natgillin/translations-raw huggingface dataset:
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).
Based on this trial and population pharmacokinetic analysis of data derived from clinical trials in various tumour types, it is concluded, that adjustments to the starting dose in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²), or severe (eGFR 15-29 mL/min/1.73m²) renal impairment are not necessary, but patients with severe impairment should be monitored (see “Population pharmacokinetic analysis in special populations” below and section 4.2). 
Na temelju ovog ispitivanja i populacijske farmakokinetičke analize podataka proizašlih iz kliničkih ispitivanja na različitim vrstama tumora, zaključeno je da nisu potrebne prilagodbe početne doze u bolesnika s blagim (eGFR 60-89 ml/min/1,73 m2), umjerenim (eGFR
Cystitis 
Cistitis
One film-coated tablet contains 235 mg lactose (as monohydrate). 
Jedna filmom obložena tableta sadrži 235 mg laktoze (u obliku hidrata).
Odds Ratio (OR) (95%CI) p-value 
Omjer izgleda (OR) (95%CI) p-vrijednost
Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5 
Izloženost u plazmi (AUCτ,ss) se povećala za 26% kod bolesnika s 42 kg (2,5 percentila), te smanjila za 22% kod bolesnika od 95 kg (97,5 percentila) u odnosu na bolesnike s 62 kg (medijan tjelesne težine bolesnika u ukupnoj bolesničkoj populaciji).
Subjects with severe renal impairment (n=8; eGFR 15-29 mL/min/1.73m², according to the 
Ispitanici s umjerenim oštećenjem bubrega (n=8; eGFR 30-59 ml/min/1,73 m2, sukladno jednadžbi MDRD, od engl.
What GIOTRIF looks like and contents of the pack GIOTRIF 20 mg film-coated tablets are white to yellowish and round shaped. 
GIOTRIF 20 mg filmom obložene tablete su bijele do žućkaste boje i okruglog oblika.
Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²) or severe (eGFR 15-29 mL/min/1.73m²) renal impairment. 
Prilagodbe početne doze nisu potrebne u bolesnika s blagim (eGFR 60-89 ml/min/1,73 m2), umjerenim
Rhinorrhoea 
Rinoreja
GIOTRIF 20 mg film-coated tablets Hypromellose (E464) Macrogol 400 
GIOTRIF 20 mg filmom obložene tablete hipromeloza (E464) makrogol 400 titanijev dioksid (E171) talk (E553b)
Dose escalation 
Povećanje doze
PFS Months (median) 
Preživljenje bez progresije (PFS) Mjeseci (medijan)
Pemetrexed/ Cisplatin (N=57) 
Pemetreksed/ cisplatin (N=57)
GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate). 
GIOTRIF 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
MedDRA Preferred Term 
Preporučeni izrazi po MedDRA-i
• Inflammation of the lining of the bladder with burning sensations during urination and frequent, 
• Upala sluznice mjehura s osjećajem pečenja tijekom mokrenja, te česta, hitna potreba za mokrenjem
White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. 
Bijela do žućkasta, okrugla, bikonveksna filmom obložena tableta sa ukošenim rubovima i utisnutom oznakom “T20” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
Table 2: Summary of ADRs per frequency category 
Tablica 2: Pregled nuspojava na lijek po kategoriji učestalosti
Reporting the frequency of patients with all causality AEs 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 
*prijavljene su učestalosti za bolesnike s nuspojavama svih kauzalnosti uključuje paronihiju, infekciju nokta, infekciju ležišta nokta uključuje stomatitis, aftozni stomatitis, upalu sluznice, ulceraciju usta, eroziju sluznice usta, eroziju sluznice, ulceraciju sluznice uključuje skupinu preporučenih termina za osip uključuje akne, pustulozne akne, akneiformni dermatitis
Metabolism and nutrition disorders Decreased appetite 
Preporučeni izrazi po MedDRA-i Infekcije i infestacije Paronihija Poremećaji metabolizma i prehrane Smanjeni apetit
Hazard Ratio/ Odds Ratio (95%CI) 
Omjer hazarda (HR)/ Omjer izgleda (OR) (95% CI)
Skin and subcutaneous tissue disorders Rash 
Poremećaji kože i potkožnog tkiva Osip
The efficacy results at the time of the primary analysis of OS including all randomized patients are summarized in Figure 2 and Table 10. 
Na slici 2 i u tablici 10 sažeti su rezultati djelotvornosti u trenutku primarne analize ukupnog preživljenja koja je uključivala sve randomizirane bolesnike.
GIOTRIF (40 mg/day) N=160 
GIOTRIF (40 mg/dan) N=392
INFORMATION IN BRAILLE GIOTRIF 20 mg 
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 20 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 20 mg
GIOTRIF 20 mg film-coated tablets 
GIOTRIF 20 mg filmom obložene tablete
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 20 mg
Gastrointestinal disorders Diarrhoea Stomatitis 
Proljev Stomatitis Mučnina Povraćanje
Hepatic impairment 
Poremećaji nokata
- The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, 
- 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).
GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate). 
GIOTRIF 30 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
INFORMATION IN BRAILLE GIOTRIF 50 mg 
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 50 mg
GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate). 
GIOTRIF 40 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
What GIOTRIF looks like and contents of the pack GIOTRIF 30 mg film-coated tablets are dark blue and round shaped. 
GIOTRIF 30 mg filmom obložene tablete su tamnoplave boje i okruglog oblika.
GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate). 
GIOTRIF 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
Each film-coated tablet contains 20 mg of afatinib (as dimaleate). 
Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
Hazard Ratio (HR) (95%CI) p-value 
Omjer hazarda (HR)/ Omjer izgleda (OR) (95%CI) p-vrijednost
Pemetrexed/ Cisplatin (N=47) 
Pemetreksed/ cisplatin (N=47)
INFORMATION IN BRAILLE GIOTRIF 30 mg 
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 30 mg
GIOTRIF 20 mg film-coated tablets afatinib 
GIOTRIF 20 mg filmom obložene tablete afatinib
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/879/010
GIOTRIF 50 mg film-coated tablets EU/1/13/879/010 
GIOTRIF 50 mg filmom obložene tablete EU/1/13/879/010
GIOTRIF 30 mg film-coated tablets 
GIOTRIF 30 mg filmom obložene tablete
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 30 mg
GIOTRIF 40 mg film-coated tablets 
GIOTRIF 40 mg filmom obložene tablete
What GIOTRIF looks like and contents of the pack GIOTRIF 40 mg film-coated tablets are light blue and round shaped. 
GIOTRIF 40 mg filmom obložene tablete su svijetloplave boje i okruglog oblika.
• Stomach pain, indigestion, heartburn 
• Bol u želucu, probavne tegobe, žgaravica
INFORMATION IN BRAILLE GIOTRIF 40 mg 
16. PODACI NA BRAILLEOVOM PISMU GIOTRIF 40 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 50 mg
NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib 
NAZIV LIJEKA GIOTRIF 20 mg tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 20 mg)
Severe hepatic impairment 
Teško oštećenje jetre
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 40 mg
What GIOTRIF looks like and contents of the pack GIOTRIF 50 mg film-coated tablets are dark blue and oval shaped. 
GIOTRIF 50 mg filmom obložene tablete su tamnoplave boje i ovalnog oblika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 40 mg
GIOTRIF 50 mg film-coated tablets 
GIOTRIF 50 mg filmom obložene tablete
Each film-coated tablet contains 50 mg of afatinib (as dimaleate). 
Jedna filmom obložena tableta sadrži 50 mg afatiniba (u obliku afatinibdimaleata).
Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. 
Tamnoplava, okrugla, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T30” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib 
NAZIV LIJEKA GIOTRIF 50 mg tablete afatinib
Each film-coated tablet contains 40 mg of afatinib (as dimaleate). 
Jedna filmom obložena tableta sadrži 40 mg afatiniba (u obliku afatinibdimaleata).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE ALUMINIJSKA VREĆICA za 50 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER za 30 mg
GIOTRIF 30 mg film-coated tablets afatinib 
GIOTRIF 30 mg filmom obložene tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 50 mg)
NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib 
NAZIV LIJEKA GIOTRIF 30 mg tablete afatinib
GIOTRIF 30 mg film-coated tablets EU/1/13/879/004 
GIOTRIF 30 mg filmom obložene tablete EU/1/13/879/004
They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. 
Imaju utisnutu oznaku “T20” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
GIOTRIF 20 mg film-coated tablets EU/1/13/879/001 
GIOTRIF 20 mg filmom obložene tablete EU/1/13/879/001
Each film-coated tablet contains 30 mg of afatinib (as dimaleate). 
Jedna filmom obložena tableta sadrži 30 mg afatiniba (u obliku afatinibdimaleata).
NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib 
NAZIV LIJEKA GIOTRIF 40 mg tablete afatinib
6.9 vs. 3.4 HR 0.70; p=0.0220 values presented for GIOTRIF vs. chemotherapy, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test 
vrijednosti predstavljene za GIOTRIF naspram kemoterapije; p-vrijednost temeljena na logističkoj regresiji p-vrijednost za vrijeme do pogoršanja temeljena na stratificiranom log-rank testu
GIOTRIF 40 mg film-coated tablets afatinib 
GIOTRIF 40 mg filmom obložene tablete afatinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 30 mg)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 20 mg filmom obložene tablete afatinib
Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. 
Tamnoplava, ovalna, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T50” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. 
Imaju utisnutu oznaku “T50” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
GIOTRIF 40 mg film-coated tablets EU/1/13/879/007 
GIOTRIF 40 mg filmom obložene tablete EU/1/13/879/007
Dyspepsia 
Dispneja
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 20 mg afatiniba (u obliku afatinibdimaleata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (KUTIJA ZA BLISTER za 40 mg)
GIOTRIF 50 mg film-coated tablets afatinib 
GIOTRIF 50 mg filmom obložene tablete afatinib
They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. 
Imaju utisnutu oznaku “T30” na jednoj strani i logo tvrtke Boehringer Ingelheim na drugoj.
Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other. 
Svijetloplava, okrugla, bikonveksna filmom obložena tableta s ukošenim rubovima i utisnutom oznakom “T40” na jednoj strani i logom tvrtke Boehringer Ingelheim na drugoj.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIOTRIF 30 mg filmom obložene tablete afatinib