FrancophonIA/ELRC3.0 huggingface dataset:
English: Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts, which are prone to rupture, weight gain, dyspnoea, oliguria or the presence of ascites within a clinical picture of circulatory dysfunction.
Croatian: Sindrom hiperstimulacije jajnika može postati ozbiljan medicinski slučaj karakteriziran velikim cistama jajnika sklonim rupturama, dobivanjem na tjelesnoj težini, dispneji, oliguriji ili prisutnosti ascitesa unutar kliničke slike poremećaja cirkulacije.
English: • It is supplied in packs of 1 pre-filled pen and 1 injection needle.
Croatian: • Isporučuje se u pakiranju s 1 napunjenom brizgalicom i 1 iglom za injekciju.
English: • Ovarian, uterine or mammary carcinoma
Croatian: • Karcinom jajnika, maternice ili dojke
English: Driving and using machines It is not expected that Ovitrelle will affect your ability to drive and use machines.
Croatian: Ne očekuje se da će Ovitrelle utjecati na sposobnost upravljanja vozilima i strojevima.
English: The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg.
Croatian: Bistra, bezbojna do blago žuta otopina. pH otopine je 7,0 ± 0,3; a njena osmolalnost je 250 - 400 mOsm/kg.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Psychiatric disorders
Croatian: Poremećaji imunološkog sustava Vrlo rijetko: blage do teške reakcije preosjetljivosti uključujući anafilaktičke reakcije i šok
English: • After the injection, dispose of the used needle safely, and discard the pen.
Croatian: • Nakon injekcije, odložite korištenu iglu na siguran način te bacite brizgalicu.
English: • Each pre-filled syringe is for single use only.
Croatian: • Svaka napunjena štrcaljka namijenjena je samo za jednokratnu primjenu.
English: This event is uncommon (may affect up to 1 in 100 people).
Croatian: Ovaj događaj je manje čest (pogađa najviše 1 od 100 osoba).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 250 mikrograma koriogonadotropina alfa* (što odgovara približno 6500 IU) u 0,5 ml otopine.
English: Uncommon: Depression, irritability, restlessness Nervous system disorders
Croatian: Psihijatrijski poremećaji Manje često: depresija, razdražljivost, nemir
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1 NAPUNJENOM ŠTRCALJKOM
English: Severe OHSS could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Croatian: Ozbiljan sindrom hiperstimulacije jajnika mogao bi u rijetkim slučajevima imati komplikacije poput hematoperitoneuma, akutnog plućnog distresa, torzije jajnika i tromboembolije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/165/008
English: Pack of 1 pre-filled pen and 1 injection needle.
Croatian: Pakiranje sadrži 1 napunjenu brizgalicu i 1 iglu za injiciranje.
English: • Each pre-filled syringe contains 250 micrograms / 0.5 mL (equivalent to 6500 IU).
Croatian: • Jedna napunjena štrcaljka sadrži 250 mikrograma / 0,5 ml (što odgovara 6500 IU)
English: This event is common (may affect up to 1 in 10 people).
Croatian: Ovaj događaj je čest (pogađa najviše 1 od 10 osoba).
English: If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing, do not give yourself the Ovitrelle injection and talk to your doctor straight away (see section 4).
Croatian: Nemojte si dati injekciju i odmah se obratite liječniku ako osjetite bol u donjem dijelu trbuha, počnete naglo dobivati na tjelesnoj težini, osjećate mučninu ili povraćate, ili imate poteškoća u disanju (vidjeti dio 4).
English: • Hold the Ovitrelle pre-filled pen with the needle pointing upward.
Croatian: • Držite Ovitrelle napunjenu brizgalicu tako da je igla usmjerena prema gore.
English: • Each pre-filled pen contains 250 micrograms choriogonadotropin alfa in 0.5 mL (equivalent to approximately 6,500 International Units, IU).
Croatian: • Jedna napunjena brizgalica sadrži 250 mikrograma koriogonadotropina alfa u 0,5 ml (što odgovara približno 6500 internacionalnih jedinica, IU).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/165/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/165/007
English: Hold the pen with the needle pointing upward.
Croatian: 2. Držite brizgalicu s iglom usmjerenom prema gore.
English: How to store Ovitrelle
Croatian: Kako čuvati Ovitrelle
English: • The recommended dose is 1 pre-filled syringe (250 micrograms/0.5 mL) given as a single injection.
Croatian: • Preporučena doza je 1 napunjena brizgalica (250 mikrograma/0,5 ml) koja se daje u jednoj injekciji.
English: Mannitol
Croatian: • Proljev
English: • Breast pain.
Croatian: • Bol u dojkama
English: • Once you have finished your injection, dispose of the used needle safely.
Croatian: • Kad ste dovršili injiciranje, zbrinite korištenu iglu na siguran način.
English: 1 pre-filled pen of 0.5 mL solution 1 injection needle
Croatian: 1 napunjena brizgalica s 0,5 ml otopine 1 igla za injekciju
English: How to use your Ovitrelle pre-filled pen
Croatian: Kako koristiti Ovitrelle napunjenu brizgalicu
English: To minimise the risk of OHSS, ultrasonographic assessments of follicular development and/or determination of serum estradiol levels should be performed prior to treatment and at regular intervals during treatment.
Croatian: Kako bi se rizik od OHSS-a sveo na najmanju moguću mjeru, prije liječenja i u redovitim razmacima tijekom liječenja potrebno je provesti ultrazvučno praćenje razvoja folikula i/ili mjerenja razina serumskog estradiola.
English: During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Croatian: Tijekom terapije lijekom Ovitrelle moguća je manja stimulacija štitnjače.
English: • The active substance is choriogonadotropin alfa, produced by recombinant DNA technology.
Croatian: • Djelatna tvar je koriogonadotropin alfa proizveden tehnologijom rekombinantne DNK.
English: • The other ingredients are mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water for injections.
Croatian: • Drugi sastojci su: manitol, metionin, poloksamer 188, fosfatna kiselina, natrijev hidroksid, voda za injekcije
English: Common (may affect up to 1 in 10 people)
Croatian: Često (pogađa najviše 1 od 10 osoba)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains: 250 micrograms (6500 IU) of Choriogonadotropin alfa
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži: 250 mikrograma (6500 IU) koriogonadotropina alfa
English: • Each pen contains 0.5 mL of solution.
Croatian: • Svaka napunjena brizgalica sadrži 0,5 ml otopine.
English: 6.3 Disposal
Croatian: 6.3 Zbrinjavanje
English: How to use Ovitrelle
Croatian: Kako primjenjivati Ovitrelle
English: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved.
Croatian: Jedna napunjena štrcaljka lijeka Ovitrelle (250 mikrograma) daje se 24 do 48 sati nakon posljednjeg davanja folikul stimulirajućeg hormona (FSH) ili preparata humanog menopauzalnog gonadotropina (hMG), tj. kada je postignuta optimalna stimulacija rasta folikula.
English: One pre-filled pen of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved.
Croatian: Jedna napunjena brizgalica lijeka Ovitrelle (250 mikrograma) daje se 24 do 48 sati nakon posljednjeg davanja folikul stimulirajućeg hormona (FSH) ili preparata humanog menopauzalnog gonadotropina (hMG), tj. kada je postignuta optimalna stimulacija rasta folikula.
English: • This pen is for single use only.
Croatian: • Brizgalica je namijenjena samo za jednokratnu uporabu.
English: How to use your Ovitrelle pre-filled pen Before you start using your Ovitrelle pre-filled pen Getting your Ovitrelle pre-filled pen ready for injection Setting the dose - “How to set the dose to 250” Injecting the dose
Croatian: Ovitrelle napunjene brizgalice za injekciju Podešavanje doze - „Kako podesiti dozu na 250“
English: Each pre-filled pen contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU).
Croatian: Jedna napunjena brizgalica sadrži 250 mikrograma koriogonadotropina alfa* (što odgovara približno 6500 IU).
English: Mannitol, methionine, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Croatian: Manitol, metionin, poloksamer 188, fosfatna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: What Ovitrelle looks like and contents of the pack Ovitrelle is provided as solution for injection.
Croatian: Ovitrelle se isporučuje kao otopina za injekciju.
English: Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Croatian: Ovitrelle je lijek koji sadrži koriogonadotropin alfa proizveden tehnikom rekombinantne DNK.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje često (pogađa najviše 1 od 100 osoba)
English: Vomiting, nausea, abdominal pain Uncommon: Diarrhoea Skin and subcutaneous tissue disorders Very rare:
Croatian: povraćanje, mučnina, bol u trbuhu Manje često: proljev
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms/0.5 mL solution for injection Choriogonadotropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ovitrelle 250 mikrograma/0,5 ml otopina za injekciju koriogonadotropin alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU BRIZGALICU
English: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
Croatian: Jedna napunjena štrcaljka lijeka Ovitrelle (250 mikrograma) daje se 24 do 48 sati nakon što je postignuta optimalna stimulacija rasta folikula.
English: Mannitol, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Croatian: Manitol, metionin, natrijev hidrogenfosfat dihidrat, natrijev dihidrogen fosfat hidrat, poloksamer 188, fosfatna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms solution for injection Choriogonadotropin alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ovitrelle 250 mikrograma otopina za injekciju koriogonadotropin alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 250 micrograms (approximately 6,500 IU) choriogonadotropin alfa
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica sadrži 250 mikrograma (približno 6500 IU) koriogonadotropina alfa.
English: Instructions For Use OVITRELLE 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Croatian: Upute za uporabu OVITRELLE 250 mikrograma otopina za injekciju u napunjenoj brizgalici koriogonadotropin alfa
English: • The other ingredients are mannitol, methionine disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
Croatian: • Drugi sastojci su: manitol, metionin, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat hidrat, poloksamer 188, fosfatna kiselina, (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Ovitrelle 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj štrcaljki
English: Ovitrelle 250 micrograms/0.5 mL solution for injection in a pre-filled syringe Choriogonadotropin alfa
Croatian: Ovitrelle 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj štrcaljki koriogonadotropin alfa
English: See the “Instructions for use” provided in the carton.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Pogledajte „Upute za uporabu“ koje se nalaze u kutiji.
English: Miscarriage
Croatian: Pobačaj
English: NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Ovitrelle 250 mikrograma otopina za injekciju u napunjenoj brizgalici
English: • Discard the pen.
Croatian: • Bacite brizgalicu.
English: Renal or hepatic impairment
Croatian: Oštećenje jetre ili bubrega
English: • Gently turn the dose setting knob clockwise.
Croatian: • Lagano okrenite gumb za podešavanje doze u smjeru kazaljke na satu.
English: • Remove the outer needle cap by pulling it gently.
Croatian: • Nježno povucite vanjski zatvarač igle i uklonite ga.
English: Ovitrelle 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Croatian: Ovitrelle 250 mikrograma otopina za injekciju u napunjenoj brizgalici koriogonadotropin alfa
English: Mild reversible skin reactions manifesting as rash Reproductive system and breast disorders Common:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo rijetko: blage reverzibilne kožne reakcije izražene kao osip
English: Blood clotting problems (thromboembolic events)
Croatian: Krvožilni poremećaji Vrlo rijetko: tromboembolija (povezana ili nepovezana s OHSS-om)
English: Subcutaneous use
Croatian: Supkutano
English: Tap the reservoir holder gently.
Croatian: 3. Tapkajte držač spremnika lagano prstom.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Poloxamer 188
Croatian: 6.1 Popis pomoćnih tvari manitol metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat hidrat poloksamer 188 fosfatna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: Date of first authorisation: 18 February 2016
Croatian: Datum prvog odobrenja: 18. veljače 2016.
English: If your gout gets worse
Croatian: Ako se Vaš giht pogorša
English: None of these were serious or required hospitalisation.
Croatian: Nijedan od tih slučajeva nije bio ozbiljan niti je zahtijevao hospitalizaciju.
English: Two litres is a good amount to drink.
Croatian: Dobro je popiti količinu od dvije litre.
English: Your doctor will tell you how long to take these other medicines for.
Croatian: Vaš liječnik će Vam reći koliko dugo trebate uzimati te druge lijekove.
English: Zurampic should be taken in the morning with food and water.
Croatian: Zurampic treba primijeniti ujutro s hranom i vodom.
English: Difference in proportion (95% C.I.)
Croatian: Razlika udjela (95% C.I.)
English: Do not take Zurampic if any of the above apply to you.
Croatian: Nemojte uzimati Zurampic ako se bilo što od gore navedenog odnosi na Vas.
English: What Zurampic is and what it is used for
Croatian: Što je Zurampic i za što se koristi
English: Do not take more than one (1) tablet of Zurampic per day.
Croatian: Nemojte uzeti više od jedne (1) tablete lijeka Zurampic dnevno.
English: This is also the maximum dose (see section 4.4).
Croatian: To je ujedno i maksimalna doza (vidjeti dio 4.4).
English: Tests and checks
Croatian: Pretrage i provjere
English: If you stop taking Zurampic Do not stop taking Zurampic without the advice of your doctor even if you feel better.
Croatian: Ako prestanete uzimati Zurampic Nemojte prestati uzimati Zurampic bez savjeta Vašeg liječnika, čak i ako se osjećate bolje.
English: How Zurampic works:
Croatian: Kako Zurampic djeluje:
English: Ask your doctor or pharmacist if you are not sure about how to take your next dose.
Croatian: Upitajte svog liječnika ili ljekarnika ako niste sigurni kako uzeti Vašu sljedeću dozu.
English: Treatment Group:
Croatian: Terapijska skupina:
English: If you forget to take Zurampic
Croatian: Ako ste zaboravili uzeti Zurampic
English: It is unclear if metabolite plasma exposures are minimal.
Croatian: Nije jasno je li izloženost metabolitima u plazmi minimalna.
English: Therapeutic experience in patients 75 years and older is limited.
Croatian: Terapijsko iskustvo u bolesnika u dobi od 75 ili više godina je ograničeno.
English: These serum creatinine elevations generally resolved, most without treatment interruption.
Croatian: Ova su povišenja serumskog kreatinina općenito razriješena, većinom bez prekida liječenja.
English: Months 4, 5, 6
Croatian: 4., 5. i 6. mjesec
English: The absolute bioavailability of lesinurad is approximately 100%.
Croatian: Apsolutna bioraspoloživost lesinurada je otprilike 100%.
English: The standard INR monitoring schedule should be applied, and no further actions are required.
Croatian: Potrebno je primijeniti standarno praćenje INR-a, te nisu potrebne dodatne mjere.
English: Package leaflet: Information for the Patient
Croatian: Uputa o lijeku: Informacije za bolesnika
English: What you need to know before you take Zurampic
Croatian: Što morate znati prije nego počnete uzimati Zurampic
English: Over time, your gout attacks will happen less often if you keep taking Zurampic as advised by your doctor.
Croatian: S vremenom će se Vaši napadaji gihta rjeđe pojavljivati ako nastavite uzimati Zurampic kako Vam je savjetovao Vaš liječnik.
English: If you miss a dose of Zurampic, do not take a double dose to make up for a forgotten dose.
Croatian: Ako propustite dozu lijeka Zurampic, nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Croatian: Lesinurad se opsežno veže na proteine u plazmi (više od 98%), uglavnom na albumin.
English: There are no restrictions for doses of salicylates of 325 mg or less per day (i.e. for cardiovascular protection).
Croatian: Ne postoje restrikcije za doze salicilata od 325 mg ili manje dnevno (tj. za kardiovaskularnu protekciju).
English: Lesinurad does not accumulate following multiple doses.
Croatian: Lesinurad se ne akumulira nakon primjene višestrukih doza.
English: There is no specific treatment in the event of an overdose, and symptoms of overdose are not established.
Croatian: Ne postoji specifično liječenje u slučaju predoziranja te nisu ustanovljeni simptomi predoziranja.
English: Clear (PVC/PVDC/Aluminium) blister of 10 or 14 (calendar blister) tablets.
Croatian: Prozirni (PVC/PVDC/Aluminij) blister s 10 ili 14 (kalendarski blister) tableta.
English: The safety and efficacy of Zurampic in children under 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Zurampic u djece mlađe od 18 godina nisu još ustanovljene.
English: Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare (<1/10,000).
Croatian: Kategorije učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000) i vrlo rijetko (<1/10 000).
English: Elderly (≥65 years)
Croatian: Starije osobe (u dobi od ≥65 godina)
English: Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day).
Croatian: Bolesnike treba uputiti da održavaju dobru hidraciju (npr. 2 litre tekućine dnevno).
English: If you take Zurampic on its own you may be more likely to get kidney problems - drink plenty of water during the day.
Croatian: Ako uzmete samo Zurampic, veća je vjerojatnost da ćete razviti probleme s bubrezima - tijekom dana pijte puno vode.
English: Experience in very elderly (≥75 years) is limited (see section 4.4).
Croatian: Iskustvo u vrlo starih osoba (u dobi od ≥75 godina) je ograničeno (vidjeti dio 4.4).
English: Most of the radioactivity recovered in urine (>60% of dose) occurred in the first 24 hours.
Croatian: Većina radioaktivnosti nađene u mokraći (>60% doze) javila se unutar prva 24 sata.
English: Pregnancy There are no data from the use of lesinurad in pregnant women.
Croatian: Trudnoća Nema podataka o primjeni lesinurada u trudnica.
English: Some people may have more gout attacks (gout flares) when they start using Zurampic and during the first weeks or months of treatment.
Croatian: Neke osobe mogu imati više napadaja gihta kada počnu primjenjivati Zurampic i tijekom prvih nekoliko tjedana ili mjeseci liječenja.
English: Do not take Zurampic: - if you are allergic to lesinurador any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Zurampic: - ako ste alergični na lesinurad ili neki drugi sastojak ovog lijeka (navedeni u dijelu 6).
English: Following multiple once daily dosing of Zurampic, there was no evidence of time dependent changes in pharmacokinetic properties and dose proportionality was preserved.
Croatian: Nakon primjene višestrukih doza lijeka Zurampic jedanput dnevno, nije bilo dokaza o promjenama farmakokinetičkih svojstava ovisnih o vremenu te je očuvana proporcionalnost doze.
English: Based on its mechanism of action, lesinurad may not be effective in these patients (see section 5.1).
Croatian: S obzirom na njegov mehanizam djelovanja, lesinurad možda neće biti učinkovit u ovih bolesnika (vidjeti dio 5.1).
English: Pre-existing cardiovascular disease
Croatian: Prethodno postojeća kardiovaskularna bolest
English: Also some other medicines can affect the way Zurampic works.
Croatian: Također, neki drugi lijekovi mogu utjecati na način na koji Zurampic djeluje.
English: Patients with tumour lysis syndrome or Lesch-Nyhan syndrome.
Croatian: Bolesnici sa sindromom lize tumora ili Lesch-Nyhanovim sindromom.
English: Clinically relevant interactions with other medicinal products
Croatian: Klinički značajne interakcije s drugim lijekovima
English: Tablets are engraved with “LES200” on one side.
Croatian: Tablete imaju utisnutu oznaku “LES200” s jedne strane.
English: In case of overdose, patients should be managed by symptomatic and supportive care including adequate hydration.
Croatian: U slučaju predoziranja, liječenje bolesnika treba biti simptomatsko i suportivno, uključujući odgovarajuću hidraciju.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines as they may interact with Zurampic and your doctor will need to know:
Croatian: Posebno obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova jer oni mogu stupiti u interakciju s lijekom Zurampic i Vaš liječnik to mora znati:
English: CYP2B6 has not been studied in vivo.
Croatian: CYP2B6 nije ispitan in vivo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci nisu pokazali posebne rizike za ljude, s obzirom na konvencionalna ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, karcinogenog potencijala te reproduktivne i razvojne toksičnosti.
English: No studies have been conducted in patients with secondary hyperuricaemia (including organ transplant recipients).
Croatian: Nisu provedena ispitivanja u bolesnika sa sekundarnom hiperuricemijom (uključujući primatelje presadaka organa).
English: Very elderly (≥75 years)
Croatian: Vrlo stare osobe (u dobi od ≥75 godina)
English: --o-- Placebo + Allopurinol,
Croatian: --o-- Placebo + Alopurinol,
English: Unchanged lesinurad in urine accounted for approximately 30% of the dose.
Croatian: Nepromijenjeni lesinurad u mokraći činio je otprilike 30% doze.