FrancophonIA/ELRC3.0 huggingface dataset:
English: Spleen volume normalised by Months 12 and 24 for 9.7% of patients in the TKT024 Weekly group with splenomegaly.
Croatian: Volumen slezene se također normalizirao do 12. i 24. mjeseca za 9,7% u bolesnika sa splenomegalijom u ispitivanju TKT024 u skupini koja je lijek dobivala jednom tjedno.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded by your healthcare professional.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, Vaš zdravstveni radnik treba jasno evidentirati naziv i broj serije primijenjenog lijeka.
English: It is not known whether idursulfase is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se idursulfaza u majčino mlijeko.
English: In the post-hoc immunogenicity analysis of data from TKT024/024EXT studies, 51% (32/63) patients treated with 0.5mg/kg weekly idursulfase had at least 1 blood sample that tested positive for antiidursulfase antibodies, and 37 % (23/63) tested positive for antibodies on at least 3 consecutive study visits.
Croatian: U post-hoc analizi podatka o imunogenosti iz ispitivanja TKT024/024EXT, 51 % bolesnika (32/63) liječenih s 0,5 mg/kg idursulfaze tjedno imalo je najmanje 1 uzorak krvi pozitivan na protutijela na idursulfazu, a 37 % (23/63) ih je bilo pozitivno na protutijela u najmanje 3 uzastopna studijska posjeta.
English: All patients with the complete deletion/large rearrangement genotype developed antibodies, and the majority of them (7/8) also tested positive for neutralizing antibodies on at least 3 consecutive occasions.
Croatian: Svi bolesnici s potpunom delecijom/velikim preslagivanjem u genotipu razvila su protutijela, a većina (7/8) ih je također bila pozitivna na neutralizirajuća protutijela u najmanje tri uzastopna posjeta.
English: All patients with the frameshift/splice site mutation genotype developed antibodies and 4/6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Croatian: Svi bolesnici s „frameshift“/„splice site“ mutacijom u genotipu razvili su protutijela, a 4/6 je također bilo pozitivno na neutralizirajuća protutijela u najmanje tri uzastopna studijska posjeta.
English: Study TKT024
Croatian: Ispitivanje TKT024
English: During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Croatian: Tijekom kliničkih ispitivanja najčešće reakcije povezane s infuzijom uključivale su kožne reakcije (osip, pruritus, urtikariju), pireksiju, glavobolju, hipertenziju i navale crvenila.
English: Patients who tested antibody-positive displayed less reduction in urinary output of glycosaminoglycans than antibody-negative patients.
Croatian: Bolesnici koji su bili pozitivni na protutijela pokazali su manje smanjenje urinarnog izlučivanja glikozaminoglikana od bolesnika negativnih na protutijela.
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Način primjene Za uputu o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: At most time points tested, patients who were from the original TKT024 weekly treatment group improved their walking distance to a greater extent that patients in the other 2 treatment groups.
Croatian: U većini testiranih vremenskih točaka bolesnici koji su u ispitivanju TKT024 lijek dobivali jednom tjedno u većoj su mjeri poboljšali prijeđene udaljenosti u odnosu na bolesnike iz druge dvije liječene skupine.
English: - The solution in the vials should not be used if it is discoloured or if particulate matter is present.
Croatian: - Otopina u bočicama ne smije se koristiti ako je promijenila boju ili su u njoj prisutne čestice.
English: The other ingredients are Polysorbate 20, sodium chloride, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, monohydrate and water for injections.
Croatian: Drugi sastojaci su polisorbat 20, natrijev klorid, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat i voda za injekcije.
English: Changes in urinary GAG levels were the earliest signs of clinical improvement with idursulfase treatment and the greatest decreases in urinary GAG were seen within the first 4 months of treatment in all treatment groups; changes from Month 4 to 36 were small.
Croatian: Promjene u razini GAG-a u urinu bile su jedan od najranijih znakova kliničkog poboljšanja i najveći padovi u razini GAG-a u urinu zabilježeni su unutar prva 4 mjeseca liječenja u svim ispitivanim skupinama.
English: Among patients who were originally randomised to weekly idursulfase in TKT024, mean maximum improvement in distance walked during six minutes occurred at Month 20 and mean percent predicted FVC peaked at Month 16.
Croatian: U bolesnika koji su u početku randomizirani u skupinu koja je primala idursulfazu jednom tjedno u kliničkom ispitivanju TKT024, srednja vrijednost maksimalnog povećanja u prohodanim udaljenostima tijekom šest minuta nastupilo je u 20. mjesecu, a srednja vrijednost postotka predviđenog FVC-a bila je najveća u 16. mjesecu.
English: ≥ 40 and < 50 (n=5)
Croatian: ≥ 40 i < 50 (n=5)
English: Analyses of genotypes of patients in study HGT-ELA-038
Croatian: Analize genotipova bolesnika iz ispitivanja HGT-ELA-038
English: For single use only Read the package leaflet before use Intravenous use
Croatian: Prije uporabe pročitajte uputu o lijeku Za intravensku primjenu
English: The complete deletion/ large rearrangement genotype was most commonly associated with development of high titre of antibodies and neutralising antibodies to idursulfase and was most likely to display a muted response to the medicinal product.
Croatian: Potpuna delecija/znatno preslagivanje genotipa najčešće je povezan s razvojem visokog titra protutijela i neutralizirajućih protutijela na idursulfazu s najvećom vjerojatnošću slabog odgovora na lijek.
English: Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Croatian: Zbog metaboliziranja u staničnim lizosomima nije vjerojatno da će doći do interakcije idursulfaze s drugim lijekovima putem citokroma P450.
English: Cyanosis, arrhythmia, tachycardia
Croatian: Cijanoza, aritmija, tahikardija
English: • Shortness of breath, wheezing
Croatian: • Nedostatak zraka, piskanje pri disanju
English: ≥ 30 and < 40 (n=9)
Croatian: ≥ 30 i < 40 (n=9)
English: Patients who developed a high titre of antibodies displayed less response to idursulfase as assessed by urine output of glycosaminoglycans and by liver and spleen size.
Croatian: Bolesnici koji su razvili visoki titar protutijela pokazali su slabiji odgovor na idursulfazu, što je ocijenjeno izlučivanjem glikozaminoglikana u urinu i veličinom jetre i slezene.
English: Patients with this genotype have a higher probability of developing infusion-related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume compared to patients with the missense genotype.
Croatian: Bolesnici s tim genotipom imaju višu vjerojatnost da će razviti nuspojave povezane s infuzijom i skloniji su pokazivanju slabog odgovora, što je procijenjeno smanjivanjem izlučivanja glikozaminglikana u urinu, veličinom jetre i veličinom slezene u usporedbi s bolesnicima koji imaju „missense“ mutaciju (mutacija krivog smisla).
English: Study HGT-ELA-038
Croatian: Ispitivanje HGT-ELA-038
English: Anaphylactoid/ anaphylactic reaction
Croatian: Anafilaktoidne/anafilaktičke reakcije
English: Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m (maximum at Month 20) and from 6.4% to 13.3% (maximum at Month 24) respectively.
Croatian: TKT024 koji su bili na placebu) uočen je u udaljenostima tijekom šestominutnog testa hodanja (6MWT) kod svih bolesnika u većini testiranih vremenskih točaka, sa značajnim porastom u srednjim vrijednostima i u postotcima u rasponu od 13,7 m do 41,5 m (najviše u 20. mjesecu), odnosno od 6,4% do 13,3% (najviše u 24. mjesecu).
English: Common side effects (may affect up to 1 in 10 people) are:
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) su:
English: Patients with complete deletion/large rearrangement genotype have a higher probability of developing infusion related adverse events (see section 4.4).
Croatian: Kod bolesnika s potpunom delecijom/velikim preslagivanjem u genotipu veća je vjerojatnost da će se pojaviti nuspojave povezane s infuzijom (vidjeti dio 4.4).
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili medicinskoj sestri.
English: The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Croatian: Djelatna tvar je idursulfaza, oblik ljudskog enzima iduronat-2-sulfataze.
English: Patients with the complete deletion/large rearrangement genotype Paediatric patients with the complete deletion/large rearrangement genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to exposure to idursulfase.
Croatian: Pedijatrijski bolesnici s potpunom delecijom/velikim preslagivanjem u genotipu imaju veliku vjerojatnost da će razviti protutijela, uključujući neutralizirajuća protutijela, kao odgovor na izloženost idursulfazi.
English: ≥ 20 and < 30 (n=18)
Croatian: ≥ 20 i < 30 (n=18)
English: Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT024 phase II/III 52-week placebo-controlled study were almost all mild to moderate in severity.
Croatian: Prijavljene nuspojave za 32 bolesnika liječena s 0,5 mg/kg idursulfaze jednom tjedno u placebom kontroliranom ispitivanju faze II/III, TKT024, u trajanju od 52 tjedna bile su uglavnom blage do umjerene težine.
English: A clear to slightly opalescent, colourless solution.
Croatian: Bistra do blago opalescentna, bezbojna otopina.
English: Gastrointestinal disorders Abdominal pain, nausea, diarrhoea, vomiting
Croatian: Poremećaji probavnog sustava Bol u abdomenu, mučnina, dijareja, povraćanje
English: No formal medicinal product interaction studies have been conducted with idursulfase.
Croatian: Službena ispitivanja interakcija idursulfaze s drugim lijekovima nisu provedena.
English: Pharmacokinetic parameters at week 1 as a function of body weight in studies TKT024 and HGT-ELA-038
Croatian: Tablica 4. Farmakokinetički parametri u 1. tjednu kao funkcija tjelesne težine u ispitivanjima TKT024 i HGT-ELA-038
English: Each vial contains 3 ml of concentrate for solution for infusion.
Croatian: Svaka bočica sadrži 3 ml koncentrata za otopinu za infuziju.
English: How to store Elaprase
Croatian: Kako čuvati Elaprase
English: At their final visit 21/31 patients in the TKT024 Weekly group, 24/32 in the TKT024 EOW group and 18/31 patients in the TKT024 placebo group had final normalised urine GAG levels that were below the upper limit of normal.
Croatian: Pri završnom pregledu 21 od 31 bolesnika iz ispitivanja TKT024 skupine koja je dobivala lijek jednom tjedno, 24/32 bolesnika iz ispitivanja TKT024 skupine koja je dobivala lijek svaki drugi tjedan i 18/31 bolesnika iz skupine ispitivanja TKT024 koja je dobivala placebo imali su normalizirane razine GAG-a u urinu koje su bile ispod gornje granice normale.
English: • Abdominal pain, nausea, vomiting, frequent and/or loose stools
Croatian: • Bol u trbuhu, mučnina, povraćanje, česte i/ili mekane stolice
English: 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
Croatian: Bočica od 5 ml (staklo tip I) s čepom (butilna guma obložena fluororesinom), jednodijelnim prstenom i plavim „flip-off“ zatvaračem.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane od najozbiljnije do najmanje ozbiljne.
English: Treatment of Hunter syndrome patients with intravenous idursulfase provides exogenous enzyme for uptake into cellular lysosomes.
Croatian: Liječenje bolesnika s Hunterovim sindromom intravenskom primjenom idursulfaze osigurava egzogeni enzim za unos u stanične lizosome.
English: Pharmacokinetic parameters at week 1 as a function of age in Studies TKT024 and HGT-ELA-038
Croatian: Tablica 3. Farmakokinetički parametri u 1. tjednu kao funkcija dobi u ispitivanjima TKT024 i HGT-ELA-038
English: Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency.
Croatian: Bolesnici s oštećenjem funkcije bubrega ili jetre Nema kliničkih iskustava u bolesnika s bubrežnom ili jetrenom insuficijencijom (vidjeti dio 5.2).
English: Animal studies have shown excretion of idursulfase in breast milk.
Croatian: U ispitivanjima na životinjama nije uočeno izlučivanje idursulfaze u majčino mlijeko.
English: Elaprase 2 mg/ml concentrate for solution for infusion
Croatian: Elaprase 2 mg/ml koncentrat za otopinu za infuziju
English: How to use Elaprase
Croatian: Kako primjenjivati Elaprase
English: There have been post-marketing reports of anaphylactoid/anaphylactic reactions (see section 4.4).
Croatian: Prijavljeni su slučajevi anafilaktoidnih/anafilaktičkih reakcija u izvješćima nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7.
English: Anaphylactoid/anaphylactic reactions, which have the potential to be life threatening, have been observed in some patients treated with idursulfase up to several years after initiating treatment.
Croatian: U nekoliko bolesnika liječenih idursulfazom do nekoliko godina nakon početka liječenja, uočena je pojava anafilaktoidnih/anafilaktičkih reakcija potencijalno opasnih za život.
English: Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion .
Croatian: Razrijedite ukupni volumen potrebnog Elaprase koncentrata za otopinu za infuziju u 100 ml otopine natrijevog klorida za infuziju od 9 mg/ml (0,9%).
English: Adverse reaction (preferred term)
Croatian: Nuspojava (preporučeni pojam)
English: • Hives, rash, itching, redness of the skin
Croatian: • Urtikarija, osip, svrbež, crvenilo kože
English: Elaprase 2 mg/ml sterile concentrate idursulfase
Croatian: Elaprase 2 mg/ml sterilni koncentrat idursulfaza i.v.
English: * idursulfase is produced by recombinant DNA technology in a continuous human cell line.
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1. *idursulfaza se proizvodi tehnologijom rekombinantne DNK na kontinuiranoj liniji ljudskih stanica.
English: Tabulated list of adverse reactions
Croatian: Tablica s popisom nuspojava
English: Idursulfase
Croatian: Sljedivost
English: This medicinal product contains 0.482 mmol sodium (or 11.1 mg) per vial.
Croatian: Ovaj lijek sadrži 0,482 mmol (ili 11,1 mg) natrija po bočici, što odgovara 0,6 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: - The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Croatian: - Ukupni potrebni volumen lijeka Elaprase treba razrijediti u 100 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za infuziju.
English: Elaprase 2 mg/ml concentrate for solution for infusion idursulfase
Croatian: Elaprase 2 mg/ml koncentrat za otopinu za infuziju idursulfaza
English: The most common of these infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria, and erythema), pyrexia, flushing, wheezing, dyspnoea, headache, vomiting,
Croatian: Najčešće reakcije povezane s infuzijom uključivale su kožne reakcije (osip, pruritus, urtikariju i eritem), vrućicu, navale crvenila, piskanje pri disanju, dispneju, glavobolju, povraćanje, bol u abdomenu, mučninu i bol u prsnom košu.
English: Excipient with known effect Each vial contains 0.482 mmol of sodium.
Croatian: Jedna bočica sadrži 0,482 mmol natrija.
English: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Wheezing, dyspnoea
Croatian: Krvožilni poremećaji Navale crvenila Hipertenzija, hipotenzija Poremećaji dišnog sustava, prsišta i sredoprsja Piskanje pri disanju, dispneja
English: The solution should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Prije primjene potrebno je vizualno pregledati otopinu na prisutnost čestica i promjenu boje.
English: % Predicted FVC 4.2 (1.6)
Croatian: % predviđenog FVC-a
English: Assessment of long term pulmonary morbidity (e.g., incidence of infections, pulmonary function status) and mortality Assessment of long term cardiovascular morbidity (e.g., incidence of events, and echocardiography data, where available) and mortality Assessment of long term urinary GAG excretion patterns Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
Croatian: - Procjena dugotrajnog kardiovaskularnog pobolijevanja (npr. incidencija događaja, podaci ehokardiografije, kada su dostupni) i smrtnosti
English: Each vial of Elaprase contains 6 mg of idursulfase.
Croatian: Jedna bočica lijeka Elaprase sadrži 6 mg idursulfaze.
English: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Water for injections
Croatian: polisorbat 20 natrijev klorid natrijev hidrogenfosfat, heptahidrat natrijev dihidrogenfosfat, hidrat voda za injekcije
English: • Dizziness, tremor
Croatian: • Omaglica, nevoljno drhtanje
English: Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use.
Croatian: Elaprase je namijenjen za intravensku infuziju i mora se prije primjene razrijediti u 0,9%tnoj (9 mg/ml) otopini natrijevog klorida za infuziju.
English: Each ml contains 2 mg of idursulfase
Croatian: Svaki ml sadrži 2 mg idursulfaze
English: • Chest pain
Croatian: • Bol u prsnom košu
English: Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, erythema Musculoskeletal and connective disorders Arthralgia General disorders and administration site conditions Pyrexia, chest pain
Croatian: Poremećaji kože i potkožnog tkiva Urtikarija, osip, pruritus, eritem Poremećaji mišićno-koštanog sustava i vezivnog tkiva Artralgija
English: The mean and percent changes from treatment baseline were greatest in the group of patients from the TKT024 study who had received the weekly dosing, across all time points.
Croatian: Najveći porast u srednjim vrijednostima i postotcima u odnosu na početne vrijednosti uočen je u skupini koja je tijekom ispitivanja TKT024 primala lijek jednom tjedno u svim vremenskim točkama.
English: Each ml contains 2 mg of idursulfase*.
Croatian: Jedan ml sadrži 2 mg idursulfaze*.
English: Elaprase has to be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion before use.
Croatian: Elaprase mora prije primjene biti razrijeđen u 9 mg/ml (0,9%-tnoj) otopini natrijevog klorida za infuziju.
English: Sodium chloride
Croatian: Idursulfaza Placebo
English: • Infusion-site swelling, swelling of the extremities, facial swelling
Croatian: • Oticanje na mjestu infuzije, oticanje udova, oticanje lica
English: All patients received weekly idursulfase up to 3.2 years in an extension to this study (TKT024EXT).
Croatian: U nastavku ovog ispitivanja (TKT024EXT) svi su bolesnici primali idursulfazu jednom tjedno tijekom 3,2 godine.
English: Each ml contains 2 mg of idursulfase.
Croatian: Jedan ml sadrži 2 mg idursulfaze.
English: Each vial contains 6 mg of idursulfase.
Croatian: Svaka bočica sadrži 6 mg idursulfaze.
English: • Swollen tongue, indigestion
Croatian: • Natečen jezik, probavne tegobe
English: VIAL
Croatian: OBLIK
English: abdominal pain, nausea, and chest pain.
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrućica, bol u prsnom košu
English: The majority of these reactions were mild or moderate.
Croatian: Većina tih reakcija bila je blaga ili umjerena.
English: If a benefit is not observed, treatment should be stopped.
Croatian: Ne dođe li do poboljšanja, liječenje se mora prekinuti.
English: Furthermore, Revestive showed an acceptable safety profile.
Croatian: Osim toga, pokazalo se da Revestive ima prihvatljiv sigurnosni profil.
English: Revestive teduglutide
Croatian: Revestive teduglutid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Revestive na snazi u Europskoj uniji od 30. kolovoza 2012.
English: What measures are being taken to ensure the safe and effective use of Revestive?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Revestive?
English: What is Revestive and what is it used for?
Croatian: Što je Revestive i za što se koristi?
English: Patients or their carers can inject the medicines once they have received adequate training.
Croatian: Bolesnici ili njihovi njegovatelji lijek mogu injektirati nakon što prođu odgovarajuću obuku.
English: Revestive is given as an injection under the skin of the abdomen.
Croatian: Revestive se primjenjuje kao injekcija pod kožu abdomena.
English: The company will provide more data about the medicine's safety from a registry of patients.
Croatian: Tvrtka će dostaviti više podataka o sigurnoj primjeni lijeka iz registra bolesnika.
English: It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years.
Croatian: Ne smije se koristiti u osoba koje su imale gastrointestinalni rak (rak želudca, crijeva ili jetre) u zadnjih pet godina.
English: The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je zaključio da koristi od lijeka Revestive nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje u promet.
English: Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely.
Croatian: Bolesnici kojima je potrebna velika količina parenteralne prehrane mogu imati koristi od značajnog smanjenja potrebne količine, dok bolesnici kojima je potrebna manja količina imaju šanse za potpuno izlječenje.
English: This is a summary of the European public assessment report (EPAR) for Revestive.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Revestive.
English: The full EPAR for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Revestive nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Revestive
Croatian: Ostale informacije o lijeku Revestive
English: The medicine can only be obtained with a prescription, and treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje se smije započeti samo pod nadzorom liječnika s iskustvom u liječenju sindroma kratkog crijeva.