natgillin/translations-raw huggingface dataset:
The embryo-foetal development studies performed on afatinib revealed no indication of teratogenicity.
Ispitivanja embrio-fetalnog razvoja provedena s afatinibom nisu otkrila rizik teratogenosti.
Posology The recommended dose is 40 mg once daily.
Doziranje Preporučena doza je 40 mg jedanput dnevno.
Patients were screened for the presence of activating EGFR mutations (Del 19 and/or L858R) using the TheraScreen
U bolesnika je napravljen probir za prisutnost aktivirajućih EGFR mutacija (Del 19 i/ili L858R) pomoću PCR kompleta TheraScreen
values presented for GIOTRIF vs. erlotinib, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test c p-values were not adjusted for multiplicity
vrijednosti predstavljene za GIOTRIF naspram erlotiniba; p-vrijednost temeljena na logističkoj regresiji p-vrijednost za vrijeme do pogoršanja temeljena na stratificiranom log-rank testu p-vrijednosti nisu bile prilagođene za višestruke usporedbe
CR=complete response; PR=partial response p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression
CR = potpuni odgovor; PR = djelomični odgovor p-vrijednost za PFS/OS temeljena na stratificiranom log-rank testu; p-vrijednost za stopu objektivnog odgovora temeljena na logističkoj regresiji
Symptoms such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Bolesnici kod kojih se pojavi akutna upala oka ili njezino pogoršanje, suzenje, preosjetljivost na svjetlost, zamagljeni vid, bol u očima i/ili crvenilo očiju moraju se odmah uputiti oftalmologu.
If you forget to take GIOTRIF
Ako ste zaboravili uzeti GIOTRIF
Effects of P-gp inducers on afatinib
P-gp induktora na afatinib
• If your next scheduled dose is more than 8 hours away, take the missed dose as soon as you remember.
• Ako je Vaša sljedeća doza za više od 8 sati, uzmite zaboravljenu dozu čim se sjetite.
The PFS hazard ratio for patients with DEL 19 mutations and L858R mutations was 0.76 (95% CI [0.55, 1.06]; p=0.1071), and 0.71 (95% CI [0.47, 1.06]; p=0.0856) respectively for afatinib vs gefitinib.
Omjer hazarda (HR) za PFS za bolesnike s mutacijama DEL 19 i mutacijama L858R bio je 0,76 (95% CI [0,55; 1,06]; p=0,1071) i 0,71 (95% CI [0,47; 1,06]; p=0,0856) za afatinib naspram gefitiniba.
Among the patients randomised, 65% were female, the median age was 61 years, the baseline ECOG performance status was 0 (39%) or 1 (61%), 26% were Caucasian and 72% were Asian.
Među randomiziranim bolesnicima, 65% su bile žene, medijan dobi je bio 61 godina, početno ECOG funkcionalno stanje bilo je 0 (39%) ili 1 (61%), a 26% su bili bijelci i 72% azijati.
No starting dose adjustments appear necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Ne smatra se da je potrebna prilagodba početne doze lijeka kod bolesnika s blagim ili umjerenim oštećenjem jetre (vidjeti dio 4.2).
At the time of the analysis, 14 Nov 2013, 176 patients (76.5%) in the afatinib arm and 70 patients (60.9%) in the chemotherapy arm experienced an event contributing to the PFS analysis, i.e. disease progression as determined by central independent review or death.
U vrijeme analize, 14. studenog 2013., u 176 bolesnika (76,5%) iz skupine u kojoj se primjenjivao afatinib te u 70 bolesnika (60,9%) iz skupine u kojoj se primjenjivala kemoterapija došlo je do događaja koji doprinosi
Table 9: Efficacy results of GIOTRIF vs. gefitinib (LUX-Lung 7) based on primary analysis as of August
Tablica 9: Rezultati djelotvornosti primjene GIOTRIFA naspram gefitiniba (LUX-Lung 7) na temelju primarne analize iz kolovoza 2015.
Grade 2 ALT elevations occurred in 1% and Grade 3 elevations occurred in 0.8% of patients treated with GIOTRIF (see section 4.4).
Povećanje ALT-a stupnja 2 javilo se kod 1% bolesnika, a povećanje ALT-a stupnja 3 javilo se kod 0,8% bolesnika liječenih GIOTRIFOM (vidjeti dio 4.4).
Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Izloženost afatinibu je bila povećana u bolesnika s umjerenim ili teškim oštećenjem bubrega (vidjeti dio 5.2).
In patients with tumours harbouring exon 20 insertions (N=23) the confirmed ORR was 8.7% and the median duration of response was 7.1 months.
U bolesnika čiji su tumori nosili insercije u egzonu 20 (N=23) potvrđeni ORR iznosio je 8,7%, a medijan trajanja odgovora iznosio je 7,1 mjesec.
Table 10: Efficacy results for GIOTRIF vs erlotinib in LUX-Lung 8, based on primary analysis of OS, including all randomized patients
Tablica 10: Rezultati djelotvornosti za GIOTRIF naspram erlotiniba u ispitivanju LUX-LUNG 8 na temelju primarne analize ukupnog preživljenja koja je uključivala sve randomizirane bolesnike.
In the pre-defined subgroup of common mutations (combined Del 19 and L858R) for GIOTRIF and chemotherapy, the median PFS was 13.6 months vs. 6.9 months (HR 0.48; 95% CI 0.35-0.66; p<0.0001; N=307) in LUX-Lung 3, and 11.0 months vs. 5.6 months (HR 0.24; 95% CI 0.17-0.35; p<0.0001; N=324) in LUX-Lung 6, respectively.
U prethodno definiranoj podskupini čestih mutacija (kombinirane Del 19 i L858R) za GIOTRIF i kemoterapiju, medijan PFS-a je bio 13,6 mjeseci naspram 6,9 mjeseci (HR 0,48; 95% CI 0,35 - 0,66; p < 0,0001; N = 307) u ispitivanju LUX-Lung 3, odnosno 11,0 mjeseci naspram 5,6 mjeseci (HR 0,24; 95% CI 0,17 - 0,35; p < 0,0001; N = 324) u ispitivanju LUX-Lung 6.
In LUX-Lung-3 Grade 3 ALT/AST elevations were about 3.5 fold higher in patients with abnormal baseline liver tests.
U ispitivanju LUX-Lung 3 porast ALT/AST stupnja 3 bio je za oko 3,5 vrijednosti porasta veći kod bolesnika s patološkim početnim vrijednostima jetrenih enzima.
Dyspepsia Cheilitis
Dispepsija Heilitis
Dermatitis acneiform
Akneiformni dermatitis
The most frequent ADRs were diarrhoea and skin related adverse events (see section 4.4) as well as stomatitis and paronychia (see also Table 3, 4 and 5).
Pregled svih nuspojava prikazan je u tablici 2. Najčešće nuspojave na lijek bile su proljev i nuspojave povezane s kožom (vidjeti dio 4.4) kao i stomatitis, te paronihija (vidjeti također tablicu 3, 4 i 5).
Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.
Obavijestite liječnika ako razvijete iznenadne simptome bolesti oka, kao što su bol, crvenilo i suhoća oka, ili ako dođe do njihovog pogoršanja.
Patients were screened for the presence of 29 different EGFR mutations using a polymerase chain reaction (PCR)-based method (TheraScreen
Bolesnici su provjereni na prisutnost 29 različitih EGFR mutacija uz upotrebu metode temeljene na lančanoj reakciji polimeraze (PCR) (TheraScreen EGFR29 Mutation Kit, Qiagen Manchester Ltd).
Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 3 and LUX-Lung 7 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Tables 3 and 4.
Vrlo česte nuspojave na lijek u bolesnika liječenih GIOTRIFOM koje su se javile kod najmanje 10% bolesnika u ispitivanju LUX-Lung 3 i LUX-Lung 7 prikazane su u tablicama 3 i 4 prema stupnjevima Zajedničkih kriterija toksičnosti Nacionalnog instituta za rak (NCI-CTC).
If P-gp inhibitors need to be taken, they should be administered using staggered dosing, i.e. the P-gp inhibitor dose should be taken as far apart in time as possible from the GIOTRIF dose.
P-gp inhibitora se mora uzeti sa što je moguće duljim vremenskim razmakom od uzimanja doze GIOTRIFA.
Based on in vitro data, afatinib is a moderate inhibitor of P-gp.
Na osnovi in vitro podataka, afatinib je umjereni P-gp inhibitor.
7.7 vs. 1.7 HR 0.53; p<0.0001
7,7 naspram 1,7 HR 0,53; p< 0,0001
In three clinical trials of GIOTRIF with prospective tumour genotyping (Phase 3 trials LUX-Lung 3 and -6, and single arm Phase 2 trial LUX-Lung 2), an analysis was conducted of data from a total of 75 TKI-naïve patients with advanced (stage IIIb-IV) lung adenocarcinomas harbouring uncommon EGFR mutations, which were defined as all mutations other than Del 19 and L858R mutations.
Analiza djelotvornosti GIOTRIFA u bolesnika koji prethodno nisu bili liječeni EGFR TKI-om, a čiji su tumori imali manje česte mutacije EGFR-a (LUX-Lung 2, -3 i -6) U tri klinička ispitivanja GIOTRIFA s prospektivnom genotipizacijom tumora (ispitivanja faze 3 LUX-Lung 3 i -6 te ispitivanje faze 2 LUX-Lung 2 provedeno u jednoj skupini), provedena je analiza u ukupno 75 bolesnika koji prethodno nisu bili liječeni EGFR TKI-om, a imali su uznapredovali (stadij IIIb-IV) adenokarcinom pluća s manje čestim mutacijama EGFR-a, koje su bile definirane kao sve mutacije osim mutacija Del 19 i L858R.
MDRD formula) had an exposure of 122% (Cmax) and 150% (AUC0-tz) in comparison to their healthy controls.
Modification of Diet in Renal Disease) imali su izloženost 101% (Cmax) i 122% (AUC0-tz) u usporedbi s njihovim zdravim kontrolama.
4.2 vs. 3.1 HR 0.83; p=0.1882
4,2 naspram 3,1 HR 0,83; p= 0,1882
71% vs. 48%; p<0.0001
71% naspram 48%; p<0,0001
40% vs. 39%; p=0.7752
40% naspram 39%; p=0,7752
If any of these apply to you, your doctor may monitor you more closely as the side effects may be more pronounced.
Liječnik će Vas pažljivije pratiti ako imate nešto od spomenutog jer postoji mogućnost da nuspojave budu izraženije.
They should therefore be taken as far apart in time as possible from GIOTRIF.
Stoga se oni moraju uzimati što je prije ili poslije GIOTRIFA moguće.
Interactions with drug uptake transport systems
Interakcije s prijenosnim sustavima lijekova
In general, rash manifests as a mild or moderate erythematous and acneiform rash, which may occur or worsen in areas exposed to sun. For patients who are exposed to sun, protective clothing, and use of sun screen is advisable.
Općenito, osip se manifestira u obliku blagog ili umjerenog eritematoznog i akneiformnog osipa koji se može pojaviti ili pogoršati na područjima koja su izložena suncu.
GIOTRIF significantly improved PFS and ORR in EGFR mutation positive patients compared to gefitinib.
GIOTRIF je značajno poboljšao PFS i ORR u bolesnika s EGFR mutacijom u usporedbi s gefitinibom.
LUX-Lung 2 was a single arm Phase II trial in 129 EGFR TKI-naïve patients with stage IIIB or IV lung adenocarcinoma with EGFR mutations.
LUX-Lung 2 je bilo ispitivanje faze II provedeno na jednoj skupini od 129 bolesnika koji prethodno nisu bili liječeni EGFR TKI-om s adenokarcinomom pluća stadija IIIB ili IV i EGFR mutacijama.
Table 11: Symptom outcomes for GIOTRIF vs. erlotinib in trial LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
Tablica 11: Ishodi vezani uz simptome za GIOTRIF naspram erlotiniba u ispitivanju LUX-Lung 8 (EORTC QLQ-C30 & QLQ-LC13)
When to take GIOTRIF
Kada uzeti GIOTRIF
Patients with mild and moderate hepatic impairment as identified by abnormal liver tests did not correlate with any significant change in afatinib exposure.
Abnormalan nalaz jetrenih enzima u bolesnika s blagim do umjerenim oštećenjem jetre nije bio u korelaciji niti s jednom značajnom promjenom u izloženosti afatinibu.
Enzyme-catalyzed metabolic reactions play a negligible role for afatinib in vivo.
Metaboličke reakcije katalizirane enzimima imaju zanemarivu ulogu za afatinib in vivo.
67% vs. 60%; p=0.2133
67% naspram 60%; p=0,2133
Subjects with moderate renal impairment (n=8; eGFR 30-59 mL/min/1.73m², according to the Modification of Diet in Renal Disease [MDRD] formula) had an exposure of 101% (Cmax) and 122% (AUC0-tz) in comparison to their healthy controls.
Ispitanici s teškim oštećenjem bubrega (n=8; eGFR 15-29 ml/min/1,73 m2, sukladno jednadžbi MDRD) imali su izloženost 122% (Cmax) i 150% (AUC0-tz) u usporedbi s njihovim zdravim kontrolama.
31.1 vs. 10.3 HR 0.46; p=0.0001
31,1 naspram 10,3 HR 0,46; p= 0,0001
Table 5: Very common ADRs in trial LUX-Lung 8* GIOTRIF (40 mg/day)
Tablica 4: Vrlo česte nuspojave u ispitivanju LUX-Lung 7 GIOTRIF (40 mg/dan)
Monitor patients with severe renal impairment (eGFR 15-29 mL/min/1.73m²) and adjust GIOTRIF dose if not tolerated.
Potrebno je nadzirati bolesnike s teškim oštećenjem bubrega (eGFR 15-29 ml/min/1,73 m 2) i prilagoditi dozu GIOTRIFA
Skin related adverse events
Nuspojave povezane s kožom
GIOTRIF (40 mg/day) N=229
GIOTRIF (40 mg/dan) N=229
Mothers should be advised against breast-feeding while receiving this medicinal product.
Majkama se mora savjetovati da ne doje tijekom primjene ovog lijeka.
Interstitial Lung Disease (ILD)
Bolest plućnog intersticija (BPI)
Table 8: Symptom outcomes for GIOTRIF vs. chemotherapy in trials LUX-Lung 3 and LUX-Lung 6 (EORTC QLQ-C30 & QLQ-LC13)
Tablica 8: Ishodi simptoma za GIOTRIF naspram kemoterapije u ispitivanjima LUX-Lung 3 i LUX-Lung 6 (EORTC QLQ-C30 i QLQ-LC13)
GIOTRIF in patients with NSCLC of squamous histology
GIOTRIF kod bolesnika s NSCLC sa skvamoznim stanicama u histološkom nalazu
Patients with a history of ILD have not been studied.
Bolesnici s anamnezom BPI-a nisu bili ispitivani.
PHARMACEUTICAL FORM AND CONTENTS 7 x 1 film-coated tablets
OBLIK I SADRŽAJ 7 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta 28 x 1 filmom obložena tableta
27.0 vs. 8.0 HR 0.60; p=0.0062
27,0 naspram 8,0 HR 0,60; p= 0,0062
In the first-line setting, the efficacy and safety of GIOTRIF in patients with EGFR mutation-positive locally advanced or metastatic NSCLC (stage IIIB or IV) were assessed in a global, randomised, multicentre, open-label trial.
U prvoj liniji, djelotvornost i sigurnost GIOTRIFA ocjenjivani su kod bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om (stadij IIIB ili IV) pozitivnim na EGFR mutaciju u sklopu globalnog, randomiziranog, multicentričnog, otvorenog ispitivanja.
Similar to LUX-Lung 3, patients with previously untreated NSCLC were screened for EGFR mutations using TheraScreen
Slično kao u ispitivanju LUX-Lung 3, bolesnici s prethodno neliječenim NSCLC-om ispitani su na prisutnost EGFR mutacija pomoću testa TheraScreen EGFR29 Mutation Kit (Qiagen Manchester Ltd).
Figure 2: Kaplan-Meier Curve for OS by treatment group in LUX-Lung 8
Slika 2: Kaplan-Meierova krivulja OS prema ispitivanoj skupini u ispitivanju LUX-Lung 8
The efficacy and safety of GIOTRIF in Asian patients with Stage IIIB/IV EGFR mutation-positive locally advanced or metastatic adenocarcinoma of the lung was evaluated in a randomised, multicentre, open-label trial.
Djelotvornost i sigurnost GIOTRIFA u azijatskih bolesnika s lokalno uznapredovalim ili metastatskim adenokarcinomom pluća stadija IIIB/IV i pozitivnim na EGFR mutaciju ocjenjivani su u sklopu randomiziranog, multicentričnog, otvorenog ispitivanja.
60% vs. 48%; p=0.0427
60% naspram 48%; p=0,0427
Treatment at the first signs of diarrhoea is important.
Liječenje proljeva u početnoj fazi je važno.
43% vs. 35%; p=0.0294
43% naspram 35%; p=0,0294
Table 6: Efficacy results of GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) (Independent review)
Tablica 6: Rezultati djelotvornosti GIOTRIFA naspram kombinacije pemetreksed/cisplatin (LUX-Lung 3) i gemcitabin/cisplatin (LUX -Lung 6) (nezavisna procjena).
Rash/acne has been reported in patients treated with this medicinal product (see section 4.8).
Prijavljeni su slučajevi pojave osipa/akni kod bolesnika liječenih ovim lijekom (vidjeti dio 4.8).
51% vs. 44%; p=0.0605
51% naspram 44%; p=0,0605
2.6 vs. 1.9 HR 0.79; p=0.0078
2,6 naspram 1,9 HR 0,79; p=0,0078
Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Crospovidone (type A) Magnesium stearate (E470b)
Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460) silicijev dioksid, koloidni, bezvodni (E551) krospovidon (vrste A) magnezijev stearat (E470b)
Progression-free survival Months (median) Hazard Ratio (HR) (95%CI) p-value
Preživljenje bez progresije Mjeseci (medijan) Omjer hazarda (HR) (95%CI) p-vrijednost
Gemcitabine/ Cisplatin (N=122)
Gemcitabin/ cisplatin (N=122)
Covalent adducts to proteins were the major circulating metabolites of afatinib.
Glavni cirkulirajući metaboliti afatiniba bili su kovalentno vezani na proteine.
® 40 mg orally once daily (N=160) or gefitinib 250 mg orally once daily (N=159).
Bolesnici (N=319) su bili randomizirani (1:1) na primanje GIOTRIFA 40 mg peroralno jedanput dnevno (N=160) ili gefitiniba 250 mg peroralno jedanput dnevno (N=159).
GIOTRIF has not been studied in patients with eGFR <15 mL/min/1.73m² or on dialysis.
GIOTRIF nije ispitan u bolesnika s eGFR<15 ml/min/1,73 m 2 ili na dijalizi.
GIOTRIF treatment in patients with eGFR <15 mL/min/1.73m² or on dialysis is not recommended.
Terapija lijekom GIOTRIF ne preporučuje se kod bolesnika s eGFR<15 ml/min/1,73 m2 ili na dijalizi.
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), indigo carmine (E132) aluminium hydroxide.
- Drugi sastojci su laktoza hidrat, mikrokristalična celuloza (E460), koloidni bezvodni silicijev dioksid (E551), krospovidon vrste A, magnezijev stearat (E470b), hipromeloza (E464), makrogol 400, titanijev dioksid (E171), talk (E553b), polisorbat 80 (E433), indigo carmine (E132) aluminijev hidroksid.
Periodic liver function testing is recommended in patients with pre-existing liver disease.
Kod bolesnika s od ranije postojećom bolešću jetre preporučuje se periodična kontrola jetrene funkcije.
If ILD is diagnosed, GIOTRIF should be permanently discontinued and appropriate treatment initiated as necessary (see section 4.2).
Ako se dijagnosticira BPI, primjena GIOTRIFA mora se trajno prekinuti, te prema potrebi započeti odgovarajuće liječenje (vidjeti dio 4.4).
• if you develop diarrhoea.
• razvijete proljev.
Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression CR=complete response; PR=partial response
Ukupno preživljenje (OS) Mjeseci (medijan) Omjer hazarda (HR) (95%CI) p-vrijednost p-vrijednost za PFS/OS temeljena na stratificiranom log-rank testu; p-vrijednost za stopu objektivnog odgovora temeljena na logističkoj regresiji
Interstitial Lung Disease (ILD) should be considered if a patient develops acute or worsening of respiratory symptoms in which case treatment should be interrupted pending evaluation.
Ako bolesnik razvije akutne respiratorne simptome ili dođe do pogoršanja ranije prisutnih respiratornih simptoma, potrebno je razmotriti mogućnost razvoja bolesti plućnog intersticija (BPI), te se u tom slučaju liječenje mora prekinuti do postavljanja dijagnoze.
• Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
• odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica (NSCLC, od engl. non-small cell lung cancer) i aktivnom(im) EGFR mutacijom(ama) koji prethodno nisu bili liječeni TK inhibitorima receptora epidermalnog faktora rasta (EGFR, od engl.
How to take GIOTRIF
Kako uzimati GIOTRIF
4.5 vs. 3.7 HR 0.89; p=0.2562
4,5 naspram 3,7 HR 0,89; p=0,2562
• Mouth sores and inflammation
• Ranice u ustima i upala
Grade 2 (> 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in < 8% of patients treated with this medicinal product.
Povećanje ALT-a stupnja 2 (> 2,5 do 5,0 puta više vrijednosti od gornje granice normale [GGN]) javilo se kod < 8% bolesnika, a povećanje ALT-a stupnja 3 (> 5,0 do 20,0 puta GGN) javilo se kod < 4% bolesnika liječenih GIOTRIFOM (vidjeti dio 4.4).
10.4 vs. 2.9 HR 0.68; p=0.0129
10,4 naspram 2,9 HR 0,68; p= 0,0129
Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value
Ukupno preživljenje (OS) Mjeseci (medijan) Omjer hazarda (HR) (95%CI) p-vrijednost
Dose adjustment for adverse reactions
Prilagodba doze za nuspojave
65% vs. 50%; p=0.0078
65% naspram 50%; p=0,0078
Among 795 patients randomized, the majority were males (84%), white (73%), current or former smokers (95%) with baseline performance status ECOG 1 (67%) and ECOG 0 (33%).
Od 795 randomiziranih bolesnika, većina su bili muškarci (84%), bijelci (73%), aktivni ili bivši pušači (95%)
76% vs. 55%; p=0.0003
76% naspram 55%; p=0,0003
65% vs. 47%; p=0.0017
65% naspram 47%; p=0,0017
Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 8 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 5.
Vrlo česte nuspojave u bolesnika liječenih GIOTRIFOM koje su se pojavile u barem 10% bolesnika u ispitivanju LUX-Lung 8 sažeto su prikazane prema stupnjevima, određenim sukladno zajedničkim kriterijima toksičnosti Nacionalnog instituta za tumore (engl.
Table 3: Very common ADRs in trial LUX-Lung 3
Tablica 3: Vrlo česte nuspojave na lijek u ispitivanju LUX-Lung 3
Paronychia
Paronihija
• Vomiting
• Povraćanje
Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Za bolesnike koji su izloženi suncu, savjetuje se upotreba zaštitne odjeće i zaštitnih krema.
Gemcitabine/ Cisplatin (N=62)
Gemcitabin/ cisplatin (N=62)
Weight decreased Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform Includes Pruritus, Pruritus generalised Includes Dry skin, Skin chapped Based on post-marketing experience Includes Nail disorder, Onycholysis, Nail toxicity, Onychoclasis, Ingrowing nail, Nail pitting, Onychomadesis, Nail discoloration, Nail dystrophy, Nail ridging, and Onychogryphosis
Smanjena težina uključuje paronihiju, infekciju nokta, infekciju ležišta nokta uključuje stomatitis, aftozni stomatitis, upalu sluznice, ulceraciju usta, eroziju sluznice usta, eroziju sluznice, ulceraciju sluznice uključuje skupinu termina za osip uključuje akne, pustulozne akne, akneiformni dermatitis uključuje pruritus, generalizirani pruritus uključuje suhu kožu, raspucanu kožu na temelju iskustva nakon stavljanja lijeka u promet Uključuje poremećaj nokata, oniholizu, toksičnost za nokte, onihoklaziju, urasli nokat, udubljenja na noktu, onihomadezu, promjenu boje nokta, distrofiju nokta, brazde na noktu i onihogrifozu
There were no Grade 3 ALT/AST elevations in patients with abnormal baseline liver tests in LUX-Lung 8 (see section 4.8).
U ispitivanju LUX-Lung 8 nije bilo porasta ALT/AST stupnja 3 kod bolesnika s patološkim početnim vrijednostima jetrenih enzima (vidjeti dio 4.8).
Gemcitabine/ Cisplatin (N=46)
Gemcitabin/ cisplatin (N=46)
Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test
Ukupno preživljenje (OS) Mjeseci (medijan) Omjer hazarda (HR) (95%CI) p-vrijednost p-vrijednost za PFS/OS temeljena na stratificiranom log-rank testu
Discontinuation due to ADRs diarrhoea and rash/acne was 1.3% and 0% in LUX-Lung 3 and 3.8% and 2.0% in LUX-Lung 8, respectively.
Trajni prekid liječenja bio je potreban kod 1,3% slučajeva zbog proljeva i 0% slučajeva zbog osipa/akni u ispitivanju LUX-Lung 3, odnosno 3,8% slučajeva zbog proljeva i 2% zbog osipa/akni u LUX-Lung 8 ispitivanju.
Pemetrexed/ Cisplatin (N=115)
Pemetreksed/ cisplatin (N=115)
2.5 vs. 2.4 HR 0.99; p=0.8690
2,5 naspram 2,4 HR 0,99; p=0,8690
One film-coated tablet contains 294 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 294 mg laktoze (u obliku hidrata).
How to store GIOTRIF
Kako čuvati GIOTRIF
One film-coated tablet contains 118 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 118 mg laktoze (u obliku hidrata).
One film-coated tablet contains 176 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 176 mg laktoze (u obliku hidrata).