FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Vargatef 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Vargatef 100 mg
English: In case of specific changes in liver values (AST/ALT > 3 x ULN; total bilirubin ≥ 2 x ULN and ALKP < 2 x ULN) treatment with Vargatef should be interrupted.
Slovenian: Pri specifičnih spremembah jetrnih vrednosti (AST/ALT > 3 x ULN; celokupni bilirubin ≥ 2 x ULN in ALKP < 2 x ULN) je treba zdravljenje z zdravilom Vargatef prekiniti.
English: The addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 21 % for the overall population (hazard ratio (HR) 0.79; 95 % confidence interval (CI): 0.68 - 0.92; p = 0.0019) as determined by the Independent Review Committee.
Slovenian: Dodajanje nintedaniba k docetakselu je povzročilo statistično značilno zmanjšanje tveganja za napredovanje bolezni ali smrt za 21 % za celotno populacijo (razmerje ogroženosti (RO) 0,79; 95-odstotni interval zaupanja (IZ): 0,68-0,92; p = 0,0019), kot je ugotovila IRC.
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 x 1 mehka kapsula.
English: Patients who developed thromboembolic events during treatment and who required anticoagulant treatment were allowed to continue Vargatef and did not show an increased frequency of bleeding events.
Slovenian: Bolniki, pri katerih so se med zdravljenjem razvili trombembolični dogodki in so potrebovali zdravljenje z antikoagulanti, so lahko nadaljevali z jemanjem zdravila Vargatef.
English: Talk to your doctor or pharmacist before taking this medicine - if you have or had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung - if you have or ever had problems with your kidney - if you take blood-thinning medicines (such as warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clotting.
Slovenian: - če imate ali ste imeli težave z jetri ali ste kadarkoli imeli krvavitve, zlasti nedavno krvavitev v pljuča; - če imate ali ste imeli težave z ledvicami, - če jemljete zdravila za redčenje krvi (kot so varfarin, fenprokumon, heparin ali acetilsalicilna kislina) za preprečevanje strjevanja krvi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER (100 mg - multipack of 120 capsules - contains Blue Box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (100 mg - večkratno pakiranje po 120 kapsul - vsebuje Blue Box)
English: No dedicated trials investigating the effect of nintedanib on wound healing were performed.
Slovenian: Namenskih preskušanj za proučevanje učinka nintedaniba na celjenje ran niso opravili.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg - 60 capsules for multipack - without Blue Box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (100 mg - 60 kapsul v večkratnem pakiranju brez Blue Box)
English: Co-administration with nintedanib should be carefully considered.
Slovenian: O sočasnem dajanju nintedaniba je treba skrbno premisliti.
English: A statistically significant improvement in OS favouring treatment with nintedanib plus docetaxel was demonstrated in patients with adenocarcinoma with a 17 % reduction in the risk of death (HR 0.83, p = 0.0359) and a median OS improvement of 2.3 months (10.3 versus 12.6 months, Figure 1).
Slovenian: Bolniki z adenokarcinomom so imeli dokazano statistično značilno izboljšanje celokupnega preživetja v korist zdravljenja z nintedanibom in docetakselom, s 17-odstotnim zmanjšanjem tveganja smrti (RO 0,83, p = 0,0359) in mediano vrednostjo izboljšanja celokupnega preživetja 2,3 meseca (10,3 v primerjavi z 12,6 meseci, slika 1).
English: Treatment with Vargatef is not recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Slovenian: Zdravljenje z zdravilom Vargatef za bolnike z zmerno ali hudo jetrno okvaro ni priporočeno (glejte poglavje 4.2).
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 x 1 mehka kapsula
English: Therapy with Vargatef should be permanently discontinued in patients who develop gastrointestinal perforation.
Slovenian: Zdravljenje z zdravilom Vargatef je treba za stalno ukiniti bolnikom, pri katerih se pojavi predrtje prebavil.
English: What Vargatef contains The active substance is nintedanib.
Slovenian: Kaj vsebuje zdravilo Vargatef Učinkovina je nintedanib.
English: Teratogenic effects on the aortic arches in combination with the heart and the urogenital system were noted at an exposure 4 times higher than at the MRHD and on the embryofoetal development of the axial skeleton at an exposure 3 times higher than at the MRHD.
Slovenian: Teratogene učinke na aortne loke v kombinaciji s srcem in sečili so opazili pri izpostavljenosti, ki je bila približno 4-krat večja od največjega priporočenega odmerka za ljudi, vpliv na razvoj aksialnega okostja zarodka pa pri izpostavljenosti , ki je bila 3-krat večja od največjega priporočenega odmerka pri ljudeh.
English: The most frequently reported adverse drug reactions (ADRs) specific for nintedanib were diarrhoea, increased liver enzyme values (ALT and AST) and vomiting.
Slovenian: Neželeni učinki, specifični za nintedanib, o katerih so najpogosteje poročali, so bili driska, zvišane ravni jetrnih encimov (ALT in AST) in bruhanje.
English: There was no evidence of liver enzyme increases in rats, dogs, and Cynomolgus monkeys.
Slovenian: Pri podganah, psih in opicah Cynomolgus ni dokazov o povečanju jetrnih encimov.
English: In both cases, you should take one capsule of the appropriate strength twice daily approximately 12 hours apart with food (for example in the morning and in the evening) at about the same time of the day.
Slovenian: V obeh primerih vzemite po eno kapsulo ustrezne jakosti dvakrat na dan s hrano, s približno 12-urnim časovnim presledkom (na primer eno kapsulo zjutraj in eno zvečer) ob približno istem času dneva.
English: Capsule content:Triglyceridesmedium-chain, hard fat, soya lecithin (E322) Capsule shell:Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172),
Slovenian: Vsebina kapsule:trigliceridi, srednjeverižni;trda maščoba,sojin lecitin(E322) Ovojnica kapsule:želatina, glicerol (85%), titanov dioksid (E171), rdeči železov oksid(E172),
English: Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, for example loperamide, and may require interruption, dose reduction or discontinuation of therapy with Vargatef (see section 4.2).
Slovenian: Drisko je treba zdraviti takoj, ko se pojavijo prvi znaki, in sicer z ustrezno hidracijo in zdravili proti driski, kot je na primer loperamid, včasih je treba zdravljenje z zdravilom Vargatef prekiniti, zmanjšati odmerek ali ga trajno ukiniti (glejte poglavje 4.2).
English: In order to investigate suitable bio-/tumour markers (including VEGF) to allow identification and selection of a more targeted population of patients most likely to benefit from the treatment of nintedanib, the Applicant will conduct and submit results from a Biomarkers research programme including: 1.
Slovenian: Da bi raziskali ustrezne bio-/tumorske markerje (vključno z VEGF), ki bi omogočili identifikacijo in izbiro ciljne populacije bolnikov, ki bi imela največjo možnost za učinkovito zdravljenje z nintedanibom, mora vlagatelj izvesti in predložiti rezultate programa za raziskovanje biomarkerjev, vključno z: 1. zbranimi vzorci krvi iz študij LUME-Lung 1 in LUME-Lung 2, ki bodo ocenjeni na podlagi genetske raznovrstnosti zarodnih linij, angiogenetskih dejavnikov, vključno z VEGF ali njihovih posledičnih receptorjev.
English: Elevation of AST and/or ALT values to > 3 x ULN in conjunction with an increase of total bilirubin to ≥ 2 x ULN and ALKP < 2 x ULN
Slovenian: Povečane vrednosti AST in/ali ALT na > 3 x ULN v povezavi s povečanimi vrednostmi celokupnega bilirubina na ≥ 2 x ULN in ALKP < 2 x ULN
English: If the patient becomes pregnant while receiving Vargatef, she should be apprised of the potential hazard to the foetus.
Slovenian: Če bolnica med uporabo zdravila Vargatef zanosi, je treba oceniti možno nevarnost za plod.
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Slovenian: Bolezni prebavil driska, bruhanje, navzea, trebušna bolečina perforacija pankreatitis kolitis
English: Non-serious and serious bleeding events, some of which were fatal, have been reported in the postmarketing period, including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding (for clinical trials' data, see also ‘Therapeutic anticoagulation' below).
Slovenian: V obdobju trženja zdravila (pri bolnikih zdravljenih z ali brez antikoagulantov ali drugimi zdravili, ki bi lahko povzročili krvavitve) so poročali o neresnih in resnih krvavitvah, od katerih jih je bilo nekaj s smrtnim izidom (za podatke iz kliničnih preskušanj glejte tudi »Terapevtska antikoagulacija« spodaj).
English: Number of Deaths, n (%) Median OS [months] HR (95 % CI)
Slovenian: Število smrti ali napredovanj bolezni,n (%) Mediana celokupnega preživetja [meseci] RO (95-odstotni IZ)
English: Recommended dose adjustments for Vargatef (nintedanib) in case of diarrhoea, vomiting and other non-haematological or haematological adverse reactions
Slovenian: Prilagajanje priporočenega odmerka za zdravilo Vargatef (nintedanib) v primeru driske, bruhanja in drugih nehematoloških ali hematoloških neželenih učinkov Neželeni učinki po CTCAE*
English: ° Adjusted mean of best-% change from baseline and p-value generated from an ANOVA model adjusting for baseline ECOG PS (0 versus 1), brain metastases at baseline (yes versus no) and prior treatment with bevacizumab (yes versus no).
Slovenian: ° Prilagojena srednja vrednost najboljše spremembe v odstotkih od izhodišča in vrednost p sta pridobljeni iz modela ANOVA, s prilagoditvijo za izhodiščno stanje zmogljivosti po ECOG (0 ali 1), metastaze v možganih na izhodišču (da ali ne) in predhodno zdravljenje z bevacizumabom (da ali ne).
English: A multipack containing 120 capsules (2 boxes of 60 capsules each, bundled together by a wrapping foil).
Slovenian: Večkratno pakiranje vsebuje 120 kapsul (2 škatli s 60 kapsulami, ki sta skupaj oviti s folijo).
English: No increased frequency of cerebral bleeding in patients with adequately pre-treated brain metastases which were stable for ≥ 4 weeks before start of treatment with Vargatef was observed.
Slovenian: Pri bolnikih z ustrezno predhodno zdravljenimi metastazami v možganih, ki so bili pred uvedbo zdravila Vargatef ≥ 4 tedne stabilni, niso opazili povečane pogostnosti možganskih krvavitev.
English: Table 1:
Slovenian: Preglednica 1:
English: Race and body weight
Slovenian: Rasa in telesna masa
English: In rats, embryofoetal lethality and teratogenic effects were observed at exposure levels below human exposure, at the maximum recommended human dose (MRHD) of 200 mg b.i.d.
Slovenian: Pri podganah so smrtnost zarodka in ploda ter teratogene učinke opazi li pri izpostavljenosti, ki je manjša od največjega za ljudi priporočenega odmerka 200 mg dvakrat na dan.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see also section 4.4).
Slovenian: Če ni ugotovljen drug razlog, je treba zdravljenje z zdravilom Vargatef trajno ukiniti (glejte tudi poglavje 4.4).
English: Table 3:
Slovenian: Preglednica 3:
English: In this case your doctor will prescribe Vargatef 150 mg soft capsules for your treatment.
Slovenian: V tem primeru vam bo za zdravljenje predpisal mehke 150 mg kapsule Vargatef.
English: In rabbits, embryofoetal lethality was observed at an exposure approximately 8 times higher than at the MRHD.
Slovenian: Pri kuncih so smrtnost zarodka ali ploda opazili pri izpostavljenosti, ki je bila približno 8-krat večja od največjega priporočenega odmerka za ljudi.
English: D-55216 Ingelheim am Rhein Germany
Slovenian: D-55216 Ingelheim am Rhein NEMČIJA
English: This daily dose should be split into two doses of two capsules about 12 hours apart, for example two capsules in the morning and two capsules in the evening.
Slovenian: Dnevni odmerek razdelite na dva odmerka s po dvema kapsulama, ki jih vzemite s približno 12-urnim časovnim presledkom, na primer dve kapsuli zjutraj in dve kapsuli zvečer.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (logo)
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim
English: nd dose reduction is considered necessary - from 150 mg twice daily to 100 mg twice daily.
Slovenian: Kadar je potrebno še drugo zmanjšanje odmerka, preidemo s 150 mg dvakrat na dan na 100 mg dvakrat na dan.
English: Pharmacokinetic/pharmacodynamic relationship(s) In exploratory pharmacokinetic adverse event analyses, higher exposure to nintedanib tended to be associated with liver enzyme elevations, but not with gastrointestinal adverse events.
Slovenian: V eksploracijskih farmakokinetičnih analizah neželenih učinkov se je pri večji izpostavljenosti nintedanibu kazal trend k povezavi s povečanjem vrednosti jetrnih encimov, ne pa tudi z neželenimi učinki v prebavilih.
English: Mucositis (including stomatitis), Rash, Alopecia
Slovenian: Bolezni kože in podkožja mukozitis (vključno s stomatitisom), izpuščaj, alopecija pruritus
English: Liver-related adverse reactions occurred in 42.8 % of nintedanib-treated patients.
Slovenian: Povišanje ravni jetrnih encimov in hiperbilirubinemija Neželeni učinki, povezani z jetri, so se pojavili pri 42,8 % bolnikov, zdravljenih z nintedanibom.
English: Febrile neutropenia, Abscesses, Sepsis
Slovenian: Infekcijske in parazitske bolezni febrilna nevtropenija, abscesi, sepsa
English: The safety, efficacy and pharmacokinetics of nintedanib have not been studied in patients with severe hepatic impairment (Child Pugh C).
Slovenian: Varnosti,učinkovitosti in farmakokinetike nintedaniba niso proučevali pri bolnikih s hudo jetrno okvaro (Child Pugh C).
English: Table 4:
Slovenian: Preglednica 4:
English: The highest single dose of nintedanib administered in phase I studies was 450 mg once daily.
Slovenian: Specifičnega antidota ali zdravljenja za preveliko odmerjanje nintedaniba ni. Njegov največji enkratni odmerek, ki so ga uporabili v študijah I. faze, je bil 450 mg enkrat na dan.
English: Therefore treatment with Vargatef will usually be interrupted if you are having surgery.
Slovenian: Zato je treba zdravljenje z zdravilom Vargatef običajno prekiniti pred načrtovano operacijo.
English: Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.
Slovenian: Pri izpostavljenosti, ki je bila nižja od terapevtskega odmerka, so opazili tudi učinke na razvoj aksialnega okostja in razvoj velikih arterij.
English: The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C).
Slovenian: Varnosti,učinkovitosti in farmakokinetike nintedaniba niso proučili pri bolnikih s hudo jetrno okvaro (Child Pugh C).
English: Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible after having contacted your doctor.
Slovenian: Takoj, ko je mogoče, po posvetu z zdravnikom, začnite jemati ustrezno zdravilo proti driski, npr. loperamid.
English: A higher frequency of neutropenia of CTCAE grade ≥ 3 was observed in patients treated with Vargatef in combination with docetaxel as compared to treatment with docetaxel alone.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Vargatef v kombinaciji z docetakselom, so v primerjavi z zdravljenimi samo z docetakselom zasledili večjo pogostnost nevtropenije stopnje ≥ 3 po CTCAE.
English: Each capsule contains 1.8 mg of soya lecithin.
Slovenian: Pomožne snovi z znanim učinkom Ena kapsula vsebuje 1,8 mg sojinega lecitina.
English: D-55216Ingelheim am Rhein Germany
Slovenian: D-55216 Ingelheim am Rhein Nemčija
English: Table 2:
Slovenian: Preglednica 2:
English: You should take one capsule of this strength twice daily approximately 12 hours apart with food (for example in the morning and in the evening) at about the same time of the day.
Slovenian: Vzemite po eno kapsulo te jakosti dvakrat na dan s hrano, s približno 12-urnim časovnim presledkom ob približno istem času dneva (na primer zjutraj in zvečer).
English: Frequent monitoring of complete blood counts should be performed at the beginning of each treatment cycle and around the nadir for patients receiving treatment with nintedanib in combination with docetaxel, and as clinically indicated after the administration of the last combination cycle.
Slovenian: Na začetku vsakega terapevtskega cikla in ob mejhnih vrednostih za bolnike, ki se zdravijo z nintedanibom v kombinaciji z docetakselom, je treba spremljati kompletno krvno sliko; če je klinično indicirano, pa tudi po dajanju zadnjega kombiniranega cikla.
English: This daily dose should be split into two doses of one capsule about 12 hours apart, for example one capsule in the morning and one capsule in the evening.
Slovenian: Dnevni odmerek razdelite na dva dela, in sicer vzemite eno kapsulo s približno 12-urnim časovnim presledkom, na primer eno kapsulo zjutraj in eno kapsulo zvečer.
English: The majority of adverse reactions appeared in close temporal relationship with the administration of docetaxel.
Slovenian: Večina neželenih učinkov je tesno časovno sovpadala z dajanjem docetaksela.
English: Each capsule contains 1.2 mg of soya lecithin.
Slovenian: Pomožne snovi z znanim učinkom Ena kapsula vsebuje 1,2 mg sojinega lecitina.
English: th percentile) and increased by 13 % for a 76-year old patient (95
Slovenian: Vrednost AUCτ,ss se je zmanjšala za 16 % pri 45-letnem bolniku (5. percentil) in povečala za 13 % pri 76-letnem bolniku (95. percentil) glede na bolnike z mediano starostjo 62 let.
English: In this case your doctor will prescribe Vargatef 100 mg soft capsules for your treatment.
Slovenian: V tem primeru vam bo zdravnik predpisal 100 mg mehke kapsule zdravila Vargatef.
English: Table 3 provides a summary of the adverse reactions by System Organ Class (SOC).
Slovenian: Preglednica 2 prikazuje povzetek neželenih učinkov po organskih sistemih.
English: Vargatef 100 mg soft capsules
Slovenian: Vargatef 100 mg mehke kapsule
English: Not all pack-sizes of Vargatef 100 mg soft capsules may be marketed.
Slovenian: Na trgu morda ni vseh velikosti pakiranj zdravila Vargatef 100 mg mehke kapsule.
English: Brain metastasis
Slovenian: Metastaze v možganih
English: The majority of patients were non-Asian (81.6 %), the median age was 60.0 years, the baseline ECOG
Slovenian: Večina bolnikov je bilo Neazijcev (81,6 %), mediana starost je bila 60,0 let, izhodiščno stanje zmogljivosti po ECOG je bilo 0 (28,6 %) ali 1 (71,3 %); en bolnik je imel izhodiščno stanje zmogljivosti po ECOG 2.
English: One box contains 60 capsules (6 aluminium blisters of 10 capsules each).
Slovenian: Ena škatla vsebuje 60 kapsul (6 aluminijevih pretisnih omotov po 10 kapsul).
English: In the post-marketing period non-serious and serious bleeding events, some of which fatal, have been reported, including patients with or without anticoagulant therapy or other medicinal products that could cause bleeding.
Slovenian: V obdobju trženja zdravila (pri bolnikih zdravljenih z ali brez antikoagulantov ali drugimi zdravili, ki bi lahko povzročili krvavitve) so poročali o neresnih in resnih krvavitvah, od katerih jih je bilo nekaj s smrtnim izidom.
English: One box containing 120 capsules (12 aluminium blisters of 10 capsules each).
Slovenian: Ena škatla vsebuje 120 kapsul (12 aluminijevih pretisnih omotov po 10 kapsul).
English: Preclinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5 % of the administered dose) were secreted into milk of lactating rats.
Slovenian: Predklinične študije kažejo, da se pri podganah v obdobju laktacije v mleko izloča majhna količina nintedaniba in njegovih presnovkov (≤ 0,5 % uporabljenega odmerka).
English: For posology, methods of administration, and dose modifications of docetaxel, please refer to the corresponding product information for docetaxel.
Slovenian: Za odmerjanje, način uporabe in spreminjanje odmerka docetaksela glejte ustrezna navodila o tem zdravilu.
English: Diarrhoea was the most frequently reported gastro-intestinal adverse reaction and appeared in close temporal relationship with the administration of docetaxel (see section 4.8).
Slovenian: Med neželenimi učinki na prebavila so najpogosteje poročali o driski, ki je časovno tesno sovpadala z dajanjem docetaksela (glejte poglavje 4.8).
English: Vargatef 150 mg soft capsules
Slovenian: Vargatef 150 mg mehke kapsule
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see section 4.2).
Slovenian: Če ni ugotovljen drugi vzrok, je treba zdravljenje z zdravilom Vargatef trajno ukiniti (glejte poglavje 4.2).
English: Nausea and vomiting, mostly of mild to moderate severity, were frequently reported gastrointestinal adverse reactions (see section 4.8).
Slovenian: Pogosta neželena učinka na prebavila sta bila navzea in bruhanje, večinoma blage do zmerne resnosti (glejte poglavje 4.8).
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported with nintedanib in the post-marketing period.
Slovenian: V obdobju trženja nintedaniba so poročali o resnih primerih driske s posledično dehidracijo in elektrolitskimi motnjami.
English: Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173
Slovenian: Imetnik dovoljenja za promet z zdravilom Boehringer Ingelheim International GmbH Binger Strasse 173
English: Metabolism
Slovenian: trombocitopenija
English: There are no human or animal data on potential effects of nintedanib on female fertility available.
Slovenian: O možnih vplivih nintedaniba na plodnost pri ženskah ali živalskih samicah ni podatkov.
English: Renal failure
Slovenian: Ledvična okvara
English: Summary of ADRs per frequency category
Slovenian: Povzetek neželenih učinkov po kategorijah pogostnosti Organski sistem Zelo pogosti
English: Neutropenia (includes febrile neutropenia)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (vključno s febrilno nevtropenijo)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (150 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (150 mg)
English: If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required (see section 4.2).
Slovenian: Kadar so izmerjene povečane vrednosti encimov relevantne, bo mogoče treba zdravljenje z zdravilom Vargatef prekiniti, zmanjšati odmerek ali trajno ukiniti (glejte poglavje 4.2).
English: Mild to moderate epistaxis represented the most frequent bleeding event.
Slovenian: Najpogostnejša krvavitev je bila blaga do zmerna epistaksa.
English: What Vargatef looks like and contents of the pack Vargatef 150 mg soft capsules (capsules) are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Slovenian: Zdravilo Vargatef, 150mg mehke kapsule(kapsule), so rjave barve, neprozorne in podolgovate, ki imajo na eni strani v črni barvivtisnjenooznakopodjetjaBoehringer Ingelheim in številko 150.
English: No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
Slovenian: V preskušanju LUME-Lung 1 niso opazili večje pogostnosti slabšega celjenja ran.
English: Co-administration with other medicinal products
Slovenian: Sočasno dajanje z drugimi zdravili
English: However, an increased frequency of arterial thromboembolic events was observed in patients with idiopathic pulmonary fibrosis (IPF) when treated with nintedanib monotherapy.
Slovenian: Toda pri bolnikih z idiopatsko pljučno fibrozo (IPF), zdravljenih z nintedanibom kot monoterapijo, so opazili večjo pogostnost arterijskih trombemboličnih dogodkov.
English: Breast-feeding should be discontinued during treatment with Vargatef.
Slovenian: Med zdravljenjem z zdravilom Vargatef je treba prenehati z dojenjem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (100 mg)