natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO ZA 20 mg/0,72 ml
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). 
• 332 bolesnika koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom
BATCH NUMBER Lot 
*Neprilagođeni log-rang test
min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 
(TCis), ili Docetaksel 75 mg/m2 u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m2 primijenjen tijekom 6
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 
• 300 bolesnika s adenokarcinomom želuca (221 bolesnik u fazi III studije i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION 
UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 80 mg/2,88 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
Very common adverse reactions Common adverse reactions 
Vrlo česte nuspojave Česte nuspojave
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; 
Poremećaji probavnog sustava mučnina; proljev; povraćanje;
Dizziness; Headache (G3/4: <1%); 
bol u udovima (G3/4: <1%);
95% CI p-value* 
(95% CI) *p-vrijednost
At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%). 
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), limfedem je i dalje bio prisutan u 6 bolesnika (0,8%) u TAC skupini te u
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel 
Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
Negative 
Negativan Pozitivan
In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm. 
U ispitivanju GEICAM 9805 periferna senzorna neuropatija koja je počela tijekom perioda liječenja i dalje je bila prisutna u 10 bolesnika (1,9%) u TAC skupini i 4 bolesnika (0,8%) u FAC skupini.
Oral candidiasis (G3/4: <1%) 
parestezija (G3/4: <1%)
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128. 
skupinu (medijan OS: 18,6 prema 14,5 mjeseci) s rizikom smanjenja smrtnosti od 28%, p=0,0128.
Median progression free survival (months) (95%CI) 
Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI)
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy 
doksorubicin i ciklofosfamid (TAC režim).
Gastrointestinal haemorrhage (G3/4: 
Poremećaji oka konjuktivitis (G3/4:
1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 
Docetaxel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg/m2 (521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0 
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Stomatitis/Pharyngitis (G3/4: 
stomatitis (G3/4:
Hazard ratio (95% CI) *p-value 
Omjer rizika (95% CI) *p-vrijednost
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine 
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s kapecitabinom
Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 
proljev (G3/4: 3,4%); konstipacija (G3/4:
Diarrhoea (G3/4: 1.2%); 
stomatitis (G3/4: 1,7%);
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION 
UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 20 mg/0,72 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion 
Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2%) in TAC arm and 35 patients (6.7%) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9%) in TAC arm and 30 patients (5.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm. 
U GEICAM 9805 studiji, alopecija koja je počla tijekom perioda lječenja i dalje bila prisutna tijekom perioda praćenja i zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel 
Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes 
• Indukcijska kemoterapija praćena kemoradioterapijom (TAX 324)
Alopecia (persisting Skin disorder (G3/4: 
Poremećaji kože i potkožnog tkiva alopecija (G3/4:
Disease free survival 
zimica letargija
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil 
Opis odabranih nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Nausea (G3/4: 13.9%); Stomatitis (G3/4: 
proljev (G 3/4: 1,2%); stomatitis/faringitis (G3/4:
In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%). 
U ispitivanju TAX 316 amenoreja koja je počela tijekom perioda liječenja te je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije zabilježena je u 202 od 744 bolesnice (27,2%) u TAC
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent 
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u monoterapiji
Docetaxel Teva is supplied as single-dose vials. 
Teva je dostupan u jednodoznim bočicama.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer. 
U bolesnika koji primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke, treba razmotriti primarnu profilaksu s G-CSF.
Hazard ratio (95% CI) **p-value 
Omjer rizika (95% CI) **p-vrijednost
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%) 
vrućica (G3/4: 2,3%); retencija tekućine (teška/opasna po život: 1%)
Nausea (G3/4:13.9%); 
Poremećaji probavnog sustava mučnina (G 3/4: 13,9%);
Skin reaction (G3/4: 
retencija tekućine (G3/4:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva 20 mg/0.72 ml 
Otapalo za Docetaksel Teva 20 mg/0,72 ml
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion 
Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml). 
27,73 mg/ml (volumen punjenja 24,4 mg/0,88 ml).
Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za Docetaksel 75 mg/m2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 
(G3/4:0%); somnolencija (G3/4:
Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%) 
Opći poremećaji i reakcije na mjestu primjene astenija (G3/4: 3%); pireksija (G3/4: 1%); umor/slabost (G3/4: 5%); periferni edem (G3/4: 1%)
No of positive nodes Overall 
Broj pozitivnih limfnih čvorova
G3/4 Blood bilirubin increased (< 5%); 
G3/4 povećanje bilirubina u krvi (<5%); G3/4 povećanje alkalne fosfataze u krvi (<4%);
in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm. 
Na kraju perioda praćenja (medijan vremena praćenja iznosio je 10 godina i 5 mjeseci), alopecija je i dalje bila prisutna u 3 bolesnika (0,6%) u TAC skupini, te u 1 bolesnika (0,2%) u FAC skupini.
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%) 
prsišta i sredoprsja epistaksa (G3/4: 0%); dispneja (G3/4: 0,6%); kašalj (G3/4: 0%)
Hypersensitivity (G3/4: 1.7%) 
proljev (G3/4: 1,7%)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
Česte nuspojave Manje česte nuspojave
Febrile neutropenia (G3/4: NA) 
vrućica (G3/4: ND);
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml) 
2,88 ml (Punjenje 3,40 ml)
Nausea (G3/4: 3.3%); 
stomatitis (G3/4: 23,7%);
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4: 
Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 4,0%); pireksija (G3/4: 3,6%);
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%) 
Poremećaji krvi i limfnog sustava neutropenija (G4: 54,2%); anemija (G3/4: 10,8%); trombocitopenija (G4: 1,7 %)
Diarrhoea (G3/4: Vomiting (G3/4: 0.6%) 
hipotenzija (G3/4: flebitis (G3/4: 0%)
Polysorbate 80 
Koncentrat polisorbat 80 etanol, bezvodni
What the solvent vial contains: Water for injections. 
Teva sadrži vodu za injekcije.
Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value 
Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/
Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%) 
dermatitis eritematozni osip (G 3/4: <1%) promjena boje nokta; oniholiza (G 3/4: 1%)
Solvent vial: water for injections. 
Teva je voda za injekcije.
Myalgia (severe: 1.4%) Arthralgia 
Poremećaji mišićno koštanog sustava i vezivnog tkiva mijalgija (teška: 1,4%) artralgija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg docetaxel. 
Jedana bočica s koncentratom Docetaksel Teva sadrži 80 mg/2,88 ml docetaksela.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe 
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%); disgeuzija (G3/4: 0%)
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u monoterapiji
Dry skin; 
kožna toksičnost
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention; 
Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 3,4%); pireksija (G3/4: 0,6%);
The solvent for Docetaxel Teva is water for injections. 
Docetaksel Teva otopine za infuziju
2-year estimate (%) Hazard ratio (95% CI) *p-value 
Medijan preživljenja (mjeseci) (95% CI) dvogodišnja procjena (%) Omjer rizika (95% CI) *p-vrijednost
Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%) 
Poremećaji krvi i limfnog sustava neutropenija (G3/4: anemija (G3/4: 9,2%); trombocitopenija (G3/4: 5,2%)
The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1-to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion. 
SCCHN), preporučena doza docetaksela iznosi 75 mg/m2 i daje se kao jednosatna intravenska infuzija na prvi dan, nakon čega slijedi cisplatin 100 mg/m2 primjenjen kao 30-minutna do 3 satna infuzija.
• chest tightness; difficulty in breathing 
• bol u trbuhu • probavne tegobe
Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain 
prsišta i sredoprsja epistaksa; bol u ždrijelu i grkljanu; nazofaringitis, dispneja; kašalj; rinoreja
Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%) 
mučnina (G 3/4: 4%); povraćanje (G 3/4: 3%)
In a phase III study, 1,218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml. 
Ispitivanje faze III provedeno je na 1218 bolesnika s neoperabilnim karcinomom nemalih stanica pluća stadija IIIB ili IV s KPS od 70% ili više, koji nisu ranije primali kemoterapiju za tu bolest.
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29). 
Pri medijanu vremena praćenja od 77 mjeseci ukupno ukupno preživljenje (OS) također je bilo duže u bolesnika u TAC skupini, uz 24% smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini
Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805) Data from a multi-centre open-label randomised trial support the use of Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy. 
Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s
Myalgia (severe: 0.5%) 
(teška: 0,7%)
Anaemia (G3/4: 10.8%); 
povraćanje (G3/4: 0,8%);
Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%); 
Poremećaji probavnog sustava stomatitis (G3/4: proljev (G 3/4: 4%);
Hand-foot syndrome (G3/4: Alopecia (G3/4: 6%); 
stomatitis (G3/4: proljev (G3/4: 6,2%);
Discard unused contents appropriately. 
Neiskorišteni lijek treba odgovarajuće zbrinuti.
Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro. 
Više informacija o lijeku Vizimpro nalazi se na internetskim stranicama Agencije: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Vizimpro is available as tablets (15, 30 and 45 mg). 
Lijek Vizimpro dostupan je u obliku tableta (od 15, 30 i 45 mg).
Vizimpro (dacomitinib) 
Vizimpro (dakomitinib)
The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable. 
Bolesnik bi trebao uzimati tabletu od 45 mg jedanput na dan, otprilike u isto vrijeme svakoga dana, sve dok su vidljive koristi od lijeka i dok su nuspojave podnošljive.
Vizimpro (dacomitinib) EMA/89209/2019 
Vizimpro (dakomitinib) EMA/89209/2019
What measures are being taken to ensure the safe and effective use of Vizimpro? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vizimpro?
Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests. 
Prije početka terapije trebalo bi odgovarajućim testovima ispitati prisutnost mutacija u genu EGFR.
Other information about Vizimpro 
Ostale informacije o lijeku Vizimpro
In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells. 
U stanicama raka pluća EGFR je često pretjerano aktivan, što uzrokuje nekontrolirani rast stanica raka.
The European Medicines Agency therefore decided that Vizimpro's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove stoga je zaključila da koristi od lijeka Vizimpro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer. 
Blokiranjem EGFR-a dakomitinib pomaže usporiti rast i širenje raka.
What is Vizimpro and what is it used for? 
Što je Vizimpro i za što se primjenjuje?
Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines. 
Vizimpro se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick). 
Najčešće nuspojave lijeka Vizimpro (mogu se pojaviti u više od 1 na 5 osoba) jesu proljev, osip, stomatitis (upala sluznice usne šupljine), poremećaji noktiju, suha koža, gubitak apetita, konjunktivitis (crvenilo i osjećaj nelagode u oku), gubitak težine i kose, svrbež, povišene razine transaminaza(znak problema s jetrom) i mučnina (slabost).
Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Vizimpro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Why is Vizimpro authorised in the EU? 
Zašto je Vizimpro odobren u EU-u?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vizimpro have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Vizimpro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor. 
Djelatna tvar u lijeku Vizimpro, dakomitinib, pripada skupini lijekova za liječenje raka zvanih inhibitori tirozin kinaze.
What are the risks associated with Vizimpro? 
Koji su rizici povezani s lijekom Vizimpro?
Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread. 
Vizimpro je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s rakom pluća nemalih stanica (NSCLC) ako je bolest uznapredovala ili ako se proširila.
Although Vizimpro caused more side effects than gefitinib, these were considered manageable. 
Premda je lijek Vizimpro uzrokovao više nuspojava od gefitiniba, smatralo se da se one mogu kontrolirati.
The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite. 
Najčešće ozbiljne nuspojave jesu proljev, intersticijska bolest pluća (poremećaji koji uzrokuju ožiljke na plućima), osip i gubitak apetita.
As for all medicines, data on the use of Vizimpro are continuously monitored. 
Kao i za sve lijekove, podatci o primjeni lijeka Vizimpro kontinuirano se prate.
Vizimpro contains the active substance dacomitinib. 
Vizimpro sadrži djelatnu tvar dakomitinib.
involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib. 
U jednom glavnom ispitivanju kojim su bila obuhvaćena 452 bolesnika s mutacijama EGFR-a, bolesnici koji su uzimali lijek Vizimpro živjeli su u prosjeku oko 15 mjeseci bez pogoršanja bolesti, u usporedbi s 9 mjeseci u bolesnika koji primali gefitinib.
An overview of Vizimpro and why it is authorised in the EU 
Pregled informacija o lijeku Vizimpro i zašto je odobren u EU-u
Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR). 
Lijek Vizimpro primjenjuje se kao monoterapija te samo u bolesnika koji imaju određene mutacije (promjene) u genu za protein pod nazivom receptor epidermalnog čimbenika rasta (EGFR).
For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Vizimpro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib. 
Bolesnici koji su uzimali Vizimpro živjeli su šest mjeseci dulje bez pogoršanja bolesti u odnosu na bolesnike koji su uzimali gefitinib.
How does Vizimpro work? 
Kako djeluje Vizimpro?
Vizimpro has been shown to be more effective than gefitinib (another medicine for non-small cell lung cancer) at prolonging the time patients lived without their disease getting worse. 
Lijek Vizimpro pokazao se učinkovitijim od gefitiniba (drugog lijeka za liječenje raka pluća nemalih stanica) u produljenju razdoblja tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti.
What benefits of Vizimpro have been shown in studies? 
Koje su koristi od lijeka Vizimpro utvrđene u ispitivanjima?
Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse. 
Pokazalo se da lijek Vizimpro znatno produljuje razdoblje tijekom kojeg bolesnici žive bez pogoršanja bolesti.
For the full list of side effects and restrictions of Vizimpro, see the package leaflet. 
Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Vizimpro potražite u uputi o lijeku.
How is Vizimpro used? 
Kako se Vizimpro primjenjuje?
- if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis. 
- ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
3 days. 
3 godine
It may take about 4 weeks or longer until you start to feel an improvement in your condition. 
Mogu biti potrebna oko 4 tjedna ili dulje da biste ste se počeli osjećati bolje.
If possible, take your tablets or the box with you to show the doctor. 
Ako je moguće, uzmite tablete ili kutiju kako biste ih pokazali liječniku.
The tablets are packed in bottles. 
Tablete su pakirane u bočice.
For more information on these, please read section 4 (Possible side effects). 
Za daljnje informacije molimo pročitajte dio 4 (Moguće nuspojave).
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. 
Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite, osim ako se ne približava vrijeme kad morate uzeti sljedeću dozu.