FrancophonIA/ELRC3.0 huggingface dataset:
English: Vertigo Tinnitus
Croatian: Vrtoglavica Tinitus
English: In vitro studies suggest that tivozanib is an inhibitor of intestinal BCRP.
Croatian: In vitro ispitivanja sugeriraju da je tivozanib inhibitor crijevnog BCRP-a.
English: In vitro studies have shown that tivozanib is neither a substrate nor an inhibitor of the multidrug efflux pump, P-glycoprotein.
Croatian: In vitro ispitivanja pokazuju da tivozanib nije ni supstrat ni inhibitor multimedikamentnog efluks transportera, P-glikoproteina.
English: Printing ink (blue)
Croatian: Tinta za označavanje (plava)
English: Pulmonary embolism was reported in patients (0.7%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies, with the majority CTC Grade ≥ 3 (see section 4.4).
Croatian: Plućna embolija prijavljena je kod bolesnika (0,7%) koji su primali tivozanib kao inicijalnu terapiju u pet ključnih ispitivanja monoterapije RCC-a, u većini slučajeva CTC stupnja ≥ 3 (vidjeti dio 4.4).
English: Studies in pregnant rabbits showed no effect on maternal health or embryo foetal development at doses approximately 0.6 times the human exposure at the recommended dose.
Croatian: Ispitivanja provedena s gravidnim ženkama kunića pokazala su da ne postoji učinak na zdravlje majke ili embriofetalni razvoj kod doziranja koje iznosi oko 60% izloženosti ljudi kod preporučene doze.
English: Tivozanib is not recommended in patients with severe hepatic impairment.
Croatian: Tivozanib se ne preporučuje bolesnicima s teškim oštećenjem jetre.
English: It is recommended that symptoms of gastrointestinal perforation or fistula should be periodically monitored throughout treatment with tivozanib and that tivozanib should be used with caution in patients at risk for GI perforation or fistula.
Croatian: Tijekom terapije tivozanibom preporučuje se redovito praćenje simptoma želučano-crijevne perforacije ili fistule, a tivozanib treba primjenjivati oprezno kod bolesnika kod kojih postoji rizik od želučano-crijevne perforacije ili fistule.
English: Symptoms include shortness of breath or ankle swelling.
Croatian: Simptomi uključuju nedostatak zraka ili oticanje gležnjeva.
English: Dose modification
Croatian: Promjena doziranja
English: confusion, altered consciousness or sense of awareness, rapid, shallow breathing, a racing heart or excessive sweating.
Croatian: osjećali ste tjeskobu, smetenost, promjenu svijesti ili osjećaja svjesnosti, brzo i plitko ste disali, otkucaji srca bili su vam ubrzani i prekomjerno ste se znojili.
English: Tivozanib should be used with caution in patients with mild and moderate hepatic impairment with close monitoring of tolerability.
Croatian: Tivozanib bi trebalo oprezno davati bolesnicima s blagim i umjerenim oštećenjem jetre uz pažljivo praćenje podnošljivosti.
English: Talk to your doctor if you are already breastfeeding.
Croatian: Obavijestite liječnika ako već dojite.
English: Thyroid function should be monitored before initiation of, and periodically throughout treatment with tivozanib.
Croatian: Funkciju štitnjače potrebno je pratiti prije početka i redovito tijekom liječenja tivozanibom.
English: • Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stomach; swollen and painful tongue; inflamed painful and/or bleeding gums.
Croatian: • Nadimanje; žgaravica; teško i bolno gutanje; grlobolja; naduti trbuh; otečen i bolan jezik;
English: Tivozanib exposure was increased in patients with severe hepatic impairment (mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment (mean AUC0-∞ by 2.6-fold).
Croatian: Izloženost tivozanibu povećana je kod bolesnika s teškim oštećenjem jetre (srednji AUC0-∞ povećan 4,0 puta) i kod bolesnika s umjerenim oštećenjem jetre (srednja vrijednost AUC0-∞ povećana 2,6 puta).
English: CYP3A4 inhibitors
Croatian: Inhibitori enzima CYP3A4
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: The most frequent adverse reactions leading to tivozanib dose reduction/ interruption were hypertension (4.7%), diarrhoea (3.1%), fatigue
Croatian: Najčešće nuspojave koje dovode do smanjenja doze/privremenog prekida terapije tivozanibom bile su hipertenzija (4,7%), dijareja (3,1%) i umor (1,8%).
English: After chronic dosing of tivozanib in RCC patients for 21 days followed by 7 days without administration of tivozanib, tivozanib Cmin is approximately 16.0 to 30.9 ng/mL.
Croatian: Kod kronične terapije tivozanibom kod bolesnika s karcinomom bubrežnih stanica tijekom 21 dana, nakon čega je uslijedila stanka od 7 dana bez primjene tivozaniba, Cmin tivozaniba iznosio je oko 16,0 do 30,9 ng/mL.
English: Skin exfoliation Erythema22 Pruritus23
Croatian: Ljuštenje kože Eritem22
English: • if you have problems with your thyroid gland or use medicines to treat thyroid disease.
Croatian: • ako imate problema sa štitnjačom ili uzimate lijekove za reguliranje bolesti štitnjače.
English: Haemorrhage adverse reactions were reported in the core monotherapy studies during initial treatment (see section 4.4).
Croatian: Prijavljene su nuspojave krvarenja u ključnim ispitivanjima monoterapije tijekom inicijalne terapije (vidjeti dio 4.4).
English: Wound healing complications
Croatian: Komplikacije kod zacjeljivanja rana
English: Pooled data of 674 patients with advanced RCC who continued to receive tivozanib as their initial on trial therapy in the five core RCC monotherapy studies have been evaluated in the overall assessment of safety and tolerability of tivozanib.
Croatian: Združeni podaci 674 bolesnika s uznapredovalim karcinomom bubrežnih stanica (RCC) koji su nastavili primati tivozanib kao početnu ispitivanu terapiju u pet ključnih ispitivanja monoterapije kod karcinoma bubrežnih stanica (RCC) procijenjeni su u cjelokupnom ocjenjivanju sigurnosti i podnošljivosti tivozaniba.
English: • if you have had problems with blood clots.
Croatian: • ako ste imali problema s krvnim ugrušcima.
English: Tivozanib was shown to cause growth plate hypertrophy, absence of active corpora lutea and no maturing follicles in cynomolgus monkeys at dose levels that produced exposures equivalent to those seen at the recommended clinical dose.
Croatian: Pokazalo se da je tivozanib izazvao hipertrofiju zona rasta kosti, izostanak aktivnog žutog tijela i nesazrijevanje folikula kod makaki majmuna pri razinama doza koje su stvorile izloženost jednaku izloženosti uočenoj kod preporučenih kliničkih doza.
English: How to store Fotivda
Croatian: Kako čuvati Fotivdu
English: Venous thromboembolism11
Croatian: Venska tromboembolija11
English: Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 4.4 and section 5.2).
Croatian: Bolesnike s umjerenim oštećenjem jetre trebalo bi se liječiti samo jednom kapsulom tivozaniba od 1340 mikrograma svaki drugi dan, jer bi kod njih mogla postojati povećana opasnost od nuspojava zbog povećane izloženosti kod doziranja od 1340 mikrograma svaki dan (vidjeti dio 4.4 i dio 5.2).
English: • Fever; chest pain; swelling of feet and legs; chills and low body temperature.
Croatian: • Povišena temperatura, bol u prsištu, oticanje stopala i nogu; zimica i niska tjelesna temperatura
English: Your doctor may recommend that you temporarily stop taking Fotivda if you have an operation or surgery, as it could affect wound healing.
Croatian: • ako Vam je potrebna operacija ili drugi oblik kirurškog zahvata Vaš će Vam liječnik možda preporučiti da privremeno prekinete uzimanje Fotivde ako se podvrgavate operaciji ili kirurškom zahvatu, jer bi ona mogla utjecati na zacjeljivanje rane.
English: • Nerve damage including numbness, pins and needles, sensitive skin or numbness and weakness in the arms and legs.
Croatian: • Oštećenje živaca uključujući obamrlost, trnce i bockanje, osjetljivu kožu, obamrlost i slabost ruku i nogu
English: Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Croatian: Neovisna radiološka procjena pokazao je da kod tivozaniba postoji statistički značajno poboljšanje PFS-a i ORR-a u usporedbi sa sorafenibom (Tablica 2 i Slika 1).
English: • Itchy skin; rash; itching of the body; skin peeling; dry skin; hair loss; redness of the skin including the hands and body; acne.
Croatian: • Svrbež kože; osip; svrbež po tijelu; ljuštenje kože; suha koža; gubitak kose; crvenilo kože uključujući šake i tijelo; akne
English: Tivozanib should be used with caution in patients with moderate hepatic impairment and the dose reduced to one 1340 microgram capsule every other day.
Croatian: Tivozanib treba primjenjivati oprezno kod bolesnika s umjerenim oštećenjem jetre, a doza mora biti smanjena na jednu kapsulu od 1340 mikrograma svaki drugi dan.
English: For patients who develop Grade 2 (> 1.0-3.4 g/24 hours) or Grade 3 (≥ 3.5 g/24 hours) proteinuria (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), the dose of tivozanib has to be reduced or the treatment temporarily interrupted.
Croatian: Kod bolesnika kod kojih se razvije proteinurija 2. stupnja (> 1,0-3,4 g/24 sata) ili 3. stupnja (≥ 3,5 g/24 sata) (prema Zajedničkim terminološkim kriterijima za nuspojave američkog Nacionalnog instituta za rak [engl.
English: The recommended dose of tivozanib is 1340 microgram once daily for 21 days, followed by a 7-day rest period to comprise one complete treatment cycle of 4 weeks.
Croatian: Preporučena doza tivozaniba je 1340 mikrograma jednom dnevno tijekom 21 dana, nakon čega slijedi stanka od 7 dana i, što zajedno čini jedan kompletan ciklus terapije od 4 tjedna.
English: - Printing ink, blue: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminium lake (E132).
Croatian: - Tinta za označavanje, plava: šelak, propilenglikol, jaka otopina amonijaka, Indigo carmine aluminium lake (E132).
English: If you develop high blood pressure, your doctor may prescribe a medicine to treat your high blood pressure, lower your dose of Fotivda, or stop your treatment with Fotivda.
Croatian: Ako Vam se krvni tlak povisi Vaš liječnik će propisati lijek za snižavanje krvnog tlaka, smanjiti dozu Fotivde ili prekinuti terapiju Fotivdom.
English: In vitro studies with tivozanib indicate that it is not a CYP enzyme inducer.
Croatian: In vitro ispitivanja s tivozanibom ukazuju da tivozanib nije induktor enzima CYP.
English: In clinical studies with tivozanib, venous thromboembolic events (VTEs) have been reported including pulmonary embolism and deep vein thrombosis (see section 4.8).
Croatian: U kliničkim ispitivanjima s tivozanibom zabilježeni su venski tromboembolijski događaji (VTE), uključujući i plućnu emboliju i duboku vensku trombozu (vidjeti dio 4.8).
English: Patients with moderate hepatic impairment should only be treated with one tivozanib 1340 microgram capsule every other day as they may be at an increased risk of adverse reactions due to increased exposure with the dose of 1340 microgram every day (see section 5.2).
Croatian: Bolesnike s umjerenim oštećenjem jetre trebalo bi liječiti samo jednom kapsulom tivozaniba od 1340 mikrograma svaki drugi dan, jer bi kod njih mogao postojati povećani rizik od nuspojava zbog povećane izloženosti kod doziranja od 1340 mikrograma svaki dan (vidjeti dio 5.2).
English: 16 Stomatitis including oral discomfort, oral disorder and stomatitis 17 Pancreatitis including pancreatitis and pancreatitis acute 18 Dysphagia including dysphagia, odynophagia and oropharyngeal pain 19 Glossitis including glossitis and glossodynia
Croatian: 16 Stomatitis uključujući nelagodu u ustima, poremećaj usne šupljine i stomatitis 17 Pankreatitis uključujući pankreatitis i akutni pankreatitis 18 Disfagija uključujući disfagiju, odinofagiju i orofaringealnu bol 19 Glositis uključujući glositis i glosodiniju
English: No dose adjustment is required when administering tivozanib to patients with mild hepatic impairment.
Croatian: Prilagodba doze nije potrebna kad se tivozanib primjenjuje kod bolesnika s blagim oštećenjem jetre.
English: [14C] Tivozanib was the predominant drug-related material in faeces.
Croatian: C] tivozanib je bio dominantan sastojak stolice povezan s lijekovima.
English: Coronary artery insufficiency
Croatian: Plućni edem Insuficijencija koronarne arterije
English: Cross-over to the tivozanib arm was permitted upon Response Evaluation Criteria In Solid Tumours (RECIST)-defined progression on sorafenib according to the protocol of a separate extension study.
Croatian: Response Evaluation Criteria In Solid Tumours, RECIST) u skladu s protokolom odvojenog nastavka ispitivanja.
English: No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Croatian: Kod bolesnika s blagim ili umjerenim oštećenjem bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Tivozanib may have a minor influence on the ability to drive and use machines.
Croatian: Tivozanib može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: No significant increase in exposure was observed in patients with mild (Child-Pugh Class A) hepatic impairment (mean AUC0-∞ by 1.2-fold).
Croatian: U bolesnika s blagim oštećenjem jetre (Child-Pugh stupanj A) nije primijećeno značajnije povećanje izloženosti (srednja vrijednost AUC0-∞ povećana 1,2 puta).
English: Tell your doctor right away as these may be symptoms of heart failure.
Croatian: • ako primijetite nedostatak zraka ili oticanje gležnjeva Odmah o tome obavijestite liječnika jer ovo mogu biti simptomi zatajenja srca.
English: In the case of a missed dose a replacement dose must not be taken to make up for a forgotten dose.
Croatian: Ako ste propustili dozu, ne smijete uzeti zamjensku dozu kako biste nadoknadili dozu koju ste zaboravili uzeti.
English: Tivozanib has not been studied in patients who had a VTE within the preceding 6 months of clinical study initiation.
Croatian: Tivozanib nije ispitivan kod bolesnika koji su imali VTE tijekom 6 mjeseci koji su prethodili početku kliničkog ispitivanja.
English: No adverse reaction was experienced by the second patient who took 2 doses of 1340 microgram tivozanib in one day (total 2680 microgram).
Croatian: Drugi bolesnik, koji je uzeo 2 doze od 1340 mikrograma tivozaniba u jednom danu (ukupno 2680 mikrograma), nije osjetio nikakve nuspojave.
English: In female rats, an increase in non-viable foetuses was noted at a dose 0.7-fold the recommended clinical dose, while dose levels ≥ 2 fold the recommended clinical dose produced infertility.
Croatian: Kod ženki štakora, povećani broj nevijabilnih fetusa zabilježen je pri doziranju koje je bilo 0,7 puta veće od preporučene kliničke doze, dok su razine doziranja ≥ 2 puta veće od preporučene kliničke doze rezultirale neplodnošću.
English: Arthralgia Myalgia Musculoskeletal chest pain
Croatian: Artralgija Mialgija Mišićno-koštana bol u prsištu
English: Within each SOC, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog organskog sustava nuspojave su navođene prema ozbiljnosti, od najozbiljnije do najmanje ozbiljne.
English: In clinical studies with tivozanib, elevations of ALT, AST, and bilirubin have been reported (see section 4.8).
Croatian: U kliničkim ispitivanjima s tivozanibom, prijavljene su povišene vrijednosti ALT, AST i bilirubina (vidjeti dio 4.8).
English: If necessary, your doctor may reduce your dose of Fotivda, or interrupt or stop this treatment.
Croatian: Ako je potrebno, Vaš liječnik može smanjiti dozu Fotivde ili privremeno ili potpuno prekinuti terapiju.
English: Tivozanib has not been studied in patients who had an ATE within the preceding 6 months of clinical study initiation.
Croatian: Tivozanib nije ispitivan kod bolesnika koji su imali ATE tijekom 6 mjeseci koji su prethodili početku kliničkog ispitivanja.
English: In clinical studies with tivozanib, hypertension (including persistent severe hypertension) has occurred (see section 4.8).
Croatian: U kliničkim ispitivanjima s tivozanibom, nastupila je hipertenzija (uključujući i perzistirajuću tešku hipertenziju) (vidjeti dio 4.8).
English: During treatment, patients should be monitored for hypertension and treated as needed with anti-hypertensive therapy according to standard medical practice.
Croatian: Tijekom liječenja potrebno je pratiti bolesnike zbog hipertenzije i po potrebi primijeniti terapiju za snižavanje krvnog tlaka u skladu sa standardnom medicinskom praksom.
English: 14 Dyspnoea including dyspnoea and exertional dyspnoea 15 Abdominal pain including abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and abdominal rigidity
Croatian: 15 Abdominalna bol uključujući abdominalnu neugodu, abdominalnu bol, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i tvrdi abdomen
English: 20 Gingivitis including gingival bleeding, gingival disorder, gingival pain and gingivitis 21 Alanine aminotransferase (ALT) increased / Aspartate aminotransferase (AST) increased including ALT increased and AST increased
Croatian: 20 Gingivitis uključujući krvarenje desni, poremećaj desni, bolove u desnima i gingivitis 21 Povišena alanin aminotransferaza (ALT) / aspartat aminotransferaza (AST) uključujući povišeni ALT i AST 22 Eritem uključujući eritem, generalizirani eritem i eritem dlanova 23 Svrbež uključujući generalizirani svrbež i svrbež
English: No concentration dependence of plasma protein binding was observed over the range of 0.1 to 5 µmol/L tivozanib.
Croatian: U rasponu od 0,1 do 5 µmol/L tivozaniba nije uočena ovisnost vezivanja proteina u plazmi o koncentraciji.
English: • Joint pain; muscle pain.
Croatian: • Bol u zglobovima; bol u mišićima
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Croatian: PRES je neurološki poremećaj koji se može manifestirati glavoboljom, napadajima, letargijom, konfuzijom, sljepoćom i drugim poremećajima vida i neurološkim poremećajima.
English: Strong ammonia solution Indigo carmine aluminium lake (E132)
Croatian: Indigo carmine aluminium lake (E132)
English: In clinical studies with tivozanib as monotherapy for the treatment of patients with RCC, cardiac failure has been reported (see section 4.8).
Croatian: U kliničkim ispitivanjima u kojima je tivozanib bio jedina terapija kod bolesnika s karcinomom bubrežnih stanica (RCC) prijavljeno je i zatajenje srca (vidjeti dio 4.8).
English: There was no unchanged tivozanib recovered in the urine indicating that tivozanib does not undergo renal excretion.
Croatian: U urinu nije pronađen nepromijenjen tivozanib što upućuje da se tivozanib ne izlučuje putem bubrega.
English: • Bruising easily, bleeding into the skin.
Croatian: • Sklonost nastanku modrica, krvarenje u kožu
English: 27 Pain including bone pain, cancer pain, flank pain, groin pain, oral pain, pain, pain in extremity and tumour pain 28 Chest pain including chest pain and non-cardiac chest pain 29 Chills including chills and hypothermia
Croatian: 26 Dermatitis uključujući dermatitis i bulozni dermatitis 27 Bol uključujući bol u kostima, bol izazvanu rakom, bol u slabinama, bol u preponama, bol u ustima, bol, bol u ekstremitetima i bolove izazvane tumorom28 Bol u prsištu uključujući bol u prsištu i nekardiološku bol u prsištu 29 Zimica uključujući zimicu i hipotermiju
English: Strong CYP3A4 inducers
Croatian: Jaki induktori enzima CYP3A4
English: Your doctor will regularly monitor how well your thyroid gland is working before and during treatment with Fotivda (e.g. with blood tests).
Croatian: Vaš će liječnik redovito pratiti rad Vaše štitnjače prije i tijekom terapije Fotivdom (npr. krvnim pretragama).
English: Your doctor will check your blood pressure regularly during treatment with Fotivda.
Croatian: Vaš liječnik redovito će tijekom terapije Fotivdom provjeravati Vaš tlak.
English: Pulmonary oedema was reported in two patients (0.3%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies.
Croatian: Plućni edem prijavljen je kod dva bolesnika (0,3%) koji su primali tivozanib kao inicijalnu terapiju u pet ključnih ispitivanja monoterapije kod karcinoma bubrežnih stanica.
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke (mogu se javiti u manje od 1 na 1000 osoba)
English: This controlled clinical study was a Phase 3 multi-centre, open-label, international, randomised study comparing tivozanib with sorafenib in patients with advanced RCC. Five hundred and seventeen (517) patients with recurrent or metastatic RCC with a clear cell component were randomised (1:1) to receive either tivozanib 1340 microgram once daily on a schedule of 3 weeks on treatment followed by 1 week off (schedule 3/1) or sorafenib 400 mg twice a day.
Croatian: Petsto sedamnaest (517) bolesnika s rekurentnim ili metastatskim karcinomom bubrežnih stanica (RCC) s jasnom staničnom komponentom randomizirano je (1:1) kako bi primali tivozanib od 1340 mikrograma jednom dnevno tijekom terapije od 3 tjedna iza čega je slijedio 1 tjedan stanke (raspored 3/1) ili sorafenib od 400 mg dvaput dnevno.
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Croatian: Titanijev dioksid (E171) Žuti željezov oksid (E172)
English: In cases of suspected overdose, tivozanib should be discontinued and the patient monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Croatian: U slučajevima u kojima se sumnja na predoziranje, potrebno je prekinuti primjenu tivozaniba i kontrolirati visinu tlaka bolesnika te po potrebi korigirati standardnom terapijom za hipertenziju.
English: Fungal infection Pustular rash
Croatian: Gljivične infekcije Gnojni osip
English: Hypothyroidism Hyperthyroidism Goitre1
Croatian: Hipertireoza Struma1
English: • Tiredness and lack of energy.
Croatian: • Bolovi u leđima • Umor i nedostatak energije
English: Deep vein thrombosis was also reported in two patients (0.3%) and was CTC Grade ≥ 3 in one patient (0.1%) receiving initial tivozanib therapy.
Croatian: Duboka venska tromboza prijavljena je također kod dva bolesnika koji su primali inicijalnu terapiju tivozanibom (0,3%) i kod jednog se radilo o CTC-u ≥ 3. stupnja (0,1%).
English: Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172)
Croatian: Titanijev dioksid (E171) Indigo carmine (E132) Žuti željezov oksid (E172)
English: Proteinuria has been reported in clinical studies with tivozanib (see section 4.8).
Croatian: Proteinurija je prijavljena u kliničkim ispitivanjima s tivozanibom (vidjeti dio 4.8).
English: Arterial thromboembolism10
Croatian: Arterijska tromboembolija10