FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic reactions have been reported with frequency not known (cannot be estimated from the available data) in patients taking Tandemact.
Croatian: Kod bolesnika koji su uzimali Tandemact zabilježene su alergijske reakcije s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, zato što neki lijekovi mogu oslabiti ili pojačati učinke lijeka Tandemact na razinu šećera u krvi.
English: In animals, glimepiride is excreted in milk.
Croatian: Glimepirid se izlučuje u mlijeko životinja.
English: There was no relevant accumulation.
Croatian: Nije bilo znatnijeg nakupljanja lijeka.
English: Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Croatian: Farmakokinetika u stanju dinamičke ravnoteže u bolesnika u dobi od 65 ili više godina slična je onoj u mlađih osoba.
English: It is recommended, therefore, that patients treated with Tandemact undergo periodic monitoring of liver enzymes.
Croatian: Stoga se u bolesnika liječenih lijekom Tandemact preporučuje povremeno određivati jetrene enzime.
English: Each tablet contains approximately 214 mg lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži približno 214 mg laktoze hidrata (vidjeti dio 4.4).
English: Each tablet contains approximately 125 mg lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži približno 125 mg laktoze hidrata (vidjeti dio 4.4).
English: There have been rare reports of elevated liver enzymes and hepatocellular dysfunction during post-marketing experience with pioglitazone and glimepiride (see section 4.8).
Croatian: Nakon stavljanja pioglitazona i glimepirida u promet zabilježeni su rijetki slučajevi povišenja jetrenih enzima i poremećaja hepatocelularne funkcije (vidjeti dio 4.8).
English: 4.7 Effects on ability to drive and use machines Tandemact has minor influence on the ability to drive and use machines.
Croatian: Tandemact malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Croatian: Pioglitazon se mora primjenjivati s oprezom tijekom istodobne primjene inhibitora (npr. gemfibrozil) ili induktora (npr. rifampicin) citokroma P450 2C8.
English: 3 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Croatian: 3 Nakon stavljanja lijeka na tržište, kod bolesnika liječenih pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
English: Tandemact 45 mg/4 mg tablets
Croatian: Tandemact 45 mg/4 mg tablete
English: - headache - inflammation of the sinuses (sinusitis) - vertigo - abnormal vision - sweating - tiredness - difficulty sleeping (insomnia) - decreased blood sugar - sugar in urine - proteins in urine - increased appetite - increase of an enzyme called lactic dehydrogenase (LDH)
Croatian: Manje često (mogu se pojaviti u do 1 na 100 osoba) - glavobolja - upala sinusa (sinusitis) - osjećaj vrtnje (vrtoglavica) - poremećaj vida - znojenje - umor - poteškoće sa spavanjem (nesanica) - snižen šećer u krvi - šećer u mokraći - proteini u mokraći - pojačan apetit - povišenje enzima laktat dehidrogenaze (LDH)
English: It is not known whether pioglitazone is secreted in human milk.
Croatian: Nije poznato izlučuje li se pioglitazon u majčino mlijeko.
English: An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions reports of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8).
Croatian: Analiza objedinjenih podataka o prijelomima kostiju kao nuspojavi u randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (vidjeti dio 4.8) pokazala je povećanu incidenciju prijeloma kostiju u žena.
English: Hypoglycaemia (low blood sugar) has been reported uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact.
Croatian: U bolesnika koji uzimaju Tandemact manje često je zabilježena hipoglikemija (snižen šećer u krvi) (može se javiti u do 1 na 100 osoba).
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Croatian: Zabilježeno je da istovremena primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira sniženjem AUC-a pioglitazona za 54%.
English: INFORMATION IN BRAILLE Tandemact 45 mg/4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tandemact 45 mg/4 mg
English: EU/1/06/366/005 EU/1/06/366/006 EU/1/06/366/007 EU/1/06/366/008 EU/1/06/366/009 EU/1/06/366/010 EU/1/06/366/011 EU/1/06/366/012 EU/1/06/366/013 EU/1/06/366/014 EU/1/06/366/015 EU/1/06/366/016 EU/1/06/366/017
Croatian: EU/1/06/366/005 EU/1/06/366/006 EU/1/06/366/007 EU/1/06/366/008 EU/1/06/366/009 EU/1/06/366/010 EU/1/06/366/011 EU/1/06/366/012 EU/1/06/366/013 EU/1/06/366/014 EU/1/06/366/015 EU/1/06/366/016 EU/1/06/366/017 EU/1/06/366/018 EU/1/06/366/019 EU/1/06/366/020 EU/1/06/366/021 EU/1/06/366/022
English: General disorders and administration site conditions oedema8
Croatian: Opći poremećaji i reakcije na mjestu primjene edemi8
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Croatian: Zabilježeno je da istovremena primjena pioglitazona s gemfibrozilom (inhibitorom citokroma P450 2C8) rezultira trostrukim povećanjem AUC-a pioglitazona.
English: not known not known itching2
Croatian: nepoznato nepoznato osip2
English: The following data are findings in studies performed with pioglitazone or glimepiride individually.
Croatian: Sljedeći podaci dobiveni su iz ispitivanja posebno pioglitazona i posebno glimepirida.
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Croatian: U bolesnika, naročito u žena koje uzimaju pioglitazon primijećen je veći broj prijeloma kostiju.
English: INFORMATION IN BRAILLE Tandemact 30 mg/2 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tandemact 30 mg/2 mg
English: Frequency of adverse reactions Pioglitazone Glimepiride Tandemact
Croatian: Učestalost nuspojava Pioglitazon Glimepirid
English: Tandemact 30 mg/4 mg tablets
Croatian: Tandemact 30 mg/4 mg tablete
English: HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Croatian: U većini kliničkih ispitivanja opaženo je sniženje ukupnih triglicerida i slobodnih masnih kiselina u plazmi te povišenje razine HDL-kolesterola u usporedbi s placebom, uz malo, ali ne i klinički značajno povišenje razine LDL-kolesterola.
English: Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets Tandemact 45 mg/4 mg tablets pioglitazone/glimepiride
Croatian: Tandemact 30 mg/4 mg tablete Tandemact 45 mg/4 mg tablete pioglitazon/glimepirid
English: This check should be repeated at intervals.
Croatian: Tu ćete pretragu redovito ponavljati.
English: INFORMATION IN BRAILLE Tandemact 30 mg/4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tandemact 30 mg/4 mg
English: Nervous system disorders dizziness common hypo-aesthesia common common headache uncommon insomnia uncommon uncommon
Croatian: Poremećaji živčanog sustava omaglica često hipoestezija često često glavobolja manje često nesanica manje često manje često
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs; ATC code: A10BD06.
Croatian: Farmakoterapijska skupina: Lijekovi za primjenu kod šećerne bolesti, kombinirani peroralni lijekovi za sniženje glukoze u krvi.
English: This can lead to a risk of hyperglycaemia (high blood sugar level): - oestrogens, progestogens (female sex hormones) - thiazide diuretics and saluretics also called water tablets (to treat high blood pressure) - levothyroxine (to stimulate the thyroid gland) - glucocorticoids (to treat allergies and inflammation) - chlorpromazine and other phenothiazine derivatives (to treat severe mental disorders) - adrenaline and sympathicomimetics (to increase heart beat, to treat asthma or nasal congestion,
Croatian: To može dovesti do rizika od hiperglikemije (povišene razine šećera u krvi): - estrogeni, progestageni (ženski spolni hormoni) - tiazidski diuretici i saluretici koji se još zovu tablete za mokrenje (za liječenje povišenog krvnog tlaka) - levotiroksin (za stimulaciju štitne žlijezde) - glukokortikoidi (za liječenje alergija i upala) - klorpromazin i drugi derivati fenotiazina (za liječenje teških duševnih poremećaja) - adrenalin i simpatomimetici (za povećanje brzine rada srca, za liječenje astme ili začepljenosti nosa, kašlja i prehlade ili za primjenu u hitnim, životno opasnim stanjima) - nikotinska kiselina (za liječenje povišene razine kolesterola) - dugotrajna uporaba laksativa (za liječenje zatvora) - fenitoin (za liječenje napadaja) - barbiturati (za liječenje nervoze i tegoba sa spavanjem) - azetazolamid (za liječenje povišenog tlaka u oku, tj. glaukoma) - diazoksid (za liječenje povišenog tlaka u oku ili niskog šećera u krvi) - rifampicin (za liječenje infekcija, tuberkuloze) - glukagon (za liječenje jako niske razine šećera u krvi)
English: What Tandemact looks like and contents of the pack - Tandemact 30 mg/2 mg tablets are white to off-white, round, convex and debossed ‘4833 G' on one face and ‘30/2' on the other.
Croatian: Kako Tandemact izgleda i sadržaj pakiranja - Tandemact 30 mg/2 mg tablete su bijele do gotovo bijele, okrugle, konveksne s utisnutim ‘4833 G' na jednoj strani i ‘30/2' na drugoj strani.
English: Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Tandemact in combination with insulin.
Croatian: Bolesnici koji uzimaju Tandemact u kombinaciji s inzulinom često su imali lokalizirano oticanje (edeme) (može se javiti u do 1 na 10 osoba).
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Croatian: Prije početka terapije pioglitazonom nužno je provjeriti svaku makroskopsku hematuriju.
English: Each Tandemact 45 mg/4 mg tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Croatian: - Jedna tableta lijeka Tandemact od 45 mg/4 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: If you experience any of these, talk to your doctor as soon as possible.
Croatian: Ako osjetite ijedan od ovih simptoma, obratite se čim prije svom liječniku.
English: EU/1/06/366/005 14 tablets EU/1/06/366/006 28 tablets EU/1/06/366/007 30 tablets EU/1/06/366/008 50 tablets EU/1/06/366/009 90 tablets EU/1/06/366/010 98 tablets
Croatian: EU/1/06/366/005 14 tableta EU/1/06/366/006 28 tableta EU/1/06/366/007 30 tableta EU/1/06/366/008 50 tableta EU/1/06/366/009 90 tableta EU/1/06/366/010 98 tableta
English: EU/1/06/366/017 14 tablets EU/1/06/366/018 28 tablets EU/1/06/366/019 30 tablets EU/1/06/366/020 50 tablets EU/1/06/366/021 90 tablets EU/1/06/366/022 98 tablets
Croatian: EU/1/06/366/017 14 tableta EU/1/06/366/018 28 tableta EU/1/06/366/019 30 tableta EU/1/06/366/020 50 tableta EU/1/06/366/021 90 tableta EU/1/06/366/022 98 tableta
English: EU/1/06/366/011 14 tablets EU/1/06/366/012 28 tablets EU/1/06/366/013 30 tablets EU/1/06/366/014 50 tablets EU/1/06/366/015 90 tablets EU/1/06/366/016 98 tablets
Croatian: EU/1/06/366/011 14 tableta EU/1/06/366/012 28 tableta EU/1/06/366/013 30 tableta EU/1/06/366/014 50 tableta EU/1/06/366/015 90 tableta EU/1/06/366/016 98 tableta
English: Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Croatian: Bolesnike, osobito one sa smanjenom srčanom rezervom, je nužno nadzirati zbog moguće pojave znakova i simptoma zatajenja srca te povećanja tjelesne težine ili edema.
English: NAME OF THE MEDICINAL PRODUCT Tandemact 45 mg/4 mg tablets pioglitazone/glimepiride
Croatian: NAZIV LIJEKA Tandemact 45 mg/4 mg tablete pioglitazon/glimepirid
English: NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets pioglitazone/glimepiride
Croatian: NAZIV LIJEKA Tandemact 30 mg/2 mg tablete pioglitazon/glimepirid
English: Very rare (may affect up to 1 in 10,000 people) - liver disease
Croatian: Često (mogu se pojaviti u do 1 na 10 osoba) - povećanje tjelesne težine - omaglica - vjetrovi - infekcija dišnih puteva - utrnulost
English: Broken bones
Croatian: Prijelom kostiju
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Tandemact.
Croatian: Bolesnici koji uzimaju Tandemact manje su često razvili karcinom mokraćnog mjehura (može se javiti u do 1 na 100 osoba).
English: 1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancyto-penia may occur.
Croatian: 1 Mogu nastati umjerena do teška trombocitopenija, leukopenija, eritrocitopenija, granulocitopenija,
English: Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Croatian: Jedna tableta sadrži 45 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: Each Tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride.
Croatian: - Jedna tableta lijeka Tandemact od 30 mg/2 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 2 mg glimepirida.
English: - Tandemact 45 mg/4 mg tablets are white to off-white, round, flat and debossed ‘4833 G' on one face and ‘45/4' on the other.
Croatian: - Tandemact 45 mg/4 mg tablete su bijele do gotovo bijele, okrugle, plosnate s utisnutim ‘4833 G' na jednoj strani i ‘45/4' na drugoj strani.
English: Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 2 mg glimepirida.
English: Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Croatian: - Jedna tableta lijeka Tandemact od 30 mg/4 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: 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.
Croatian: Tandemact 45 mg/4 mg tablete Bijela do gotovo bijela, okrugla, plosnate s utisnutim ‘4833 G' na jednoj strani i ‘45/4' na drugoj.
English: Extrapancreatic activity
Croatian: Djelovanje izvan gušterače
English: Tandemact should be discontinued if any deterioration in cardiac state occurs.
Croatian: Ako nastupi bilo kakvo pogoršanje srčanog statusa, primjenu lijeka Tandemact nužno je prekinuti.
English: NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/4 mg tablets pioglitazone/glimepiride
Croatian: NAZIV LIJEKA Tandemact 30 mg/4 mg tablete pioglitazon/glimepirid
English: Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: 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.
Croatian: Tandemact 30 mg/2 mg tablete Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G' na jednoj strani i ‘30/2' na drugoj.
English: particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Croatian: 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).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 45 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: No unchanged substance was detected in the urine.
Croatian: U mokraćni nije otkriven neizmijenjeni glimepirid.
English: - 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.
Croatian: - 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.
English: 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.
Croatian: Tandemact 30 mg/4 mg tablete Bijela do gotovo bijela, okrugla, konveksna s utisnutim ‘4833 G' na jednoj strani i ‘30/4' na drugoj.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 2 mg glimepirida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida) i 4 mg glimepirida.
English: NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets
Croatian: Tandemact 30 mg/2 mg tablete
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Croatian: U tom se ispitivanju zabilježio povećani broj zatajenja srca.
English: Subcutaneous use pre-filled syringe (glass) in prefilled pen (VarioJect)
Croatian: 45 mg/0,45 ml Otopina za injekciju napunjena štrcaljka (staklo) u napunjenoj brizgalici (VarioJect)
English: MA (EU) number (Invented) name
Croatian: EMA broj postupka
English: The treatment is usually short-term.
Croatian: Liječenje je obično kratkotrajno.
English: - The usual dose is one tablet daily.
Croatian: - Uobičajena doza je jedna tableta dnevno.
English: Date of first authorisation: 28 March 2019
Croatian: Datum prvog odobrenja: 28. ožujka, 2019.
English: BLISTER (PVC/PVDC/PVC//Alu)
Croatian: BLISTER (PVC/PVDC/PVC//Al)
English: Do not stop taking Febuxostat Krka without the advice of your doctor even if you feel better.
Croatian: Nemojte prestati uzimati Febuxostat Krka bez savjetovanja s liječnikom, čak i ako se osjećate bolje.
English: Blister (PVC/PVDC/PVC//Alu): 14, 28, 56 or 84 film-coated tablets, in a box.
Croatian: Blister (PVC/PVDC/PVC//Al): 14, 28, 56 ili 84 filmom obloženih tableta, u kutiji.
English: 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.
Croatian: Napadi se neće pojaviti kod svih bolesnika, ali ih možete imati i ako uzimate Febuxostat Krka, a posebno tijekom prvih tjedana ili mjeseci liječenja.
English: What Febuxostat Krka is and what it is used for
Croatian: Što je Febuxostat Krka i za što se koristi
English: - The tablets should be taken by mouth and can be taken with or without food.
Croatian: - Tablete se uzimaju kroz usta i mogu se uzeti uz hranu ili bez nje.
English: Rare (may affect up to 1 in 1,000 people): - muscle damage, a condition which on rare occasions can be serious.
Croatian: Rijetke nuspojave (mogu se javiti kod manje od 1 na 1000 osoba) su: - oštećenje mišića, stanje koje u rijetkim slučajevima može biti ozbiljno.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
English: Four pharmacologically active hydroxyl metabolites have been identified, of which three occur in plasma of humans.
Croatian: Identificirana su četiri farmakološki aktivna hidroksil metabolita, od kojih se tri pojavljuju u plazmi u ljudi.
English: Long-term, open label extension studies
Croatian: Dugotrajni, otvoreni produžeci ispitivanja
English: It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Croatian: Također mogu biti prisutne ulceracije u ustima, ždrijelu, nosu i genitalijama te konjunktivitis (crvene i natečene oči).
English: Your doctor might decide to permanently stop treatment with Febuxostat Krka.
Croatian: Vaš liječnik može odlučiti trajno prekinuti liječenje lijekom Febuxostat Krka.
English: There was no significant increase in any other tumour type in either male or female mice or rats.
Croatian: Nije bilo značajnog povećanja incidencije tumora bilo kojeg drugog tipa, kako u mužjaka tako i ženki miševa ili štakora.
English: See section 2 "Febuxostat Krka contains lactose and sodium".
Croatian: Vidjeti dio 2. „Febuxostat Krka sadrži laktozu i natrij“.
English: 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
Croatian: Što je Febuxostat Krka i za što se koristi Što morate znati prije nego počnete uzimati Febuxostat Krka Kako uzimati Febuxostat Krka Moguće nuspojave
English: Start taking Febuxostat Krka two days before chemotherapy and continue its use according to your doctor's advice.
Croatian: Počnite uzimati Febuxostat Krka dva dana prije kemoterapije i nastavite s primjenom prema uputi Vašeg liječnika.
English: Do not take Febuxostat Krka - if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Febuxostat Krka - ako ste alergični na febuksostat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The safety and efficacy of Febuxostat Krka in children below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Febuxostat Krka u djece mlađe od 18 godina nije ustanovljena.
English: It is important to keep taking Febuxostat Krka even if you have a flare, as Febuxostat Krka is still working to lower uric acid.
Croatian: 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.
English: Should you experience allergic reactions to Febuxostat Krka, stop taking this medicine (see also section 4).
Croatian: Ako se pojavi alergijska reakcija na Febuxostat Krka, prestanite uzimati ovaj lijek (vidjeti i dio 4.).
English: The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Croatian: Urez služi samo kako bi Vam olakšao lomljenje tablete ako imate poteškoća s gutanjem cijele tablete.
English: Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol.
Croatian: Neki, ali ne svi, od tih bolesnika imali su oštećenje funkcije bubrega i/ili su ranije prijavili preosjetljivost na alopurinol.
English: Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Croatian: Sindrom tumorske lize: u pivotalnom ispitivanju faze 3 (FLORENCE) samo su ispitanici s teškom jetrenom insuficijencijom bili isključeni iz ispitivanja.
English: About 69 % of patients required no treatment change to achieve a final stable treatment.
Croatian: U oko 69% bolesnika nije bilo potrebno mijenjati liječenje kako bi se postigao stabilan učinak.
English: Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure.
Croatian: Identificirani faktori rizika u tih bolesnika bili su aterosklerotska bolest i/ili infarkt miokarda u anamnezi, ili kongestivno zatajenje srca.
English: What you need to know before you take Febuxostat Krka
Croatian: Što morate znati prije nego počnete uzimati Febuxostat Krka
English: Excipient(s) with known effect - lactose: 73 mg
Croatian: Pomoćna tvar s poznatim učinkom - laktoza: 73 mg