FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies).
Croatian: Koncentracije fenilbutirata i njegovih metabolita u plazmi i urinu utvrđene su u zdravih ljudi na tašte koji su primili jednokratnu dozu od 5 g natrijevog fenilbutirata, i u bolesnika s poremećajima ciklusa ureje, hemoglobinopatijama i cirozom koji su primili jednokratne i ponovljene peroralne doze od do 20 g/dan (nekontrolirana ispitivanja).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Croatian: 6.1 Popis pomoćnih tvari kuglice šećera (saharoza i kukuruzni škrob), hipromeloza, etilceluloza N7, makrogol 1500, povidon K25.
English: In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting.
Croatian: U većine bolesnika s poremećajima ciklusa ureje ili hemoglobinopatijama koji su primali različite doze fenilbutirata (300 - 650 mg/kg/dan do 20 g/dan) nije mogla biti utvrđena razina fenilacetata u plazmi nakon cjelonoćnog gladovanja.
English: Pheburane is contra-indicated during breast-feeding (see section 4.3).
Croatian: Pheburane je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Croatian: Ponavljanja doziranja fenilacetata pokazala su postojanje indukcije klirensa.
English: Do not use PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP.
Croatian: PHEBURANE se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
English: Bottle: 174 g granules.
Croatian: Bočica: 174 g granula.
English: PHEBURANE should be administered orally.
Croatian: PHEBURANE se primjenjuje peroralno.
English: PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders.
Croatian: PHEBURANE sadrži djelatnu tvar natrijev fenilbutirat koji se koristi za liječenje bolesnika svih starosnih skupina s poremećajima ciklusa ureje.
English: • PHEBURANE is considered high in sodium.
Croatian: • PHEBURANE se smatra lijekom s visokim sadržajem natrija.
English: Common rash, abnormal skin odor
Croatian: Često osip, nenormalni miris kože
English: These symptoms are consistent with the accumulation of phenylacetate, which showed dose-limiting neurotoxicity when administered intravenously at doses up to 400 mg/kg/day.
Croatian: Jednaki simptomi javljaju se pri akumulaciji fenilacetata koji pokazuje dozno limitirajuću neurotoksičnost ako se primijeni intravenski u dozama višim od 400 mg/kg/dan.
English: Because of its slow dissolution, PHEBURANE should not be administered by nasogastric or gastrostomy tubes.
Croatian: Zbog spore topivosti PHEBURANE se ne bi smio primjenjivati kroz nazogastričnu ili gastrostomsku sondu.
English: PHEBURANE has negligible influence on the ability to drive and use machines.
Croatian: PHEBURANE zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
Croatian: Ovaj lijek sadrži 768 mg saharoze po 1 g natrijevog fenilbutirata.
English: Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Croatian: Temeljeno na ispitivanjima izlučivanja fenilacetilglutamina u bolesnika s poremećajem ciklusa ureje može se procijeniti da se po svakom gramu primijenjenog natrijevog fenilbutirata stvara između 0,12 i 0,15 g fenilacetilglutaminskog dušika.
English: CARTON AND BOTTLE LABEL
Croatian: OZNAKA NA KUTIJI I BOČICI
English: However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Croatian: PHEBURANE se treba koristiti zajedno s dijetom s ograničenim unosom proteina, koju je Vaš liječnik ili dijetetičar posebno osmislio za Vas.
English: Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Croatian: Ispitivanja s visokim intravenskim dozama fenilacetata pokazala su nelinearno farmakokinetičko svojstvo saturacijom njegovog metaboliziranja u fenilacetilglutamin.
English: Nutritional management PHEBURANE must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
Croatian: PHEBURANE treba kombinirati s dijetom s ograničenim unosom proteina, u nekim slučajevima uz suplementaciju esencijalnim aminokiselinama i karnitinom.
English: Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Croatian: Suplementacija citrulina ili arginina potrebna je u bolesnika kod kojih se deficijencija karbamilfosfat sintetaze i ornitin transkarbamilaze pojavila u novorođenačkoj dobi u dozi 0,17 g/kg/dan ili 3,8 g/m2/dan,
English: Only use the calibrated measuring spoon provided.
Croatian: Koristiti samo priloženu kalibriranu mjernu žličicu.
English: • Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Croatian: • Tijekom liječenja potrebno je nadzirati razinu kalija u serumu budući da izlučivanje fenilacetilglutamina putem bubrega može inducirati gubitak kalija urinom.
English: This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
Croatian: Ovaj lijek sadrži 124 mg (5,4 mmol) natrija po 1 g natrijevog fenilbutirata.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog grupiranja po učestalosti nuspojave se navode prema svojoj težini, od težih prema manje teškima.
English: PHEBURANE contains sodium and sucrose
Croatian: PHEBURANE sadrži natrij i sukrozu
English: There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni natrijevog fenilbutirata u trudnica ograničeni.
English: The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/m²) or phenylacetate.
Croatian: Raspoloživost fenilbutirata i njegovih metabolita također je ispitivana na onkološkim bolesnicima koji su primili intravensku infuziju natrijevog fenilbutirata (do 2 g/m²) ili fenilacetata.
English: Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.
Croatian: Manje česte nuspojave (mogu se javiti kod više od 1 na 1000 ljudi): nedostatak eritrocita zbog zatajivanja koštane srži, stvaranje modrica, promjena srčanog ritma, krvarenje iz rektuma, upala želuca (gastritis), čir želuca, upala gušterače.
English: Common abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Croatian: Često bol u abdomenu, povraćanje, mučnina, konstipacija, disgeuzija Manje često pankreatitis, peptički ulkus, krvarenje iz rektuma, gastritis
English: Phenylbutyrate is rapidly absorbed under fasting conditions.
Croatian: Fenilbutirat se brzo apsorbira na tašte.
English: The active substance is sodium phenylbutyrate.
Croatian: Djelatna tvar je natrijev fenilbutirat.
English: Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Croatian: Fenilacetat je metabolički aktivni spoj koji se acetilacijom konjugira s glutaminom i tvori fenilacetilglutamin, koji se potom izlučuje putem bubrega.
English: The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Croatian: Dnevna doza PHEBURANEA temeljit će se na Vašoj tjelesnoj težini i tjelesnoj površini i bit će prilagođena prema Vašoj toleranciji na proteine i dijeti.
English: PHEBURANE is unlikely to affect your ability to drive and use machines.
Croatian: Malo je vjerojatno da PHEBURANE utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: A calibrated measuring spoon is provided.
Croatian: Priložena je kalibrirana mjerna žličica.
English: More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used.
Croatian: Kada se oni koriste savjetuje se češća kontrola razine amonijaka u plazmi.
English: PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Croatian: PHEBURANE je indiciran kao pomoćna terapija u dugotrajnom liječenju poremećaja ciklusa ureje, uključujući nedostatak karbamilfosfat sintetaze, ornitin transkarbamilaze ili argininosukcinat sintetaze.
English: PHEBURANE 483 mg/g granules
Croatian: PHEBURANE 483 mg/g granule
English: PHEBURANE 483 mg/g {For carton only}
Croatian: PHEBURANE 483 mg/g {Samo na kutiji}
English: • Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
Croatian: • Unatoč liječenju kod određenog broja bolesnika može se pojaviti hiperamonijemijska encefalopatija.
English: In the table below all adverse reactions are listed below, by system organ class and by frequency.
Croatian: U sljedećoj tablici sve nuspojave navedene su prema klasifikaciji organskih sustava i učestalosti.
English: A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Croatian: S lijekom se isporučuje kalibrirana mjerna žličica kojom se može dozirati do 3 g natrijevog fenilbutirata, graduirana po 250 mg.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Croatian: Nakon jednokratne peroralne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilbutirata u plazmi utvrđene su nakon 15 minuta.
English: • Pregnancy.
Croatian: • Dojenje.
English: PHEBURANE 483 mg/g granules sodium phenylbutyrate
Croatian: PHEBURANE 483 mg/g granule natrijev fenilbutirat
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Croatian: Nakon jednokratne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilacetata i fenilacetilglutamina u plazmi utvrđene su nakon 30 odnosno 60 minuta.
English: In case of any doubt, ask your doctor or pharmacist.
Croatian: U slučaju ikakve dvojbe obratite se svom liječniku ili ljekarniku.
English: How to take PHEBURANE
Croatian: Kako uzimati PHEBURANE
English: Only use this measuring spoon to measure out the dose.
Croatian: Za doziranje koristite samo ovu mjernu žličicu.
English: Carton: One bottle with 174 g granules.
Croatian: Kutija: Jedna bočica sa 174 g granula.
English: Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Croatian: Natrijev fenilbutirat bio je negativan u 2 testa mutagenosti, tj.
English: In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom U slučaju da se granule miješaju s krutom hranom ili tekućinom važno je pripremljeno uzeti odmah nakon miješanja.
English: How to store PHEBURANE
Croatian: Kako čuvati PHEBURANE
English: Granules.
Croatian: OBLIK Granule.
English: • are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati PHEBURANE: ako ste alergični na natrijev fenilbutirat ili neki drugi sastojak ovog lijeka (naveden u dijelu ako ste trudni ako dojite.
English: Each bottle contains 174g of granules.
Croatian: Jedna bočica sadrži 174 g granula.
English: PHEBURANE granules are white to off-white.
Croatian: Kako PHEBURANE izgleda i sadržaj pakiranja PHEBURANE granule su bijele do gotovo bijele boje.
English: Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Croatian: Ispitivanja kancerogenosti i ispitivanja utjecaja fenilbutirata na plodnost nisu provedena.
English: It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk.
Croatian: Nema dovoljno podataka o izlučivanju natrijevog fenilbutirata/metabolita u majčino mlijeko.
English: As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Croatian: Nakon što se bjelančevine unesene hranom u tijelu razgrade, suvišni se dušik nakuplja u organizmu u obliku amonijaka jer ne može biti izlučen.
English: Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate.
Croatian: Istovremena primjena probenecida može utjecati na izlučivanje produkata konjugacije s natrijevim fenilbutiratom putem bubrega.
English: Each gram of granules contains 483 mg of sodium phenylbutyrate.
Croatian: Jedan gram granula sadrži 483 mg natrijevog fenilbutirata.
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Croatian: Poznato je da fenilbutirat u bubrezima i jetri oksidira u fenilacetat koji se potom s glutaminom enzimatski konjugira i tvori fenilacetilglutamin.
English: info@frostpharma.com info@frostpharma.com
Croatian: info@lucanepharma.com info@lucanepharma.com
English: • suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete PHEBURANE ako: patite od kongestivne insuficijencije srca (oblik srčane bolesti u kojoj srce ne može dovoljno dobro pumpati krv u organizmu) ili oslabljene funkcije bubrega. imate oslabljenu funkciju bubrega ili jetre budući da se PHEBURANE iz tijela izlučuje putem bubrega i jetre.
English: A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
Croatian: S lijekom se isporučuje kalibrirana mjerna žličica kojom se može dozirati do 3 g natrijevog fenilbutirata.
English: Excretion
Croatian: Eliminacija
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: OBLIK I SADRŽAJ Granule.
English: Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Uncommon arrhythmia
Croatian: Manje često aritmija
English: General considerations
Croatian: Opća upozorenja
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept. (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: What PHEBURANE looks like and contents of the pack
Croatian: Što PHEBURANE sadrži
English: Method of administration
Croatian: Nutricijski menadžment
English: Eurocept International BV
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eurocept International BV
English: As a consequence, sodium phenylbutyrate reduces elevated plasma ammonia and glutamine levels in patients with urea cycle disorders.
Croatian: Kao posljedica ovoga, u bolesnika s poremećenim ciklusom ureje natrijev fenilbutirat snizuje povišene razine amonijaka i glutamina.
English: Mechanism of action and pharmacodynamic effects Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Croatian: Natrijev fenilbutirat je neaktivni lijek koji se brzo metabolizira u djelatnu tvar fenilacetat.
English: To measure the dose:
Croatian: Kako dozirati:
English: : + 33 153 868 750 info@lucanepharma.com
Croatian: Sími: + 33 153 868 750 info@lucanepharma.com
English: Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
Croatian: Tél/Tel: + 33 153 868 750 info@lucanepharma.com
English: Common oedema
Croatian: Često edem
English: Lucane Pharma Tél: + 33 153 868 750 info@lucanepharma.com
Croatian: Tél: + 33 153 868 750 info@lucanepharma.com
English: Lucane Pharma Τηλ: + 33 153 868 750 info@lucanepharma.com
Croatian: Τηλ: + 33 153 868 750 info@lucanepharma.com
English: However, the relevance to humans is unknown.
Croatian: Međutim, značaj ovog nalaza za ljude nije poznat.
English: Response was assessed every 4 weeks until disease progression.
Croatian: Odgovor je procjenjivan svaka 4 tjedna do napredovanja bolesti.
English: The doctor may also adjust the doses of the other medicines.
Croatian: Liječnik također može prilagoditi dozu drugih lijekova.
English: Median overall survival was not reached in either regimen.
Croatian: Medijan ukupnog preživljenja nije dostignut ni u jednom režimu.
English: Second reduction to
Croatian: Drugo smanjenje na
English: Prior to initiating a new cycle of therapy:
Croatian: Prije početka novog ciklusa terapije:
English: Each blister contains one capsule).
Croatian: Svaki blister sadrži jednu kapsulu).
English: Median (months) p-value*
Croatian: Medijan (mjeseci) p-vrijednost*
English: The other ingredients are:
Croatian: • Ostali sastojci su:
English: Age, gender, race
Croatian: Dob, spol, rasa
English: PFS results are summarised in Table 4 and Figure 1.
Croatian: Rezultati za PFS sažeti su u tablici 4 i na slici 1.
English: It should not be crushed, chewed, or opened (see section 6.6).
Croatian: Ne smije se lomiti, žvakati niti otvarati (vidjeti dio 6.6).
English: NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
Croatian: NINLARO se uzima jedanput tjedno (istog dana u tjednu) tijekom prva 3 tjedna tog ciklusa.
English: Recommended actions
Croatian: Preporučeni postupci
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s lijekovima i drugi oblici interakcija
English: A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče, stoga dojenje treba prekinuti.
English: The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Croatian: Medijan dobi iznosio je 66 godina, u rasponu od 38 do 91 godina; 58% bolesnika bilo je starije od 65 godina.
English: You should read the Package Leaflets of these other medicines for further information on their use and effects.
Croatian: Trebate pročitati upute o lijeku za te druge lijekove za više informacija o njihovoj uporabi i učincima.
English: Reproductive and embryo-foetal development
Croatian: Reproduktivni i embriofetalni razvoj
English: Animal toxicology and/or pharmacology
Croatian: Životinjska toksikologija i/ili farmakologija
English: Date of Last Renewal: 16 September 2019
Croatian: Datum posljednje obnove odobrenja: 16. rujna 2019.
English: Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Croatian: Prije početka uzimanja lijeka NINLARO i tijekom terapije podvrgnut ćete se testiranju krvi kako bi se provjerilo imate li dovoljno krvnih stanica.
English: PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
Croatian: PVC-aluminij/aluminij blister zalijepljen unutar ovitka koji sadrži jednu kapsulu.
English: Consider adding G-CSF as per clinical guidelines.
Croatian: Razmotrite dodavanje G-CSF prema kliničkim smjernicama.
English: Discontinue treatment regimen.
Croatian: Prekinite režim liječenja.
English: Progression-Free Survival Events, n (%)
Croatian: Preživljenje bez napredovanja bolesti Događaji, n (%)
English: Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Croatian: Primarno refraktorna bolest, definirana kao najbolji odgovor stabilne bolesti ili napredovanje bolesti na svim prethodnim terapijama, dokumentirana je u 6% bolesnika.
English: Other medicines and NINLARO
Croatian: Drugi lijekovi i NINLARO
English: If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected.
Croatian: Ako se lenalidomid uzima tijekom trudnoće očekuje se teratogeni učinak na ljude.
English: Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Croatian: Trajanje terapije lijekom NINLARO Morate nastaviti s liječenjem sve dok Vam liječnik ne kaže da prestanete.
English: The recommended dose is one 4 mg capsule taken by mouth.
Croatian: Preporučena doza je jedna kapsula od 4 mg uzeta kroz usta.
English: Children and adolescents NINLARO is not recommended for use in children and adolescents aged under 18 years.
Croatian: Djeca i adolescenti NINLARO se ne preporučuje za primjenu u djece i adolescenata u dobi do 18 godina.
English: Fifty seven percent of patients were male.
Croatian: Pedeset i sedam posto bolesnika bili su muškarci.
English: The patient should be monitored for symptoms of peripheral neuropathy.
Croatian: Bolesnika je potrebno nadzirati za simptome periferne neuropatije.
English: If you take more NINLARO than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više lijeka NINLARO nego što ste trebali, razgovarajte s liječnikom ili odmah otiđite u bolnicu.
English: The safety and efficacy of ixazomib in children below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost iksazomiba u djece mlađe od 18 godina nisu ustanovljene.
English: Patients should be advised not to drive or operate machines if they experience any of these symptoms.
Croatian: Bolesnike treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako iskuse ijedan od tih simptoma.
English: The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Croatian: Početne demografske karakteristike i karakteristike bolesti bile su uravnotežene i usporedive između ispitivanih režima.
English: These are structures inside the cell that digest proteins and are important for cell survival.
Croatian: To su strukture unutar stanice koje razgrađuju proteine i važne su za preživljavanje stanice.
English: The patient should be evaluated for underlying causes and provide supportive care, as necessary.
Croatian: U bolesnika je potrebno procijeniti podležeće uzroke i po potrebi pružiti potpornu skrb.
English: Direct contact with the capsule contents should be avoided.
Croatian: Potrebno je izbjegavati izravan doticaj sa sadržajem kapsule.
English: • Do not let the contents of the capsule come into contact with your skin.
Croatian: • Pazite da sadržaj kapsule ne dođe u dodir s Vašom kožom.
English: • Take NINLARO at least one hour before or at least two hours after food.
Croatian: • Uzmite NINLARO barem jedan sat prije ili najmanje dva sata nakon obroka.
English: Eighty five percent of the population was White, 9% Asian and 2% Black.
Croatian: Osamdeset i pet posto ispitanika bilo je bijele rase, 9% azijske i 2% crne rase.