natgillin/translations-raw huggingface dataset:
Missed doses should not be replaced and treatment should resume with the next scheduled daily dose (see Section 4.9).
Izpuščeni odmerki se ne smejo nadomeščati in zdravljenje se mora nadaljevati z naslednjim načrtovanim dnevnim odmerkom (glejte poglavje 4.9).
It belongs to a group of medicines called ‘tyrosine kinase inhibitors' used to block cancer cells and treat breast cancer.
Pripada skupini zdravil, imenovanih zaviralci tirozin kinaze, ki se uporabljajo za zaviranje rakavih celic in zdravljenje raka dojke.
Population pharmacokinetic modelling revealed that creatinine clearance did not explain the variability between patients, hence, no dose modifications are recommended for patients with mild to moderate renal impairment.
S populacijskim farmakokinetičnim modeliranjem je bilo ugotovljeno, da očistek kreatinina ni pojasnil variabilnosti med bolniki, zato za bolnike z blago do zmerno okvaro ledvic ni priporočil za prilagajanje odmerka.
Nerlynx should be taken with food, preferably in the morning.
Zdravilo Nerlynx je treba jemati skupaj s hrano, po možnosti zjutraj.
Your doctor will discuss with you the benefits and risks of taking Nerlynx during this time.
Zdravnik se bo z vami posvetoval o koristih in tveganjih jemanja zdravila Nerlynx v tem obdobju.
Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm.
10,5 x 4,3 mm, njena debelina pa je 3,1 mm.
The tablets should be swallowed whole preferably with water and should not be crushed or dissolved, and should be taken with food, preferably in the morning (see Section 5.2).
Tablete je treba pogoltniti cele, po možnosti z vodo, in se ne smejo drobiti ali raztapljati, vzeti pa jih je treba skupaj s hrano, po možnosti zjutraj (glejte poglavje 5.2).
The patient educational material:
Izobraževalno gradivo za bolnike:
Do not take grapefruit while you are taking Nerlynx - this includes eating them, drinking the juice or taking a supplement that might contain them.
Med jemanjem zdravila Nerlynx ne uživajte grenivk - to pomeni, da jih ne smete jesti, piti soka iz njih in uživati prehranskih dopolnil, ki bi jih lahko vsebovala.
It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Trenutno ni znano, ali zdravilo Nerlynx zmanjša učinkovitost sistemsko delujočih hormonskih kontracepcijskih sredstev.
The ‘HER2 receptor' is a protein found on the surface of cells in the body.
Receptor HER2 je beljakovina, ki jo je mogoče najti na površini celic v telesu.
Approximately 10% of patients had Stage I tumours, approximately 40% had Stage II tumours and approximately 30% had Stage III tumours.
Pri približno 10 % bolnic so bili prisotni tumorji stopnje I, pri približno 40 % so bili prisotni tumorji stopnje II, pri približno 30 % pa so bili prisotni tumorji stopnje III.
- Do not stop taking Nerlynx without talking to your doctor.
- Ne prenehajte jemati zdravila Nerlynx, ne da bi se o tem posvetovali z zdravnikom.
Therefore, women using systemically acting hormonal contraceptives should add a barrier method (see Section 4.6).
Zato morajo ženske, ki uporabljajo sistemsko delujoča hormonska kontracepcijska sredstva, dodatno uporabljati pregradno metodo (glejte poglavje 4.6).
Prior to launch of Nerlynx in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom zdravila Nerlynx na trg v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom sprejeti dogovor o vsebini in obliki izobraževalnega programa, vključno z mediji za komunikacijo, načini distribucije in vsemi drugimi vidiki programa.
What you need to know before you take Nerlynx 3.
Kaj morate vedeti, preden boste vzeli zdravilo Nerlynx 3.
Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 1, Table 2, Table 3, and Table 4.
Za obvladovanje nekaterih neželenih učinkov bo morda treba prekiniti odmerjanje in/ali zmanjšati odmerek, kot je prikazano v preglednicah 1, 2, 3, in 4.
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
The MAH shall ensure that in each Member State where Nerlynx is marketed, all healthcare professionals who are expected to prescribe/dispense Nerlynx, as well as all patients/carers who are expected to use Nerlynx, have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je v vsaki državi članici, v kateri se zdravilo Nerlynx trži, vsem zdravstvenim delavcem, za katere se pričakuje, da bodo predpisovali/izdajali zdravilo Nerlynx, in vsem bolnikom/negovalcem, za katere se pričakuje, da bodo uporabljali zdravilo Nerlynx, zagotovljen dostop do naslednjih izobraževalnih gradiv oziroma prejmejo ta gradiva:
Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Prilagoditev odmerka je lahko potrebna tudi zaradi drugih kliničnih stanj, kot je klinično indicirano (npr. toksičnosti, ki jih ni mogoče prenašati, nenehni neželeni učinki stopnje 2 itd.).
Diarrhoea generally occurred in the first month, with 83.6% of patients reporting this toxicity in the first week, 46.9% in the second week, 40.2% in the third week and 43.2% in the fourth week (median time to first onset was 2 days).
Driska se je običajno pojavila v prvem mesecu, pri čemer je 83,6 % bolnikov o tej vrsti toksičnosti poročalo v prvem tednu, 46,9 % v drugem, 40,2 % v tretjem, 43,2 % pa v četrtem tednu (mediani čas do prvega pojava je znašal dva dni).
Nerlynx treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.
Zdravljenje z zdravilom Nerlynx mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
• diltiazem, verapamil (calcium-channel blockers)
• diltiazem, verapamil (zaviralca kalcijevih kanalčkov);
This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
S tem se ustvari trajno zaviranje teh poti, ki omogočajo rast pri raku dojke z pomnoženim oziroma prekomerno izraženim HER2, ali raku dojke z mutantnim HER2.
Also some other medicines can affect the way Nerlynx works.
Poleg tega lahko tudi nekatera druga zdravila vplivajo na način delovanja zdravila Nerlynx.
A 6-month carcinogenicity study in Tg.rasH2 transgenic mice and the rat 2-year data showed no signs of carcinogenic potential.
Podatki, zbrani v šestmesečni študiji karcinogenosti pri transgenskih miših Tg.rasH2 in podatki, zbrani v dveh letih pri podganah, ne nakazujejo karcinogenega potenciala.
For the full list of excipients, see Section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Patients who are treated with BCRP inhibitors (e.g., rosuvastatin and sulfasalazine) should be monitored carefully.
Bolnike, zdravljene z zaviralci BCRP (npr. z rosuvastatinom in sulfasalazinom), je treba skrbno spremljati.
Oval, red film-coated tablet with ‘W104' debossed on one side.
Ovalna, rdeča filmsko obložena tableta z oznako W104, vtisnjeno na eni strani.
The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Pojavnost stopenj 1 in 2 je znašala 6,2 oziroma 1,4 %.
- Your doctor will also tell you if you need to change the dose of Nerlynx because of diarrhoea.
- Zdravnik vam bo tudi povedal, ali morate zaradi driske spremeniti odmerek zdravila Nerlynx.
A decision must be made whether to discontinue breast-feeding or to discontinue Nerlynx, taking into account the importance of Nerlynx to the mother and the benefit of breast-feeding to the child.
Odločiti se je treba med prenehanjem dojenja in prenehanjem jemanja zdravila Nerlynx, pri čemer je treba pretehtati pomembnost zdravila Nerlynx za mater in prednosti dojenja za otroka.
ULN=Upper Limit Normal; ALT= Alanine Aminotransferase * Per CTCAE v4.0
ULN = zgornja meja normalnih vrednosti; ALT= alanin-aminotransferaza
Distribution Binding of neratinib to human plasma proteins, including covalent binding to human serum albumin (HSA), was greater than 98% and independent of concentration.
Vezava neratiniba na človeške plazemske beljakovine, vključno s kovalentno vezavo na človeški serumski albumin (HSA), je znašala več kot 98 % in ni bila odvisna od koncentracije.
What Nerlynx is and what it is used for 2.
Kaj je zdravilo Nerlynx in za kaj ga uporabljamo 2.
There was no Grade 3 or 4 adverse reactions of blood bilirubin increased.
Neželenih učinkov stopnje 3 ali 4 zaradi povečanega bilirubina v krvi ni bilo.
Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Neratinib ni zaviral transporterjev privzema OATP1B1*1a, OATP1B3, OAT1, OAT3 in OCT2, pri čemer so poročali o vrednostih IC50 > 10 µM.
The diarrhoea may be severe and associated with dehydration.
Driska je lahko huda in povezana z dehidracijo.
• Grade 3 diarrhoea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days
• Driska stopnje 3 (povečanje za ≥ 7 odvajanj dnevno glede na izhodišče; inkontinenca; indicirana hospitalizacija; omejena zmožnost vsakodnevne skrbi zase), ki traja ≤ 2 dni.
If you are pregnant, the doctor will assess the potential benefit to you and risk to the foetus before giving this medicine to you.
Če ste noseči, bo zdravnik ocenil možne koristi za vas in tveganje za plod, preden vam bo dal to zdravilo.
Breast cancer resistance protein inhibitors
Zaviralci rezistentnega proteina raka dojke
- Your doctor will tell you how to take the anti-diarrhoea medicine.
- Zdravnik vam bo povedal, kako jemati zdravilo za zdravljenje driske.
Recommended starting dose
Priporočeni začetni odmerek
• Relevant information of Gastrointestinal toxicity (diarrhoea) (e.g. signs and symptoms to be detailed (seriousness, severity, frequency, time to onset, duration, risks and consequences))
• ustrezne informacije o toksičnosti za prebavila (driski) (npr. podrobno navedene znake in simptome [kritičnost, resnost, pogostnost, čas do prvega pojava, trajanje, tveganja in posledice]);
Contents of the pack and other information What Nerlynx contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nerlynx
• For patients that are unable to tolerate 120 mg daily
• ki ne prenašajo odmerka 120 mg dnevno.
The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Pogostnost dogodkov stopnje 3 je bila pri Azijcih in belcih podobna (1,6 v primerjavi z 1,0 %).
• Name of the product, active substance and approved indication of the product
• ime zdravila, učinkovino in odobrene indikacije zdravila;
This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
To predsistemsko medsebojno delovanje neratiniba in digoksina je lahko klinično pomembno pri substratih za P-gp z ozkim terapevtskim oknom (npr. dabigatranu, digoksinu in feksofenadinu).
• Grade 4 diarrhoea [life-threatening consequences; urgent intervention indicated]
• Driska stopnje 4 (smrtno nevarne posledice; indicirano je nujno posredovanje).
Patients with symptomatic skin and subcutaneous tissue disorders should be carefully monitored (see Section 4.8).
Bolnike s simptomatskimi boleznimi kože in podkožja je treba skrbno spremljati (glejte poglavje 4.8).
Of the 1,660 patients treated with Nerlynx monotherapy without loperamide prophylaxis, 94.6% experienced at least 1 episode of diarrhoea.
Od 1.660 bolnikov, ki so bili zdravljeni z monoterapijo z zdravilom Nerlynx brez profilakse z loperamidom, se je pri 94,6 % bolnikov pojavila vsaj ena epizoda driske.
The side effects of Nerlynx (for example, dehydration and dizziness resulting from diarrhoea, fatigue, and fainting) may affect how tasks that require judgment, motor or cognitive skills are carried out.
Neželeni učinki zdravila Nerlynx (na primer dehidracija in omotica zaradi driske, utrujenost in omedlevica) lahko vplivajo na izvajanje opravil, pri katerih so potrebne sposobnost presoje, motorične spretnosti ali kognitivne sposobnosti.
It is not known if elimination is as unchanged drug or metabolites.
Ni znano, ali je šlo pri izločanju za nespremenjeno zdravilo ali presnovke.
The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
Priporočeni odmerek zdravila Nerlynx je šest tablet enkrat dnevno (skupaj 240 mg).
• carbamazepine, phenobarbital, phenytoin (antiepileptics)
• karbamazepin, fenobarbital, fenitoin (zdravila proti epilepsiji);
For hormone receptor positive patients, the relative treatment benefit of Nerlynx within pre-specified patient subgroups is presented in Figure 2.
Pri bolnicah, pozitivnih za hormonski receptor, je relativna korist zdravljenja z zdravilom Nerlynx v predhodno opredeljenih podskupinah bolnic prikazana na sliki 2.
There are no data from the use of Nerlynx in pregnant women.
Nosečnost Podatkov o uporabi zdravila Nerlynx pri nosečnicah ni.
Studies in animals have shown embryo-foetal lethality and foetal morphological anomalies (see Section 5.3).
Študije pri živalih so dokazale smrtonosnost za zarodek/plod ter morfološke anomalije ploda (glejte poglavje 5.3).
• erythromycin (antibiotic)
• eritromicin (antibiotik).
1-3 Positive Nodes
1-3 pozitivne bezgavke
The mass balance after administration of a single oral dose of 200 mg of neratinib was studied in six healthy subjects.
Masno ravnovesje po dajanju enkratnega peroralnega odmerka 200 mg neratiniba so preučili pri šestih zdravih osebah.
Your doctor will tell you if you need to keep taking anti-diarrhoea medicine after the first two months to control your diarrhoea.
Zdravnik vam bo povedal, ali morate za nadzor driske po prvih dveh mesecih še jemati zdravilo za zdravljenje driske.
It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method.
Trenutno ni znano, ali lahko neratinib zmanjša učinkovitost sistemsko delujočih hormonskih kontracepcijskih sredstev, zato morajo ženske, ki takšna sredstva uporabljajo, dodatno uporabljati pregradno metodo.
At baseline, 57.4% had hormone receptor positive disease (defined as ER-positive and/or PgR-positive), 23.6% were node negative, 46.8% had one to three positive nodes and 29.6% had four or more positive nodes.
V izhodišču je imelo 57,4 % bolezen, pozitivno za hormonski receptor (opredeljeno kot ER-pozitivna in/ali PGR-pozitivna), pri 23,6 % so bile bezgavke negativne, pri 46,8 % je bilo pozitivnih bezgavk od ena do tri, pri 29,6 % pa so bile pozitivne štiri bezgavke ali več.
The primary analysis of the study after 2 years post-randomisation demonstrated that Nerlynx significantly reduced the risk of invasive disease recurrence or death by 34% (HR=0.66 with 95% CI (0.49, 0.90), two-sided p = 0.008) in the ITT population.
Primarna analiza študije dve leti po randomizaciji je pokazala, da je zdravilo Nerlynx v populaciji z namenom zdravljenja pomembno zmanjšalo tveganje za ponovitev invazivne bolezni ali smrti za 34 % (HR = 0,66 s 95-odstotnim intervalom zaupanja (0,49, 0,90), dvostranska vrednost p = 0,008).
In HER2-positive breast cancer, the cancer cells have a large amount of HER2 receptors on their surface.
Pri HER2-pozitivnem raku dojke imajo rakave celice na površini veliko receptorjev HER2.
All Patients
Vse bolnice
Nerlynx is used for patients who have early stage breast cancer which: - is human epidermal growth factor receptor 2-positive (HER2-positive) and - has previously been treated with another medicine called ‘trastuzumab'.
Zdravilo Nerlynx se uporablja pri bolnikih z rakom dojke zgodnje stopnje, ki: - je pozitiven za humani epidermalni receptor 2 za rastni faktor (HER2-pozitiven) in - je bil že zdravljen z drugim zdravilom, imenovanim trastuzumab.
1236 patients were <65 years, 172 were ≥65 years, of whom 25 were 75 years or older.
52 let, 1.236 bolnikov je bilo starih < 65 let, 172 jih je bilo starih ≥ 65 let, med slednjimi pa jih je bilo
In subjects with severe pre-existing hepatic impairment (Child-Pugh Class C) without cancer, the clearance of neratinib was decreased by 36% and exposure to neratinib increased by about 3-fold as compared to healthy volunteers.
Pri osebah s hudo obstoječo okvaro jeter (stopnje C po ChildPughovi klasifikaciji), ki nimajo raka, se je očistek kreatinina v primerjavi z vrednostmi pri zdravih prostovoljcih zmanjšal za 36 %, izpostavljenost neratinibu pa povečala za približno trikrat.
Nerlynx dose modifications and management - general toxicities* Severity of toxicity†
Preglednica 2: Prilagoditev in določanje odmerka zdravila Nerlynx - splošne toksičnosti* Resnost toksičnosti†
In patients with known cardiac risk factors, conduct cardiac monitoring, including assessment of LVEF, as clinically indicated.
spremljajte delovanje srca, vključno z oceno LVEF, kot je klinično indicirano.
Severe hepatic impairment (Child-Pugh C).
Huda okvara jeter (stopnje C po Child-Pughovi klasifikaciji).
2 Unstratified Cox proportional hazards model 3 Unstratified 2-sided log-rank test for all endpoints, except for CNS recurrence for which Gray's method was used.
3 Nestratificirani dvostranski test log-rank za vse cilje študije, razen za ponovitev v CŽS, za katero je bila uporabljena Grayeva metoda.
Placebo Better hydroxyl neratinib N-oxide and neratinib bis-N-oxide (M11).
Boljše - placebo neratinib bis-N-oksida (M11).
Nerlynx should not be used during pregnancy unless the clinical condition of the woman requires treatment with neratinib.
Zdravila Nerlynx se ne sme uporabljati med nosečnostjo, razen če je zdravljenje z neratinibom potrebno zaradi kliničnega stanja ženske.
This is because Nerlynx can affect the way some other medicines work.
To morate storiti, ker lahko zdravilo Nerlynx vpliva na način delovanja nekaterih drugih zdravil.
Nerlynx dose modification is recommended based on individual safety and tolerability.
Prilagoditev odmerka zdravila Nerlynx je priporočena na podlagi varnosti za posameznika in njegove sposobnosti prenašanja zdravila.
Women who can become pregnant must use an effective method of contraception, including a barrier method: - while taking Nerlynx and - for one month after treatment has finished.
Ženske, ki bi lahko zanosile, morajo uporabljati učinkovito metodo kontracepcije, vključno s pregradno metodo: - med jemanjem zdravila Nerlynx in - en mesec po koncu zdravljenja.
Nerlynx can cause changes in liver function - these are shown in blood tests.
Zdravilo Nerlynx lahko povzroči spremembe delovanja jeter - te se pokažejo v preiskavah krvi.
Neratinib at 10 µM appeared to inhibit the BCRP efflux transporter.
Izkazalo se je, da neratinib pri 10 µM zavira izlivni transporter BCRP.
Then resume Nerlynx at the next lower dose level.
Nato zdravilo Nerlynx znova začnite dajati v naslednji zmanjšani velikosti odmerka.
Neratinib is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).
Neratinib je ireverzibilni homolog onkogenih virusov paneritroblastne levkemije (ERBB), zaviralec tirozin-kinaze (TKI), ki zavira transdukcijo signala mitogenega rastnega faktorja s kovalentno vezjo z visoko afiniteto za vezavo na vezavno mesto za ATP treh receptorjev za epidermalni rastni faktor (EGFR): EGFR (ki ga kodira ERBB1), HER2 (ki ga kodira ERBB2) in HER4 (ki ga kodira ERBB4) ali njihove aktivne heterodimere s HER3 (ki ga kodira ERBB3).
Diarrhoea management requires the correct use of an anti-diarrhoeal medicinal product, dietary changes, and appropriate dose modifications of Nerlynx.
Za obvladovanje driske je treba pravilno uporabiti zdravilo proti driski, uvesti spremembe prehrane in ustrezno prilagoditi odmerek zdravila Nerlynx.
The median duration of a single episode of any grade diarrhoea was 2 days.
Povprečno trajanje posamezne epizode driske ne glede na stopnjo je znašalo dva dni.
Nerlynx has not been studied in patients with severe renal impairment including patients on dialysis.
Zdravilo Nerlynx ni bilo preučeno pri bolnikih s hudo okvaro ledvic, vključno z bolniki na dializi.
Do not crush or dissolve.
Ne drobite jih in jih ne raztapljajte.
Secondary endpoints of the study included disease-free survival (DFS) including ductal carcinoma in situ (DFS-DCIS), time to distant recurrence (TTDR), distant disease-free survival (DDFS), cumulative incidence of central nervous system recurrence and overall survival (OS).
Sekundarni cilji študije so vključevali preživetje brez ponovitve bolezni (DFS), vključno z duktalnim karcinomom in situ (DFSDCIS), čas do oddaljene ponovitve (TTDR), preživetje brez oddaljene ponovitve bolezni (DDFS), skupna pojavnost ponovitve v centralnem živčnem sistemu in celokupno preživetje (OS).
The median cumulative duration of any grade diarrhoea was 59 days and the median cumulative duration of Grade 3 diarrhoea was 5 days.
Povprečno skupno trajanje driske ne glede na stopnjo je znašalo 59 dni, povprečno skupno trajanje driske stopnje 3 pa pet dni.
Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Predhodno metabolno profiliranje v človeški plazmi kaže, da se neratinib po peroralnem dajanju presnovi oksidativno prek CYP3A4.
You should take an anti-diarrhoea medicine so that your diarrhoea does not become severe, and to prevent you from getting dehydrated during treatment with Nerlynx.
Jemati morate zdravilo za zdravljenje driske, da ta ne postane resna in da med zdravljenjem z zdravilom Nerlynx ne bi dehidrirali.
Pharmacokinetic studies in patients with renal impairment or undergoing dialysis have not been carried out.
Farmakokinetičnih študij pri bolnikih z okvaro ledvic ali bolnikih na dializi niso izvedli.
This leaflet was last revised in MM/YYYY Other sources of information
Navodilo je bilo nazadnje revidirano dne MM/LLLL.
Nerlynx is associated with skin and subcutaneous tissue disorders.
Zdravilo Nerlynx povezujejo z boleznimi kože in podkožja.
Patients with a significant chronic gastrointestinal disorder Patients with a significant chronic gastrointestinal disorder with diarrhoea as a major symptom were not included in the pivotal study, and should be carefully monitored.
Bolniki z resno kronično boleznijo prebavil Bolniki z resno kronično boleznijo prebavil, pri katerih je driska glavni simptom, niso bili vključeni v osrednjo študijo in jih je treba skrbno spremljati.
The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year.
Priporočeni odmerek zdravila Nerlynx je 240 mg (šest 40-miligramskih tablet), ki se jemljejo peroralno enkrat dnevno neprekinjeno eno leto.
In a dose escalation study in healthy volunteers, single oral doses of Nerlynx up to 800 mg were administered.
V študiji povečevanja odmerka pri zdravih prostovoljcih so bili uporabljeni enkratni peroralni odmerki zdravila Nerlynx do 800 mg.
Pooled safety data of 1710 patients treated with Nerlynx monotherapy showed a higher incidence of dermatologic toxicities in Asian patients (57.1%) versus Caucasian patients (34.6%).
Zbrani varnostni podatki pri 1.710 bolnikih, ki so bili zdravljeni z monoterapijo z zdravilom Nerlynx, so pokazali večjo pojavnost dermatoloških toksičnosti pri azijskih bolnikih (57,1 %) kot pri belcih (34,6 %).
• Grade 3 diarrhoea lasting between 2 days and 3 weeks‡
• Driska stopnje 3, ki traja od dva dni do tri tedne‡.