FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased a see subsections below for additional information Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 4.9% and 5.7% versus 3.5%; HDL-cholesterol 3.3% and 3.6% versus 0.4 %; LDL-cholesterol 9.5% and 10.0% versus 7.5%; triglycerides 9.2% and 9.9% versus 10.5%.
Slovenian: Povprečno zvišanje vrednosti od izhodiščne za zdravljenje z empagliflozinom 10 mg in 25 mg v primerjavi s placebom je bilo 4,9 % in 5,7 % v primerjavi z 3,5 % za celokupni holesterol; 3,3 % in 3,6 % v primerjavi z 0,4 % za holesterol HDL;9,5 % in 10,0 % v primerjavi z 7,5 % za holesterol LDL; 9,2% in 9,9 % v primerjavi z 10,5 % za trigliceride.
English: Film coating Hypromellose Titanium dioxide (E171) Talc
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) smukec makrogol (400) rumeni železov oksid (E172)
English: Major hypoglycaemia (events requiring assistance) No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, add-on to pioglitazone with or without metformin, add-on to linagliptin and metformin, as adjunct to standard care therapy and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components.
Slovenian: Huda hipoglikemija (dogodki, zaradi katerih je potrebno posredovanje) Povečanja pojava hude hipoglikemije niso opazili z empagliflozinom v primerjavi s placebom kot samostojno zdravljenje, kot dodatno zdravljenje z metforminom, kot dodatno zdravljenje z metforminom in sulfonilsečnino, kot dodatno zdravljenje s pioglitazonom z metforminom ali brez njega, dodatno zdravljenje z linagliptinom in metforminom, kot dodatek k standardnemu zdravljenju in za zdravljenje s kombinacijo empagliflozina z metforminom pri predhodno nezdravljenih bolnikih v primerjavi z bolniki, zdravljenimi z empagliflozinom in metforminom kot posameznima komponentama.
English: In a pre-specified pooled analysis of three phase 3 studies, treatment with open-label empagliflozin 25 mg in patients with severe hyperglycaemia (N=184, mean baseline HbA1c 11.15%) resulted in a clinically meaningful reduction in HbA1c from baseline of 3.27% at week 24; no placebo or empagliflozin 10 mg arms were included in these studies.
Slovenian: Bolniki z visoko izhodiščno vrednostjo HbA1c >10 % V vnaprej specificirani analizi zbranih podatkov treh študij III. faze je zdravljenje z odprto uporabljenim empagliflozinom 25 mg pri bolnikih s hudo hiperglikemijo (N = 184, povprečna izhodiščna vrednost HbA1c 11,15 %) povzročilo klinično pomembno zmanjšanje vrednosti HbA1c glede na izhodiščno vrednost 3,27 % v 24. tednu; v te študije nista bili vključeni roki s placebom ali empagliflozinom 10 mg.
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor.
Slovenian: V dolgoročnih kliničnih študijah z drugim zaviralcem SGLT2 so opazili povečano število primerov amputacij na spodnjih okončinah (predvsem prstov na nogah).
English: Jardiance 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin.
Slovenian: Jardiance 25 mg filmsko obložene tablete Ena tableta vsebuje 25 mg empagliflozina.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l and 687 nmol/l with empagliflozin 25 mg once daily.
Slovenian: Z enkratno dnevno uporabo empagliflozina sta bili vrednost v plazmi v stanju dinamičnega ravnovesja AUC 1.870 nmol.h/l in vrednost Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h/l in vrednost Cmax 687 nmol/l za empagliflozin 25 mg. Sistemska izpostavljenost empagliflozinu se je večala sorazmerno z odmerkom.
English: Jardiance 10 mg film-coated tablets Each tablet contains 10 mg empagliflozin.
Slovenian: Jardiance 10 mg filmsko obložene tablete Ena tableta vsebuje 10 mg empagliflozina.
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Jardiance with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.
Slovenian: Če jemljete zdravilo Jardiance skupaj s še enim zdravilom, ki lahko zniža krvni sladkor, kot je sulfonilsečnina ali insulin, je vaše tveganje za nizek krvni sladkor večje.
English: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), add-on to basal insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1%, placebo 35.3% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8%, empagliflozin 25 mg: 41.3%, placebo: 37.2% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1%, empagliflozin 25 mg: 57.7%, placebo: 58% over the 52-week trial).
Slovenian: Večjo pogostnost so opazili pri uporabi kot dodatno zdravljenje z metforminom in sulfonilsečnino (empagliflozin 10 mg: 16,1 %, empagliflozin 25 mg: 11,5 %, placebo: 8,4 %), kot dodatno zdravljenje k bazalnemu insulinu z metforminom ali brez njega ali s sulfonilsečnino ali brez nje (empagliflozin 10 mg: 19,5 %, empagliflozin 25 mg: 28,4 %, placebo: 20,6 % v prvih 18 tednih zdravljenja, ko insulina ni bilo mogoče prilagoditi; empagliflozin 10 mg in 25 mg: 36,1 %, placebo 35,3 % v 78-tedenskem preskušanju) in dodatno zdravljenje k večkratnim dnevnim odmerkom insulina (MDI) z metforminom ali brez njega (empagliflozin 10 mg: 39,8 %, empagliflozin 25 mg: 41,3 %, placebo: 37,2 % v prvih 18 tednih, ko insulina ni bilo mogoče prilagoditi; empagliflozin 10 mg: 51,1 %, empagliflozin 25 mg: 57,7 %, placebo: 58 % v 52-tedenskem preskušanju).
English: An increased frequency was noted when given as add-on to basal insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.5%, placebo: 0.5% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, placebo: 1.6% over the 52-week trial).
Slovenian: Večjo pogostnost so opazili pri uporabi kot dodatno zdravljenje k bazalnemu insulinu z metforminom ali brez njega ali s sulfonilsečnino ali brez nje (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo: 0 % v prvih 18 tednih zdravljenja, ko insulina ni bilo mogoče prilagoditi; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo 0 % v 78-tedenskem preskušanju) in dodatno zdravljenje k večkratnim dnevnim odmerkom insulina (MDI) z metforminom ali brez njega (empagliflozin 10 mg: 0,5 %, empagliflozin 25 mg: 0,5 %, placebo: 0,5 % v prvih 18 tednih, ko insulina ni bilo mogoče prilagoditi; empagliflozin 10 mg: 1,6 %, empagliflozin 25 mg: 0,5 %, placebo: 1,6 % v 52-tedenskem preskušanju).
English: Post-marketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin.
Slovenian: V obdobju trženja so pri bolnikih, zdravljenih z empagliflozinom, poročali o primerih zapletenih okužb sečil, vključno s pielonefritisom in urosepso.Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi empagliflozina.
English: • Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
Slovenian: • Če imate težave z ledvicami, vam bo vaš zdravnik morda odmerek omejil na 10 mg enkrat na dan.
English: What Jardiance is used for
Slovenian: Za kaj uporabljamo zdravilo Jardiance
English: Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Slovenian: Jardiance 10 mg filmsko obložene tablete Jardiance 25 mg filmsko obložene tablete empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets empagliflozin
Slovenian: IME ZDRAVILA Jardiance 10 mg tablete empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets empagliflozin
Slovenian: IME ZDRAVILA Jardiance 25 mg tablete empagliflozin
English: Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Slovenian: Zato je treba pri teh bolnikih posebno pozornost nameniti vnosu tekočin v primeru sočasnega zdravljenja z zdravili, ki lahko povzročijo zmanjšanje volumna (npr. diuretiki, zaviralci ACE).Terapevtske izkušnje pri bolnikih, starih 85 let in več, so omejene.
English: Pruritus (generalised) Rash
Slovenian: Bolezni kože in podkožja pruritus (generaliziran) izpuščaj urtikarija angioedem
English: You may need to take it for months or even years.
Slovenian: Morda ga boste morali jemati več mesecev ali let.
English: You may not experience any of them.
Slovenian: Mogoče ne boste imeli nobenega od njih.
English: Study BIG 1-98
Slovenian: Študija BIG 1-98
English: Study D2407
Slovenian: Študija D2407
English: The results are summarised in Table 9:
Slovenian: Rezultati so povzeti v preglednici 9:
English: (5.4, 6.3 months)
Slovenian: (5,4, 6,3 meseca)
English: 6.0 months
Slovenian: 6,0 meseca
English: Time to progression Median
Slovenian: čas do napredovanja mediana
English: 9.4 months
Slovenian: 9,4 meseca
English: Show them the pack of tablets.
Slovenian: Osebju pokažite škatlico s tabletami.
English: {Invented Name}
Slovenian: {Izmišljeno ime}
English: Anorexia, appetite increase
Slovenian: anoreksija, povečan apetit
English: Your doctor will regularly monitor your condition to check whether the treatment is having the right effect.
Slovenian: Vaš zdravnik vas bo redno pregledoval, da bi ugotovil, ali zdravljenje dosega želeni učinek.
English: Adult and elderly patients
Slovenian: Odrasle in starejše bolnice
English: Older people (age 65 years and over) People aged 65 years and over can use this medicine at the same dose as for other adults.
Slovenian: Starejše osebe (stare 65 let ali več) Osebe, ki so stare 65 let ali več, lahko uporabljajo to zdravilo v enakih odmerkih kot drugi odrasli.
English: (95% CI for median) (8.9, 11.6 months)
Slovenian: (95 % IZ za mediano) (8,9, 11,6 meseca)
English: No specific treatment for overdose is known; treatment should be symptomatic and supportive.
Slovenian: Specifično zdravljenje prevelikega odmerjanja ni znano; zdravljenje naj bo simptomatsko in podporno.
English: Children and adolescents (below 18 years) Children and adolescents should not use this medicine.
Slovenian: Otroci in mladostniki (stari manj kot 18 let) Otroci in mladostniki ne smejo uporabljati tega zdravila.
English: The majority of the adverse reactions occurred during the first few weeks of treatment.
Slovenian: Do večine neželenih učinkov je prišlo v prvih nekaj tednih zdravljenja.
English: It is used to prevent cancer from happening again.
Slovenian: Zdravilo uporabljamo za preprečevanje ponovitve raka.
English: As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body.
Slovenian: Posledica tega je, da tumorske celice upočasnijo ali ustavijo svoje razmnoževanje in/ali širjenje po drugih delih telesa.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno s tistimi, ki ste jih dobili brez recepta.
English: The apparent terminal elimination half-life in plasma is about 2 days.
Slovenian: Navidezni končni razpolovni čas v plazmi je približno 2 dni.
English: Its apparent volume of distribution at steady state is about 1.87  0.47 l/kg.
Slovenian: Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja je približno 1,87  0,47 l/kg.
English: • Premenopausal endocrine status
Slovenian: • predmenopavzni endokrini status
English: Thrombophlebitis (including superficial and deep vein thrombophlebitis)
Slovenian: tromboflebitis (vključno s površinskim in globokim tromboflebitisom)
English: Otherwise, take the dose as soon as your remember, and then take the next tablet as you would normally.
Slovenian: - Sicer vzemite pozabljeni odmerek takoj, ko se spomnite, nato pa vzemite naslednjo tableto kot običajno.
English: Preclinical observations were confined to those associated with the recognised pharmacological action, which is the only safety concern for human use derived from animal studies.
Slovenian: Predklinična opazovanja so bila omejena na tista, ki so povezana z znanim farmakološkim delovanjem, ki je edino pomembno vprašanje glede varnosti za uporabo pri ljudeh, ki izhaja iz študij na živalih.
English: Menopausal status
Slovenian: Menopavzni status
English: Limited data are available and no recommendation on a posology can be made.
Slovenian: Na voljo je le malo podatkov in priporočil o odmerjanju ni mogoče dati.
English: Thus, glucocorticoid and mineralocorticoid supplementation is not necessary.
Slovenian: Dodajanje glukokortikoidov in mineralokortikoidov zato ni potrebno.
English: Medical treatment may be necessary.
Slovenian: Morda boste potrebovali zdravniško oskrbo.
English: Oestrogen suppression was maintained throughout treatment in all these patients.
Slovenian: Supresija estrogenov je bila pri vseh teh bolnicah ohranjena ves čas zdravljenja.
English: The frequency category for these adverse reactions is described in Table 1.
Slovenian: Kategorije pogostnosti za te neželene učinke so navedene v preglednici 1.
English: Maximum suppression is achieved in 48-78 hours.
Slovenian: Najvišjo raven zaviranja doseže zdravilo v 48-78 urah.
English: Each film-coated tablet contains 2.5 mg letrozole.
Slovenian: Ena filmsko obložena tableta vsebuje 2,5 mg letrozola.
English: Extended adjuvant treatment (MA-17)
Slovenian: Podaljšano adjuvantno zdravljenje (študija MA-17)
English: Hormone antagonist and related agents: aromatase inhibitor, ATC code: L02BG04.
Slovenian: Hormonski antagonisti in sorodne učinkovine: zaviralec aromataze, oznaka ATC: L02BG04.
English: Time to distant metastasis (secondary)
Slovenian: čas do pojava oddaljenih metastaz (sek.
English: The safety and efficacy of {Invented Name} in children and adolescents aged up to 17 years have not been established.
Slovenian: Varnost in učinkovitost zdravila {Izmišljeno ime} pri otrocih in mladostnikih, starih največ 17 let, nista bili dokazani.
English: Systemic exposure to metabolites is therefore low.
Slovenian: Sistemska izpostavljenost presnovkom je zato majhna.
English: The recommended dose of {Invented Name} is 2.5 mg once daily.
Slovenian: Priporočeni odmerek zdravila {Izmišljeno ime} je 2,5 mg enkrat na dan.
English: Your doctor will take this into account during your treatment with {Invented Name}.
Slovenian: Zdravnik bo med vašim zdravljenjem z zdravilom {Izmišljeno ime} to upošteval.
English: Note: Median duration of treatment 60 months.
Slovenian: Opomba: mediana vrednost trajanja zdravljenja je bila 60 mesecev.
English: In a variety of preclinical safety studies conducted in standard animal species, there was no evidence of systemic or target organ toxicity.
Slovenian: Pri celi vrsti predkliničnih študij varnosti, opravljenih na običajnih živalskih vrstah, niso opažali nikakršnih znakov sistemske toksičnosti ali toksičnosti za tarčne organe.
English: Letrozole is rapidly and completely absorbed from the gastrointestinal tract (mean absolute bioavailability: 99.9%).
Slovenian: Letrozol se hitro in v celoti absorbira iz prebavil (povprečna absolutna biološka uporabnost: 99,9 %).
English: In dogs letrozole caused signs of moderate toxicity at 100 mg/kg.
Slovenian: Pri psih je letrozol povzročal znake zmerne toksičnosti pri odmerku 100 mg/kg.
English: Method of administration {Invented Name} should be taken orally and can be taken with or without food.
Slovenian: Način uporabe Zdravilo {Izmišljeno ime} je treba jemati peroralno, mogoče ga je jemati s hrano ali brez nje.
English: What {Invented Name} is and what it is used for What you need to know before you take {Invented Name} How to take {Invented Name} Possible side effects
Slovenian: Kaj je zdravilo {Izmišljeno ime} in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo {Izmišljeno ime} Kako jemati zdravilo {Izmišljeno ime} Možni neželeni učinki
English: The benefit in favour of letrozole was observed regardless of nodal status.
Slovenian: Korist v prid letrozolu so ugotavljali ne glede na status bezgavk.
English: Do not be alarmed by this list of possible side effects.
Slovenian: Naj vas ta seznam možnih neželenih učinkov ne prestraši.
English: The effect of potent CYP450 inhibitors is unknown.
Slovenian: Vpliv močnih zaviralcev encima CYP450 ni znan.
English: The concentration of letrozole in erythrocytes is about 80% of that in plasma.
Slovenian: Koncentracija letrozola v eritrocitih je približno 80 % koncentracije v plazmi.
English: Investigations Common:
Slovenian: Preiskave pogosti:
English: 3, including deaths from any cause
Slovenian: z upoštevanjem smrti iz kateregakoli vzroka dogodki
English: It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years treatment with tamixofen.
Slovenian: Lahko ga uporabljamo kot prvo zdravilo pred operacijo raka dojke, če takojšnja operacija ni primerna, lahko kot prvo zdravilo po operaciji raka dojke ali pa po petletnem zdravljenju s tamoksifenom.
English: Cox model Pvalue
Slovenian: Coxov model vrednost P
English: Percentages in parentheses indicate event frequencies any time after randomisation, including post study treatment period.
Slovenian: Odstotki v oklepaju opisujejo pogostnost dogodkov kadarkoli po randomizaciji, kar vključuje tudi čas zdravljenja po zaključku študije.
English: If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate any tools or machines until you feel normal again.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če čutite omotičnost, utrujenost, zaspanost ali se na splošno slabo počutite, ne vozite in ne upravljajte naprav ali strojev, dokler se ne počutite spet povsem normalno.
English: If the response is not adequate, treatment with {Invented Name} should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Slovenian: Če odziv ni zadosten, je treba zdravljenje z zdravilom {Izmišljeno ime} prekiniti in se z bolnico dogovoriti za kirurški poseg in/ali druge možnosti zdravljenja.
English: The frequencies of adverse reactions for {Invented Name} are mainly based on data collected from clinical trials.
Slovenian: Pogostnosti neželenih učinkov zdravila {Izmišljeno ime} večinoma temeljijo na podatkih, ki so jih pridobili v kliničnih preskušanjih.
English: The symptom that bothered most patients in both treatment arms was aching muscles, with a statistically significant difference in favour of placebo.
Slovenian: Simptomi, ki so motili večino bolnic v obeh zdravljenih skupinah, so bili bolečine v mišicah, in sicer s statistično značilno razliko v prid placebu.
English: Metabolism of letrozole is partly mediated via CYP2A6 and CYP3A4.
Slovenian: Metabolizem letrozola se deloma odvija s pomočjo encimov CYP2A6 in CYP3A4.
English: Reporting period includes treatment period plus 30 days after stopping treatment.
Slovenian: Obdobje poročanja neželenih učinkov vključuje obdobje zdravljenja in 30 dni po zaključku zdravljenja.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common 10%, common 1% to 10%, uncommon 0.1% to 1%, rare 0.01% to 0.1%, very rare 0.01%, not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, pri čemer je uporabljen naslednji dogovor: zelo pogosti ≥10%, pogosti ≥1% do <10%, občasni ≥0,1% do <1%, redki ≥0,01% do <0,1%, zelo redki <0,01%, neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Other medicines and {Invented Name}
Slovenian: Druga zdravila in zdravilo {Izmišljeno ime}
English: In repeated-dose toxicity studies in rats and dogs up to 12 months, the main findings observed can be attributed to the pharmacological action of the compound.
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih, ki so jih izvajali na podganah in psih in so trajale največ 12 mesecev, je mogoče glavne izsledke pripisati farmakološkemu delovanju spojine.
English: Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogens in your body.
Slovenian: Do nekaterih od teh neželenih učinkov, kot so vročinski oblivi, izpadanje las ali krvavitev iz nožnice, lahko pride zaradi pomanjkanja estrogenov v vašem telesu.
English: Women of perimenopausal status or child-bearing potential {Invented Name} should only be used in women with a clearly established postmenopausal status (see section 4.4).
Slovenian: Ženske s perimenopavznim statusom ali v rodni dobi Zdravilo {Izmišljeno ime} smejo uporabljati samo ženske z jasno ugotovljenim postmenopavznim statusom (glejte poglavje 4.4).
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Slovenian: Opomba: Ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, veljavne ob izdaji Odločbe komisije.
English: However, your doctor should discuss with you about using effective contraceptive, as you may still have the potential to become pregnant during treatment with {Invented Name}.
Slovenian: Vsekakor se z zdravnikom pogovorite o uporabi učinkovite kontracepcije, saj sicer še vedno obstaja možnost, da bi zanosili v času zdravljenja z zdravilom {Izmišljeno ime}.
English: Stratified by receptor status, nodal status and prior adjuvant chemotherapy.
Slovenian: s stratifikacijo na receptorski status, status bezgavk in predhodno adjuvantno kemoterapijo.
English: In a 104-week rat carcinogenicity study, no treatment-related tumours were noted in male rats.
Slovenian: V 104-tedenski raziskavi kancerogenosti na podganah niso pri podganjih samcih našli nikakršnih z zdravilom povezanih tumorjev.
English: {Invented Name} is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.
Slovenian: Zdravilo {Izmišljeno ime} uporabljamo tudi za preprečevanje širjenja raka v druge dele telesa pri bolnicah z napredovalim rakom dojke.
English: Important additional adverse reactions that may occur with {Invented Name} are: skeletal events such as osteoporosis and/or bone fractures and cardiovascular events (including cerebrovascular and thromboembolic events).
Slovenian: Drugi pomembni neželeni učinki, do katerih lahko pride pri uporabi zdravila {Izmišljeno ime}, so: skeletni dogodki, kot so osteoporoza in/ali zlomi kosti, ter kardiovaskularni dogodki (vključno s cerebrovaskularnimi in trombemboličnimi dogodki).
English: Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%).
Slovenian: Letrozol se v približno 60 % veže na beljakovine v plazmi, predvsem na albumine (v 55 %).
English: The final analysis conducted at a median follow-up of 62 months confirmed the significant reduction in the risk of breast cancer recurrence with {Invented Name}.
Slovenian: Rezultati končne analize po medianem trajanju spremljanja 62 mesecev so potrdili značilno zmanjšanje tveganja za ponovitev raka dojke pri uporabi zdravila {Izmišljeno ime}.