natgillin/translations-raw huggingface dataset:
In addition, the corresponding frequency category for each adverse reaction is based on the CIOMS III convention and is defined as: 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 available data).
Poleg tega ustrezne kategorije pogostnosti za vsak neželeni učinek temeljijo na konvenciji CIOMS III in so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
This includes herbal medicines and medicines obtained without a prescription.
To velja tudi za zdravila rastlinskega izvora in druga zdravila, ki ste jih dobili brez recepta.
TAGRISSO may affect how well the following medicines work and/or increase side effects of these medicines:
Zdravilo TAGRISSO lahko vpliva na to, kako dobro delujejo naslednja zdravila in/ali poveča njihove neželene učinke:
All cases were isolated incidents of patients taking an additional daily dose of TAGRISSO in error, without any resulting clinical consequences.
Vsi primeri so bili posamični dogodki pri bolnikih, ki so pomotoma vzeli dodaten dnevni odmerek zdravila TAGRISSO, in niso imeli nobenih kliničnih posledic.
However, if it is less than 12 hours until your next dose is due, skip the missed dose.
Če pa je do naslednjega odmerka manj kot 12 ur, pozabljeni odmerek izpustite.
Represents the incidence of patients who had a QTcF prolongation >500msec.
Predstavlja incidenco bolnikov s podaljšanjem QTcF > 500 msec.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Če imate vprašanja o tem, kako deluje to zdravilo ali zakaj ste ga dobili, vprašajte zdravnika.
There are no data on the effect of TAGRISSO on human fertility.
Podatkov o vplivu zdravila TAGRISSO na plodnost pri človeku ni.
TAGRISSO as monotherapy is indicated for:
Zdravilo TAGRISSO je kot monoterapija indicirano za:
Frequency of CTCAE grade 3 or higher
Pogostnost 3. ali višje stopnje po CTCAE
The tablet should be swallowed whole with water and it should not be crushed, split or chewed.
Tableto je treba zaužiti celo z vodo in se je ne sme drobiti, lomiti ali gristi.
It should be dropped in the water, without crushing, stirred until dispersed and immediately swallowed.
Mora jo dati v vodo (ne da bi jo zdrobil), jo mešati, dokler se ne dispergira, in jo zaužiti takoj.
• If you develop watery eyes, sensitivity to light, eye pain, eye redness, or vision changes.
• Če se vam pojavijo solzenje, občutljivost na svetlobo, bolečine v očesu, pordelost očesa ali spremembe vida.
Further catalyzing enzymes have not been identified.
Dodatnih katalizacijskih encimov niso odkrili.
One event (0.1%) led to discontinuation.
En primer (0,1 %) je povzročil prenehanje uporabe zdravila.
If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR' (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with TAGRISSO.
Če je preiskava pokazala, da ima vaš rak določene spremembe (mutacije) gena, imenovanega "EGFR" (receptor za epidermalni rastni faktor), in se vam je razširil na drugo pljučno krilo ali v druge organe, se bo vaš rak verjetno odzval na zdravljenje z zdravilom TAGRISSO.
No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status (see section 5.2).
Odmerka ni treba prilagoditi glede na bolnikovo starost, telesno maso, spol, etnično pripadnost ali kadilski status (glejte poglavje 5.2).
Severe renal impairment may influence the elimination of hepatically eliminated medicinal products.
Huda okvara ledvic lahko vpliva na izločanje zdravil, ki se odstranjujejo preko jeter.
Swallow the tablet whole with water.
Tableto zaužijte celo z vodo.
• If necessary, your doctor may reduce your dose to one 40 mg tablet each day.
• Po potrebi vam zdravnik lahko odmerek zmanjša na eno 40 mg tableto vsak dan.
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
V primeru potrebe po zmanjšanju odmerka je treba odmerek zmanjšati na 40 mg enkrat na dan.
These exposure changes due to body weight or baseline albumin differences are not considered clinically relevant.
Te spremembe izpostavljenosti zaradi razlik v telesni masi ali izhodiščni koncentraciji albumina ne veljajo za klinično pomembne.
Adverse reactions are listed according to system organ class (SOC) in MedDRA.
Neželeni učinki so navedeni po organskih sistemih (SOC - system organ class) MedDRA.
Patients with CLcr less than 15 mL/min were not included in the clinical trials.
Bolniki z očistkom kreatinina manj kot 15 ml/min niso bili vključeni v klinična preizkušanja.
The European Medicines Agency has waived the obligation to submit the results of studies with TAGRISSO in all subsets of the paediatric population in NSCLC (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom TAGRISSO za vse podskupine pediatrične populacije pri NSCLC (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Osimertinib may increase the exposure of breast cancer resistant protein (BCRP) and P-glycoprotein (P-gp) substrates.
Osimertinib lahko poveča izpostavljenost substratom BCRP (breast cancer resistant protein) in P-glikoproteina (P-gp).
Objective response rates by BICR above 50% were observed in all predefined subgroups analysed, including line of therapy, ethnicity, age and region.
Po BICR ocenjen objektivni delež odziva nad 50 % je bil opažen v vseh vnaprej opredeljenih analiziranih podskupinah, vključno glede na linijo zdravljenja, etnično pripadnost, starost in regijo.
The AUC and Cmax increased dose proportionally over 20 to 240 mg dose range.
AUC in Cmax sta se v razponu odmerkov od 20 do 240 mg povečevali sorazmerno z odmerkom.
Seventy-two percent (72%) of patients were never smokers, 100% of patients had a World Health Organization (WHO) performance status of 0 or 1.
Dvainsedemdeset odstotkov (72 %) bolnikov ni nikoli kadilo, 100 % bolnikov je imelo stanje zmogljivosti 0 ali 1 po Svetovni zdravstveni organizaciji (WHO - World Health Organization).
If the patient is unable to swallow the tablet, the tablet may first be dispersed in 50 mL of non-carbonated water.
Če bolnik tablete ne more pogoltniti, lahko tableto dispergira v 50 ml negazirane vode.
The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.
Disperzijo in ostanke zdravila je treba bolniku dati v 30 minutah po tem, ko so bile tablete dane v vodo.
Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher.
Pri starejših bolnikih (> 65 let) ali bolnikih z nizko telesno maso (< 50 kg) je lahko prisotno povečano tveganje za pojav neželenih učinkov 3. ali višje stopnje.
Name and address of the manufacturer responsible for batch release AstraZeneca AB
Ime in naslov izdelovalca, odgovornega za sproščanje serij AstraZeneca AB
Cardiac QTc interval greater than 500 msec on at least 2 separate ECGs
Interval QTc je več kot 500 msec na vsaj 2 ločenih posnetkih EKG
Thirty-one percent (31%) (N=129) had received 1 prior line of therapy (EGFR-TKI treatment only), 69% (N=282) had received 2 or more prior lines.
Enaintrideset odstotkov (31 %) (n = 129) je prejelo 1 predhodno linijo zdravljenja (le zdravljenje z EGFR-TKI) in 69 % (n = 282) jih je prejelo 2 ali več predhodnih linij.
Median follow-up time was 15.0 months for patients receiving TAGRISSO and 9.7 months for patients receiving EGFR TKI comparator
Mediani čas spremljanja je bil 15,0 mesecev pri bolnikih, ki so prejemali zdravilo TAGRISSO, in 9,7 meseca pri bolnikih, ki so prejemali primerjalni EGFR TKI.
Tell your doctor straight away if you notice the serious side effects listed above.
Zdravnika takoj obvestite, če opazite zgoraj opisane resne neželene učinke.
• Efavirenz and etravirine - used to treat HIV infections/AIDS.
• efavirenz in etravirin - uporabljata se za zdravljenje okužbe s HIV/aidsa.
Intestinal inhibition of UGT1A1 is possible but the clinical impact is unknown.
Zavrtje UGT1A1 v črevesu je možno, a njegov klinični vpliv ni znan.
The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established.
Varnost in učinkovitost zdravila TAGRISSO nista dokazani pri otrocih in mladostnikih, mlajših od 18 let.
5 CTCAE grade 5 events (fatal) were reported.
Poročali so o 5 primerih dogodkov 5. stopnje (smrtni izid) po CTCAE.
Your doctor will decide with you whether you should carry on taking TAGRISSO.
Zdravnik bo presodil, ali naj še naprej jemljete zdravilo Tagrisso.
Tell your doctor if your diarrhoea does not go away or becomes severe.
Zdravnika morate obvestiti, če driska ne mine ali če postane huda.
Osimertinib pharmacokinetic parameters have been characterised in healthy subjects and NSCLC patients.
Farmakokinetične parametre osimertiniba so raziskali pri zdravih osebah in bolnikih z NSCLC.
Do not breast-feed while taking this medicine.
Dojenje Med jemanjem tega zdravila ne dojite.
The median time to onset of ILD or ILD-like adverse reactions was 85 days (see section 4.4).
Mediani čas do pojava IBP ali njej podobnih neželenih učinkov je bil 85 dni (glejte poglavje 4.4).
• The other ingredients are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide (see section 2 “Information on other ingredients in this medicine”).
• Druge sestavine zdravila so manitol, mikrokristalna celuloza, nizkosubstituirana hidroksipropilceluloza, natrijev stearilfumarat, polivinilalkohol, titanov dioksid, makrogol 3350, smukec, rumeni železov oksid, rdeči železov oksid, črni železov oksid (glejte poglavje 2 “Informacije o drugih sestavinah tega zdravila”).
The main metabolic pathway of osimertinib was oxidation and dealkylation.
Glavna pot presnove osimertiniba je oksidacija in dealkilacija.
One event was reported in a post-marketing study, and the frequency has been derived from the FLAURA and AURA studies and the post-marketing study (N=4720).
V študiji po prihodu zdravila na trg je bil poročan en dogodek, pogostnost pa je ugotovljena na podlagi študij FLAURA in AURA ter študije po prihodu zdravila na trg (N = 4720).
The safety and efficacy of this medicinal product has not been established in patients with end-stage renal disease [creatinine clearance (CLcr) <15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis.
Varnost in učinkovitost tega zdravila nista ugotovljeni pri bolnikih s končno odpovedjo ledvic (očistek kreatinina < 15 ml/min, izračunan po Cockroft-Gaultovi enačbi) in pri bolnikih na dializi.
• Rifabutin or rifampicin - used for tuberculosis (TB).
• rifabutin ali rifampicin - uporabljata se za zdravljenje tuberkuloze (TBC).
ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate
EKG: elektrokardiogram, QTc: interval QT, korigiran glede na srčno frekvenco
These effects were seen at a maternally tolerated dose of 20 mg/kg where exposure was equivalent to the human exposure at the recommended dose of 80 mg daily (based on total AUC).
Te učinke so opažali ob maternalno toleriranem odmerku 20 mg/kg, ko je bila izpostavljenost enakovredna izpostavljenosti človeka ob priporočenem odmerku 80 mg na dan (na podlagi celotne AUC).
Exposure at doses of 20 mg/kg and above during organogenesis caused reduced foetal weights but no adverse effects on external or visceral foetal morphology.
Izpostavljenost ob odmerkih 20 mg/kg ali več med obdobjem organogeneze je povzročila zmanjšano telesno maso plodov, ni pa imela neželenih učinkov na zunanjo ali visceralno morfologijo plodov.
Target organ Adverse reaction
Ciljni organ Neželeni učinek
Patients received study therapy until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Bolniki so prejemali študijsko zdravljenje, dokler se ni pojavilo neprenašanje zdravljenja ali dokler raziskovalec ni ugotovil, da zdravljenje bolniku klinično ne koristi več.
Chemotherapy consisted of pemetrexed 500 mg/m2 with carboplatin AUC5 or pemetrexed 500 mg/m2 with cisplatin 75 mg/m2 on Day 1 of every 21-day cycle for up to 6 cycles.
Kemoterapija je obsegala pemetreksed 500 mg/m2 s karboplatinom AUC5 ali pemetreksed 500 mg/m2 s cisplatinom 75 mg/m2 1. dan vsakega 21-dnevnega ciklusa in do 6 ciklusov.
• Modafinil -used for sleep disorders.
• modafinil - uporablja za zdravljenje težav s spanjem.
Until additional data become available, use in patients with severe hepatic impairment is not recommended (see section 5.2).
Dokler ni na voljo dodatnih podatkov, uporaba pri bolnikih s hudo okvaro jeter ni priporočljiva (glejte poglavje 5.2).
• Rosuvastatin - used to lower cholesterol.
• rosuvastatin - uporablja se za zmanjševanje koncentracije holesterola.
When possible, the use of osimertinib in patients with congenital long QT syndrome should be avoided.
Uporabi osimertiniba se je treba pri bolnikih s prirojenim sindromom dolgega intervala QT izogniti, če je le mogoče.
• asthe first medicine you receive for your cancer or
• kot prvo zdravilo za zdravljenje raka, ali
If you have trouble swallowing the tablet, you can mix it in water:
Če tableto težko pogoltnete, jo lahko zmešate z vodo.
Haematological events
Hematološki dogodki
The OS analysis was not adjusted for the potentially confounding effects of crossover (94 [67%] patients on the chemotherapy arm received subsequent osimertinib treatment).
Celokupna analiza ni bila prilagojena za morebitne moteče učinke navzkrižnega prehoda (94 [67 %] bolnikov v skupini s kemoterapijo je pozneje prejemalo osimertinib).
Low body weight
Nizka telesna masa
Randomisation was stratified by EGFR mutation type (Ex19del or L858R) and ethnicity (Asian or non-Asian).
Randomizacija je bila stratificirana glede na tip mutacije EGFR (Ex19del ali L858R) in glede na etnično pripadnost (azijska ali neazijska).
• Bosentan - used for high blood pressure in the lungs.
• bosentan - uporablja se za zdravljenje visokega krvnega tlaka v pljučih.
What TAGRISSO is and what it is used for
Kaj je zdravilo TAGRISSO in za kaj ga uporabljamo
Using moisturisers regularly on your skin and nails can help with this.
Pomaga lahko redna uporaba vlažil na koži in nohtih.
• Men - keep using contraception for 4 months after.
• Moški - kontracepcijo uporabljajte še 4 mesece po koncu zdravljenja.
Only robust, reliable and sensitive tests with demonstrated utility for the determination of EGFR mutation status of tumour derived DNA (from a tissue or a plasma sample) should be used.
Uporabiti se sme le robustne, zanesljive in občutljive preiskave z dokazano uporabnostjo za določanje stanja mutacije EGFR v tumorski DNK (iz vzorca tkiva ali plazme).
Based on population pharmacokinetic analysis, osimertinib apparent plasma clearance is 14.3 L/h, apparent volume of distribution is 918 L and terminal half-life of approximately 44 hours.
Na podlagi populacijske farmakokinetične analize je navidezni plazemski očistek osimertiniba 14,3 l/uro, navidezni volumen porazdelitve je 918 l in terminalni razpolovni čas je približno 44 ur.
In the evaluable for response population, 85% (223/262) had documentation of response at the time of the first scan (6 weeks); 94% (247/262) had documentation of response at the time of the second scan (12 weeks).
V populaciji, ocenljivi za odziv, je imelo 85 % (223/262) bolnikov dokumentiran odziv ob času prvega slikanja (6 tednov), 94 % (247/262) pa je imelo dokumentiran odziv ob času drugega slikanja (12 tednov).
Secondary efficacy outcome measures included Duration of Response (DoR) and Progression-Free Survival (PFS).
Sekundarna merila izida učinkovitosti so vključevala trajanje odziva (DoR - duration of response) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
• If TAGRISSO is the first protein kinase inhibitor medicine you are receiving, it means that your cancer contains defects in the EGFR gene, for example ‘exon 19 deletions' or ‘exon 21 substitution mutations'.
• Če je zdravilo TAGRISSO prvi zaviralec protein-kinaze, ki ga prejemate, to pomeni, da ima vaš rak v genu EGFR spremembe (mutacije), imenovane "delecije eksona 19" ali "substitucije eksona 21".
Do not take TAGRISSO if:
Ne jemljite zdravila TAGRISSO:
TAGRISSO may be restarted at the same dose (80 mg) or a lower dose (40 mg)
Ponovno lahko začnete zdravljenje z zdravilom TAGRISSO v enakem (80 mg) ali manjšem odmerku (40 mg).
Subjects on the chemotherapy arm who had objective radiological progression (by the investigator and confirmed by independent central imaging review) were given the opportunity to begin treatment with TAGRISSO.
Preiskovanci v skupini s kemoterapijo, ki se jim je pojavilo objektivno radiološko napredovanje (po raziskovalčevi oceni in potrjeno z neodvisnim centralnim pregledom slik), so imeli možnost, da začnejo zdravljenje z zdravilom TAGRISSO.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Pri vsakem organskem sistemu so neželeni učinki razvrščeni po pogostnosti; najpogostejši neželeni učinki so navedeni najprej.
• Diarrhoea - this may come and go during treatment.
• Driska - med zdravljenjem se lahko pojavi in izgine.
• If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M'.
• Če je vaš rak napredoval med zdravljenjem s kakšnim drugim zaviralcem protein-kinaze, to pomeni, da ima rak gensko napako, imenovano "T790M".
The model included patient, treatment, visit, treatment-by-visit interaction, baseline symptom score, and baseline symptom score-by-visit interaction and used an unstructured covariance matrix.
Model je vključil bolnika, zdravljenje, obisk, interakcijo zdravljenja in obiska, izhodiščno oceno simptomov ter interakcijo izhodiščne ocene simptomov in obiska; uporabljena je bila nestrukturirana kovariančna matrika.
When considering the use of TAGRISSO, EGFR mutation status in tumour or plasma specimens should be determined using a validated test method (see section 4.4).
Pri odločanju o uporabi zdravila TAGRISSO je treba določiti stanje mutacije EGFR v vzorcih tumorja ali plazme z uporabo validirane testne metode (glejte poglavje 4.4).
Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
Zdravniku morate pred začetkom jemanja zdravila TAGRISSO povedati, če jemljete katero od naslednjih zdravil:
In FLAURA and AURA3 (N=1142), 43% of patients were 65 years of age and older, and 13% were 75 years of age and older.
V študijah FLAURA in AURA3 (N = 1142) je bilo 43 % bolnikov starih 65 let ali več in 13 % jih je bilo starih 75 let ali več.
See ‘Serious side effects' in section 4 for more information.
Za več informacij glejte “Resni neželeni učinki” v poglavju 4.
• in certain circumstances if you have beentreated for your cancer before with other protein kinase inhibitor medicines.
• v določenih okoliščinah, če ste zaradi raka že predhodno prejemali kakšno drugo zdravilo iz skupine zaviralcev protein-kinaze.
Patients whose disease has not progressed after four cycles of platinum-based chemotherapy may receive pemetrexed maintenance therapy (pemetrexed 500 mg/m2 on Day 1 of every 21-day cycle).
Bolniki, pri katerih bolezen po štirih ciklusih kemoterapije na podlagi platine ni napredovala, so lahko prejeli vzdrževalno zdravljenje s pemetreksedom (pemetreksed 500 mg/m 1. dan vsakega 21-dnevnega ciklusa).
(AUC increase by 6% (90% CI -5, 19) and Cmax decrease by 7% (90% CI -19, 6)).
(Povečanje AUC za 6 % (90 % IZ: -5 do 19) in zmanjšanje Cmax za 7 % (90 % IZ: -19 do 6)).
• you are taking St. John's Wort (Hypericum perforatum).
• če jemljete šentjanževko (Hypericum perforatum).
This is because TAGRISSO can affect the way some other medicines work.
Zdravilo TAGRISSO namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Adjusted mean and estimated differences obtained from a Mixed Model Repeated Measures (MMRM) analysis.
Prilagojeno povprečje in ocenjene razlike, dobljene z analizo z mešanim modelom s ponavljajočimi se meritvami.
This analysis demonstrated a consistent treatment effect (HR 0.28; 95% CI: 0.20, 0.38) with that observed by investigator assessment.
Ta analiza je pokazala učinek zdravljenja (ROg 0,28; 95 % IZ: 0,20; 0,38), ki se je skladal z raziskovalčevo oceno.
If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
Če bolnik izpusti odmerek zdravila TAGRISSO, ga mora vzeti, razen če je do naslednjega odmerka že manj kot 12 ur.
If you are taking any of the medicines listed above, tell your doctor before taking TAGRISSO.
Če jemljete katero od zgoraj naštetih zdravil, morate to povedati zdravniku, preden začnete jemati zdravilo TAGRISSO.
TAGRISSO N=61
Zdravilo TAGRISSO N = 61
In patients with a confirmed response by BICR, the median DoR was 12.5 months (95% CI: 11.1, NE).
Pri bolnikih s potrjenim odzivom po BICR je bilo mediano DoR 12,5 meseca (95 % IZ: 11,1; NI).
Similarly, the exposure to metabolite AZ5104 decreased by 82% for the AUC and 78% for Cmax.
Podobno se je zmanjšala izpostavljenost presnovku AZ5104 (AUC za 82 % in Cmax za 78 %).
Forty-two percent (42%) of patients had metastatic bone disease.
Dvainštirideset odstotkov (42 %) bolnikov je imelo metastatsko bolezen kosti.
Non-clinical data indicate that osimertinib and its metabolite (AZ5104) inhibit the h-ERG channel, and QTc prolonging effect cannot be excluded.
Predklinični podatki kažejo, da osimertinib in njegov presnovek (AZ5104) zavirata h-ERG-kanal in vpliva na podaljšanje intervala QTc ni mogoče izključiti.
Osimertinib is a Tyrosine Kinase Inhibitor (TKI).
Osimertinib je zaviralec tirozin kinaze (TKI - tyrosine kinase inhibitor).
These patients received TAGRISSO at a dose of 80 mg daily in two randomised Phase 3 studies (FLAURA, first line and AURA3, second line only), two single-arm studies (AURAex and AURA2, second line or greater) and one Phase 1 study (AURA1, first-line or greater) (see section 5.1).
Ti bolniki so prejemali zdravilo TAGRISSO v odmerku 80 mg na dan v dveh randomiziranih študijah 3. faze (FLAURA - prva linija in AURA3 - le druga linija), dveh študijah z eno samo skupino (AURAex in AURA2 - druga linija ali več) in eni študiji 1. faze (AURA1 - prva linija ali več) (glejte poglavje 5.1).
TAGRISSO (N=279)
Zdravilo TAGRISSO (N = 279)
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Glede na varnost in prenašanje pri posameznem bolniku je lahko potrebna prekinitev odmerjanja in/ali zmanjšanje odmerka.
• Skin and nail problems - signs may include pain, itching, dry skin, rash, redness around the fingernails.
• Težave s kožo in nohti - med znaki so lahko bolečina, srbenje, suha koža, izpuščaj, pordelost okrog nohtov na rokah.
Unchanged osimertinib accounted for approximately 2% of the elimination with 0.8% in urine and 1.2% in faeces.
Na račun nespremenjenega osimertiniba je šlo približno 2 % izločanja, 0,8 % v urinu in 1,2 % v blatu.
TAGRISSO has no or negligible influence on the ability to drive and use machines.
Zdravilo TAGRISSO nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Data is cumulative from FLAURA and AURA (AURA3, AURAex, AURA 2 and AURA1) studies; only events for patients receiving at least one dose of TAGRISSO as their randomised treatment are summarised.
Podatki so kumulativni za študije FLAURA in AURA (AURA3,AURAex, AURA2 in AURA1); povzeti so le dogodki pri bolnikih, ki so kot randomizirano zdravljenje dobili vsaj en odmerek zdravila TAGRISSO.
Older patients reported more Grade 3 or higher adverse reactions compared to younger patients (13.4% versus 9.3%).
Pri starejših bolnikih je bilo poročanih neželenih učinkov 3. ali višje stopnje več kakor pri mlajših (13,4 % v primerjavi z 9,3 %).