FrancophonIA/ELRC3.0 huggingface dataset:
English: In phase 3 studies with SBS patients who received teduglutide for ≥2 years, 28% of patients developed antibodies against E. coli protein (residual host cell protein from the manufacture).
Croatian: U ispitivanjima faze 3 u bolesnika sa SKC-om koji su teduglutid primali ≥ 2 godine, 28% bolesnika razvilo je antitijela na protein E.coli (rezidualni protein stanica domaćina iz proizvodnje).
English: The dose will be given in millilitres (ml) of solution.
Croatian: Doza se daje u mililitrima (ml) otopine.
English: In addition, a jejunal adenocarcinoma was observed in a male rat administered the lowest dose tested (animal:human plasma exposure margin of approximately 10-fold).
Croatian: Dodatno, zabilježen je adenokarcinom jejunuma kod mužjaka štakora koji je primao najnižu ispitivanu dozu (margina plazmatske izloženosti kod životinje u odnosu na ljude od otprilike 10 puta).
English: Caution is needed when administering Revestive to persons with a known hypersensitivity to tetracycline (see section 4.3).
Croatian: Potreban je oprez kad se lijek Revestive primjenjuje osobama s poznatom preosjetljivošću na tetraciklin (vidjeti dio 4.3).
English: Due to the heterogeneity of the SBS population, a carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment.
Croatian: Zbog heterogenosti populacije sa SKC-om, kod nekih se bolesnika dnevna doza može oprezno titrirati na niže kako bi se poboljšala podnošljivost terapije.
English: In several nonclinical studies, teduglutide has been shown to preserve mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth.
Croatian: U nekoliko pretkliničkih ispitivanja pokazano je da teduglutid štiti integritet sluznice potičući obnovu i normalni rast crijeva povećanjem visine resica i dubine kripti.
English: The symptoms include sudden weight gain, swollen ankles and/or shortness of breath.
Croatian: Simptomi uključuju iznenadno dobivanje na težini, oteknuće gležnjeva i/ili nedostatak zraka.
English: There continued to be evidence of increased response to treatment for up 2.5 years in all groups exposed to teduglutide in terms of parenteral nutrition volume reduction, gaining additional days off parenteral nutrition per week, and achieving weaning of parenteral support.
Croatian: U svim skupinama izloženima teduglutidu i dalje su postojali dokazi povećanog odgovora na liječenje do 2,5 godine u smislu smanjenja volumena parenteralne prehrane, povećanje broja dana tjedno bez parenteralne prehrane i postizanja ukidanja parenteralne potpore.
English: 4.7 Dispose all needles and syringes in a sharps disposal container or hard-walled container (for example, a detergent bottle with a lid).
Croatian: 4.7 Odložite sve igle i štrcaljke u spremnik za oštre predmete ili spremnik čvrstih stijenki (npr. plastičnu bocu od deterdženta sa zatvaračem).
English: If there is still some undissolved powder, discard the vial and start the preparation again from the beginning with a new vial.
Croatian: Ako i dalje ima neotopljenog praška, bacite bočicu i ponovno započnite pripremu s novom bočicom.
English: Do not use Revestive
Croatian: Nemojte primjenjivati Revestive
English: Detailed instructions on the preparation and injection of Revestive are provided in the package leaflet.
Croatian: Detaljne upute o pripremi i ubrizgavanju lijeka Revestive dostupne su u uputi o lijeku.
English: 4.6 Pull the needle straight out of the skin and discard the needle and syringe together into the sharps disposal container.
Croatian: 4.6 Izvucite iglu ravno iz kože i bacite iglu i štrcaljku zajedno u spremnik za oštre predmete.
English: This usually includes the monitoring of small bowel function, gallbladder and bile ducts, and pancreas for signs and symptoms, and, if indicated, additional laboratory investigations and appropriate imaging techniques.
Croatian: To obično uključuje praćenje funkcije tankog crijeva, žučnog mjehura i žučnih vodova te gušterače kako bi se uočili znakovi i simptomi, a prema potrebi učinile dodatne laboratorijske pretrage te pretrage odgovarajućom tehnikom slikovnog prikaza.
English: Determination of the number of vials needed for administration of one dose must be based on the individual patient's weight and the recommended dose of 0.05 mg/kg/day.
Croatian: Broj bočica potrebnih za primjenu jedne doze treba odrediti na temelju tjelesne težine svakog pojedinog bolesnika i preporučene doze od 0,05 mg/kg/dan.
English: Patients should be advised to contact their physician in case of sudden weight gain, swollen ankles and/or dyspnoea.
Croatian: Bolesnicima treba savjetovati da se obrate liječniku u slučaju naglog porasta težine, oticanja gležnjeva i/ili dispneje.
English: • Obligations to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.
Croatian: Podaci o primjeni u ispitanika s umjerenim oštećenjem funkcije jetre ne ukazuju na potrebu ograničavanja primjene.
English: Four subjects (26.7%) on the recommended teduglutide dose achieved at least a three-day reduction in parenteral nutrition needs.
Croatian: Četiri ispitanika (26,7%) na preporučenoj dozi teduglutida postigla su smanjenje potrebe za parenteralnom prehranom od najmanje tri dana.
English: If a dose is missed, that dose should be injected as soon as possible on that day.
Croatian: Ako se propusti doza, treba je primijeniti isti dan što je prije moguće.
English: - Store below 25°C.
Croatian: - Čuvati na temperaturi ispod 25 C.
English: Teduglutide was rapidly absorbed from subcutaneous injection sites with maximum plasma levels occurring approximately 3-5 hours after dose administration at all dose levels.
Croatian: Teduglutid se brzo apsorbira s mjesta supkutane injekcije i postiže maksimalnu koncentraciju u plazmi približno 3-5 sati nakon primjene bez obzira na dozu.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije komplikacija gastrointestinalne stome
English: 4.3 Remove the plastic cap from the needle of the prepared injection syringe.
Croatian: 4.3 Uklonite plastični poklopac s igle na pripremljenoj injekcijskoj štrcaljki.
English: Sixteen (16, 55.2%) of the 29 completers achieved a 20% or greater reduction of parenteral nutrition.
Croatian: Šesnaestoro (16; 55,2%) od 29 ispitanika koji su završili ispitivanje postiglo je 20% ili veće smanjenje parenteralne prehrane.
English: Following subcutaneous administration, teduglutide has an apparent volume of distribution of 26 litres in patients with SBS.
Croatian: Nakon supkutane primjene, teduglutid ima prividni volumen distribucije od 26 litara kod bolesnika sa SKC-om.
English: Of responders in the pivotal study who completed the extension study, 21 out of 22 (96%) sustained their response to teduglutide after an additional 2 years of continuous treatment.
Croatian: Od bolesnika koji su odgovorili u ključnom ispitivanju i koji su završili produžetak ispitivanja, 21 od 22 (96%) održalo je odgovor na teduglutid nakon dodatne 2 godine kontinuiranog liječenja.
English: Talk to your doctor before using Revestive: - if you have severely decreased liver function.
Croatian: Obratite se svom liječniku prije nego primijenite Revestive: - ako imate jako smanjenu funkciju jetre.
English: The naturally occurring human glucagon-like peptide-2 (GLP-2) is a peptide secreted by L cells of the intestine which is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease intestinal motility.
Croatian: Prirodni ljudski glukagonu sličan peptid-2 (GLP-2) je peptid kojeg luče L stanice crijeva i za kojeg je poznato da povećava crijevni i portalni protok krvi, inhibira sekreciju želučane kiseline, te smanjuje motilitet crijeva.
English: Medical check-ups before and during treatment with Revestive Before you start treatment with this medicine, your doctor will need to perform a colonoscopy (a procedure to see inside your colon and rectum) to check for the presence of polyps (small abnormal growths) and remove them.
Croatian: Medicinski pregledi prije i tijekom liječenja lijekom Revestive Prije početka liječenja ovim lijekom, liječnik će trebati napraviti kolonoskopiju (postupak za pregled unutrašnjosti debelog crijeva i završnog dijela crijeva (rektuma)) kako bi provjerio postoje li polipi (male abnormalne izrasline) i odstranio ih.
English: There are no data on the effects of teduglutide on human fertility.
Croatian: Nema podataka o utjecaju teduglutida na plodnosti kod ljudi.
English: Subsequent faecal occult blood testing should be done annually in children and adolescents while they are receiving Revestive.
Croatian: Kasnija testiranja stolice na okultno krvarenje u djece i adolescenata treba provoditi jednom godišnje sve dok primaju Revestive.
English: If you forget to use Revestive
Croatian: Ako ste zaboravili primijeniti Revestive
English: Talk to your child's doctor before using Revestive: - if your child has severely decreased liver function.
Croatian: Obratite se djetetovu liječniku prije nego primijenite Revestive: - ako Vaše dijete ima jako smanjenu funkciju jetre.
English: Once you have all the materials ready, you need to assemble the pre-filled syringe.
Croatian: Nakon što pripremite sve što Vam je potrebno, sastavite napunjenu štrcaljku.
English: Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: 4.5 Inject the medicine slowly by pushing steadily on the plunger until all the medicine is injected and the syringe is empty.
Croatian: Polako ubrizgajte lijek ravnomjerno pritišćući klip sve dok ne ubrizgate sav lijek i štrcaljka ostane prazna.
English: Reproductive and developmental toxicity studies evaluating teduglutide have been carried out in rats and rabbits at doses of 0, 2, 10 and 50 mg/kg/day subcutaneously.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti teduglutida provedena su na štakorima i kunićima u dozama od 0, 2, 10 i 50 mg/kg/dan primijenjenim potkožno.
English: If you stop using Revestive
Croatian: Ako prestanete primjenjivati Revestive
English: Shaking the vial may produce foam, which makes it difficult to extract the solution from the vial.
Croatian: Protresanje bočice može stvoriti pjenu, koja otežava izvlačenje otopine iz bočice.
English: The mean reduction in parenteral nutrition (n=30) was 7.55 l/week (a 65.6% reduction from baseline).
Croatian: Srednje smanjenje parenteralne prehrane (n=30) bilo je 7,55 l/tjedno (smanjenje za 65,6% od početne vrijednosti).
English: Teduglutide treatment induced expansion of the absorptive epithelium by significantly increasing villus height in the small intestine.
Croatian: Liječenje teduglutidom potaknulo je povećanje apsorpcijskog epitela značajnim povećanjem visine resica u tankom crijevu.
English: Injection site reactions occurred in 26% of SBS patients treated with teduglutide, compared to 5% of patients in the placebo arm.
Croatian: Reakcije na mjestu primjene injekcije javile su se kod 26% bolesnika sa SKC-om liječenih teduglutidom u usporedbi s 5% bolesnika u skupini koja je primala placebo.
English: For paediatric patients with a body weight >20 kg, the 5 mg strength vial should be used.
Croatian: Za pedijatrijske bolesnike tjelesne težine >20 kg treba primijeniti bočicu jačine 5 mg.
English: It should be kept below 25°C and maximum storage time is three hours.
Croatian: Treba je držati na temperaturi nižoj od 25°C, a vrijeme čuvanja ne smije biti dulje od tri sata.
English: As a precautionary measure, it is preferable to avoid the use of Revestive during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Revestive tijekom trudnoće.
English: It improves the absorption of nutrients and fluid from your remaining gastrointestinal tract (gut).
Croatian: Ona poboljšava apsorpciju hranjivih tvari i tekućine iz preostalog gastrointestinalnog trakta (crijeva).
English: Store below 25°C.
Croatian: Čuvati na temperaturi ispod 25 C.
English: The mean reduction in parenteral nutrition was 4.0 l/week (39.4% reduction from baseline - the start of the extension study) and 4 of the 6 completers (66.7%) achieved a 20% or greater reduction in parenteral support.
Croatian: Srednje smanjenje parenteralne prehrane bilo je 4,0 l/tjedno (39,4% smanjenje u odnosu na početnu vrijednost - početak produžetka ispitivanja), a 4 od 6 ispitanika koji su završili ispitivanje (66,7%) postiglo je 20% ili veće smanjenje parenteralne potpore.
English: Teduglutide increases villus height and crypt depth of the intestinal epithelium.
Croatian: Teduglutid povećava visinu crijevnih resica i dubinu kripti crijevnog epitela.
English: Twenty-one (21) patients treated with teduglutide (48.8%) versus 9 on placebo (20.9%) achieved at least a one day reduction in parenteral nutrition administration (p=0.008).
Croatian: Dvadeset jedan (21) bolesnik liječen teduglutidom (48,8%) naspram 9 koji su primali placebo (20,9%) smanjio je primjenu parenteralne prehrane (p=0,008) barem za jedan dan.
English: Driving, cycling and using machines
Croatian: Upravljanje vozilima, vožnja bicikla i rukovanje strojevima
English: - Keep Revestive out of the sight and reach of children.
Croatian: - Čuvajte Revestive izvan pogleda i dohvata djece.
English: Of the 39 placebo subjects, 29 completed 24 months of treatment with teduglutide.
Croatian: Od 39 ispitanika koji su primali placebo, 29 je završilo 24-mjesečno liječenje teduglutidom.
English: Your doctor may have to change your dose of other medicines.
Croatian: Liječnik će Vam možda morati promijeniti dozu drugih lijekova.
English: Patients receiving oral concomitant medicinal products requiring titration or with a narrow therapeutic index should be monitored closely due to potential increased absorption (see section 4.5).
Croatian: Bolesnike koji istodobno uzimaju peroralne lijekove za koje je potrebno titrirati dozu ili imaju usku terapijsku širinu treba pomno nadzirati zbog potencijalnog povećanja apsorpcije (vidjeti dio 4.5).
English: - The active substance is teduglutide.
Croatian: - Djelatna tvar je teduglutid.
English: Solvent for Revestive
Croatian: Otapalo za Revestive
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or trace residues of tetracycline.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili tetraciklin koji je preostao u tragovima.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego primijenite ovaj lijek.
English: This medicine may cause you to feel dizzy.
Croatian: Ovaj lijek može izazvati omaglicu.
English: This medicine may cause your child to feel dizzy.
Croatian: Ovaj lijek može u Vašeg djeteta izazvati omaglicu.
English: Instructions for preparing and injecting Revestive
Croatian: Upute za pripremu i primjenu lijeka Revestive
English: Of the patients who achieved at least a 20% reduction of parenteral nutrition at Weeks 20 and 24 in the initial study, 75% sustained this response on teduglutide after up to 1 year of continuous treatment.
Croatian: Među bolesnicima koji su u prvotnom ispitivanju postigli smanjenje parenteralne prehrane od barem 20% u tjednima 20 i 24, 75% je održalo odgovor na teduglutid do 1 godine kontinuiranog liječenja.
English: These 10 subjects had required parenteral nutrition support for 1.2 to 15.5 years, and prior to treatment with teduglutide had required between 3.5 l/week and 13.4 l/week of parenteral nutrition support.
Croatian: Tih 10 ispitanika trebalo je potporu parenteralnom prehranom od 1,2 do 15,5 godina, a prije liječenja teduglutidom trebali su potporu parenteralnom prehranom od 3,5 l/tjedno do 13,4 l/tjedno.
English: Fluid overload
Croatian: Preopterećenje tekućinom
English: Gently grasp the cleaned skin at the injection site with one hand.
Croatian: Jednom rukom nježno uhvatite očišćenu kožu na mjestu predviđenom za davanje injekcije.
English: Do not stop using this medicine without consulting your doctor, as a sudden stop can cause changes in your fluid balance.
Croatian: Ne prekidajte primjenu bez savjetovanja s liječnikom, jer nagli prestanak liječenja može izazvati promjene u ravnoteži tekućine.
English: Tell the doctor, pharmacist or nurse if your child is using, has recently used or might use any other medicines.
Croatian: Obavijestite liječnika, ljekarnika ili medicinsku sestru ako Vaše dijete prima, nedavno je primilo ili bi moglo primiti bilo koje druge lijekove.
English: Carcinogenicity / mutagenicity Teduglutide was negative when tested in the standard battery of tests for genotoxicity.
Croatian: Teduglutid je bio negativan kad je ispitan u standardnoj skupini testova genotoksičnosti.
English: Common (may affect up to 1 in 10 people): - Congestive heart failure.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): - Kongestivno zatajenje srca.
English: Due to the risk of dehydration, discontinuation of treatment with Revestive should be managed carefully.
Croatian: Prekid terapije Zbog rizika od dehidracije, prekid liječenja lijekom Revestive treba provoditi pažljivo.
English: If two vials are needed, the procedure for the second vial must be repeated and the additional solution sucked up into the injection syringe containing the solution from the first vial.
Croatian: Ako su potrebne dvije bočice, postupak treba ponoviti za drugu bočicu, te u štrcaljku za injekciju s otopinom iz prve bočice uvući dodatnu otopinu.
English: Teduglutide was studied in a 12-week, open-label, clinical study in 42 paediatric subjects aged 1 year through 14 years with SBS who were dependent on parenteral nutrition.
Croatian: Teduglutid je ispitan u 12-tjednom, otvorenom kliničkom ispitivanju u 42 pedijatrijska ispitanika u dobi od 1 do 14 godina sa SKC-om koji su ovisili o parenteralnoj prehrani.
English: Do not stop using this medicine without consulting the doctor, as a sudden stop can cause changes in your child's fluid balance.
Croatian: Ne prekidajte primjenu bez savjetovanja s liječnikom, jer nagli prestanak liječenja može u Vašega djeteta izazvati promjene u ravnoteži tekućine.
English: Three subjects (3/15, 20%) on the recommended teduglutide dose were weaned off parenteral nutrition by Week 12.
Croatian: Tri ispitanika (3/15, 20%) na preporučenoj dozi teduglutida prestali su s parenteralnom prehranom do 12. tjedna.
English: It improves the absorption of nutrients and fluid from your child's remaining gastrointestinal tract (gut).
Croatian: Ona poboljšava apsorpciju hranjivih tvari i tekućine iz djetetova preostalog gastrointestinalnog trakta (crijeva).
English: Revestive has not been studied in patients with severe hepatic impairment.
Croatian: Revestive nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre.
English: In case the injection into the abdomen is hampered by pain, scarring or hardening of the tissue, the thigh can also be used.
Croatian: Ako je primjena u trbuh otežana zbog boli, ožiljaka ili otvrdnuća tkiva, može se primijeniti i u bedro.
English: Revestive has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Lijek Revestive nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: The rate and extent of absorption of teduglutide is dose-proportional at single and repeated subcutaneous doses up to 20 mg.
Croatian: Stopa i razmjeri apsorpcije teduglutida proporcionalni su dozi nakon pojedinačne i uzastopne supkutane primjene u dozama do 20 mg.
English: Of the 12 subjects not randomised in the pivotal study, 6 completed 24 months of treatment with teduglutide.
Croatian: Od 12 ispitanika koji nisu randomizirani u ključnom ispitivanju, 6 je završilo 24 mjeseca liječenja teduglutidom.
English: At Week 16 (4 weeks following the end of treatment) parenteral nutrition volume reductions were still evident but less than observed at Week 12 when subjects were still on teduglutide (mean decrease of -31.80% (±39.26) compared to a 3.92% (±16.62) increase in the standard of care group).
Croatian: U 16. tjednu (4 tjedna nakon završetka liječenja) smanjenja volumena parenteralne prehrane još su bila očita, ali manje nego ona opažena u 12. tjednu kada su ispitanici još uvijek primali teduglutid (srednja vrijednost smanjenja od -31,80% (±39,26) u usporedbi s povećanjem od 3,92% (±16,62) u skupini na standardnoj skrbi).
English: In case of malignancy, Revestive treatment must be discontinued (see sections 4.3 and 5.3).
Croatian: U slučaju maligne bolesti terapiju lijekom Revestive mora se prekinuti (vidjeti dijelove 4.3 i 5.3).
English: Such events might impact the ability to drive, ride a bicycle, or use machines.
Croatian: Takvi događaji mogu utjecati na sposobnost upravljanja vozilima, vožnje bicikla ili rada sa strojevima.
English: Gender No clinically relevant gender differences were observed in clinical studies.
Croatian: Spol U kliničkim ispitivanjima nisu opažene klinički značajne razlike između spolova.
English: Revestive can be used in children and adolescents (aged 1 year and above).
Croatian: Revestive se može primjenjivati u djece i adolescenata (od navršene 1 godine nadalje).
English: Cases of cholecystitis, cholangitis, and cholelithiasis have been reported in clinical studies.
Croatian: U kliničkim ispitivanjima prijavljeni su slučajevi kolecistitisa, kolangitisa i kolelitijaze.
English: When starting and while getting treated with Revestive, your doctor may adjust the amount of intravenous fluids or nutrition you receive.
Croatian: Kada započnete liječenje ili tijekom liječenja lijekom Revestive, liječnik Vam može prilagoditi količinu tekućina ili prehrane koju intravenski primate.
English: In a rat carcinogenicity study, treatment related benign neoplasms included tumours of the bile duct epithelium in males exposed to teduglutide plasma levels approximately 32- and 155-fold higher than obtained in patients administered the recommended daily dose (incidence of 1 out of 44 and 4 out of 48, respectively).
Croatian: U ispitivanju kancerogenosti na štakorima, benigne novotvorine povezane s liječenjem uključivale su tumore epitela žučovoda u mužjaka izloženih plazmatskoj koncentraciji teduglutida koja za 32, odnosno 155 puta premašuje onu koja se postiže kod bolesnika primjenom preporučene dnevne doze (incidencija 1 na 44, odnosno 4 na 48).
English: The objectives of the study were to evaluate safety, tolerability, and efficacy of teduglutide compared to standard of care.
Croatian: Ciljevi ispitivanja bili su procijeniti sigurnost, podnošljivost te djelotvornost teduglutida u usporedbi sa standardnom skrbi.
English: It should be kept below 25°C and maximum storage time is twenty-four hours.
Croatian: Treba je držati na temperaturi nižoj od 25°C, a vrijeme čuvanja ne smije biti dulje od dvadeset i četiri sata.
English: In case of malignancy, Revestive therapy must be discontinued (see section 4.3).
Croatian: U slučaju maligne bolesti, terapiju lijekom Revestive mora se prekinuti (vidjeti dio 4.3).
English: The proportion of teduglutide-treated subjects achieving a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was statistically significantly different from placebo (27 out of 43 subjects, 62.8% versus 13 out of 43 patients, 30.2%, p=0.002).
Croatian: Udio bolesnika liječenih teduglutidom kod kojih je parenteralna prehrana smanjena za 20% do 100% u tjednu 20 i 24 bio je statistički značajno različit u odnosu na placebo (27 od 43 ispitanika, 62,8% naspram 13 od 43 bolesnika, 30,2%, p=0,002).