natgillin/translations-raw huggingface dataset:
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with ketoconazole. 
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kada se primjenjuje istodobno s ketokonazolom.
CELSENTRI dose should be increased to 600 mg twice daily when coadministered with carbamazepine, phenobarbital or phenytoin in the absence of a potent CYP3A4 inhibitor. 
Dozu lijeka CELSENTRI treba povećati na 600 mg 2x dnevno kada se primjenjuje istodobno s karbamazepinom, fenobarbitalom ili fenitoinom, a bez snažnog inhibitora CYP3A4.
Atazanavir concentrations not measured, no effect is expected. 
Koncentracije atazanavira nisu određivane, učinak nije očekivan.
boceprevir, telaprevir) 
nelfinavir, ritonavir, sakvinavir, boceprevir, telaprevir)
Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin. 
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 75 mg sadrži 0,42 mg sojinog lecitina.
Tipranavir/ritonavir 500 mg/200 mg BID (maraviroc 150 mg BID) 
Tipranavir/ritonavir 500 mg/200 mg 2x dnevno (maravirok 150 mg 2x dnevno)
2x carton for blister pack containing 300 mg maraviroc film-coated tablets - without Blue Box 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 2x kutija za blister pakiranja koja sadrži filmom obložene tablete od 300 mg maraviroka - bez plavog okvira
CELSENTRI dose should be increased to 600 mg twice daily when co-administered with rifampicin in the absence of a potent CYP3A4 inhibitor. 
Dozu lijeka CELSENTRI treba povećati na 600 mg 2x dnevno kad se primjenjuje istodobno s rifampicinom bez prisustva snažnih CYP3A4 inhibitora.
Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”. 
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 8,56 mm x 15,5 mm, sutisnutom oznakom „MVC 150“.
Maraviroc 300 mg twice daily + OBT N=426 
Maravirok 300 mg 2x dnevno +OBT N = 426
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with clarithromycin and telithromycin. 
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kad se primjenjuje istodobno s klaritromicinom ili telitromicinom.
Each film-coated tablet contains 75 mg of maraviroc. 
Jedna filmom obložena tableta sadrži 75 mg maraviroka.
Each film-coated tablet contains 300 mg of maraviroc. 
Jedna filmom obložena tableta sadrži 300 mg maraviroka.
2x carton for blister pack containing 150 mg maraviroc film-coated tablets - without Blue Box 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 2x kutija za blister pakiranja koja sadrži filmom obložene tablete od 150 mg maraviroka - bez plavog okvira
Efavirenz concentrations not measured, no effect is expected. 
Koncentracije efavirenza nisu određivane, učinak nije očekivan.
Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”. 
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 6,74 mm x 12,2 mm, s utisnutom oznakom „MVC 75“.
Maraviroc Cmax: ↑ 1.25 
Maravirok Cmax:  1,25
Midazolam 7.5 mg Single Dose (maraviroc 300 mg BID) 
Midazolam 7,5 mg jednokratna doza (maravirok 300 mg 2x dnevno)
Protease Inhibitors (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID) 
Inhibitori proteaze (IP) Atazanavir 400 mg 1x dnevno (maravirok 300 mg 2x dnevno)
CELSENTRI 20 mg/ml oral solution 
NAZIV LIJEKA CELSENTRI 20 mg/ml oralna otopina
Anti-HCV Ribavirin 
Lijekovi za hepatitis C Ribavirin
Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”. 
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 10,5 mm x 19,0 mm, s utisnutom oznakom „MVC 300“.
Maraviroc concentrations not measured, no effect is expected. 
Koncentracije maraviroka nisu određivane, učinak nije očekivan.
Maraviroc Cmax: ↑ 4.78 
Maravirok Cmax:  4,78
Maraviroc AUC12: ↑ 2.53 
Maravirok AUC12:  2,53
Discontinue maraviroc and other suspect agents immediately if signs or symptoms of severe skin or hypersensitivity reactions develop. 
Ako se pojave znakovi ili simptomi teških kožnih reakcija ili reakcija preosjetljivosti, odmah prekinite primjenu maraviroka i drugih suspektnih lijekova.
Maraviroc AUC12: ↓ 0.55 
Maravirok AUC12:  0,55
Gastrointestinal disorders Amylase 
Poremećaji probavnog sustava Amilaza
Atazanavir/ritonavir concentrations not measured, no effect is expected. 
Koncentracije atazanavira/ritonavira nisu određivane, učinak nije očekivan.
ANTIFUNGALS Ketoconazole 400 mg QD (maraviroc 100 mg BID) 
ANTIMIKOTICI Ketokonazol 400 mg 1x dnevno (maravirok 100 mg 2x dnevno)
Serious side effects - get medical help immediately Serious allergic or skin reactions 
Ozbiljne nuspojave - odmah potražite liječničku pomoć
• skin rash or itching 
• kožni osip ili svrbež
Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin. 
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 150 mg sadrži 0,84 mg sojinog lecitina.
50 mg twice daily 
50 mg dva puta na dan
Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin. 
Pomoćna tvar s poznatim učinkom: jedna filmom obložena tableta od 25 mg sadrži 0,14 mg sojinog lecitina.
Tenofovir concentrations not measured, no effect is expected. 
Koncentracije tenofovira nisu određivane, učinak nije očekivan.
Each film-coated tablet contains 25 mg of maraviroc. 
Jedna filmom obložena tableta sadrži 25 mg maraviroka.
Tenofovir 300 mg QD (maraviroc 300 mg BID) 
Tenofovir 300 mg 1x dnevno (maravirok 300 mg 2x dnevno)
120 film-coated tablets 
60 filmom obloženih tableta
300 mg twice daily 
300 mg dva puta na dan
Antiretrovirals 
ANTIKONVULZIVI
celsentri 20 mg/ml 
16. PODACI NA BRAILLEOVOM PISMU celsentri 20 mg/ml
Maraviroc Cmax: ↑ 2.29 
Maravirok Cmax:  2,29
Atazanavir/ritonavir 300 mg/100 mg QD (maraviroc 300 mg BID) 
Atazanavir/ritonavir 300 mg/100 mg 1x dnevno (maravirok 300 mg 2x dnevno)
100 mg twice daily 
100 mg dva puta na dan
Maraviroc Cmax: ↑ 2.67 
Maravirok Cmax:  2,67
Darunavir/ritonavir 600 mg/100 mg BID (maraviroc 150 mg BID) 
Darunavir/ritonavir 600 mg/100 mg 2x dnevno (maravirok 150 mg 2x dnevno)
Zidovudine Cmax: ↔ 0.92 
Zidovudin Cmax:  0,92
Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and mouse bone marrow micronucleus. 
Brojni in vitro i in vivo testovi (uključujući reverznu mutaciju bakterija, kromosomske aberacije u limfocitima čovjeka i mikronukleus koštane srži miša) nisu pokazali postojanje mutagenosti kao niti genotoksičnosti maraviroka.
Maraviroc Cmax: ↑ 2.26 
Maravirok Cmax:  2,26
Maraviroc Cmax: ↔ 0.86 
Maravirok Cmax:  0,86
CELSENTRI 300 mg twice daily should be administered with caution when co-administered with fluconazole. 
Doza lijeka CELSENTRI je 300 mg 2x dnevno kod istodobne primjene s flukonazolom uz pojačani oprez.
Zidovudine AUC12: ↔ 0.98 
Levonorgestrel AUC12:  0,98
Rifampicin 600 mg QD (maraviroc 100 mg BID) 
Rifampicin 600 mg 1x dnevno (maravirok 100 mg 2x dnevno)
Each film-coated tablet contains 150 mg of maraviroc. 
Jedna filmom obložena tableta sadrži 150 mg maraviroka.
Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”. 
Plave, bikonveksne, ovalne filmom obložene tablete približnih dimenzija 4,6 mm x 8,0 mm, s utisnutom oznakom „MVC 25“.
CELSENTRI 300 mg twice daily and sulphamethoxazole/ trimethoprim can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i sulfametoksazol/trimetoprim mogu se istodobno primijeniti bez prilagođavanja doze.
Maraviroc Cmax: ↑ 2.09 
Maravirok Cmax:  2,09
Maraviroc Cmax: ↔ 1.19 
Maravirok Cmax:  1,19
Maraviroc AUC12 ↔ 1.02 
Maravirok AUC12:  1,02
Studies in Treatment-Experienced Paediatric Patients Infected with CCR5-tropic Virus 
Ispitivanja u prethodno liječenih pedijatrijskih bolesnika zaraženih CCR5-tropnim virusom
Each ml of oral solution contains 20 mg maraviroc. 
2. NAVOĐENJE DJELATNE(IH) TVARI Jedan ml oralne otopine sadrži 20 mg maraviroka.
Raltegravir 400 mg BID (maraviroc 300 mg BID) 
Raltegravir 400 mg 2x dnevno (maravirok 300 mg 2x dnevno)
Laboratory abnormalities 
Laboratorijska patološka odstupanja
Lopinavir/ritonavir concentrations not measured, no effect is expected. 
Koncentracije lopinavira/ritonavira nisu određivane, učinak nije očekivan.
CELSENTRI 75 mg film-coated tablets maraviroc 
NAZIV LIJEKA CELSENTRI 75 mg filmom obložene tablete maravirok
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and a PI. 
Doza lijeka CELSENTRI se mora smanjiti na 150 mg dva puta na dan kad se primjenjuje istodobno s etravirinom, u prisutnosti IP.
Maraviroc Cmax: ↑ 1.97 
Maravirok Cmax:  1,97
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with itraconazole. 
Dozu lijeka CELSENTRI treba smanjiti na 150 mg 2x dnevno kod istodobne primjene s itrakonazolom.
Ethinylestradiol 30 mcg QD (maraviroc 100 mg BID) 
Etinilestradiol 30 mcg 1x dnevno (maravirok 100 mg 2x dnevno)
CELSENTRI 300 mg twice daily and raltegravir can be co-administered without dose adjustment. 
CELSENTRI 300 mg dva puta na dan i raltegravir mogu se primjenjivati istodobno bez prilagođavanja doze.
Etravirine 200 mg BID (maraviroc 300 mg BID) 
Etravirin 200 mg 2x dnevno (maravirok 300 mg 2x dnevno)
celsentri 75 mg 
16. PODACI NA BRAILLEOVOM PISMU celsentri 75 mg
AUC: ↔ 1.18 Midazolam. 
AUC:  1,18
Studies in Treatment-Experienced Adult Patients Infected with Non-CCR5-tropic Virus 
Ispitivanja u prethodno liječenih odraslih bolesnika zaraženih virusima koji nisu CCR5-tropni
Studies in Treatment-Experienced Adult Patients Infected with CCR5-tropic Virus 
Ispitivanja u prethodno liječenih odraslih bolesnika zaraženih CCR5-tropnim virusom
Lopinavir/ritonavir 400 mg/100 mg BID (maraviroc 300 mg BID) 
Lopinavir/ritonavir 400 mg/100 mg 2x dnevno (maravirok 300 mg 2x dnevno)
The adverse reactions and laboratory abnormalities presented below are not exposure adjusted. 
Prilikom procjene nuspojava i patoloških laboratorijskih nalaza navedenih u tablicama nisu u obzir uzimane doze lijeka kojima su bolesnici bili izloženi.
Efavirenz, saquinavir/ritonavir concentrations not measured, no effect expected. 
Koncentracije efavirenza, sakvinavira/ritonavira nisu određivane, učinak nije očekivan.
CELSENTRI 300 mg twice daily and digoxin can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i digoksin mogu se istodobno primijeniti bez prilagodbe doze.
Anaemia common 
Anemija često
Fosamprenavir/ritonavir 700 mg/100 mg BID (maraviroc 300 mg BID) 
Fosamprenavir/ritonavir 700 mg/100 mg 2x dnevno (maravirok 300 mg 2x dnevno)
Efavirenz, lopinavir/ritonavir concentrations not measured, no effect expected. 
Koncentracije efavirenza, lopinavira/ritonavira nisu određivane, učinak nije očekivan.
Concomitant use of maraviroc and St. John's Wort or products containing St. John's Wort is not recommended. 
Ne preporučuje se istodobna primjena maraviroka i gospine trave ili proizvoda koji sadrže gospinu travu.
Maraviroc Cmax: ↓ 0.34 
Maravirok Cmax:  0,34
Package leaflet: information for the user CELSENTRI 20 mg /ml oral solution maraviroc 
NAZIV LIJEKA CELSENTRI 20 mg/ml oralna otopina maravirok
Maraviroc AUC12 ↑ 4.88 
Maravirok AUC12:  4,88
Saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID) 
sakvinavir/ritonavir 1000 mg/ 100 mg 2x dnevno (maravirok 100 mg 2x dnevno)
Tel: + 420 222 001 111 cz.info@gsk.com 
Česká republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 cz.info@gsk.com
180 film-coated tablets 
4. FARMACEUTSKI OBLIK I SADRŽAJ 180 filmom obloženih tableta
Liver problems 
Česte nuspojave
Maraviroc Cmax: ↑ 3.38 
Maravirok Cmax:  3,38
Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you (or your child, if they are the patient). 
Da bi procijenio je li CELSENTRI primjeren lijek za Vas (ili Vaše dijete, ako je ono bolesno), liječnik će Vam morati uzeti uzorak krvi.
 chest pain (caused by reduced blood flow to the heart)  decrease in muscle size  some types of cancer, such as of the gullet (oesophagus) and bile duct  decrease in number of blood cells (seen in blood test results). 
• bol u prsnom košu (uzrokovana smanjenim protokom krvi prema srcu)
diarrhoea, fatigue and headache. 
Bol u zglobovima, ukočenost i tegobe s kostima
30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 
4. FARMACEUTSKI OBLIK I SADRŽAJ 90 filmom obloženih tableta.
 feeling dizzy, faint or light headed when standing up  kidney failure, protein in the urine 
• omaglica, nesvjestica ili ošamućenost pri ustajanju
Rare side effects These may affect up to 1 in 1,000 people: 
Mogu se javiti u do 1 na 1000 bolesnika:
• stomach pain or tenderness 
• bol ili osjetljivost u trbuhu
CELSENTRI 25 mg film-coated tablets maraviroc 
NAZIV LIJEKA CELSENTRI 25 mg filmom obložene tablete maravirok
Maraviroc AUC12 ↑ 9.77 
Maravirok AUC12:  9,77
CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i metadon se mogu istodobno primijeniti bez prilagodbe doze.
Virologic Escape 
Virusna rezistencija
Maraviroc Cmax: ↓ 0.49 
Maravirok Cmax:  0,49
Elvitegravir/ritonavir 150/100mg QD (maraviroc 150 mg BID) 
Inhibitori integraze Elvitegravir/ritonavir 150/100 mg 1x dnevno (maravirok 150 mg 2x dnevno)
Saquinavir/ritonavir concentrations not measured, no effect is expected. 
Koncentracije sakvinavira/ritonavira nisu određivane, učinak nije očekivan.
Carton for bottles containing 75 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu koja sadrži maravirok 75 mg filmom obložene tablete
Joint pain, stiffness and bone problems 
• bol u zglobovima, ukočenost i tegobe s kostima
celsentri 300 mg 
16. PODACI NA BRAILLEOVOM PISMU celsentri 300 mg
Carton for bottle containing 25 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu koja sadrži maravirok 25 mg filmom obložene tablete
Recommendations concerning coadministration in adults 
Preporuke pri istodobnoj primjeni s drugim lijekovima u odraslih
Reporting of side effects 
Učinci na koncentraciju djelatne tvari
CELSENTRI 300 mg twice daily and midazolam can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i midazolam se mogu istodobno primijeniti bez prilagođavanja doze.
CELSENTRI dose should be increased to 600 mg twice daily when co-administered with efavirenz in the absence of a potent CYP3A4 inhibitor. 
Dozu lijeka CELSENTRI treba povisiti na 600 mg 2x dnevno kada se primjenjuje istodobno s efavirenzom, a bez IP ili drugih snažnih inhibitora CYP3A4.
Etravirine Cmax: ↔ 1.08 
Etravirin Cmax 1,08 Etravirin C12  0,81
Maraviroc AUC12: ↓ 0.47 
Maravirok AUC12:  4,05
Celsentri 150 mg film-coated tablets maraviroc 
NAZIV LIJEKA CELSENTRI 150 mg filmom obložene tablete maravirok
CELSENTRI 300 mg film-coated tablets maraviroc 
NAZIV LIJEKA CELSENTRI 300 mg filmom obložene tablete maravirok
Celsentri 300 mg film-coated tablets maraviroc 
NAZIV LIJEKA Celsentri 300 mg filmom obložene tablete maravirok
CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i buprenorfin se mogu istodobno primijeniti bez prilagodbe doze.
Pneumonia, oesophageal candidiasis uncommon 
Pneumonija, ezofagealna kandidijaza manje često
Bottle label - 75 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci - 75 mg filmom obložene tablete
celsentri 25 mg 
16. PODACI NA BRAILLEOVOM PISMU celsentri 25 mg
ANTI-INFECTIVES 
• plućna infekcija
Bottle label - 25 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci - 25 mg filmom obložene tablete
CELSENTRI 300 mg twice daily and pegylated interferon can be co-administered without dose adjustment. 
Moguće je istodobno primijeniti CELSENTRI 300 mg 2x dnevno i pegilirani interferon bez prilagodbe doze.
CELSENTRI 300 mg twice daily and levonorgestrel can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i levonorgestrel se mogu istodobno primijeniti bez prilagođavanja doze.
CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment. 
CELSENTRI 300 mg 2x dnevno i statini se mogu istodobno primijeniti bez prilagođavanja doze.
Your doctor will decide the correct dose of CELSENTRI based on weight and on other medicines being taken at the same time. 
Adolescenti i djeca od navršene 2 godine i tjelesne težine od najmanje 10 kg Liječnik će odrediti točnu dozu lijeka CELSENTRI na temelju tjelesne težine i drugih lijekova koji se istodobno primjenjuju.
Symptoms may include:  muscle weakness  weakness beginning in the hands and feet and moving up towards the trunk of the body  palpitations or tremor  hyperactivity (excessive restlessness and movement). 
• slabost koja počinje u šakama i stopalima i širi se prema trupu
celsentri 150 mg 
16. PODACI NA BRAILLEOVOM PISMU celsentri 150 mg
Carton for bottles containing 300 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu koja sadrži maravirok 300 mg filmom obložene tablete
CELSENTRI 300 mg twice daily and ribavirin can be co-administered without dose adjustment. 
Moguće je istodobno primijeniti CELSENTRI 300 mg 2x dnevno i ribavirin bez prilagodbe doze.
Bottle label - 300 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci - 300 mg filmom obložene tablete
Carton for bottles containing 150 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu koja sadrži maravirok 150 mg filmom obložene tablete
Rifampicin concentrations not measured, no effect expected. 
Koncentracije rifampicina nisu određivane, učinak nije očekivan.
Carton for blister pack containing 300 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blister pakiranja koja sadrži filmom obložene tablete od 300 mg maraviroka
Bottle label - 150 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci - 150 mg filmom obložene tablete
Carton for blister pack containing 150 mg maraviroc film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blister pakiranja koja sadrži filmom obložene tablete od 150 mg maraviroka
Maraviroc AUC12 ↑ 3.95 
Maravirok AUC12:  3,95
Cmax: ↔ 1.04 
Digoksin: Cmax:  1,04
Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA <400 copies/mL 
Postotak bolesnika s HIV-1 RNA  400 kopija/ml
Do not open them. 
Nemojte ih otvarati.
Number of subjects at risk Month 
Broj ispitanika pod rizikom Mjesec
Tell your doctor if any of these affect you. 
Obavijestite svog liječnika ako se bilo što od ovoga odnosi na Vas.
The secondary objectives were to compare overall response rate (ORR) and overall survival (OS). 
Sekundarni ciljevi su bili usporediti ukupnu stopu odgovora (ORR) i ukupno preživljenje (OS).
See also section 4 “Possible side effects”. 
Također pogledajte dio 4 “Moguće nuspojave”.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment: 
Odmah se obratite svom liječniku ako primijetite bilo koje od sljedećih nuspojava - možda će Vam biti potrebna hitna medicinska pomoć:
It may help shrink tumours associated with this type of cancer. 
Može pomoći smanjiti tumore povezane s ovom vrstom raka.
Dose reductions are recommended for events that, if persistent, could become serious or intolerable. 
Smanjenje doze se preporučuje u događajima koji, ako potraju, mogu postati ozbiljni ili nepodnošljivi.
The median time to first dose reduction was 43 days, and to first dose interruption was 33 days. 
Medijan vremena do prvog smanjenja doze iznosio je 43 dana, a do prvog prekida doze 33 dana.
Component of a 28 day pack, can't be sold separately. 
Sastojci pakiranja za 28 dana ne mogu se prodavati odvojeno.
For an additional 115 subjects the RET mutational status could not be determined or was unclear. 
Kod preostalih 115 ispitanika RET mutacijski status se nije mogao odrediti ili nije bio dovoljno jasan.
In case of such combination, INR values should be monitored. 
U slučaju takve kombinacije, potrebno je pratiti INR vrijednosti.
To remove the capsules for your dose: 
Da biste izvadili kapsule za svoju dozu:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta.
No specific dosing recommendations can be made. 
Nije moguće dati specifične preporuke o doziranju.
You should continue to take this medicine until your doctor decides to stop your treatment. 
Morate uzimati ovaj lijek dok Vaš liječnik ne odluči prekinuti Vaše liječenje.
The capsules should be swallowed whole and not opened. 
Kapsule se mora progutati cijele i neotvorene.
The clinical significance of these potential interactions is unknown. 
Nije poznat klinički značaj ovih mogućih interakcija.
Depending on the dose you were prescribed, the number of capsules to take are as follows: 
Ovisno o dozi koja vam je propisana, broj kapsula koje trebate uzeti je sljedeći:
COMETRIQ is not recommended for children or adolescents. 
COMETRIQ se ne preporučuje za djecu i adolescente.
Your doctor may also prescribe other medicines to help control your side effects. 
Liječnik Vam također može propisati druge lijekove koji će pomoći kontrolirati nuspojave.
Not Known (unknown frequency) 
Nepoznato (učestalost nije poznata)
The capsule contains an off-white to white powder. 
Kapsula sadrži gotovo bijeli do bijeli prašak.
Do not store above 25°C. 
Ne čuvati na temperaturi iznad 25ºC.
30 September 
30 rujna 2020
Evaluations in juvenile rats (comparable to a <2 year old pediatric population) have not been performed. 
Ispitivanja na mladim štakorima (koji su usporedivi s pedijatrijskom populacijom starosti <2 godine) nisu provedena.
(1/55)c a Response = CR + PR b Disease Control Rate = SD+ ORR c Includes patients who were evaluable for response 
(1/55)c a Odgovor = CR + PR b Stopa kontrole bolesti = SD+ ORR c Uključuje bolesnike koji su bili podobni za odgovor
Two dose reductions were required in 41% of patients. 
U 41% bolesnika bila su potrebna dva smanjenja doze.
The clinical relevance of the observed neoplastic lesions in rats is uncertain, but likely to be low. 
Klinički značaj uočenih neoplastičnih lezija u štakora nije izvjestan, ali je vjerojatno nizak.
COMETRIQ should be taken once a day. 
COMETRIQ se mora uzimati jednom dnevno.
T. Narbuto 5, 
Narbuto 5,
Median Overall Survival 
Medijan ukupnog preživljenja
No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended. 
Nije preporučena specifična prilagodba doze prilikom uporabe kabozantiniba u starijih osoba (≥ 65 godina).
There are no data on human fertility. 
Nema podataka o učinku na ljudsku plodnost.
Date of first authorisation: 21 March 2014 Date of latest renewal: 28 March 2019 
Datum posljednje obnove odobrenja: 28. ožujka 2019.
Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati COMETRIQ - ako ste alergični na kabozantinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
This could mean that your doctor needs to change the dose(s) that you take. 
Vaš liječnik bi prema tome trebao promijeniti dozu(e) koju uzimate.
Push capsule through foil 
Gurnite kapsulu kroz foliju
Your doctor will determine if you need your dose adjusted, particularly during the first eight weeks of therapy with COMETRIQ. 
Vaš liječnik će odlučiti je li potrebno prilagoditi Vašu dozu, naročito tijekom prvih osam tjedana terapije lijekom COMETRIQ.
PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging. 
PVC/PE/PCTFE-Al blisteri s pokrovnom folijom, toplinom zalijepljeni u sekundarno kartično pakiranje.