FrancophonIA/ELRC3.0 huggingface dataset:
English: If ILD is diagnosed, GIOTRIF should be permanently discontinued and appropriate treatment initiated as necessary (see section 4.2).
Slovenian: Pri diagnozi IPB je treba zdravljenje z zdravilom GIOTRIF trajno ukiniti in po potrebi uvesti ustrezno zdravljenje IPB (glejte poglavje 4.2).
English: Pemetrexed/ Cisplatin (N=115)
Slovenian: pemetreksed/ cisplatin (N = 115)
English: Metabolism and nutrition disorders Decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan tek
English: Hazard Ratio/ Odds Ratio (95%CI)
Slovenian: Razmerje tveganja/ razmerje obetov (95-% IZ)
English: 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.
Slovenian: Če se razvijejo akutni respiratorni simptomi ali se slabšajo, je treba pomisliti na intersticijsko pljučno bolezen (IPB) in zdravljenje prekiniti do ocene stanja.
English: Dermatitis acneiform
Slovenian: • laktoza monohidrat
English: 65% vs. 47%; p=0.0017
Slovenian: 65 % v primerjavi s p = 0,0017
English: 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
Slovenian: *Poročanje pogostnosti bolnikov s celokupno vzročno povezanostjo neželenih učinkov 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
English: The primary endpoint was progression free survival (PFS) by independent review; the secondary endpoints included overall survival and objective response rate.
Slovenian: Sekundarna opazovana dogodka sta bila skupno preživetje in stopnja objektivnega odziva.
English: LUX-Lung 2 was a single arm Phase II trial in 129 EGFR TKI-naïve patients with stage IIIB or IV lung adenocarcinoma with EGFR mutations.
Slovenian: faze, v kateri je sodelovalo 129 bolnikov s pljučnim adenokarcinomom stopnje IIIB ali IV in mutacijami EGFR, ki se še niso zdravili z zaviralcem EGFR TK.
English: One film-coated tablet contains 294 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 294 mg laktoze (v obliki monohidrata).
English: • Vomiting
Slovenian: • bruhanje
English: Gastrointestinal disorders Diarrhoea Stomatitis
Slovenian: Bolezni prebavil diareja stomatitis navzea
English: Enzyme-catalyzed metabolic reactions play a negligible role for afatinib in vivo.
Slovenian: Presnovne reakcije, ki jih katalizirajo encimi, imajo in vivo zanemarljiv vpliv na afatinib.
English: Rash/acne has been reported in patients treated with this medicinal product (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s tem zdravilom, so poročali o pojavu izpuščaja ali aken (glejte poglavje 4.8).
English: Nervous system disorders
Slovenian: Bolezni živčevja disgevzija
English: One film-coated tablet contains 176 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 176 mg laktoze (v obliki monohidrata).
English: One film-coated tablet contains 118 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 118 mg laktoze (v obliki monohidrata).
English: 10.4 vs. 2.9 HR 0.68; p=0.0129
Slovenian: 10,4 v primerjavi z razmerje tveganja 0,68; p = 0,0129
English: Dyspepsia
Slovenian: Dispneja
English: OR 1.87
Slovenian: 56 % Razmerje obetov 1,87
English: Very common
Slovenian: Pogoste
English: One film-coated tablet contains 235 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 235 mg laktoze (v obliki monohidrata).
English: Progression-free survival Months (median) Hazard Ratio (HR) (95%CI) p-value
Slovenian: Preživetje brez napredovanja bolezni Meseci (mediana) Razmerje tveganja (95-%IZ)
English: Dose interruption may become necessary in patients who experience worsening of liver function (see section 4.2).
Slovenian: Bolnikom, ki se jim poslabša jetrno delovanje, je včasih treba prekiniti zdravljenje s tem zdravilom (glejte poglavje 4.2).
English: In LUX-Lung-3 Grade 3 ALT/AST elevations were about 3.5 fold higher in patients with abnormal baseline liver tests.
Slovenian: Med bolniki z nenormalnimi izhodiščnimi izvidi jetrnih preiskav v raziskavi LUX-Lung 3 so bile te vrednosti ALT/AST stopnje 3 približno 3,5-krat večje.
English: Ask your doctor if you are unsure of when to take these medicines.
Slovenian: Če ste negotovi glede tega, kdaj je treba vzeti ta zdravila, se posvetujte s svojim zdravnikom.
English: GIOTRIF significantly improved PFS and ORR in EGFR mutation positive patients compared to gefitinib.
Slovenian: Zdravilo GIOTRIF je pri bolnikih z mutacijo EGFR pomembno izboljšalo preživetje brez napredovanja bolezni (PFS) in stopnjo objektivnega odziva na zdravljenje (ORR) v primerjavi z bolniki z gefitinibom.
English: In humans, excretion of afatinib is primarily via the faeces.
Slovenian: Afatinib se pri ljudeh izloči pretežno z blatom.
English: Table 2: Summary of ADRs per frequency category
Slovenian: Preglednica 2: Povzetek neželenih reakcij na zdravilo po pogostnostnih skupinah Organski sistem Zelo pogoste
English: Grade 2 (prolonged c or intolerable) or
Slovenian: ni prekinitve ni prilagoditve odmerka stopnja 2 (traja dalj časa c ali ga bolnik ne prenaša) ali stopnja > 3
English: ® 40 mg orally once daily (N=160) or gefitinib 250 mg orally once daily (N=159).
Slovenian: ® EGFR RGQ PCR Kit, Qiagen Manchester Ltd. Bolnike (N = 319) so naključno razvrstili (1:1) v skupino ki je prejemala zdravilo GIOTRIF po 40 mg peroralno enkrat na dan (N = 160) ali gefitinib 250 mg peroralno enkrat na dan (N = 159).
English: Body weight Plasma exposure (AUCτ,ss) was increased by 26% for a 42 kg patient (2.5
Slovenian: Plazemska izpostavljenost (AUCτ,ss) se je v primerjavi z bolnikom s telesno maso 62 kg (mediana telesna masa celotne populacije bolnikov) pri bolniku s telesno maso 42 kg (percentil 2,5) povečala za 26%, pri bolniku s telesno maso 95 kg (percentil 97,5) pa zmanjšala za 22%.
English: The co-primary endpoints include PFS by independent review and OS.
Slovenian: Del sestavljenega primarnega opazovana dogodka sta bila neodvisno ocenjeno preživetje brez napredovanja bolezni (PFS) in skupno preživetje (OS).
English: Odds Ratio (OR) (95%CI) p-value
Slovenian: Razmerje tveganja/ Razmerje obetov (95 % IZ) Vrednost p
English: Pemetrexed/ Cisplatin (N=57)
Slovenian: pemetreksed/ cisplatin (N = 57)
English: GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate).
Slovenian: GIOTRIF 20 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 20 mg afatiniba (v obliki dimaleata).
English: Aspartate aminotransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov povečanje alanin-aminotransferaze povečanje aspartat-aminotransferaze
English: If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
Slovenian: > 48 ur driske in/ali > 7 dni izpuščaja Če bolnik ne prenaša odmerka po 20 mg na dan, je treba presoditi o ukinitvi zdravila GIOTRIF.
English: 67% vs. 60%; p=0.2133
Slovenian: % bolnikov z izboljšanjem a 67 % v primerjavi s p = 0,2133
English: Secondary endpoints include ORR and DCR.
Slovenian: Sekundarni opazovani dogodki so vključevali stopnjo objektivnega odziva na zdravljenje (ORR) in stopnjo nadzora bolezni (DCR).
English: Liver function test abnormalities
Slovenian: Nenormalni izvidi jetrnih preiskav
English: How to store GIOTRIF
Slovenian: Shranjevanje zdravila GIOTRIF
English: Includes Acne, Acne pustular, Dermatitis acneiform
Slovenian: Bolezni kože in podkožja izpuščaj akneiformni dermatitis
English: INFORMATION IN BRAILLE GIOTRIF 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI GIOTRIF 20 mg
English: Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test
Slovenian: Vrednost p vrednost p za PFS/OS na osnovi stratificiranega testa log-rank
English: GIOTRIF 20 mg film-coated tablets
Slovenian: GIOTRIF 20 mg filmsko obložene tablete
English: In humans it was found that enzyme-catalyzed metabolic reactions play a negligible role for the metabolism of afatinib.
Slovenian: Odkrili so, da imajo pri presnovi afatiniba pri ljudeh presnovne reakcije, ki jih katalizirajo encimi, le naznatno vlogo.
English: 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.
Slovenian: Bela do rumenkasta okrogla, obojestransko izbočena filmsko obložena tableta z zaobljenimi robovi in z oznako ''T20'' na eni in logom podjetja Boehringer Ingelheim na drugi strani.
English: 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.
Slovenian: Svetlo modra, okrogla, obojestransko izbočena filmsko obložena tableta z zaobljenimi robovi in z oznako ''T40'' na eni in logom podjetja Boehringer Ingelheim na drugi strani.
English: INFORMATION IN BRAILLE GIOTRIF 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI GIOTRIF 50 mg
English: 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.
Slovenian: Učinki zaviralcev P-glikoproteina (P-gp) in proteina odpornosti pri raku dojke (BCRP - breast canacer resistance protein) na afatinib
English: GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate).
Slovenian: GIOTRIF 30 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 30 mg afatiniba (v obliki dimaleata).
English: GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate).
Slovenian: GIOTRIF 40 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 40 mg afatiniba (v obliki dimaleata).
English: INFORMATION IN BRAILLE GIOTRIF 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI GIOTRIF 30 mg
English: 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
Slovenian: 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
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 20 mg)
English: • Nail problems
Slovenian: • težave z nohti
English: Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg afatiniba (v obliki dimaleata).
English: Pruritus
Slovenian: Driska
English: GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate).
Slovenian: GIOTRIF 50 mg filmsko obložene tablete Ena filmsko obloženo tableta vsebuje 50 mg afatiniba (v obliki dimaleata).
English: INFORMATION IN BRAILLE GIOTRIF 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI GIOTRIF 40 mg
English: Pemetrexed/ Cisplatin (N=47)
Slovenian: pemetreksed/ cisplatin (N = 47)
English: Liver function test abnormalities (including elevated ALT and AST) were observed in patients receiving GIOTRIF 40 mg.
Slovenian: Pri bolnikih, ki so jemali odmerke zdravila GIOTRIF po 40 mg, so opažali nenormalne izvide jetrnih preiskav (tudi povečanje ALT in AST).
English: GIOTRIF 30 mg film-coated tablets
Slovenian: GIOTRIF 30 mg filmsko obložene tablete
English: GIOTRIF 20 mg film-coated tablets afatinib
Slovenian: GIOTRIF 20 mg filmsko obložene tablete afatinib
English: GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
Slovenian: GIOTRIF 50 mg filmsko obložene tablete EU/1/13/879/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/010
English: 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.
Slovenian: 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.
English: GIOTRIF 40 mg film-coated tablets
Slovenian: GIOTRIF 40 mg filmsko obložene tablete
English: Each film-coated tablet contains 40 mg of afatinib (as dimaleate).
Slovenian: Ena filmsko obložena tableta vsebuje 40 mg afatiniba (v obliki dimaleata).
English: Each film-coated tablet contains 50 mg of afatinib (as dimaleate).
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg afatiniba (v obliki dimaleata).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 30 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 50 mg)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 20 mg
Slovenian: ALUMINIJASTA VREČKA za 20 mg
English: Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg afatiniba (v obliki dimaleata).
English: GIOTRIF 50 mg film-coated tablets
Slovenian: GIOTRIF 50 mg filmsko obložene tablete
English: GIOTRIF 30 mg film-coated tablets afatinib
Slovenian: GIOTRIF 30 mg filmsko obložene tablete afatinib
English: GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Slovenian: GIOTRIF 30 mg filmsko obložene tablete EU/1/13/879/004
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 40 mg
Slovenian: ALUMINIJASTA VREČKA za 40 mg
English: GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Slovenian: GIOTRIF 20 mg filmsko obložene tablete EU/1/13/879/001
English: • Mouth sores and inflammation
Slovenian: • rane in vnetje v ustni votlini
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 20 mg filmsko obložene tablete afatinib
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 50 mg
Slovenian: ALUMINIJASTA VREČKA za 50 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (ŠKATLA ZA PRETISNI OMOT za 40 mg)
English: Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavje 5.2) je izpostavljenost afatinibu povečana.
English: 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
Slovenian: 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
English: GIOTRIF 40 mg film-coated tablets afatinib
Slovenian: GIOTRIF 40 mg filmsko obložene tablete afatinib
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM POUCH for 30 mg
Slovenian: ALUMINIJASTA VREČKA za 30 mg
English: GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
Slovenian: GIOTRIF 40 mg filmsko obložene tablete EU/1/13/879/007
English: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Slovenian: Temno modra, podolgovata, obojestransko izbočena tableta z oznako ''T50'' na eni in logom podjetja Boehringer Ingelheim na drugi strani.
English: GIOTRIF 50 mg film-coated tablets afatinib
Slovenian: GIOTRIF 50 mg filmsko obložene tablete afatinib
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 30 mg filmsko obložene tablete afatinib
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 40 mg filmsko obložene tablete afatinib
English: GIOTRIF (40 mg/day) N=160
Slovenian: GIOTRIF (40 mg/dan)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 50 mg film-coated tablets afatinib
Slovenian: IME ZDRAVILA IN POT(I) UPORABE GIOTRIF 50 mg filmsko obložene tablete afatinib
English: 76% vs. 55%; p=0.0003
Slovenian: % bolnikov z izboljšanjem a 76 % v primerjavi s p = 0,0003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/004
English: GIOTRIF 30, 40 and 50 mg film-coated tablets Hypromellose (E464)
Slovenian: GIOTRIF 30, 40 in 50 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/001
English: Nausea
Slovenian: Bolečina
English: Progression-free survival
Slovenian: Ocenjena verjetnost preživetja brez napredovanja bolezni
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg
Slovenian: PERFORIRAN PRETISI OMOT za 40 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg
Slovenian: PERFORIRAN PRETISI OMOT za 30 mg
English: • Itching
Slovenian: • navzea
English: Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration
Slovenian: 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
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg
Slovenian: PERFORIRAN PRETISI OMOT za 50 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/879/007
English: Stomatitis
Slovenian: Dojenje
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 20 mg
Slovenian: PERFORIRAN PRETISI OMOT za 20 mg
English: • Lip inflammation
Slovenian: • mišični krči
English: Dose escalation
Slovenian: Povečevanje odmerka
English: a Adverse reactions
Slovenian: Opozorila in previdnostni ukrepi
English: MA (EU)Number
Slovenian: Številka (EU) dovoljenja za promet
English: 30th January 2020
Slovenian: 30. januar 2020
English: • you have had an organ transplant.
Slovenian: • ste imeli presaditev organa.
English: Events (%)
Slovenian: Dogodki (%)
English: Improvement of PFS was observed across pre-specified subgroups.
Slovenian: Izboljšanje PFS so opazili v vseh predhodno določenih podskupinah.
English: Unopened vial 2 years
Slovenian: Neodprta viala 2 leti
English: Your doctor will decide how many treatments you need.
Slovenian: Vaš zdravnik se bo odločil, koliko ciklov zdravljenja potrebujete.
English: Do not try to treat yourself with other medicines.
Slovenian: Ne poskušajte se sami zdraviti z drugimi zdravili.
English: Dose escalation or reduction is not recommended.
Slovenian: Povečevanja ali zmanjševanja odmerka se ne priporoča.
English: After opening
Slovenian: Po odprtju
English: Stopping your treatment may stop the effect of the medicine.
Slovenian: Prekinitev zdravljenja lahko ustavi učinek zdravila.
English: Date of first authorisation: 18 September 2017 Date of latest renewal: 20 June 2019
Slovenian: Datum prve odobritve: 18. september 2017 Datum zadnjega podaljšanja: 20. junij 2019
English: For any of the following:
Slovenian: Za vse naslednje pojave:
English: A risk to the breast-fed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: Any partially used or empty vials have to be discarded.
Slovenian: Delno uporabljene ali prazne viale morate zavreči.
English: Confirmed best overall response (BOR)
Slovenian: Potrjen najboljši celokupni odziv (BOR)
English: (18, not estimable)
Slovenian: (18, ni mogoče oceniti)
English: The treatment is directed to the management of symptoms.
Slovenian: Zdravljenje je usmerjeno k obravnavi simptomov.
English: Some side effects may not have symptoms and may only be discovered through blood tests.
Slovenian: Nekateri neželeni učinki morda nimajo simptomov in jih je možno odkriti le s krvnimi preiskavami.
English: (10.2, not estimable)
Slovenian: (10,2; ni mogoče oceniti)
English: PC SN NN
Slovenian: PC SN
English: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Slovenian: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Švica
English: • give you other medicines in order to prevent complications and reduce your symptoms,
Slovenian: • da druga zdravila, da prepreči zaplete in zmanjša simptome,
English: Some side effects may happen weeks or months after your last dose.
Slovenian: Nekateri neželeni učinki se lahko pojavijo več tednov ali mesecev po vašem zadnjem odmerku.
English: Your doctor may
Slovenian: Vaš zdravnik vam lahko
English: Bavencio can cause harm to your unborn baby.
Slovenian: Zdravilo Bavencio lahko škoduje vašemu nerojenemu otroku.
English: You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor.
Slovenian: Zdravilo Bavencio boste prejeli v bolnišnici ali kliniki pod nadzorom izkušenega zdravnika.
English: The volume of distribution at steady state was 4.72 L.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je bil 4,72 l.
English: Bavencio is used in adults to treat:
Slovenian: Zdravilo Bavencio se uporablja pri odraslih za zdravljenje:
English: Total systemic clearance increases with body weight.
Slovenian: Celokupni sistemski očistek se s telesno maso povečuje.
English: Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik, z izkušnjami v zdravljenju raka.
English: • you receive medicines to suppress your immune system;
Slovenian: • prejemate zdravila za zaviranje imunskega sistema;
English: Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before all of your Bavencio treatments.
Slovenian: 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.