natgillin/translations-raw huggingface dataset:
Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
- Jedna tableta lijeka Tandemact od 30 mg/4 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
Tandemact 45 mg/4 mg tablets White to off-white, round, flat and debossed ‘4833 G' on one face and ‘45/4' on the other.
Tandemact 45 mg/4 mg tablete Bijela do gotovo bijela, okrugla, plosnate s utisnutim ‘4833 G' na jednoj strani i ‘45/4' na drugoj.
Extrapancreatic activity
Djelovanje izvan gušterače
Tandemact should be discontinued if any deterioration in cardiac state occurs.
Ako nastupi bilo kakvo pogoršanje srčanog statusa, primjenu lijeka Tandemact nužno je prekinuti.
NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/4 mg tablets pioglitazone/glimepiride
NAZIV LIJEKA Tandemact 30 mg/4 mg tablete pioglitazon/glimepirid
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
Tandemact 30 mg/2 mg tablets White to off-white, round, convex and debossed ‘4833 G' on one face and ‘30/2' on the other.
Tandemact 30 mg/2 mg tablete Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G' na jednoj strani i ‘30/2' na drugoj.
particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Bolesnike se mora početi liječiti najnižom dostupnom dozom i postupno je povećavati, osobito kad se pioglitazon primjenjuje u kombinaciji s inzulinom (vidjeti dio 4.4 Zadržavanje tekućine i zatajenje srca).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 45 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
No unchanged substance was detected in the urine.
U mokraćni nije otkriven neizmijenjeni glimepirid.
- Tandemact 30 mg/4 mg tablets are white to off-white, round, convex and debossed ‘4833 G' on one face and ‘30/4' on the other.
- Tandemact 30 mg/4 mg tablete su bijele do gotovo bijele, okrugle, konveksne s utisnutim ‘4833 G' na jednoj strani i ‘30/4' na drugoj strani.
Tandemact 30 mg/4 mg tablets White to off-white, round, convex and debossed ‘4833 G' on one face and ‘30/4' on the other.
Tandemact 30 mg/4 mg tablete Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G' na jednoj strani i ‘30/4' na drugoj.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 2 mg glimepirida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets
Tandemact 30 mg/2 mg tablete
This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
U tom se ispitivanju zabilježio povećani broj zatajenja srca.
Subcutaneous use pre-filled syringe (glass) in prefilled pen (VarioJect)
45 mg/0,45 ml Otopina za injekciju napunjena štrcaljka (staklo) u napunjenoj brizgalici (VarioJect)
MA (EU) number (Invented) name
EMA broj postupka
The treatment is usually short-term.
Liječenje je obično kratkotrajno.
- The usual dose is one tablet daily.
- Uobičajena doza je jedna tableta dnevno.
Date of first authorisation: 28 March 2019
Datum prvog odobrenja: 28. ožujka, 2019.
Do not stop taking Febuxostat Krka without the advice of your doctor even if you feel better.
Nemojte prestati uzimati Febuxostat Krka bez savjetovanja s liječnikom, čak i ako se osjećate bolje.
Blister (PVC/PVDC/PVC//Alu): 14, 28, 56 or 84 film-coated tablets, in a box.
Blister (PVC/PVDC/PVC//Al): 14, 28, 56 ili 84 filmom obloženih tableta, u kutiji.
Not everyone gets flares, but you could get a flare-up even if you are taking Febuxostat Krka, and especially during the first weeks or months of treatment.
Napadi se neće pojaviti kod svih bolesnika, ali ih možete imati i ako uzimate Febuxostat Krka, a posebno tijekom prvih tjedana ili mjeseci liječenja.
What Febuxostat Krka is and what it is used for
Što je Febuxostat Krka i za što se koristi
- The tablets should be taken by mouth and can be taken with or without food.
- Tablete se uzimaju kroz usta i mogu se uzeti uz hranu ili bez nje.
Rare (may affect up to 1 in 1,000 people): - muscle damage, a condition which on rare occasions can be serious.
Rijetke nuspojave (mogu se javiti kod manje od 1 na 1000 osoba) su: - oštećenje mišića, stanje koje u rijetkim slučajevima može biti ozbiljno.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
Four pharmacologically active hydroxyl metabolites have been identified, of which three occur in plasma of humans.
Identificirana su četiri farmakološki aktivna hidroksil metabolita, od kojih se tri pojavljuju u plazmi u ljudi.
Long-term, open label extension studies
Dugotrajni, otvoreni produžeci ispitivanja
It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Također mogu biti prisutne ulceracije u ustima, ždrijelu, nosu i genitalijama te konjunktivitis (crvene i natečene oči).
Your doctor might decide to permanently stop treatment with Febuxostat Krka.
Vaš liječnik može odlučiti trajno prekinuti liječenje lijekom Febuxostat Krka.
There was no significant increase in any other tumour type in either male or female mice or rats.
Nije bilo značajnog povećanja incidencije tumora bilo kojeg drugog tipa, kako u mužjaka tako i ženki miševa ili štakora.
See section 2 "Febuxostat Krka contains lactose and sodium".
Vidjeti dio 2. „Febuxostat Krka sadrži laktozu i natrij“.
What Febuxostat Krka is and what it is used for What you need to know before you take Febuxostat Krka How to take Febuxostat Krka Possible side effects
Što je Febuxostat Krka i za što se koristi Što morate znati prije nego počnete uzimati Febuxostat Krka Kako uzimati Febuxostat Krka Moguće nuspojave
Start taking Febuxostat Krka two days before chemotherapy and continue its use according to your doctor's advice.
Počnite uzimati Febuxostat Krka dva dana prije kemoterapije i nastavite s primjenom prema uputi Vašeg liječnika.
Do not take Febuxostat Krka - if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
Nemojte uzimati Febuxostat Krka - ako ste alergični na febuksostat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
The safety and efficacy of Febuxostat Krka in children below the age of 18 years have not been established.
Sigurnost i djelotvornost lijeka Febuxostat Krka u djece mlađe od 18 godina nije ustanovljena.
It is important to keep taking Febuxostat Krka even if you have a flare, as Febuxostat Krka is still working to lower uric acid.
Važno je da nastavite uzimati Febuxostat Krka čak i ako imate napad, s obzirom na to da Febuxostat Krka i dalje djeluje na snižavanje razine mokraćne kiseline.
Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4).
Ako se pojavi alergijska reakcija na Febuxostat Krka, prestanite uzimati ovaj lijek (vidjeti i dio 4.).
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Urez služi samo kako bi Vam olakšao lomljenje tablete ako imate poteškoća s gutanjem cijele tablete.
Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol.
Neki, ali ne svi, od tih bolesnika imali su oštećenje funkcije bubrega i/ili su ranije prijavili preosjetljivost na alopurinol.
Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Sindrom tumorske lize: u pivotalnom ispitivanju faze 3 (FLORENCE) samo su ispitanici s teškom jetrenom insuficijencijom bili isključeni iz ispitivanja.
About 69 % of patients required no treatment change to achieve a final stable treatment.
U oko 69% bolesnika nije bilo potrebno mijenjati liječenje kako bi se postigao stabilan učinak.
Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure.
Identificirani faktori rizika u tih bolesnika bili su aterosklerotska bolest i/ili infarkt miokarda u anamnezi, ili kongestivno zatajenje srca.
What you need to know before you take Febuxostat Krka
Što morate znati prije nego počnete uzimati Febuxostat Krka
Excipient(s) with known effect - lactose: 73 mg
Pomoćna tvar s poznatim učinkom - laktoza: 73 mg
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Krka and your doctor may wish to consider necessary measures: - Mercaptopurine (used to treat cancer) - Azathioprine (used to reduce immune response) - Theophylline (used to treat asthma)
Posebno je važno da obavijestite svog liječnika ili ljekarnika ako uzimate lijekove koji sadrže neku od sljedećih tvari, s obzirom na to da one mogu stupiti u interakciju s lijekom Febuxostat Krka i Vaš liječnik će možda morati poduzeti potrebne mjere: - merkaptopurin (koristi se za liječenje karcinoma) - azatioprin (koristi se za smanjivanje imunološkog odgovora)
In healthy subjects concomitant use of febuxostat and naproxen 250 mg twice daily was associated with an increase in febuxostat exposure (Cmax 28%, AUC 41% and t1/2 26%).
U zdravih ispitanika istodobna primjena febuksostata i naproksena 250 mg dvaput dnevno bila je povezana s povećanjem izloženosti febuksostatu (Cmax 28%, AUC 41% i t1/2 26%).
In general, febuxostat pharmacokinetic parameters estimated by these analyses are consistent with those obtained from healthy subjects, indicating that healthy subjects are representative for pharmacokinetic/pharmacodynamic assessment in the patient population with gout.
Općenito, farmakokinetički parametri febuksostata čija je procjena rađena tim analizama konzistentni su s onima dobivenima u zdravih ispitanika, što upućuje na to da su zdravi ispitanici reprezentativni za procjenu farmakokinetike/farmakodinamike u populaciji bolesnika koji boluju od gihta.
Febuxostat Krka should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Krka treba uvesti dva dana prije početka citotoksične terapije i nastaviti s uzimanjem najmanje 7 dana; međutim liječenje može biti produljeno do 9 dana u skladu s trajanjem kemoterapije, prema kliničkoj procjeni.
Keeping uric acid levels low by taking Febuxostat Krka once every day stops crystals building up, and over time it reduces symptoms.
Održavanjem niskih razina mokraćne kiseline uzimanjem lijeka Febuxostat Krka jednom dnevno sprječava se nakupljanje kristala urata, a simptomi se s vremenom smanjuju.
Primary endpoints were serum uric acid area under the curve (AUCsUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Primarni ishodi bili su površina ispod krivulje za mokraćnu kiselinu u serumu (AUCsMK1-8) i promjena razine serumskog kreatinina (sK), oboje od početnih vrijednosti do dana 8.
Excipient(s) with known effect - lactose: 109 mg
Pomoćna tvar s poznatim učinkom - laktoza: 109 mg
In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events.
U kliničkim ispitivanjima, primjena naproksena ili drugih nesteroidnih protuupalnih lijekova/inhibitora Cox-2 nije bila povezana s klinički značajnim povećanjem učestalosti štetnih događaja.
Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
Pokazalo se da istodobni unos antacida koji sadržavaju magnezijev hidroksid i aluminijev hidroksid odgađa apsorpciju febuksostata (za oko 1 sat) i dovodi do 32%-tnog smanjenja Cmax, ali nisu uočene značajne promjene AUC-a.
Talk to your doctor or pharmacist before taking Febuxostat Krka: - if you have or have had heart failure or heart problems or stroke, - if you have or have had kidney disease and/or serious allergic reaction to Allopurinol (a medicine used for the treatment of gout),
Obratite se svom liječniku ili ljekarniku prije nego uzmete Febuxostat Krka: - ako imate ili ste imali zatajenje srca, druge srčane bolesti ili moždani udar - ako imate ili ste imali bubrežnu bolest i/ili ozbiljnu alergijsku reakciju na alopurinol (lijek za liječenje gihta)
- if you have or have had liver disease or liver function test abnormalities, - if you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood), - if you have thyroid problems.
- ako imate ili ste imali bolest jetre ili abnormalne rezultate pretraga funkcije jetre - ako ste se liječili zbog visokih razina mokraćne kiseline uzrokovanih Lesch-Nyhanovim sindromom (rijetkom nasljednom bolesti kod koje postoji prevelika količina mokraćne kiseline u krvi) - ako imate problema sa štitnjačom.
Tablet dimension: approximatelly 16 mm × 8 mm.
Dimenzije tablete: približno 16 mm x 8 mm.
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Djelotvornost i sigurnost nisu u potpunosti procijenjeni u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min, vidjeti dio 5.2).
The endpoints (primary and secondary) were analysed according to the intention-to-treat (ITT) analysis including all subjects who were randomized and received at least one dose of double-blind study medication.
Mjere ishoda (primarne i sekundarne) analizirane su u populaciji predviđenoj za liječenje (engl. intent to treat, ITT), koja je uključivala sve ispitanike koji su bili randomizirani i koji su primili barem jednu dozu lijeka u dvostruko slijepom ispitivanju.
The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Djelotvornost febuksostata dokazana je u tri pivotalna ispitivanja faze 3 (niže su opisana dva pivotalna ispitivanja APEX i FACT, i dodatno CONFIRMS ispitivanje) koja su provedena na 4101 bolesniku s hiperuricemijom i gihtom.
Tablet dimension: approximatelly 19 mm × 8 mm.
Dimenzije tablete: približno 19 mm x 8 mm.
Pancytopenia, thrombocytopenia, agranulocytosis*
Pancitopenija, trombocitopenija, agranulocitoza*
Febuxostat Krka 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Krka 120 mg tablete se koriste i za liječenje i prevenciju visoke razine mokraćne kiseline u krvi koja se može pojaviti kada počnete dobivati kemoterapiju za rak krvi.
The plasma protein binding of febuxostat is approximately 99.2%, (primarily to albumin), and is constant over the concentration range achieved with 80 and 120 mg doses.
Vezanje febuksostata na proteine plazme je oko 99,2%, (ponajprije na albumin) i konstantno je u rasponu koncentracije koja se postiže dozama od 80 i 120 mg.
The effect of Febuxostat Krka on human fertility is unknown.
Učinak lijeka Febuxostat Krka na plodnost u čovjeka nije poznat.
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.
U bolesnika u kojih je brzina stvaranja urata znatno povećana (npr. maligna bolest i njezino liječenje, Lesch-Nyhanov sindrom), apsolutna koncentracija ksantina u urinu u rijetkim se slučajevima može povećati u dovoljnoj mjeri da uslijedi njegovo taloženje u urinarnom traktu.
Continue to take Febuxostat Krka every day even when you are not experiencing gout flare or attack.
Nastavite uzimati Febuxostat Krka svaki dan, čak i ako nemate napade gihta.
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with Febuxostat Krka.
Ako trenutačno imate napad gihta (nagla pojava jake boli, osjetljivosti, crvenila, topline i otoka zgloba), pričekajte da se napad gihta smiri prije nego što počnete liječenje lijekom Febuxostat Krka.
Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat Krka does not adversely affect performance.
Bolesnici trebaju postupati s oprezom tijekom upravljanja vozilima i strojevima i sudjelovanja u opasnim aktivnostima, sve dok nisu prilično sigurni da Febuxostat Krka kod njih ne utječe negativno na provedbu tih aktivnosti.
Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000) adverse reactions occurring in patients treated with febuxostat are listed below.
Česte (≥ 1/100 i < 1/10), manje česte (≥ 1/1000 i < 1/100) i rijetke ( 1/10 000 i < 1/1000) nuspojave koje se pojavljuju kod bolesnika liječenih febuksostatom navedene su ispod.
Following multiple oral doses of febuxostat, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Nakon višekratnih oralnih doza febuksostata, Cmax i AUC su bili 24%, odnosno 12% viši u žena nego u muškaraca.
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Kako nema iskustva o primjeni febuksostata, ne preporučuje se njegova primjena u bolenika s Lesch-Nyhanovim sindromom.
Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Mokraćna kiselina je krajnji proizvod metabolizma purina u ljudi i stvara se u kaskadi hipoksantin  ksantin  mokraćna kiselina.
Rash (including various types of rash reported with lower frequencies, see below) Uncommon
Osip (uključujući razne tipove osipa s manjom učestalošću, vidjeti niže u tekstu)
No dose adjustment is needed based on gender.
Nije potrebna prilagodba doze s obzirom na spol.
Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively.
Incidencija svih znakova i simptoma te nuspojava opaženih nakon početka liječenja bila je 67,6% naspram 64,7% i 6,4% naspram 6,4% na febuksostatu odnosno na alopurinolu.
In the additional phase 3 CONFIRMS study, for which results became available after the marketing authorisation for febuxostat was first issued, the primary efficacy endpoint was the proportion of patients whose serum urate level was < 6.0 mg/dL at the final visit.
U dodatnom ispitivanju faze 3, CONFIRMS, za koje su rezultati postali dostupni nakon odobrenja za stavljanje febuksostata u promet, primarni ishod ispitivanja bio je omjer bolesnika u kojih je na zadnjoj kontroli razina urata u serumu bila < 6,0 mg/dl.
Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis.
Liječenje febuksostatom treba odmah prekinuti ako se pojave ozbiljne alergijske reakcije/reakcije preosjetljivosti, uključujući Stevens-Johnsonov sindrom, jer je raniji prekid liječenja povezan s boljom prognozom.
Oral use Febuxostat Krka should be taken by mouth and can be taken with or without food.
Febuxostat Krka treba uzimati na usta i može se uzimati s hranom ili bez nje.
Thus, coadministration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Zato se ne očekuje da će istodobna primjena febuksostata s drugim supstratima CYP2D6 zahtijevati prilagodbu doze tih spojeva.
There were no clinically significant differences in the percent decrease in serum uric acid concentration in healthy subjects irrespective of their renal function (58% in the normal renal function group and 55% in the severe renal dysfunction group).
Nisu postojale klinički značajne razlike u postotnom smanjenju koncentracije mokraćne kiseline u serumu u zdravih ispitanika, neovisno o njihovoj bubrežnoj funkciji (58% u skupini s urednom funkcijom bubrega i 55% u skupini s teškim oštećenjem funkcije bubrega).
Co-administration of febuxostat 80 mg and theophylline 400 mg single dose in healthy subjects showed absence of any pharmacokinetic interaction (see section 4.5).
Istodobna primjena 80 mg febuksostata i jednokratne doze teofilina od 400 mg u zdravih ispitanika pokazala je da nema farmakokinetičkih interakcija (vidjeti dio 4.5).
If you have developed Stevens-Johnson Syndrome with the use of febuxostat, you must not be re-started on Febuxostat Krka at any time.
Ako se tijekom primjene febuksostata razvio Stevens-Johnsonov sindrom, ne smijete više nikada započeti terapiju lijekom Febuxostat Krka.
A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
Brojčano veća incidencija kardiovaskularnih APTC događaja koje su prijavili ispitivači (definirane mjere ishoda prema Anti-Platelet Trialists' Collaboration (APTC), uključujući kardiovaskularnu smrt, nefatalni infarkt miokarda, nefatalni moždani udar) uočena je u ukupnoj skupini koja je primala febuksostat, u usporedbi sa skupinom koja je primala alopurinol, u ispitivanjima APEX i FACT (1,3 u odnosu na 0,3 događaja na 100 bolesnik/godina), ali ne i u CONFIRMS ispitivanju (vidjeti dio 5.1 za detaljne karakteristike ispitivanja).
Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Potreban je oprez pri primjeni febuksostata u bolesnika s promijenjenom funkcijom štitne žlijezde (vidjeti dio 5.1).
Febuxostat showed a superior and faster urate lowering activity compared to allopurinol.
Febuksostat je pokazao superiorno i brže djelovanje na sniženje urata u odnosu na alopurinol.
Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Primjena febuksostata (80 mg ili 120 mg jednom dnevno) s varfarinom nije utjecala na farmakokinetiku varfarina u zdravih ispitanika.
You should not take Febuxostat Krka if you are breast feeding, or if you are planning to breastfeed.
Nemojte uzimati Febuxostat Krka ako dojite ili planirate dojiti.
In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
U pivotalnom ispitivanju sindroma tumorske lize primjenjivao se febuksostat u dozi od 120 mg dnevno u bolesnika koji su podvrgnuti različitim kemoterapijskim režimima, uključujući i monoklonska protutijela.
Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels.
Febuksostat od 80 mg može se koristiti u bolesnika istodobno liječenih teofilinom bez rizika od porasta razine teofilina u plazmi.