FrancophonIA/ELRC3.0 huggingface dataset:
English: With regard to the interactions with CYP3A4 inhibitors, although the concomitant use with Durogesic is not recommended, in cases where the benefits outweigh the increased risk of adverse effects, a washout period of 2 days before the first Durogesic patch is applied was considered to be sufficient in most cases.
Slovenian: Kar se tiče interakcij z zaviralci CYP3A4, hkratna uporaba z zdravilom Durogesic ni priporočena, v tistih primerih, kjer koristi odtehtajo povečano tveganje za neželene učinke, pa se je štelo za zadostno obdobje izpiranja dva dni pred uporabo prvega obliža Durogesic.
English: As outlined in the October 2007 Public Assessment Report regarding paediatric data, the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs.
Slovenian: Kot je bilo v zvezi s pediatričnimi podatki opisano v javnem poročilu o oceni zdravila oktobra 2007, je dolgotrajno zdravljenje hude kronične bolečine pri otrocih, starih dve ali več let, ki prejemajo opioidno zdravljenje, indicirano v poglavju 4.1 predlaganega usklajenega povzetka glavnih značilnosti zdravila in zapisano tudi v večini povzetkov glavnih značilnosti zdravila.
English: In such cases, the potential for life-threatening hypoventilation has been added as a warning.
Slovenian: Zaradi takih primerov je bilo dodano opozorilo o možnosti življenjsko nevarne hipoventilacije.
English: As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable.
Slovenian: Ker v informaciji o varnosti zdravila ni bilo bistvenih razlik med odraslimi in pediatričnimi preiskovanci, je bila odločitev imetnika dovoljenja za promet z zdravilom, da ne vključi ločene preglednice, ocenjena kot sprejemljiva.
English: The results of all pharmacodynamic or efficacy studies conducted in paediatric patients has been included in this section and the number of paediatric patients has been brought in line with the other sections of the harmonised SmPC.
Slovenian: V ta razdelek so bili vključeni rezultati vseh farmakodinamičnih študij in študij o učinkovitosti, ki so bile izvedene pri pediatričnih bolnikih, število pediatričnih bolnikov pa je bilo usklajeno z drugimi poglavji usklajenega povzetka glavnih značilnosti zdravila.
English: Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved.
Slovenian: Obravnavane in odpravljene so bile glavne razlike med povzetki glavnih značilnosti zdravila v zvezi s pripisanimi pogostostmi posameznih neželenih učinkov.
English: The wording regarding tolerance and dependence, opioid withdrawal symptoms, and neonatal withdrawal syndrome follow exactly the wording included in the CSP and is considered to be acceptable.
Slovenian: Besedilo o toleranci in zasvojenosti, simptomih odtegnitve opioidov in neonatalnem odtegnitvenem sindromu natančno sledijo besedilu v ključni informaciji o zdravilu in so obravnavane kot sprejemljive.
English: However a warning has been added that more time would be needed for CYP3A4 inhibitors with a long half-life (such as amiodarone) or CYP3A4 inhibitors with time-dependent or mechanism-based inhibition (such as erythromycin, nicardipine, idelalisib, ritonavir), and that the product information of the CYP3A4 inhibitor must be consulted for the half-life and duration of the inhibitory effect before applying the first Durogesic patch.
Slovenian: Dodano pa je bilo tudi opozorilo, da bi bil pri zaviralcih CYP3A4 z dolgo razpolovno dobo (npr. amjodaronom) ali zaviralcih CYP3A4 s časovno odvisnim ali na mehanizmu temelječim zaviranjem (npr. eritromicinu, nikardipinu, idelalisibu, ritonavirju) potreben daljši čas in da je treba pred uporabo prvega obliža Durogesic v navodilih za uporabo zaviralca CYP3A4 preveriti razpolovni čas in trajanje zaviralnega učinka.
English: Although clinical experience is limited with Durogesic in opioid-naïve patients and in general the transdermal route is not recommended in opioid-naïve patients, the MAH recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered, when commencing with oral opioids is not considered appropriate.
Slovenian: Čeprav so klinične izkušnje z zdravilom Durogesic pri bolnikih, ki prej niso prejemali opioidov, omejene in pri njih transdermalna pot v splošnem ni priporočljiva, imetnik dovoljenja za promet z zdravilom ugotavlja, da bi se v izrednih kliničnih okoliščinah lahko pretehtala uporaba 12 μg/h fentanilnega obliža, kadar zdravljenja ni primerno začeti s peroralnimi opioidi.
English: Children aged 16 years and above follow adult dosage, and for children 2-16 years a table with recommended Durogesic dosages for paediatric patients based upon daily oral morphine dose has been provided.
Slovenian: Za otroke, stare od 2 do 16 let, je predložena preglednica s priporočenimi odmerki zdravila Durogesic na osnovi dnevnega peroralnega odmerka morfina.
English: The initially proposed Table 1 was simplified at the request of the CHMP, where the conversion factors from a drug to oral morphine are already provided, with the intention of reducing the risk of errors in conversion from other opioids to oral morphine, due to less calculation.
Slovenian: Sprva predlagana Preglednica 1 je bila z namenom zmanjšanja tveganja za napake pri pretvorbi z drugih opioidov na peroralni morfin na predlog odbora CHMP poenostavljena tako, da so faktorji za pretvorbo z zdravila na peroralni morfin že podani in je potrebnega manj računanja.
English: Therefore the MAH's proposal to give a common broad indication wording, not explicitly differentiating between cancer and non-cancer pain, was endorsed by the CHMP.
Slovenian: CHMP je zato sprejel predlog imetnika dovoljenja za promet z zdravilom za skupno besedilo s široko zastavljeno indikacijo brez izrecnega razlikovanja med bolečino pri raku in nepovezano z rakom.
English: The wording in this section has been amended according to the PSUR worksharing (2010), that Durogesic may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Slovenian: Dodano je bilo, da lahko zdravilo Durogesic zmanjša duševno ali fizično sposobnost, potrebno za izvajanje potencialno nevarnih nalog, kot sta vožnja in upravljanje strojev.
English: • The committee agreed on a harmonised summary of product characteristic, labelling, package leaflet for Durogesic and associated names.
Slovenian: • Odbor se je strinjal z usklajenim povzetkom glavnih značilnosti zdravila, označevanjem ter navodilom za uporabo zdravila Durogesic in povezanih imen.
English: The wording for the subsection ‘Fertility' has been amended to ensure consistency across the different fentanyl-containing medicinal products.
Slovenian: Besedilo za podpoglavje „Plodnost“ je bilo popravljeno tako, da bi bila dosežena večja usklajenost različnih zdravil, ki vsebujejo fentanil.
English: Overdose of an opioid such as fentanyl could lead to persistent hypotension due to peripheral vasodilation.
Slovenian: Poglavje 4.9 - Preveliko odmerjanje Preveliko odmerjanje opioida, kot je fentanil, bi lahko vodilo v trajno hipotenzijo zaradi periferne vazodilatacije.
English: The table with adverse reactions from clinical trials and post-marketing data for both adult and paediatric subjects together, in line with the current table of adverse reactions in the Core Safety Profile (CSP) was proposed.
Slovenian: Preglednica z neželenimi učinki iz kliničnih preizkušanj in podatkov v obdobju trženja za odrasle in pediatrične preiskovance skupaj, v skladu s trenutno preglednico neželenih učinkov v ključni informaciji o varnosti zdravila.
English: The wording for this subsection has been amended in line with the available information to ensure consistency across the different fentanyl-containing medicinal products.
Slovenian: Besedilo tega podpoglavja je bilo popravljeno v skladu z dostopnimi podatki, da bi bila dosežena usklajenost med različnimi zdravili, ki vsebujejo fentanil.
English: Revisions were made to the sections; use in opioid-naïve and not opioid-tolerant patients and use during fever or external heat application, and cautionary statements on interchangeability have been deleted as local guidance is required to be followed on the distribution of fentanyl patches, which may differ between Member States.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Poglavja so bila revidirana; uporaba pri bolnikih, ki prej niso bili zdravljeni z opioidi, in tistih, ki opioidov ne prenašajo, uporaba ob zvišani temperaturi ali zunanjem ogrevanju in previdnostne izjave o medsebojni zamenljivosti so bili izbrisani, saj so pri distribuciji fentanilnih obližev potrebna lokalna navodila, ki se med državami članicami lahko razlikujejo.
English: According to the EMA Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain (EMA/CHMP/970057/2011, Corr. 11) and the WHO Guideline on Cancer Pain Relief, pain severity can be classified as mild, moderate and severe.
Slovenian: Skladno s smernico Evropske agencije za zdravila o kliničnem razvoju zdravil, namenjenih zdravljenju bolečine (EMA/CHMP/970057/2011, popr.
English: Contraindications relating to severe respiratory depression, hypersensitivity to the active substance or to any of the excipients use in acute or postoperative pain and use in acute or postoperative pain has been included in the harmonised SmPC.
Slovenian: V usklajeni povzetek glavnih značilnosti zdravila so bile vključene kontraindikacije, povezane s hudo respiratorno depresijo, preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, ki se uporablja pri akutni in pooperacijski bolečini, in uporaba pri akutni in pooperacijski bolečini.
English: The use of fentanyl patches is well established as reflected by the large database, in both malignant and severe non-malignant pain conditions (eg.
Slovenian: Kot je razvidno iz velike podatkovne zbirke, so fentanilni obliži dobro uveljavljeni pri malignih in hudih nemalignih bolečinskih stanjih (npr. pri hudih opeklinah in popoškodbenih okvarah).
English: The information provided in section 4.2 is partly presented in up to three tables and are only be used to convert from other opioids to Durogesic and not vice versa:
Slovenian: Uporabljajo naj se le za pretvorbo z drugih opioidov na zdravilo Durogesic in ne obratno.
English: The wording proposed for lactation/breast-feeding that was agreed for fentanyl-containing transdermal patches during two previous PSUR-WS procedures, was endorsed by the CHMP.
Slovenian: o katerem je bilo v zvezi s transdermalnimi obliži, ki vsebujejo fentanil, doseženo soglasje v prejšnjih dveh postopkih PSUR-WS, je odobril odbor CHMP.
English: the CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Durogesic and associated names.
Slovenian: Odbor CHMP je priporočil spremembo pogojev dovoljenj za promet z zdravilom Durogesic in povezanimi imeni, za katera so v Prilogi III navedeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo.
English: Whereas
Slovenian: Odbor
English: In opioid-naïve elderly or patients with renal or hepatic impairment, there may be some instances in which the initiation of opioid treatment with a transdermal formulation is necessary and appropriate (e.g. in cases of difficulties swallowing).
Slovenian: Opioidno zdravljenje je pri opioidno naivnih starejših bolnikih in bolnikih z okvaro ledvic ali jeter v nekaterih primerih morda treba začeti s transdermalno obliko (npr. pri oteženem požiranju).
English: As placental passage of fentanyl is known to occur in human pregnancies and the potential risk for humans is unknown, a cautionary statement that Durogesic should not be used during pregnancy unless clearly necessary has been included.
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in laktacija Ker je znano, da pri človeški nosečnosti lahko pride do placentarnega prehoda fentanila in potencialno tveganje za ljudi ni znano, je bila dodana previdnostna izjava, da se zdravilo Durogesic ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno.
English: Vasodilation is effectively reversed by naloxone.
Slovenian: Vazodilatacijo učinkovito izniči nalokson.
English: The efficacy of Durogesic has been shown in six studies in adults with non-malignant pain, of which five were open-label and 3 did not have a comparator arm.
Slovenian: Učinkovitost zdravila Durogesic je bila dokazana v šestih študijah pri odraslih z nemaligno bolečino,
English: Grounds for the CHMP opinion
Slovenian: Podlaga za mnenje odbora CHMP Ob upoštevanju naslednjega:
English: A warning for renally impaired patients has been included that careful observation for signs of fentanyl toxicity is warranted (and the dose reduced if necessary) as fentanyl pharmacokinetics has not been evaluated in this patient population.
Slovenian: Vključeno je bilo opozorilo za bolnike z ledvično okvaro, da je upravičeno dosledno ugotavljanje znakov fentanilne toksičnosti (in da se odmerek, če je treba,
English: Package Leaflet (PL)
Slovenian: PRILOGA II
English: The proposed pharmacodynamic-related interactions were endorsed in the PSUR worksharings in 2010 and 2015.
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Predlagane s farmakodinamiko povezane interakcije so bile sprejete v postopku razdelitve dela pri pripravi Periodičnega poročila o varnosti zdravila (PSUR) leta 2010 in 2015.
English: The PL has been harmonised taking into account all revisions of the SmPC that are relevant to the PL.
Slovenian: Navodilo za uporabo je bilo usklajeno z upoštevanjem vseh revizij povzetka glavnih značilnosti zdravila, ki so relevantne za navodilo za uporabo.
English: The MAH has summarised the most commonly reported adverse reactions in this section based on the pooled safety data derived from 11 clinical trials with a total of 1854 participating adult and paediatric subjects.
Slovenian: 11 kliničnih preizkušanj, v katerih je sodelovalo skupaj 1 854 odraslih in pediatričnih preiskovancev, povzel najpogosteje poročane neželene učinke.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES v zvezi z zdravilom Durogesic transdermalni obliži; • Odbor je obravnaval razlike, prepoznane v obvestilu za zdravilo Durogesic in povezana imena ter preostale razdelke povzetka glavnih značilnosti zdravila, označevanju in navodilu za uporabo.
English: ANNEX II SCIENTIFIC CONCLUSIONS
Slovenian: Znanstveni zaključki
English: The vaccine is injected into the shoulder muscle.
Slovenian: Cepivo se injicira v ramensko mišico.
English: The fourth injection is given four months after the third.
Slovenian: Četrto injekcijo bolnik prejme štiri mesece po tretji.
English: The antibodies will help to protect against the disease caused by the virus.
Slovenian: Protitelesa bodo pomagala ščititi proti bolezni, ki jo povzroča ta virus.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fendrix, veljavno po vsej Evropski uniji, izdala 2. februarja 2005.
English: There should be a gap of one month between the first and second, and between the second and third injections.
Slovenian: Med prvo in drugo ter med drugo in tretjo injekcijo mora miniti en mesec.
English: The full EPAR for Fendrix 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 cepivo Fendrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Slovenian: Ta sistem okrepi odziv imunskega sistema, kar lahko pomaga, če se cepiva uporabljajo pri bolnikih, ki imajo morda slabši odziv, kot so na primer bolniki, ki imajo težave z ledvicami.
English: This is a summary of the European public assessment report (EPAR) for Fendrix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fendrix.
English: Other information about Fendrix
Slovenian: Druge informacije o zdravilu Fendrix
English: For more information about treatment with Fendrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fendrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years.
Slovenian: Zdravilna učinkovina cepiva Fendrix je na voljo v drugih cepivih, ki so v Evropski uniji (EU) odobrena že vrsto let.
English: It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).
Slovenian: Uporablja se lahko pri bolnikih od 15. leta starosti dalje, vključno z bolniki, ki potrebujejo hemodializo (tj. tehnika čiščenja krvi pri bolnikih z obolenjem ledvic).
English: The CHMP decided that Fendrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi cepiva Fendrix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Fendrix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The company also presented information on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment of the vaccine.
Slovenian: Družba je predstavila tudi podatke o uporabi cepiva Fendrix pri bolnikih s presajenimi jetri, vendar je vlogo za uporabo cepiva Fendrix pri teh bolnikih med ocenjevanjem cepiva umaknila.
English: Fendrix is a vaccine, which is available as a suspension for injection.
Slovenian: Zdravilo Fendrix je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
English: Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Slovenian: Cepivo Fendrix so raziskovali tudi v eni glavni študiji, ki je vključevala 165 bolnikov, starih 15 let in več, ki so imeli obolenje ledvic in so zato potrebovali hemodializo.
English: What benefit has Fendrix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Fendrix izkazalo med študijami?
English: The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki cepiva Fendrix (opaženi pri več kot 1 bolniku od 10) so glavobol, bolečina, rdečina, otekanje na mestu injiciranja in utrujenost.
English: Fendrix is a vaccine.
Slovenian: Zdravilo Fendrix je cepivo.
English: Because the active substance in Fendrix has been available in the EU in other vaccines, some of the information used to support the use of the other vaccines was used to support the use of Fendrix.
Slovenian: Ker je zdravilna učinkovina cepiva Fendrix v EU že na voljo v drugih cepivih, so bili za podporo cepivu Fendrix uporabljeni tudi nekateri podatki, ki podpirajo uporabo drugih cepiv.
English: The recommended vaccination schedule for Fendrix is four doses.
Slovenian: Priporočeno shemo cepljenja s cepivom Fendrix sestavljajo štirje odmerki.
English: Fendrix was as effective as a double dose of the comparator vaccine.
Slovenian: Cepivo Fendrix je bilo učinkovitejše od dvojnega odmerka primerjalnega cepiva.
English: The surface antigens are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Slovenian: Površinske antigene proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri kvasovka prejeme gen (DNK), s katerim lahko tvori beljakovine.
English: The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
Slovenian: Učinek cepiva Fendrix je trajal dlje kot učinek primerjalnega cepiva: 80 % bolnikov, ki so prejemali cepivo Fendrix, je obdržalo zaščitne ravni protiteles do tri leta, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 51 %.
English: It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Slovenian: Priporočeno je, da posamezniki, ki prejmejo prvi odmerek cepiva Fendrix, končajo celoten program zdravljenja.
English: In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus.
Slovenian: V prihodnosti lahko imunski sistem ob izpostavitvi virusu hepatitisa B hitreje ustvarja protitelesa.
English: In Fendrix, it is used with an ‘adjuvant system' which contains ‘MPL', a purified fat from bacteria, and an aluminium compound.
Slovenian: V cepivu Fendrix se uporablja s „sistemom adjuvansov”, ki vsebuje „MPL”, prečiščeno maščobo iz bakterij in aluminijevo spojino.
English: What is the risk associated with Fendrix?
Slovenian: Kakšna tveganja so povezana z zdravilom Fendrix?
English: One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.
Slovenian: En mesec po zadnjem odmerku je imelo 91 % bolnikov, ki so prejemali cepivo Fendrix, zaščitne ravni protiteles proti virusu hepatitisa B, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 84 %.
English: Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Slovenian: Cepivo Fendrix se uporablja za zaščito bolnikov z ledvičnimi težavami proti virusu hepatitisa B (obolenju jeter zaradi okužbe z virusom hepatitisa B).
English: The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies against the hepatitis B virus.
Slovenian: Glavno merilo učinkovitosti je bil delež oseb, pri katerih se je pojavila zaščitna raven protiteles proti virusu hepatitisa B.
English: A booster dose of Fendrix may be given, according to official recommendations.
Slovenian: Bolnik lahko skladno z uradnimi priporočili prejme tudi poživitveni odmerek cepiva Fendrix.
English: It contains parts of the hepatitis B virus as the active substance.
Slovenian: Kot zdravilno učinkovino vsebuje dele virusa hepatitisa B.
English: Why has Fendrix been approved?
Slovenian: Zakaj je bilo zdravilo Fendrix odobreno?
English: For the full list of side effects reported with Fendrix, see the package leaflet.
Slovenian: Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Fendrix, glejte navodilo za uporabo.
English: Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Slovenian: Fendrix adsorbirano cepivo proti hepatitisu B (rDNA) z adjuvansom