FrancophonIA/ELRC3.0 huggingface dataset:
English: A double-blind, randomised study to examine the prophylactic antiviral activity and efficacy of repeat dose zanamivir 600 mg every 12 hours intravenously compared to placebo in healthy male volunteers against infection from inoculation with influenza A/Texas/91 (H1N1) virus was conducted.
Croatian: 12 sati u odnosu na placebo u sprječavanju infekcije u zdravih dobrovoljaca muškoga spola nakon inokulacije virusom gripe tipa A/Texas/91 (H1N1).
English: Dectova 10 mg/mL solution for infusion zanamivir
Croatian: Dectova 10 mg/ml otopina za infuziju zanamivir
English: NA 2.49 118
Croatian: 14 0,305 ND 2,49 118
English: This substitution has no effect on zanamivir; therefore, viruses with the H275Y substitution retain full susceptibility to zanamivir.
Croatian: virusi sa supstitucijom H275Y zadržavaju punu osjetljivost na zanamivir.
English: Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.
Croatian: Tijekom primjene zanamivira u bolesnika s gripom, osobito djece i adolescenata, prijavljeni su neuropsihijatrijski događaji, uključujući epileptičke napadaje, delirij, halucinacije i neuobičajeno ponašanje.
English: Also contains sodium chloride, water for injections
Croatian: POPIS POMOĆNIH TVARI Također sadrži natrijev klorid i vodu za injekcije
English: • Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection included - this can also be removed if considered necessary.
Croatian: • Infuzijske vrećice mogu sadržavati više od deklarirane količine otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) - taj se dodatni volumen također može izbaciti, ako se ocijeni da je potrebno.
English: Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Croatian: Poremećaji jetre i žuči povišene vrijednosti alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST)
English: Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Croatian: Djeca i adolescenti (u dobi od 6 godina do manje od 18 godina i tjelesne težine manje od 50 kg) te dojenčad i mala djeca (u dobi od 6 mjeseci do manje od 6 godina) kojima klirens kreatinina (CLcr) ili klirens kontinuiranom bubrežnom nadomjesnom terapijom (CLCRRT) iznosi < 80 ml/min trebaju primiti početnu dozu, a zatim odgovarajuću dozu održavanja dvaput na dan kako je prikazano u
English: Preparation of Dectova
Croatian: Priprema lijeka Dectova
English: Begin maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Croatian: *CLcr ili CLCRRT izražen u ml/min za adolescente u dobi od 13 do manje od 18 godina, odnosno u ml/min/1,73 m2 za djecu u dobi od 6 godina do manje od 13 godina.
English: Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously must be reduced in patients with renal impairment (see section 4.2).
Croatian: Oštećenje funkcije bubrega Budući da se zanamivir eliminira bubrežnim klirensom, u bolesnika s oštećenjem bubrežne funkcije doza lijeka Dectova mora se smanjiti kod intravenske primjene (vidjeti dio 4.2).
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL).
Croatian: Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata) u 20 ml otopine (10 mg/ml).
English: Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions' in section 4).
Croatian: Simptomi mogu uključivati oticanje kože ili grla, otežano disanje, kožni osip praćen mjehurićima ili ljuštenje kože
English: Each mL of Dectova contains 10 mg of zanamivir (as hydrate).
Croatian: Jedan ml lijeka Dectova sadrži 10 mg zanamivira (u obliku hidrata).
English: The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric patients between 6 months and <6 years and 12 mg/kg for those between 6 years and <18 years of age were similar to those seen in adults who received 600 mg twice daily intravenously.
Croatian: Farmakokinetika zanamivira nakon intravenske primjene doze od 14 mg/kg dvaput na dan u pedijatrijskih bolesnika u dobi od 6 mjeseci do < 6 godina te u dozi od 12 mg/kg u bolesnika u dobi od
English: A Phase I, open-label study to evaluate serum and lower respiratory pharmacokinetics following administration of intravenous and inhaled zanamivir to healthy adult subjects utilising bronchoalveolar lavage fluid was conducted.
Croatian: Ispitivanje uz bronhoalveolarnu lavažu Provedeno je otvoreno ispitivanje faze I u kojem su se uz pomoć tekućine za bronhoalveolarnu lavažu ocjenjivali farmakokinetički parametri u serumu i donjim dišnim putovima nakon intravenske i inhalacijske primjene zanamivira zdravim odraslim ispitanicima.
English: Table 2: Initial and maintenance dose regimens for adults and children (6 years and over with a body weight of 50 kg or above) with renal impairment
Croatian: Tablica 2: Početna doza i doza održavanja za odrasle i djecu (u dobi od 6 ili više godina i tjelesne težine od 50 kg ili više) s oštećenjem bubrežne funkcije
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection, the MAH should submit the results of a prospective observational study in patients with complicated influenza infection.
Croatian: Kako bi se ocijenila klinička učinkovitost liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s kompliciranom gripom, nositelj odobrenja treba dostaviti rezultate prospektivnog opservacijskog ispitivanja u bolesnika s kompliciranom gripom.
English: Begin twice daily maintenance dosing 48 hours after the initial dose
Croatian: Doza održavanja dvaput na dan počinje se primjenjivati 48 sati nakon početne doze
English: Common side effects that may show up in your blood tests: • increase in the level of liver enzymes (raised aminotransferases).
Croatian: • povišene vrijednosti jetrenih enzima (povišene razine aminotransferaza)
English: Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:
Croatian: A ili B u odraslih i pedijatrijskih bolesnika (u dobi od ≥ 6 mjeseci):
English: Begin maintenance dosing 12 hours after the initial dose
Croatian: Doza održavanja počinje se primjenjivati 12 sati nakon početne doze
English: • rash.
Croatian: • osip
English: How to store Dectova
Croatian: Kako čuvati lijek Dectova
English: There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Croatian: Usporedbe terapija u cjelokupnoj IPP populaciji i dvama unaprijed specificiranim podskupinama nisu pokazale značajne razlike s obzirom na TTCR
English: Cmin (g/mL)
Croatian: (μg/ml)
English: Your doctor will decide how much Dectova is right for you.
Croatian: Liječnik će odrediti dozu lijeka Dectova primjerenu za Vas.
English: Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays.
Croatian: U testovima inhibicije neuraminidaze opažena je križna rezistencija između zanamivira i oseltamivira ili peramivira.
English: A prospective observational study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection
Croatian: Prospektivno opservacijsko ispitivanje s ciljem ocjenjivanja kliničke učinkovitosti liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s kompliciranom gripom.
English: A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection
Croatian: Retrospektivno opservacijsko ispitivanje pregledom zdravstvenih kartona s ciljem ocjenjivanja kliničke učinkovitosti liječenja otopinom zanamivira za infuziju od 10 mg/ml u kohorti bolesnika s kompliciranom gripom liječenih u jedinicama intenzivnog liječenja.
English: Begin maintenance dosing 24 hours after the initial dose
Croatian: Doza održavanja počinje se primjenjivati 24 sata nakon početne doze
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Croatian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in ICU-treated influenza patients, the MAH should submit the results of an observational chart review effectiveness study of IV zanamivir in ICU-treated influenza patients.
Croatian: Kako bi se ocijenila klinička učinkovitost liječenja otopinom zanamivira za infuziju od 10 mg/ml u bolesnika s gripom liječenih u jedinicama intenzivnog liječenja, nositelj odobrenja treba dostaviti rezultate opservacijskog ispitivanja učinkovitosti provedenog pregledom zdravstvenih kartona bolesnika s gripom liječenih intravenskom formulacijom zanamivira u jedinicama intenzivnog liječenja.
English: Begin twice daily maintenance dosing 12 hours after the initial dose
Croatian: Doza održavanja dvaput na dan počinje se primjenjivati 12 sati nakon početne doze
English: Table 4: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight of 42.8 kg or above) with renal impairment
Croatian: Tablica 4: Početna doza i doza održavanja za dojenčad i malu djecu (u dobi od 6 mjeseci do manje od 6 godina i tjelesne težine od 42,8 kg ili više) s oštećenjem bubrežne funkcije
English: 7 36.2 21 75.3 23 NA NA 1.84 19
Croatian: 23 ND ND 1,84 19
English: Begin twice daily maintenance dosing 24 hours after the initial dose
Croatian: Doza održavanja dvaput na dan počinje se primjenjivati 24 sata nakon početne doze
English: The potential for interactions with other medicines is low, based on the known elimination pathway of zanamivir.
Croatian: S obzirom na poznati put eliminacije zanamivira, potencijal za interakcije s drugim lijekovima je nizak.
English: Age Group
Croatian: Dobna skupina
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Croatian: Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata) u 20 ml otopine.
English: Each mL of solution contains 10 mg of zanamivir (as hydrate).
Croatian: Jedan ml otopine sadrži 10 mg zanamivira (u obliku hidrata).
English: years mg/kg
Croatian: 1 do < 2 godine mg/kg
English: 12 mg/kg 8 mg/kg twice daily
Croatian: 12 mg/kg 8 mg/kg dvaput na dan
English: • Discard any unused portion of the vial.
Croatian: • Bacite sav neupotrijebljen lijek koji je preostao u bočici.
English: Each vial contains 200 mg of zanamivir (as hydrate).
Croatian: Jedna bočica sadrži 200 mg zanamivira (u obliku hidrata).
English: 600 mg 400 mg twice daily
Croatian: 600 mg 400 mg dvaput na dan
English: 600 mg 60 mg twice daily
Croatian: 600 mg 60 mg dvaput na dan
English: 600 mg 150 mg twice daily
Croatian: 600 mg 150 mg dvaput na dan
English: Uncommon side effects that may show up in your blood tests: • increase in the level of liver or bone enzymes (raised alkaline phosphatase).
Croatian: • povišene vrijednosti jetrenih ili koštanih enzima (povišene razine alkalne fosfataze)
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test
Croatian: Medijan razlike između terapija, dani (95% CI)
English: 12 mg/kg 5 mg/kg twice daily
Croatian: 12 mg/kg 5 mg/kg dvaput na dan
English: • Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL
Croatian: • Koristeći sterilnu iglu i štrcaljku, iz infuzijske vrećice izvucite volumen otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) koji odgovara volumenu lijeka Dectova i bacite ga.
English: 12 mg/kg 3 mg/kg twice daily
Croatian: 12 mg/kg 3 mg/kg dvaput na dan
English: Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1).
Croatian: Adolescenti, djeca i dojenčad trebaju primati lijek u dozi određenoj prema tjelesnoj težini tijekom
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italy
Croatian: 90 43056 San Polo di Torrile, Parma Italija
English: Common side effects These may affect up to 1 in 10 people
Croatian: Mogu se javiti u do 1 na 10 osoba • proljev
English: 14 mg/kg twice daily
Croatian: 14 mg/kg dvaput na dan
English: • confused thinking
Croatian: • neuobičajeno ponašanje
English: 600 mg 250 mg twice daily
Croatian: 600 mg 250 mg dvaput na dan
English: Česká republika GlaxoSmithKline, s.r.o.
Croatian: GlaxoSmithKline Slovakia s. r. o.
English: • the in vitro activity of zanamivir;
Croatian: Djelatna tvar je zanamivir.
English: How much Dectova is given
Croatian: Kako se Dectova primjenjuje Koliko lijeka Dectova se primjenjuje
English: Table 5: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight less than 42.8 kg) with renal impairment
Croatian: Tablica 5: Početna doza i doza održavanja za dojenčad i malu djecu (u dobi od 6 mjeseci do manje od 6 godina i tjelesne težine manje od 42,8 kg) s oštećenjem bubrežne funkcije CLcr ili CLCRRT (ml/min/1,73 m2)
English: Gastrointestinal disorders diarrhoea common
Croatian: Poremećaji probavnog sustava proljev često
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Symptom onset 4 days subgroup, N Median TTCR, days
Croatian: ≤ 4 dana nakon nastupa simptoma, N Medijan TTCR-a, dani
English: CARTON
Croatian: Cmin
English: • diarrhoea
Croatian: • smetenost
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Intensive Care Unit/Mechanical Ventilation subgroup, N Median TTCR, days
Croatian: Podskupina bolesnika u jedinici intenzivnog liječenja / na mehaničkoj ventilaciji, N
English: 1.4 mg/kg twice daily
Croatian: 14 mg/kg 1,4 mg/kg dvaput na dan
English: 9.3 mg/kg twice daily
Croatian: 14 mg/kg 9,3 mg/kg dvaput na dan
English: THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: ANNEX I
Croatian: A ili B
English: Date of first authorisation: 16 November 2017
Croatian: Datum prvog odobrenja: 16 studenog 2017
English: Some infections can be serious and may lead to death.
Croatian: Neke infekcije mogu biti ozbiljne i mogu dovesti do smrti.
English: Do not store above 30 °C.
Croatian: Ne čuvati na temperaturi iznad 30 °C.
English: Children under 18 years of age should not be given Zejula.
Croatian: Djeci mlađoj od 18 godina ne smije se davati Zejula.
English: All clinical studies have only been performed in adults.
Croatian: Sva klinička ispitivanja provedena su samo u odraslih.
English: Discontinue treatment.
Croatian: Prekinite liječenje.
English: These can include:
Croatian: To može uključivati:
English: It is recommended that treatment should be continued until disease progression.
Croatian: Preporučuje se da liječenje traje do progresije bolesti.
English: The clinical relevance of these findings is not known.
Croatian: Klinički značaj ovih nalaza nije poznat.
English: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost nirapariba u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: 1114 AB Amsterdam-Duivendrecht
Croatian: 1114 AB Amsterdam-Duivendrecht Nizozemska
English: Zejula can cause high blood pressure, which in some cases, could be severe.
Croatian: Zejula može uzrokovati visok krvni tlak koji u nekim slučajevima može biti vrlo visok.
English: Additionally, decreased spermatogenesis was seen in both species.
Croatian: Dodatno je uočena smanjena spermatogeneza u obje vrste.
English: • Abnormal taste in mouth
Croatian: • neuobičajen okus u ustima
English: • if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na niraparib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Clinic visits occurred each cycle (4 weeks ± 3 days).
Croatian: Posjeti klinici obavljali su se u svakom ciklusu (4 tjedna ± 3 dana).
English: The hard capsules are packed in blister packs of
Croatian: Tvrde kapsule su pakirane u blister pakiranja od
English: He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary.
Croatian: On ili ona Vam može dati lijek za liječenje visokog krvnog tlaka te Vam prilagoditi dozu lijeka Zejula ako je potrebno.
English: There are no clinical data on fertility.
Croatian: Nema kliničkih podataka o plodnosti.
English: If you take more than your normal dose, contact your doctor immediately.
Croatian: Ako uzmete više od svoje uobičajene doze, odmah se obratite liječniku.
English: In general, it is recommended to first interrupt the treatment (but no longer than 28 consecutive days) to allow the patient to recover from the adverse reaction and then restart at the same dose.
Croatian: Općenito se preporučuje najprije prekinuti liječenje (ali ne dulje od 28 dana uzastopno) kako bi se bolesniku omogućio oporavak od nuspojave, a zatim ponovno započeti s istom dozom.
English: Contents of the pack and other information What Zejula contains
Croatian: Sadržaj pakiranja i druge informacije Što Zejula sadrži
English: Based on individual laboratory values, weekly monitoring for the second month may be warranted.
Croatian: Na temelju individualnih laboratorijskih vrijednosti može se preporučiti tjedni nadzor i u drugom mjesecu.
English: If you take more Zejula than you should
Croatian: Ako uzmete više lijeka Zejula nego što ste trebali
English: PFS was measured from the time of randomisation (which occurred up to 8 weeks after completion of the chemotherapy regimen) to disease progression or death.
Croatian: PFS je mjeren od vremena randomizacije (koja je bila najviše 8 tjedana nakon završetka režima kemoterapije) do progresije bolesti ili smrti.
English: Zejula can be taken without regard to meals.
Croatian: Zejula se može uzimati bez obzira na obroke.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Croatian: Bolesnike treba potaknuti da svoju dozu uzimaju u približno isto vrijeme svakog dana.
English: Other medicines and Zejula
Croatian: Drugi lijekovi i Zejula
English: • Palpitations (feeling like your heart is skipping beats or beating harder than usual)
Croatian: • palpitacije (osjećaj kao da Vam srce preskače otkucaje ili kuca jače nego inače)
English: Patients with low body weight
Croatian: Bolesnici s malom tjelesnom težinom
English: No dose adjustment is necessary for elderly patients (≥ 65 years).
Croatian: Nije potrebna prilagodba doze za starije bolesnike (≤ 65 godina).
English: This results in tumour cell death, helping to control the cancer.
Croatian: To ima za posljedicu smrt stanica raka, što pomaže kontrolirati rak.
English: Neutrophil < 1,000/µL or Haemoglobin < 8 g/dL
Croatian: Neutrofili < 1000/µl ili hemoglobin < 8 g/dl
English: Take Zejula at approximately the same time each day.
Croatian: Uzimajte lijek Zejula svaki dan u približno isto vrijeme.
English: PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired.
Croatian: PARP pomaže stanicama popraviti oštećenu DNK tako da njegova blokada znači da se DNK stanica raka ne može popraviti.
English: In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
Croatian: U slučaju predoziranja liječnici trebaju slijediti opće potporne mjere i liječiti simptomatski.
English: • Pink eye
Croatian: • crveno oko
English: Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije ili tijekom uzimanja ovog lijeka ako se bilo što od sljedećeg odnosi na Vas:
English: Ask your doctor for advice before taking this medicine.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Do not take an additional dose if you miss a dose or vomit after taking Zejula.
Croatian: Nemojte uzeti dodatnu dozu ako propustite dozu ili povraćate nakon uzimanja lijeka Zejula.
English: Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies.
Croatian: Sveukupno su MDS/AML bili zabilježeni u 7 od 751 (0,9 %) bolesnika liječenih lijekom Zejula u kliničkim ispitivanjima.
English: There is no specific treatment in the event of Zejula overdose, and symptoms of overdose are not established.
Croatian: Nema specifičnog liječenja u slučaju predoziranja lijekom Zejula, a simptomi predoziranja nisu ustanovljeni.
English: This medicine has not been studied in this age group.
Croatian: Ovaj lijek nije ispitan u ovoj dobnoj skupini.
English: What Zejula looks like and contents of the pack
Croatian: Kako Zejula izgleda i sadržaj pakiranja
English: • Sunburn-like reactions following exposure to light
Croatian: • reakcije nalik opeklinama nakon izlaganja svjetlosti
English: Overall, in almost half of the presented cases, the causality could not be excluded or was related to the study drug.
Croatian: Ukupno se u gotovo polovice prikazanih slučajeva uzročna veza s ispitivanim lijekom nije mogla isključiti ili su slučajevi bili povezani s primjenom lijeka.
English: Zejula should not be taken during pregnancy as it could harm your baby.
Croatian: Zejula se ne smije uzimati tijekom trudnoće jer može naškoditi Vašem djetetu.
English: Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information).
Croatian: Znakovi i simptomi na koje morate obratiti pažnju uključuju vrućicu ili infekciju i nenormalno nastajanje modrica ili krvarenje (vidjeti dio 4 za više informacija).
English: The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters.
Croatian: Glavni primarni ciljni organ toksičnosti u obje vrste bila je koštana srž, s popratnim promjenama hematoloških parametara na periferiji.
English: All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy.
Croatian: Svi su bolesnici primili više kemoterapijskih režima koji su sadržavali platinu, a mnogi su također primili druge lijekove koji oštećuju DNK i radioterapiju.
English: Take your next dose at its scheduled time.
Croatian: Svoju sljedeću dozu uzmite u uobičajeno vrijeme.
English: Tartrazine (E 102)
Croatian: Tartrazin (E 102)
English: Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tvrda kapsula sadrži 254,5 mg laktoza hidrata (vidjeti dio 4.4).
English: The duration of Zejula treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years.
Croatian: Trajanje liječenja bolesnika lijekom Zejula prije razvoja MDS/AML variralo je od 1 mjeseca do > 2 godine.
English: There are limited clinical data in patients aged 75 or over.
Croatian: Klinički podaci za bolesnike u dobi od 75 godina i starije su ograničeni.
English: The capsules should not be chewed or crushed.
Croatian: Kapsule se ne smiju žvakati ili zdrobiti.