FrancophonIA/ELRC3.0 huggingface dataset:
English: A periodic eye examination is needed to identify this condition early and timely treatment should be provided when it occurs to prevent vision loss.
Croatian: Potrebni su periodični pregledi očiju kako bi se ovo stanje rano otkrilo i kad se utvrdi, potrebno je na vrijeme početi s liječenjem kako bi se spriječio gubitak vida.
English: For the immediate-release formulation of cysteamine bitartrate, approximately 35% of patients can be expected to experience adverse reactions.
Croatian: Pri uporabi oblika cisteaminhidrogentartarata s trenutnim oslobađanjem, očekuje se kako će približno 35% bolesnika imati nuspojave.
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Rijetke nuspojave (mogu zahvatiti do 1 na 100 osoba):
English: INFORMATION IN BRAILLE PROCYSBI 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU PROCYSBI 75 mg
English: The cysteamine dose can be increased to a maximum of 1.95 g/m2/day to achieve this level.
Croatian: Doza cisteamina može se povećati na najviše 1,95 g/m2/dan kako bi se postigla ta razina.
English: PROCYSBI may need to be temporarily stopped until the rash goes away.
Croatian: Može biti potrebno privremeno prekinuti uzimanje lijeka PROCYSBI dok osip ne nestane.
English: Cysteamine may cause drowsiness.
Croatian: Cisteamin može uzrokovati omamljenost.
English: If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.
Croatian: Ako se ustanovi ili planira trudnoća, treba pažljivo razmotriti liječenje i bolesnici se mora objasniti mogući teratogeni rizik cisteamina.
English: It cannot be excluded that cysteamine is a clinically relevant inducer of CYP enzymes, inhibitor of P-gp and BCRP at the intestinal level and inhibitor of liver uptake transporters (OATP1B1, OATP1B3 and OCT1).
Croatian: Ne može se isključiti da je cisteamin klinički značajan induktor CYP enzima, inhibitor P-gp-a i BCRPa na razini crijeva te inhibitor jetrenih transportera za unos (OATP1B1, OATP1B3 i OCT1).
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) was first described in cystic fibrosis patients who were given high doses of pancreatic enzymes in the form of tablets with an enteric coating of methacrylic acid - ethyl acrylate copolymer (1:1), one of the excipients in PROCYSBI.
Croatian: Strikture ileocekuma i debelog crijeva (fibrozirajuća kolonopatija) su prvo opisane kod bolesnika s cističnom fibrozom koji su primali visoke doze gušteračnih enzima u obliku tableta s želučanootpornom ovojnicom od kopolimera etil akrilata metakrilne kiseline (1:1), jedne od pomoćnih tvari lijeka PROCYSBI.
English: * measured using the mixed leukocyte assay
Croatian: *mjereno testom s pomiješanim leukocitima
English: Intact capsules of PROCYSBI should not be administered to children under the age of approximately 6 years due to risk of aspiration (see section 4.2).
Croatian: Djeci mlađoj od približno 6 godina ne smiju se davati cijele kapsule lijeka PROCYSBI zbog rizika od aspiracije (vidjeti dio 4.2).
English: Women of child-bearing potential should be advised to alert the treating physician if they become pregnant during treatment.
Croatian: Ženama koje mogu zatrudnjeti mora se savjetovati da obavijeste svog liječnika ako zatrudne tijekom liječenja.
English: In order for this medicine to work correctly, you must do the following: - Swallow the whole capsule with an acidic drink (such as orange juice or any acidic juice) or water.
Croatian: Kako bi lijek ispravno djelovao, morate provoditi sljedeće: - Progutajte cijelu kapsulu s kiselim napitkom (kao što je sok od naranče ili bilo koji kiseli sok) ili vodom.
English: Histology showed a membranous glomerulonephritis of the renal allograft in one case and hypersensitivity interstitial nephritis in the other.
Croatian: Histološki nalaz bio je membranski glomerulonefritis bubrežnog alopresatka u jednom i intersticijski nefritis uslijed preosjetljivosti u drugom slučaju.
English: Oral cysteamine has not been shown to prevent eye deposition of cystine crystals.
Croatian: Nije dokazano da oralni cisteamin sprječava odlaganje kristala cistina u oku.
English: Your doctor will monitor you for benign intracranial hypertension (or pseudotumor cerebri (PTC)) and/or swelling of the optic nerve (papilledema) associated with cysteamine treatment.
Croatian: Vaš liječnik će Vas pratiti za benignu intrakranijalnu hipertenziju (ili pseudotumor cerebri) i/ili oticanje vidnog živca (edem papile) koji su povezani s liječenjem cisteaminom.
English: Uncommon: Somnolence, convulsions Very common: Vomiting, nausea, diarrhoea Common: Abdominal pain, breath odour, dyspepsia, gastroenteritis
Croatian: Manje često: Somnolencija, konvulzije Vrlo često: Povraćanje, mučnina, proljev Često: Bol u abdomenu, zadah, dispepsija, gastroenteritis
English: The determination of WBC cystine and/or plasma cysteamine must be obtained 12.5 hours after the evening dose the day before, and therefore 30 minutes after the following morning dose is given.
Croatian: Određivanje cistina u leukocitima i/ili koncentracije cisteamina u plazmi mora se provesti 12,5 sati nakon večernje doze prethodnog dana i stoga 30 minuta poslije uzimanja iduće jutarnje doze.
English: Two (2) patients were excluded from the per-protocol analysis because their WBC cystine level increased over 2 nmol hemicystine/mg protein during the immediate-release cysteamine treatment period.
Croatian: Dva (2) ispitanika su isključena iz analize prema planu ispitivanja jer se njihova razina cistina u leukocitima povećala iznad 2 nmola hemicistina/mg proteina tijekom razdoblja liječenja cisteaminom s trenutnim oslobađanjem.
English: Physicians should instruct patients to report any of the following symptoms: headache, tinnitus, dizziness, nausea, diplopia, blurred vision, loss of vision, pain behind the eye or pain with eye movement.
Croatian: Liječnici moraju uputiti bolesnika da izvijesti o bilo kojem od sljedećih simptoma: glavobolja, tinitus, omaglica, mučnina, diplopija, zamućeni vid, gubitak vida, bol iza oka ili bol pri očnim pokretima.
English: Cysteamine therapy must be initiated promptly once the diagnosis is confirmed (i.e., increased WBC cystine) to achieve maximum benefit.
Croatian: Liječenje cisteaminom mora se započeti odmah nakon potvrde dijagnoze (tj. povišenog cistina u leukocitima) kako bi se postigla maksimalna korist.
English: Post-marketing experience with immediate-release cysteamine bitartrate Benign intracranial hypertension (or pseudotumor cerebri (PTC)) with papilledema; skin lesions, molluscoid pseudotumors, skin striae, skin fragility; joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture and scoliosis have been reported with immediate-release cysteamine bitartrate (see section 4.4).
Croatian: Za cisteaminhidrogentartarat s trenutnim oslobađanjem prijavljeni su benigna intrakranijalna hipertenzija (ili pseudotumor cerebri) s edemom papile; kožne lezije, moluskoidni pseudotumori, strije, lomljivost kože; hiperekstenzija zglobova, bol u nogama, genu valgum, osteopenija, kompresivne frakture i skolioza (vidjeti dio 4.4).
English: In this study, the WBC cystine measured using the mixed leukocyte assay was always on average under optimal control at < 1 nmol hemicystine/mg protein.
Croatian: U ovom ispitivanju, razina cistina u leukocitima (mjerena testom s pomiješanim leukocitima) je uvijek bila u prosjeku pod optimalnom kontrolom na < 1 nmol hemicistina/mg proteina.
English: White blood cell (WBC) cystine concentration may for instance be measured by a number of different techniques such as specific WBC subsets (e.g., granulocyte assay) or the mixed leukocyte assay with each assay having different target values.
Croatian: Koncentraciju cistina u leukocitima može se, primjerice, mjeriti velikim brojem različitih tehnika kao što su testovi s određenom podvrstom leukocita (npr. granulocitni test) ili test s pomiješanim leukocitima, s time da svaki test ima različite ciljne vrijednosti.
English: Single doses of the drug inhibit prolactin secretion in animals.
Croatian: Jednostruke doze lijeka inhibiraju lučenje prolaktina kod životinja.
English: A pivotal phase 3 randomized, crossover PK and PD study (which was also the first ever randomized study with immediate-release cysteamine bitartrate) demonstrated that at steady-state, patients receiving PROCYSBI every 12 hours (Q12H) maintained a comparable depletion of WBC cystine levels compared to immediate-release cysteamine bitartrate every 6 hours (Q6H).
Croatian: Pivotalno randomizirano, ukriženo ispitivanje faze 3 za FK (farmakokinetiku) i FD (farmakodinamiku) (koje je također prvo ikad randomizirano ispitivanje cisteaminhidrogentartarata s trenutnim oslobađanjem) pokazalo je da u stanju dinamičke ravnoteže ispitanici koji primaju PROCYSBI svakih 12 sati (Q12H) održavaju smanjenje razina cistina u leukocitima koje je usporedivo s onim cisteaminhidrogentartarata s trenutnim oslobađanjem svakih 6 sati (Q6H).
English: No carcinogenic studies have been conducted with cysteamine bitartrate gastro-resistant hard capsules.
Croatian: Nisu provedena ispitivanja kancerogenosti sa želučanootpornim tvrdim kapsulama cisteaminhidrogentartarata.
English: Low white blood cell count.
Croatian: Nizak broj bijelih krvnih stanica (leukocita).
English: Take the capsule with an acidic drink (such as orange juice or any acidic juice) or water.
Croatian: Uzmite kapsulu s kiselim napitkom (kao što je sok od naranče ili bilo koji kiseli sok) ili vodom.
English: Clinical studies experience with PROCYSBI
Croatian: Iskustva iz kliničkih ispitivanja s lijekom PROCYSBI
English: Transferring patients from immediate-release cysteamine bitartrate hard capsules Patients with cystinosis taking immediate-release cysteamine bitartrate may be transferred to a total daily dose of PROCYSBI equal to their previous total daily dose of immediate-release cysteamine bitartrate.
Croatian: Prelaženje bolesnika s tvrdih kapsula s trenutnim oslobađanjem cisteaminhidrogentartarata Bolesnici s cistinozom koji uzimaju cisteaminhidrogentartarat s trenutnim oslobađanjem mogu prijeći na ukupnu dnevnu dozu lijeka PROCYSBI koja odgovara njihovoj prethodnoj dnevnoj dozi cisteaminhidrogentartarata s trenutnim oslobađanjem.
English: There have been reports of benign intracranial hypertension (or pseudotumor cerebri (PTC)) and/or papilledema associated with cysteamine bitartrate treatment that has resolved with the addition of diuretic therapy (post-marketing experience with the immediate-release cysteamine bitartrate).
Croatian: Postoje izvješća o benignoj intrakranijalnoj hipertenziji (ili pseudotumor cerebri) i/ili edemu papile povezanim s liječenjem cisteaminhidrogentartaratom koji su se povukli uz dodatak diuretika u terapiju (iskustvo poslije stavljanja lijeka u promet s cisteaminhidrogentartaratom s trenutnim oslobađanjem).
English: This may be followed by 250 mL of an acceptable acidic liquid - fruit juice (e.g., orange juice or any acidic fruit juice) or water.
Croatian: Nakon toga može se popiti 250 ml odgovarajuće kisele tekućine - voćnog soka (npr. sok od naranče ili bilo koji kiseli voćni sok) ili vode.
English: Severe allergic reaction (seen uncommonly): Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava - možda će Vam biti potrebno hitno medicinsko liječenje: Teška alergijska reakcija (javlja se manje često): Potražite hitnu liječničku pomoć ako imate bilo koji od ovih znakova alergijske reakcije: osip; teškoće disanja; oteklina lica, usana, jezika ili grla.
English: Patients should try to consistently avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing.
Croatian: Bolesnici moraju pokušati dosljedno izbjegavati obroke i mliječne proizvode najmanje 1 sat prije i 1 sat poslije uzimanja lijeka PROCYSBI.
English: This medicinal product can be administered by swallowing the intact capsules as well as sprinkling the capsule contents (enteric coated beads) on food or delivery through a gastric feeding tube.
Croatian: Ovaj se lijek može primjenjivati tako da se kapsule progutaju cijele, kao i da se sadržaj kapsule (želučanootporne kuglice) pospe po hrani ili unese kroz nazogastričnu sondu za hranjenje.
English: There have been reports of serious skin lesions in patients treated with high doses of immediaterelease cysteamine bitartrate or other cysteamine salts that have responded to cysteamine dose reduction.
Croatian: Postoje izvješća o ozbiljnim kožnim lezijama kod bolesnika liječenih visokim dozama cisteaminhidrogentartarata s trenutnim oslobađanjem ili drugim solima cisteamina, koja su odgovorila na smanjenje doze cisteamina.
English: The cap is child resistant and has a foil seal.
Croatian: Zatvarač je siguran za djecu i zapečaćen je folijom.
English: In vitro: Cysteamine bitartrate is a substrate of P-gp and OCT2, but not a substrate of BCRP, OATP1B1, OATP1B3, OAT1, OAT3 and OCT1.
Croatian: In vitro: Cisteaminhidrogentartarat je supstrat P-gp-a i OCT2, no nije supstrat BCRP, OATP1B1, OATP1B3, OAT1, OAT3 i OCT1.
English: The targeted maintenance dose of 1.3 g/m2/day can be approximated according to the following table, which takes surface area as well as weight into consideration.
Croatian: Novodijagnosticirani bolesnici u pedijatrijskoj populaciji Ciljna doza održavanja od 1,3 g/m2/dan može se približno odrediti prema sljedećoj tablici koja u obzir uzima i površinu tijela i tjelesnu težinu.
English: Cysteamine bitartrate can be administered with an acidic fruit juice or water.
Croatian: Cisteaminhidrogentartarat se može primijeniti s kiselim voćnim sokom ili vodom.
English: The mixture must be administered (drunk) within 30 minutes after preparation and must be refrigerated from the time of preparation to the time of administration.
Croatian: Smjesa se mora primijeniti (popiti) unutar 30 minuta nakon pripreme i mora se čuvati na hladnom od trenutka pripreme do primjene.
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe PROCYSBI prior to the launch.
Croatian: Nositelj odobrenja će prije stavljanja lijeka u promet pripremiti edukativne pakete namijenjene svim liječnicima za koje se očekuje da će propisivati PROCYSBI.
English: Dose administration options are provided below:
Croatian: Mogućnosti za primjenu doze su navedene u nastavku:
English: Capsules for either the morning or evening dose should be opened and the contents sprinkled onto approximately 100 grams of apple sauce or berry jelly.
Croatian: Kapsule za jutarnju ili večernju dozu moraju se otvoriti i sadržaj se mora posuti na približno 100 grama pirea od jabuke ili želea od bobica.
English: To get the most benefit from this medicine, try to avoid meals and dairy products for at least 1 hour before and 1 hour after PROCYSBI dosing.
Croatian: Kako bi Vam lijek najviše koristio, pokušajte dosljedno izbjegavati obroke i mliječne proizvode najmanje 1 sat prije i 1 sat nakon uzimanja lijeka PROCYSBI.
English: Tell your doctor right away if you develop any of the following symptoms while taking PROCYSBI: headache, buzzing or "whooshing" sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye or pain with eye movement.
Croatian: Odmah se javite svom liječniku ako razvijete bilo koji od sljedećih simptoma dok uzimate PROCYSBI: glavobolja, zujanje ili šum u uhu, omaglica, mučnina, dvoslike, zamućeni vid, gubitak vida, bol iza oka ili bol pri očnim pokretima.
English: The total usual dose should not exceed 1.95 g/m2/day.
Croatian: Uobičajena ukupna doza ne smije premašivati 1,95 g/m2/dan.
English: PROCYSBI is indicated for the treatment of proven nephropathic cystinosis.
Croatian: PROCYSBI je indiciran za liječenje dokazane nefropatske cistinoze.
English: The maximum recommended dose of cysteamine is 1.95 g/m2/day.
Croatian: Maksimalna preporučena doza cisteamina je 1,95 g/m2/dan.
English: Cysteamine therapy should be initiated promptly after confirmation of the diagnosis of cystinosis to achieve maximum benefit.
Croatian: Liječenje cisteaminom mora se započeti odmah nakon potvrde dijagnoze kako bi se postigla najveća korist od liječenja.
English: PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 60 capsules
Croatian: OBLIK I SADRŽAJ Želučanootporna tvrda kapsula 60 kapsula
English: The cylinders may be discarded with the bottle after use.
Croatian: Nakon uporabe cilindrični se spremnici mogu baciti zajedno s bocom.
English: (1:1), hypromellose, talc, triethyl citrate, sodium lauryl sulfate.
Croatian: hipromeloza, talk, trietilcitrat, natrijev laurilsulfat.
English: Each gastro-resistant hard capsule contains 25 mg or 75 mg of cysteamine.
Croatian: Svaka tvrda želučanootporna kapsula sadrži 25 mg ili 75 mg cisteamina.
English: •The need to advise patients about: The method of administration and timing of medicine intake The need to contact the treating physician if they experience the following events: Problems or changes with their skin Upset in their normal bowel habit, Lethargy, somnolence depression, fits Any suspicion that they might be pregnant
Croatian: Potrebu da se obrate svom liječniku ako se javi sljedeće: Problemi ili promjene na koži Promjene u njihovom normalnom radu crijeva, Letargija, pospanost, depresija, napadaji Bilo kakva sumnja da bi mogle biti trudne.
English: Gently stir the contents into the soft food, creating a mixture of cysteamine granules and the soft food.
Croatian: Lagano umiješajte sadržaj u mekanu hranu, praveći smjesu granula cisteamina i mekane hrane.
English: In vitro data suggests that cysteamine bitartrate is likely to be metabolized by multiple CYP enzymes, including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Croatian: Podaci in vitro ukazuju da se cisteaminhidrogentartarat vjerojatno metabolizira putem više CYP enzima, uključujući CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP2E1.
English: Administration of cysteamine in neonate rats induced cataracts.
Croatian: Primjena cisteamina kod novorođenih štakora poticala je nastanak katarakte.
English: Individuals with cystinosis have elevations of WBC cystine above 2 nmol hemicystine/mg protein.
Croatian: Pojedinci s cistinozom imaju povećanu razinu cistina u leukocitima iznad 2 nmol hemicistina/mg proteina.
English: How to take PROCYSBI
Croatian: Kako uzimati PROCYSBI
English: Gently stir the contents into the soft food, creating a mixture of cysteamine granules and food.
Croatian: Lagano umiješajte sadržaj u mekanu hranu, praveći smjesu granula cisteamina i hrane.
English: PROCYSBI contains sodium
Croatian: PROCYSBI sadrži natrij
English: In-use shelf life: 30 days.
Croatian: 24 mjeseci Rok valjanosti od otvaranja: 30 dana.
English: Sprinkling on food
Croatian: Primjena uz hranu
English: Co-administration of the proton pump inhibitor omeprazole and PROCYSBI in vivo showed no effects on cysteamine bitartrate exposure.
Croatian: Istovremena primjena inhibitora protonske pumpe omeprazola i lijeka PROCYSBI in vivo nije pokazala utjecaj na izloženost cisteaminhidrogentartaratu.
English: Benign intracranial hypertension, also called pseudotumor cerebri, has been reported with cysteamine use.
Croatian: Uz uporabu cisteamina prijavljena je benigna intrakranijalna hipertenzija, poznata i kao pseudotumor cerebri.
English: Cysteamine bitartrate is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in vitro.
Croatian: Cisteaminhidrogentartarat in vitro nije inhibitor enzima CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4.
English: Normal individuals and persons heterozygous for cystinosis have white blood cell cystine levels of < 0.2 and usually below 1 nmol hemicystine/mg protein, respectively, when measured using the mixed leukocyte assay.
Croatian: Zdravi pojedinci i osobe koje su heterozigoti za cistinozu imaju razine cistina u leukocitima <0,2 i obično ispod 1 nmol hemicistina/mg proteina, navedenim redom (kad se mjeri testom s pomiješanim leukocitima).
English: PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 250 capsules
Croatian: OBLIK I SADRŽAJ Želučanootporna tvrda kapsula 250 kapsula
English: Patients with renal impairment Dose adjustment is not normally required; however, WBC cystine levels should be monitored.
Croatian: Obično nije potrebno prilagoditi dozu; međutim, moraju se nadzirati razine cistina u leukocitima.
English: Your doctor may interrupt and change your dose if these occur.
Croatian: Ako se to pojavi, Vaš liječnik može prekinuti liječenje ili promijeniti Vašu dozu.
English: The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.4).
Croatian: Ne preporučuje se uporaba doza viših od 1,95 g/m2/dan (vidjeti dio 4.4).
English: Therefore, healthcare professionals should refer to the assay-specific therapeutic targets provided by individual testing laboratories.
Croatian: Stoga liječnici trebaju uzeti u obzir da su terapijski ciljevi specifični za test koji provodi pojedini laboratorij.
English: • The risk of fibrosing colonopathy and relevant risk minimisation advice: Patients should be informed about the potential risk of fibrosing colonopathy; Patients should be advised of the signs and symptoms of fibrosing colonopathy and to alert the treating physician if they develop any.
Croatian: • Rizik od fibrozirajuće kolonopatije i važne savjete za smanjenje rizika: Bolesnici moraju biti obaviješteni o potencijalnom riziku od fibrozirajuće kolonopatije.
English: The use of doses higher than 1.95 g/m2/day is not recommended (see section 4.2).
Croatian: Ne preporučuje se uporaba doza većih od 1,95 g/m2/dan (vidjeti dio 4.2).
English: The dose should be raised if there is adequate tolerance and the WBC cystine level remains > 1 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay).
Croatian: Dozu se mora povećati ako postoji odgovarajuća tolerancija i razina cistina u leukocitima ostaje > 1 nmol hemicistina/mg proteina (kad se mjeri testom s pomiješanim leukocitima).
English: CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine.
Croatian: Simptomi SŽS-a kao što su napadaji, letargija, somnolencija, depresija i encefalopatija povezani su s cisteaminom.
English: Frequency: adverse reaction
Croatian: Manje često: Anafilaktička reakcija
English: Patients with poorer tolerability still receive significant benefit if white blood cell cystine levels are below 2 nmol hemicystine/mg protein (when measured using the mixed leukocyte assay).
Croatian: Bolesnici sa slabijom podnošljivosti i dalje imaju značajne koristi ako su razine cistina u leukocitima ispod 2 nmol hemicistina/mg proteina (kad se mjeri testom s pomiješanim leukocitima).
English: The use of doses higher than 1.95 g/m2/day is not recommended.
Croatian: Ne preporučuje se uporaba doza viših od 1,95 g/m2/dan.
English: For children and patients who have problems to swallow, please refer to section 3 How to take PROCYSBIMethod of administration.
Croatian: Za djecu i bolesnike koji imaju poteškoća s gutanjem, pogledajte dio 3.
English: If this is not possible, you can eat a small amount (about 100 grams) of food (preferably carbohydrates e.g. bread, pasta, fruits) during the hour before and after taking PROCYSBI.
Croatian: Ako to nije moguće, možete jesti male količine (oko 100 grama) hrane (najbolje ugljikohidrata, npr. kruha, tjestenine, voća) tijekom jednog sata prije i nakon uzimanja lijeka PROCYSBI.
English: If fasting during this period is not possible, it is acceptable to eat only a small amount ( 100 grams) of food (preferentially carbohydrates) during the hour before and after PROCYSBI administration.
Croatian: Ako nije moguće ostati natašte tijekom tog razdoblja, prihvatljivo je jesti male količine ( 100 grama) hrane (najbolje ugljikohidrata) tijekom jednog sata prije i poslije primjene lijeka PROCYSBI.
English: Common: Liver function tests abnormal
Croatian: Često: Abnormalni nalazi testova jetrene funkcije