FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Croatian: Ispitanike se mora upozoriti na primjenu supstrata P-gp-a (npr. feksofenadin, aliskiren, ambrisentan, dabigatran eteksilat, digoksin, kolhicin, maravirok, posakonazol, ranolazin, saksagliptin, sitagliptin, talinolol, tolvaptan) za vrijeme primjene kabozantiniba.
English: Infections and infestations abscess (including visceral, skin, tooth), pneumonia, folliculitis, fungal infection (including skin, oral, genital)
Croatian: Infekcije i infestacije apscesi (uključujući apscese visceralnih organa, kože, zuba), pneumonija, folikulitis, gljivične infekcije (uključujući kožne, oralne, genitalne)
English: • Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
Croatian: • Oslabljen rad štitnjače; simptomi mogu uključivati: umor, dobitak na težini, zatvor, osjećaj hladnoće te suhu kožu
English: Patients with severe hepatic impairment have not been studied.
Croatian: Bolesnici s teškim oštećenjem funkcije bubrega nisu ispitivani.
English: 4.0 months HR: 0.28 (0.19, 0.40) p <0.0001
Croatian: 4,0 mjeseci HR: 0,28 (0,19; 0,40) p < 0,0001
English: Nervous system disorders dysgeusia, headache, dizziness cerebrovascular accident, peripheral neuropathy, paraesthesia, ageusia, tremor ataxia, disturbance in attention, hepatic encephalopathy, loss of consciousness, speech disorder, posterior reversible encephalopathy syndrome
Croatian: Poremećaji živčanog sustava disgeuzija, glavobolja, omaglica cerebrovaskularni inzult, periferna neuropatija, parestezija, ageuzija, tremor ataksija, poremećaj pažnje, hepatalna encefalopatija, gubitak svijesti, poremećaj govora, sindrom posteriorne reverzibilne encefalopatije
English: Results from a study in patients with renal impairment indicate that the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment, compared to subjects with normal renal function.
Croatian: Rezultati ispitivanja kod bolesnika s oštećenom funkcijom bubrega ukazuju na to da su omjeri geometrijskih srednjih vrijednosti dobivenih metodom najmanjih kvadrata za kabozantinib u plazmi, Cmax i AUC0-inf bili 19 % i 30 % viši, za ispitanike s blagim oštećenjem funkcije bubrega (90% CI za Cmax 91,60 % do 155,51 %; AUC0-inf 98,79 % do 171,26 %) te 2 % i 6-7 % viši (90% CI za Cmax 78,64 % do 133,52 %; AUC0-inf 79,61 % do 140,11 %), za ispitanike s umjerenim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: When dose reduction is necessary, it is recommended to reduce to 100 mg daily,
Croatian: Kada je smanjenje doze neophodno, preporučuje se smanjiti dozu na
English: Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution.
Croatian: Stoga je neophodan oprez prilikom istodobne primjene inhibitora MRP2 (npr. ciklosporina, efavirenza, emtricitabina).
English: Investigations weight decreased, serum ALT, AST, and ALP increased, blood LDH increased, blood TSH increased, lymphopenia, neutropenia, thrombocytopenia blood creatinine phosphokinase increased activated partial thromboplastin time shortened, eosinophil count increased, platelet count increased
Croatian: Pretrage smanjenje težine, povišen ALT, AST i ALP u serumu, povišen LDH u krvi, povišen TSH u krvi, limfopenija, neutropenija, trombocitopenija povišena kreatinin fosfokinaza u krvi skraćenje aktiviranog parcijalnog tromboplastinskog vremena, povećanje broja eozinofila, povećanje broja trombocita
English: Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis.
Croatian: Kabozantinib se ne smije primjenjivati u bolesnika s ozbiljnim krvarenjem ili nedavnom hemoptizom.
English: Figure 1: Kaplan Meier curve of progression free survival
Croatian: Slika 1: Kaplan Meierova krivulja preživljenja bez progresije bolesti
English: Taking COMETRIQ with food
Croatian: Uzimanje lijeka COMETRIQ s hranom
English: • Abscess (collection of pus, with swelling and inflammation) in the abdomen or pelvis area or in your teeth/gums
Croatian: • Gnojna upala (nakupina gnoja, s oticanjem i upalom) u trbuhu ili području zdjelice te na zubima/desnima
English: • Redness, swelling or pain in the mouth or throat, difficulty in speaking, hoarseness
Croatian: • Crvenilo, oticanje ili bol u ustima ili grlu, otežan govor, promuklost
English: The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80 mg orange capsule and three 20 mg grey capsules.
Croatian: Preporučena doza lijeka COMETRIQ iznosi 140 mg jedanput dnevno, a uzima se kao jedna narančasta kapsula od 80 mg i tri sive kapsule od 20 mg.
English: Vascular disorders hypertension hypotension, venous thrombosis, pallor, peripheral coldness arterial thrombosis Aneurysms and artery dissections
Croatian: Krvožilni poremećaji hipertenzija hipotenzija, venska tromboza, bljedilo, periferna hladnoća arterijska tromboza aneurizme i disekcije arterije
English: The most common serious adverse reactions associated with cabozantinib are pneumonia, mucosal inflammation, hypocalcaemia, dysphagia, dehydration, pulmonary embolism, and hypertension.
Croatian: Najčešće ozbiljne nuspojave povezane s kabozantinibom su pneumonija, upala sluznice, hipokalcemija, disfagija, dehidracija, plućna embolija i hipertenzija.
English: Stearic acid
Croatian: Sekvestranti žučne kiseline
English: How to take COMETRIQ 4.
Croatian: Kako uzimati COMETRIQ 4. Moguće nuspojave
English: How to take COMETRIQ
Croatian: Kako uzimati COMETRIQ
English: The ORR was 27.9% and 0% for subjects in the cabozantinib arm and placebo arm, respectively (p<0.0001; Table 2).
Croatian: ORR je iznosio 27,9% za skupinu ispitanika u kojih je primjenjivan kabozantinib i 0% za skupinu ispitanika u kojih je primjenjivan placebo (p< 0,0001; Tablica 2).
English: When dose reduction is necessary, it is recommended to reduce to 100 mg daily, taken as one 80 mg orange capsule and one 20 mg grey capsule, and then to 60 mg daily, taken as three 20 mg grey capsules.
Croatian: Kada je smanjenje doze neophodno, preporučuje se smanjiti dozu na 100 mg dnevno, pri čemu se doza uzima kao jedna narančasta kapsula od 80 mg i jedna siva kapsula od 20 mg te zatim smanjiti dozu na 60 mg dnevno, pri čemu se doza uzima kao tri sive kapsule od 20 mg.
English: Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Croatian: Primjenom jakog inhibitora CYP3A4 ketokonazola (400 mg dnevno tijekom 27 dana) u zdravih dobrovoljaca se smanjio klirens kabozantiniba (za 29%) te povećala jednokratna ekspozicija kabozantiniba u plazmi (AUC) za 38%.
English: Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Croatian: Stoga primjena inhibitora MRP2 može dovesti do povećanja koncentracija kabozantiniba u plazmi.
English: • Swelling, pain in your hands and feet, or shortness of breath.
Croatian: • Oticanje, bol u šakama i stopalima ili nedostatak zraka.
English: Administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.
Croatian: Primjena inhibitora MRP2 može dovesti do povećanja koncentracija kabozantiniba u plazmi.
English: Ipsen Pharma SAS Lietuvos filialas
Croatian: Ipsen Pharma SAS Lietuvos filialas T.
English: • Symptoms including pain in the abdomen, nausea, vomiting, constipation, or fever.
Croatian: • Simptomi kao što su bol u trbuhu, mučnina, povraćanje, zatvor ili vrućica.
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Croatian: Nije potrebno prilagođavanje doze kada se lijekovi koji mijenjaju pH želuca (tj. inhibitori protonske pumpe, antagonisti H2 receptora i antacidi) primjenjuju istodobno s kabozantinibom.
English: A multi-center, randomized double-blind study comparing cabozantinib (N = 219) with placebo (N = 111) was conducted in patients with unresectable locally advanced or metastatic MTC and documented radiographic disease progression within 14 months prior to study entry.
Croatian: (N = 219) s placebom (N = 111) u bolesnika s inoperabilnim lokalno uznapredovalim ili metastatskim medularnim karcinomom štitnjače i dokumentiranom radiografskom progresijom bolesti unutar 14 mjeseci prije početka ispitivanja.
English: Cabozantinib should be discontinued in patients who develop nephrotic syndrome.
Croatian: Mora se prekinuti s primjenom kabozantiniba u bolesnika u kojih se pojavi nefrotski sindrom.
English: • Inflammation of the oesophagus; symptoms can include heartburn, chest pain, feeling sick, altered taste, bloating, belching and indigestion
Croatian: • Upala jednjaka; simptomi mogu uključivati žgaravicu, bol u prsima, mučninu, izmijenjen osjet okusa, nadutost, podrigivanje i probavne tegobe
English: In case of hypertensive crisis, cabozantinib should be discontinued.
Croatian: Ako se javi hipertenzivna kriza, mora se prekinuti s primjenom kabozantiniba.
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, if possible.
Croatian: Ako je moguće, mora se prekinuti liječenje kabozantinibom najmanje 28 dana prije zakazane operacije.
English: • 100 mg (1 orange 80 mg capsule and 1 grey 20 mg capsule)
Croatian: • 100 mg (1 narančasta kapsula od 80 mg i 1 siva kapsula od 20 mg)
English: CYP3A4 inducers and inhibitors
Croatian: Inhibitori i induktori CYP3A4
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Croatian: Istodobna primjena inhibitora protonske pumpe (IPP) esomeprazola (40 mg dnevno tijekom 6 dana) s jednokratnom dozom od 100 mg kabozantiniba u zdravih dobrovoljaca nije imala klinički značajan učinak na izloženost kabozantinibu u plazmi (AUC).
English: In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted.
Croatian: U slučaju sumnje na predoziranje, mora se prestati s primjenom kabozantiniba te uvesti potpornu njegu.
English: Therefore, cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp.
Croatian: Prema tome, moguće je da kabozantinib može povećati koncentracije u plazmi supstrata P-gp-a koji se primjenjuju istodobno s njim.
English: • 140 mg (1 orange 80 mg capsule and 3 grey 20 mg capsules)
Croatian: • 140 mg (1 narančasta kapsula od 80 mg i 3 sive kapsule od 20 mg)
English: - Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin, and rifampicin - Allergy medicines such as fexofenadine and ranolazine - Steroids used to reduce inflammation or treat a number of different diseases of the immune system - Medicines used to treat epilepsy or fits such as phenytoin, carbamazepine, and phenobarbital - Herbal preparations containing St. John's Wort (Hypericum perforatum), sometimes used for treating depression or depression-related conditions such as anxiety - Medicines used to thin the blood, such as warfarin - Medicines to treat high blood pressure or other heart conditions, such as aliskiren, ambrisentan,
Croatian: klaritromicin i rifampicin - Lijekovi protiv alergija kao što su feksofenadin i ranolazin - Steroidi koji se koriste za smanjenje upale ili liječenje niza različitih bolesti imunološkog sustava - Lijekovi koji se koriste za liječenje epilepsije ili napadaja kao što su fenitoin, karbamazepin i fenobarbital - Biljni preparati koji sadrže gospinu travu (Hypericum perforatum), koja se ponekad koristi za liječenje depresije ili stanja povezanih s depresijom kao što je tjeskoba - Lijekovi koji razrjeđuju krv, kao što je varfarin - Lijekovi koji se koriste za liječenje visokog krvnog tlaka ili drugih srčanih stanja, kao što su aliskiren, ambrisentan, dabigatran eteksilat, digoksin, talinolol i tolvaptan - Lijekovi za dijabetes, kao što su saksagliptin i sitagliptin - Lijekovi koji se koriste za liječenje gihta, kao što je kolhicin - Lijekovi koji se koriste za liječenje HIV-a ili AIDS-a, kao što su ritonavir, maravirok i emtricitabin
English: • Blister, pain of the hands or soles of the feet, rash or redness of the skin, dry skin
Croatian: • Mjehurići, bol u šakama ili tabanima, osip ili crvenilo kože, suha koža
English: Concurrent administration of cabozantinib with the strong CYP3A4 inhibitor ketoconazole resulted in an increase in cabozantinib plasma exposure.
Croatian: Istodobna primjena kabozantiniba s jakim inhibitorom CYP3A4 ketokonazolom dovela je do porasta ekspozicije kabozantiniba u plazmi.
English: • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: • Bol u ustima, zubima i/ili čeljusti, oticanje ili ranice u ustima, utrnulost ili osjećaj težine u čeljusti ili klimanje zuba.
English: Reproductive system and breast disorders amenorrhoea, vaginal haemorrhage
Croatian: Poremećaji reproduktivnog sustava i dojki amenoreja, vaginalno krvarenje
English: Cabozantinib should be used with caution in patients with mild or moderate renal impairment.
Croatian: Kabozantinib se mora primjenjivati s oprezom u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: • Abnormal connection of the tissue in your trachea (airway), oesophagus, or lungs
Croatian: • Abnormalno spajanje tkiva u dušniku (dišnim putovima), jednjaku ili plućima
English: Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Croatian: Kabozantinib se mora primjenjivati s oprezom u bolesnika koji spadaju u rizičnu skupini ili imaju anamnezu ovakvih slučajeva.
English: Wound complications
Croatian: Komplikacije s ranama
English: Serious GI perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježene su ozbiljne, u nekim slučajevima i smrtonosne, gastrointestinalne perforacije i fistule te intraabdominalni apscesi.
English: Package leaflet inside pouch.
Croatian: Uputa o lijeku nalazi se unutar vrećice.
English: Events of venous thromboembolism and events of arterial thromboembolism have been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježeni su događaji venske tromboembolije i arterijske tromboembolije.
English: Concurrent administration of cabozantinib with the strong CYP3A4 inducer rifampicin resulted in a decrease in cabozantinib plasma exposure.
Croatian: Istodobna primjena kabozantiniba s jakim induktorom CYP3A4 rifampicinom dovela je do smanjenja ekspozicije kabozantiniba u plazmi.
English: Administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 31 days) to healthy volunteers increased cabozantinib clearance (4.3-fold) and decreased single-dose plasma cabozantinib exposure (AUC) by 77%.
Croatian: Primjenom jakog induktora CYP3A4 rifampicina (600 mg dnevno tijekom 31 dana) u zdravih dobrovoljaca se povećao klirens kabozantiniba (za 4,3 puta) te smanjila jednokratna ekspozicija kabozantiniba u plazmi (AUC) za 77%.
English: confusion, or finding it difficult to concentrate
Croatian: glavobolje, smetenost ili poteškoće s koncentriranjem
English: There is a possibility your fertility could be affected by treatment with COMETRIQ.
Croatian: Moguće je da liječenje lijekom COMETRIQ utječe na Vašu plodnost.
English: In rats, cabozantinib caused postimplantation loss, foetal oedema, cleft palate/lip, dermal aplasia and kinked or rudimentary tail.
Croatian: Kabozantinib je u štakora uzrokovao postimplantacijski gubitak embrija, fetalni edem, rascjep nepca/usne, aplaziju kože te savijen ili rudimentarni rep.
English: Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Croatian: Stoga se moraju oprezno istodobno primjenjivati jaki inhibitori CYP3A4 (npr. ritonavir, itrakonazol, eritromicin, klaritromicin, sok od grejpa) i kabozantinib.
English: • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth
Croatian: • Bol u ustima, zubima i/ili čeljusti, oticanje ili ranice u ustima, utrnulost ili osjećaj težine u čeljusti ili klimanje zuba
English: Cabozantinib is not recommended for use in patients with severe hepatic impairment as safety and efficacy have not been established in this population.
Croatian: Ne preporučuje se primjena kabozantiniba u bolesnika s teškim oštećenjem funkcije bubrega jer sigurnost i djelotvornost lijeka nije utvrđena u ovoj populaciji.
English: • Chest pain due to blockage in arteries, rapid heartbeat
Croatian: • Bol u prsnom košu zbog začepljenja arterija, ubrzani otkucaji srca
English: The hard capsules are grey with “XL184 20mg” printed in black on the body of the capsule.
Croatian: Tvrde kapsule su sive s crno otisnutom oznakom “XL184 20mg” na tijelu kapsule.
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, hair colour changes, rash, dry skin, alopecia, erythema hyperkeratosis, acne, blister, hair growth abnormal, skin exfolation, skin hypopigmentation skin ulcer, telangiectasia
Croatian: Poremećaji kože i potkožnog tkiva sindrom palmarnoplantarne eritrodizestezije, promjena boje kose, osip, suha koža, alopecija, eritem hiperkeratoza, akne, mjehurići, abnormalan rast dlaka, eksfolijacija kože, hipopigmentacija kože ulceracija kože, telangiektazija
English: An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in cancer patients.
Croatian: U kontroliranoj kliničkoj studiji kod bolesnika s rakom zabilježeno je povećanje u odnosu na početne vrijednosti QT intervala korigiranog po Fridericia formuli (QTcF) od 10 - 15 ms na dan 29 (ali ne na dan 1) nakon početka liječenja kabozantinibom (pri dozi od 140 mg jednom dnevno).
English: How to store COMETRIQ
Croatian: Kako čuvati COMETRIQ
English: Chronic co-administration of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort [Hypericum perforatum]) with cabozantinib should therefore be avoided.
Croatian: Stoga se mora izbjegavati istodobna kronična primjena jakih induktora CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, fenobarbital ili biljni preparati koji sadrže gospinu travu [Hypericum perforatum]) s kabozantinibom.
English: Each daily dose is given in one row and contains three 20 mg capsules:
Croatian: Svaka dnevna doza se nalazi u jednom redu i sadrži tri kapsule od 20 mg:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD 140 mg dose
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU BLISTER KARTICA, doza od 140 mg
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Croatian: otprilike 81% od ukupne primijenjene radioaktivnosti je izlučeno, od čega 54% u fecesu i 27% u urinu.
English: Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
Croatian: Kabozantinib se mora nastaviti u smanjenoj dozi kada se sindrom palmarnoplantarne eritrodizestezije smanji do 1. stupnja.
English: Black iron oxide (E172) Propylene glycol
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms, pain in extremity musculoskeletal chest pain, osteonecrosis of jaw rhabdomyolysis
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija, spazmi mišića, bol u ekstremitetima muskuloskeletna bol u prsima, osteonekroza čeljusti rabdomioliza
English: Gastrointestinal disorders diarrhoea, nausea, stomatitis, constipation, vomiting, abdominal pain, dyspepsia, dysphagia, glossodynia gastrointestinal perforation, gastrointestinal haemorrhage, pancreatitis, haemorrhoids, anal fissure, anal inflammation, cheilitis gastrointestinal fistula, oesophagitis
Croatian: Poremećaji probavnog sustava proljev, mučnina, stomatitis, konstipacija, povraćanje, bol u abdomenu, dispepsija, disfagija, glosodinija gastrointestinalna perforacija, gastrointestinalno krvarenje, pankreatitis, hemoroidi, analna fisura, analna upala, heilitis gastrointestinalna fistula, ezofagitis
English: 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) 28 day pack containing:
Croatian: 21 kapsulu od 20 mg (dnevna doza od 60 mg za primjenu tijekom 7 dana) Pakiranje za 28 dana sadržava:
English: 140 mg/day dose
Croatian: 140 mg/dnevna doza
English: • Inflammation in the eye, cataracts
Croatian: • Upala oka, katarakta
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, and abdominal pain
Croatian: • Nadražen želudac, uključujući proljev, mučninu, povraćanje, zatvor, probavne smetnje te bol u trbuhu
English: Each 60 mg daily dose contains a combination of three grey 20 mg capsules.
Croatian: Svaka dnevna doza od 60 mg sadrži tri sive kapsule od 20 mg.
English: - Capsule contents: microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, silica colloidal anhydrous, and stearic acid
Croatian: Sadržaj kapsule celuloza, mikrokristalična karmelozanatrij, umrežena natrijev škroboglikolat silicijev dioksid, koloidni, bezvodni stearatna kiselina
English: EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/002 7 kapsula od 20 mg i 7 kapsula od 80 mg (dnevna doza od 100 mg za primjenu tijekom 7 dana) EU/1/13/890/003 21 kapsula od 20 mg i 7 kapsula od 80 mg (dnevna doza od 140 mg za primjenu tijekom 7 dana) EU/1/13/890/005 56 kapsula (4 blister kartice od: 7 x 20 mg i 7 x 80 mg) (dnevna doza od 100 mg za primjenu tijekom 28 dana) EU/1/13/890/006 112 kapsula (4 blister kartice od: 21 x 20 mg i 7 x 80 mg) (dnevna doza od 140 mg za primjenu tijekom 28 dana)
English: • Liver damage, kidney failure
Croatian: • Oštećenje jetre, zatajenje bubrega
English: Renal and urinary disorders proteinuria, dysuria, haematuria renal failure acute
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija, dizurija, hematurija akutno zatajenje bubrega
English: Pack for the 140 mg daily dose
Croatian: Pakiranje za dnevnu dozu od 140 mg
English: Pack for the 100 mg daily dose
Croatian: Pakiranje za dnevnu dozu od 100 mg
English: NAME OF THE MEDICINAL PRODUCT COMETRIQ 20 mg hard capsules
Croatian: NAZIV LIJEKA COMETRIQ 20 mg tvrde kapsule
English: Black iron oxide (E172)
Croatian: Ovojnica kapsule želatina željezov oksid, crni (E172) titanijev dioksid (E171)
English: Hard capsules 20 mg
Croatian: tri sive kapsule od 20 mg
English: 140 mg Dose
Croatian: Doza od 140 mg
English: • Haemorrhoids
Croatian: • Zamagljen vid
English: Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Croatian: Svaka dnevna doza od 140 mg sadrži tri sive kapsule od 20 mg i jednu narančastu kapsulu od 80 mg.