natgillin/translations-raw huggingface dataset:
Thromboembolism (both in association with and separate from OHSS) Gastrointestinal disorders
trombembolizem (tako v povezavi z OHSS in nepovezano z njim) Bolezni prebavil
May be stored at or below +25°C for up to 30 days without being refrigerated again during this period and must be discarded if not used during these 30 days.
Zdravilo lahko shranjujete pri temperaturi do +25 °C do 30 dni, brez ponovnega shranjevanja v hladilniku v tem času, in ga morate zavreči, če ga ne uporabite v teh 30 dneh.
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
Glavno farmakodinamično delovanje pri ženskah je ponoven pojav meioze oocitov, ruptura folikla (ovulacija), tvorba rumenega telesca in izločanje progesterona in estradiola iz rumenega telesca.
dose setting knob dose display plunger piston reservoir holder threaded needle connector pen cap peel-off seal tab removable needle inner needle shield 10. outer needle cap 11. alcohol swabs 12. sharps disposal container
gumb za nastavitev odmerka prikaz odmerka potiskalo bata prostor za tekočino navojni priključek za iglo pokrovček injekcijskega peresnika jeziček, ki se odlepi odstranljiva injekcijska igla notranji ščitnik igle 10. zunanji pokrovček igle 11. alkoholne blazinice 12. vsebnik za odlaganje ostrih odpadkov
Pregnancy outside of the womb (an ectopic pregnancy) may occur in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb).
Nosečnost zunaj maternice (zunajmaternična nosečnost) se lahko pojavi pri ženskah s poškodovanimi jajcevodi.
If you do not see a tiny drop(s) of fluid at or near the tip:
Če prvič ne opazite drobnih kapelj na ali blizu konice igle:
Inject the solution by pushing gently on the plunger.
Raztopino injicirajte z rahlim potiskanjem bata.
5.4 Inject the dose as you were trained to do by your doctor or nurse
5.4 Injicirajte odmerek, kot vas je poučil vaš zdravnik ali medicinska sestra
Since infertile women undergoing ART, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased.
Ker imajo neplodne ženske, ki se zdravijo s postopki asistirane reprodukcije, zlasti oploditve in vitro, pogosto abnormalnosti jajcevodov, je lahko incidenca zunajmaterničnih nosečnosti večja.
Mild or moderate OHSS
blag do zmeren OHSS
• Do not push or pull the dose setting button while you turn it.
• Gumba za nastavitev odmerka med sukanjem ne pritiskajte in ne vlecite.
Patients undergoing ovarian stimulation are at an increased risk of developing OHSS due to multiple follicular development.
Sindrom hiperstimulacije jajčnikov (Ovarian Hyperstimulation Syndrome - OHSS) Pri bolnicah, ki so v postopku stimulacije jajčnikov, je povečano tveganje za razvoj OHSS zaradi razvoja več foliklov.
• Each pre-filled syringe is for single use only.
• Vsaka napolnjena injekcijska brizga je samo za enkratno uporabo.
Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. age) may also be associated with an increased chance of birth defects.
Z večjo možnostjo prirojenih okvar so lahko povezane tudi večplodne nosečnosti in specifične značilnosti parov, ki imajo težave s plodnostjo (npr. zaradi starosti).
This medicine may increase your risk of developing OHSS.
Sindrom hiperstimulacije jajčnikov (Ovarian Hyperstimulation Syndrome - OHSS) To zdravilo lahko poveča tveganje za razvoj OHSS.
Within its shelf-life, the solution may be stored at or below 25°C for up to 30 days without being refrigerated again during this period.
V času roka uporabnosti lahko raztopino shranjujete pri temperaturi do 25 °C do 30 dni, brez ponovnega shranjevanja v hladilniku v tem času.
• Inject Ovitrelle as your doctor or nurse taught you.
• Zdravilo Ovitrelle si injicirajte, kot vas je naučil vaš zdravnik ali medicinska sestra.
This shows that the complete dose was delivered.
To pomeni, da ste odmerek injicirali v celoti.
Mild reversible skin reactions manifesting as rash Reproductive system and breast disorders Common:
blaga prehodna kožna reakcija v obliki izpuščaja Motnje reprodukcije in dojk Pogosti:
Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Zdravnik ali medicinska sestra sta vas že poučila kam si dati injekcijo (npr. v trebuh, sprednji del stegna).
Other medicines will be given first to develop and ripen the follicles.
Najprej dajemo druga zdravila, da se doseže rast in razvoj foliklov.
• After the injection, dispose of the used needle safely, and discard the pen.
• Po vsakem injiciranju varno odstranite uporabljeno iglo in zavrzite peresnik.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
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.
Na konici igle se mora prikazati majhna kaplja tekočine, kar pomeni, da je napolnjen injekcijski peresnik pripravljen na injiciranje.
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.
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.
Uncommon: Severe OHSS, breast pain General disorders and administration site conditions Common:
hud OHSS, boleče dojke Splošne težave in spremembe na mestu aplikacije Pogosti:
Tiredness, injection site reactions.
utrujenost, reakcije na mestu injiciranja
Pack of 1 pre-filled pen and 1 injection needle.
Pakiranje z enim napolnjenim injekcijskim peresnikom in 1injekcijsko iglo.
What Ovitrelle contains
Kaj vsebuje zdravilo Ovitrelle
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution.
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.
5.1 Choose the injection site in the area your doctor or nurse has told you to give the injection.
5.1 Izberite mesto, kamor boste dali injekcijo na predelu, ki vam ga je svetoval zdravnik ali medicinska sestra.
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.
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.
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.
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.
1 pre-filled pen of 0.5 mL solution 1 injection needle
1 napolnjen injekcijski peresnik z 0,5 ml raztopine 1 injekcijska igla
Ovitrelle contains a medicine called ‘choriogonadotropin alfa', made in a laboratory by a special recombinant DNA technique.
Zdravilo Ovitrelle vsebuje zdravilno učinkovino, imenovano "horiogonadotropin alfa", izdelano v laboratoriju z uporabo posebne tehnologije rekombinantne DNA.
• Each pre-filled pen contains 250 micrograms choriogonadotropin alfa in 0.5 mL (equivalent to approximately 6,500 International Units, IU).
• Vsak napolnjen injekcijski peresnik vsebuje 250 mikrogramov horiogonadotropin alfa v 0,5 ml (kar ustreza približno 6.500 mednarodnim enotam, i.e.).
• Each pre-filled syringe contains 250 micrograms / 0.5 mL (equivalent to 6500 IU).
• Vsaka napolnjena injekcijska brizga vsebuje 250 mikrogramov/0,5 ml (kar ustreza 6.500 i.e.).
• The other ingredients are mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water for injections.
• Druge sestavine zdravila so manitol, metionin, poloksamer 188, fosforjeva kislina, natrijev hidroksid, voda za injekcije.
• The active substance is choriogonadotropin alfa, produced by recombinant DNA technology.
• Učinkovina je horiogonadotropin alfa, pridobljena s tehnologijo rekombinantne DNA.
• 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.
• Odraslih žensk brez ovulacije ali z oligoovulacijo: pri teh ženskah se zdravilo Ovitrelle uporablja za sprožitev ovulacije in luteinizacije po stimulaciji folikelske rasti.
• Each pre-filled pen is for single use only.
• Vsak napolnjen injekcijski peresnik je samo za enkratno uporabo.
• The recommended dose is 1 pre-filled syringe (250 micrograms/0.5 mL) given as a single injection.
• Priporočeni odmerek je 1 napolnjena injekcijska brizga (250 mikrogramov/0,5 ml), ki se daje kot enkratna injekcija.
Getting your Ovitrelle pre-filled pen ready for injection 3.1 Take off the pen cap
Priprava zdravila Ovitrelle napolnjen injekcijski peresnik za injiciranje 3.1 Odstranite pokrovček injekcijskega peresnika
Each pre-filled pen contains 0.5 mL of solution for injection.
En napolnjeni injekcijski peresnik vsebuje 0,5 ml raztopine za injiciranje.
Renal or hepatic impairment
Okvarjeno delovanje ledvic ali jeter
• Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
• Ženske, v postopku sprožitve superovulacije pred postopki asistirane reprodukcije, kot je npr.
• Hold the Ovitrelle pre-filled pen with the needle pointing upward.
• Držite zdravilo Ovitrelle napolnjen injekcijski peresnik z iglo navzgor.
• Then grip the outer needle cap and unscrew the needle.
• Primite zunanji pokrovček igle in odvijte iglo.
What Ovitrelle is
Kaj je zdravilo Ovitrelle
• Carefully put the outer needle cap onto the needle.
• Previdno namestite zunanji pokrovček igle na injekcijsko iglo.
• This pen is for single use only.
• Ta injekcijski peresnik je samo za enkratno uporabo.
This event is common (may affect up to 1 in 10 people).
To je pogost dogodek (pojavi se lahko pri največ 1 od 10 bolnikov).
This event is uncommon (may affect up to 1 in 100 people).
To je občasen dogodek (pojavi se lahko pri največ 1 od 100 bolnikov).
Mannitol, methionine, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Manitol, metionin, poloksamer 188, fosforjeva kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH), voda za injekcije.
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.
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.
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
Priprava zdravila Ovitrelle napolnjen injekcijski peresnik za injiciranje Nastavitev odmerka - "Kako nastaviti odmerek na 250" Injiciranje odmerka
• Fibroid tumours of the uterus incompatible with pregnancy
• maternični miomi, ki niso združljivi z nosečnostjo,
In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births (mostly twins) is increased compared with natural conception.
Incidenca večplodne nosečnosti in rojstev (povečini dvojčkov) je pri bolnicah, zdravljenih z indukcijo ovulacije, večja kot pri tistih, ki naravno zanosijo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 NAPOLNJENO INJEKCIJSKO BRIZGO
INFORMATION IN BRAILLE ovitrelle 250 pen
PODATKI V BRAILLOVI PISAVI ovitrelle 250 napolnjen injekcijski peresnik
Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Zdravilo Ovitrelle je zdravilo s horiogonadotropinom alfa, pridobljenim s tehnologijo rekombinantne DNA.
Each pre-filled pen contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU).
En napolnjen injekcijski peresnik vsebuje 250 mikrogramov horiogonadotropina alfa* (kar ustreza približno 6.500 i.e.).
Severe OHSS could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Pri hudem sindromu hiperstimulacije jajčnikov je lahko v redkih primerih zaplet hemoperitonej, respiratorna stiska, zasuk jajčnika in trombembolija.
Miscarriage
Dojenje
Mannitol, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Manitol, metionin, dinatrijev fosfat dihidrat, natrijev dihidrogenfosfat monohidrat, poloksamer 188, fosforjeva kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH), voda za injekcije.
• After the injection, dispose of the used syringe safely.
• Po injiciranju varno zavrzite brizgo.
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.
Zaradi postopka asistirane reprodukcije, ki ga uporabi vaš zdravnik, se lahko pojavijo zunajmaternična nosečnost, zasuk jajčnikov (stanje, ki prizadene vaše jajčnike) in drugi zapleti.
• 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.
• 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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains: 250 micrograms (6500 IU) of Choriogonadotropin alfa
NAVEDBA ENE ALI VEČ UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje: 250 mikrogramov (6.500 i.e.) horiogonadotropina alfa.
Solution for injection in pre-filled syringe.
FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjeni injekcijski brizgi.
One pre-filled syringe of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
En napolnjen injekcijski peresnik zdravila Ovitrelle (250 mikrogramov) se injicira 24 do 48 ur potem, ko je dosežena optimalna stimulacija folikelske rasti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms/0.5 mL solution for injection Choriogonadotropin alfa
IME ZDRAVILA IN POT(I) UPORABE Ovitrelle 250 mikrogramov/0,5 ml raztopina za injiciranje horiogonadotropin alfa subkutana uporaba
NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
IME ZDRAVILA Ovitrelle 250 mikrogramov/0,5 ml, raztopina za injiciranje v napolnjeni injekcijski brizgi
How to store Ovitrelle
Shranjevanje zdravila Ovitrelle
Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration.
Po dajanju hCG bolnicam so poročali o zunajmaternični nosečnosti, torziji jajčnikov in drugih zapletih.
• Diarrhoea.
• driska
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.
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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovitrelle 250 micrograms solution for injection Choriogonadotropin alfa
IME ZDRAVILA IN POT(I) UPORABE Ovitrelle 250 mikrogramov raztopina za injiciranje horiogonadotropin alfa subkutana uporaba
If it is not, you must adjust it
Če temu ni tako, morate odmerek prilagoditi (glejte korak "4.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 250 micrograms (approximately 6,500 IU) choriogonadotropin alfa
NAVEDBA ENE ALI VEČ UČINKOVIN Vsak napolnjen injekcijski peresnik vsebuje 250 mikrogramov (približno 6.500 i.e.) horiogonadotropina alfa.
Instructions For Use OVITRELLE 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Navodilo za uporabo OVITRELLE 250 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Horiogonadotropin alfa
• Hold the pre-filled pen firmly by the reservoir holder.
• Čvrsto primite napolnjen injekcijski peresnik v predelu prostora za tekočino.
• Gently turn the dose setting knob clockwise.
• Nežno sukajte gumb za nastavitev odmerka v smeri urinega kazalca.
How to use your Ovitrelle pre-filled pen
Kako uporabljati zdravilo Ovitrelle napolnjen injekcijski peresnik
Ovitrelle 250 micrograms/0.5 mL solution for injection in a pre-filled syringe Choriogonadotropin alfa
Ovitrelle 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Horiogonadotropin alfa
Before you start using your Ovitrelle pre-filled pen
Kaj morate vedeti, preden boste začeli uporabljati zdravilo Ovitrelle napolnjen injekcijski peresnik
Vomiting, nausea, abdominal pain Uncommon: Diarrhoea Skin and subcutaneous tissue disorders Very rare:
Bolezni kože in podkožja Zelo redki:
NAME OF THE MEDICINAL PRODUCT Ovitrelle 250 micrograms solution for injection in pre-filled pen
IME ZDRAVILA Ovitrelle 250 mikrogramov, raztopina za injiciranje v napolnjenem injekcijskem peresniku
What Ovitrelle looks like and contents of the pack Ovitrelle is provided as solution for injection.
Zdravilo Ovitrelle je v obliki raztopine za injiciranje.
Batch
driska
Ovitrelle 250 micrograms solution for injection in pre-filled pen Choriogonadotropin alfa
Ovitrelle 250 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku horiogonadotropin alfa
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Poloxamer 188
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
• Now put the pen cap back onto the pen.
• Zdaj na injekcijski peresnik ponovno namestite pokrovček injekcijskega peresnika.
Date of first authorisation: 18 February 2016
Datum prve odobritve: 18. februar 2016
Your doctor will tell you how long to take these other medicines for.
Zdravnik vam bo povedal, koliko časa morate jemati ta druga zdravila.
If your gout gets worse
Če se vam protin poslabša
None of these were serious or required hospitalisation.
Nobeden od teh primerov ni bil resen in nobeden ni zahteval sprejema v bolnišnico.
This is also the maximum dose (see section 4.4).
To je tudi največji odmerek (glejte poglavje 4.4).
Do not take more than one (1) tablet of Zurampic per day.
Ne vzemite več kot ene (1) tablete zdravila Zurampic na dan.
Most of the radioactivity recovered in urine (>60% of dose) occurred in the first 24 hours.
Večina radioaktivnosti v urinu (> 60 % odmerka) se je pojavila v prvih 24 urah.
Months 4, 5, 6
4., 5., 6. mesec
Time from Baseline in Months
Čas od izhodišča v mesecih
Zurampic should be taken in the morning with food and water.
Zdravilo Zurampic je treba vzeti zjutraj s hrano in vodo.
Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Lesinurad je v veliki meri vezan na beljakovine v plazmi (več kot 98 %), predvsem na albumin.
The standard INR monitoring schedule should be applied, and no further actions are required.
Izvajati je treba kontrole INR po običajnem razporedu in dodatni ukrepi niso potrebni.
Unchanged lesinurad in urine accounted for approximately 30% of the dose.
Nespremenjeni lesinurad v urinu je predstavljal približno 30 % odmerka.
Therapeutic experience in patients 75 years and older is limited.
Terapevtskih izkušenj pri bolnikih, starih 75 let ali več, je malo.
What Zurampic is and what it is used for
Kaj je zdravilo Zurampic in za kaj ga uporabljamo
The absolute bioavailability of lesinurad is approximately 100%.
Absolutna biološka uporabnost lesinurada je približno 100 %.
In case of overdose, patients should be managed by symptomatic and supportive care including adequate hydration.
V primeru prevelikega odmerjanja mora biti bolnik deležen simptomatskega in podpornega zdravljenja, vključno z ustrezno hidracijo.
Difference in proportion (95% C.I.)
Razlika v deležu (95 % IZ)
Lesinurad has no or negligible influence on the ability to drive and use machines.
Lesinurad nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Following multiple once daily dosing of Zurampic, there was no evidence of time dependent changes in pharmacokinetic properties and dose proportionality was preserved.
Po večkratnem odmerjanju zdravila Zurampic enkrat na dan ni bilo znakov od časa odvisnih sprememb farmakokinetičnih lastnosti in sorazmernost odmerka se je ohranila.
These serum creatinine elevations generally resolved, most without treatment interruption.
Ta zvišanja kreatinina v serumu so na splošno izginila, večinoma brez prekinitve zdravljenja.
Children and adolescents Zurampic is not recommended for use in children and adolescents below 18 years of age.
Otroci in mladostniki Zdravila Zurampic ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day).
Bolnikom je treba naročiti, naj poskrbijo za dobro hidracijo (npr. 2 litra tekočine na dan).
Additionally, lesinurad led to a 6-8% decrease in International Normalised Ratio (INR) and Prothrombin Time (PT).
Poleg tega je lesinurad povzročil od 6- do 8-odstotno znižanje internacionalnega normaliziranega razmerja (INR) in protrombinskega časa (PČ).
The safety and efficacy of Zurampic in children under 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Zurampic še nista bili ugotovljeni pri otrocih, mlajših od 18 let.
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).
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).
However, individual values were well within the range observed in the extensive metaboliser subjects.
Toda individualne vrednosti so bile v okviru razpona, ugotovljenega pri izrazitih metabolizatorjih.
No studies have been conducted in patients with secondary hyperuricaemia (including organ transplant recipients).
Študij pri bolnikih s sekundarno hiperurikemijo (vključno s prejemniki presajenih organov) niso izvedli.
Clinically relevant interactions with other medicinal products
Klinično pomembna medsebojna delovanja z drugimi zdravili
Renal clearance is 25.6 mL/min (CV=56%).
Ledvični očistek je 25,6 ml/min (KV = 56 %).