natgillin/translations-raw huggingface dataset:
The capsules are axially printed with ‘MYLAN' over ‘AR200' in black ink on cap and body. 
Na kapsulama je uzduž osi otisnuto „MYLAN” iznad „AR200” crnom tintom na kapici i tijelu.
Voriconazole 200 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) 
Vorikonazol 200 mg dvaput na dan (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
Capsule shell body 150 mg 
Želatina Tijelo kapsule od 150 mg
Atazanavir Mylan with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4, and 
Atazanavir Mylan s ritonavirom ne smije se primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
OPA/Aluminium/PVC - Aluminium blisters containing 30, 30 x 1 (unit dose) capsules. 
OPA/aluminij/PVC - aluminijski blisteri koji sadrže 30, 30 x 1 (jedinična doza) kapsula.
The capsules are axially printed with ‘MYLAN' over ‘AR300' in black ink on cap and body. 
Na kapsulama je uzduž osi otisnuto „MYLAN” iznad „AR300” crnom tintom na kapici i tijelu.
Clarithromycin Cmin ↑160% 
Klaritromicin Cmin ↑160% (↑135%
Co-administration of salmeterol with atazanavir is not recommended (see section 4.4). 
Ne preporučuje se istovremena primjena salmeterola i atazanavira (vidjeti dio 4.4).
OPA/Aluminium/PVC - Aluminium blisters containing 60, 60 x 1 (unit dose) capsules. 
OPA/aluminij/PVC - aluminijski blisteri koji sadrže 60, 60 x 1 (jedinična doza) kapsula.
BOTTLE LABEL FOR 150 MG HARD CAPSULES 
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 150 MG
(atazanavir 400 mg once daily with ritonavir 200 mg once daily) 
(atazanavir 400 mg jedanput na dan s ritonavirom 200 mg jedanput na dan)
Capsule shell cap 150 mg 
Kapica kapsule od 150 mg
Voriconazole 50 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) 
Vorikonazol 50 mg dvaput na dan (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
• dyspnoea (shortness of breath) 
• otežano disanje (nedostatak zraka)
Co-administration of atazanavir and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated 
Istodobna primjena atazanavira i elbasvira/grazoprevira je kontraindicirana zbog značajnog povišenja koncentracije grazoprevira u plazmi te povezanim mogućim povećanjem rizika povišenja ALT-a (vidjeti dio 4.3).
BLISTER CARTON FOR 200 MG HARD CAPSULES 
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 200 MG
Atazanavir Mylan 150 mg hard capsules atazanavir 
Atazanavir Mylan 150 mg tvrde kapsule atazanavir
Atazanavir Mylan 200 mg hard capsules 
Atazanavir Mylan 200 mg tvrde kapsule
BLISTER CARTON FOR 150 MG HARD CAPSULES 
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 150 MG
Capsule shell body 300 mg 
Tijelo kapsule od 300 mg
Atazanavir Mylan 150 mg hard capsules 
Atazanavir Mylan 150 mg tvrde kapsule
Atazanavir Mylan with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2). 
Primjena lijeka Atazanavir Mylan u kombinaciji s ritonavirom kontraindicirana je u bolesnika s umjerenom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
BOTTLE CARTON FOR 150 MG HARD CAPSULES 
KUTIJA BOCE ZA TVRDE KAPSULE OD 150 MG
Capsule shell cap 200 mg 
Kapica kapsule od 200 mg
Atazanavir Mylan with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2). 
Ne preporučuje se primjenjivati Atazanavir Mylan s ritonavirom u bolesnika na hemodijalizi (vidjeti dijelove 4.4 i 5.2).
Capsule shell body 200 mg 
Tijelo kapsule od 200 mg
PVC/PVDC/Aluminium blisters containing 30, 60, 60 x 1 (unit dose) capsules. 
PVC/PVDC/aluminijski blisteri koji sadrže 30, 60, 60 x 1 (jedinična doza) kapsula.
Kidney stones have been reported in patients taking atazanavir. 
U bolesnika koji uzimaju atazanavir zabilježeni su bubrežni kamenci.
Atazanavir Mylan 200 mg hard capsules atazanavir 
Atazanavir Mylan 200 mg tvrde kapsule atazanavir
Atazanavir Mylan 300 mg hard capsules 
Atazanavir Mylan 300 mg tvrde kapsule
Iron oxide red (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin 
Crveni željezov oksid (E172) Titanijev dioksid (E171) Boja Patent blue V (E131) Želatina
Iron oxide yellow (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin 
Žuti željezov oksid (E172) Titanijev dioksid (E171) Boja Patent blue V (E131) Želatina
The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction. 
Mehanizam interakcije između nevirapina i atazanavira je indukcija enzima CYP3A4.
Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine or pain when you urinate. 
• Manje često mogu se pojaviti bubrežni kamenci u osoba koje uzimaju Atazanavir Mylan . Odmah se obratite liječniku ako razvijete simptome bubrežnih kamenaca mogu uključivati bol u donjem dijelu leđa ili donjem dijelu trbuha, krv u mokraći ili bol pri mokrenju.
Atazanavir Mylan 300 mg hard capsules atazanavir 
Atazanavir Mylan 300 mg tvrde kapsule atazanavir
Co-administration with bepridil is contraindicated (see section 4.3) 
Istovremena primjena s bepridilom je kontraindicirana (vidjeti dio 4.3)
(atazanavir 300 mg/ritonavir 100 mg once daily) 
(atazanavir 300 mg / ritonavir 100 mg jednom dnevno)
PVC/PVDC/Aluminium blisters containing 30, 30 x 1 (unit dose) capsules. 
PVC/PVDC/aluminijski blisteri koji sadrže 30, 30 x 1 (jedinična doza) kapsula.
BLISTER CARTON FOR 300 MG HARD CAPSULES 
KUTIJA BLISTERA ZA TVRDE KAPSULE OD 300 MG
BOTTLE LABEL FOR 300 MG HARD CAPSULES 
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 300 MG
• if you have type A or B haemophilia 
• ako imate hemofiliju tipa
Capsules/ritonavir (300 mg/100 mg once daily) n=25 
Bolesnici koji su prethodno bili liječeni kapsualama atazanavira i ritonavirom (300 mg/100 mg jedanput na dan) n=25
Caution should be exercised when verapamil is co-administered with atazanavir. 
Potreban je oprez kad se verapamil primjenjuje istovremeno s atazanavirom.
Haemophiliac patients 
Bolesnici s hemofilijom
PVC/PVDC/Aluminium blisters containing 60, 60 x 1 (unit dose) capsules. 
PVC/PVDC/aluminijski blisteri koji sadrže 60, 60 x 1 (jedinična doza) kapsula.
Diltiazem Cmax ↑98% (↑78% 
Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
The frequency of this is unknown (see section 4.4). 
Mehanizam ovog smanjenja nije poznat. (Vidjeti dijelove 4.2 i 4.4)
BOTTLE LABEL FOR 200 MG HARD CAPSULES 
NALJEPNICA NA BOCI ZA TVRDE KAPSULE OD 200 MG
Ethinyloestradiol AUC ↓19% 
Etinilestradiol AUC ↓19% (↓25%
(300 mg/ 100 mg once daily) n=120 
100 mg jedanput na dan) n=120
(atazanavir 400 mg once daily with ritonavir 100 mg once daily) 
(atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
uncommon: dyspnoea 
manje često: ginekomastija
BOTTLE CARTON FOR 300 MG HARD CAPSULES 
KUTIJA BOCE ZA TVRDE KAPSULE OD 300 MG
Each hard capsule contains 150 mg atazanavir (as sulphate). 
Jedna tvrda kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
Each hard capsule contains 200 mg atazanavir (as sulphate). 
Jedna tvrda kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
Each hard capsule contains 300 mg atazanavir (as sulphate). 
Jedna tvrda kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
Atazanavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
Atazanavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
Capsule shell cap 300 mg 
Kapica kapsule od 300 mg
Co-administration of atorvastatin with atazanavir is not recommended. 
Ne preporučuje se istovremena primjena atorvastatina s atazanavirom.
OPIOIDS 
LIJEKOVI
The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition. 
Mehanizam interakcije diltiazema s atazanavirom je inhibicija enzima CYP3A4.
Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% 
Atazanavir Cmax ↑12 % (↑1 % ↑24
In antiretroviral experienced adult patients 
U odraslih bolesnika koji su prethodno bili liječeni antiretrovirusnim lijekovima
(atazanavir 300 mg once daily with ritonavir 100 mg once daily) 
(atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Each capsule contains 200 mg atazanavir (as sulphate) 
Jedna kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction. 
Mehanizam interakcije efavirenza s atazanavirom je indukcija CYP3A4.
Reporting of side effects 
Preporuke kod istovremene primjene
25-O-desacetyl-rifabutin Cmax ↑677% (↑513% ↑883%) ** 
25-O-dezacetil -rifabutin Cmax ↑677%
Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
Lopinavir/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tableti, jedanput na dan).
BOTTLE CARTON FOR 200 MG HARD CAPSULES 
KUTIJA BOCE ZA TVRDE KAPSULE OD 200 MG
(atazanavir 300 mg and ritonavir 100 mg once daily) 
(atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
Each capsule contains 150 mg atazanavir (as sulphate) 
Jedna kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil 
EREKTILNA DISFUNKCIJA Inhibitori PDE5
ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
ATV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
(range: 2 to 800 cells/ mm 3) and mean baseline plasma HIV 1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml). 
(raspon od 2 do 810 stanica/mm i prosječna početna vrijednost HIV-1 RNK u plazmi bila je 4,94 log10 kopija/ml (raspon od 2,6 do 5,8 8 log10 kopija/ml)
Lactose monohydrate Crospovidone Magnesium stearate 
Magnezijev stearat
Each capsule contains 300 mg atazanavir (as sulphate) 
Jedna kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).
If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage. 
Uklanjanje neapsorbiranog atazanavira može se postići poticanjem povraćanja ili ispiranjem želuca, ako za to postoji indikacija.
With tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily 
Primjena atazanavira/ritonavira u povišenoj dozi od 400/100 mg jedanput na dan u bolesnika zaraženih HIV-om Famotidin 20 mg dvaput na dan
Atazanavir is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition. 
Zbog inhibicije CYP3A4 očekuje se da će primjena atazanavira povisiti razine lurasidona u plazmi.
LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
LPV/RTV s tenofovirdizoproksilfumaratom/emtricitabinom (fiksna doza 300 mg/200 mg, u tabletama, jedanput na dan).
Atazanavir Mylan once daily dose ritonavir once daily dose a 
Doza lijeka Atazanavir Mylan jedanput na dan
Raltegravir C12hr↑ 77% 
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% Mehanizam je inhibicija UGT1A1.
Each capsule contains 168 mg lactose monohydrate 
Jedna kapsula sadrži 168 mg laktoza hidrata Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
SEDATIVES Benzodiazepines Midazolam 
Benzodiazepini
Atazanavir Cmax ↓21% (↓36% ↓4%) 
Atazanavir AUC ↓21% (↓34% ↓4%)
Norgestimate Cmin ↑102% (↑77% 
Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77%
• fatigue (extreme tiredness) 
• iscrpljenost (jaki umor)
Tel: +34 900 102 712 
Mylan Pharmaceuticals, S.L. Tel: +34 900 102 712
Famotidine 20 mg twice daily Atazanavir AUC ↑18% (↑6.5% 
Atazanavir AUC ↑18% (↑6.5%
eczema, vasodilatation 
, vezikulobulozni osip, ekcem, vazodilatacija
(n=392 
(n=392f)
Ritonavir 100 mg once daily 
Elbasvir 50 mg jednom dnevno
Atazanavir should be discontinued if severe rash develops. 
Ako se razvije teški osip, primjenu atazanavira treba prekinuti.
This summary was last updated in 11-2014. 
Ovaj sažetak je posljednji put ažuriran u 11. 2014.
The recommended dose is 200 mg taken twice a day (around 12 hours apart). 
Preporučena doza je 200 mg dva puta na dan (u razmaku od otprilike 12 sati).
The full EPAR and risk management plan summary for Vargatef can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vargatef nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food. 
Vargatef je dostupan kao kapsule (100 i 150 mg) koje se uzimaju peroralno, po mogućnosti sa hranom.
The European Commission granted a marketing authorisation valid throughout the European Union for Vargatef on 21 November 2014. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vargatef na snazi u Europskoj uniji od 21. studenog 2014.
Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients. 
Vargatef se ne smije koristiti u bolesnika koji su preosjetljivi (alergični) must na nintedanib, kikiriki ili soju ili bilo koje druge sastojke.
If severe side effects persist, treatment should be permanently discontinued. 
Ako se ozbiljne nuspojave nastave, liječenje treba odmah prekinuti.
This is a summary of the European public assessment report (EPAR) for Vargatef. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vargatef.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vargatef's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Vargatef nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
By blocking these enzymes, nintedanib helps to reduce the growth and spread of the cancer and to cut off the blood supply that keeps cancer cells growing. 
Inhibirajući ove enzime, nintedanib pomaže u smanjivanju rasta i širenju raka, te prekida opskrbu krvlju koja održava rast stanica raka.
Other information about Vargatef 
Ostale informacije o lijeku Vargatef
Why is Vargatef approved? 
Zašto je Vargatef odobren?
What measures are being taken to ensure the safe and effective use of Vargatef? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vargatef?
What is Vargatef and what is it used for? 
Što je Vargatef i za što se koristi?
In addition, the company that markets Vargatef will conduct studies to find ways to identify those patients who are most likely to benefit from treatment with the medicine. 
Nadalje, tvrtka koja stavlja u promet lijek Vargatef provest će ispitivanje kako bi pronašla način za identificiranje onih bolesnika koji su najizgledniji da će imati koristi od liječenja ovim lijekom.
These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels. 
Ovi se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGF i PDGF) na površini stanica raka i u stanicama koje okružuju tkivo (primjerice krvne žile), pri čemu se aktivira nekoliko postupaka, uključujući diobu stanica i rast krvnih žila.
Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable. 
Liječenje lijekom Vargatef može se nastaviti nakon prekida liječenjem docetakselom, tako dugo dok se bolest ne poboljša ili ostane stabilna, a nuspojave su podnošljive.
It is not intended to provide practical advice on how to use Vargatef. 
Svrha sažetka nije davati praktične savjete o korištenju lijeka Vargatef.
The most common side effects with Vargatef (which may affect more than 1 in 10 people) include diarrhoea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems). 
Najčešće nuspojave lijeka Vargatef (mogu se javiti u više od 1 na 10 osoba) uključuju proljev, povraćanje i poviše vrijednosti određenih jetrenih enzima u krvi (znak mogućih problema s jetrom).
If severe side effects develop, the doctor may decide to interrupt treatment with Vargatef and resume it at a lower dose. 
Ako se razviju ozbiljne nuspojave, liječnik može donijeti odluku o prekidu liječenja lijekom Vargatef te nastaviti sa nižom dozom.
The medicine is used in combination with a chemotherapy medicine called docetaxel in patients who have already received previous treatment with chemotherapy. 
Lijek se koristi u kombinaciji s kemoterapijskim lijekom naziva docetaksel u bolesnika koji su već primili prethodno liječenje kemoterapijom.
A risk management plan has been developed to ensure that Vargatef is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vargatef.
Vargatef is used to treat a type of non-small cell lung cancer called ‘adenocarcinoma', when the cancer is locally advanced, metastatic (when cancer cells have spread from the original site to other parts of the body) or locally recurrent (when the cancer has come back in the same area). 
Vargatef se koristi za liječenje karcinoma pluća ne-malih stanica poznatim pod nazivom „adenokarcinom“, ako je karcinom lokalno uznapredovao, metastazirao (nakon što su se stanice karcinoma proširile s izvornog mjesta u druge dijelove tijela) ili lokalno rekurentan (ako su se stanice karcinom vratile u neke dijelove tijela).
The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type. 
CHMP je napomenuo da je Vargatef djelotvoran u usporavanju progresije bolesti i produčjivanju života u podgrupi bolesnika s karcinom pluća ne-malih stanica tipa adenocarcinoma.
The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. 
Djelatna tvar lijeka Vargatef, nintedanib, inhibira djelovanje pojedinih enzima poznatih pod nazivom tirozin kinaza.
Vargatef can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines. 
Vargatef se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni terapije protiv raka.
What are the risks associated with Vargatef? 
Koji su rizici povezani s lijekom Vargatef?
In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone. 
Nadalje, Vargatef je uzrokovao poboljšanje u cjelokupnom preživljenju (koliko su dugo bolesnici preživjeli) u podgrupi bolesnika s karcinomom pluća ne-malih stanica tipa adenokarcinoma: ukupno preživljnje je bilo 12,6 mjeseci u bolesnika liječenih lijekom Vargatef i docetakselom u usporedbi s 10,3 mjeseci u bolesnika liječenih monoterapijom docetakselom.
In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer. 
U glavnom ispitivanju koje je obuhvatilo 1.314 bolesnika s uznapredovalim ili rekuretnim karcinomom pluća ne-malih stanica koji nisu odgovorili na prethodno liječenje, utvrđeno je da je Vargatef primijenjen u kombinaciji s docetakselom bio djelotvorniji od monoterapije docetakselom u odgodi progresije karcinoma.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Vargatef nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer. 
Vargatef je citostatik koji se koristi za liječenje odraslih osoba s tipom raka pluća poznatim kao karcinom pluća ne-malih stanica.
For more information about treatment with Vargatef, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Vargatef pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku
Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone. 
Preživljenje bez progresije (vrijeme tijekom kojeg su bolesnici preživjeli bez progresije bolesti) iznosilo je 3,5 mjeseca koji su primali lijek Vargatef zajedno s docetakselom, u usporedbi s 2,7 mjeseca u bolesnika koji su primali samo monoterapiju docetakselom.
Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions. 
Vezano uz sigurnu primjenu, iako je prijavljeno više nuspojava u bolesnika liječenih lijekom Vargatef plus docetakselom u odnosu na one liječene monoterapijom docetakselom, nuspojave se smatraju upravljivima s smanjenim dozama, podržavaju liječenje i prekide liječenja.
Vargatef contains the active substance nintedanib. 
Vargatef sadrži djelatnu tvar nintedanib.
Because Vargatef must not be given on the same day as docetaxel and because docetaxel is given on day 1 of a 21-day treatment 
Vargatef ne smije primjenjivati na isti dan kao docetaksel i budući da se docetaksel primjenjuje prvog dana 21-dnevnog ciklusa liječenja, Vargatef se primjenjuje 2 do 21 s docetakselom koji s primjenjuje prvog dana.
For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o korištenju lijeka Vargatef pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
How does Vargatef work? 
Kako djeluje Vargatef?
How is Vargatef used? 
Kako se Vargatef koristi?
What benefits of Vargatef have been shown in studies? 
Koje su koristi lijeka Vargatef utvrđene u ispitivanjima?
For the full list of all side effects and restrictions with Vargatef, see the package leaflet. 
Potpuni popis nuspojava i ograničenja s lijekom Vargatef, potražite u uputi o lijeku.
This summary was last updated in July 2014. 
Sažetak je posljednji put dopunjen u srpnju 2014.
The period of protection is 8 weeks. 
Razdoblje imunizacije je 8 tjedana.
These reactions are very rare (affecting less than 1 bird in 10,000). 
Ove su reakcije vrlo rijetke (zahvaćaju manje od 1 ptice na 10.000).
In the future if the animals are exposed to the virus the immune system will be able to respond more quickly. 
U buduće ako se životinje izlože virusu, imuni sustav moći će brže reagirati.
Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus. 
Ruke i oprema trebaju se oprati i dezinficirati nakon cjepiva kako bi se izbjeglo širenje virusa.
If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR). 
Ako želite više informacija na temelju preporuka CVMP-a, pročitajte znanstvenu raspravu (također dio EPAR-a).
The Committee recommended that a further overdose study should be submitted. 
Odbor je preporučio dostavljanje daljnjih ispitivanja o predoziranju.