FrancophonIA/ELRC3.0 huggingface dataset:
English: Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after one year of treatment, every 5 years thereafter while on continuous treatment with Revestive, and if they have new or unexplained gastrointestinal bleeding.
Croatian: Preporučuje se napraviti kolonoskopiju/sigmoidoskopiju kod sve djece i adolescenata nakon jedne godine liječenja, a potom, kod daljnje kontinuirane primjene lijeka Revestive, jednom svakih 5 godina te ako imaju novo ili neobjašnjeno gastrointestinalno krvarenje.
English: Prepare the injection syringe
Croatian: Pripremite injekcijsku štrcaljku
English: In a phase 1 study no difference in pharmacokinetics of teduglutide could be detected between healthy subjects younger than 65 years versus older than 65 years.
Croatian: U ispitivanjima faze 1 nije utvrđena razlika u farmakokinetici teduglutida između zdravih ispitanika mlađih od 65 godina u odnosu na starije od 65 godina.
English: Teduglutide was not associated with effects on reproductive performance, in utero or developmental parameters measured in studies to investigate fertility, embryo-foetal development and pre- and post-natal development.
Croatian: Teduglutid nije bio povezan s djelovanjem na reprodukciju, in utero ili na razvojne parametre izmjerene u ispitivanjima plodnosti, embriofetalnog razvoja i pred- i postnatalnog razvoja.
English: No dose adjustment is necessary in patients above the age of 65 years.
Croatian: Nije potrebna prilagodba doze u bolesnika starijih od 65 godina.
English: Important information about some of the ingredients in Revestive
Croatian: Važne informacije o nekim sastojcima lijeka Revestive
English: Teduglutide is an analogue of GLP-2.
Croatian: Teduglutid je analog GLP-2.
English: The efficacy data presented are derived from 2 controlled studies in paediatric patients up to 24 weeks duration.
Croatian: Navedeni podaci o učinkovitosti dobiveni su iz 2 kontrolirana ispitivanja kod pedijatrijskih bolesnika u trajanju do 24 tjedna.
English: The maximum dose of teduglutide studied during clinical development was 86 mg/day for 8 days.
Croatian: Maksimalna doza teduglutida ispitana tijekom kliničkog razvoja lijeka iznosila je 86 mg/dan tijekom 8 dana.
English: Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.
Croatian: Preopterećenje tekućinom kao nuspojava događalo se najčešće u prva 4 tjedna terapije, a s vremenom se smanjilo.
English: In the event of an overdose, the patient should be carefully monitored by the medical professional.
Croatian: U slučaju predoziranja bolesnik treba biti pod pažljivim nadzorom liječnika.
English: The majority of reactions were moderate in severity and no occurrences led to drug discontinuation.
Croatian: Većina reakcija bila je umjerene težine i nijedna od njih nije dovela do prekida primjene lijeka.
English: Patients should be stable following a period of intestinal adaptation after surgery.
Croatian: Bolesnici trebaju biti stabilni nakon razdoblja adaptacije crijeva poslije operacije.
English: This is because there is no experience with Revestive in this age group.
Croatian: To je zato što nema iskustva s primjenom lijeka Revestive u toj dobnoj skupini.
English: 3.7 Your dose in ml has been calculated by your doctor.
Croatian: 3.7 Vaš liječnik je izračunao Vašu dozu u ml.
English: If a neoplasia is detected, it should be removed.
Croatian: Ako se utvrdi novotvorina, treba je ukloniti.
English: Withdraw the solution from the second vial into the same injection syringe by repeating step 3.
Croatian: Uvucite tekućinu iz druge bočice u istu štrcaljku ponavljanjem koraka 3.
English: No unexpected systemic adverse reactions were seen (see section 4.8).
Croatian: Nisu zabilježene neočekivane sistemske nuspojave (vidjeti dio 4.8).
English: The pharmacokinetic profile of Revestive in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights.
Croatian: Farmakokinetički profil teduglutida u toj pedijatrijskoj populaciji, procijenjeno prema klirensu i volumenu distribucije, razlikovao se od onog opaženog u odraslih nakon korekcije za tjelesnu težinu.
English: Of these, 28 patients (93%) achieved a 20% or greater reduction of parenteral support.
Croatian: Od tog broja, 28 bolesnika (93%) postiglo je 20% ili veće smanjenje parenteralne potpore.
English: The doctor will consider this when prescribing this medicine.
Croatian: Liječnik će to uzeti u obzir kad propisuje ovaj lijek.
English: Overall, the safety profile of teduglutide (including type and frequency of adverse reactions, and immunogenicity) in children and adolescents (ages 1-17 years) was similar to that in adults.
Croatian: Sveukupno gledano, sigurnosni profil teduglutida (uključujući vrstu i učestalost nuspojava te imunogenost) bio je u djece i adolescenata (u dobi od 1 do 17 godina) sličan onome u odraslih osoba.
English: However, cases of syncope have been reported in clinical studies (see section 4.8).
Croatian: Međutim, u kliničkim ispitivanjima prijavljeni su slučajevi sinkope (vidjeti dio 4.8).
English: If the solution is cloudy or contains particulate matter, do not inject it.
Croatian: Ako je otopina mutna ili sadrži vidljive čestice, ne smijete je ubrizgati.
English: The metabolism of teduglutide is not fully known.
Croatian: Metabolizam teduglutida nije potpuno poznat.
English: These observations were potentially associated with the expected intended pharmacology of teduglutide and were to a varying degree reversible within an 8-13 week recovery period following chronic administration.
Croatian: Ta su opažanja možda povezana s očekivanom i ciljanom farmakologijom teduglutida, a bila su do različitog stupnja reverzibilna unutar razdoblja oporavka od 8 do 13 tjedana nakon kronične primjene.
English: What you need to know before you use Revestive
Croatian: Što morate znati prije nego počnete primjenjivati Revestive
English: The doctor will tell you which dose to inject.
Croatian: Reći će Vam koju dozu trebate ubrizgati.
English: A treatment period of 6 months is recommended after which treatment effect should be evaluated.
Croatian: Preporučuje se liječenje u trajanju od 6 mjeseci, a nakon toga je potrebno procijeniti učinak liječenja.
English: Following intravenous administration teduglutide plasma clearance was approximately 127 ml/hr/kg which is equivalent to the glomerular filtration rate (GFR).
Croatian: Nakon intravenske primjene plazmatski klirens teduglutida bio je približno 127 ml/hr/kg što odgovara brzini glomerularne filtracije (GFR).
English: Subjects were maintained on teduglutide even if no longer requiring parenteral nutrition.
Croatian: Ispitanici su nastavili liječenje teduglutidom čak i ako im više nije trebala parenteralna prehrana.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Revestive in one or more subsets of the paediatric population in the treatment of SBS (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Revestive u jednoj ili više podskupina pedijatrijske populacije u liječenju SKC-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If this happens to your child, they should not drive, ride a bicycle or use machines until they feel better.
Croatian: Ako se to dogodi, Vaše dijete ne smije upravljati vozilima, voziti bicikl ili rukovati strojevima dok se ne bude osjećalo bolje.
English: After a 4-week washout period, two of these patients had reinitiated parenteral nutrition support.
Croatian: Nakon razdoblja bez terapije (engl. wash-out) u trajanju od 4 tjedna, dva od tih bolesnika ponovno su započela s potporom parenteralnom prehranom.
English: Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies.
Croatian: Sukladno potencijalnim značajkama imunogenosti lijekova koji sadrže peptide, primjena lijeka Revestive može potencijalno potaknuti stvaranje antitijela.
English: An in vitro study indicates that teduglutide does not inhibit cytochrome P450 drug metabolising enzymes.
Croatian: In vitro ispitivanje ukazuje da teduglutid ne inhibira citokrom P450 enzime.
English: Revestive has not been studied in patients with severe, clinically unstable concomitant diseases, (e.g., cardiovascular, respiratory, renal, infectious, endocrine, hepatic, or CNS), or in patients with malignancies within the last five years (see section 4.3).
Croatian: Revestive nije ispitivan u bolesnika s teškim, klinički nestabilnim pratećim bolestima (npr. kardiovaskularnim, dišnim, bubrežnim, zaraznim, endokrinim, jetrenim ili središnjeg živčanog sustava) ili u bolesnika sa zloćudnim bolestima u posljednjih pet godina (vidjeti dio 4.3).
English: Based on the findings derived from pre-clinical studies (see sections 4.4 and 5.3) and the proposed mechanism of action with the trophic effects on intestinal mucosa, there appears to be a risk for the promotion of small intestinal and/or colonic neoplasia.
Croatian: Na temelju opažanja iz pretkliničkih ispitivanja (vidjeti dijelove 4.4 i 5.3) i predloženog mehanizma djelovanja s trofičkim učincima na crijevnu sluznicu, čini se da postoji rizik od pospješivanja novotvorine tankog i/ili debelog crijeva.
English: If heart rate and breathing is normal and you awaken fast, speak to your doctor.
Croatian: Ako su brzina otkucaja srca i disanje normalni i brzo dođete k svijesti, obratite se liječniku.
English: Structural adaptations were transient in nature and returned to baseline levels within three weeks of discontinuing the treatment.
Croatian: Strukturalne adaptacije bile su prolaznog karaktera, i vraćale su se na početne vrijednosti unutar tri tjedna po prekidu liječenja.
English: The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.
Croatian: Pri svakom posjetu liječnik treba izvagati bolesnika, odrediti dnevnu dozu koju treba primjenjivati do sljedećeg posjeta te s tim upoznati bolesnika.
English: Pharmacokinetics in subpopulations
Croatian: Farmakokinetika u podskupinama bolesnika
English: A small amount of bleeding may occur.
Croatian: Može se javiti blago krvarenje.
English: Sixty-five (65) patients entered a follow-up SBS study for up to an additional 28 weeks of treatment.
Croatian: Šezdeset pet (65) bolesnika uključeno je u ispitivanje praćenja SKC-a s trajanjem do 28 dodatnih tjedana liječenja.
English: With progressive renal impairment up to and including end-stage renal disease the primary pharmacokinetic parameters of teduglutide increased up to a factor of 2.6 (AUCinf) and 2.1 (Cmax) compared to healthy subjects.
Croatian: S progresivnim zatajenjem bubrega sve do i uključujući završni stadij zatajenja bubrega primarni farmakokinetički parametri teduglutida povećali su se do faktora 2,6 (AUCinf) i 2,1 (Cmax) u odnosu na zdrave ispitanike.
English: Continued treatment is recommended for patients who have weaned off parenteral nutrition.
Croatian: Preporučuje se daljnje liječenje za bolesnike kojima je ukinuta parenteralna prehrana.
English: In rats, mean teduglutide concentration in milk was less than 3% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg.
Croatian: Kod štakora je srednja koncentracija teduglutida u mlijeku iznosila manje od 3% plazmatske koncentracije kod majke nakon pojedinačne supkutane injekcije od 25 mg/kg.
English: If you see any blood in the syringe, withdraw the needle and replace the needle on the injection syringe with a clean one of the same size.
Croatian: Ako se u štrcaljki pojavi krv, izvucite iglu i zamijenite iglu na injekcijskoj štrcaljki novom, iste veličine.
English: Management of fluids during treatment with Revestive In patients receiving Revestive, parenteral support should be reduced carefully and should not be discontinued abruptly.
Croatian: Prilagodba tekućina tijekom liječenja lijekom Revestive U bolesnika koji primaju Revestive, parenteralnu potporu treba pažljivo smanjivati i ona se ne smije prekinuti naglo.
English: There are no data from the use of Revestive in pregnant women.
Croatian: Nema podataka o primjeni lijeka Revestive u trudnica.
English: Four interim reports will be provided within six months after the data lock points (i.e., Q4 2016, Q4 2018, Q4 2020, and Q4 2022).
Croatian: Q4 2016, Q4 2018, Q4 2020 i Q4 2022).
English: Interim data for the NIS should be provided every second year.
Croatian: Interim podatke iz neintervencijskog ispitivanja treba dostaviti svake druge godine.
English: 4.4 Pull back the plunger slightly.
Croatian: 4.4 Lagano povucite klip.
English: *A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology.
Croatian: *analog glukagonu sličnog peptida-2 (GLP-2) proizveden tehnologijom rekombinantne DNK u stanicama Escherichia coli
English: The reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen.
Croatian: Rekonstituiranu otopinu treba primijeniti supkutanom injekcijom jedanput dnevno, izmjenjujući mjesto primjene između 1 od 4 kvadranta trbuha.
English: Animal data do not indicate any impairment of fertility.
Croatian: Podaci na životinjama ne upućuju na oštećenje plodnosti.
English: If any powder remains, repeat steps 2.5 and 2.6.
Croatian: Ako opazite zaostali prašak, ponovite korake 2.5 i 2.6. Ne tresite bočicu.
English: The mean reduction in parenteral nutrition was 3.11 l/week (an additional 28.3% reduction).
Croatian: Srednje smanjenje parenteralne prehrane bilo je 3,11 l/tjedno (dodatno smanjenje od 28,3%).
English: The vial should not be shaken, but can be rolled between the palms and gently turned upside-down once.
Croatian: Bočica se ne smije tresti, ali može je se provrtjeti među dlanovima i jednom nježno preokrenuti goredolje.
English: Similar to GLP-2, teduglutide is 33 amino acids in length with an amino acid substitution of alanine by glycine at the second position of the N-terminus.
Croatian: Slično kao GLP-2, teduglutid čine 33 aminokiseline sa supstitucijom alanina na drugom mjestu N-terminalnog dijela glicinom.
English: In total 88 patients participated in this extension study, thereof 39 treated with placebo and 12 enrolled, but not randomised, in the previous study; 65 of 88 patients completed the extension study.
Croatian: U produžetku ispitivanja sudjelovalo je ukupno 88 bolesnika, od kojih je 39 prethodno liječeno placebom i 12 koji su bili uključeni, ali ne i randomizirani u prethodnom ispitivanju; 65 od 88 bolesnika završilo je produžetak ispitivanja.
English: Then gently push up the plunger to expel the air.
Croatian: Zatim pažljivo gurajte klip prema gore da istisnete zrak.
English: The powder is white and the solvent is clear and colourless.
Croatian: Prašak je bijeli, a otapalo bistro i bezbojno.
English: In two completed clinical trials, there were 87 paediatric subjects (aged 1 to 17 years) enrolled and exposed to teduglutide for a duration of up to 6 months.
Croatian: U dva završena klinička ispitivanja bilo je uključeno 87 pedijatrijskih ispitanika (u dobi od 1 do 17 godina) i izloženo teduglutidu tijekom razdoblja od najviše 6 mjeseci.
English: Based upon the pharmacodynamic effect of teduglutide, there is a potential for increased absorption of concomitant medicinal products (see section 4.4).
Croatian: Na temelju farmakodinamičkog djelovanja teduglutida, postoji mogućnost povećane apsorpcije lijekova koji se istodobno uzimaju (vidjeti dio 4.4).
English: Treatment resulted in enhanced gastrointestinal fluid absorption of approximately 750-1000 ml/day with improvements in the absorption of macronutrients and electrolytes, decreased stomal or faecal fluid and macronutrients excretion, and enhanced key structural and functional adaptations in the intestinal mucosa.
Croatian: Liječenje je rezultiralo porastom gastrointestinalne apsorpcije tekućine za približno 750-1000 ml/dan s poboljšanom apsorpcijom makronutrijenata i elektrolita; smanjenjem stomalnog ili fekalnog izlučivanja tekućine i makronutrijenata te poboljšanim ključnim strukturalnim i funkcionalnim adaptacijama crijevne sluznice.
English: Several cases of benign colorectal polyps occurred during the course of the trials, however, the frequency was not increased compared to placebo-treated patients.
Croatian: Za trajanja ispitivanja javilo se nekoliko slučajeva benignih kolorektalnih polipa, no učestalost nije bila povećana u usporedbi s bolesnicima koji su liječeni placebom.
English: This medicine should not be used in children under 1 year of age.
Croatian: Ovaj lijek se ne smije primjenjivati u djece mlađe od 1 godine.
English: Modest increases of C-reactive protein of approximately 25 mg/l have been observed within the first seven days of teduglutide treatment, which decreased continuously under ongoing daily injections.
Croatian: Umjereno povećanje C-reaktivnog proteina od otprilike 25 ml/l primijećeno je u prvih sedam dana liječenja teduglutidom te se smanjivalo tijekom svakodnevne primjene injekcija.
English: Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gut.
Croatian: Sindrom kratkog crijeva je poremećaj koji je posljedica nemogućnosti apsorpcije hranjivih tvari i tekućine iz crijeva.
English: You will find detailed instructions for injections at the end of this leaflet.
Croatian: Detaljan opis postupka davanja injekcija možete naći na kraju ove upute.
English: The most commonly reported adverse reactions were abdominal pain and distension (45%), respiratory tract infections (28%) (including nasopharyngitis, influenza, upper respiratory tract infection, and lower respiratory tract infection), nausea (26%), injection site reactions (26%), headache (16%), and vomiting (14%).
Croatian: Najčešće prijavljene nuspojave bile su abdominalna bol i distenzija (45%), infekcije dišnog sustava (28%) (uključujući nazofaringitis, gripu, infekciju gornjeg dijela dišnog sustava i infekciju donjeg dijela dišnog sustava), mučnina (26%), reakcije na mjestu primjene (26%), glavobolja (16%) i povraćanje (14%).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX08.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, različiti lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX08.
English: Approximately 52% of the patients treated with teduglutide experienced adverse reactions (versus 36% of the patients given placebo).
Croatian: Približno 52% bolesnika liječenih teduglutidom imalo je nuspojave (naspram 36% bolesnika koji su dobivali placebo).
English: Allow the area to air-dry.
Croatian: Pričekajte da se to područje osuši na zraku.
English: Revestive should not be administered intravenously or intramuscularly.
Croatian: Revestive se ne smije primjenjivati intravenski niti intramuskularno.
English: After 24 weeks of teduglutide treatment, patients showed small overall increase in C-reactive protein of approximately 1.5 mg/l on average.
Croatian: Nakon 24 tjedna liječenja teduglutidom, u bolesnika je zabilježeno malo ukupno povećanje C-reaktivnog proteina od prosječno približno 1,5 ml/l.
English: 2.5 Gently roll the vial between your palms for about 15 seconds.
Croatian: Nježno vrtite bočicu između dlanova oko 15 sekundi.
English: If necessary, press gently on the injection site with an alcohol swab or 2x2 gauze until any bleeding has stopped.
Croatian: Ako je potrebno, lagano pritisnite mjesto primjene injekcije alkoholom natopljenim jastučićem ili gazom veličine 2x2 cm dok krvarenje ne prestane.
English: Includes the following preferred terms: Pancreatitis, Pancreatitis acute, and Pancreatitis chronic.
Croatian: Uključuje sljedeće preporučene pojmove: pankreatitis, akutni pankreatitis i kronični pankreatitis.
English: Colo-rectal polyps/Neoplasia
Croatian: Kolorektalni polipi/novotvorine
English: The maximum exposure and the overall extent of exposure to teduglutide following single 20 mg subcutaneous doses were lower (10-15%) in subjects with moderate hepatic impairment relative to those in healthy matched controls.
Croatian: Maksimalna izloženost i ukupna izloženost teduglutidu nakon jednokratne supkutane primjene doze od 20 mg bila je niža (10-15%) u ispitanika s umjerenim oštećenjem jetre u odnosu na podudarne zdrave kontrolne ispitanike.
English: Ninety-seven percent (97%) of patients (37 out of 39 patients treated with teduglutide) that completed the placebo-controlled study entered a long-term extension study where all patients received 0.05 mg/kg of Revestive daily for up to an additional 2 years.
Croatian: Devedeset sedam posto (97%) bolesnika (37 od 39 bolesnika liječenih teduglutidom) koji su završili placebom kontrolirano ispitivanje uključeno je u dugotrajni produžetak ispitivanja u kojem su svi bolesnici primali 0,05 mg/kg lijeka Revestive dnevno tijekom dodatne 2 godine.
English: Revestive should not be used if a cancer is detected during colonoscopy.
Croatian: Revestive se ne smije primati ako se kolonoskopijom otkrije rak.
English: In pre-clinical studies, severe granulomatous inflammations were found associated with the injection sites.
Croatian: U pretkliničkim ispitivanjima zabilježene su teške granulomatozne upale povezane s mjestom primjene injekcije.
English: Thirty (30) of the 43 teduglutide-treated patients from the pivotal study who entered the extension study completed a total of 30 months of treatment.
Croatian: Tridesetoro (30) od 43 bolesnika liječenih teduglutidom iz ključnog ispitivanja koji su ušli u produžetak ispitivanja završilo je ukupno 30 mjeseci liječenja.
English: Attach the needle to the injection syringe containing the medicine.
Croatian: Pričvrstite iglu na injekcijsku štrcaljku koja sadrži lijek.
English: - Revestive is for injection under the skin (subcutaneous injection).
Croatian: - Revestive se ubrizgava pod kožu (supkutana injekcija).
English: The corresponding change in the standard of care cohort was 4.31% (±5.36).
Croatian: Sukladna promjena u skupini na standardnoj skrbi iznosila je 4,31% (±5,36).
English: No data are available for paediatric patients with moderate to severe renal impairment and end-stage renal disease (ESRD).
Croatian: Nisu dostupni podaci za pedijatrijske bolesnike s umjerenim do teškim oštećenjem funkcije bubrega i završnim stadijem bolesti bubrega (ESRD).
English: The single amino acid substitution relative to naturally occurring GLP-2 results in resistance to in vivo degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in an extended half-life.
Croatian: Supstitucija jedne aminokiseline u odnosu na prirodni GLP-2 rezultira otpornošću na degradaciju enzimom dipeptidil peptidaza-IV (DPP-IV) in vivo te ima za posljedicu produljeni poluživot.
English: Patients with a history of malignancies in the gastrointestinal tract, including the hepatobiliary system and pancreas within the last five years.
Croatian: Bolesnici s anamnezom zloćudnih bolesti gastrointestinalnog trakta, uključujući hepatobilijarni sustav i gušteraču, u posljednjih pet godina.
English: Revestive may affect how other medicines are absorbed from the gut and therefore how well they work.
Croatian: Revestive može utjecati na apsorpciju drugih lijekova iz crijeva i stoga na njihovo djelovanje.
English: - if you suffer from certain cardiovascular diseases (affecting the heart and/or blood vessels) such as high blood pressure (hypertension) or have a weak heart (cardiac insufficiency).
Croatian: - ako bolujete od određenih kardiovaskularnih bolesti (koje zahvaćaju srce i/ili krvne žile) poput visokog krvnog tlaka (hipertenzije) ili imate oslabljeno srce (insuficijencija srca).