natgillin/translations-raw huggingface dataset:
Effects of P-gp and breast cancer resistance protein (BCRP) inhibitors on afatinib In vitro studies have demonstrated that afatinib is a substrate of P-gp and BCRP. 
Učinki zaviralcev P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast canacer resistance protein) na afatinib
GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate). 
GIOTRIF 30 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 30 mg afatiniba (v obliki dimaleata).
GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate). 
GIOTRIF 40 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 40 mg afatiniba (v obliki dimaleata).
INFORMATION IN BRAILLE GIOTRIF 30 mg 
PODATKI V BRAILLOVI PISAVI GIOTRIF 30 mg
MedDRA Preferred Term Infections and infestations Paronychia Metabolism and nutrition disorders Decreased appetite Respiratory, thoracic and mediastinal disorders Epistaxis Gastrointestinal disorders Diarrhoea Stomatitis Cheilitis Skin and subcutaneous tissue disorders Rash Dermatitis acneiform Dry skin Pruritus Investigations Weight decreased 
Priporočeni izraz v MedDRA Infekcijske in parazitske bolezni paronihija cistitis Presnovne in prehranske motnje zmanjšan tek hipokaliemija Bolezni dihal, prsnega koša in mediastinalnega prostora rinoreja epistaksa Bolezni prebavil diareja stomatitis navzea bruhanje dispepsija Bolezni jeter, žolčnika in žolčevodov povečanje alanin-aminotransferaze Bolezni kože in podkožja izpuščaj suha koža pruritus akneiformni dermatitis General disorders and administration site conditions pireksija Preiskave zmanjšanje telesne mase zajema paronihijo, okužbo nohtov, okužbo nohtnega ležišča zajema cistitis, okužbo sečil zajema hipokaliemijo, zmanjšano raven kalija v krvi zajema rinorejo, vnetje nosne sluznice zajema stomatitis, aftozni stomatitis, vnetje sluznice, ulceracijo v ustni votlini, erozijo sluznice zajema skupino priporočenih izrazov za izpuščaj zajema pruritus, generalizirani pruritus zajema akneiformni dermatitis, akne
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 20 mg)
• Nail problems 
• težave z nohti
Each film-coated tablet contains 20 mg of afatinib (as dimaleate). 
Ena filmsko obložena tableta vsebuje 20 mg afatiniba (v obliki dimaleata).
Pruritus 
Driska
GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate). 
GIOTRIF 50 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 50 mg afatiniba (v obliki dimaleata).
INFORMATION IN BRAILLE GIOTRIF 40 mg 
PODATKI V BRAILLOVI PISAVI GIOTRIF 40 mg
Pemetrexed/ Cisplatin (N=47) 
pemetreksed/ cisplatin (N = 47)
Liver function test abnormalities (including elevated ALT and AST) were observed in patients receiving GIOTRIF 40 mg. 
Pri bolnikih, ki so jemali odmerke zdravila GIOTRIF po 40 mg, so opažali nenormalne izvide jetrnih preiskav (tudi povečanje ALT in AST).
GIOTRIF 30 mg film-coated tablets 
GIOTRIF 30 mg filmsko obložene tablete
GIOTRIF 20 mg film-coated tablets afatinib 
GIOTRIF 20 mg filmsko obložene tablete afatinib
GIOTRIF 50 mg film-coated tablets EU/1/13/879/010 
GIOTRIF 50 mg filmsko obložene tablete EU/1/13/879/010
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/010
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. 
Temno modra okrogla, obojestransko izbočena filmsko obložena tableta z zaobljenimi robovi in z oznako ''T30'' na eni in logom podjetja Boehringer Ingelheim na drugi strani.
GIOTRIF 40 mg film-coated tablets 
GIOTRIF 40 mg filmsko obložene tablete
Each film-coated tablet contains 40 mg of afatinib (as dimaleate). 
Ena filmsko obložena tableta vsebuje 40 mg afatiniba (v obliki dimaleata).
Each film-coated tablet contains 50 mg of afatinib (as dimaleate). 
Ena filmsko obložena tableta vsebuje 50 mg afatiniba (v obliki dimaleata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 30 mg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 50 mg)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg 
ALUMINIJASTA VREČKA za 20 mg
Each film-coated tablet contains 30 mg of afatinib (as dimaleate). 
Ena filmsko obložena tableta vsebuje 30 mg afatiniba (v obliki dimaleata).
GIOTRIF 50 mg film-coated tablets 
GIOTRIF 50 mg filmsko obložene tablete
GIOTRIF 30 mg film-coated tablets afatinib 
GIOTRIF 30 mg filmsko obložene tablete afatinib
GIOTRIF 30 mg film-coated tablets EU/1/13/879/004 
GIOTRIF 30 mg filmsko obložene tablete EU/1/13/879/004
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg 
ALUMINIJASTA VREČKA za 40 mg
GIOTRIF 20 mg film-coated tablets EU/1/13/879/001 
GIOTRIF 20 mg filmsko obložene tablete EU/1/13/879/001
• Mouth sores and inflammation 
• rane in vnetje v ustni votlini
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib 
IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 20 mg filmsko obložene tablete afatinib
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg 
ALUMINIJASTA VREČKA za 50 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 40 mg)
Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2). 
Pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavje 5.2) je izpostavljenost afatinibu povečana.
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 
vrednosti za GIOTRIF v primerjavi s kemoterapijo; vrednost p na osnovi logistične regresije vrednost p za čas do poslabšanja na osnovi stratificiranega testa log-rank
GIOTRIF 40 mg film-coated tablets afatinib 
GIOTRIF 40 mg filmsko obložene tablete afatinib
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg 
ALUMINIJASTA VREČKA za 30 mg
GIOTRIF 40 mg film-coated tablets EU/1/13/879/007 
GIOTRIF 40 mg filmsko obložene tablete EU/1/13/879/007
Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. 
Temno modra, podolgovata, obojestransko izbočena tableta z oznako ''T50'' na eni in logom podjetja Boehringer Ingelheim na drugi strani.
GIOTRIF 50 mg film-coated tablets afatinib 
GIOTRIF 50 mg filmsko obložene tablete afatinib
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib 
IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 30 mg filmsko obložene tablete afatinib
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib 
IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 40 mg filmsko obložene tablete afatinib
GIOTRIF (40 mg/day) N=160 
GIOTRIF (40 mg/dan)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 50 mg film-coated tablets afatinib 
IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 50 mg filmsko obložene tablete afatinib
76% vs. 55%; p=0.0003 
% bolnikov z izboljšanjem a 76 % v primerjavi s p = 0,0003
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/004
GIOTRIF 30, 40 and 50 mg film-coated tablets Hypromellose (E464) 
GIOTRIF 30, 40 in 50 mg filmsko obložene tablete
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/001
Nausea 
Bolečina
Progression-free survival 
Ocenjena verjetnost preživetja brez napredovanja bolezni
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg 
PERFORIRAN PRETISI OMOT za 40 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg 
PERFORIRAN PRETISI OMOT za 30 mg
• Itching 
• navzea
Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration 
Preiskave zmanjšanje telesne mase zajema paronihijo, okužbo nohtov, okužbo nohtnega ležišča zajema stomatitis, aftozni stomatitis, vnetje sluznice, ulceracijo v ustni votlini, erozijo ustne sluznice, erozijo sluznice, ulceracije sluznice zajema skupino priporočenih izrazov za izpuščaj zajema akne, pustularne akne, akneiformni dermatitis zajema suho kožo, razpokano kožo zajema pruritus, generalizirani pruritus
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg 
PERFORIRAN PRETISI OMOT za 50 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/007
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg 
PERFORIRAN PRETISI OMOT za 20 mg
• Lip inflammation 
• mišični krči
Dose escalation 
Povečevanje odmerka
a Adverse reactions 
Opozorila in previdnostni ukrepi
MA (EU)Number 
Številka (EU) dovoljenja za promet
30th January 2020 
30. januar 2020
• you have had an organ transplant. 
• ste imeli presaditev organa.
Events (%) 
Dogodki (%)
Improvement of PFS was observed across pre-specified subgroups. 
Izboljšanje PFS so opazili v vseh predhodno določenih podskupinah.
Unopened vial 2 years 
Neodprta viala 2 leti
Your doctor will decide how many treatments you need. 
Vaš zdravnik se bo odločil, koliko ciklov zdravljenja potrebujete.
Do not try to treat yourself with other medicines. 
Ne poskušajte se sami zdraviti z drugimi zdravili.
Dose escalation or reduction is not recommended. 
Povečevanja ali zmanjševanja odmerka se ne priporoča.
After opening 
Po odprtju
Stopping your treatment may stop the effect of the medicine. 
Prekinitev zdravljenja lahko ustavi učinek zdravila.
Date of first authorisation: 18 September 2017 Date of latest renewal: 20 June 2019 
Datum prve odobritve: 18. september 2017 Datum zadnjega podaljšanja: 20. junij 2019
For any of the following: 
Za vse naslednje pojave:
A risk to the breast-fed child cannot be excluded. 
Tveganja za dojenega otroka ne moremo izključiti.
Any partially used or empty vials have to be discarded. 
Delno uporabljene ali prazne viale morate zavreči.
Confirmed best overall response (BOR) 
Potrjen najboljši celokupni odziv (BOR)
(18, not estimable) 
(18, ni mogoče oceniti)
The treatment is directed to the management of symptoms. 
Zdravljenje je usmerjeno k obravnavi simptomov.
Some side effects may not have symptoms and may only be discovered through blood tests. 
Nekateri neželeni učinki morda nimajo simptomov in jih je možno odkriti le s krvnimi preiskavami.
(10.2, not estimable) 
(10,2; ni mogoče oceniti)
Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland 
Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Švica
• give you other medicines in order to prevent complications and reduce your symptoms, 
• da druga zdravila, da prepreči zaplete in zmanjša simptome,
Some side effects may happen weeks or months after your last dose. 
Nekateri neželeni učinki se lahko pojavijo več tednov ali mesecev po vašem zadnjem odmerku.
Your doctor may 
Vaš zdravnik vam lahko
Bavencio can cause harm to your unborn baby. 
Zdravilo Bavencio lahko škoduje vašemu nerojenemu otroku.
You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor. 
Zdravilo Bavencio boste prejeli v bolnišnici ali kliniki pod nadzorom izkušenega zdravnika.
The volume of distribution at steady state was 4.72 L. 
Volumen porazdelitve v stanju dinamičnega ravnovesja je bil 4,72 l.
Bavencio is used in adults to treat: 
Zdravilo Bavencio se uporablja pri odraslih za zdravljenje:
Total systemic clearance increases with body weight. 
Celokupni sistemski očistek se s telesno maso povečuje.
Treatment should be initiated and supervised by a physician experienced in the treatment of cancer. 
Zdravljenje mora uvesti in nadzorovati zdravnik, z izkušnjami v zdravljenju raka.
• you receive medicines to suppress your immune system; 
• prejemate zdravila za zaviranje imunskega sistema;
Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before all of your Bavencio treatments. 
Odvisno od odziva vašega telesa na zdravljenje se vaš zdravnik lahko odloči, da vam bo ta zdravila dajal še naprej pred vsakim ciklom vašega zdravljenja z zdravilom Bavencio.
• you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS); 
• imate okužbo z virusom humane imunske pomanjkljivosti (HIV) ali sindrom pridobljene imunske pomanjkljivosti (AIDS);
Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded. 
Ker je znano, da se lahko protitelesa izločajo v materino mleko, tveganja za dojenega novorojenca/otroka ne moremo izključiti.
Guillain-Barré Syndrome* 
Guillain-Barréjev sindrom*
• Brief introduction to avelumab (indication and purpose of this tool) 
• Kratka predstavitev avelumaba (indikacija in namen kartice)
Time to response (TTR) 
Čas do odziva (TTR)
• Feeling tired or weak 
• občutek utrujenosti ali šibkost
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• Inflammatory reaction of the whole body (Systemic inflammatory response syndrome) 
• vnetna reakcija celega telesa (sindrom sistemskega vnetnega odziva)
The efficacy endpoints were based on 29 patients with 13 weeks of follow-up. 
Izidi učinkovitosti so temeljili na 29 bolnikih s 13-tedenskim spremljanjem.
Decreased appetite 
Zelo pogosti zmanjšan apetit
If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines. 
Če med uporabo zdravila Bavencio doživite katerega koli od teh simptomov, jih ne poskušajte sami zdraviti z drugimi zdravili.
What you need to know before you use Bavencio Do not use Bavencio if you are allergic to avelumab or any of the other ingredients of this medicine (listed in section 6). 
Kaj morate vedeti, preden boste uporabili zdravilo Bavencio Ne uporabljajte zdravila Bavencio če ste alergični na avelumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression. 
Večina (n = 160, 71,4 %) bolnikov z napredovalo boleznijo je po napredovanju nadaljevala zdravljenje z obema zdraviloma.
Bavencio has not been studied in children and adolescents below 18 years of age. 
Zdravila Bavencio niso preučili pri otrocih in mladostnikih, starih manj kot 18 let.
• you have an autoimmune disease (a condition where the body attacks its own cells); 
• imate avtoimunsko bolezen (bolezen, pri kateri telo napada lastne celice);
Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space. 
Pričakuje se, da se avelumab porazdeli v sistemski cirkulaciji, v manjši meri pa v zunajceličnem prostoru.
• you have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C 
• ste kadar koli imeli kronično virusno okužbo jeter, vključno s hepatitisom B (HBV) ali hepatitisom C (HCV);
• Reminder to carry the Patient Alert Card at all times and to show it to all healthcare professionals that may treat them. 
• Opomnik, da naj imajo opozorilno kartico za bolnika vedno s seboj in jo pokažejo vsem zdravstvenim delavcem, ki jih bodo morda zdravili.
• Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy) 
• Življenje ogrožujoči ali neželeni učinki 4. stopnje (razen endokrinopatij, nadzorovanih z nadomestnim hormonskim zdravljenjem)
You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment. 
Med zdravljenjem boste opravljali krvne preiskave in vaš zdravnik bo pred in med zdravljenjem preverjal vašo telesno maso.
Please note that in some cases symptoms may be delayed, and may develop after your last dose. 
Vedeti morate, da se ti simptomi včasih pojavijo pozno in da se lahko razvijejo po vašem zadnjem odmerku.
As expected for an antibody, avelumab does not bind to plasma proteins in a specific manner. 
Kot se za protitelesa pričakuje, se avelumab ne veže na plazemske proteine na specifičen način.
Patients should be advised to use caution when driving or operating machinery until they are certain that avelumab does not adversely affect them. 
Bolnikom je treba svetovati, naj bodo pri vožnji ali upravljanju strojev previdni, dokler niso prepričani, da avelumab pri njih nima neželenih učinkov.
BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable. 
BICR: slepi neodvisni centralni pregled; IZ: interval zaupanja; NE: ni mogoče oceniti; TTR (Time To Response).
The MAH shall ensure that in each Member State where Bavencio is marketed, all patients/carers who are expected to use Bavencio have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer bo zdravilo Bavencio na trgu, vsi bolniki/skrbniki, za katere se pričakuje, da bodo zdravilo Bavencio uporabljali, imeli dostop do/prejeli sledeča izobraževalna gradiva:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Če zdravilo ni uporabljeno takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo.
Consistent with a limited extravascular distribution, the volume of distribution of avelumab at steady state is small. 
Skladno z omejeno ekstravaskularno porazdelitvijo je volumen porazdelitve avelumaba v stanju dinamičnega ravnovesja majhen.
Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 20°C to 25°C and room light. 
Dokazana je 24-urna kemična in fizikalna stabilnost razredčene raztopine med uporabo pri temperaturi od 20 °C do 25 °C pri sobni svetlobi.
If you miss an appointment, ask your doctor when to schedule your next dose. 
Če termin zamudite, se posvetujte z zdravnikom za načrtovanje naslednjega odmerka.
The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg. 
Razpon pH-vrednosti raztopine je med 5,0 in 5,6, osmolalnost pa je med 270 in 330 mOsm/kg.
With a median OS follow-up of 19 months, OS data were immature with 27% deaths. 
Mediana spremljanja OS je bila 19 mesecev, podatki OS s 27 % smrtnih primerov so bili še nezreli.
Suspected pneumonitis should be confirmed with radiographic imaging. 
Sum na pnevmonitis je treba potrditi z rentgenskim slikanjem.
• Reminder of the importance to consult their doctor before any change of treatment or in case of side effect 
• Opomnik o pomenu posvetovanja z zdravnikom pred spremembo zdravljenja ali v primeru pojava neželenih učinkov
Bavencio acts on your immune system and may cause inflammation in parts of your body (see section 2). 
Zdravilo Bavencio učinkuje na vaš imunski sistem in lahko povzroči vnetje v posameznih delih vašega telesa (glejte poglavje 2).
Additional secondary endpoints included objective response (OR), time to response (TTR) and duration of response (DOR). 
Dodatni sekundarni izidi so vključevali objektivni odziv (OR, objective response), čas do odziva (TTR, time to response) in trajanje odziva (DOR, duration of response).
Blood tests and weight checks: 
Krvne preiskave in preverjanje telesne mase:
Although there was no clear dose-response relationship, it cannot be excluded that this finding was related to avelumab treatment. 
Čeprav ni bilo očitnega razmerja med odzivom in odmerkom, ni mogoče izključiti dejstva, da je to odkritje povezano z zdravljenjem z avelumabom.
Confirmed pancreatitis 
Potrjeni pankreatitis
Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1) and region (United States vs. Canada/Western Europe vs. the rest of the world). 
Randomizacija je bila stratificirana skladno s statusom zmogljivosti (PS, Performance Status) po Vzhodni kooperativni onkološki skupini (ECOG, Eastern Cooperative Oncology Group) (0 proti 1) in regiji (Združene države Amerike v primerjavi s Kanado/Zahodno Evropo v primerjavi z ostalim svetom).
PD-L1 is found on the surface of certain tumour cells, and helps protect them from the immune system (the body's natural defences). 
PD-L1 najdemo na površini določenih tumorskih celic in jih ščiti pred imunskim sistemom (naravno obrambo telesa).
You must not use Bavencio if you are pregnant unless your doctor specifically recommends it. 
Zdravila Bavencio ne smete uporabljati, če ste noseči, razen če tako izrecno priporoča zdravnik.
The management guidelines for these adverse reactions are described in section 4.4. 
Smernice za obravnavo teh neželenih učinkov so opisane v poglavju 4.4.
• Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves. 
• Opozorilo za bolnike glede pomena takojšnjega posvetovanja z zdravnikom, če se razvije kateri koli od navedenih znakov in simptomov, in da je pomembno, da jih ne poskušajo zdraviti sami.
The elimination half-life (t½) at the recommended dose is 6.1 days based on the population PK analysis. 
Razpolovni čas izločanja (t½) pri priporočenem odmerku je 6,1 dni na podlagi populacijske farmakokinetične analize.
Many of the male monkeys used in these studies were sexually immature and thus no explicit conclusions regarding effects on male reproductive organs can be made. 
Več opičjih samcev, uporabljenih v tej študiji, je bilo spolno nezrelih, kar ne dopušča eksplicitnega sklepanja glede učinkov na moške spolne organe.
Patients were randomised (1:1) to one of the following treatment arms: 
Bolniki so bili randomizirani (1:1) v enega od naslednjih krakov zdravljenja:
Store in a refrigerator (2°C to 8°C). 
Shranjujte v hladilniku (2 °C do 8 °C).
All 5 patients with Type 1 diabetes mellitus were treated with insulin. 
Vseh 5 bolnikov s sladkorno boleznijo tipa 1 je bilo zdravljenih z inzulinom.
Avelumab ORR (95% CI) 
Avelumab ORR (95 % IZ)
Most immune-related adverse reactions with avelumab were reversible and managed with temporary or permanent discontinuation of avelumab, administration of corticosteroids and/or supportive care. 
Večina imunsko pogojenih neželenih učinkov z avelumabom je bilo reverzibilnih in obvladljivih z začasno ali trajno prekinitvijo dajanja avelumaba, dajanjem kortikosteroidov in/ali podporno oskrbo.
Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. 
Avelumab veže PD-L1 in blokira medsebojno delovanje med PD-L1 in receptorji programirane smrti 1 (PD-1) in B7.1.
If you have any questions about axitinib, ask your doctor. 
Če imate vprašanja glede aksitiniba, se posvetujte z zdravnikom.
Pack size of 1 vial. 
Velikost pakiranja 1 viala.
Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. 
Bolnike je treba spremljati zaradi pojava sprememb delovanja žleze ščitnice (ob začetku zdravljenja, periodično med zdravljenjem in nato kot je določeno na podlagi klinične ocene) in za klinične znake in simptome motenj delovanja žleze ščitnice.