FrancophonIA/ELRC3.0 huggingface dataset:
English: Eleven (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
Slovenian: Vrednost QTcF se je glede na izhodišče pri enem bolniku (2 %) zvišala za ≥ 60 ms, pri 11 bolnikih (21 %) pa za ≥ 30 ms do < 60 ms.
English: Skin and subcutaneous tissue disorders
Slovenian: ŠKATLA ZA PRETISNE OMOTE
English: XALKORI 250 mg hard capsules crizotinib
Slovenian: XALKORI 250 mg trde kapsule krizotinib
English: XALKORI 200 mg hard capsules crizotinib
Slovenian: XALKORI 200 mg trde kapsule krizotinib
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see section 4.8).
Slovenian: Če so motnje vida trdovratne ali se poslabšajo, je priporočljiv oftalmološki pregled (glejte poglavje
English: Packaging
Slovenian: Vsebina Velikost pakiranja
English: Keytruda has been authorised in the EU since July 2015.
Slovenian: Zdravilo Keytruda je v EU odobreno od julija 2015.
English: Further information on Keytruda's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o trenutnih uporabah zdravila Keytruda je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The measures of effectiveness were the number of patients whose cancer shrank in size (overall response rate) and the time patients lived without their disease getting worse (progression free survival).
Slovenian: Merili učinkovitosti sta bili število bolnikov, pri katerih se je velikost raka zmanjšala (skupna stopnja odziva), in čas, ki so ga bolniki preživeli brez poslabšanja bolezni (preživetje brez napredovanja bolezni).
English: The CHMP's main concern was that the available data did not allow firm conclusions on the effectiveness and safety of Keytruda in these patients and further data from ongoing studies were needed in order to assess its benefits and risks.
Slovenian: Glavna skrb odbora CHMP je bila, da razpoložljivi podatki niso dovoljevali trdnih zaključkov o učinkovitosti in varnosti zdravila Keytruda pri teh bolnikih, zato so potrebni nadaljnji podatki iz potekajočih študij, da bi ocenili njegove koristi in tveganja.
English: It contains the active substance pembrolizumab.
Slovenian: Vsebuje zdravilno učinkovino pembrolizumab.
English: On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Slovenian: Družba Merck Sharp & Dohme je 11. oktobra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za razširitev uporabe zdravila Keytruda pri nedrobnoceličnem raku pljuč (NSCLC), da bi vključila metastatski neskvamozni NSCLC v kombinaciji s kemoterapijo.
English: Keytruda is also authorised to treat melanoma (a skin cancer), classical Hodgkin lymphoma (a blood cancer) and urothelial cancer (a cancer of the bladder and urinary tract).
Slovenian: Zdravilo Keytruda je odobreno tudi za zdravljenje melanoma (kožnega raka), klasičnega Hodgkinovega limfoma (krvnega raka) in urotelijskega karcinoma (raka sečnega mehurja in sečil).
English: Some cancers can make proteins called PD-L1 and PD-L2 that combine with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Slovenian: Nekatere vrste raka lahko tvorijo beljakovini, imenovani PD-L1 in PD-L2, ki se vežeta z receptorjem PD-1 in izklopita dejavnost določenih celic imunskega sistema (naravne obrambe telesa), s čimer jim preprečita napadanje raka.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the CHMP's consideration that uncertainties remain due to the limited number of patients included in the main study, despite the data provided for Keytruda in the applied use.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da njena odločitev temelji na mnenju odbora CHMP o preostalih negotovostih glede majhnega števila bolnikov, vključenih v glavno študijo, kljub podatkom, ki jih je za predlagano uporabo zdravila Keytruda družba predložila.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Keytruda.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Keytruda.
English: The applicant presented data from a study involving 123 patients with locally advanced or metastatic NSCLC, which compared Keytruda taken together with pemetrexed and carboplatin chemotherapy with chemotherapy alone.
Slovenian: Predlagatelj je predložil podatke iz študije, ki je vključevala 123 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč, v kateri so zdravilo Keytruda skupaj s kemoterapijo s pemetreksedom in karboplatinom primerjali s kemoterapijo kot samostojnim zdravljenjem.
English: Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body (metastatic).
Slovenian: Zdravilo Keytruda se zlasti uporablja, ko tumor tvori beljakovino, imenovano PDL1, in je napredoval ali se razširil na druge dele telesa (metastatski rak).
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.
Slovenian: Pembrolizumab z zaviranjem receptorja PD-1 prepreči raku, da bi ta izklopil navedene imunske celice, s čimer poveča sposobnost imunskega sistema za uničevanje rakavih celic.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and block a receptor called PD-1.
Slovenian: Zdravilna učinkovina v zdravilu Keytruda, pembrolizumab, je monoklonsko protitelo (tj. vrsta beljakovine), ki je bila zasnovano tako, da prepozna receptor, imenovan PD-1, in ga zavre.
English: There are no consequences on the use of Keytruda in its authorised uses.
Slovenian: Umik vloge nima nobenih posledic za uporabo zdravila Keytruda pri odobrenih indikacijah.
English: Keytruda was also expected to be used in combination with the chemotherapy medicines pemetrexed and carboplatin in NSCLC patients with metastatic ‘non-squamous' NSCLC, irrespective of whether their tumour produced the PD-L1 protein.
Slovenian: Zdravilo Keytruda naj bi se uporabljalo v kombinaciji s kemoterapevtskima zdraviloma pemetreksed in karboplatin pri bolnikih z metastatskim neskvamoznim nedrobnoceličnim rakom pljuč, ne glede na to, ali tumor tvori beljakovino PD-L1.
English: What was Keytruda expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Keytruda uporabljalo?
English: What is Keytruda?
Slovenian: Kaj je zdravilo Keytruda?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Keytruda could not have been approved for the treatment of metastatic non-squamous NSCLC in combination with pemetrexed and carboplatin.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Keytruda ni mogoče odobriti za zdravljenje metastatskega neskvamoznega nedrobnoceličnega raka pljuč v kombinaciji s pemetreksedom in karboplatinom.
English: Keytruda is a cancer medicine already authorised for use on its own to treat NSCLC.
Slovenian: Keytruda je zdravilo proti raku, ki je že odobreno za samostojno zdravljenje nedrobnoceličnega raka pljuč.
English: What is happening with Keytruda in its authorised uses?
Slovenian: Kakšne so posledice za odobrene uporabe zdravila Keytruda?
English: This summary was last updated in 11-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 12-2012.
English: For the other infections, they are taken for five days.
Slovenian: Pri drugih okužbah se jemljejo pet dni.
English: It must also not be used with a number of medicines.
Slovenian: Ne sme se uporabljati skupaj s številnimi zdravili.
English: It is used when betalactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.
Slovenian: Uporablja se, ko betalaktami niso primerni, v državah ali regijah, kjer je odpornost proti makrolidom visoka.
English: These are closely related to the macrolides.
Slovenian: Ti so zelo sorodni makrolidom.
English: The full EPAR for Ketek 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 Ketek je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For pneumonia, the tablets should be taken for seven to 10 days.
Slovenian: Pri pljučnici je treba tablete jemati od sedem do 10 dni.
English: What benefit has Ketek shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ketek izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Ketek.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ketek.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ketek, veljavno po vsej Evropski uniji, odobrila
English: What is the risk associated with Ketek?
Slovenian: Kakšna tveganja so povezana z zdravilom Ketek?
English: Ketek has been studied in 10 main studies involving a total of over 4,000 patients.
Slovenian: Zdravilo Ketek so raziskali v 10 glavnih študijah, v katerih je sodelovalo več kot 4 000 bolnikov.
English: Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision.
Slovenian: Nekateri od teh neželenih učinkov so lahko resni, vključno s poslabšanjem miastenije gravis, prehodne izgube zavesti in začasnih motenj vida.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ketek, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove
English: Why has Ketek been approved?
Slovenian: Zakaj je bilo zdravilo Ketek odobreno?
English: For more information about treatment with Ketek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ketek preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.
Slovenian: Osebe, ki zdravilo predpišejo, morajo upoštevati uradne smernice o uporabi protibakterijskih sredstev in lokalne ravni odpornosti proti antibiotikom.
English: Ketek was as effective as the comparator antibiotics.
Slovenian: Zdravilo Ketek je bilo enako učinkovito kot primerjalni antibiotiki.
English: The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘satisfactory' reductions in the amount of bacteria detected in samples taken
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so ob koncu zdravljenja ozdraveli, kakor je pokazalo zmanjšanje simptomov, oziroma delež bolnikov z zadovoljivim zmanjšanjem količine bakterij, odkritih v vzorcih, vzetih iz grla.
English: The recommended dose of Ketek is 800 mg (two tablets) once a day.
Slovenian: Priporočeni odmerek zdravila Ketek je 800 mg (dve tableti) enkrat na dan. Tablete je treba pogoltniti cele z vodo.
English: The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea.
Slovenian: Najpogostejši neželeni učinek zdravila Ketek (opažen pri več kot 1 bolniku od 10) je driska.
English: Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Slovenian: Jemanje zdravila Ketek pred spanjem lahko zmanjša morebitni vpliv neželenih učinkov, kot sta motnja vida ali izguba zavesti.
English: Telithromycin works by blocking the bacteria's ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Slovenian: Telitromicin deluje tako, da zavre ribosome bakterij (dele celice, kjer se tvorijo beljakovine) in s tem preprečuje rast bakterij.
English: The CHMP concluded that Ketek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ketek večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: All but two of the studies compared Ketek with other antibiotics.
Slovenian: V vseh študijah razen dveh so zdravilo Ketek primerjali z učinki drugih antibiotikov.
English: Ketek is a medicine that contains the active substance telithromycin.
Slovenian: Ketek je zdravilo, ki vsebuje zdravilno učinkovino telitromicin.
English: However, the Committee noted that Ketek is associated with a greater risk of certain side effects than other antibiotics.
Slovenian: Vendar je opomnil, da je zdravilo Ketek povezano z večjim tveganjem pojava določenih neželenih učinkov kot drugi antibiotiki.
English: • acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the
Slovenian: • akutnim sinuzitisom (kratkotrajno okužbo sinusov, z zrakom napolnjenih prehodov v kosteh okrog
English: Ketek must not be taken by patients with a history or a family history of ‘long QT syndrome' or with ‘acquired QT interval prolongation' (disruption of the heartbeat).
Slovenian: Zdravila Ketek ne smejo jemati bolniki z anamnezo ali družinsko anamnezo „sindroma podaljšanega intervala QT“ ali s „pridobljenim podaljšanjem intervala QT“ (motnjo srčnega ritma).
English: For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment.
Slovenian: Pri pljučnici in kroničnem bronhitisu je bilo zdravilo Ketek enako učinkovito kot amoksicilin, klaritromicin, trovafloksacin, amoksicilin/klavulanska kislina in cefuroksim aksetil, pri čemer ob koncu zdravljenja med 82 in 95 % bolnikov ni imelo nobenih simptomov.
English: A lower dose may be needed in patients who have severe kidney problems.
Slovenian: Pri bolnikih s hudimi ledvičnimi težavami bo morda potreben manjši odmerek.
English: Ketek must not be used in people who are hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients.
Slovenian: Zdravila Ketek ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) telitromicin, kateri koli makrolid ali katero koli drugo sestavino zdravila.
English: How is Ketek used?
Slovenian: Kako se zdravilo Ketek uporablja?
English: Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
Slovenian: V štirih študijah so proučevali učinke zdravila na blago do zmerno pljučnico, dobljeno v domačem okolju, v dveh študijah so opazovali učinke na akutni sinuzitis, v dveh učinke na akutno poslabšanje kroničnega bronhitisa, v dveh pa so proučevali učinke na tonzilitis ali faringitis.
English: It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic):
Slovenian: Uporablja se tudi za zdravljenje odraslih z naslednjimi okužbami, ki so jih povzročile bakterije in ki so ali bi lahko bile odporne proti betalaktamom ali makrolidom (vrsti antibiotikov) ali neobčutljive nanje:
English: The full list of bacteria against which Ketek is active can be found in the summary of product characteristics (also
Slovenian: Celoten seznam bakterij, proti katerim je zdravilo Ketek učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes.
Slovenian: Zdravilo Ketek se uporablja tudi za zdravljenje bolnikov, starejših od 12 let, s tonzilitisom ali faringitisom (vnetjem mandljev ali grla), ki jo povzroča bakterija Streptococcus pyogenes.
English: • acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the
Slovenian: • akutnim poslabšanjem (ponovnim izbruhom) kroničnega bronhitisa (dolgotrajnega vnetja dihalnih
English: It must not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness), or who have had hepatitis (inflammation of the liver) or jaundice when they have taken telithromycin in the past.
Slovenian: Zdravila ne smejo uporabljati bolniki z miastenijo gravis (boleznijo živcev, pri kateri postajajo mišice šibke), bolniki, ki so imeli hepatitis (vnetje jeter) ali zlatenico, ko so v preteklosti jemali telitromicin.
English: The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ketolides'.
Slovenian: Zdravilna učinkovina zdravila Ketek, telitromicin, je antibiotik iz skupine „ketolidov“.
English: Therefore, the Committee decided that its use should be reserved to the treatment of communityacquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics
Slovenian: Odbor je zato zaključil, da je treba uporabo zdravila omejiti na zdravljenje pljučnice, pridobljene v domačem okolju, zdravljenje bronhitisa in sinuzitisa, povzročenih z bakterijami, ki so odporne na betalaktamske ali makrolidne antibiotike ter na zdravljenje tonzilitisa/faringitisa, če teh antibiotikov ni mogoče uporabiti.
English: In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/clavulanic acid.
Slovenian: Pri bolnikih z akutnim sinuzitisom so bile stopnje ozdravitve po 5- in 10-dnevnem zdravljenju z zdravilom Ketek podobne tistim, opaženim ob uporabi amoksicilina/klavulanske kisline.
English: For more information, see
Slovenian: Za več informacij glejte navodilo za uporabo.
English: For the full list of all side effects reported with Ketek, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ketek, glejte navodilo za uporabo.
English: For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels
Slovenian: Pri tonzilitisu ali faringitisu je bilo znižanje količin bakterij v vzorcih, ki so jih odvzeli iz grla, zadovoljivo pri 84-92 % bolnikov, ki so jemali zdravilo Ketek, penicilin ali
English: It is available as tablets
Slovenian: Na voljo je v obliki tablet (400 mg).
English: Ketek is used to treat adults with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Slovenian: Zdravilo Ketek se uporablja za zdravljenje odraslih z blago ali zmerno pljučnico, dobljeno v domačem
English: The application was withdrawn at ‘day 120'.
Slovenian: Vlogo so umaknili na „120.
English: EMA/CHMP/602611/2012 EMEA/H/C/002027
Slovenian: 14. september 2012 EMA/602611/2012 EMEA/H/C/002027
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovenian: To pomeni, da je CHMP dotlej ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
English: The CHMP also noted that the clinical relevance of the study results was unclear.
Slovenian: CHMP je prav tako navedel, da klinična pomembnost rezultatov študije ni jasna.
English: The main measures of effectiveness were based on the sensitivity of the scans (how well they detected abnormalities in the ducts) and their specificity (how well normal ducts were identified as normal).
Slovenian: Glavna merila za učinkovitost so temeljila na občutljivosti slikanja (kako dobro je slikanje zaznalo nepravilnosti v duktusih) in njegovi specifičnosti (kako dobro so bili normalni duktusi prepoznani kot normalni).
English: Withdrawal of the marketing authorisation application for SecreFlo (secretin human) EMA/602611/2012
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom SecreFlo (humani sekretin) EMA/602611/2012
English: SecreFlo is a medicine that contains the active substance secretin human.
Slovenian: SecreFlo je zdravilo, ki vsebuje zdravilno učinkovino humani sekretin.
English: The Committee was concerned that there may not have been adequate safeguards to ensure that the final readings of the scans were not biased.
Slovenian: Odbor je menil, da morda ni bilo zadostnih zaščitnih ukrepov, s katerimi bi zagotovili, da so končne interpretacije slik nepristranske.
English: On 15 August 2012, Repligen Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for SecreFlo, intended for use in the detection of duct abnormalities in the pancreas.
Slovenian: Družba Repligen Europe Limited je dne 15. avgusta 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom SecreFlo, namenjenim za uporabo pri odkrivanju nepravilnosti v duktusih v trebušni slinavki.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was based on the fact that the concerns raised by the CHMP could not be addressed in the available timeframe.
Slovenian: Družba je v svojem dopisu, v katerem agencijo obvešča o umiku svoje vloge, navedla, da umik temelji na dejstvu, da pomislekov, ki jih je izpostavil CHMP, ni bilo mogoče obravnavati v razpoložljivem časovnem okviru.
English: Images from the scans were read by expert radiologists without prior knowledge of the patients' condition and the results were compared with what was already known from other tests.
Slovenian: Slike so interpretirali specialisti radiologi, ki niso poznali bolnikovega stanja, rezultate pa so primerjali s podatki, ki so bili znani iz predhodnih preiskav.
English: Withdrawal of the marketing authorisation application for SecreFlo (secretin human)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom SecreFlo (humani sekretin)
English: Another concern was the fact that patients in the study (patients with a history of acute pancreatitis) were not representative of patients for whom the medicine was intended (patients with known or suspected pancreatitis).
Slovenian: Drugi pomislek odbora je bil, da bolniki v študiji (bolniki z akutnim pankreatitisom v anamnezi) niso bili reprezentativni za bolnike, ki jim je zdravilo namenjeno (bolnikom s potrjenim pankreatitisom ali sumom nanj).