FrancophonIA/ELRC3.0 huggingface dataset:
English: In group 2, the adjusted geometric mean ratios (90% CI)) were 97% (86% - 110%) and 95% (86% - 106%) for Cmax,ss and AUCτ,ss of pirfenidone, respectively (n=12 for intraindividual comparison).
Slovenian: V drugi skupini je bilo razmerje prilagojenega geometričnega povprečja pirfenidona (90-% IZ) za Cmax,ss 97 % (86 % - 110 %) in za AUCτ,ss 95 % (86 % - 106 %) (n = 12 za primerjavo med posamezniki).
English: INFORMATION IN BRAILLE Ofev 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ofev 100 mg
English: The following medicines are examples that may lower the levels of nintedanib in your blood and thus may reduce the effectiveness of Ofev: - an antibiotic used to treat tuberculosis (rifampicin) - medicines to treat seizures (carbamazepine, phenytoin) - a herbal medicine to treat depression (St. John's Wort)
Slovenian: Naslednja zdravila lahko znižajo ravni nintedaniba v krvi in s tem zmanjšajo učinkovitost zdravila Ofev: - antibiotik za zdravljenje tuberkuloze (rifampicin), - zdravila za zdravljenje epileptičnih napadov (karbamazepin in fenitoin), - zdravilo rastlinskega izvora za zdravljenje depresije (šentjanževka).
English: Talk to your doctor or pharmacist before taking Ofev, - if you have or ever had liver problems, - if you have or ever had problems with your kidney, - if you have or ever had bleeding problems, - if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting, - if you take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems, - if you have or ever had problems with your heart (for example a heart attack), - if you have recently had surgery.
Slovenian: Pred začetkom jemanja zdravila Ofev se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste kdaj imeli težave z jetri, - če imate ali ste kdaj imeli težave z ledvicami, - če imate ali ste kdaj imeli težave s krvavitvijo, - če jemljete zdravila za redčenje krvi (kot so varfarin, fenprokumon ali heparin) za preprečevanje strjevanja krvi, - če jemljete pirfenidon, saj to lahko poveča tveganje za pojav driske, siljenja na bruhanje,
English: In INPULSIS-1, the increase from baseline in SGRQ total score at week 52 was comparable between nintedanib and placebo (difference between treatment groups: -0.05; 95% CI: -2.50, 2.40; p=0.9657).
Slovenian: V preskušanju INPULSIS-1 je bilo povečanje skupnega seštevka SGRQ od izhodišča v 52. tednu primerljivo med skupinama z nintedanibom in placebom (razlika med skupinama zdravljenja: -0,05; 95 % IZ: -2,50; 2,40; p=0,9657).
English: Bleeding (see section 4.4)
Slovenian: Žilne bolezni krvavitev (glejte poglavje 4.4)
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Slovenian: V njih se je ob sočasnem dajanju močnega induktorja P-gp rifampicina izpostavljenost nintedanibu zmanjšala za 50,3 % na podlagi AUC in za 60,3 % na podlagi Cmax v primerjavi z dajanjem samega nintedaniba.
English: INFORMATION IN BRAILLE Ofev 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Ofev 150 mg
English: In group 1, the adjusted geometric mean ratios (90% confidence interval (CI)) were 93% (57% - 151%) and 96% (70% - 131%) for Cmax and AUC0-tz of nintedanib, respectively (n=12 for intraindividual comparison).
Slovenian: V prvi skupini je bilo razmerje prilagojenega geometričnega povprečja nintedaniba (90-% interval zaupanja (IZ)) za Cmax 93 % (57 % - 151 %) in za AUC0-tz 96 % (70 % - 131 %) (n = 12 za primerjavo med posamezniki).
English: In this case your doctor will prescribe Ofev 100 mg capsules for your treatment.
Slovenian: V tem primeru vam bo zdravnik predpisal 100 mg mehke kapsule zdravila Ofev.
English: For the management of selected adverse reactions please also refer to section 4.4.
Slovenian: Za obravnavo izbranih neželenih učinkov glejte tudi poglavje 4.4.
English: 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 8.7-fold higher (90% CI 5.7 - 13.1) based on AUC, respectively, compared to healthy volunteers.
Slovenian: 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.
English: The recommended dose is one capsule of 150 mg twice daily (a total of 300 mg per day).
Slovenian: Priporočeni odmerek je ena kapsula po 150 mg dvakrat na dan (skupaj 300 mg na dan).
English: Co-administration with pirfenidone
Slovenian: Sočasno dajanje s pirfenidonom
English: Posology
Slovenian: Prenos
English: See Figure 1 for the evolution of change from baseline over time in both treatment groups, based on the pooled analysis of studies INPULSIS-1 and INPULSIS-2.
Slovenian: Za razvoj spremembe od izhodišča glede na čas v obeh skupinah zdravljenja na podlagi združene analize študij INPULSIS-1 in INPULSIS-2 glejte sliko 1.
English: In a pre- and postnatal development study in rats, effects on pre- and post-natal development were seen at an exposure below the MRHD.
Slovenian: V študiji razvoja pri podganah pred kotitvijo in po njej so opazili učinke na razvoj pred kotitvijo in po njej pri izpostavljenosti, ki je bila manjša od največjega priporočenega odmerka za ljudi.
English: Venous thromboembolism
Slovenian: Venska trombembolija
English: In the INPULSIS trials with Ofev, the frequency of patients who experienced bleeding AEs was slightly higher in the Ofev arm (10.3%) than in the placebo arm (7.8%).
Slovenian: V preskušanjih INPULSIS z zdravilom Ofev je bila pogostnost pojava neželenega učinka krvavitve pri bolnikih, nekoliko višja v skupini, ki je prejemala zdravilo Ofev (10,3 %), kot v skupini, ki je prejemala placebo (7,8 %).
English: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Gamma glutamyl transferase (GGT) increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvečana vrednost jetrnih encimov zvečana vrednost alaninaminotransferaze (ALT), zvečana vrednost aspartataminotransferaze (AST), zvečana vrednost gama-glutamiltransferaze (GGT)
English: In the pre-specified pooled analysis of survival data of the INPULSIS trials, overall mortality over 52 weeks was lower in the nintedanib group (5.5%) compared with the placebo group (7.8%).
Slovenian: V vnaprej specificirani združeni analizi podatkov preživetja v preskušanjih INPULSIS je bila celokupna smrtnost v 52 tednih manjša v skupini z nintedanibom (5,5 % bolnikov) kot v skupini s placebom (7,8 % bolnikov).
English: Due to the mechanism of action of nintedanib patients might have an increased risk of thromboembolic events.
Slovenian: Zaradi mehanizma delovanja nintedaniba je lahko pri bolnikih tveganje za trombembolične dogodke večje.
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 ravneh izpostavljenosti, manjših od terapevtskih, so opazili tudi učinke na razvoj aksialnega okostja in razvoj velikih arterij.
English: 5% threshold Number (%) of FVC responders
Slovenian: Število analiziranih bolnikov 5-% prag Število (%) odzivnih
English: Nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies, either.
Slovenian: V predkliničnih študijah nintedanib, BIBF 1202 in njen glukuronid BIBF 1202 niso zavirali ali inducirali encimov CYP.
English: If the patient becomes pregnant while receiving Ofev, she should be apprised of the potential hazard to the foetus.
Slovenian: Če bolnica med uporabo zdravila Ofev zanosi, je treba oceniti možno nevarnost za plod.
English: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Slovenian: - 30 x 1 mehka kapsula v perforiranih enoodmernih pretisnih omotih aluminij/aluminij - 60 x 1 mehka kapsula v perforiranih enoodmernih pretisnih omotih aluminij/aluminij
English: Hypertension
Slovenian: Hipertenzija
English: See Table 5 for individual and pooled study results.
Slovenian: Za posamične in združene rezultate študij glejte preglednico 5.
English: Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Slovenian: Pomožna snov z znanim učinkom Ena 100 mg mehka kapsula vsebuje 1,2 mg sojinega lecitina.
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.
Slovenian: V obdobju trženja zdravila so poročali o resnih primerih driske s posledično dehidracijo in elektrolitskimi motnjami.
English: Therefore your treatment with Ofev will usually be stopped for a while if you are having a surgery.
Slovenian: Zato je treba zdravljenje z zdravilom Ofev običajno pred načrtovano operacijo za nekaj časa prekiniti.
English: Concomitant treatment with nintedanib and pirfenidone has been investigated in an exploratory openlabel, randomised trial of nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times a day) compared to nintedanib 150 mg twice daily alone in 105 randomised patients for 12 weeks.
Slovenian: Sočasno zdravljenje z nintedanibom in pirfenidonom so preučevali v eksploracijskem, odprtem, randomiziranem preskušanju, kjer so pri 105 randomiziranih bolnikih primerjali sočasno jemanje nintedaniba 150 mg dvakrat na dan in pirfenidona (titriranega do 801 mg trikrat na dan) ter jemanje samo nintedaniba 150 mg dvakrat na dan 12 tednov.
English: The recommended dose is one capsule of 100 mg twice daily (a total of 200 mg per day).
Slovenian: Priporočeni odmerek je ena kapsula po 100 mg dvakrat na dan (skupaj 200 mg na dan).
English: Diarrhoea, nausea and vomiting were the most frequent adverse events reported in 20 (37.7%) versus 16 (31.4%), in 22 (41.5%) versus 6 (11.8%) and in 15 (28.3%) versus 6 (11.8%) patients, treated with pirfenidone added to nintedanib versus nintedanib alone, respectively.
Slovenian: O driski so poročali pri 20 (37,7 %) bolnikih, ki so poleg nintedaniba jemali tudi pirfenidon, oz. pri 16 (31,4 %) bolnikih, ki so jemali samo nintedanib, o navzei so poročali pri 22 (41,5 %) oz. 6 (11,8 %) bolnikih in o bruhanju pri 15 (28,3 %) oz. 6 (11,8 %) bolnikih.
English: Therapy with Ofev should be permanently discontinued in patients who develop gastrointestinal perforation.
Slovenian: Zdravljenje z zdravilom Ofev je treba trajno ukiniti pri bolnikih, pri katerih se pojavi predrtje prebavil.
English: Each 150 mg soft capsule contains 1.8 mg of soya lecithin.
Slovenian: Pomožna snov z znanim učinkom Ena 150 mg mehka kapsula vsebuje 1,8 mg sojinega lecitina.
English: In the pooled analysis of the INPULSIS trials, a numerically lower risk of first acute exacerbation was observed in patients receiving nintedanib compared to placebo.
Slovenian: V združeni analizi preskušanj INPULSIS je bilo tveganje opaženega prvega akutnega poslabšanja številčno manjše pri bolnikih, ki so prejemali nintedanib, v primerjavi s placebom.
English: In rabbits, embryo-foetal lethality and teratogenic effects were observed at an exposure approximately 3 times higher than at the MRHD but equivocal effects on the embryo-foetal development of the axial skeleton and the heart were noted already at an exposure below that at the MRHD of 150 mg twice daily.
Slovenian: Pri kuncih so smrtnost zarodka in ploda ter teratogene učinke opazili pri izpostavljenosti, ki je bila približno 3-krat večja od največjega za ljudi priporočenega odmerka, vendar so vprašljiveučinke na razvoj aksialnega okostja in srca zarodka in ploda opazili že pri izpostavljenostih, manjših od največjega za ljudi priporočenega odmerka, 150 mg dvakrat na dan.
English: Renal failure (see section 4.4)
Slovenian: Bolezni sečil ledvična odpoved (glejte poglavje 4.4)
English: Myocardial infarction
Slovenian: Srčne bolezni miokardni infarkt
English: Frequency of patients with acute IPF exacerbations over 52 weeks and time to first exacerbation analysis based on investigator-reported events in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Slovenian: Preglednica 5: Pogostnost bolnikov z akutnimi poslabšanji IPF v 52. tednih in analiza časa do prvega poslabšanja na podlagi dogodkov, o katerih so poročali raziskovalci v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
English: Comparison vs placebo
Slovenian: Primerjava s placebom vrednost p
English: In case of persisting severe diarrhoea despite symptomatic treatment, therapy with Ofev should be discontinued.
Slovenian: Pri trdovratni hudi driski, ki se na simptomatsko zdravljenje ne odziva, je treba zdravljenje z zdravilom Ofev ukiniti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/979/001
English: The estimated hazard ratio of nintedanib versus placebo was 0.16 (95% CI 0.04, 0.71; p=0.0054).
Slovenian: Ocenjeno razmerje tveganja za nintedanib v primerjavi s placebom je bilo 0,16 (95 % IZ 0,04; 0,71; p=0,0054).
English: Frequency of patients with ≥ 10% absolute decline of FVC % predicted or death over 52 weeks and time to progression in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Slovenian: Preglednica 4: Pogostnost bolnikov z ≥ 10 % absolutnim poslabšanjem FVC ali smrtjo v 52. tednih in analiza časa do poslabšanja v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki - zdravljeni bolniki
English: Common side effects (may affect up to 1 in 10 people) - Vomiting - Loss of appetite - Weight loss - Bleeding - Rash - Headache
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - bruhanje - izguba apetita - zmanjšanje telesne mase - krvavitev - izpuščaj - glavobol
English: Two pack-sizes of Ofev 100 mg capsules are available:
Slovenian: Na voljo sta dve velikosti pakiranj zdravila Ofev 100 mg kapsule:
English: Group 2 received steady state treatment of 801 mg pirfenidone three times a day and had a PK profiling before and after at least 7 days of co-treatment with 150 mg nintedanib twice daily (N=17 patients treated).
Slovenian: Druga skupina je prejela 801 mg pirfenidona v stanju dinamičnega ravnovesja trikrat na dan; pri njej je bilo opravljeno farmakokinetično profiliranje pred sočasnim jemanjem 150 mg nintedaniba dvakrat na dan in vsaj 7 dni po tem (N = 17 zdravljenih bolnikov).
English: Nausea led to discontinuation of nintedanib in 2.0% of patients.
Slovenian: Zaradi navzee so ukinili zdravljenje z nintedanibom pri 2,0 % bolnikov.
English: The primary endpoint, rate of decline in FVC over 52 weeks was lower in the nintedanib arm (-0.060 L/year, N=84) than the placebo arm (-0.190 L/year, N=83).
Slovenian: Primarni opazovani dogodek, stopnja upada FVC v 52 tednih, je bil nižji v skupini z nintedanibom (-0,060 l/leto, N=84), kot v skupini s placebom (-0,190 l/leto, N=83).
English: From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily (see section 5.3).
Slovenian: Študije subkronične in kronične toksičnosti niso pokazale, da bi sistemska izpostavljenost, primerljiva izpostavljenosti največjemu priporočenemu odmerku pri ljudeh, 150 mg dvakrat na dan, imela škodljiv vpliv na sposobnost razmnoževanja pri podganjih samicah (glejte poglavje 5.3).
English: Ofev 150 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Slovenian: Zdravilo Ofev 150 mg mehke kapsule je na voljo v naslednjih velikostih pakiranj: - 30 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij - 60 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij
English: In rats, embryo-foetal lethality and teratogenic effects were observed at exposure levels below human exposure at the MRHD of 150 mg twice daily.
Slovenian: Pri podganah so smrtnost zarodka in ploda ter teratogene učinke opazili pri izpostavljenosti, manjši od izpostavljenosti ljudi pri največjem za ljudi priporočenem odmerku 150 mg dvakrat na dan.
English: See Table 2 for individual and pooled study results.
Slovenian: Za posamične in združene rezultate študij glejte preglednico 2.
English: Two pack-sizes of Ofev 150 mg capsules are available:
Slovenian: Na voljo sta dve velikosti pakiranj zdravila Ofev 150 mg kapsule:
English: Very common side effects (may affect more than 1 in 10 people) - Feeling sick (nausea) - Pain in the lower body (abdomen) - Abnormal liver test results.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - siljenje na bruhanje (navzea) - bolečine v spodnjem delu telesa (trebuhu) - nenormalne vrednosti jetrnih preiskav.
English: Nonserious epistaxis was the most frequent bleeding event.
Slovenian: Najpogostejša krvavitev je bila epistaksa, ki ni bila resna.
English: Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period.
Slovenian: V obdobju trženja zdravila so poročali o primerih predrtja prebavil, od katerih jih je bilo nekaj s smrtnim izidom.
English: In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group (3.53) than in the placebo group (4.96), with a difference between the treatment groups of -1.43 (95% CI: -3.09, 0.23; p=0.0923).
Slovenian: V združeni analizi preskušanj INPULSIS je bila ocenjena povprečna sprememba skupnega seštevka SGRQ od izhodišča do 52. tedna manjša v skupini z nintedanibom (3,53), kot v skupini s placebom (4,96), z razliko med skupinama zdravljenja -1,43 (95 % IZ: -3,09;
English: Do not store Ofev above 25°C.
Slovenian: Zdravilo Ofev shranjujte pri temperaturi do 25 °C.
English: In case of persisting severe symptoms therapy with Ofev should be discontinued.
Slovenian: Pri trdovratnih simptomih je treba zdravljenje z zdravilom Ofev ukiniti.
English: Printing ink shellac glaze iron oxide black (E172) propylene glycol (E1520)
Slovenian: Tiskarsko črnilo glazura iz šelaka črni železov oksid (E172) propilenglikol (E1520)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/979/003
English: Do not take more than the recommended dose of two Ofev 150 mg capsules per day.
Slovenian: Ne vzemite večjega odmerka od priporočenega, to je dveh kapsul po 150 mg zdravila Ofev na dan.
English: Ofev 100 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Slovenian: Zdravilo Ofev 100 mg mehke kapsule je na voljo v naslednjih velikostih pakiranj: - 30 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij - 60 x 1 mehka kapsula v perforiranem enoodmernem pretisnem omotu aluminij/aluminij
English: No increased frequency of impaired wound healing was observed in the INPULSIS trials.
Slovenian: V preskušanjih INPULSIS niso opazili večje pogostnosti slabšega celjenja ran.
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 zvečanju jetrnih encimov.
English: Nausea and vomiting
Slovenian: Navzea in bruhanje
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Slovenian: Učinki prenašalca in precejšnja presnova med prvim prehodom zmanjšata absorpcijo in biološko uporabnost.
English: Summary of ADRs per frequency category Frequency System Organ Class
Slovenian: Preglednica 1: Povzetek neželenih učinkov po kategorijah pogostnosti Pogostnost
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Hyperbilirubinaemia, Blood alkaline phosphatase (ALKP) increased
Slovenian: poškodba jeter zaradi zdravila, hiperbilirubinemija, zvečana vrednost alkalne-fosfataze v krvi (ALKP)
English: Once transaminases have returned to baseline values, treatment with Ofev may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (see section 4.2).
Slovenian: Ko se aminotransferaze vrnejo na izhodiščne vrednosti, se lahko zdravljenje z zdravilom Ofev nadaljuje s polnim odmerkom (150 mg dvakrat na dan) ali z zmanjšanim odmerkom (100 mg dvakrat na dan), nato pa postopoma zvišuje do polnega odmerka (glejte poglavje 4.2).
English: In patients with mild hepatic impairment (Child Pugh A), the recommended dose of Ofev is 100 mg twice daily approximately 12 hours apart.
Slovenian: Izpostavljenost se je povečala pri bolnikih z jetrno okvaro (Child Pugh A, Child Pugh B; glejte poglavje 5.2).Pri bolnikih z blago jetrno okvaro (Child Pugh A) je priporočeni odmerek zdravila Ofev 100 mg dvakrat dnevno na približno 12 ur.
English: Age
Slovenian: Starost
English: Breast-feeding should be discontinued during treatment with Ofev.
Slovenian: Med zdravljenjem z zdravilom Ofev je treba prenehati z dojenjem.
English: Diarrhoea, Nausea, Abdominal pain
Slovenian: Bolezni prebavil driska, navzea, bolečine v trebuhu bruhanje pankreatitis kolitis
English: See Table 3 for individual and pooled study results.
Slovenian: Za posamične in združene rezultate študij glejte preglednico 3.
English: Pruritus, Alopecia
Slovenian: Bolezni kože in podkožja izpuščaj pruritus, alopecija
English: Due to the mechanism of action of nintedanib patients might have an increased risk of gastrointestinal perforation.
Slovenian: Zaradi mehanizma delovanja nintedaniba je lahko pri bolnikih tveganje za predrtje prebavil večje.
English: Ofev 150 mg soft capsules
Slovenian: Ofev 150 mg mehke kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla
English: Pre-clinical 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: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Slovenian: Preglednica 2: Letna stopnja upada FVC (ml) v preskušanjih INPULSIS-1, INPULSIS-2 in združeni podatki -zdravljeni bolniki
English: Not known
Slovenian: Neznana pogostnost
English: Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid = twice daily
Slovenian: Povprečna (SEM) opažena sprememba FVC od izhodišča (ml) glede na čas, združeni študiji INPULSIS-1 in INPULSIS-2
English: Diarrhoea and vomiting accompanied by reduced food consumption and loss of body weight were observed in toxicity studies in non-rodents.
Slovenian: V študijah toksičnosti pri neglodalcih so zasledili drisko in bruhanje, ki sta ju spremljala zmanjšan vnos hrane in izguba telesne mase.
English: How to store Ofev
Slovenian: Shranjevanje zdravila Ofev
English: Body weight
Slovenian: Telesna masa
English: th percentile) and decreased by 19% for a 100 kg patient th percentile) relative to a patient with the median weight of 71.5 kg.
Slovenian: Vrednost AUCτ,ss se je povečala za 25 % pri 50-kilogramskem bolniku (5. percentil) in zmanjšala za 19 % pri 100-kilogramskem (95. percentil) glede na tiste s srednjo telesno maso 71,5 kg.
English: Ofev 100 mg soft capsules
Slovenian: Ofev 100 mg mehke kapsule
English: Do not take more than the recommended dose of two Ofev 100 mg capsules per day.
Slovenian: Ne vzemite večjega odmerka od priporočenega, to je dveh kapsul po 100 mg zdravila Ofev na dan.
English: Drug induced liver injury,
Slovenian: Zapleti s celjenjem rane