: What is happening with Erbitux for the treatment of other diseases?
Slovenian: Kakšne so posledice za zdravilo Erbitux, indicirano za zdravljenje drugih bolezni?
English: In cancer that is recurrent (has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination.
Slovenian: Pri ponavljajočem se (ki se ponovi po predhodnem zdravljenju) ali metastatskem raku se zdravilo Erbitux uporablja v kombinaciji z zdravili proti raku na osnovi platine.
English: Erbitux was also expected to be used to treat advanced or metastatic non-small cell lung cancer, when the tumour cells have high levels of EGFR on their surface.
Slovenian: Zdravilo Erbitux naj bi se uporabljalo tudi za zdravljenje napredovalega ali metastatskega nedrobnoceličnega pljučnega raka, kadar imajo tumorske celice na svoji površini visoke ravni receptorjev za epidermalni rastni faktor.
English: The company informed the CHMP that there were no ongoing clinical trials with Erbitux in non-small cell lung cancer at the time of the withdrawal.
Slovenian: Družba je obvestila CHMP, da v času umika ni potekalo nobeno klinično preizkušanje z zdravilom Erbitux pri nedrobnoceličnem pljučnem raku.
English: The active substance in Erbitux, cetuximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to EGFR, which can be found on the surface of some tumour cells.
Slovenian: Zdravilna učinkovina v zdravilu Erbitux, cetuksimab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna receptorje za epidermalni rastni faktor, ki se nahajajo na površini nekaterih tumorskih celic, in se veže nanje.
English: Multaq dronedarone
Slovenian: Multaq dronedaron
English: The European Commission granted a marketing authorisation valid throughout the European Union for Multaq on 26 November 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Multaq, veljavno po vsej Evropski uniji, izdala 26. novembra 2009.
English: The full EPAR for Multaq can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Multaq je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Multaq.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Multaq.
English: What measures are being taken to ensure the safe use of Multaq?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Multaq?
English: Multaq is available as tablets (400 mg) and the recommended dose is one tablet twice a day, with the morning and evening meals.
Slovenian: Zdravilo Multaq je na voljo v obliki tablet (400 mg), priporočeni odmerek pa je ena tableta dvakrat na dan ob jutranjem in večernem obroku.
English: This followed a review of data that became available since its authorisation including data from the PALLAS study.1
Slovenian: Ta omejitev je bila sprejeta na podlagi pregleda podatkov, ki postali razpoložljivi po odobritvi zdravila, vključno s podatki iz študije PALLAS.1
English: It must also not be used in patients with some other heart problems, such as some problems with the electrical activity, very slow heart beats or heart failure.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z drugimi srčnimi težavami, kot so denimo težave z električno dejavnostjo, zelo počasen utrip ali srčno popuščanje.
English: What benefits of Multaq have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Multaq izkazalo v študijah?