natgillin/translations-raw huggingface dataset:
Other information on drug-drug interactions
Drugi podatki o medsebojnem delovanju zdravil
As expected via its mechanism of action perforation might occur in patients treated with nintedanib.
Kot je zaradi mehanizma delovanja pričakovano, se lahko pri bolnikih, zdravljenih z nintedanibom, predrejo prebavila.
Efficacy results for trial LUME-Lung 1 for patients with adenocarcinoma tumour histology
Izsledki o učinkovitosti v preskušanju LUME-Lung 1 za bolnike s histologijo adenokarcinoma
Stratified Log-Rank Test p-value*
Vrednost p iz stratificiranega log-rang testa *
Neutropenia, febrile neutropenia and sepsis
Nevtropenija, febrilna nevtropenija in sepsa
Drug-induced liver injury
z zdravilom povzročena poškodba jeter
Inform your doctor immediately while taking this medicine - if you get diarrhoea.
Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: - dobili drisko.
Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Zdravljenje z zdravilom Vargatef mora uvesti in nadzirati zdravnik, ki ima izkušnje z uporabo onkoloških zdravil.
You need to pay special attention if you get the following side effects during treatment with Vargatef:
Bodite posebno pozorni na pojav naslednjih neželenih učinkov med zdravljenjem z zdravilom Vargatef:
For information about special populations, recommended measures and dosing adjustments in case of liver enzyme and bilirubin elevations, see sections 4.4 and 4.2, respectively.
Za informacije o priporočenih ukrepih in prilagajanje odmerjanja v primeru zvišanih ravni jetrnih encimov in bilirubina pri posebnih populacijah glejte poglavji 4.4 in 4.2.
Vargatef 150 mg soft capsules EU/1/14/954/004
Vargatef 150 mg mehke kapsule EU/1/14/954/004
Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Vargatef is not recommended (see sections 4.4 and 5.2).
Zdravljenja bolnikov z zmerno (Child Pugh B) in hudo (Child Pugh C) jetrno okvaro z zdravilom Vargatef ni priporočeno (glejte poglavji 4.4 in 5.2).
Vargatef should be discontinued in patients with life-threatening venous thromboembolic reactions.
Uporabo zdravila Vargatef je treba ukiniti pri bolnikih z življenje ogrožajočimi venskimi trombemboličnimi reakcijami.
If co-administered with nintedanib, potent P-gp inhibitors (e.g. ketoconazole or erythromycin) may increase exposure to nintedanib.
Pri sočasnem dajanju z nintedanibom pa lahko močni zaviralci P-gp (npr. ketokonazol ali eritromicin) povečajo izpostavljenost nintedanibu.
In the clinical trial (LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable (see section 4.8).
V kliničnem preskušanju (LUME-Lung 1; glejte poglavje 5.1) zdravila Vargatef je bila pogostnost krvavitve pri obeh zdravljenih skupinah primerljiva
Elevation of AST and/or ALT values to > 5 x ULN
Povečane vrednosti AST in/ali ALT na > 5 x ULN
In the overall population, 16.0 % of the patients had disease stage < IIIB/IV, 22.4 %, had disease stage IIIB and 61.6 % had disease stage IV. 9.2 % of the patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
V celotni populaciji je 16,0 % bolnikov imelo bolezen stopnje < IIIB/IV, 22,4 % bolezen stopnje IIIB in 61,6 % jih je imelo bolezen stopnje IV. 9,2 % bolnikov je vstopilo v preskušanje z lokalno ponovljeno boleznijo na stopnji izhodiščne ocene.
Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Ker učinka nintedaniba na presnovo in učinkovitost kontraceptivov niso proučevali, je treba kot drugo obliko kontracepcije uporabiti še pregradno metodo.
After food intake, nintedanib exposure increased by approximately 20 % compared to administration under fasted conditions (CI: 95.3 - 152.5 %) and absorption was delayed (median tmax fasted: 2.00 hours; fed: 3.98 h).
Po vnosu hrane se je izpostavljenost nintedanibu povečala za približno 20 % v primerjavi z uporabo na tešče (IZ: 95,3 do 152,5 %), absorpcija pa je bila upočasnjena (mediana tmax na tešče: 2,00 uri; s hrano: 3,98 ure).
Urinary excretion of the unchanged active substance within 48 h was about 0.05 % of the dose (31.5 % gCV) after oral and about 1.4 % of dose (24.2 % gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6 % gCV).
V 48 urah se je s sečem izločilo približno 0,05 % odmerka nespremenjene zdravilne učinkovine (31,5 % gCV) po peroralnem zaužitju in približno 1,4 % odmerka (24,2 % gCV) po intravenskem vnosu; ledvični očistek je bil 20 ml/min (32,6 % gCV).
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Farmakoterapevtska skupina: zdravila proti novotvorbam, zaviralci proteinskih kinaz; oznaka ATC: L01XE31.
Stable brain metastasis
Stabilne metastaze v možganih
Single arm study to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival (OS) in NSCLC patients eligible for treatment with nintedanib.
2. študijo z eno skupino z namenom ugotoviti, če bi pregled genetskih/genomskih markerjev (izoliranih ali v kombinaciji s kliničnimi sočasnimi spremenljivkami), lahko uporablja za napoved celokupnega preživetja (CP) med bolniki z NSCLC, primernimi za zdravljenje z zdravilom nintedanib.
In a dedicated single dose phase I trial and compared to healthy subjects, exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment (Child Pugh A; 90 % CI 1.3 - 3.7 for Cmax and 1.2 - 3.8 for AUC, respectively).
V namenskem preskušanju z enojnim odmerkom faze I in v primerjavi z zdravimi osebami, je bila izpostavljenost nintedanibu na podlagi Cmax in AUC 2,2-krat večja pri prostovoljcih z blago jetrno okvaro (Child Pugh A; 90-% IZ 1,3 - 3,7 za Cmax oz. 1,2 - 3,8 za AUC).
The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy and based on data observed during the post-marketing period.
V spodnjih poglavjih navajamo podatke o varnosti, ki temeljijo na globalnem, dvojno slepem randomiziranem ključnem preskušanju 3. faze 1199.13 (LUME-Lung 1), v katerem so primerjali zdravljenje z nintedanibom in docetakselom s placebom in docetakselom pri bolnikih z lokalno napredovalim ali metastatskim ali ponovljivim NSCLC po kemoterapiji prve izbire in na podlagi podatkov, opaženih v obdobju trženja.
Nintedanib may cause foetal harm in humans (see section 5.3).
Nintedanib lahko poškoduje človeški plod (glejte poglavje 5.3).
If you forget to take Vargatef
Če ste pozabili vzeti zdravilo Vargatef
If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef.
Če zaradi neželenih učinkov ne prenašate priporočenega odmerka 400 mg zdravila Vargatef na dan (glejte 4. poglavje), lahko zdravnik zmanjša vaš dnevni odmerek.
iron oxide yellow (E172)
rumeni železov oksid (E172)
Recommended dose adjustments for Vargatef (nintedanib) in case of AST and/or ALT and bilirubin elevations
Prilagajanje priporočenega odmerka za zdravilo Vargatef (nintedanib) v primeru povečanja ravni AST in/ali ALT in bilirubina Povečanje ravni AST/ALT in bilirubina
Observed adverse events were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Neželeni učinki, ki so jih opazili, so bili skladni z znanim profilom varnosti nintedaniba, ki zajema povečanje jetrnih encimov in prebavnih simptomov.
There are no data available from clinical trials for patients with inherited predisposition to bleeding or for patients receiving a full dose of anticoagulative treatment prior to start of treatment with Vargatef (for post-marketing experience, see ‘Haemorrhage' above).
Podatki iz kliničnih preskušanj za bolnike z dedno nagnjenostjo h krvavitvam ali tiste, ki so pred začetkom zdravljenja z zdravilom Vargatef prejemali polne odmerke antikoagulantov, niso na voljo (za podatke v obdobju trženja glejte »Krvavitev« zgoraj).
Aluminium/aluminium blisters containing 10 capsules each.
Pretisni omoti aluminij/aluminij; vsak vsebuje 10 kapsul.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Vargatef.
Ženskam je treba svetovati, naj obvestijo zdravnika ali farmacevta, če med zdravljenjem z zdravilom Vargatef zanosijo.
Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are not expected, since nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies nor was nintedanib metabolized by CYP enzymes to a relevant extent.
Medsebojnega delovanja med nintedanibom in substrati CYP, zaviralci CYP ali induktorji CYP ni pričakovati, saj nintedanib, BIBF 1202 in glukuronid BIBF 1202 v predkliničnih študijah niso zavirali ali inducirali encimov CYP, pa tudi nintedaniba encimi CYP niso presnavljali v pomembnem obsegu.
Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies(see section 5.2).
V predkliničnih študijah nintedanib in njegovi presnovki, prosta kislina BIBF 1202 in njen glukuronid BIBF 1202 niso zavirali ali inducirali encimov CYP (glejte poglavje 5.2).
In particular, treatment of tumour xenografts with nintedanib led to a rapid reduction in tumour micro vessel density, pericytes vessel coverage and tumour perfusion.
Še zlasti je zdravljenje tumorskih ksenograftov z nintedanibom hitro zmanjšalo gostoto mikrožilja v tumorju in njegovo perfuzijo ter prekritje žil s periciti.
In addition, 2 patients had an overdose of maximum 600 mg twice daily (b.i.d.)
Poleg tega sta 2 bolnika dobivala prevelik odmerek največ 600 mg dvakrat na dan do osem dni.
Taking the medicine this way ensures that a steady amount of nintedanib is maintained in the body.
Tako boste zagotovili enakomerno količino nintedaniba v telesu.
Vargatef has minor influence on the ability to drive and use machines.
Zdravilo Vargatef ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The recommended dose is four capsules per day (this is a total of 400 mg nintedanib per day).
Priporočeni odmerek so štiri kapsule na dan (skupaj 400 mg nintedaniba na dan).
Peripheral neuropathy is also known to occur with docetaxel treatment.
Znano je tudi, da se med zdravljenjem z docetakselom pojavlja periferna nevropatija.
Placebo Nintedanib
Verjetnost preživetja placebo nintedanib
Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1).
Bolnik ne sme vzeti zdravila Vargatef istega dne, ko prejme kemoterapijo z docetakselom (to je 1. dne).
The excipients are:
Druge sestavine zdravila so:
PHARMACEUTICAL FORM AND CONTENTS Multipack: 120 (2 packs of 60 x1) soft capsules.
FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 120 (2 pakiranji s po 60 x1) mehkih kapsul.
The following side effects were observed under treatment with this medicine:
Pri zdravljenju s tem zdravilom so opazili naslednje neželene učinke:
Decreased appetite, Electrolyte imbalance
Presnovne in prehranske motnje zmanjšan apetit, neravnovesje elektrolitov dehidracija, zmanjšanje telesne mase
No adjustment of the starting dose is needed for patients with mild hepatic impairment (Child Pugh A) based on clinical data.
Začetnega odmerka pri bolnikih z blago jetrno okvaro (Child Pugh A) na podlagi kliničnih podatkov ni treba prilagajati.
Most patients recovered from diarrhoea following treatment interruption, anti-diarrhoeal therapy and nintedanib dose reduction.
Pri večini bolnikov je driska prenehala po prekinitvi zdravljenja, jemanju zdravil proti driski in zmanjšanju odmerka nintedaniba.
In case of bleeding, dose adjustment, interruption or discontinuation should be considered based on clinical judgement (see section 4.2).
V primeru krvavitve je treba razmisliti o prilagoditvi odmerka, prekinitvi ali trajni ukinitvi zdravljenja na podlagi klinične ocene (glejte poglavje 4.2).
No QT prolongation was observed for nintedanib in the clinical trial program (see section 5.1).
V programu kliničnega preskušanja z nintedanibom niso opazili podaljšanja intervala QT (glejte poglavje 5.1)
Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min, 28.8 % gCV).
Skupni plazemski očistek po intravenskem infundiranju je bil velik (očistek: 1.390 ml/min, 28,8 % gCV).
Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory (see also section 4.4).
Krvavitve v obdobju trženja zdravila vključujejo prebavila, dihala in organe osrednjega živčnega sistema, vendar na njih niso omejene, najbolj pogoste pa so krvavitve v dihalih (glejte tudi poglavje 4.4).
Hyperbilirubinaemia, Gammaglutamyltransferase (GGT) increased
hiperbilirubinemija, povečana vrednost gama-glutamiltrans feraze (GGT)
Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A; see sections 4.2 and 5.2).
Na podlagi večje izpostavljenosti se lahko poveča tudi tveganje za neželene dogodke pri bolnikih z blago jetrno okvaro (Child Pugh A; glejte poglavji 4.2 in 5.2).
As shown in Table 4, the addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 23 % for the adenocarcinoma population (HR 0.77; 95 % CI: 0.62 - 0.96).
Kot prikazuje preglednica 4, je dodajanje nintedaniba k docetakselu povzročilo statistično značilno zmanjšanje tveganja za napredovanje bolezni ali smrt za 23 % za populacijo z adenokarcinomom (RO 0,77; 95-odstotni IZ: 0,62-0,96).
Peripheral neuropathy was reported in 16.5 % of patients in the placebo arm and in 19.1 % of patients in the nintedanib arm.
O njej so poročali pri 16,5 % bolnikov v skupini s placebom in pri 19,1 % bolnikov v skupini z nintedanibom.
Do not use this medicine after the expiry date which is stated on the carton and blisters.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Sočasno dajanje z močnim zaviralcem P-gp, ketokonazolom, je povečalo izpostavljenost nintedanibu za 1,61-krat na podlagi AUC in za 1,83-krat na podlagi Cmax v namenskih študijah o medsebojnem delovanju med zdravili.
Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy.
Znano je, da sojini prehranski izdelki pri osebah z alergijo na sojo povzročajo alergijske reakcije, vključno z resno anafilaksijo.
The recommended dose is two capsules per day (this is a total of 300 mg nintedanib per day).
Priporočeni odmerek sta dve kapsuli na dan (skupaj 300 mg nintedaniba na dan).
PK-efficacy analyses were not performed for clinical endpoints.
Farmakokinetičnih analiz učinkovitosti za klinične opazovane dogodke niso opravili.
If you cannot tolerate the recommended dose of 300 mg per day because of side effects (see section 4), your doctor may reduce your recommended daily dose of Vargatef to 200 mg per day (two capsules of 100 mg).
Če zaradi neželenih učinkov ne prenašate priporočenega odmerka 300 mg zdravila Vargatef na dan (glejte 4. poglavje), lahko zdravnik zmanjša vaš dnevni odmerek na 200 mg na dan (dve kapsuli po 100 mg).
Therefore, women should not breast-feed during treatment with Vargatef.
Zato ženske med zdravljenjem z zdravilom Vargatef ne bi smele dojiti.
In case of specific elevations of aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) values to > 3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥ 2 x ULN and alkaline phosphatase (ALKP) < 2 x ULN (see Table 2) treatment with Vargatef should be interrupted.
V primeru specifičnih povišanih vrednosti aspartat-aminotransferaze (AST) / alanin-aminotransferaze (ALT) na > 3 x zgornjo mejo normalnih vrednosti (ULN) v povezavi s povečanjem celokupnega bilirubina na ≥ 2 x ULN in alkalne fosfataze (ALKP) < 2 x ULN (glejte Preglednico 2) je treba zdravljenje z zdravilom Vargatef prekiniti.
Vargatef 150 mg soft capsules Pack-size: 60 capsules.
Vargatef 150 mg mehke kapsule Velikost pakiranja: 60 kapsul.
If you stop taking Vargatef
Če ste prenehali jemati zdravilo Vargatef
Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) status (0 versus 1), bevacizumab pretreatment (yes versus no), brain metastasis (yes versus no) and tumour histology (squamous versus non-squamous tumour histology).
Randomizacija je bila stratificirana glede na stanje zmogljivosti po lestvici Eastern Cooperative Oncology Group (ECOG) (0 ali 1), predhodno zdravljenje z bevacizumabom (da ali ne), metastaze v možganih (da ali ne) in histologijo tumorja (ploščatocelična ali neploščatocelična histologija tumorja).
For patients with tumour of adenocarcinoma histology, 15.8 % had disease stage < IIIB/IV, 15.2 %, had disease stage IIIB and 69.0 % had disease stage IV. 5.8 % of the adenocarcinoma patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Pri bolnikih s tumorjem s histologijo adenokarcinoma je 15,8 % bolnikov imelo bolezen stopnje < IIIB/IV, 15,2 % bolezen stopnje IIIB in 69,0 % jih je imelo bolezen stopnje IV. 5,8 % bolnikov z adenokarcinomom je vstopilo v preskušanje z lokalno ponovljeno boleznijo na stopnji izhodiščne ocene.
In volunteers with moderate hepatic impairment (Child Pugh B), exposure was 7.6-fold higher based on Cmax (90 % CI 4.4 - 13.2) and 8.7fold higher (90 % CI 5.7 - 13.1) based on AUC, respectively, compared to healthy volunteers.
Pri prostovoljcih z zmerno jetrno okvaro (Child Pugh B) je bila izpostavljenost v primerjavi z zdravimi osebami 7,6-krat večja na podlagi Cmax (90-% IZ 4,4 - 13,2) oz. 8,7-krat večja (90-% IZ 5,7 - 13,1) na podlagi AUC.
Figure 1: Kaplan-Meier curve for overall survival for patients with adenocarcinoma tumour histology by treatment group in trial LUME-Lung 1
Kaplan-Meierjeva krivulja celokupnega preživetja za bolnike s tumorjem z adenokarcinomsko histologijo po skupinah v preskušanju LUME-Lung 1
Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Vargatef and for at least 3 months after stopping treatment.
Ženske, ki lahko zanosijo, morajo med jemanjem zdravila Vargatef in še vsaj 3 mesece po koncu zdravljenja, uporabljati zanesljivo kombinacijo kontracepcije, vključno s pregradnimi metodami kot drugo obliko kontracepcije.
You will be prescribed the appropriate capsule strength by your doctor if this happens.
Če se to zgodi, vam bo zdravnik predpisal kapsule ustrezne jakosti.
Do not use this medicine after the expiry date which is stated on the carton, wrapper and blisters.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, ovojnini ali pretisnih omotih.
If a dose of nintedanib is missed, administration should resume at the next scheduled time at the recommended dose.
Če bolnik pozabi vzeti priporočeni odmerek nintedaniba, naj ga začne ponovno jemati ob naslednjem načrtovanem času.
For recommended measures and dosing adjustments in case of diarrhoea, see sections 4.4 and 4.2, respectively.
Za priporočene ukrepe in prilagajanje odmerjanja pri driski glejte poglavji 4.4 in 4.2.
After treatment interruption and recovery of transaminase-values to ≤ 2.5 x ULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Po prekinitvi zdravljenja in vrnitvi vrednosti transaminaze na ≤ 2,5 x ULN in bilirubina na normalno vrednost je treba odmerek zmanjšati z 200 mg dvakrat na dan na 150 mg dvakrat na dan.
In preclinical disease models nintedanib, as single agent, effectively interfered with the formation and maintenance of the tumour vascular system resulting in tumour growth inhibition and tumour stasis.
V predkliničnih modelih te bolezni je nintedanib kot samostojna učinkovina uspešno oviral nastajanje in ohranjanje tumorskega žilnega sistema, kar je zavrlo rast tumorja in povzročilo njegov zastoj.
The frequency of gastrointestinal perforation was comparable between the treatment arms in the clinical trial.
Pogostnost predrtja prebavil je bila v kliničnem preskušanju med dvema skupinama primerljiva.
Vargatef capsules contain the active substance nintedanib.
Kapsule Vargatef vsebujejo zdravilno učinkovino nintedanib.
For the management of selected adverse reactions, see section 4.4.
Za obravnavo izbranih neželenih učinkov glejte poglavje 4.4.
This could be symptoms of serious liver problems - if you develop fever as this could be a symptom of febrile neutropenia or sepsis (see section 4) - if you experience severe pain in your stomach area, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation') - if you experience pain, swelling, reddening, warmth of a limb or if you experience chest pain and difficulty to breathe as these could be symptoms of a blood clot in one of your veins - if you have any major bleeding - if you experience chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack - if any side effect(s) you may get (see section 4) becomes serious
To so lahko simptomi resnih težav z jetri; - če se pojavi zvišana telesna temperatura, saj je lahko to simptom febrilne nevtropenije ali sepse (glejte poglavje 4); - če se pojavijo: huda bolečina v predelu trebuha, zvišana telesna temperatura, mrzlica, siljenje na bruhanje, bruhanje, otrdelost ali napihnjenost trebuha, ker so to lahko simptomi luknje v črevesni steni (predrtja prebavil); - če se pojavijo bolečina, oteklina, rdečina, toplota okončine ali bolečina v prsnem košu in oteženo dihanje, saj so to lahko simptomi krvnega strdka v kateri od ven; - če imate kakršnokoli večjo krvavitev, - če vas tišči ali boli v prsih, običajno na levi strani telesa, imate bolečine v vratu, čeljusti, rami ali roki, vam srce hitreje bije, imate kratko sapo, vam je slabo, bruhate, saj so to lahko simptomi srčnega infarkta; - če katerikoli neželeni učinek/učinki (glejte poglavje 4) postanejo resni.
Elevation of AST and/or ALT values to > 2.5 x ULN in conjunction with total bilirubin elevation to ≥ 1.5 x ULN
Povečane vrednosti AST in/ali ALT na > 2,5 x ULN, v povezavi s povečanimi celokupnimi vrednostmi bilirubina ≥1,5 x ULN ALI
The following medicines may increase the blood levels of nintedanib, the active substance of Vargatef, and hence may increase the risk for side effects (see section 4): - Ketoconazole (used to treat fungal infections) - Erythromycin (used to treat bacterial infections) The following medicines may decrease the blood levels of nintedanib and thus may lead to reduction of the effectiveness of Vargatef: - Rifampicin (an antibiotic used to treat tuberculosis) - Carbamazepine, phenytoin (used to treat seizures) - St. John's Wort (a herbal medicine to treat depression)
Zdravili, ki lahko povečata raven nintedaniba (zdravilne učinkovine v zdravilu Vargatef) v krvi, in s tem tveganje za neželene učinke (glejte poglavje 4): - ketokonazol (za zdravljenje glivičnih okužb), - eritromicin (uporablja se za zdravljenje bakterijskih okužb), Zdravila, ki lahko zmanjšajo raven nintedaniba v krvi in s tem učinkovitost zdravila Vargatef, pa so: - rifampicin (antibiotik za zdravljenje tuberkuloze), - karbamazepin in fenitoin (za zdravljenje epileptičnih napadov), - šentjanževka (zdravilo rastlinskega izvora za zdravljenje depresije).