FrancophonIA/ELRC3.0 huggingface dataset:
English: • rifampicin (antimycobacterial)
Slovenian: • rifampicin (antimikobakterijsko zdravilo).
English: Concomitant use of strong CYP3A4/P-gp inhibitors (e.g. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, and voriconazole) should be avoided.
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A4/P-gp (npr. atazanavirja, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, ketokonazola, itrakonazola, klaritromicina, telitromicina in vorikonazola) se je treba izogibati.
English: Following oral administration of 240 mg neratinib, absorption was slow and peak plasma concentrations of neratinib occurred around 7 hours after administration.
Slovenian: Po peroralnem dajanju 240 mg neratiniba je bila absorpcija počasna, največje vrednosti koncentracij neratiniba v plazmi pa so se pojavile približno sedem ur po dajanju.
English: Diarrhoea has been reported during treatment with Nerlynx (see Section 4.2 and Section 4.8).
Slovenian: Med zdravljenjem z zdravilom Nerlynx so poročali o driski (glejte poglavji 4.2 in 4.8).
English: 1 Event-free rates for all endpoints, except for CNS recurrence for which cumulative incidence is reported.
Slovenian: 1 Stopnje brez dogodkov za vse cilje študije, razen za ponovitev v CŽS, za katero je navedena skupna pojavnost.
English: Nerlynx 40 mg film-coated tablets
Slovenian: Nerlynx 40 mg filmsko obložene tablete
English: Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Slovenian: Neratinib se v jetrnih mikrosomih pretežno presnavlja s CYP3A4, v manjši meri pa z monooksigenazo, ki vsebuje flavin (FMO).
English: Patients with renal impairment are at a higher risk of complications of dehydration if they develop diarrhoea, and these patients should be carefully monitored (see Section 4.2).
Slovenian: Če bolniki z okvaro ledvic dobijo drisko, je tveganje za zaplete zaradi dehidracije pri njih večje in te bolnike je treba skrbno spremljati (glejte poglavje 4.2).
English: No significant changes in fertility parameters in male and female rats were detected in dosing up to 12 mg/kg/day (see Section 5.3).
Slovenian: Pri odmerjanju do 12 mg/kg/dan niso zaznali pomembnih sprememb parametrov plodnosti pri podganjih samcih in samicah (glej poglavje 5.3).
English: 52.3 years (59.9% was ≥50 years old, 12.3% was ≥65 years old); 81.0% were Caucasian, 2.6% black or African American, 13.6% Asian and 2.9% other.
Slovenian: 12,3 % jih je bilo starih ≥ 65 let); belcev je bilo 81,0 %, črnskega ali afroameriškega 2,6 %, azijskega
English: • Diarrhoea recurs to Grade 2 or higher at 120 mg per day
Slovenian: • Pri odmerku 120 mg dnevno se znova pojavi driska stopnje 2 ali višje.
English: Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive.
Slovenian: Pred uporabo zdravila Nerlynx je treba preveriti, ali je rak pri vas HER2-pozitiven.
English: P-glycoprotein transporters
Slovenian: Prenašalci glikoproteina P
English: The most common Grade 3-4 adverse reactions were diarrhoea (Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade 4, 0.1%).
Slovenian: Najpogostejša neželena učinka stopnje 3-4 sta bila driska (stopnje 3 36,9 % in stopnje 4 0,2 %) ter bruhanje (stopnje 3 3,4 % in stopnje 4 0,1 %).
English: If you take more Nerlynx than you should, contact a doctor or a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Nerlynx, kot bi smeli, se takoj obrnite na zdravnika ali bolnišnico.
English: Talk to your doctor before taking Nerlynx if you are breast-feeding or plan to breast-feed because small amounts of this medicine may pass into your breast milk.
Slovenian: Če dojite ali nameravate dojiti, se pred jemanjem zdravila Nerlynx posvetujte z zdravnikom, saj lahko majhne količine tega zdravila preidejo v vaše mleko.
English: Fractionated bilirubin and prothrombin time should also be collected during hepatotoxicity evaluation.
Slovenian: Med ocenjevanjem hepatotoksičnosti je treba zbrati tudi podatke o frakcioniranem bilirubinu in protrombinskem času.
English: If grade 3 toxicity does not recover within 3 weeks, discontinue Nerlynx permanently.
Slovenian: Če se toksičnost stopnje 3 ne izboljša v treh tednih, dajanje zdravila Nerlynx trajno ukinite.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE45
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE45
English: Third dose reduction
Slovenian: Tretje zmanjšanje odmerka
English: Guidelines for dose adjustment of Nerlynx in the event of liver toxicity are shown in Table 4.
Slovenian: Smernice za prilagoditev odmerka zdravila Nerlynx pri jetrni toksičnosti so prikazane v preglednici 4.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Nerlynx.
Slovenian: Če kar koli od zgoraj naštetega velja za vas (ali če o tem niste prepričani), se pred jemanjem zdravila
English: Dose modifications for hepatotoxicity
Slovenian: Prilagoditve odmerka za hepatotoksičnost
English: The MedDRA frequency convention and system organ class database has been utilised for the classification of frequency: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data)
Slovenian: pogosti (≥ 1/100 do < 1/10) občasni (≥ 1/1.000 do < 1/100) redki (≥ 1/10.000 do < 1/1.000) zelo redki (< 1/10.000)
English: Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
Slovenian: Moški morajo pregradno kontracepcijsko metodo uporabljati med zdravljenjem in tri mesece po koncu zdravljenja.
English: If you become pregnant while taking this medicine, the doctor will assess the potential benefit to you and the risk to the foetus, of continuing this medicine.
Slovenian: Če zanosite med jemanjem tega zdravila, bo zdravnik ocenil možne koristi za vas in tveganje za plod, ki jih pomeni nadaljevanje zdravljenja s tem zdravilom.
English: The serious adverse reactions most frequently reported in the ≥65 years-old group were vomiting (2.3%), diarrhoea (1.7%), dehydration (1.2%), and renal failure (1.2%).
Slovenian: Resni neželeni učinki, o katerih so najpogosteje poročali v starostni skupini bolnikov, starih ≥ 65 let, so bili bruhanje (2,3 %), driska (1,7 %), dehidracija (1,2 %) in odpoved ledvic (1,2 %).
English: Other medicines and Nerlynx
Slovenian: Druga zdravila in zdravilo Nerlynx
English: Patients should be instructed to initiate prophylactic treatment with an anti-diarrhoeal medicinal product with the first dose of Nerlynx, and maintain regular dosing of the anti-diarrhoeal medicinal product during the first 1-2 months of Nerlynx treatment, titrating to 1-2 bowel movements per day.
Slovenian: Bolniki morajo pri prvem odmerku zdravila Nerlynx dobiti navodila za začetek profilaktičnega zdravljenja z zdravilom za zdravljenje driske, v prvih dveh mesecih zdravljenja z zdravilom Nerlynx pa morajo jemati redne odmerke zdravila za zdravljenje driske, pri čemer naj bo odmerek tak, da bodo dnevno odvajali enkrat do dvakrat.
English: Grapefruit or grapefruit juice may also increase neratinib plasma concentrations and should be avoided.
Slovenian: Koncentracije neratiniba v plazmi se lahko povečajo tudi zaradi grenivke in grenivkinega soka, zato se jima je treba izogibati.
English: A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Slovenian: Pri enkratnem 240-miligramskem odmerku neratiniba v kombinaciji z lansoprazolom, se je vrednost AUC zmanjšala za do 70 %.
English: Nerlynx works by blocking the HER2 receptors on the cancer cells.
Slovenian: Zdravilo Nerlynx deluje tako, da zavira receptorje HER2 na rakavih celicah.
English: - lansoprazole, omeprazole or similar medicines called ‘proton pump inhibitors' or PPIs and ranitidine, cimetidine or similar medicines called ‘H2 receptor antagonists' are not recommended.
Slovenian: - lansoprazol, omeprazol ali podobna zdravila, imenovana „zaviralci protonske črpalke‟ ali PPI, in ranitidin, cimetidin ali podobna zdravila, imenovana „antagonisti receptorja H2‟, uporabe teh zdravil se ne priporoča;
English: Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
Slovenian: Neratinib se je vezal predvsem na HSA in človeški alfa-1 kisli glikoprotein (AAG).
English: If you stop taking Nerlynx
Slovenian: Če ste prenehali jemati zdravilo Nerlynx
English: Prior Trastuzumab
Slovenian: Pred trastuzumabom
English: What Nerlynx is and what it is used for What Nerlynx is
Slovenian: Kaj je zdravilo Nerlynx in za kaj ga uporabljamo Kaj je zdravilo Nerlynx
English: • fluconazole (antifungal)
Slovenian: • flukonazol (antimikotik);
English: Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Slovenian: Zdravilo Nerlynx je indicirano za podaljšano adjuvantno zdravljenje odraslih bolnikov z rakom dojke v zgodnji fazi, pri katerem so prisotni hormonski receptorji oziroma je prekomerno izražen/pomnožen HER2, in ki so adjuvantno zdravljenje s trastuzumabom zaključili pred manj kot enim letom.
English: Nerlynx can cause diarrhoea early during treatment.
Slovenian: Zdravilo Nerlynx lahko v zgodnjem obdobju zdravljenja povzroči drisko.
English: Elderly No dose adjustment is required.
Slovenian: Prilagajanje odmerka ni potrebno.
English: What you need to know before you take Nerlynx Do not take Nerlynx
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Nerlynx Ne jemljite zdravila Nerlynx:
English: Paediatric population There is no relevant use of Nerlynx in the paediatric population in the indication breast cancer.
Slovenian: Zdravilo Nerlynx ni namenjeno za uporabo pri pediatrični populaciji za indikacijo raka dojke.
English: Figure 2:
Slovenian: Slika 2:
English: Circulating metabolites include neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine N-oxide (M7) and traces of
Slovenian: Med presnovki v obtoku so neratinib piridin N-oksid (M3), Ndesmetil neratinib (M6), neratinib dimetilamin N-oksid (M7) ter sledi hidroksil-neratinib N-oksida in
English: Stop Nerlynx until recovery to Grade ≤1 or baseline within 3 weeks of stopping treatment.
Slovenian: Prekinite dajanje zdravila Nerlynx, dokler v treh tednih po prekinitvi zdravljenja ne nastopi izboljšanje na stopnjo ≤ 1 ali izhodiščno stopnjo.
English: Grapefruit juice should be avoided during treatment with Nerlynx (see Section 4.5).
Slovenian: Med zdravljenjem z zdravilom Nerlynx se je treba izogibati uživanju grenivkinega soka (glejte poglavje 4.5).
English: The clearance values of digoxin were equivalent following digoxin and digoxin plus neratinib.
Slovenian: Vrednosti očistkov digoksina so bile po dajanju digoksina ter digoksina in neratiniba enake.
English: Single doses of Nerlynx greater than 800 mg have not been administered in the clinical studies.
Slovenian: V kliničnih študijah niso bili uporabljeni enkratni odmerki zdravila Nerlynx, večji od 800 mg.
English: • Stop Nerlynx until recovery to ≤ Grade 1
Slovenian: • Prekinite dajanje zdravila Nerlynx, dokler se stanje ne izboljša na stopnjo ≤ 1.
English: In vitro studies demonstrated that neratinib is a substrate for P-glycoprotein (P-gp).
Slovenian: V študijah in vitro so dokazali, da je neratinib substrat za P-glikoprotein (P-gp).
English: Treatment of patients with severe renal impairment or on dialysis is not recommended (see Section 5.2).
Slovenian: Zdravljenje bolnikov s hudo okvaro ledvic ali bolnikov na dializi ni priporočljivo (glejte poglavje 5.2).
English: Nerlynx 40 mg film-coated tablets neratinib
Slovenian: Nerlynx 40 mg filmsko obložene tablete neratinib
English: • Grade 2 diarrhoea lasting 5 days or longer‡
Slovenian: • Driska stopnje 2, ki traja pet ali več dni‡.
English: Carcinogenesis, mutagenesis Nerlynx was neither clastogenic nor mutagenic in the standard battery of genotoxicity studies.
Slovenian: V standardnem naboru študij genotoksičnosti zdravilo Nerlynx ni bilo ne klastogeno ne mutageno.
English: What Nerlynx looks like and contents of the pack
Slovenian: Izgled zdravila Nerlynx in vsebina pakiranja
English: • Grade 2 diarrhoea [increase of 4-6 stools per day over baseline] lasting < 5 days
Slovenian: • Driska stopnje 2 (povečanje za 4-6 odvajanj dnevno glede na izhodišče), ki traja < 5 dni.
English: 26 vs. 55
Slovenian: s 55
English: Diarrhoea usually happens early in treatment with Nerlynx and may be severe, causing you to get dehydrated.
Slovenian: Driska se običajno pojavlja v zgodnjem obdobju zdravljenja z zdravilom Nerlynx in je lahko tako huda, da dehidrirate.
English: It is not known whether neratinib is excreted in human milk.
Slovenian: Ni znano, ali se neratinib izloča v materino mleko.
English: • Key messages on how to prevent and minimise GI toxicity through appropriate monitoring (with reference to treatment journal) and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o when to alert HCP and the importance of it for further treatment adjustment
Slovenian: • ključna sporočila o tem, kako preprečevati in zmanjšati toksičnost za prebavila z ustreznim spremljanjem (s sklicem na dnevnik zdravljenja) in ukrepi:
English: Concomitant treatment with inhibitors of CYP3A4 and P-gp Concomitant treatment with strong CYP3A4 and P-gp inhibitors should be avoided due to risk of increased exposure to neratinib (see Section 4.2 and Section 4.5).
Slovenian: Sočasno zdravljenje z zaviralci CYP3A4 in P-gp Zaradi tveganja povečane izpostavljenosti neratinibu se je treba sočasnemu zdravljenju z močnimi zaviralci CYP3A4 in P-gp izogibati (glejte poglavji 4.2 in 4.5).
English: This results in the cancer cells dividing and growing faster.
Slovenian: Zato se rakave celice hitreje delijo in hitreje rastejo.
English: Grade 3 ALT or bilirubin occurs again despite one dose reduction, permanently discontinue Nerlynx.
Slovenian: Če se kljub zmanjšanju odmerka spet pojavi ALT ali bilirubin stopnje 3, trajno ukinite dajanje zdravila Nerlynx.
English: - If you forget a dose, wait until the next day before you take the next dose.
Slovenian: Če ste pozabili vzeti zdravilo Nerlynx - Če pozabite vzeti odmerek, naslednji odmerek vzemite naslednji dan. - Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Neratinib represents the most prominent component in plasma and systemic exposure to the metabolites (M3, M6, M7 and M11) after oral administration of neratinib is between 10% and 33% lower than parent in healthy subjects.
Slovenian: Neratinib je najpomembnejša oblika v plazmi in sistemska izpostavljenost presnovkom (M3, M6, M7 in M11) po peroralnem dajanju neratiniba je pri zdravih osebah za 10 do 33 % nižja od sistemske izpostavljenosti nespremenjeni učinkovini.
English: - antacid medicines - the dose of these medicines and Nerlynx should be separated by at least 3 hours.
Slovenian: - antacidi - med jemanjem odmerka teh zdravil in odmerka zdravila Nerlynx naj pretečejo vsaj tri ure.
English: Dose reductions occurred in 24.7% of Nerlynx-treated patients.
Slovenian: Do zmanjšanja odmerka je prišlo pri 24,7 % bolnikov, zdravljenih z zdravilom Nerlynx.
English: Second dose reduction
Slovenian: Drugo zmanjšanje odmerka
English: The incidence of Grade 1 and Grade 2 was 13.3% and 2.9% respectively; 0.4% of Nerlynx-treated patients experienced Grade 3 rash.
Slovenian: Pojavnost stopenj 1 in 2 je bila 13,3 oziroma 2,9 %; pri 0,4 % bolnikov, zdravljenih z zdravilom Nerlynx, se je pojavil izpuščaj stopnje 3.
English: Hormone receptor positive patients, disease-free survival by patient subgroup
Slovenian: Bolnice, pozitivne za hormonski receptor, preživetje brez ponovitve bolezni glede na podskupino bolnic
English: In patients with severe hepatic impairment (Child-Pugh C) there is a 2.8-fold increase of exposure to neratinib (see Section 5.2).
Slovenian: Bolniki s hudo okvaro jeter (stopnje C po Child-Pughovi klasifikaciji) so 2,8-krat bolj izpostavljeni neratinibu (glejte poglavje 5.2).
English: Use of CYP3A4/P-gp inhibitors If the inhibitor cannot be avoided, reduce Nerlynx dose to 40 mg (one 40 mg tablet) taken once daily with a strong CYP3A4/P-gp inhibitor.
Slovenian: Če se zaviralcu ni mogoče izogniti, zmanjšajte odmerek zdravila Nerlynx na 40 mg (ena 40miligramska tableta), ki se jemlje enkrat dnevno z močnim zaviralcem CYP3A4/P-gp.
English: In rabbits, there were no effects on mating or the ability of animals to become pregnant, but embryofoetal lethality and foetal morphologic anomalies (e.g. domed head, dilation of brain ventricles and misshapen anterior fontanelles and enlarged anterior and/or posterior fontanelles) were observed at doses that may be considered to be clinically relevant.
Slovenian: Pri kuncih ni bilo učinkov na parjenje ali zmožnost obrejitve, vendar so pri klinično relevantnih odmerkih, opazili povečano smrtnost zarodkov/plodov in morfološke anomalije ploda (npr. kupolasta glava, razširitev možganskih ventriklov, deformirana sprednja mečava ter povečana sprednja in/ali zadnja mečava).
English: Tell your doctor or pharmacist if you notice any of the following side effects:
Slovenian: Zdravnika ali farmacevta zlasti obvestite, če jemljete katero od naslednjih zdravil:
English: First dose reduction
Slovenian: Prvo zmanjšanje odmerka
English: Abdominal distension, dry mouth and dyspepsia
Slovenian: pogosti napenjanje v trebuhu, suha usta in dispepsija
English: This is because the grapefruit may interact with Nerlynx and affect how the medicine works.
Slovenian: To morate upoštevati zato, ker lahko grenivka medsebojno deluje z zdravilom Nerlynx in vpliva na njegovo delovanje.
English: Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib.
Slovenian: Ena filmsko obložena tableta vsebuje neratinibijev maleat, kar ustreza 40 mg neratiniba.
English: 19 vs. 35
Slovenian: s 35
English: Elderly In the pivotal phase III study, ExteNET (3004), the mean age was 52 years in the Nerlynx arm,
Slovenian: Starejši bolniki V ključni študiji III. faze, ExteNET (3004), je bila povprečna starost v kraku z zdravilom Nerlynx
English: • For toxicities that result in a treatment delay > 3 weeks, or
Slovenian: • pri katerih se stanje zaradi toksičnosti, povezane z zdravljenjem, ne izboljša na stopnjo od 0 do • pri katerih obstajajo toksičnosti, zaradi katerih je treba zdravljenje odložiti za > 3 tedne, ali
English: Dose modifications for hepatotoxicity Severity of hepatotoxicity*
Slovenian: Preglednica 4: Prilagoditve odmerka za hepatotoksičnost Resnost hepatotoksičnosti*
English: Clinical efficacy and safety
Slovenian: Varnosti in učinkovitosti zdravila
English: • Grade 1 diarrhoea [increase of < 4 stools per day over baseline]
Slovenian: • Driska stopnje 1 (povečanje za < 4 odvajanja dnevno glede na izhodišče).
English: Do not use Nerlynx if you notice any signs of damage to the packaging or if there are any signs of tampering (e.g., inner seal is broken).
Slovenian: Če opazite kakršne koli znake, da je ovojnina poškodovana, ali znake, da je bila že odprta (npr. če je notranja zaščitna folija pretrgana), zdravila Nerlynx ne uporabljajte.
English: Treatment of patients with Child-Pugh C hepatic impairment is not recommended (see Section 5.2).
Slovenian: Zdravljenje bolnikov z okvaro jeter stopnje C po Child-Pughovi klasifikaciji ni priporočljivo (glejte poglavje 5.2).
English: Diarrhoea led to hospitalisation in 1.9% of Nerlynx-treated patients.
Slovenian: Zaradi driske je bilo hospitaliziranih 1,9 % bolnikov, zdravljenih z zdravilom Nerlynx.
English: Package leaflet: Information for the patient Nerlynx 40 mg film-coated tablets neratinib This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Nerlynx 40 mg filmsko obložene tablete neratinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Nail disorder3, skin fissures and dry skin
Slovenian: pogosti bolezen nohtov3, razpoke na koži in suha koža
English: Hepatic-associated adverse reactions in the pivotal phase III study, ExteNET (3004), were reported more frequently in the Nerlynx arm compared to the placebo arm (12.4% vs. 6.6%), due primarily to alanine aminotransferase (ALT) increased (8.5% vs. 3.2%), aspartate aminotransferase (AST) increased (7.4 vs 3.3%) and blood alkaline phosphatase increased (2.1% vs. 1.1%).
Slovenian: V ključni študiji III. faze, ExteNET (3004), so o neželenih učinkih, povezanih z jetri, v kraku z zdravilom Nerlynx poročali pogosteje kot v kraku s placebom (12,4 v primerjavi s 6,6 %), pretežno zaradi povečanja vrednosti alanin aminotransferaze (ALT) (8,5 v primerjavi s 3,2 %), povečanja vrednosti aspartat-aminotransferaze (AST) (7,4 v primerjavi s 3,3 %) in povečanja vrednosti alkalne fosfataze v krvi (2,1 v primerjavi z 1,1 %).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
English: Severity of diarrhoea*
Slovenian: Resnost driske*
English: The diarrhoea may be severe, and you may get dehydrated.
Slovenian: Driska je lahko huda in lahko dehidrirate.
English: Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3.
Slovenian: Smernice za prilagoditev odmerkov zdravila Nerlynx pri stanju z drisko so prikazane v preglednici 3.
English: - Keep taking anti-diarrhoea medicine during the first one to two months of Nerlynx treatment.
Slovenian: - Zdravilo za zdravljenje driske jemljite v obdobju prvega oziroma prvih dveh mesecev zdravljenja z zdravilom Nerlynx.
English: Diarrhoea was also the most common adverse reaction leading to discontinuation, 14.4 % of patients treated with Nerlynx without loperamide prophylaxis discontinued treatment due to diarrhoea.
Slovenian: zaradi driske je zdravljenje prekinilo 14,4 % bolnikov, zdravljenih z zdravilom Nerlynx brez profilakse z loperamidom.
English: The patient information pack should contain: o Patient information leaflet o A patient/carer treatment guide o “My Treatment Journal” The Patient/carer guide shall contain the following key messages (in lay language)
Slovenian: Vodnik po zdravljenju za bolnika/negovalca mora vsebovati naslednja ključna sporočila (v laičnem jeziku):
English: In patients that were hormone receptor negative, regardless of time from trastuzumab therapy, the hazard ratio for iDFS at 2 years was 0.93, with 95% CI (0.60, 1.43).
Slovenian: Pri bolnicah, ki so bile ne glede na čas, ki je pretekel od zdravljenja s trastuzumabom, negativne za hormonski receptor, je razmerje tveganj za iDFS po dveh letih znašalo 0,93 z intervalom zaupanja
English: Diarrhoea generally occurs early during the first or second week of treatment with Nerlynx and may be recurrent.
Slovenian: V splošnem se driska med zdravljenjem z zdravilom Nerlynx pojavi zgodaj, v prvem ali drugem tednu zdravljenja, in se lahko ponavlja.
English: Following the administration of a single radiolabelled dose of 200 mg neratinib oral solution, 97.1% and 1.1% of the administered dose was recovered in the faeces and urine, respectively.
Slovenian: Neratinib se pretežno izloča z blatom Po dajanju enkratnega radioaktivno označenega odmerka 200 mg neratiniba v obliki peroralne raztopine so v blatu in urinu dokazali 97,1 % oziroma 1,1 % danega odmerka.
English: Adverse reactions reported as serious included diarrhoea (1.9%), vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine aminotransferase increased (0.4%), aspartate aminotransferase increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and decreased appetite (0.2%).
Slovenian: dehidracija (1,1 %), navzea (0,5 %), povečana vrednost alanin-aminotransferaze (0,4 %), povečana vrednost aspartat-aminotransferaze (0,4 %), bolečine v trebuhu (0,3 %), utrujenost (0,3 %) in zmanjšan tek (0,2 %).
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Driska