FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, for Section 4.8 - Undesirable Effects, the wording was significantly shortened and condensed.
Slovenian: Zlasti za poglavje 4.8 - Neželeni učinki je bilo besedilo močno skrajšano in zgoščeno.
English: A referral under Article 30(2) of Directive 2001/83/EC, as amended was therefore triggered to resolve these divergences and thus harmonise the product information (PI) across the EU.
Slovenian: Zato je bila na podlagi člena 30 (2) Direktive 2001/83/ES, kakor je bila spremenjena, sprožena napotitev za razrešitev teh razhajanj in s tem uskladitev informacij o zdravilu v EU.
English: In conclusion, the following harmonised indications were adopted for Femara:
Slovenian: Na koncu so bile sprejete naslednje usklajene indikacije za zdravilo Femara:
English: Overall summary of the scientific evaluation of Femara and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Femara in z njim povezanih imen (glejte Prilogo I)
English: The CHMP therefore considered it justified to qualify the indication with “invasive”.
Slovenian: Zato je CHMP menil, da lahko indikacijo upravičeno označimo z „invazivno“.
English: While a contraindication in these patients was not warranted, the CHMP inserted a precaution.
Slovenian: Čeprav kontraindikacija pri teh bolnikih ni bila utemeljena, je CHMP vključil previdnostni ukrep.
English: Women with a history of fractures and/or osteoporosis experienced higher rates of bone fractures than women without such a history, irrespective of treatment.
Slovenian: Ženske z anamnezo zlomov in/ali osteoporoze so imele pogostejše zlome kosti kot ženske brez takšne anamneze, ne glede na zdravljenje.
English: In addition, no studies on DCIS (ductal carcinoma in situ) or LCIS (lobular carcinoma in situ) patients have been performed.
Slovenian: Poleg tega niso bile opravljene študije pri bolnicah z DCIS (duktalni karcinom in situ) ali LCIS (lobularni karcinom in situ).
English: The CHMP therefore added a statement regarding bone effects associated with the use of Femara.
Slovenian: Zato je CHMP dodal izjavo glede učinkov na kosti, povezanih z uporabo zdravila Femara.
English: The CHMP considered that reviews of clinical databases are poorly suited to assess the risk for interactions or to assess reports of lack of interaction and therefore removed references to these reviews.
Slovenian: CHMP je menil, da pregledi kliničnih podatkovnih baz niso primerni za oceno tveganja za interakcije ali za oceno poročil o pomanjkanju interakcije, zato je odstranil sklicevanje na te preglede.
English: Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Femara and associated names is favourable.
Slovenian: Po preučitvi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, poročil o oceni, ki sta jih priskrbela poročevalec in soporočevalec, in znanstvenih razprav v Odboru, je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Femara in z njim povezanih imen ugodno.
English: Regarding children, invasive breast cancer is extremely rare in children and adolescents but has been reported.
Slovenian: Pri otrocih in mladostnikih je invazivni rak dojke izredno redek, čeprav so že poročali o njem.
English: The CHMP also added a warning that oestrogens and/or tamoxifen may reduce letrozole plasma levels, thus reducing its pharmacological action, and that co-administration should therefore be avoided.
Slovenian: CHMP je dodal opozorilo tudi, da lahko estrogeni in/ali tamoksifen zmanjšajo ravni letrozola v plazmi, kar zmanjšuje njegovo farmakološko delovanje, zato se je treba izogibati sočasni uporabi.
English: Regarding adjuvant and extended adjuvant treatment, studies show that efficacy was sustained over the median duration of 5 years of treatment.
Slovenian: Glede adjuvantnega in podaljšanega adjuvantnega zdravljenja študije kažejo, da se je učinkovitost zdravila ohranila za mediano trajanje zdravljenja 5 let.
English: Regarding duration of treatment, the CHMP considered that studies show that Femara treatment should be continued until further progression of disease becomes evident.
Slovenian: Glede trajanje zdravljenja je CHMP menil, da študije kažejo, da je treba zdravljenje z zdravilom Femara nadaljevati, dokler se ne pokaže napredovanje bolezni.
English: Regarding the description of selected adverse reactions, the CHMP agreed to separate the metastatic, adjuvant and extended adjuvant indications.
Slovenian: Glede opisa izbranih neželenih učinkov se je CHMP strinjal, da se ločijo metastatske, adjuvantne in podaljšane adjuvantne terapije.
English: Regarding “invasive”, it is not common practice to prescribe aromatase inhibitors to patients with no invasive component.
Slovenian: Glede „invazivnega“ se zaviralcev aromataze v splošni praksi ne predpisuje bolnicam brez invazivne komponente.
English: No studies have been performed in DCIS or LCIS on the use of extended adjuvant aromatase inhibitors after tamoxifen and there is no reason to suggest a different mechanism of action in the extended adjuvant setting compared with the adjuvant setting.
Slovenian: Pri ženskah z DCIS ali LCIS niso izvedli nobenih študij o uporabi razširjenih adjuvantnih zaviralcev aromataze po tamoksifenu in ni razlogov, da bi v podaljšanem adjuvantnem zdravljenju v primerjavi z adjuvantnim zdravljenjem predlagali drug mehanizem ukrepanja.
English: The CHMP endorsed the 2.5 mg daily dose in adults, based on several dose-finding studies.
Slovenian: CHMP je na podlagi več študij za ugotavljanje odmerka potrdil 2,5-miligramski dnevni odmerek pri odraslih.
English: The neoadjuvant (pre-operative) treatment indication represented the major deviation across the nationally approved SmPCs, as it was approved in some member states in 2001 but the application was withdrawn in others, primarily because neoadjuvant endocrine treatment was not a validated concept at the time and because the results of the pivotal adjuvant study were not yet available.
Slovenian: Indikacija neoadjuvantnega (predoperativnega) zdravljenja je predstavljala glavno odstopanje v vseh povzetkih glavnih značilnosti zdravila, odobrenih na nacionalni ravni, saj je bila v nekaterih državah članicah odobrena leta 2001, druge pa so vlogo umaknile zlasti zato, ker takrat neoadjuvantno endokrino zdravljenje ni bil potrjen koncept in ker še ni bilo na voljo rezultatov ključne dopolnilne študije.
English: The CHMP noted the pivotal study for the adjuvant treatment indication, BIG 1-98, coordinated by the collaborative group IBCSG (International Breast Cancer Study Group) and the parent organization BIG (Breast International Group), which specifically excluded patients who did not have a confirmed diagnosis of invasive breast cancer.
Slovenian: CHMP je upošteval študijo BIG 1-98, ki je ključna za indikacijo adjuvantnega zdravljenja, in sta jo uskladili Mednarodna skupina za raka dojk IBCSG (International Breast Cancer Study Group) in krovna organizacija BIG (Breast International Group), pri čemer je študija izrecno izključevala bolnice brez potrjene diagnoze invazivnega raka dojke.
English: Because doubling the exposure to letrozole is not linked to safety concerns and because under-exposure should be avoided as efficacy has been shown to be dose dependent, the CHMP concluded that no dose adjustment is needed in patients with severe hepatic impairment, but that a warning should be inserted in section 4.4.
Slovenian: Ker dvakratna izpostavljenost letrozolu ni povezana s tveganjem za varnost, in ker se je treba premajhni izpostavljenosti izogibati, saj je bilo dokazano, da je učinkovitost odvisna od odmerka, je CHMP sklenil, da pri bolnikih s hudo okvaro jeter odmerka ni treba prilagajati, vendar je v poglavje 4.4 treba vnesti opozorilo.
English: A statement on the absence of studies on the use of Femara in male breast cancer was also added.
Slovenian: Prav tako so dodali izjavo o odsotnosti študij o uporabi zdravila Femara za raka dojke pri moških.
English: Letrozole inhibits the enzyme involved in the synthesis of oestrogens, which are required for proper embryo and foetal development.
Slovenian: Letrozol zavira encim, ki sodeluje pri sintezi estrogenov, ki so potrebni za pravilen razvoj zarodka in ploda.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: In addition, letrozole is not considered to have a narrow therapeutic index.
Slovenian: Poleg tega se letrozol ne uvršča med zdravila z ozkim terapevtskim indeksom.
English: For the remaining sections, the CHMP adopted a harmonised wording in line with the nationally approved SmPCs, although minor revisions were made.
Slovenian: Za ostala poglavja je CHMP sprejel usklajeno besedilo, skladno s povzetki glavnih značilnosti zdravila, ki so odobreni na nacionalni ravni, čeprav je naredil manjše popravke.
English: Femara was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Slovenian: Zdravilo Femara je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila zaradi različnih nacionalnih odločitev držav članic glede dovoljenja za promet z omenjenim zdravilom.
English: Regarding the pre-operative use of letrozole if receptor status is negative or unknown, the CHMP considered a contraindication to be unnecessary, as this is already sufficiently explained in Section 4.4.
Slovenian: Če je status receptorjev negativen ali neznan, je CHMP glede predoperativne uporabe letrozola menil, da kontraindikacija ni potrebna, saj je to že dovolj pojasnjeno v poglavju 4.4.
English: A statement recommending against the use of Femara for patients with problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption was also added.
Slovenian: Dodana je bila tudi izjava, ki odsvetuje uporabo zdravila Femara za bolnike z intoleranco za galaktozo, hudim pomanjkanjem laktaze ali malabsorpcijo glukoze/galaktoze.
English: In the absence of clinical trials, the CHMP therefore concluded that the safety and efficacy of Femara in this population is not established.
Slovenian: Ker ni bilo kliničnih preskušanj, je CHMP zaključil, da varnost in učinkovitost zdravila Femara pri tej populaciji nista dokazani.
English: Regarding use in elderly, the CHMP did not consider dose adjustment to be required, based on analyses of efficacy and safety conducted for all pivotal studies with Femara.
Slovenian: Glede uporabe pri starejših je CHMP menil, da prilagoditev odmerka ni potrebna, kar je ugotovil na podlagi analize učinkovitosti in varnosti, izvedene za vse ključne študije za zdravilo Femara.
English: The CHMP instead included a warning in Section 4.4 stating that safety data in patients with significant organ impairment are lacking.
Slovenian: Zato je CHMP v poglavje 4.4 raje vključil opozorilo, ki navaja, da ni dovolj podatkov o varnosti za bolnike s hudo okvaro organov.
English: The CHMP noted that while elimination of metabolites is expected to be slower in patients with renal impairment, the available data show that this did not affect the safety profile and did not alter pharmacokinetics in patients with severe renal impairment.
Slovenian: CHMP je ugotovil, da je sicer izločanje presnovkov po pričakovanjih počasnejše pri bolnikih z ledvično okvaro, vendar razpoložljivi podatki kažejo, da to ni vplivalo na varnostni profil zdravila in ni spremenilo farmakokinetike pri bolnikih s hudo okvaro ledvic.
English: As a result, efficacy was suboptimal and high rates of menopausal symptoms such as hot flushes occurred, as their perimenopausal status was insufficient to suppress the feedback loop of oestrogen synthesis.
Slovenian: Zaradi tega je bila učinkovitost suboptimalna in so se pojavili številni simptomi menopavze, kot so vročinski oblivi, saj njihov perimenopavzni status ni zadoščal za zaviranje encimov, ki sodelujejo pri sintezi estrogenov.
English: Regarding bone effects, the CHMP reviewed data from studies showing that long-term use of Femara is associated with a significantly higher rate of osteoporosis and a significantly higher rate of bone fractures than tamoxifen (adjuvant setting) or placebo (extended adjuvant setting).
Slovenian: Glede učinkov na kosti je CHMP pregledal podatke iz študij, ki kažejo, da je dolgoročna uporaba zdravila Femara povezana z bistveno višjo stopnjo osteoporoze in bistveno višjo stopnjo zlomov kosti kot pri tamoksifenu (adjuvantnem zdravljenju) ali placebu (podaljšanem adjuvantnem zdravljenju).
English: The CHMP considered the term “hormone-dependent” to be justified, as letrozole has no efficacy in hormone receptor negative breast cancer.
Slovenian: CHMP je menil, da je izraz „hormonsko odvisen“ upravičen, saj letrozol ni učinkovit pri raku dojke z negativnimi hormonskimi receptorji.
English: Finally, the CHMP inserted a statement advising against the co-administration of Femara with tamoxifen, other anti-oestrogens or oestrogens.
Slovenian: Nazadnje je CHMP dodal izjavo, ki odsvetuje sočasno uporabo zdravila Femara z tamoksifenom, drugimi antiestrogeni ali estrogeni.
English: Regarding male breast cancer, the CHMP noted the absence of clinical trials or specific systematic investigation on the use of Femara in male breast cancer.
Slovenian: Glede raka dojke pri moških je CHMP ugotovil, da ni kliničnih preskušanj ali posebne sistematične preiskave o uporabi zdravila Femara za raka dojke pri moških.
English: For Section 5.1Pharmacodynamic Properties, the wording was substantially shortened to focus on information relevant to the prescriber for the approved indications.
Slovenian: Za poglavje 5.1 - Farmakodinamične lastnosti je bilo besedilo močno skrajšano, da so poudarjene informacije za odobrene indikacije, ki so pomembne za zdravnika, ki to zdravilo predpisuje.
English: The CHMP also clarified the contraindications for pregnancy and breast-feeding, making the information more visible and included a contraindication for known hypersensitivity to letrozole or to any of the excipients.
Slovenian: CHMP je pojasnil tudi kontraindikacije med nosečnostjo in dojenjem, tako da so podatki bolj vidni, in vključil kontraindikacije za znano preobčutljivost na letrozol ali katero koli pomožno snov.
English: The CHMP also considered information on the treatment duration with tamoxifen to be justified, based on studies in which letrozole was administered after 5 years of adjuvant tamoxifen.
Slovenian: CHMP je prav tako menil, da je upravičen tudi podatek o trajanju zdravljenja s tamoksifenom, ki temelji na študijah, v katerih so letrozol dajali po 5 letih adjuvantnega zdravljenja s tamoksifenom.
English: Regarding renal impairment, the CHMP noted that there is very limited information about patients whose creatinine clearance is below 10 ml/min and therefore agreed on a precaution for these patients.
Slovenian: Glede ledvične okvare je CHMP ugotovil, da obstaja zelo malo podatkov za bolnike z očistkom kreatinina pod 10 ml/min, zato je soglašal, da je pri teh bolnikih potrebna previdnost.
English: Femara contains letrozole, an aromatase inhibitor which inhibits the conversion of androgens to oestrogens.
Slovenian: Zdravilo Femara vsebuje letrozol, zaviralec aromataze, ki zavira pretvorbo androgenov v estrogene.
English: The CHMP considered the indication to be well-established and that confirmation of postmenopausal endocrine status of women before initiation of treatment is justified for both efficacy and safety reasons, as studies have shown that women with induced menopausal status may not be of postmenopausal endocrine status.
Slovenian: CHMP je menil, da je indikacija dobro utemeljena in da je potrditev pomenopavznega endokrinega statusa žensk pred začetkom zdravljenja upravičena tako zaradi učinkovitosti kot tudi varnosti, saj so študije pokazale, da ženske z induciranim menopavznim statusom morda nimajo pomenopavznega endokrinega statusa.
English: Regarding neoadjuvant treatment, recent studies investigating duration of therapy show higher response rates and more patients becoming suitable for BCS at 4-8 months, with very little incremental benefit beyond that and that the minimum duration is 4-6 months.
Slovenian: Glede neoadjuvantnega zdravljenja so najnovejše študije, ki so raziskovale trajanje zdravljenja, pokazale večjo stopnjo odzivnosti in več bolnic, ki so po 4-8 mesecih postale primerne za ohranitveno operacijo dojke, po tem obdobju pa je bila korist le malo večja, in da traja zdravljenje vsaj 4-6 mesecev.
English: The CHMP was also of the opinion that there is a concern of reduced efficacy of letrozole in premenopausal or perimenopausal women.
Slovenian: CHMP je menil tudi, da obstaja pomislek glede zmanjšane učinkovitosti letrozola pri ženskah pred menopavzo ali v perimenopavzi.
English: Letrozole is thus predicted to have a potential for adverse effects on the embryo-foetus, as confirmed by studies in pregnant rats and rabbits.
Slovenian: Zato se predvideva, da ima lahko Letrozol neželene učinke za zarodek ali plod, kar je bilo potrjeno v študijah na brejih podganah in kunkah.
English: Regarding hepatic impairment, the CHMP considered that a strict contraindication is not appropriate for letrozole, which is a potentially life-saving treatment with a relatively benign safety profile.
Slovenian: Glede okvare jeter je CHMP menil, da stroga kontraindikacija ni primerna za zdravljenje z letrozolom, ki lahko rešuje življenja in ima relativno benigen varnostni profil.
English: The CHMP concluded that no specific warnings or dose adjustments recommendations are needed for patients with CrCl  10 ml/min.
Slovenian: CHMP je zaključil, da pri bolnicah z očistkom kreatinina  10 ml/min niso potrebna posebna opozorila ali priporočila glede prilagoditve odmerkov.
English: The CHMP noted the absence of adequate clinical trials in pregnant women and that isolated cases of birth defects have been reported in pregnant women exposed to Femara, while nonclinical studies have shown that letrozole is embryotoxic and foetotoxic.
Slovenian: CHMP je ugotovil, da ni ustreznih kliničnih preskušanj pri nosečnicah in da so poročali o posameznih primerih prirojenih napak pri nosečnicah, ki so bile izpostavljene zdravilu Femara, medtem ko so predklinične študije pokazale, da je letrozol embriotoksičen in fetotoksičen.
English: Femara is approved for a number of indications related to the treatment of breast cancer in postmenopausal women with disease progression.
Slovenian: Zdravilo Femara je odobreno za številne indikacije, ki so povezane z zdravljenjem napredovalega raka dojke pri ženskah po menopavzi.
English: Regarding renal impairment, the CHMP noted the available pharmacokinetics report and observed that letrozole is mainly cleared by the hepatic metabolism, with renal clearance reported to be less than 5%.
Slovenian: Glede ledvične okvare je CHMP preučil razpoložljivo farmakokinetično poročilo in ugotovil, da se letrozol v glavnem izloča z jetrno presnovo, poročani ledvični očistek pa je manj kot 5 %.
English: The CHMP reviewed the potential for interaction of a number of substances, including cimetidine and anti-cancer agents, as well as the role played by CYP2A6 and CYP3A4 in the metabolism of letrozole.
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij CHMP je pregledal možnosti za medsebojno delovanje številnih snovi, vključno s cimetidinom in zdravili proti raku, pa tudi vlogo, ki jo imata CYP2A6 in CYP3A4 v presnovi letrozola.
English: Regarding hepatic impairment, the CHMP noted that studies have shown that Femara is safe in mild to moderate hepatic insufficiency but that there is limited experience of use in patients with severely impaired hepatic function, non-cancer patients with liver cirrhosis and/or Child-Pugh stage C liver insufficiency.
Slovenian: Glede okvare jeter je CHMP ugotovil, da so študije pokazale, da je zdravilo Femara varno pri blagi do zmerni jetrni insuficienci, da pa je malo izkušenj z uporabo pri bolnikih s hudo okvaro delovanja jeter, nerakavih bolnikih s cirozo jeter in/ali jetrno insuficienco razreda C po razvrstitvi Child-Pugh.
English: The CHMP also noted the limitations of the pregnancy prevention tools and therefore considered that postmenopausal status must be fully established before initiation of and during treatment of Femara and that Femara should not be used in women when postmenopausal status is not fully established.
Slovenian: CHMP je opozoril tudi na omejitev sredstev za preprečevanje nosečnosti, zato je menil, da je treba pred začetkom in med zdravljenjem z zdravilom Femara dokončno ugotoviti pomenopavzni status in da ženske, ki nimajo dokončno ugotovljenega pomenopavznega statusa, ne smejo uporabljati zdravila Femara.
English: Regarding premenopausal endocrine status, the CHMP noted that although no clinical trials testing the safety or efficacy of Femara in premenopausal women have been conducted, there are safety reasons for not treating premenopausal or even perimenopausal women with letrozole.
Slovenian: Glede predmenopavznega endokrinega statusa je CHMP ugotovil, da čeprav niso bila izvedena klinična preskušanja za varnost ali učinkovitost zdravila Femara pri ženskah pred menopavzo, obstajajo varnostni razlogi proti zdravljenju žensk pred menopavzo ali celo v perimenopavzi z letrozolom.
English: “Section 4.1 - Therapeutic indications
Slovenian: „Poglavje 4.1 - Terapevtske indikacije
English: Regarding hepatic impairment, the CHMP noted that no signal was raised regarding the safety of Femara in patients with severe impairment of hepatic function.
Slovenian: Glede okvare jeter je CHMP ugotovil, da ni bilo opozorilnega znaka v zvezi z varnostjo zdravila Femara pri bolnikih s hudo okvaro delovanja jeter.
English: The CHMP concluded that there are significant safety concerns warranting a contraindication in premenopausal women, specifically in women of premenopausal endocrine status.
Slovenian: CHMP je zaključil, da obstajajo resna tveganja glede varnosti, ki utemeljujejo kontraindikacijo pri ženskah pred menopavzo, zlasti pri ženskah s predmenopavznim endokrinim statusom.
English: The adverse drug reactions table was structured according to the SmPC guideline and several ADRs were relocated under more appropriate system organ class.
Slovenian: Razpredelnica neželenih učinkov zdravila je bila oblikovana v skladu s smernicami za povzetek glavnih značilnosti zdravila, poleg tega pa je bilo več neželenih učinkov prestavljenih v ustreznejši razred organskega sistema.
English: The CHMP considered this indication to be well-established and noted that the wording was consistent with the wording in the nationally approved SmPCs.
Slovenian: CHMP je menil, da je ta indikacija dobro utemeljena, in opazil, da je besedilo skladno z besedilom povzetkov glavnih značilnosti zdravila, odobrenih na nacionalni ravni.
English: The CHMP introduced a warning regarding postmenopausal endocrine status, as studies have shown sub-optimal efficacy and increased frequency and severity of adverse events in women with perimenopausal status.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi CHMP je predstavil opozorilo o pomenopavznem endokrinem statusu, saj so študije pokazale suboptimalno učinkovitost in večjo pogostnost in resnost neželenih dogodkov pri ženskah s perimenopavznim statusom.