FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the top of the needle; this shows that your pre-filled pen is ready for injection.
Slovenian: Na konici igle se mora prikazati majhna kaplja tekočine, kar pomeni, da je napolnjen injekcijski peresnik pripravljen na injiciranje.
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.
Slovenian: Sindrom hiperstimulacije jajčnikov se lahko razvije v resen zaplet, za katerega so značilne velike ciste na jajčnikih, nagnjene k rupturi, povečanje telesne mase, dispneja, oligurija ali pojav ascitesa v klinični sliki disfunkcije obtočil.
English: Uncommon: Severe OHSS, breast pain General disorders and administration site conditions Common:
Slovenian: hud OHSS, boleče dojke Splošne težave in spremembe na mestu aplikacije Pogosti:
English: Tiredness, injection site reactions.
Slovenian: utrujenost, reakcije na mestu injiciranja
English: Pack of 1 pre-filled pen and 1 injection needle.
Slovenian: Pakiranje z enim napolnjenim injekcijskim peresnikom in 1injekcijsko iglo.
English: What Ovitrelle contains
Slovenian: Kaj vsebuje zdravilo Ovitrelle
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.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov horiogonadotropina alfa* (kar ustreza približno 6.500 i.e.) v 0,5 ml raztopine.
English: 5.1 Choose the injection site in the area your doctor or nurse has told you to give the injection.
Slovenian: 5.1 Izberite mesto, kamor boste dali injekcijo na predelu, ki vam ga je svetoval zdravnik ali medicinska sestra.
English: In anovulation, the risk of OHSS is increased by a serum estradiol level > 1,500 pg/mL (5,400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
Slovenian: Pri ženskah brez ovulacije je tveganje za sindrom hiperstimulacije jajčnikov povečano, če imajo serumsko koncentracijo estradiola >1.500 pg/ml (5.400 pmol/l) in več kot 3 folikle s premerom 14 mm ali več.
English: OHSS 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.
Slovenian: OHSS se lahko razvije v resen zaplet, za katerega so značilne velike ciste na jajčnikih, nagnjene k rupturi, povečanje telesne mase, dispneja, oligurija ali pojav ascitesa v klinični sliki disfunkcije obtočil.
English: 1 pre-filled pen of 0.5 mL solution 1 injection needle
Slovenian: 1 napolnjen injekcijski peresnik z 0,5 ml raztopine 1 injekcijska igla
English: Ovitrelle contains a medicine called ‘choriogonadotropin alfa', made in a laboratory by a special recombinant DNA technique.
Slovenian: Zdravilo Ovitrelle vsebuje zdravilno učinkovino, imenovano "horiogonadotropin alfa", izdelano v laboratoriju z uporabo posebne tehnologije rekombinantne DNA.
English: • Each pre-filled pen contains 250 micrograms choriogonadotropin alfa in 0.5 mL (equivalent to approximately 6,500 International Units, IU).
Slovenian: • Vsak napolnjen injekcijski peresnik vsebuje 250 mikrogramov horiogonadotropin alfa v 0,5 ml (kar ustreza približno 6.500 mednarodnim enotam, i.e.).
English: • Each pre-filled syringe contains 250 micrograms / 0.5 mL (equivalent to 6500 IU).
Slovenian: • Vsaka napolnjena injekcijska brizga vsebuje 250 mikrogramov/0,5 ml (kar ustreza 6.500 i.e.).
English: • The other ingredients are mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water for injections.
Slovenian: • Druge sestavine zdravila so manitol, metionin, poloksamer 188, fosforjeva kislina, natrijev hidroksid, voda za injekcije.
English: • The active substance is choriogonadotropin alfa, produced by recombinant DNA technology.
Slovenian: • Učinkovina je horiogonadotropin alfa, pridobljena s tehnologijo rekombinantne DNA.
English: • Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth.
Slovenian: • Odraslih žensk brez ovulacije ali z oligoovulacijo: pri teh ženskah se zdravilo Ovitrelle uporablja za sprožitev ovulacije in luteinizacije po stimulaciji folikelske rasti.
English: • Each pre-filled pen is for single use only.
Slovenian: • Vsak napolnjen injekcijski peresnik je samo za enkratno uporabo.
English: • The recommended dose is 1 pre-filled syringe (250 micrograms/0.5 mL) given as a single injection.
Slovenian: • Priporočeni odmerek je 1 napolnjena injekcijska brizga (250 mikrogramov/0,5 ml), ki se daje kot enkratna injekcija.
English: Getting your Ovitrelle pre-filled pen ready for injection 3.1 Take off the pen cap
Slovenian: Priprava zdravila Ovitrelle napolnjen injekcijski peresnik za injiciranje 3.1 Odstranite pokrovček injekcijskega peresnika
English: Each pre-filled pen contains 0.5 mL of solution for injection.
Slovenian: En napolnjeni injekcijski peresnik vsebuje 0,5 ml raztopine za injiciranje.
English: Renal or hepatic impairment
Slovenian: Okvarjeno delovanje ledvic ali jeter
English: • Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Slovenian: • Ženske, v postopku sprožitve superovulacije pred postopki asistirane reprodukcije, kot je npr.
English: • Hold the Ovitrelle pre-filled pen with the needle pointing upward.
Slovenian: • Držite zdravilo Ovitrelle napolnjen injekcijski peresnik z iglo navzgor.
English: • Then grip the outer needle cap and unscrew the needle.
Slovenian: • Primite zunanji pokrovček igle in odvijte iglo.
English: What Ovitrelle is
Slovenian: Kaj je zdravilo Ovitrelle
English: • Carefully put the outer needle cap onto the needle.
Slovenian: • Previdno namestite zunanji pokrovček igle na injekcijsko iglo.
English: • This pen is for single use only.
Slovenian: • Ta injekcijski peresnik je samo za enkratno uporabo.
English: This event is common (may affect up to 1 in 10 people).
Slovenian: To je pogost dogodek (pojavi se lahko pri največ 1 od 10 bolnikov).
English: This event is uncommon (may affect up to 1 in 100 people).
Slovenian: To je občasen dogodek (pojavi se lahko pri največ 1 od 100 bolnikov).
English: Mannitol, methionine, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Slovenian: Manitol, metionin, poloksamer 188, fosforjeva kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH), voda za injekcije.
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.
Slovenian: En napolnjen injekcijski peresnik zdravila Ovitrelle (250 mikrogramov) se injicira 24 do 48 ur po zadnji aplikaciji pripravka s folikle stimulirajočim hormonom (FSH) ali humanim menopavznim gonadotropinom (hMG), to je, ko je dosežena optimalna stimulacija folikelske rasti.
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
Slovenian: Priprava zdravila Ovitrelle napolnjen injekcijski peresnik za injiciranje Nastavitev odmerka - "Kako nastaviti odmerek na 250" Injiciranje odmerka
English: • Fibroid tumours of the uterus incompatible with pregnancy
Slovenian: • maternični miomi, ki niso združljivi z nosečnostjo,
English: In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births (mostly twins) is increased compared with natural conception.
Slovenian: Incidenca večplodne nosečnosti in rojstev (povečini dvojčkov) je pri bolnicah, zdravljenih z indukcijo ovulacije, večja kot pri tistih, ki naravno zanosijo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 NAPOLNJENO INJEKCIJSKO BRIZGO
English: INFORMATION IN BRAILLE ovitrelle 250 pen
Slovenian: PODATKI V BRAILLOVI PISAVI ovitrelle 250 napolnjen injekcijski peresnik
English: Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Slovenian: Zdravilo Ovitrelle je zdravilo s horiogonadotropinom alfa, pridobljenim s tehnologijo rekombinantne DNA.
English: Each pre-filled pen contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU).
Slovenian: En napolnjen injekcijski peresnik vsebuje 250 mikrogramov horiogonadotropina alfa* (kar ustreza približno 6.500 i.e.).
English: Severe OHSS could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Slovenian: Pri hudem sindromu hiperstimulacije jajčnikov je lahko v redkih primerih zaplet hemoperitonej, respiratorna stiska, zasuk jajčnika in trombembolija.
English: Miscarriage
Slovenian: Dojenje
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.
Slovenian: Manitol, metionin, dinatrijev fosfat dihidrat, natrijev dihidrogenfosfat monohidrat, poloksamer 188, fosforjeva kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH), voda za injekcije.
English: • After the injection, dispose of the used syringe safely.
Slovenian: • Po injiciranju varno zavrzite brizgo.
English: Pregnancy outside your womb, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted reproductive techniques your doctor may use.
Slovenian: Zaradi postopka asistirane reprodukcije, ki ga uporabi vaš zdravnik, se lahko pojavijo zunajmaternična nosečnost, zasuk jajčnikov (stanje, ki prizadene vaše jajčnike) in drugi zapleti.
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.
Slovenian: • Druge sestavine zdravila so manitol, metionin, dinatrijev fosfat dihidrat, natrijev dihidrogenfosfat monohidrat, poloksamer 188, fosforjeva kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains: 250 micrograms (6500 IU) of Choriogonadotropin alfa
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje: 250 mikrogramov (6.500 i.e.) horiogonadotropina alfa.
English: Solution for injection in pre-filled syringe.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
Slovenian: En napolnjen injekcijski peresnik zdravila Ovitrelle (250 mikrogramov) se injicira 24 do 48 ur potem, ko je dosežena optimalna stimulacija folikelske rasti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms/0.5 mL solution for injection Choriogonadotropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ovitrelle 250 mikrogramov/0,5 ml raztopina za injiciranje horiogonadotropin alfa subkutana uporaba
English: NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
Slovenian: IME ZDRAVILA Ovitrelle 250 mikrogramov/0,5 ml, raztopina za injiciranje v napolnjeni injekcijski brizgi
English: CONTENTS
Slovenian: VSEBINA
English: How to store Ovitrelle
Slovenian: Shranjevanje zdravila Ovitrelle
English: Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration.
Slovenian: Po dajanju hCG bolnicam so poročali o zunajmaternični nosečnosti, torziji jajčnikov in drugih zapletih.
English: • Diarrhoea.
Slovenian: • driska
English: See your doctor straight away if you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing.
Slovenian: Če se pojavijo bolečine v spodnjem delu trebuha, hitro povečanje telesne mase, če vam je slabo ali bruhate in če imate težave z dihanjem, pojdite takoj k zdravniku.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms solution for injection Choriogonadotropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ovitrelle 250 mikrogramov raztopina za injiciranje horiogonadotropin alfa subkutana uporaba
English: If it is not, you must adjust it
Slovenian: Če temu ni tako, morate odmerek prilagoditi (glejte korak "4.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 250 micrograms (approximately 6,500 IU) choriogonadotropin alfa
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Vsak napolnjen injekcijski peresnik vsebuje 250 mikrogramov (približno 6.500 i.e.) horiogonadotropina alfa.
English: Instructions For Use OVITRELLE 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Slovenian: Navodilo za uporabo OVITRELLE 250 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Horiogonadotropin alfa
English: • Hold the pre-filled pen firmly by the reservoir holder.
Slovenian: • Čvrsto primite napolnjen injekcijski peresnik v predelu prostora za tekočino.
English: • Gently turn the dose setting knob clockwise.
Slovenian: • Nežno sukajte gumb za nastavitev odmerka v smeri urinega kazalca.
English: How to use your Ovitrelle pre-filled pen
Slovenian: Kako uporabljati zdravilo Ovitrelle napolnjen injekcijski peresnik
English: Ovitrelle 250 micrograms/0.5 mL solution for injection in a pre-filled syringe Choriogonadotropin alfa
Slovenian: Ovitrelle 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Horiogonadotropin alfa
English: Before you start using your Ovitrelle pre-filled pen
Slovenian: Kaj morate vedeti, preden boste začeli uporabljati zdravilo Ovitrelle napolnjen injekcijski peresnik
English: Vomiting, nausea, abdominal pain Uncommon: Diarrhoea Skin and subcutaneous tissue disorders Very rare:
Slovenian: Bolezni kože in podkožja Zelo redki:
English: NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Ovitrelle 250 mikrogramov, raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: What Ovitrelle looks like and contents of the pack Ovitrelle is provided as solution for injection.
Slovenian: Zdravilo Ovitrelle je v obliki raztopine za injiciranje.
English: Batch
Slovenian: driska
English: Ovitrelle 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Slovenian: Ovitrelle 250 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku horiogonadotropin alfa
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Poloxamer 188
Slovenian: 6.1 Seznam pomožnih snovi manitol metionin dinatrijev fosfat dihidrat natrijev dihidrogenfosfat monohidrat poloksamer 188 fosforjeva kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: • Now put the pen cap back onto the pen.
Slovenian: • Zdaj na injekcijski peresnik ponovno namestite pokrovček injekcijskega peresnika.
English: Date of first authorisation: 18 February 2016
Slovenian: Datum prve odobritve: 18. februar 2016
English: Your doctor will tell you how long to take these other medicines for.
Slovenian: Zdravnik vam bo povedal, koliko časa morate jemati ta druga zdravila.
English: If your gout gets worse
Slovenian: Če se vam protin poslabša
English: None of these were serious or required hospitalisation.
Slovenian: Nobeden od teh primerov ni bil resen in nobeden ni zahteval sprejema v bolnišnico.
English: This is also the maximum dose (see section 4.4).
Slovenian: To je tudi največji odmerek (glejte poglavje 4.4).
English: Do not take more than one (1) tablet of Zurampic per day.
Slovenian: Ne vzemite več kot ene (1) tablete zdravila Zurampic na dan.
English: Most of the radioactivity recovered in urine (>60% of dose) occurred in the first 24 hours.
Slovenian: Večina radioaktivnosti v urinu (> 60 % odmerka) se je pojavila v prvih 24 urah.
English: Months 4, 5, 6
Slovenian: 4., 5., 6. mesec
English: Time from Baseline in Months
Slovenian: Čas od izhodišča v mesecih
English: Zurampic should be taken in the morning with food and water.
Slovenian: Zdravilo Zurampic je treba vzeti zjutraj s hrano in vodo.
English: Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Slovenian: Lesinurad je v veliki meri vezan na beljakovine v plazmi (več kot 98 %), predvsem na albumin.
English: The standard INR monitoring schedule should be applied, and no further actions are required.
Slovenian: Izvajati je treba kontrole INR po običajnem razporedu in dodatni ukrepi niso potrebni.
English: Unchanged lesinurad in urine accounted for approximately 30% of the dose.
Slovenian: Nespremenjeni lesinurad v urinu je predstavljal približno 30 % odmerka.
English: Therapeutic experience in patients 75 years and older is limited.
Slovenian: Terapevtskih izkušenj pri bolnikih, starih 75 let ali več, je malo.
English: What Zurampic is and what it is used for
Slovenian: Kaj je zdravilo Zurampic in za kaj ga uporabljamo
English: The absolute bioavailability of lesinurad is approximately 100%.
Slovenian: Absolutna biološka uporabnost lesinurada je približno 100 %.
English: In case of overdose, patients should be managed by symptomatic and supportive care including adequate hydration.
Slovenian: V primeru prevelikega odmerjanja mora biti bolnik deležen simptomatskega in podpornega zdravljenja, vključno z ustrezno hidracijo.
English: Difference in proportion (95% C.I.)
Slovenian: Razlika v deležu (95 % IZ)
English: Lesinurad has no or negligible influence on the ability to drive and use machines.
Slovenian: Lesinurad nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Following multiple once daily dosing of Zurampic, there was no evidence of time dependent changes in pharmacokinetic properties and dose proportionality was preserved.
Slovenian: Po večkratnem odmerjanju zdravila Zurampic enkrat na dan ni bilo znakov od časa odvisnih sprememb farmakokinetičnih lastnosti in sorazmernost odmerka se je ohranila.
English: These serum creatinine elevations generally resolved, most without treatment interruption.
Slovenian: Ta zvišanja kreatinina v serumu so na splošno izginila, večinoma brez prekinitve zdravljenja.
English: Children and adolescents Zurampic is not recommended for use in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravila Zurampic ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day).
Slovenian: Bolnikom je treba naročiti, naj poskrbijo za dobro hidracijo (npr. 2 litra tekočine na dan).
English: Additionally, lesinurad led to a 6-8% decrease in International Normalised Ratio (INR) and Prothrombin Time (PT).
Slovenian: Poleg tega je lesinurad povzročil od 6- do 8-odstotno znižanje internacionalnega normaliziranega razmerja (INR) in protrombinskega časa (PČ).
English: The safety and efficacy of Zurampic in children under 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Zurampic še nista bili ugotovljeni pri otrocih, mlajših od 18 let.
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).
Slovenian: Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: However, individual values were well within the range observed in the extensive metaboliser subjects.
Slovenian: Toda individualne vrednosti so bile v okviru razpona, ugotovljenega pri izrazitih metabolizatorjih.
English: No studies have been conducted in patients with secondary hyperuricaemia (including organ transplant recipients).
Slovenian: Študij pri bolnikih s sekundarno hiperurikemijo (vključno s prejemniki presajenih organov) niso izvedli.
English: Clinically relevant interactions with other medicinal products
Slovenian: Klinično pomembna medsebojna delovanja z drugimi zdravili
English: Renal clearance is 25.6 mL/min (CV=56%).
Slovenian: Ledvični očistek je 25,6 ml/min (KV = 56 %).
English: Based on population pharmacokinetic analysis, age, gender, race and ethnicity do not have a clinically meaningful effect on the pharmacokinetics of lesinurad.
Slovenian: Na podlagi populacijske farmakokinetične analize starost, spol, rasa in etnična pripadnost nimajo klinično pomembnega vpliva na farmakokinetiko lesinurada.
English: These are to help prevent or treat the symptoms of gout attacks (a sudden or severe pain and swelling in a joint).
Slovenian: Ta zdravila pomagajo preprečiti ali zdraviti simptome napadov protina (nenadne ali hude bolečine in oteklost sklepa).
English: Patients with serum creatinine elevations to greater than 1.5 times the pre-treatment value should be closely monitored.
Slovenian: Bolnike z zvišanjem kreatinina v serumu na več kot 1,5-krat tolikšno vrednost, kot je bila pred zdravljenjem, je treba skrbno nadzorovati.
English: If you miss a dose of Zurampic, do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti odmerek zdravila Zurampic, ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
English: There are no restrictions for doses of salicylates of 325 mg or less per day (i.e. for cardiovascular protection).
Slovenian: Za uporabo salicilatov v odmerkih 325 mg ali manj na dan (tj. za srčno-žilno zaščito) ni omejitev.
English: If you take more Zurampic than you should If you take more of this medicine than you should, talk to a doctor or go to the nearest hospital.
Slovenian: Če ste vzeli večji odmerek zdravila Zurampic, kot bi smeli Če ste vzeli več zdravila, kot bi smeli, se posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
English: Patients with tumour lysis syndrome or Lesch-Nyhan syndrome.
Slovenian: Bolniki s sindromom lize tumorja ali Lesch-Nyhanovim sindromom.
English: Experience in very elderly (≥75 years) is limited (see section 4.4).
Slovenian: Izkušenj z zelo starimi osebami (≥ 75 let) je malo (glejte poglavje 4.4).
English: This is because Zurampic can affect the way some other medicines work.
Slovenian: Zdravilo Zurampic namreč lahko vpliva na delovanje nekaterih drugih zdravil.
English: Very elderly (≥75 years)
Slovenian: Zelo stari bolniki (≥ 75 let)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zurampic in all subsets of the paediatric population for the treatment and prevention of hyperuricaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Zurampic za vse podskupine pediatrične populacije za zdravljenje in preprečevanje hiperurikemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Available pharmacodynamic/toxicological data in rats have shown excretion of lesinurad in milk.
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri podganah so pokazali izločanje lesinurada v mleku.