natgillin/translations-raw huggingface dataset:
• if you cannot drink enough water (see “drinking enough water” below) or if you have to restrict your fluid intake.
• če ne morete spiti dovolj vode (glejte spodaj "Zadostno pitje vode") ali če morate omejiti svoj vnos tekočin.
• if your kidneys do not work (no urine production)
• če vaše ledvice ne delajo (ne proizvajajo urina)
Pre-specified secondary endpoints were tested sequentially.
Vnaprej specificirane sekundarne opazovane dogodke so testirali zaporedoma.
If you take the higher dose very late in the day you may have to go to the toilet at night more frequently.
Če ste večji odmerek vzeli zelo pozno v dnevu, boste morda ponoči pogosteje hodili na stranišče.
Consequently, the frequency of these adverse events is qualified as "not known".
Zato je pogostnost teh neželenih učinkov opredeljena kot »neznana«.
The most frequent adverse reactions are related to water loss.
Najpogostejši neželeni učinki so povezani z izgubo vode.
The second daily dose can be taken with or without food.
Drugi dnevni odmerek se lahko jemlje s hrano ali brez nje.
If this happens to you, do not drive or use any tools or machines.
Če opazit te učinke, ne vozite avta in ne uporabljajte orodja ali strojev.
In particular this applies to patients with inadequately controlled type II diabetes.
To velja še zlasti za bolnike, pri katerih sladkorna bolezen tipa II ni pod ustreznim nadzorom.
Jinarc has not been studied in children and adolescents (under age 18) and its use is therefore not recommended in these age groups.
Zdravila Jinarc niso preučili pri otrocih in mladostnikih (starih manj kot 18 let), zato se njegova uporaba v teh starostnih skupinah ne priporoča.
If you do not take your tablets on one day, take your normal dose on the next day.
Če en dan ne vzamete svoje tablete, vzemite naslednji dan običajni odmerek.
Therefore, please inform your doctor immediately if you have signs that could indicate potential liver problems such as:
Zato takoj obvestite zdravnika, če imate znake, ki bi lahko nakazovali na može težave z jetri, kot so:
• Patients who cannot perceive or respond to thirst
• bolniki, ki žeje ne zaznavajo ali se nanjo ne morejo odzvati.
Your medicine is supplied in the following pack sizes:
Vaše zdravilo je na voljo v naslednjih velikostih pakiranja:
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Pogostnosti neželenih učinkov, o katerih so poročali med uporabo po začetku trženja, ni mogoče določiti, saj je pridobljena iz spontanih poročil.
The daily amount of Jinarc is split into two doses, one bigger than the other.
Dnevna količina zdravila Jinarc se razdeli na dva odmerka, en je večji kot drugi.
The advice of a hepatologist is recommended.
Priporoča se pridobitev nasveta hepatologa.
• jaundice (yellowing of skin or eyes)
• zlatenica (porumenelost kože ali oči)
Less than 1 % of intact active substance is excreted unchanged in the urine.
Manj kot 1 % zdravilne učinkovine se nespremenjene izloča v urinu.
Final study report should be submitted by:
Končno poročilo o študiji bo predloženo do:
There are no adequate data from the use of tolvaptan in pregnant women.
Ni zadostnih podatkov o uporabi tolvaptana pri nosečnicah.
Following an additional 2 years of tolvaptan treatment, resulting in a total of 5 years on tolvaptan therapy no new safety signals were identified.
Po dodatnih 2 letih zdravljenja s tolvaptanom, kar skupaj znaša 5 let zdravljenja s tolvaptanom, ni bilo ugotovljenih nobenih novih varnostnih signalov.
reduction in reciprocal serum creatinine during treatment [from end of titration to last on medicinal product visit])
zmanjšanje recipročnega kreatinina v serumu med zdravljenjem [od konca titriranja do zadnjega obiska z jemanjem zdravila])
A non-interventional post-authorisation safety study (PASS) to investigate the risks of:
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS) za preučitev tveganj:
• Patterns of medicinal product utilisation, especially with regards to off label use and use in patients over 50 years old
• vzorcih uporabe zdravila, zlasti glede neodobrene uporabe zdravila in njegove uporabe pri bolnikih, starih več kot 50 let
If you forget to take your medicine you should take the dose as soon as you remember on the same day.
Če ste pozabili vzeti zdravilo, vzemite enak odmerek takoj, ko se to tega dne spomnite.
During long-term treatment electrolytes have to be monitored at least every three months.
Med dolgotrajnim zdravljenjem je treba ravni elektrolitov preverjati na vsaj tri mesece.
The absolute bioavailability of tolvaptan is about 56 %.
Absolutna biološka uporabnost tolvaptana je približno 56 %.
4) worsening albuminuria
4) poslabšanje albuminurije
Stop taking Jinarc and immediately contact a doctor or go to the nearest hospital if you:
Takoj prenehajte jemati zdravilo Jinarc in pojdite k zdravniku ali v najbližjo bolnišnico, če:
Fluid and electrolyte balance
Tekočinsko in elektrolitno ravnovesje
In females, abnormal oestrus cycles were seen in both studies.
Pri samicah so v obeh študijah opazili nenormalne estrusne cikle.
Liver transplantation was necessary.
Potrebna je bila presaditev jeter.
• acute liver failure (ALF)
• akutna odpoved jeter (ALF)
The safety and efficacy of tolvaptan in children and adolescents has not yet been established.
Varnost in učinkovitost zdravila tolvaptan pri otrocih in mladostnikih še nista bili dokazani.
If you notice any of the following side effects, you may need urgent medical attention.
Če opazite kateri koli neželeni učinek v nadaljevanju, morda potrebujete nujno zdravniško pomoč.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Women of childbearing age must use reliable contraceptive measures during use of this medicine.
Ženske v rodni dobi morajo med uporabo tega zdravila uporabljati zanesljivo kontracepcijo.
Before bedtime you must drink 1 or 2 glasses of water even if you do not feel thirsty and you must also drink water after you urinating at night.
Pred spanjem morate spiti 1 ali 2 kozarca vode, četudi niste žejni, prav tako morate vodo spiti vsakič, ko greste ponoči na vodo.
The phase 3 pivotal trial (TEMPO 3:4, 156-04-251) included subjects from 129 centres in the Americas, Japan, Europe and other countries.
V osrednjem preskušanju 3. faze (TEMPO 3:4, 156-04-251) so bile vključene osebe iz 129 centrov v Ameriki, na Japonskem, v Evropi in drugih državah.
Patients have to be carefully monitored during treatment.
Med zdravljenjem je treba skrbno spremljati bolnike.
In total, 14 clinical trials involving tolvaptan have been completed worldwide in support of the ADPKD indication, including 8 trials in the US, 1 in the Netherlands, 3 in Japan, 1 in Korea, and the multinational phase 3 pivotal trial.
Po vsem svetu je bilo skupaj izvedenih 14 kliničnih preskušanj z tolvaptanom v podporo indikacije ADPKD, vključno z 8 preskušanji v ZDA, 1 na Nizozemskem, 3 na Japonskem, 1 v Koreji in multinacionalno osrednje preskušanje 3. faze.
• thirst (requiring excessive drinking of water)
• žeja (zaradi katere morate piti zelo veliko vode)
Tolvaptan binds reversibly (98 %) to plasma proteins.
Tolvaptan se reverzibilno (98 %) veže na beljakovine v plazmi.
The MAH must ensure that all healthcare professionals and patients/carers who are expected to prescribe and/or use JINARC have access to/are provided with the following educational package
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravstveni delavci in bolniki/negovalci, za katere se pričakuje, da bodo predpisovali in/ali uporabljali zdravilo JINARC, imeli dostop do/prejeli naslednji izobraževalni paket
30 mg (further reduction to 15 mg if 30 mg are not well tolerated)
30 mg (nadaljnje zmanjšanje na 15 mg, če bolnik 30 mg ne prenaša dobro)
Pregnancy and breast-feeding Do not take this medicine if you are pregnant or breast-feeding.
Nosečnost in dojenje Ne uporabljajte tega zdravila, če ste noseči ali dojite.
• diuretics or other medicines for the treatment of high blood pressure.
• diuretiki ali druga zdravila, ki se uporabljajo za zdravljenje visokega krvnega tlaka.
Appropriate replacement of water and/or electrolytes must continue until aquaresis abates.
Ustrezno nadomeščanje vode in/ali elektrolitov se mora nadaljevati, dokler se diureza ne ublaži.
Prescribing physicians must comply fully with the safety measures required below.
Zdravnik, ki zdravilo predpiše, mora v celoti upoštevati spodnje zahtevane varnostne ukrepe.
However, the safety and effectiveness of tolvaptan in ADPKD patients aged over 50 years has not yet been established.
Vendar pa varnost in učinkovitost tolvaptana pri bolnikih z ADPKD, starih več kot 50 let, še nista bili dokazani.
Patients have to be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration.
Bolnikom je treba naročiti, da pijejo vodo ali druge vodne tekočine ob prvem znaku žeje, da preprečijo pretirano žejo ali dehidracijo.
• ALT or AST > 5-times ULN for more than 2 weeks
• ravni ALT ali AST > 5-krat ULN dlje kot 2 tedna
It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.
Zato je pomembno, da imate dostop do vode in da ste zmožni spiti zadostne količine, ko začutite žejo.
Similar changes with other medicinal products have been associated with the potential to cause irreversible and potentially life-threatening liver injury.
Podobne spremembe z drugimi zdravili so bile povezane z možnostjo povzročanja nepopravljivih in potencialno življenje ogrožajočih poškodb jeter.
• if you have a condition which is associated with a very low blood volume (e.g. severe dehydration or bleeding)
• če imate stanje, povezano z zelo nizkim volumnom krvi (npr. huda dehidracija ali krvavitev).
Only the oxobutyric acid metabolite is present at greater than 10 % of total plasma radioactivity; all others are present at lower concentrations than tolvaptan.
Le presnovek okso-butirična kislina je prisoten z več kot 10 % skupne radioaktivnosti v plazmi; vsi drugi so prisotni v nižjih koncentracijah kot tolvaptan.
However, when driving vehicles or using machines it has to be taken into account that occasionally dizziness, asthenia or fatigue may occur.
Vendar pa je pri vožnji ali upravljanju strojev treba upoštevati, da se lahko občasno pojavi omotičnost, astenija ali utrujenost.
During treatment with Jinarc, your doctor will arrange monthly blood tests to check for changes in your liver function.
Med zdravljenjem z zdravilom Jinarc bo zdravnik uredil mesečne krvne preiskave, s katerimi bo preverjal spremembe delovanja jeter.
• increased need to urinate, to urinate at night, or to urinate more frequently
• večja potreba po odvajanju urina, nočnemu uriniranju ali bolj pogostem uriniranju
All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Vsi neželeni učinki zdravila so našteti po organskih sistemih in pogostnosti: 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), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Genotyping for PKD1 and PKD2 genes was conducted in a majority of patients entering the openlabel extension study (TEMPO 4:4) but the results are not yet known.
Genotipizacija za gena PKD1 in PKD2 je bila izvedena pri večini bolnikov, ki sodelujejo v podaljšku odprtega preskušanja (TEMPO 4:4), vendar rezultati še niso znani.
Information in braille:
Podatki v braillovi pisavi:
It is therefore of greatest importance that patients have access to water and are able to drink sufficient amounts of fluids.
Zato je zelo pomembno, da imajo bolniki dostop do vode in lahko pijejo zadostne količine tekočin.
• ALT or AST > 8-times ULN
• ravni ALT ali AST > 8-krat ULN
Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Ireland
Almac Pharma Service (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth - A91 P9KD Irska
Prior to launch of Jinarc in each Member State the Marketing Authorisation Holder must agree the content and format of the educational programme, including communication media and distribution modalities with each National Competent Authority.
Pred prihodom zdravila Jinarc na trg vsake države članice se mora imetnik dovoljenja za promet z zdravilom z vsakim nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskim medijem in načinom širjenja gradiva.
The educational programme is aimed at ensuring awareness about the potential risk of hepatotoxicity and providing guidance on how to manage this risk and the importance of pregnancy prevention prior to the initiation and during the treatment with Jinarc.
Namen izobraževalnega programa je zagotoviti ozaveščanje o možnih tveganjih hepatotoksičnosti in dati smernice o obravnavi teh tveganj in pomena preprečevanja nosečnosti pred uvedbo zdravljenja z zdravilom Jinarc in med njim.
• raised levels of liver enzymes in the blood
• zvišane ravni jetrnih encimov v krvi
The aim of dose titration is to block activity of vasopressin at the renal V2 receptor as completely and constantly as possible, while maintaining acceptable fluid balance (see section 4.4).
Cilj titriranja odmerka je zaviranje aktivnosti vazopresina na ledvičnem receptorju V2 tako celovito in konstantno, kot je mogoče, pri hkratnem ohranjanju sprejemljivega tekočinskega ravnovesja (glejte poglavje 4.4).
Fluid and electrolyte status must be monitored in all patients.
Pri vseh bolnikih je treba spremljati tekočinsko in elektrolitno stanje.
While these criteria were useful in enriching the study population with patients who were rapidly progressing, subgroup analyses based on stratification criteria (age, TKV, GFR, Albuminuria, Hypertension) indicated the presence of such risk factors at younger ages predicts more rapid disease progression.
Čeprav so bili ti kriteriji koristni pri obogatitvi študijske populacije z bolniki z naglim napredovanjem, so analize podskupin na podlagi stratifikacijskih kriterijev (starost, TKV, GFR, albuminurija, hipertenzija) pokazale, da prisotnost teh dejavnikov tveganja pri mlajši starosti napoveduje hitrejše napredovanje bolezni.
Studies in rats have shown excretion of tolvaptan in milk.
Študije na podganah so pokazale, da se tolvaptan izloča v mleko.
• if you have difficulties urinating or have an enlarged prostate.
• če imate težave z uriniranjem ali povečano prostato.
Fourteen metabolites have been identified in plasma, urine and faeces; all but one were also metabolised by CYP3A.
V plazmi, urinu in blatu so identificirali štirinajst presnovkov; vse razen enega presnavlja tudi encim CYP3A.
According to these split dose regimens the total daily doses are 60, 90, or 120 mg.
V skladu s temi režimi razdeljenih odmerkov je skupni dnevni odmerek 60, 90 ali 120 mg.
Your doctor may gradually increase your dose up to a maximum combination of 90 mg on waking and 30 mg after 8 hours.
Zdravnik lahko vaš odmerek postopoma povečuje na največjo kombinacijo 90 mg po prebujanju in 30 mg po 8 urah.
A pre-specified subgroup analysis suggested that tolvaptan had less of an effect in patients older than 55 years of age, a small subgroup with a notably slower rate of eGFR decline.
Vnaprej določena analiza podskupin je pokazala, da je imel tolvaptan manjši vpliv na bolnike, starejše od 55 let, ki so predstavljali majhno podskupino z izrazito počasnejšim upadanjem eGFR.
• Signs or symptoms of liver toxicity and severe dehydration
• znake in simptome toksičnosti jeter in hude dehidracije
During the first 18 months of treatment, Jinarc can only be supplied to patients whose physician has determined that liver function supports continued therapy.
V prvih 18 mesecih zdravljenja se lahko zdravilo Jinarc da le bolnikom, katerih zdravnik je ugotovil, da delovanje jeter podpira nadaljevanje zdravljenja.
In patients with severe hepatic impairment the benefits and risks of treatment with Jinarc must be evaluated carefully.
Pri bolnikih s hudo jetrno okvaro je treba skrbno ovrednotiti koristi in tveganja zdravljenja z zdravilom Jinarc.
• decreased appetite
• zmanjšan apetit
Diabetes mellitus
Diabetes melitus
Tolvaptan affinity for the human V2 receptor is 1.8 times that of native AVP.
Afiniteta tolvaptana za humani receptor V2 je 1,8-krat večja od nativnega AVP.
Since hypersensitivity is a contraindication (see section 4.3) treatment must never be restarted after an anaphylactic reaction or other serious allergic reactions.
Ker je preobčutljivost kontraindikacija (glejte poglavje 4.3), se zdravljenje po anafilaktični reakciji ali drugi resni alergijski reakciji ne sme nikoli nadaljevati.
Tolvaptan has not been extensively studied in ADPKD in combination with diuretics.
Tolvaptana niso izčrpno preučili pri ADPKD v kombinaciji z diuretiki.
Urinary output must be secured.
Zagotoviti je treba odvajanje urina.
Taken with Jinarc these may increase the risk of low blood pressure when you stand up from sitting or lying down.
Jemanje z zdravilom Jinarc lahko poveča tveganje za nizek krvni tlak, ko vstanete iz sedečega položaja ali se uležete.
What Jinarc is and what it is used for
Kaj je zdravilo Jinarc in za kaj ga uporabljamo
The design was used to minimize the impact of early discontinuation and missing data on trial endpoints.
Ta zasnova je bila uporabljena za minimalizacijo vpliva zgodnje prekinitve jemanja zdravila in manjkajočih podatkov na opazovane dogodke preskušanja.
Other potential causes of renal dysfunction or dehydration must be evaluated and addressed.
Oceniti in obravnavati je treba druge možne vzroke za ledvično disfunkcijo ali dehidracijo.
Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD United Kingdom
Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD Velika Britanija
Radio labelled tolvaptan experiments showed that 40 % of the radioactivity was recovered in the urine and 59 % was recovered in the faeces, where unchanged tolvaptan accounted for 32 % of radioactivity.
Poskusi z radiološko označenim tolvaptanom so pokazali, da je bilo 40 % radioaktivnosti najdene v urinu in 59 % v blatu, medtem ko je nespremenjen tolvaptan predstavljal 32 % radioaktivnosti.
‘Tolvaptan (n = 961) and placebo (n = 484) groups were well matched in terms of gender with an average age of 39 years.
Skupini s tolvaptanom (n = 961) in placebom (n = 484) sta si bili podobni v smislu zastopanosti po spolu, s povprečno starostjo 39 let.
Therefore, you should only stop taking Jinarc if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Zato zdravilo Jinarc prenehajte jemati le takrat, če opazite neželene učinke, ki jih je treba nujno zdraviti (glejte poglavje 4), ali če vam tako naroči zdravnik.
No clinical trials in subjects with a creatinine clearance < 10 mL/min or in patients undergoing dialysis have been conducted.
Kliničnih preskušanj pri osebah z očistkom kreatinina < 10 ml/min ali pri bolnikih na dializi niso izvedli.
Jinarc with food and drink Do not drink grapefruit juice when taking Jinarc.
Zdravilo Jinarc skupaj s hrano in pijačo Ne pijte grenivkinega soka, medtem ko jemljete zdravilo Jinarc.
• high levels of sodium, uric acid and blood sugar
• visoke ravni natrija, sečne kisline in krvnega sladkorja
The inclusion criteria identified patients who at baseline had evidence of early disease progression.
Vključitveni kriteriji so opredelili bolnike, ki so imeli ob izhodišču znake zgodnjega napredovanja bolezni.
The use of any of these medicines together with Jinarc is to be avoided because this may reduce the effects of Jinarc.
Uporabi katerega koli od teh zdravil skupaj z zdravilom Jinarc se je treba izogniti, saj lahko ta zdravila zmanjšajo učinke zdravila Jinarc.
Your treatment will normally start with a dose of 45 mg in the morning and 15 mg eight hours later.
Vaše zdravljenje se običajno začne z odmerkom 45 mg zjutraj in 15 mg osem ur kasneje.
Tablets must be swallowed without chewing and with a glass of water.
Tablete je treba zaužiti brez žvečenja s kozarcem vode.
7 tablets 28 tablets
7 tablet 28 tablet
The table is based on adverse events reported during clinical trials and/or post-marketing use.
Preglednica temelji na neželenih učinkih, o katerih so poročali med kliničnimi preskušanji in/ali med uporabo po začetku trženja.
In contrast, there was no effect of tolvaptan on either progression of hypertension or albuminuria.
Nasprotno pa tolvaptan ni vplival niti na napredovanje hipertenzije niti na albuminurijo.
If you take other medicines which can increase the effects of Jinarc you may receive lower doses.
Če jemljete druga zdravila, ki lahko povečajo učinke zdravila Jinarc, boste morda prejeli manjše odmerke.
This type of reaction occurred after the first administration of tolvaptan.
Ta vrsta reakcije se je pojavila po prvem dajanju tolvaptana.
Data related to smoking or alcohol history in ADPKD trials are too limited to determine possible interactions of smoking or alcohol with efficacy and safety of ADPKD treatment with tolvaptan.
Podatki, povezani s kajenjem ali alkoholom v anamnezi so v preskušanjih ADPKD preveč omejeni, da bi omogočali določitev možnih interakcij kajenja ali alkohola z učinkovitostjo in varnostjo zdravljenja ADPKD s tolvaptanom.
TEMPO 4:4 is an open-label extension study that included 871 subjects that completed TEMPO 3:4 from 106 centres across 13 countries.
TEMPO 4:4 je podaljšek odprtega preskušanja, ki je vključeval 871 oseb, ki so zaključile preskušanje 3. faze TEMPO 3:4 v 106 centrih v 13 državah.
Two fertility studies in rats showed effects on the parental generation (decreased food consumption and body weight gain, salivation), but tolvaptan did not affect reproductive performance in males and there were no effects on the foetuses.
Dve študiji plodnosti pri podganah sta pokazali učinke na starševsko generacijo (zmanjšan vnos hrane in pridobivanje telesne mase, slinjenje), vendar tolvaptan ni vplival na sposobnost razmnoževanja samcev in ni bilo učinkov na zarodke.
Patients taking moderate or strong CYP3A inhibitors must be managed cautiously, in particular if the inhibitors are taken more frequently than once a day.
Bolnike, ki jemljejo zmerne ali močne zaviralce CYP3A, je treba obravnavati previdno, zlasti, če zaviralce jemljejo več kot enkrat na dan.
Even though this increase has no clinical relevance, it indicates tolvaptan can potentially increase exposure to CYP3A4 substrates.
Kljub mnenju, da to zvišanje ni klinično pomembno, kaže na to, da ima tolvaptan možnost zvečati izpostavljenost substratom CYP3A4.
(CKD stage 4), respectively.
(4. stopnja KLB).
The pharmacodynamically predictable and most commonly reported adverse reactions are thirst, polyuria, nocturia, and pollakiuria occurring in approximately 55 %, 38 %, 29 % and 23 % of patients, respectively.
Farmakodinamično predvidljivi in najbolj pogosto poročani neželeni učinki so bili žeja, poliurija, nokturija in polakiurija, ki se pojavijo pri približno 55 %, 38 %, 29 % oz. 23 % bolnikov.
It is unknown whether tolvaptan is excreted in human breast milk.
Ni znano, ali se tolvaptan pri ljudeh izloča v materino mleko.
Pharmacotherapeutic group: Diuretics, vasopressin antagonists, ATC code: C03XA01.
Farmakoterapevtska skupina: diuretiki, antagonisti vazopresina, oznaka ATC: C03XA01.
Uric acid concentrations are to be evaluated prior to initiation of Jinarc therapy, and as indicated during treatment based on symptoms.
Koncentracije sečne kisline je treba oceniti pred uvedbo zdravljenja z zdravilom Jinarc in kot je nakazano med zdravljenjem na podlagi simptomov.
No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Klinično značilnih sprememb pri očistku za odmerke od 5 do 60 mg niso opazili.