natgillin/translations-raw huggingface dataset:
If not, change the needle and repeat the procedure no more than 6 times.
Če se ne, zamenjajte iglo ponovite postopek, vendar ne več kot 6- krat.
• Always check that the push-button is fully depressed and the dose selector is set at zero • Dial the number of units required by turning the dose selector clockwise (picture 2).
• Vedno preverite, da je potisni gumb povsem dol in da je izbirnik odmerka nastavljen na ničlo. • Nastavite potrebno število enot tako, da izbirnik odmerka zasučete v smeri urinega kazalca (slika 2).
You cannot set a dose larger than the number of units left in the cartridge.
105 Odmerka, ki bi bil večji od števila preostalih enot v vložku, ne morete nastaviti.
You will hear clicks as the dose selector returns to zero • After the injection, the needle must remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button • Remove the needle after each injection.
Ko se bo izbirnik odmerka vračal na ničlo, boste slišali klike. • Po injiciranju mora igla ostati pod kožo vsaj 6 sekund, da je zanesljivo injiciran celotni odmerek. • Pazite, da med injiciranjem ne boste ovirali izbirnika odmerka, kajti zagotoviti je treba, da se ta med pritiskom na potisni gumb neovirano vrne na ničlo. • Iglo po vsakem injiciranju odstranite.
Remove the needle after each injection and store InnoLet without a needle attached.
Po vsakem injiciranju morate iglo odstraniti in zavreči, InnoLet pa shraniti brez nameščene igle.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
V nasprotnem primeru lahko tekočina izteka, to pa lahko povzroči netočno odmerjanje. Zdravstveni
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
106 delavci, sorodniki in drugi, ki skrbijo za vas, morajo upoštevati splošne previdnostne ukrepe za odstranjevanje in odlaganje igel, da ne pride do nehotenih vbodov z iglo.
Dispose of your used Actrapid InnoLet carefully without the needle attached.
Odrabljen peresnik Actrapid InnoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
106 4
4
Your Actrapid InnoLet is designed to work accurately and safely.
Vaš Actrapid InnoLet je izdelan za natančno in varno delovanje.
Do not refill Actrapid InnoLet.
Peresnika Actrapid InnoLet se ne sme znova polniti.
You can clean your Actrapid InnoLet by wiping it with a medicinal swab.
Actrapid InnoLet lahko očistite tako, da ga obrišete z medicinskim zložencem.
Actrapid FlexPen 100 IU/ ml solution for injection in a pre-filled pen Insulin human (rDNA)
107 NAVODILO ZA UPORABO Actrapid FlexPen 100 i. e. / ml raztopina za injiciranje v napolnjenem injekcijskem peresniku humani insulin (rDNA)
You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you.
Morda ga boste želeli ponovno prebrati. – Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom. – Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
108 Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta- sympathomimetics; growth hormone; danazol; octreotide or lanreotide.
108 Vaša potreba po insulinu se lahko spremeni, če uporabljate tudi: peroralna antidiabetična zdravila, zaviralce monoaminooksidaze (MAOI), zaviralce receptorjev beta, zaviralce ACE, acetilsalicilno kislino, anabolne steroide, sulfonamide, peroralne kontraceptive, tiazide, glukokortikoide, zdravljenje s ščitničnimi hormoni, beta- simpatikomimetike, rastni hormon, danazol, oktreotid in lanreotid.
► In insulin infusion pumps ► If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin ► If it hasn’ t been stored correctly or been frozen (see 6 How to store Actrapid) ► If it does not appear water clear and colourless.
Ne uporabljajte zdravila Actrapid, v insulinskih infuzijskih črpalkah. ► če FlexPen pade, se poškoduje ali z njim kam udarite: obstaja nevarnost za puščanje ► insulina. če ni bilo shranjeno pravilno ali je zamrznilo (glejte poglavje 6.
109 unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
109 Če čutite, da se pojavlja hipa, si ne dajajte insulina.
110 Side effects reported uncommonly (in less than 1 patient in 100)
(manj kot 1 bolnik na 100)
Changing the site with each injection may help to prevent such skin changes.
Če na mestu injiciranja opazite ugreznjenost ali izbočenost kože, morate to povedati zdravniku ali medicinski sestri.
If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Takšne reakcije namreč lahko postanejo hujše ali spremenijo absorpcijo insulina, če ga injicirate na takšno mesto.
The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
Injekcijski peresnik FlexPen, ki ga ne uporabljate, shranjujte v hladilniku (med 2 °C in 8 °C).
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator.
Injekcijski peresnik FlexPen, ki ga uporabljate, ga boste pravkar uporabili ali ga imate pri sebi za rezervo, ne shranjujte v hladilniku!
Always keep the pen cap on your FlexPen when you’ re not using it in order to protect it from light.
111 Kadar peresnika FlexPen ne uporabljate, naj bo vedno pokrit s pokrovčkom, da bo zaščiten pred svetlobo.
– If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue d’ Orléans F-28002 Chartres, France is the manufacturer.
– Če sta drugi in tretji znak H7 ali T6, je izdelovalec Novo Nordisk Production SAS, 45 Avenue d’ Orléans, F- 28002 Chartres, Francija.
112 Introduction
112 Uvod
Please read the following instructions carefully before using your Actrapid FlexPen.
Preden uporabite Actrapid FlexPen, natančno preberite ta navodila
Actrapid FlexPen Pen cap
Actrapid FlexPen pokrovček peresnika
12 units
gumijasta 12 enot
Push-
potisni
membrane
membrana
Needle (example)
Igla (primer) zaščitna nalepka igla
Needle
notranji
Protective
pokrovček igle
tab
Vzdrževanje
Maintenance Your FlexPen is designed to work accurately and safely.
Vaš FlexPen je izdelan za natančno in varno delovanje.
Preparing your Actrapid FlexPen
Priprava peresnika Actrapid FlexPen
A Pull off the pen cap.
A Snemite pokrovček peresnika.
B Remove the protective tab from a new disposable needle.
B Odstranite zaščitno nalepko z nove igle za enkratno uporabo.
C Pull off the big outer needle cap and keep it for later.
C Snemite veliki zunanji pokrovček in ga shranite za pozneje.
E Turn the dose selector to select 2 units.
E Zavrtite izbirnik odmerka tako, da boste izbrali 2 enoti.
2 units- select ed
izbrani 2 enoti
F Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
F Držite FlexPen tako, da je igla obrnjena navzgor, in s prstom nekajkrat rahlo potrkajte po vložku, da se bodo morebitni zračni mehurčki zbrali na vrhu vložka.
G Keeping the needle upwards, press the push-button all the way in.
G Z iglo obrnjeno navzgor pritisnite potisni gumb do konca.
H Turn the dose selector to select the number of units you need to inject.
H Zavrtite izbirnik odmerka, da boste izbrali število enot, ki jih morate injicirati.
115 H
115 H
5 units select ed
izbranih 5 enot
24 unit s select ed
izbranih 24 enot
I Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer.
I Odmerek injicirajte tako, da potisni gumb pritisnete do konca in se 0 uravna s kazalnikom.
J Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin.
J Po injiciranju držite potisni gumb povsem pritisnjen, dokler igle ne potegnete iz kože.
K Lead the needle into the big outer needle cap without touching the big outer needle cap.
K Konico igle vstavite v veliki zunanji pokrovček igle, ne da bi se ga dotaknili.
• Always remove the needle after each injection otherwise the liquid may leak out which can cause inaccurate dosing.
• Po vsakem injiciranju morate iglo odstraniti in zavreči, v nasprotnem primeru lahko tekočina izteka in to lahko povzroči netočno odmerjanje.
Adenuric is a medicine containing the active substance febuxostat.
Adenuric je zdravilo, vsebujoče zdravilno učinkovino febuksostat.
It is available as yellow, capsule- shaped tablets (80 and 120 mg).
Na voljo je kot rumene tablete v obliki kapsul (80 in 120 mg).
Adenuric is used to treat chronic (long-term) hyperuricaemia (high levels of uric acid or ‘ urate ’ in the blood).
Zdravilo Adenuric se uporablja za zdravljenje kronične (dolgotrajne) hiperurikemije (visoke koncentracije sečne kisline ali urata v krvi).
When this happens in the joints and causes pain, it is known as ‘ gout’.
Ko pride do odlaganja v sklepih, ki povzroča bolečino, imenujemo to „ protin “ ali „ putika “.
Adenuric is used in patients who already have signs of a build-up of crystals, including arthritis (pain and inflammation in the joints) or tophi (‘ stones ’, larger deposits of urate crystals that can cause joint and bone damage).
Zdravilo Adenuric se uporablja pri bolnikih, ki že kažejo znake odlaganja kristalov, vključno z artritisom (bolečino in vnetjem v sklepih) ali tofi („ kamni “ – večjimi skupki kristalov urata, ki lahko povzročajo poškodbe sklepov in kosti).
The recommended dose of Adenuric is 80 mg once a day.
Priporočeni odmerek zdravila Adenuric je 80 mg enkrat dnevno.
Adenuric usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain above 6 mg per decilitre after two to four weeks.
Zdravilo Adenuric običajno zniža koncentracijo sečne kisline v krvi v dveh tednih, vendar pa je mogoče v primeru, da ostane koncentracija sečne kisline v krvi po dveh do štirih tednih nad 6 mg na deciliter, odmerek povečati na 120 mg enkrat dnevno.
Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric.
V prvih nekaj mesecih zdravljenja še vedno lahko pride do zagona protina, zato je priporočljivo, da bolnik jemlje druga zdravila za preprečevanje zagonov protina vsaj prvih 6 mesecev zdravljenja z zdravilom Adenuric.
Adenuric treatment should not be stopped if an attack happens.
V primeru zagona protina se zdravljenja z zdravilom Adenuric ne sme prekiniti.
The safety and effectiveness of Adenuric have not been studied in patients with severe kidney or liver problems.
Varnosti in učinkovitosti zdravila Adenuric pri bolnikih z hudimi težavami z ledvicami ali jetri niso preučevali.
It is not recommended for use in children or in patients who have had an organ transplant because it has not been studied in these groups.
Uporaba pri otrocih ali bolnikih po presaditvi organa ni priporočljiva, saj uporabe pri teh skupinah niso preučevali.
The active substance in Adenuric, feboxustat, reduces the formation of uric acid.
Zdravilna učinkovina feboksustat, ki jo vsebuje zdravilo Adenuric, zmanjša tvorjenje sečne kisline.
It works by blocking an enzyme called ‘ xanthine oxidase’, which is needed to make uric acid in the body.
Deluje tako, da zavira encim, imenovan ksantinska oksidaza, ki je potreben za tvorbo sečne kisline v telesu.
By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Z zmanjševanjem tvorbe sečne kisline lahko zdravilo Adenuric zniža koncentracijo sečne kisline v krvi in jo vzdržuje na nizki ravni ter tako ustavi kopičenje kristalov.
This can reduce the symptoms of gout.
To lahko zmanjša
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. simptome protina.
The effects of Adenuric were first tested in experimental models before being studied in humans.
Učinki zdravila Adenuric so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effectiveness of Adenuric has been studied in two main studies involving a total of 1,834 patients with hyperuricaemia and gout.
Učinkovitost zdravila Adenuric so preučevali v dveh glavnih študijah s skupno 1834 bolniki s hiperurikemijo in protinom.
The first study, carried out in 1,072 patients, compared the effectiveness of three doses of Adenuric (80, 120 and 240 mg once a day) with that of placebo (a dummy treatment) and of allopurinol (another medicine used to treat hyperuricaemia).
V prvi študiji, izvedeni s 1072 bolniki, so primerjali učinkovitost treh odmerkov zdravila Adenuric (80, 120 in 240 mg enkrat dnevno) z učinkovitostjo placeba (zdravila brez zdravilne učinkovine) in alopurinola (drugega zdravila, ki se uporablja za zdravljenje hiperurikemije).
The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
V drugi študiji so v obdobju enega leta pri 762 bolniki primerjali dva odmerka zdravila Adenuric (80 in 120 mg enkrat dnevno) z alopurinolom.
In both studies, allopurinol was used at a dose of 300 mg once a day, except for patients with kidney problems, who took 100 mg.
V obeh študijah so alopurinol uporabljali v odmerku 300 mg enkrat dnevno, razen pri bolnikih s težavami z ledvicami, ki so prejemali 100 mg.
The main measure of effectiveness was the number of patients whose final three blood uric acid levels were below 6 mg/ dl.
Glavno merilo učinkovitosti je bilo število bolnikov, katerih zadnje tri meritve koncentracije sečne kisline v krvi so bile nižje od 6 mg/ dl.
Adenuric was more effective than allopurinol and placebo in reducing blood uric acid levels.
Zdravilo Adenuric je bilo pri zniževanju koncentracije sečne kisline v krvi učinkovitejše od alopurinola in placeba.
In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/ dl in the final three measurements.
Pri prvi študiji je imelo 48% bolnikov (126 od 262), ki so prejemali 80 mg zdravila Adenuric enkrat dnevno, ter 65% bolnikov (175 od 269), ki so prejemali 120 mg enkrat dnevno, koncentracijo sečne kisline v krvi pod 6 mg/ dl pri zadnjih treh meritvah.
This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo.
Te rezultate so primerjali z 22% pri bolnikih, ki so prejemali alopurinol (60 od 268), in nobenim izmed 134 bolniki, ki so prejemali placebo.
Similar results were seen in the second study after a year.
Podobni rezultati so bili ugotovljeni v drugi študiji po enem letu.
The most common side effects with Adenuric (seen in between 1 and 10 patients in 100) are headache, diarrhoea, nausea (feeling sick), rash and abnormal liver test results.
Najpogostejši neželeni učinki zdravila Adenuric (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, driska, navzeja (slabost), izpuščaj in nenormalni izvidi jetrnih testov.
There may also be an increased risk of certain side effects affecting the heart and blood vessels, particularly in patients with a history of heart problems.
Možno je tudi povečano tveganje za določene neželene učinke, ki prizadenejo srce in ožilje, še posebej pri bolnikih, ki so imeli v preteklosti težave s srcem.
For the full list of all side effects reported with Adenuric, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Adenuric, glejte navodilo za uporabo.
Adenuric should not be used in people who may be hypersensitive (allergic) to feboxustat or any of the other ingredients.
Zdravila Adenuric ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) feboksustat ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels, but that it could carry a greater risk of side effects affecting the heart and blood vessels.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Adenuric učinkovitejše od alopurinola pri zniževanju koncentracije sečne kisline v krvi, vendar pa lahko pomeni večje tveganje za neželene učinke, ki prizadenejo srce in ožilje.
The Committee decided that Adenuric’ s benefits are greater than its risks for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred.
Odbor je odločil, da so koristi zdravila Adenuric pri zdravljenju kronične hiperurikemije v primerih, ko je že prišlo do odlaganja urata, večje od z njim povezanih tveganj.
The Committee recommended that Adenuric be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Adenuric odobri dovoljenje za promet.
Other information about Adenuric:
Druge informacije o zdravilu Adenuric:
The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
Evropska komisija je, dne 21. aprila 2008, odobrila dovoljenje za promet z zdravilom Adenuric, veljavno po vsej Evropski uniji.
The marketing authorisation holder is Beaufour Ipsen Pharma.
Imetnik dovoljenja za promet z zdravilom je družba Beaufour Ipsen Pharma.
The full EPAR for Adenuric can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Adenuric je na voljo tukaj.
This summary was last updated in 10-2008.
Povzetek je bil nazadnje posodobljen 10- 2008.
EU/ 1/ 08/ 447/ 001 EU/ 1/ 08/ 447/ 002 EU/ 1/ 08/ 447/ 003 EU/ 1/ 08/ 447/ 004
številka EU EU/ 1/ 08/ 447/ 001 EU/ 1/ 08/ 447/ 002 EU/ 1/ 08/ 447/ 003 EU/ 1/ 08/ 447/ 004
Adenuric Adenuric Adenuric Adenuric
izmišljeno ime Adenuric Adenuric Adenuric Adenuric
80 mg 80 mg 120 mg 120 mg
jakost 80 mg 80 mg 120 mg 120 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
farmacevtska oblika filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
Oral use Oral use Oral use Oral use
pot uporabe peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu) Blister (PVC/ Aclar/ Alu)
ovojnina pretisni omot (PVC/ Aclar/ aluminij) pretisni omot (PVC/ Aclar/ aluminij) pretisni omot (PVC/ Aclar/ aluminij) pretisni omot (PVC/ Aclar/ aluminij)
28 tablets 84 tablets 28 tablets 84 tablets
velikost pakiranja 28 tablet 84 tablet 28 tablet 84 tablet
Each tablet contains 76.50 mg of lactose monohydrate
Ena tableta vsebuje 76, 50 mg laktoze monohidrata.
Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “ 80 ” on one side.
Svetlorumene do rumene, filmsko obložene tablete v obliki kapsule, ki imajo na eni strani vtisnjeno oznako » 80 «.
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/ or gouty arthritis).
Zdravljenje kronične hiperurikemije v primerih, ko je že prišlo do odlaganja kristalov urata (vključno s primeri, kjer so ali so kdaj prej bili prisotni tofi ali uratni artritis).
If serum uric acid is > 6 mg/ dl (357 µmol/ l) after 2-4 weeks, ADENURIC 120 mg once daily may be considered.
Če je po 2- 4 tednih koncentracija sečne kisline v serumu > 6 mg/ dl (357 µmol/ l), je smiselno razmisliti o jemanju zdravila ADENURIC v odmerku 120 mg enkrat na dan.
The therapeutic target is to decrease and maintain serum uric acid below 6 mg/ dl (357μ mol/ l).
Terapevtski cilj je zmanjšati in vzdrževati koncentracijo sečne kisline v serumu pod 6 mg/ dl (357 µmol/ l).
Gout flare prophylaxis of at least 6 months is recommended (see section 4.4).
Za preprečevanje ponovnega zagona protina je priporočeno preventivno zdravljenje vsaj 6 mesecev (glejte poglavje 4. 4).
Renal insufficiency No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Ledvična insuficienca Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati.
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/ min, see section 5.2).
Učinkovitosti in varnosti pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/ min, glejte poglavje 5. 2) niso povsem ovrednotili.
Hepatic impairment The recommended dosage in patients with mild hepatic impairment is 80 mg.
Pri bolnikih z zmerno okvaro jeter ni veliko podatkov.
The efficacy and safety
Učinkovitosti in varnosti febuksostata pri bolnikih s hudo okvaro jeter (razred C po Child- Pughu) niso raziskovali.
2 of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Starostniki Pri starostnikih odmerka ni treba prilagajati (glejte poglavje 5. 2).
Children and adolescents As there has been no experience in children and adolescents, the use of febuxostat in such patients is not recommended.
2 Otroci in mladostniki Ker z uporabo pri otrocih in mladostnikih ni izkušenj, uporaba febuksostata pri teh bolnikih ni priporočljiva.
Organ transplant recipients As there has been no experience in organ transplant recipients, the use of febuxostat in such patients is not recommended (see section 5.1).
Bolniki po presaditvi organa Ker z uporabo pri bolnikih po presaditvi organa ni izkušenj, uporaba febuksostata pri teh bolnikih ni priporočljiva (glejte poglavje 5. 1).
Hypersensitivity to the active substance or to any of the excipients (see section 4.8).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 4. 8).
Cardio-vascular disorders Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended (see section 4.8).
Srčno- žilne bolezni Zdravljenje bolnikov z ishemično boleznijo srca ali kongestivnim srčnim popuščanjem s febuksostatom ni priporočljivo (glejte poglavje 4. 8).
Acute gouty attacks (gout flare) Febuxostat treatment should not be started until an acute attack of gout has completely subsided.
Akutni zagon protina (izbruhi protina) Zdravljenje s febuksostatom se ne sme začeti, dokler se akutni zagon protina popolnoma ne izboljša.
As with other urate lowering medicinal products, gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.
Kot pri vseh zdravilih za zniževanje količine urata se lahko ob začetku zdravljenja pojavi izbruh protina zaradi spremenjene ravni sečne kisline v serumu, kar povzroči mobilizacijo urata iz depozitov v tkivih.
At treatment initiation with febuxostat flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended.
Ob začetku zdravljenja s febuksostatom se za preprečitev ponovnega izbruha priporoča preventivno zdravljenje z NSAID ali kolhicinom vsaj 6 mesecev.
Xanthine deposition As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e. g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
Odlaganje ksantina Kot pri vseh zdravilih za zniževanje količine urata lahko v redkih primerih absolutna koncentracija ksantina v urinu pri bolnikih z zelo povišano stopnjo nastajanja urata (npr. maligna bolezen in njeno zdravljenje, Lesch- Nyhanov sindrom) naraste toliko, da se pojavi odlaganje v sečilih.