FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma in cancer patients given everolimus 10 mg/day.
Croatian: U bolesnika oboljelih od raka liječenih everolimusom u dozi od 10 mg/dan, približno 20% koncentracije everolimusa u punoj krvi bilo je ograničeno na plazmu.
English: Hazard Ratio = 0.45 95% CI [0.38, 0.54]
Croatian: Omjer hazarda = 0,45 95% CI [0,38, 0,54]
English: • High level of sugar in the blood (hyperglycaemia)
Croatian: • Visoka razina šećera u krvi (hiperglikemija)
English: If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o Afinitoru ili zašto
English: • Tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells (anaemia)
Croatian: • Umor, nedostatak zraka, omaglica, bljedilo kože, znakovi niske razine crvenih krvnih stanica
English: Male fertility Afinitor may affect male fertility.
Croatian: Afinitor može utjecati na plodnost muškarca.
English: In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
Croatian: Ukupno je bilo randomizirano 410 bolesnika u odnosu 1:1 u skupinu koja je primala Afinitor 10 mg/dan (n=207) ili u skupinu koja je primala placebo (n=203).
English: Wound healing complications
Croatian: Komplikacije pri cijeljenju rane
English: • Mouth ulcers
Croatian: • Suha usta
English: Hazard Ratio = 0.33 95% CI [0.25, 0.43]
Croatian: Omjer hazarda = 0,33 95% CI [0,25, 0,43]
English: Figure 4 RADIANT-4 - Kaplan-Meier progression-free survival curves (independent radiological review)
Croatian: Slika 4 RADIANT-4 - Kaplan-Meierove krivulje preživljenja bez progresije bolesti (neovisna radiološka procjena)
English: Afinitor 5 mg tablets everolimus
Croatian: Afinitor 5 mg tablete everolimus
English: Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Croatian: Neuroendokrini tumori s primarnim sijelom u gušterači Afinitor je indiciran za liječenje neresektabilnih ili metastatskih, dobro ili umjereno diferenciranih neuroendokrinih tumora s primarnim sijelom u gušterači, u odraslih bolesnika s progresivnom bolešću.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte (mogu se javiti kod do 1 na 100 osoba)
English: EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Croatian: EU/1/09/538/009 30 tableta EU/1/09/538/010 90 tableta
English: Common (may affect up to 1 in 10 people)
Croatian: Česte (mogu se javiti kod do 1 na 10 osoba)
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 4 and Figure 1).
Croatian: Rezultati djelotvornosti za mjeru primarnog ishoda dobiveni su iz završene analize preživljenja bez progresije bolesti (vidjeti Tablicu 4 i Sliku 1).
English: Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Croatian: Afinitor 5 mg tablete EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
English: Afinitor 10 mg tablets EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Croatian: Afinitor 10 mg tablete EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
English: • Dry mouth
Croatian: • Ranice u ustima
English: Baseline NSE
Croatian: Početni NSE
English: Tumour grading Liver tumour burden
Croatian: Gradus tumora Tumorsko opterećenje jetre Početni CgA
English: Common Dyspnoea Uncommon Haemoptysis, pulmonary embolism Rare
Croatian: Manje često Hemoptiza, plućna embolija
English: Common Vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, dyspepsia,
Croatian: Povraćanje, suha usta, bolovi u abdomenu, upala sluznice, bol u ustima, dispepsija, disfagija Poremećaji jetre i žuči Često
English: • Low level of phosphate in the blood (hypophosphataemia)
Croatian: • Niska razina fosfata u krvi (hipofosfatemija)
English: Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Croatian: Svaka tableta Afinitora 2,5 mg sadrži 2,5 mg everolimusa.
English: Figure 3 RADIANT-3 - Kaplan-Meier progression-free survival curves (investigator radiological review)
Croatian: Slika 3 RADIANT-3 - Kaplan-Meierove krivulje preživljenja bez progresije bolesti (radiološka procjena od strane ispitivača)
English: • Coughing up blood (haemoptysis)
Croatian: • Iskašljavanje krvi (hemoptiza)
English: • Low level of calcium in the blood (hypocalcaemia)
Croatian: • Niska razina kalcija u krvi (hipokalcijemija)
English: Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Croatian: Svaka tableta Afinitora 10 mg sadrži 10 mg everolimusa.
English: Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Croatian: Omjer hazarda = 0,48 95% CI [0,35; 0,67]
English: Afinitor is an anticancer medicine containing the active substance everolimus.
Croatian: Afinitor je lijek koji sadrži djelatnu tvar everolimus i koristi se za liječenje raka.
English: Grade 2 Temporary dose interruption until recovery to Grade 1.
Croatian: Stupanj 2 Privremeni prekid primjene do oporavka do stupnja 1. Ponovno započeti liječenje u istoj dozi.
English: Figure 2 BOLERO-6 Kaplan-Meier progression-free survival curves (investigator radiological review)
Croatian: Slika 2 BOLERO-6 Kaplan-Meierove krivulje preživljenja bez progresije bolesti (radiološka procjena od strane ispitivača)
English: • Abnormal wound healing
Croatian: • Poremećeno zacjeljivanje rana
English: Uncommon Hypersensitivity
Croatian: Manje često Preosjetljivost
English: EU/1/09/538/007 10 tablets EU/1/09/538/001 30 tablets EU/1/09/538/003 90 tablets
Croatian: EU/1/09/538/007 10 tableta EU/1/09/538/001 30 tableta EU/1/09/538/003 90 tableta
English: Each tablet contains 2.5 mg everolimus.
Croatian: Svaka tableta sadrži 2,5 mg everolimusa.
English: EU/1/09/538/008 10 tablets EU/1/09/538/004 30 tablets EU/1/09/538/006 90 tablets
Croatian: EU/1/09/538/008 10 tableta EU/1/09/538/004 30 tableta EU/1/09/538/006 90 tableta
English: Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Croatian: Svaka tableta Afinitora 5 mg sadrži 5 mg everolimusa.
English: Absence of menstrual periods (amenorrhoea) has been observed in some female patients receiving Afinitor.
Croatian: U nekih bolesnica koje su primale Afinitor zabilježen je izostanak menstruacija (amenoreja).
English: No increase in adverse reactions related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
Croatian: U bolesnica s uznapredovalim rakom dojke pozitivnim na hormonske receptore koje su primale spomenutu kombinaciju nije uočen povećani broj nuspojava povezanih s eksemestanom.
English: • Difficulty in swallowing (dysphagia)
Croatian: • Teškoće s gutanjem (disfagija)
English: Each tablet contains 10 mg everolimus.
Croatian: Svaka tableta sadrži 10 mg everolimusa.
English: Musculoskeletal and connective tissue disorders Common Arthralgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često
English: If toxicity recurs at Grade 2, interrupt treatment until recovery to Grade 1.
Croatian: Ako se vrati toksičnost stupnja 2, prekinuti liječenje do oporavka do stupnja 1. Ponovno započeti liječenje u dozi od 5 mg dnevno.
English: • Low level of potassium in the blood (hypokalaemia)
Croatian: • Niska razina kalija u krvi (hipokalijemija)
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Croatian: Ako se vrati stomatitis stupnja 2, prekinuti primjenu do oporavka do stupnja 1. Ponovno započeti liječenje u dozi od 5 mg dnevno.
English: Secondary endpoints included overall survival (OS), objective response rate, clinical benefit rate, safety, change in quality of life (QoL) and time to ECOG PS (Eastern Cooperative Oncology Group performance status) deterioration.
Croatian: Sekundarni ishodi ispitivanja uključivali su ukupno preživljenje, stopu objektivnog odgovora, stopu kliničke dobiti, sigurnost primjene, promjenu u kvaliteti života i vrijeme do pogoršanja općeg stanja prema ECOG-u.
English: Each tablet contains 5 mg everolimus.
Croatian: Svaka tableta sadrži 5 mg everolimusa.
English: Afinitor 10 mg tablets Packs containing 10, 30 or 90 tablets.
Croatian: Pakiranja sadrže 10, 30 ili 90 tableta.
English: if you have diabetes (high level of sugar in your blood).
Croatian: U tom slučaju liječnik će Vam možda propisati drugačiju dozu Afinitora. ako imate šećernu bolest (visoke razine šećera u krvi).
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by Response Evaluation Criteria in Solid Tumors (RECIST), based on independent radiology assessment.
Croatian: Primarni ishod ispitivanja je bilo preživljenje bez progresije bolesti, prema RECIST kriterijima, procijenjeno kroz slijepu neovisnu centralnu procjenu.
English: General disorders and administration site conditions Very common Fatigue, asthenia, oedema peripheral Common Pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često Umor, astenija, periferni edem Često
English: Cases of PJP/PCP, some with fatal outcome, have been reported in patients who received everolimus.
Croatian: U bolesnika koji su primali everolimus prijavljeni su slučajevi PJP/PCP, ponekad sa smrtnim ishodom.
English: Prior SSA
Croatian: Prethodni SSA
English: advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.
Croatian: Daje se ako se tumori ne mogu kirurški liječiti (neoperabilni) i ako ne stvaraju specifične hormone ili druge s njim povezane prirodne tvari u prevelikoj količini. uznapredovali rak bubrega (uznapredovali rak bubrežnih stanica) kada drugi lijekovi (zvani "VEGF-ciljana terapija") nisu pomogli u zaustavljanju bolesti.
English: What Afinitor looks like and contents of the pack Afinitor 2.5 mg tablets are white to slightly yellowish, elongated tablets.
Croatian: Afinitor 2,5 mg tablete su bijele do žućkaste izduljene tablete.
English: Grade 3 Temporary dose interruption until recovery to Grade 1.
Croatian: Stupanj 3 Privremeni prekid primjene do oporavka do stupnja 1. Ponovno započeti liječenje u dozi od 5 mg dnevno.
English: • Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, possibly due to a type of anaemia called pure red cell aplasia)
Croatian: • Umor, nedostatak zraka, omaglica, bljedilo kože (znakovi niske razine crvenih krvnih stanica,
English: These medicines should be avoided during your treatment with Afinitor.
Croatian: Tijekom liječenja Afinitorom, gore navedene lijekove potrebno je izbjegavati.
English: • Skin rash
Croatian: • Osip na koži
English: Neuroendocrine tumours of pancreatic origin
Croatian: Prognostički čimbenici kod neuroendokrinih tumora s primarnim sijelom u probavnom sustavu ili plućima
English: In favour of
Croatian: U prilog
English: Caution should therefore be exercised with the use of Afinitor in the peri-surgical period.
Croatian: Potreban je oprez pri primjeni Afinitora neposredno prije i poslije kirurškog zahvata.
English: The estimated PFS treatment effect was supported by planned subgroup analysis of PFS per investigator assessment.
Croatian: Procjenu učinka liječenja na preživljenje bez progresije bolesti podupiru i rezultati analize preživljenja bez progresije bolesti u planiranim podskupinama prema ocjeni ispitivača.
English: INN Pharmaceutical form
Croatian: INN Farmaceutski oblik
English: The referral procedure started on 15 September 2011.
Croatian: Postupak upućivanja započet je dana 15. rujna 2011. godine.
English: CVMP conclusion after re-examination
Croatian: Zaključak CVMP-a nakon ponovne procjene
English: The detailed grounds for the re-examination were submitted on 10 June 2013.
Croatian: Detaljni razlozi za ponovnu procjenu predani su 10. lipnja 2013.
English: However, the evaluation of consumer safety concerns needs to consider all possible adverse effects (not only the most severe), and these are unlikely to be detected by pharmacovigilance systems.
Croatian: Međutim, procjena sigurnosti potrošača treba uzeti u obzir sve moguće nuspojave (ne samo najozbiljnije), a nije vjerojatno da se iste mogu otkriti sustavom farmakovigilancije.
English: Thus the figure of 5% bioavailability is still considered appropriate for use in residue calculations;
Croatian: Stoga se brojčana vrijednost bioraspoloživosti od 5% još uvijek smatra odgovarajućom za upotrebu u izračunu rezidua;
English: It could only be considered that the data obtained in this study do not contradict the in vitro data.
Croatian: Može se samo smatrati da podaci dobiveni u ovom ispitivanju nisu kontradiktorni s in vitro podacima.
English: This figure is much higher than what was assumed when the MRL decision was taken.
Croatian: Ova je brojka znatno veća od pretpostavki iznijetih prilikom donošenja odluke o MRL-u.
English: Residues recovered from the injection site in cattle were in the range from 77% to 99% of the injected doses at 30 to 119 days following injection.
Croatian: Rezidui otkriveni u mjestu davanja injekcije u goveda nalazili su se unutar raspona od 77 % do 99 % injektiranih doza u razdoblju od 30. do 119. dana nakon injekcije.
English: The appropriateness of the covered time period needs to be justified and advice provided on identification and removal of the contaminated injection site area.
Croatian: Prikladnost pokrivenog vremenskog razdoblja treba opravdati te dati savjet o identifikaciji i uklanjanju zaraženog područja injekcije.
English: However, in this case no data on acute toxicity using more sensitive acute endpoints were available.
Croatian: No, u ovom slučaju ne postoje podaci o akutnoj toksičnosti uz primjenu osjetljivijih akutnih krajnjih točaka.
English: Re-examination procedure
Croatian: Postupak ponovne procjene
English: The marketing authorisation holders should provide data and propose measures that will ensure consumer safety following use of the products and in particular:
Croatian: Nositelji odobrenja trebaju osigurati podatke i predložiti mjere koje će osigurati sigurnost potrošača nakon upotrebe proizvoda te posebice:
English: Considering that the lowest LD50 is less than 10 times the possible consumer's exposure it is obvious that also a fraction of an injection site might cause toxicity if ingested.
Croatian: Uzimajući u obzir da je najmanji LD50 manji od 10 puta mogućeg izlaganja potrošača, očito je da također dio u mjestu injekcije može uzrokovati toksičnost ako se ingestira.
English: National Competent Authorities, coordinated by a reference Member State, shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Croatian: Nadležna nacionalna tijela koja koordinira referentna država članica pobrinut će se da nositelji odobrenja ispune sljedeći uvjet:
English: In the EU presence of harmful residues in food in concentrations above the level considered as safe is not permissible.
Croatian: U EU nije dopustiva prisutnost štetnih rezidua u hrani u koncentracijama većima od razina koje se smatraju sigurnima.
English: In general, as in this case, absence of pharmacovigilance data cannot be used as justification of the absence of any adverse effects in consumers.
Croatian: Općenito kao u i u ovom slučaju, odsustvo farmakovigilancijskih podataka ne može poslužiti kao opravdanje za izostanak bilo kojih nuspojava u potrošača.
English: Strength Animal species
Croatian: Jačina Životinjs ka vrsta
English: • injections containing sodium or potassium selenite, authorised for horses, cattle, sheep and pigs;
Croatian: • injekcije koje sadrže natrijev ili kalijev selenit, odobrene za konje, goveda, ovce i svinje;
English: The grounds for re-examination of the CVMP opinion of 10 April 2013 focused on the following arguments:
Croatian: Razlozi nositelja odobrenja za ponovnom procijenim mišljenja CVMP-a od 10. travnja 2013. godine usredotočili su se na sljedeće argumente:
English: Based on the data available at the time of the MRL evaluation it was assumed that the available fraction would be very low.
Croatian: Na temelju dostupnih podataka u trenutku procijene MRL-a, pretpostavljeno je da bi dostupan dio bio vrlo malen.
English: With regard to acute toxicity reference is made to studies measuring LD50 values.
Croatian: S obzirom na akutnu toksičnost navedena je referenca na ispitivanja koja su mjerila vrijednosti LD50.
English: Risk management measures
Croatian: Mjere upravljanja rizikom
English: Any health based reference value must be capable of reflecting non-serious adverse effects;
Croatian: Bilo koja referentna vrijednost za zdravlje mora moći odražavati i nuspojave koje nisu ozbiljne;
English: Due to their formulations, these alternative products for the treatment and prevention of disease relating to selenium deficiency are less convenient for some cases requiring treatment.
Croatian: Zbog njihovih formulacija, ovi alternativni VMP-ovi za liječenje i prevenciju bolesti povezanih s deficijencijom selena manje su praktični za određene slučajeve koji zahtijevaju liječenje.
English: In principle LD50 is not accepted as an endpoint from which calculations are made to estimate toxicity relevant for consumer risk assessments, acknowledging that the LD50 is a very severe endpoint (where half of the test animals die).
Croatian: Načelno, LD50 nije prihvaćen kao krajnja točka koja služi za izračune za potrebe procjene toksičnosti relevantne za ocjenu rizika za potrošače, čime se potvrđuje da je LD50 vrlo ozbiljna krajnja točka (u kojoj polovica testnih životinja umire).
English: The study also showed that even one year after treatment high amounts of selenium were found at the injection site (up to 53.229 mg/kg).
Croatian: Ispitivanjem je također utvrđeno da su čak i godinu dana nakon liječenja pronađene velike količine selena u mjestu injekcije (do 53,229 mg/kg).
English: Among available products, long acting injectables represent a convenient alternative but there are other possibilities including:
Croatian: Uz dostupne VMP-ove, injektabilni VMP-ovi predstavljaju praktičnu alternative, no postoje i druge mogućnosti uključujući:
English: • the CVMP considered that risk management measures to avoid injection site residues are currently not in place and could not be identified in this procedure due to a lack of information and sufficient data to evaluate such measures;
Croatian: • CVMP smatra da trenutno nema mjera upravljanja rizikom kako bi se izbjegli rezidui u mjestu injekcije i da se ne mogu identificirati u ovom postupku zbog nedovoljno informacija i nedostatnih podataka za procjenu takvih mjera;
English: Risk characterisation
Croatian: Karakterizacija rizika
English: The complete list of all veterinary medicinal products involved in this referral procedure is provided in annex I above.
Croatian: Potpuni popis svih veterinarsko-medicinskih proizvoda uključenih u ovaj postupak upućivanja dostavljen je u prethodno navedenom Dodatku I.
English: On 14 September 2011, the Federal Office of Consumer Protection and Food Safety of Germany submitted a notification for a referral procedure under Article 35 of Directive 2001/82/EC for all long acting formulations for injection containing barium selenate for all food producing species.
Croatian: Na dan 14. rujna 2011. godine, Savezni ured za zaštitu potrošača i sigurnost hrane Republike Njemačke podnio je zahtjev za postupak upućivanja pod člankom 35. Direktive 2001/82/EZ za sve dugodjelujuće formulacije za injekcije koje sadrže barijev selenat za sve vrste od kojih se proizvodi hrana.
English: Furthermore, while it is the case that the ADI is based on repeated exposure, the alternative threshold proposed by the marketing authorisation holders (i.e. the LD50) is not appropriate as this represents the value at which 50% mortality is expected.
Croatian: Nadalje, iako je činjenica da se ADI temelji na opetovanoj izloženosti, alternativna granica koju su predložili nositelji odobrenja (primjerice LD50) nije odgovarajuća jer predstavlja vrijednost pri kojoj se očekuje 50 %-tna smrtnost.
English: The indication of significant oral bioavailability was also supported by an in vivo study in sheep (Archer and Judson, 1994)3.
Croatian: Indikacija značajne peroralne bioraspoloživosti također je podržana in vivo ispitivanjem u ovaca (Archer i Judson, 1994)3.
English: List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene, karencije i nositelja odobrenja za stavljanje veterinarskomedicinskog proizvoda u promet u državama članicama
English: In addition residue depletion data generated with a product containing a colourant specifically aimed at marking the injection site (ferric oxide), injection sites were not clearly identifiable in all animals and could not be completely removed.
Croatian: Uz podatke o razgradnji rezidua generiranih proizvodom koji sadrži bojilo posebno namijenjeno za označavanje mjesta injekcije (željezov oksid), mjesta injekcija nisu se mogla jasno identificirati u svih životinja i nisu mogla biti u potpunosti uklonjena.
English: Despite this, residue levels at the injection site were highly variable, suggesting that sampling failed to identify the true injection site accurately and consistently.
Croatian: Usprkos tome, razine rezidua u mjestu injekcije bile su vrlo varijabilne što sugerira da se uzorkovanjem nije precizno i konzistentno identificiralo pravo mjesto injekcije.
English: However, the CVMP highlighted that conclusions based on this value should be considered with care as there can be no certainty in relation the accuracy of the derived bioavailability figure for predicting bioavailability in vivo;
Croatian: No, CVMP je naglasio da se zaključci donijeti na temelju ove vrijednosti trebaju uzimati u obzir s određenim oprezom jer nema sigurnosti u vezi s točnošću izvedene vrijednosti za bioraspoloživost za potrebe predviđanja bioraspoloživosti in vivo;
English: In 1999 the CVMP assessed barium selenate in the context of an application for the establishment of maximum residue limits under Regulation (EEC) No 2377/90.
Croatian: 1999. godine, CVMP je ocijenio barijev selenat u kontekstu zahtjeva za utvrđivanjem maksimalnih dopuštenih koncentracija rezidua u skladu s Uredbom (EEZ) br. 2377/90.
English: Selenium is an essential micronutrient for animals as well as humans, but is highly toxic if taken in excess and has only a very small safety margin between vital and toxic dose levels.
Croatian: Selen je esencijalni mikronutrijent za životinje kao i za ljude ali je vrlo toksičan ako se uzima u suvišnim količinama i ima vrlo mali raspon sigurne primjene s obzirom na vitalnu i toksičnu dozu.
English: The procedure involved 3 veterinary medicinal products with 18 marketing authorisations granted nationally or subject to on-going applications under a decentralised procedure.
Croatian: Postupkom su obuhvaćena 3 veterinarsko-medicinska proizvoda s 18 odobrenja za stavljanje VMP-a u promet koja su nacionalno izdana ili su predmetom podnijetih zahtjeva sukladno decentraliziranom postupku.
English: At present no appropriate withdrawal periods can be set for these veterinary medicinal products.
Croatian: Trenutačno nije moguće odrediti odgovarajuće karencije za ove veterinarsko-medicinske proizvode.
English: However, the design of this study did not allow for an estimation of the bioavailable selenium fraction and thus these data are supportive only.
Croatian: No dizajn ovog ispitivanja nije dozvolio procjenu dijela bioraspoloživog selena, te su stoga ovi podaci samo potkrepljujući.
English: • dietary supplementation.
Croatian: • dodaci prehrani.
English: CVMP has now been presented with data from an in vitro study simulating conditions in the human gastrointestinal tract.
Croatian: Sada su CVMP-u dostavljeni podaci iz in vitro ispitivanja koje simulira uvjete u ljudskom gastrointestinalnom traktu.