FrancophonIA/ELRC3.0 huggingface dataset:
English: If you inject more Revestive than you are told to by your doctor, you should contact your doctor, pharmacist or nurse.
Croatian: Ako ubrizgate više lijeka Revestive nego što Vam je rekao liječnik, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Five (5) subjects were enrolled in a standard of care cohort.
Croatian: U skupinu na standardnoj skrbi bilo je uključeno 5 ispitanika.
English: If polyps are found either before or during your treatment with Revestive, your doctor will decide whether you should continue using this medicine.
Croatian: Ako se prije ili tijekom liječenja lijekom Revestive pronađu polipi, liječnik će odlučiti smijete li nastaviti liječenje ovim lijekom.
English: Revestive is used to treat children and adolescents (aged 1 year and above) with Short Bowel Syndrome.
Croatian: Revestive se koristi za liječenje djece i adolescenata (od navršene 1 godine nadalje) sa sindromom kratkog crijeva.
English: Treatment with teduglutide resulted in a 4.4 l/week reduction in parenteral nutrition requirements (from a pre-treatment baseline of 12.9 litres) versus 2.3 l/week (from a pre-treatment baseline of 13.2 litres) for placebo at 24 weeks.
Croatian: Nakon 24 tjedana, liječenje teduglutidom dovelo je do smanjenja potrebe za parenteralnom prehranom od 4,4 l/tjedan (od vrijednosti 12,9 litara prije početka terapije) naspram 2,3 l/tjedan (od vrijednosti 13,2 l prije početka primjene) u skupini na placebu.
English: Decreased appetite Fluid overload
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit preopterećenje tekućinom
English: Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 5 mg teduglutide.
Croatian: Prašak Bočica (staklo) od 3 ml s gumenim čepom (brombutil), koja sadrži 5 mg teduglutida.
English: How to store Revestive
Croatian: Kako čuvati Revestive
English: Powder 3 ml vial (glass) with rubber stopper (bromobutyl) containing 1.25 mg teduglutide.
Croatian: Bočica (staklo) od 3 ml s gumenim čepom (brombutil), koja sadrži 1,25 mg teduglutida.
English: The mean decrease from baseline at Week 24 in the number of days/week on parenteral nutrition, based on subject diary data, was -1.34 (±2.24) days/week corresponding to a percentage decrease of -21.33% (±34.09).
Croatian: Na temelju podataka iz dnevnika ispitanika, srednja vrijednost smanjenja broja dana na parenteralnoj prehrani po tjednu od početka do 24. tjedna iznosila je -1,34 (±2,24) dana po tjednu, što odgovara postotnom smanjenju od -21,33% (±34,09).
English: All adverse reactions identified in post-marketing experience are italicised.
Croatian: Sve nuspojave opažene nakon stavljanja lijeka u promet otisnute su kosim pismom.
English: Cases of intestinal obstruction have been reported in clinical studies.
Croatian: U kliničkim ispitivanjima su prijavljeni slučajevi opstrukcije crijeva.
English: One subject was weaned off their parenteral support while on teduglutide.
Croatian: Jednom bolesniku ukinuta je parenteralna potpora tijekom liječenja teduglutidom.
English: Uncommon (may affect up to 1 in 100 people) - Polyps (small abnormal growths) in your small bowel
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - polipi (male neprirodne izrasline) u tankom crijevu
English: Mannitol
Croatian: Otapalo
English: Materials provided in the pack: - 28 vials with 1.25 mg teduglutide as a powder - 28 pre-filled syringes with solvent
Croatian: Sadržaj pakiranja: - 28 bočica s 1,25 mg teduglutida u obliku praška - 28 napunjenih štrcaljki s otapalom
English: In the pivotal phase 3 double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition, 43 patients were randomised to a 0.05 mg/kg/day dose of teduglutide and 43 patients to placebo for up to 24 weeks.
Croatian: U ključnom dvostruko slijepom, placebom kontroliranom ispitivanju faze III u bolesnika sa SKC-om kojima je bila potrebna parenteralna prehrana, 43 bolesnika odabrana slučajnim odabirom primala su 0,05 mg/kg/dan teduglutida, a 43 bolesnika placebo do 24 tjedna.
English: The mean change in parenteral nutrition volume from baseline at Week 24, based on subject diary data, was -23.30 (±17.50) mL/kg/day, corresponding to -41.57% (±28.90); the mean change in the SOC arm was -6.03 (±4.5) mL/kg/day (corresponding to a -10.21% [±13.59]).
Croatian: Srednja vrijednost promjene volumena parenteralne prehrane od početnog do onog u 24. tjednu, na temelju podataka iz dnevnika ispitanika, iznosila je -23,30 (±17,50) ml/kg na dan, što je odgovaralo postotnoj promjeni od -41,57% (±28,90); srednja vrijednost promjene u skupini na standardnoj skrbi iznosila je -6,03 (±4,5) ml/kg na dan (što je odgovaralo postotnoj promjeni od -10,21% [±13,59]).
English: The pre-filled syringe must be assembled with a reconstitution needle.
Croatian: Na napunjenu štrcaljku treba dodati iglu za rekonstituciju.
English: There was no reduction in PN/IV infusion days per week in the SOC arm.
Croatian: U skupini na standardnoj skrbi nije bilo smanjenja broja dana na parenteralnoj prehrani / intravenskoj infuziji po tjednu.
English: 3.3 Turn the vial upside down, slide the tip of the reconstitution needle close to the stopper and allow all the medicine to fill the syringe by pulling the plunger back gently.
Croatian: 3.3 Okrenite bočicu naopačke te pomaknite vrh igle blizu čepa i pažljivim povlačenjem klipa prema dolje uvucite sav lijek u štrcaljku.
English: If you, or the carer, are injecting the medicine, you or the carer must receive adequate training by the doctor or nurse.
Croatian: Ako injekcije primjenjujete Vi ili ih primjenjuje njegovatelj, liječnik ili medicinska sestra moraju Vas ili njegovatelja za to primjereno obučiti.
English: If polyps are found before treatment with Revestive, the doctor will decide whether your child should use this medicine.
Croatian: Ako se ustanovi postojanje polipa prije nego što započne liječenje lijekom Revestive, liječnik će odlučiti smije li Vaše dijete primati ovaj lijek.
English: 3.1 Remove the reconstitution syringe from the reconstitution needle which is still in the vial and discard the reconstitution syringe.
Croatian: 3.1 Odvojite štrcaljku za pripremu od igle za pripremu koja je još uvijek u bočici, i bacite štrcaljku za pripremu.
English: All needles and syringes should be disposed of in a sharps disposal container.
Croatian: Sve igle i štrcaljke treba odložiti u spremnik za oštre predmete.
English: - if your child suffers from certain cardiovascular diseases (affecting the heart and/or blood vessels) such as high blood pressure (hypertension) or has a weak heart (cardiac insufficiency).
Croatian: Liječnik će to uzeti u obzir kad propisuje ovaj lijek. - ako Vaše dijete boluje od određenih kardiovaskularnih bolesti (koje zahvaćaju srce i/ili krvne žile) poput visokog krvnog tlaka (hipertenzije) ili ima oslabljeno srce (insuficijencija srca).
English: 2.7 Observe the vial for any undissolved powder.
Croatian: 2.7 Provjerite ima li u bočici neotopljenog praška.
English: No new safety signals have been identified in patients exposed to 0.05 mg/kg/day of teduglutide for up to 30 months in a long-term open-label extension study.
Croatian: Kod bolesnika koji su do 30 mjeseci u dugotrajnom otvorenom produžetku ispitivanja bili izloženi dozi teduglutida od 0,05 mg/kg/dan nisu ustanovljeni novi sigurnosni signali.
English: Fluid overload has been observed in clinical trials.
Croatian: U kliničkim ispitivanjima opaženo je preopterećenje tekućinom.
English: Common (may affect up to 1 in 10 people): - Flu (influenza) or flu-like symptoms - Decreased appetite - Swelling of hands and/or feet - Problems sleeping, anxiety - Cough, shortness of breath - Polyps (small abnormal growths) in your large bowel - Passing gas (flatulence) - Narrowing or blockage of your pancreatic duct, which may cause inflammation of the pancreas - Inflammation of the gallbladder
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - gripa ili simptomi slični gripi - smanjeni apetit - oticanje šaka i/ili stopala - teškoće sa spavanjem, tjeskoba - kašalj, nedostatak zraka - polipi (male neprirodne izrasline) u debelom crijevu - vjetrovi (flatulencija) - suženje ili začepljenost gušteračnog voda što može prouzročiti upalu gušterače - upala žučnog mjehura
English: Revestive 1.25 mg powder and solvent for solution for injection Teduglutide For children and adolescents
Croatian: Revestive 1,25 mg prašak i otapalo za otopinu za injekciju teduglutid Za djecu i adolescente
English: 3.4 Remove the injection syringe from reconstitution needle leaving the needle in the vial.
Croatian: 3.4 Odvojite injekcijsku štrcaljku od igle za pripremu, a iglu ostavite u bočici.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 adult patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Croatian: Nuspojave su prikupljene iz 2 placebom kontrolirana klinička ispitivanja teduglutida kod 109 odraslih bolesnika sa SKC-om liječenih dozom od 0,05 mg/kg/dan i 0,10 mg/kg/dan do 24 tjedna.
English: EU/1/12/787/003 28 vials
Croatian: EU/1/12/787/003 28 bočica
English: Your doctor will choose the dose that is right for you depending on your body weight.
Croatian: Vaše tjelesne težine odrediti dozu koja je primjerena za Vas.
English: - If you have any further questions, ask your child's doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se djetetovu liječniku, ljekarniku ili medicinskoj sestri.
English: EU/1/12/787/002 1 vial EU/1/12/787/001 28 vials
Croatian: EU/1/12/787/002 1 bočica EU/1/12/787/001 28 bočica
English: If you, or your carer, are injecting the medicine, you or your carer must receive adequate training by your doctor or nurse.
Croatian: Ako injekcije primjenjujete sami ili Vam ih primjenjuje njegovatelj, liječnik ili medicinska sestra moraju Vas ili Vašeg njegovatelja za to primjereno obučiti.
English: Increases in enteral nutrition volume and enteral calories Based on prescribed data, the mean percentage change from baseline at Week 12 in enteral volume, in the ITT population, was 25.82% (±41.59) compared to 53.65% (±57.01) in the standard of care cohort.
Croatian: Na temelju podataka o enteralnoj prehrani koju su propisali liječnici, u populaciji predviđenoj za liječenje srednja vrijednost postotka promjene u volumenu enteralne prehrane u odnosu na početnu vrijednost iznosila je u 12. tjednu 25,82% (±41,59) u usporedbi s 53,65% (±57,01) u skupini na standardnoj skrbi.
English: Following subcutaneous administration, similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling.
Croatian: Populacijsko farmakokinetičko modeliranje pokazalo je da je nakon supkutane primjene Cmax teduglutida bio sličan u svim dobnim skupinama.
English: One additional patient in the follow-up study was weaned off parenteral nutrition.
Croatian: U ispitivanju u svrhu praćenja parenteralna je prehrana ukinuta u još jednog dodatnog bolesnika.
English: Adverse reactions were retrieved from 2 placebo-controlled clinical studies with teduglutide in 109 patients with SBS treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day for up to 24 weeks.
Croatian: Nuspojave su prikupljene iz 2 placebom kontrolirana klinička ispitivanja teduglutida kod 109 bolesnika sa SKC-om liječenih dozom od 0,05 mg/kg/dan i 0,10 mg/kg/dan do 24 tjedna.
English: Revestive comes in pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Croatian: Revestive je dostupan u pakiranju s 1 bočicom praška i 1 napunjenom štrcaljkom ili s 28 bočica praška i 28 napunjenih štrcaljki.
English: No accumulation of teduglutide was observed following repeated subcutaneous administration.
Croatian: Nakon višestruke supkutane primjene nije zabilježena akumulacija teduglutida.
English: Gallbladder and bile ducts
Croatian: Žučni mjehur i žučni vodovi
English: Revestive comes in pack sizes of 28 vials of powder with 28 pre-filled syringes.
Croatian: Revestive je dostupan u pakiranju s 28 bočica praška i 28 napunjenih štrcaljki.
English: The doctor will perform further colonoscopies if your child continues treatment with Revestive.
Croatian: Ako Vaše dijete nastavi liječenje lijekom Revestive, liječnik će i nadalje provoditi kolonoskopiju.
English: Caution should be exercised when prescribing Revestive.
Croatian: Pri propisivanju lijeka Revestive potreban je oprez.
English: Pack sizes of 1 vial of powder with 1 pre-filled syringe or 28 vials of powder with 28 pre-filled syringes.
Croatian: Pakiranja s 1 bočicom praška s 1 napunjenom štrcaljkom ili s 28 bočica praška s 28 napunjenih štrcaljki.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Croatian: Prašak: L-histidin, manitol, natrijev fosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (za podešavanje pH), kloridna kiselina (za podešavanje pH).
English: One vial of powder contains 1.25 mg of teduglutide*.
Croatian: Jedna bočica praška sadrži 1,25 mg teduglutida*.
English: ), every patient should be assessed for the need of an enhanced surveillance schedule based on the patient characteristics (e.g., age and underlying disease, previous occurrence of polyps etc.).
Croatian: Kod svakog bolesnika treba na temelju bolesnikovih karakteristika (npr. dobi, bolesti u podlozi) procijeniti jesu li potrebne češće kontrole.
English: NOTE: Once prepared, the solution should be used immediately.
Croatian: Pripremljenu otopinu treba primijeniti odmah.
English: Pack size of 28 vials of powder with 28 pre-filled syringes.
Croatian: Pakiranje s 28 bočica praška i 28 napunjenih štrcaljki.
English: One vial of powder contains 5 mg of teduglutide*.
Croatian: Jedna bočica praška sadrži 5 mg teduglutida*.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate, sodium hydroxide (pH adjustment), hydrochloric acid (pH adjustment).
Croatian: - Drugi sastojci su L-histidin, manitol, natrijev fosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid (za podešavanje pH), kloridna kiselina (za podešavanje pH).
English: One vial of powder contains 1.25 mg of teduglutide.
Croatian: Jedna bočica praška sadrži 1,25 mg teduglutida.
English: Powder: L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Croatian: Prašak: L-histidin, manitol, natrijev fosfat hidrat, natrijev hidrogenfosfat heptahidrat.
English: If polyps are found before your treatment with Revestive, your doctor will decide whether you should use this medicine.
Croatian: Ako se ustanovi postojanje polipa prije nego što započnete liječenje lijekom Revestive, liječnik će odlučiti smijete li primati ovaj lijek.
English: In case of gallbladder or bile duct-related symptoms, the need for continued Revestive treatment should be reassessed.
Croatian: U slučaju pojave simptoma vezanih za žučni mjehur i žučne vodove, treba ponovno procijeniti potrebu za daljnjim liječenjem lijekom Revestive.
English: One vial of powder contains 5 mg of teduglutide.
Croatian: Jedna bočica praška sadrži 5 mg teduglutida.
English: - Dispose of all needles and syringes in a sharps disposal container.
Croatian: - Sve igle i štrcaljke odložite u spremnik za oštre predmete.
English: An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric subjects aged 1 year through 17 years who were dependent on parenteral support.
Croatian: U 59 pedijatrijskih ispitanika u dobi od 1 do 17 godina koji su ovisili o parenteralnoj potpori provedeno je dodatno randomizirano, dvostruko slijepo, multicentrično ispitivanje u trajanju od 24 tjedna.
English: Solvent Pre-filled syringe (glass) with plungers (bromobutyl) containing 0.5 ml of solvent.
Croatian: Napunjena štrcaljka (staklo) s klipom (brombutil), koja sadrži 0,5 ml otapala.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate Sodium hydroxide (pH adjustment) Hydrochloric acid (pH adjustment)
Croatian: L-histidin manitol natrijev fosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: Two (2) subjects were weaned off their parenteral support while on teduglutide.
Croatian: Parenteralna potpora ukinuta je kod 2 ispitanika tijekom liječenja teduglutidom.
English: - The other ingredients are L-histidine, mannitol, sodium phosphate monohydrate, disodium phosphate heptahydrate.
Croatian: - Drugi sastojci su L-histidin, manitol, natrijev fosfat hidrat, natrijev hidrogenfosfat heptahidrat.
English: Colo-rectal polyps
Croatian: Kolorektalni polipi
English: In case of recurrent intestinal obstructions, the need for continued Revestive treatment should be reassessed.
Croatian: U slučaju ponavljajuće opstrukcije crijeva treba ponovno procijeniti potrebu za daljnjim liječenjem lijekom Revestive.
English: However, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Croatian: Međutim, dokazano je da je otopina kemijski i fizikalno stabilna 24 sata na temperaturi od 25 °C.
English: Revestive 1.25 mg powder and solvent for solution for injection
Croatian: Revestive 1,25 mg prašak i otapalo za otopinu za injekciju
English: Revestive 5 mg powder and solvent for solution for injection
Croatian: Revestive 5 mg prašak i otapalo za otopinu za injekciju
English: There was no change from baseline in the standard of care cohort.
Croatian: U skupini na standardnoj skrbi nije bilo promjena u odnosu na početne vrijednosti.
English: If you have any further questions on the use of this medicine, ask your child's doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se djetetovu liječniku, ljekarniku ili medicinskoj sestri.
English: However, chemical and physical stability has been demonstrated for 3 hours at 25°C.
Croatian: Međutim, dokazano je da je otopina kemijski i fizikalno stabilna 3 sata na temperaturi od 25 °C.
English: Cholecystitis Cholecystitis acute
Croatian: Poremećaji jetre i žuči kolecistitis akutni kolecistitis
English: NOTE: The final solution should be clear.
Croatian: Pripremljena otopina mora biti bistra.
English: Assemble the pre-filled syringe
Croatian: Sastavite napunjenu štrcaljku
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako u svoga djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti djetetova liječnika ili ljekarnika.
English: Revestive 1.25 mg powder for solution for injection teduglutide
Croatian: Revestive 1,25 mg prašak za otopinu za injekciju teduglutid
English: A colonoscopy with removal of polyps should be performed at the time of starting treatment with Revestive.
Croatian: U vrijeme početka terapije lijekom Revestive potrebno je učiniti kolonoskopiju i odstraniti polipe.
English: Your doctor will perform further colonoscopies if you continue treatment with Revestive.
Croatian: Ako nastavite liječenje lijekom Revestive, liječnik će i nadalje provoditi kolonoskopiju.
English: Expel any excessive volume from the syringe with the needle cap still on until your dose is reached.
Croatian: Dok je poklopac još uvijek na igli, istisnite sav suvišni volumen iz štrcaljke tako da u njoj ostane količina koja odgovara Vašoj dozi.
English: There were no clinically relevant mean increases of C-reactive protein from baseline following long-term treatment with teduglutide for up to 30 months.
Croatian: Nakon dugotrajnog liječenja teduglutidom do 30 mjeseci, nije bilo klinički značajnih srednjih povećanja C-reaktivnog proteina u odnosu na početne vrijednosti.
English: Sodium phosphate monohydrate Disodium phosphate heptahydrate
Croatian: L-histidin manitol natrijev fosfat hidrat natrijev hidrogenfosfat heptahidrat
English: Dispose of all needles and syringes in a sharps disposal container.
Croatian: Sve igle i štrcaljke odložite u spremnik za oštre predmete.
English: After reconstitution, the solution should be used immediately.
Croatian: Otopinu treba primijeniti odmah nakon rekonstitucije.
English: Revestive 5 mg powder for solution for injection teduglutide
Croatian: Revestive 5 mg prašak za otopinu za injekciju teduglutid
English: Contact the doctor or the emergency unit if your child experiences severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Croatian: Javite se liječniku ili u hitnu medicinsku službu ako Vaše dijete osjeti jaku bol u trbuhu i dobije vrućicu.
English: Revestive 1.25 mg powder and solvent for solution for injection teduglutide
Croatian: Revestive 1,25 mg prašak i otapalo za otopinu za injekciju teduglutid
English: - If the child gets any side effects, talk to your child's doctor, pharmacist or nurse.
Croatian: - Ako u djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti djetetova liječnika, ljekarnika ili medicinsku sestru.
English: - if you are allergic to teduglutide or any of the other ingredients of this medicine (listed in section 6) or trace residues of tetracycline.
Croatian: - ako ste alergični na teduglutid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ili na tetraciklin koji je preostao u tragovima - ako imate ili se sumnja da imate rak - ako ste u posljednjih pet godina liječeni od raka probavnog sustava, uključujući jetru, žučni mjehur ili žučne vodove te gušteraču.
English: SOLVENT PREFILLED SYRINGE LABEL
Croatian: NALJEPNICA ZA NAPUNJENU ŠTRCALJKU S OTAPALOM
English: Contact your doctor or the emergency unit if you experience severe stomach ache and fever - Intestinal obstruction (blockage of the bowel).
Croatian: Javite se liječniku ili u hitnu medicinsku službu ako osjetite jaku bol u trbuhu i dobijete vrućicu.
English: After reconstitution, each vial contains 1.25 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Croatian: Nakon rekonstitucije svaka bočica sadrži 1,25 mg teduglutida u 0,5 ml otopine, što odgovara koncentraciji od 2,5 mg/ml.
English: Revestive 5 mg powder and solvent for solution for injection teduglutide
Croatian: Revestive 5 mg prašak i otapalo za otopinu za injekciju teduglutid
English: For children and adolescents
Croatian: Za djecu i adolescente
English: After reconstitution, each vial contains 5 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Croatian: Nakon rekonstitucije svaka bočica sadrži 5 mg teduglutida u 0,5 ml otopine, što odgovara koncentraciji od 10 mg/ml.
English: Reconstituted product Chemical and physical in-use stablility has been demonstrated for 24 hours up to 25°C.
Croatian: Za lijek u upotrebi dokazano je da je kemijski i fizikalno stabilan 24 sata na temperaturi do 25 C.
English: - After reconstitution, from a microbiological point of view, the solution should be used immediately.
Croatian: - S mikrobiološkog stajališta, otopinu treba primijeniti odmah nakon pripreme.
English: Complete weaning
Croatian: ROK VALJANOSTI
English: After reconstitution, from a microbiological point of view, the solution should be used immediately.
Croatian: S mikrobiološkog stajališta, otopinu treba primijeniti odmah nakon pripreme.
English: Reconstituted product Chemical and physical stability has been demonstrated for 3 hours at 25°C.
Croatian: Dokazano je da je lijek kemijski i fizikalno stabilan 3 sata na temperaturi od 25 C.
English: After reconstitution, each vial contains 1.25 mg teduglutide in 0.5 ml of solution, corresponding to a concentration of 2.5 mg/ml.
Croatian: Nakon pripreme za primjenu, svaka bočica sadrži 1,25 mg teduglutida u 0,5 ml otopine, što odgovara koncentraciji od 2,5 mg/ml.
English: No dose adjustment is necessary for paediatric patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B adult subjects.
Croatian: Na temelju ispitivanja provedenog u odraslih ispitanika s Child-Pugh stadijem B, u pedijatrijskih bolesnika s blagim i umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze.
English: Metabolism and nutrition disorders
Croatian: Kancerogenost/ mutagenost
English: Hepatobiliary disorders
Croatian: Krvožilni poremećaji sinkopa