natgillin/translations-raw huggingface dataset:
As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply.
Brazgotine posledično zmanjšajo sposobnost prenosa kisika iz pljuč v krvni obtok, zato postane globoko dihanje težavno.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Serum albumin is considered to be the major binding protein.
Smatra se, da je albumin v serumu najpomembnejša vezavna beljakovina.
Ofev should only be initiated at least 4 weeks after abdominal surgery.
Zdravilo Ofev se lahko uvede najmanj 4 tedne po abdominalni operaciji.
As nintedanib may cause foetal harm also in humans, it must not be used during pregnancy.
Ker lahko nintedanib tudi pri ljudeh poškoduje plod, se ga med nosečnostjo ne sme uporabljati.
These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Te spremembe so poznane pri drugih zaviralcih VEGFR-2 in jih smatrajo kot učinek skupine zdravil.
Other medicines and Ofev
Druga zdravila in zdravilo Ofev
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano dne
At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately.
Pri prvih znakih driske spijte veliko tekočine in se takoj posvetujte z zdravnikom.
Based on a Cox's regression model.
Na podlagi Coxovega regresijskega modela.
The European Medicines Agency has waived the obligation to submit the results of studies with Ofev in all subsets of the paediatric population in IPF (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ofev za vse podskupine pediatrične populacije z IPF (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
OTHER Do not open before use.
DRUGI PODATKI Pred uporabo ne odpirajte.
Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Ne uporabljajte tega zdravila, če opazite, da je pretisni omot, ki vsebuje kapsule odprt, ali če je kapsula zlomljena.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
The recommended maximum daily dose of 300 mg should not be exceeded.
Ne sme se prekoračiti največjega priporočenega dnevnega odmerka 300 mg.
Women of childbearing potential / Contraception
Ženske v rodni dobi/kontracepcija
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Uporaba zaviralcev poti VEGF pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
4.1 Therapeutic indications
4.1 Terapevtske indikacije
The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Varnost in učinkovitost zdravila Ofev pri otrocih, starih 0 do 18 let, nista bili dokazani.
What Ofev is and what it is used for
Kaj je zdravilo Ofev in za kaj ga uporabljamo
Alternative causes of the liver enzyme elevations should be investigated.
Raziskati je treba alternativne vzroke za zvečane jetrnih encimov.
In patients with missing data, the primary analysis assumes that the decline in FVC after the last observed value would be similar to the decline in other patients in the same treatment group.
Za bolnike z manjkajočimi podatki so v primarni analizi domnevali, da bo upad FVC po zadnji opaženi vrednosti podoben upadu pri drugih bolnikih v isti zdravljeni skupini.
There is no specific antidote or treatment for Ofev overdose.
Specifičnega antidota ali zdravljenja za preveliko odmerjanje zdravila Ofev ni.
Very common
Zelo pogosti
Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Tega zdravila ne jemljite med nosečnostjo, ker lahko škoduje še nerojenemu otroku in povzroči prirojene okvare.
Do not reduce the dose or stop the treatment by yourself without consulting your doctor first.
Sami pa ne zmanjšajte odmerka in ne opustite zdravljenja, ne da bi se prej posvetovali z zdravnikom.
In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events.
Zaradi omejenega števila bolnikov je ta študija odkrila le najpogostejše neželene učinke in pokazala povečano število neželenih učinkov prebavil in trend povečanja števila jetrnih neželenih učinkov.
Before initiating Ofev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila Ofev je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
Administration of Ofev may increase blood pressure.
Dajanje zdravila Ofev lahko zviša krvni tlak.
The results of all survival endpoints (such as on-treatment mortality and respiratory mortality) showed a consistent numerical difference in favour of nintedanib.
Rezultati vseh opazovanih dogodkov preživetja (kot so smrtnost med zdravljenjem in smrtnost zaradi dihal) je pokazala dosledno številčno razliko v korist nintedaniba.
Exposure to nintedanib increased linearly with age.
Izpostavljenost nintedanibu se je večala linearno s starostjo.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC:
Children and adolescents Ofev should not be taken by children and adolescents under 18 years of age.
Otroci in mladostniki Otroci in mladostniki, stari manj kot 18 let, ne smejo jemati zdravila Ofev.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. januar 2015 Datum zadnjega podaljšanja: 23. september 2019
You should discuss the most appropriate methods of contraception for you with your doctor.
O kontracepcijskih metodah, ki so za vas najustreznejše, se morate pogovoriti z zdravnikom.
Based on the high inter-individual variability of exposure observed moderate effects are considered not clinically relevant (see section 4.4).
Na podlagi velike variabilnosti izpostavljenosti med posamezniki opaženi zmerni učinki ne veljajo za klinično pomembne (glejte poglavje 4.4).
The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
Kapsule je treba zaužiti s hrano, pogoltniti cele z vodo; ne sme se jih žvečiti ali drobiti.
Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days.
Dva bolnika v programu onkologije sta dobivala prevelik odmerek do največ 600 mg dvakrat na dan do osem dni.
Estimated based on a random coefficient regression model.
Ocenjeno na podlagi koeficienta naključnega regresijskega modela.
Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF.
Nintedanib so proučili v kliničnih preskušanjih s 1.529 bolniki z IPF.
Soft capsule (capsule).
mehka kapsula (kapsula)
Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding.
Zaviranje receptorja vaskularnega endotelijskega rastnega faktorja (VEGFR-vascular endothelial growth factor receptor) lahko poveča tveganje za krvavitev.
PHARMACEUTICAL FORM AND CONTENTS 30 x 1 soft capsules
FARMACEVTSKA OBLIKA IN VSEBINA 30 x 1 mehka kapsula
If a patient does not tolerate 100 mg twice daily, treatment with Ofev should be discontinued.
Če bolnik ne prenaša odmerka po 100 mg dvakrat na dan, je treba zdravljenje z zdravilom Ofev ukiniti.
Do not use this medicine after the expiry date which is stated on the carton and the blister.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
The majority of hepatic events occur within the first three months of treatment.
Večina jetrnih dogodkov se je pojavila v prvih treh mesecih zdravljenja.
A pre-specified sensitivity analysis of the time to first 'confirmed' or 'suspected' adjudicated acute IPF exacerbation was performed on the pooled data.
Vnaprej specificirano analizo občutljivosti časa do prve "potrditve" akutnega poslabšanja IPF ali "suma" nanj so izvedli z združenimi podatki.
Do not stop taking Ofev without consulting your doctor first.
Zdravila Ofev ne prenehajte jemati, ne da bi se prej posvetovali z zdravnikom.
AUCτ,ss decreased by 16% for a 45-year old patient and increased by 13% for a 76-year old patient relative to a patient with the median age of 62 years.
Vrednost AUCτ,ss se je zmanjšala za 16 % pri 45-letnem bolniku in povečala za 13 % pri 76-letnem bolniku v primerjavi z bolnikom s srednjo starostjo 62 let.
In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see sections 4.4 and 4.8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.
Poleg simptomatskega zdravljenja, če je potrebno, lahko obravnava neželenih učinkov pri zdravilu Ofev (glejte poglavji 4.4 in 4.8) vključuje zmanjšanje odmerka in začasno prekinitev, dokler specifični neželeni učinek ne bo izzvenel do ravni, ki omogoča nadaljevanje zdravljenja.
The same applies for nintedanib being a substrate of OCT-1.
Enako velja za nintedanib kot substrat OCT-1.
Number of analysed patients
Število analiziranih bolnikov Ocena
Nintedanib is preferentially distributed in plasma with a blood to plasma ratio of 0.869.
Nintedanib se prednostno porazdeljuje v plazmi z razmerjem med krvjo in plazmo 0,869.
FVC responder analysis
Analiza odzivnih FVC
IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time.
IPF je stanje, pri katerem se tkivo v pljučih zadebeli, postane togo in sčasoma zabrazgotinjeno.
Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Vendar je verjetneje, da bodo bolniki, stari 75 let ali več, potrebovali zmanjšanje odmerka za obvladovanje neželenih učinkov (glejte poglavje 5.2).
Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations (see section 5.2).
Izpostavljenost nintedanibu se linearno veča z bolnikovo starostjo, kar lahko povzroči večje tveganje za povečanje ravni jetrnih encimov (glejte poglavje 5.2).
Mild liver enzyme increases, which were not due to serious adverse effects such as diarrhoea were only observed in Rhesus monkeys.
Blaga zvečanja jetrnih encimov, ki niso posledica resnih neželenih učinkov, kot je driska, so opazili le pri opicah Rhesus.
The pharmacokinetics (PK) of nintedanib can be considered linear with respect to time (i.e. singledose data can be extrapolated to multiple-dose data).
Farmakokinetiko nintedaniba je mogoče smatrati kot linearno glede na čas (to pomeni, da je podatke o enkratnem odmerku mogoče ekstrapolirati na podatke za večkratne odmerke).
Patients should be advised to be cautious when driving or using machines during treatment with Ofev.
Bolnikom je treba svetovati, naj bodo med vožnjo ali upravljanjem s stroji med zdravljenjem z zdravilom Ofev previdni.
Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anticoagulative treatment were not included in the INPULSIS studies.
Bolniki z znanim tveganjem za krvavitve, vključno z bolniki z dedno nagnjenostjo h krvavitvam ali tisti, ki so pred začetkom zdravljenja z zdravilom prejemali polne odmerke antikoagulantov, niso bili vključeni v študije INPULSIS.
The benefit-risk balance of concomitant treatment with pirfenidone has not been established.
Razmerje med koristjo in tveganjem sočasnega zdravljenja s pirfenidonom ni bilo ugotovljeno.
Diarrhoea (very common, may affect more than 1 in 10 people):
Driska (zelo pogosta, pojavijo se lahko pri več kot 1 od 10 bolnikov):
Concomitant treatment with pirfenidone
Sočasno zdravljenje s pirfenidonom
For further information about special populations, recommended measures and dosing adjustments in case of diarrhoea and hepatic enzyme increased, refer additionally to sections 4.4 and 4.2, respectively.
Za nadaljnje informacije o posebnih populacijah, priporočene ukrepe in prilagajanje odmerjanja v primeru driske in zvečane vrednosti jetrnih encimov glejte poglavji 4.4 in 4.2.
A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events.
Neželeni učinek, ki ni bil ocenjen kot resen (nazofaringitis) se je pojavil in razrešil v obdobju nepravilnega odmerjanja, o drugih neželenih učinkih pa niso poročali.
Treatment with Ofev should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Zdravilo Ofev je zato dovoljeno uvesti ali v primeru perioperativne prekinitve nadaljevati njegovo jemanje le na podlagi klinične ocene ustreznega celjenja rane.
In the INPULSIS trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days.
V preskušanju INPULSIS je bil en bolnik nenamerno izpostavljen odmerku 600 mg na dan skupaj 21 dni.
Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body.
Driska lahko povzroči dehidracijo, tj. izgubo tekočine in pomembnih soli (elektrolitov, kot sta natrij in kalij) iz telesa.
They should be advised to use adequate contraception during and at least 3 months after the last dose of Ofev.
Svetovati jim je treba, naj med zdravljenjem z zdravilom Ofev in še najmanj 3 mesece po zadnjem odmerku uporabljajo ustrezno kontracepcijo.
All adverse events of acute IPF exacerbation reported by the investigator were adjudicated by a blinded adjudication committee.
Vse neželene dogodke akutnega poslabšanja IPF, o katerih so poročali raziskovalci, je ocenila zakrita komisija za vrednotenje.
Nintedanib reached maximum plasma concentrations approximately 2 - 4 h after oral administration as soft gelatine capsule under fed conditions (range 0.5 - 8 h).
Nintedanib je dosegel največje koncentracije v plazmi približno 2 do 4 ure po zaužitju mehke želatinske kapsule na tešče (razpon 0,5 do 8 ur).
The potential impact of VEGFR inhibition by nintedanib and the antiangiogenic activity of nintedanib on IPF pathology are currently not fully elucidated.
Možni vpliv zaviranja VEGFR z nintedanibom in antiangiogenska aktivnost nintedaniba na patologijo IPF trenutno niso povsem pojasnjeni.
Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease.
Pri zdravljenju bolnikov z večjim srčnožilnim tveganjem, vključno z znano koronarno arterijsko boleznijo, je potrebna previdnost.
What you need to know before you take Ofev
Kaj morate vedeti, preden boste vzeli zdravilo Ofev
Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Za vsako skupino pogostnosti so neželeni učinki prikazani po padajoči resnosti.
Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling.
Nintedanib se kompetitivno veže na vezavno mesto adenozin trifosfata (ATP) teh receptorjev in zavira znotrajcelično signaliziranje.
You should take your next 100mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.
Naslednji 100 mg odmerek zdravila Ofev vzemite ob naslednjem načrtovanem času, ki ga priporoča zdravnik ali farmacevt.
Therefore treatment with Ofev is not recommended in such patients (see section 4.2).
Zato zdravljenje z zdravilom Ofev za te bolnike ni priporočljivo (glejte poglavje 4.2).
See leaflet for further information.
Za več informacij glejte navodilo za uporabo.
As some other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when nintedanib is administered in patients who may develop QTc prolongation.
Ker je znano, da nekateri drugi zaviralci tirozin-kinaze učinkujejo na interval QT, je potrebna previdnost pri dajanju nintedaniba bolnikom, pri katerih se lahko razvije podaljšanje intervala QTc.
The terminal half-life of nintedanib was between 10 and 15 h (gCV % approximately 50%).
Končni razpolovni čas nintedaniba je bil med 10 in 15 urami (gCV % približno 50 %).
Responder patients are those with no absolute decline greater than 5% or greater than 10% in FVC % predicted, depending on the threshold and with an FVC evaluation at 52 weeks.
Odzivni bolniki so tisti brez absolutnega upada nad 5 % ali več kot 10 % napovedane FVC %, odvisno od praga, z ocenitvijo FVC pri 52 tednih.
If transaminase (AST or ALT) elevations > 3x ULN are measured, dose reduction or interruption of the therapy with Ofev is recommended and the patient should be monitored closely.
Če so izmerjene vrednosti aminotransferaz (AST ali ALT) > 3 x ULN, se priporoča zmanjšanje odmerka ali prekinitev zdravljenja z zdravilom Ofev, bolnika pa je treba natančno spremljati.
Overall, the effect of nintedanib on health-related quality of life as measured by the SGRQ total score is modest, indicating less worsening compared to placebo.
Na splošno je bil učinek nintedaniba na z zdravjem povezano kakovost življenja, izmerjene kot skupni seštevek SGRQ, skromen, kar kaže na manjše poslabšanje kot pri placebu.
Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Pri bolnikih z znano alergijo na arašidove beljakovine je tveganje za resne reakcije na izdelke s sojo povečano.
Nintedanib trough concentrations remained stable for more than one year.
Najmanjše koncentracije nintedaniba so ostale stabilne več kot eno leto.
The absolute bioavailability of a 100 mg dose was 4.69% (90% CI: 3.615 - 6.078) in healthy volunteers.
Absolutna biološka uporabnost odmerka 100 mg je bila 4,69 % (90-odstotni IZ: 3,615 do 6,078) pri zdravih prostovoljcih.
Accumulation upon multiple administrations was 1.04-fold for Cmax and 1.38-fold for AUCτ.
Kopičenje po večkratnem dajanju je bilo 1,04-kratno za Cmax in 1,38-kratno za AUCτ.
Only a weak inhibitory potential on OCT-1, BCRP, and P-gp was observed in vitro which is considered to be of low clinical relevance.
In vitro so opazili le šibek zaviralni potencial na OCT-1, BCRP in P-gp, za katerega velja, da je klinično le malo pomemben.
p-value
vrednost p
Annual rate of decline in FVC
Letna stopnja upada FVC
More than two thirds of patients experiencing diarrhoea reported its first onset already during the first three months of treatment.
Več kot dve tretjini bolnikov, ki so imeli drisko, je o prvem pojavu driske poročalo že v prvih treh mesecih zdravljenja.
Take the capsules twice daily approximately 12 hours apart at about the same time every day, for example one capsule in the morning and one capsule in the evening.
Kapsule jemljite dvakrat na dan s približno 12-urnim časovnim presledkom ob približno istem času dneva, na primer eno kapsulo zjutraj in eno zvečer.
Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90%).
Nintedanib se pretežno izloča z žolčem/blatom (> 90 %).
Nintedanib was shown to be not a substrate or inhibitor of OATP-1B1, OATP-1B3, OATP-2B1, OCT-2, or MRP-2 in vitro.
Pokazalo se je, da nintedanib in vitro ni substrat ali zaviralec OATP-1B1, OATP-1B3, OATP-2B1, OCT-2 ali MRP-2; niti ni substrat BCRP.
The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8%.
Vezava nintedaniba na beljakovine v plazmi je bila in vitro velika, z vezanim deležem kar 97,8 %.
The estimated mean change from baseline in SGRQ total score at 52 weeks was 5.46 for placebo, indicating worsening of the health-related quality of life and -0.66 for nintedanib, indicating stable health-related quality of life.
Ocenjena povprečna sprememba skupnega seštevka SGRQ od izhodišča pri 52 tednih je bila 5,46 za placebo, kar kaže na slabšanje z zdravjem povezane kakovosti življenja, in -0,66 za nintedanib, kar kaže na stabilno z zdravjem povezano kakovost življenja.
Take the capsules 12 hours apart at about the same time every day, for example one capsule in the morning and one capsule in the evening.
Kapsule jemljite s približno 12-urnim časovnim presledkom vsak dan ob približno istem času, na primer eno kapsulo zjutraj in eno zvečer.
Ofev helps to reduce scarring and stiffening of the lungs.
Zdravilo Ofev pomaga zmanjšati zabrazgotinjenost in togost pljuč.
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Preobčutljivost na nintedanib, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
Nintedanib is a substrate of P-gp.
Nintedanib je substrat P-gp.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili rastlinskega izvora in zdravili, ki ste jih dobili brez recepta.
In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
V študijah toksičnosti po ponavljajočih se odmerkih pri podganah so bili neželeni učinki (npr. odebelitev epifiznih ploščic, lezije sekalcev) večinoma povezani z mehanizmom delovanja (tj. z zaviranjem VEGFR-2) nintedaniba.
Genotoxicity studies indicated no mutagenic potential for nintedanib.
Študije genotoksičnosti ne kažejo na mutageni potencial nintedaniba.
Population pharmocokinetic analysis in special populations The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, and cancer patients.
Analiza populacijske farmokokinetike pri posebnih populacijah Farmakokinetične lastnosti nintedaniba so bile pri zdravih prostovoljcih podobne kot pri bolnikih z IPF in bolnikih z rakom.
Since the effect of nintedanib on the metabolism and efficacy of hormonal 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 hormonskih kontraceptivov niso proučevali, je treba za preprečevanje nosečnosti kot drugo obliko kontracepcije uporabiti še pregradno metodo.
NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim (logotip)