FrancophonIA/ELRC3.0 huggingface dataset:
English: 250 mg single dose
Croatian: karisoprodo l 250 mg pojedinačna doza
English: ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Croatian: ombitasvir/paritaprevir/ritonavir s dasabuvirom ili bez njega tijekom 12 ili 24 tjedna, u kombinaciji s ribavirinom doziranim prema tjelesnoj težini ili bez njega
English: Phenobarbita l
Croatian: Fenobarbita l
English: Film-coating
Croatian: Film ovojnica:
English: Caution should be used when sulfasalazine is co-administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Sulfasalazin se mora primjenjivati s oprezom istodobno s dasabuvirom + ombitasvir/paritaprevir/rito navir.
English: Without cirrhosis
Croatian: Bez ciroze
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection
Croatian: Namjena lijeka karbamazepin, fenitoin, fenobarbital za liječenje epilepsije efavirenz, etravirin, nevirapin za liječenje HIV infekcije apalutamid, enzalutamid za rak prostate lijekovi koji sadrže etinilestradiol, poput većine lijekova za sprječavanje začeća i vaginalni kontracepcijski prstenovi.
English: SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
Croatian: SAPPHIRE-I - prethodno neliječeni ispitanici s infekcijom genotipom 1, bez ciroze Dizajn:
English: Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (2 g/kg/day), resulting in dasabuvir AUC exposures approximately 19-fold higher than those in humans at the recommended dose of 500 mg (250 mg twice daily).
Croatian: 6-mjesečnom istraživanju na transgeničnim miševima, dasabuvir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (2 g/kg/dan), koja je dovela do približno 19 puta veće izloženosti dasabuviru
English: Hepatic impairment
Croatian: Dabigatrane teksilat
English: Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Croatian: Za dodatne upute o doziranju i praćenju, pročitajte sažetak opisa svojstava lijeka za takrolimus ili sirolimus.
English: dasabuvir and ombitasvir/paritaprevir /ritonavir
Croatian: dasabuvir i ombitasvir/paritaprevir/ritonavir
English: Mechanism: CYP3A4 induction by phenytoin.
Croatian: Mehanizam: indukcija CYP3A4 fenobarbital om.
English: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported post-marketing in patients treated with dasabuvir with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih dasabuvirom u kombinaciji s ombitasvirom/ paritaprevirom /ritonavirom te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili transplantacijom jetre ili smrtnim ishodom.
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Croatian: SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1b u ispitivanju
English: Prior pegIFN/RBV relapser
Croatian: Djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV
English: No dose adjustment is necessary for methadone and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za metadon i dasabuvir + ombitasvir/paritaprevir/rito
English: ↑ hydrocod one
Croatian: ↑ hidrokodon 1,27
English: CYP3A4 inhibition by ritonavir.
Croatian: učinak na takrolimus posljedica je inhibicije CYP3A4 ritonavirom.
English: Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with dasabuvir with ombitasvir/paritaprevir/ritonavir.
Croatian: Iako je dasabuvir in vitro inhibitor P-gp-a, nije primijećena značajna promjena izloženosti digoksinu,
English: aprevir/ ritonavi r ombitasvir with dasabuvir and ombitasvir/paritaprevir/r itonavir due to increase in paritaprevir exposures (see Summary of Product Characteristics of ombitasvir/paritaprevir/r itonavir).
Croatian: paritaprevir om/ritonavirom zbog povišenja izloženosti paritapreviru (vidjeti sažetak opisa svojstava lijeka ombitasvir/paritaprevir/rito navir ).
English: Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Croatian: Mjera ishoda dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna N = 200a
English: NA No dose adjustment needed for abacavir or lamivudine when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: NP Nije potrebno prilagođavati dozu abakavira ili lamivudina kada se primjenjuju s dasabuvirom + ombitasvir/paritaprevir/rito navir.
English: Exviera contains lactose.
Croatian: Exviera sadrži laktozu.
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim ombitasvir
Croatian: povećanje izloženosti dasabuviru kao moguća posljedica inhibicije CYP2C8 trimetoprim om dasabuvir ombitasvir/p aritaprevir/ri tonavir
English: Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Croatian: Postojanost odgovora Ukupno je 660 ispitanika u kliničkim ispitivanjima faze 2 i 3 postiglo željene razine HCV RNK i u trenutku određivanja SVR12 i u trenutku određivanja SVR24.
English: No dose adjustment is necessary for emtricitabine/tenofovir and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za emtricitabin/tenofovir i dasabuvir +
English: Apalutamide
Croatian: lamivudin
English: Dasabuvir and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Croatian: U bolesnika s transplantiranom jetrom preporuča se primjena dasabuvira i ombitasvira/paritaprevira/ritonavira u kombinaciji s ribavirinom tijekom 24 tjedna.
English: Mechanism: Unknown dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Croatian: Mehanizam: nepoznat dasabuvir ombitasvir/ paritaprevir /ritonavir
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Croatian: PEARL-IV - prethodno neliječeni ispitanici s infekcijom genotipom 1a, bez ciroze Dizajn:
English: Metabolism and nutrition disorders Uncommon Dehydration Psychiatric disorders Very common Insomnia Gastrointestinal disorders Very common Nausea, Diarrhoea Common
Croatian: Poremećaji jetre i žuči nepoznata učestalost dekompenzacija jetre i zatajenje jetre dekompenzacija jetre i zatajenje jetre
English: ↓ dasabuvir ↓ paritaprevir ↓ ombitasvir
Croatian: ↓ dasabuvir ↓ ombitasvir
English: Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir dasabu vir +
Croatian: Mehanizam: BCRP i Pgp inhibicija paritaprevir om, ritonavirom i dasabuviro m dasabuvir ombitasvir/ paritaprevir /ritonavir
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Croatian: Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,1% imalo je početnu razinu
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Croatian: imalo je početne razine HCV RNK od najmanje 800 000 IU/ml; 15,4% imalo je portalnu fibrozu (F2), a 8,7% premoštavajuću fibrozu (F3); 67,7% imalo je infekciju HCV-om genotipa 1a; 32,3% imalo je infekciju HCV-om genotipa 1b.
English: open-label, single-arm, global multicentre
Croatian: otvoreno, globalno, multicentrično ispitivanje s jednom skupinom
English: - Notice yellowing of your skin or eyes.
Croatian: - primjetite žutilo kože ili očiju - mokraća Vam je tamnija nego inače - smetenost
English: Mechanism: OATP1B1 inhibition by paritaprevir.
Croatian: Mehanizam: paritaprevir inhibira OATP1B1
English: A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
Croatian: Promjene za dasabuvir i ombitasvir, paritaprevir su iste kao što je prikazano iznad za paracetamol hidrokodona za 50% i/ili kliničko praćenje kada se primjenjuje s dasabuvirom ombitasvir/paritaprevir/rito navir.
English: No dose adjustment is necessary for norethindrone or dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu noretindrona ili dasabuvira ombitasvir/paritaprevir/rito navir.
English: Posology
Croatian: Pravastatin
English: Tel.: +48 22 372 78 00
Croatian: AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
English: For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Croatian: Za kontraindikacije ombitasvira/ paritaprevira /ritonavira vidjeti njihov sažetak opisa svojstava lijeka.
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failure Post-treatment relapse Otherb a. Includes all HCV GT1 subjects in Part 2 excluding Arm G subjects that did not receive recommended regimen.
Croatian: SVR12, n/N (%) [95% CI] Ishod za ispitanike koji nisu postigli SVR12
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir dasabu vir +
Croatian: Mehanizam: smanjenje kao moguća posljedica indukcije CYP1A2 ritonavirom dasabuvir ombitasvir/p aritaprevir/ri tonavir ciklobenzapri n
English: SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Croatian: Tablica 9. SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1a u ispitivanju
English: • Vomiting
Croatian: • povraćanje.
English: ↑ naloxone
Croatian: Lanzoprazol
English: Hepatic decompensation and hepatic failure
Croatian: Virološki neuspjeh tijekom liječenja
English: 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
Croatian: HCV-om genotipa 1a; 31,3% imalo je infekciju HCV-om genotipa 1b.
English: 30 mg once daily single dose3
Croatian: Ciklosporin 30 mg jednom dnevno u pojednačnoj dozi3 Mehanizam:
English: ↔ R
Croatian: (INR).
English: Sirolimus
Croatian: Dojenje
English: Immune system disorders Frequency unknown
Croatian: Poremećaji imunološkog sustava nepoznata učestalost anafilaktičke reakcije anafilaktičke reakcije
English: For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Croatian: Za interakcije s ombitasvirom/ paritaprevirom/ritonavirom vidjeti sažetak opisa svojstava lijeka.
English: No dose adjustment is necessary for buprenorphine/naloxon e and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za buprenorfin/nalokson i dasabuvir + ombitasvir/paritaprevir/rito navir.
English: Angioedema
Croatian: DIURETICI Furosemid
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks
Croatian: dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 8 tjedana
English: Upon completion of dasabuvir and ombitasvir/paritaprevir/ ritonavir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
Croatian: odgovarajuću dozu i učestalost primjene takrolimusa treba odrediti na temelju koncentracija takrolimusa u krvi.
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir dasabuvi r + ombitas vir/parit aprevir/r itonavir dolutegravir
Croatian: Mehanizam: inhibicija Pgp-a koju uzrokuju dasabuvir, paritaprevir i ritonavir dasabuvir ombitasvir/ paritaprevir /ritonavir
English: No dose adjustment is necessary for raltegravir or dasabuvir ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za raltegravir ili dasabuvir + ombitasvir/paritaprevir/rito navir.
English: ↑ levothyroxine
Croatian: ↑ fluvastatin ↑ pitavastatin
English: SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Croatian: SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1 u ispitivanju
English: dasabuvir and ombitasvir/paritaprevir/ritonavir with or without RBV for 12 or 24 weeks
Croatian: dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna
English: ↑ norbu prenorphine
Croatian: ↑ norbupre norfin
English: CYP2C8 inhibition and increase in paritaprevir is possibly due to
Croatian: povećanje izloženosti dasabuviru posljedica je inhibicije CYP2C8 a povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije OATP1B1 gemfibrozil om.
English: With RBV
Croatian: RMP-a.
English: Treatment-naïve and peginterferon+ribavirin-experienced, with compensated cirrhosis
Croatian: Prethodno neliječeni ispitanici i ispitanici prethodno liječeni kombinacijom peginterferon +
English: Laboratory abnormalities
Croatian: Odstupanja u laboratorijskim vrijednostima
English: 0.5 mg single dose5
Croatian: Sirolimus 0,5 mg pojedinačna doza5 Mehanizam:
English: Mechanism: OATP1B inhibition by paritaprevir.
Croatian: Mehanizam: paritaprevir inhibira OATP1B
English: ↔ S
Croatian: U
English: NA No dose adjustment needed for sofosbuvir when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
Croatian: NP Nije potrebno prilagođavati dozu sofosbuvira kada se primjenjuje s dasabuvirom ombitasvir/paritaprevir/rito navir.
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Croatian: 300/100 mg jedanput na dan dasabuvir ombitasvir/ paritaprevir /ritonavir
English: tenofovir dasabuvir ombitasvir paritaprevir
Croatian: Emtricitabin / tenofovir dasabuvir ombitasvir/ paritaprevir emtricitabin
English: Mechanism: CYP2C19 induction by ritonavir dasabu vir +
Croatian: Mehanizam: CYP2C19 indukcija ritonavirom dasabuvir ombitasvir/p aritaprevir/ri tonavir
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Croatian: skupina A: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV (12 tjedana) skupina B: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV (24 tjedna)
English: paritaprevir the same time as dasabuvir +ombitasvir/paritaprevi r/ritonavir.
Croatian: Učinak na dasabuvir ombitasvir/ paritaprevi r/ ritonavir
English: Retreatment
Croatian: KONTRACEPTIVI
English: ↔ digoxin 1.15
Croatian: ↔ R-metadon 1,04
English: ANTICOAGULANTS Warfarin
Croatian: ANTIKOAGULANSI
English: No dose adjustment needed for dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za dasabuvir + ombitasvir/paritaprevir/rito navir.
English: Axumin fluciclovine (
Croatian: Axumin fluciklovin (
English: The side effects seen with the product are mild and rare, and there are no serious safety risks.
Croatian: Nuspojave proizvoda rijetke su i blage i ne postoje nikakvi ozbiljni sigurnosni rizici.
English: The full EPAR for Axumin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Axumin nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Axumin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Axumin?
English: Other information about Axumin
Croatian: Ostale informacije o lijeku Axumin
English: This is a summary of the European public assessment report (EPAR) for Axumin.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Axumin.
English: Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.
Croatian: Axumin je dostupan u obliku otopine za injekciju koja se daje u venu otprilike 3 do 5 minuta prije nego što se bolesnika podvrgne PET snimanju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Axumin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi lijeka Axumin nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection.
Croatian: Najčešće nuspojave lijeka Axumin (zabilježene kod 1 do 10 bolesnika od 100) su poremećaji okusa, izmijenjen osjet njuha i bolovi ili osip na mjestu injekcije.
English: Axumin is a ‘radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.
Croatian: Axumin je „radiofarmaceutik”: sadrži djelatnu tvar fluciklovin (18F) koja ispušta malu količinu radioaktivnog zračenja.
English: Why is Axumin approved?
Croatian: Zašto je Axumin odobren?
English: PET scans with Axumin are effective in detecting prostate cancer and can help exclude the presence of the cancer.
Croatian: PET snimanja uz korištenje lijeka Axumin učinkovita su u utvrđivanju raka prostate i mogu pomoći pri isključivanju prisutnosti raka.
English: Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.
Croatian: Axumin ispušta vrlo malu količinu radioaktivnog zračenja, što može predstavljati vrlo mali rizik pojave raka ili nasljednih poremećaja.
English: All men enrolled in this study had already shown some signs that the cancer might have returned, such as increases in blood levels of PSA, a protein produced in the prostate glands.
Croatian: Kod svih muškaraca u ovom ispitivanju javili su se neki znakovi da se rak možda vratio, kao što je povećana razina bjelančevine PSA u krvi koja se proizvodi u žlijezdama prostate.
English: The company that markets Axumin will ensure that all healthcare professional expected to use this product have access to education material to reduce errors in interpreting PET scan images.
Croatian: Tvrtka koja stavlja lijek Axumin na tržište osigurat će da svi zdravstveni radnici koji bi trebali koristiti ovaj proizvod dobiju obrazovne materijale kako bi se smanjile pogreške pri iščitavanju PET snimaka.
English: It is not intended to provide practical advice on how to use Axumin.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Axumin.
English: What is Axumin and what is it used for?
Croatian: Što je Axumin i za što se koristi?
English: Axumin is a diagnostic medicine used with a body scan to check whether or not prostate cancer has returned.
Croatian: Axumin je dijagnostički lijek koji se koristi u kombinaciji sa skeniranjem tijela radi provjere je li se rak prostate vratio ili ne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Axumin have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Axumin nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Once inside the cancer cells, it emits radiation which is detected on the PET scan, enabling doctors to see where the cancer is located.
Croatian: Nakon što uđe u stanice raka, djelatna tvar ispušta radioaktivno zračenje koje se bilježi na PET snimci, što liječnicima omogućuje da vide gdje se rak nalazi.
English: For more information about treatment with Axumin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Axumin pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells.
Croatian: Djelatna tvar u lijeku Axumin, fluciklovin (18F), ispušta malu količinu radioaktivnog zračenja i djeluje na način da ulazi u stanice raka prostate preko struktura (LAT-1 i ASCT2) koje se nalaze u velikom broju na površini tih stanica.
English: It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.
Croatian: Točnije, koristi se prilikom skeniranja tijela metodom snimanja pozitronskom emisijskom tomografijom (PET) u muškaraca kod kojih krvni test na antigen karakterističan za prostatu (PSA) pokazuje moguću prisutnost raka.
English: What are the risks associated with Axumin?
Croatian: Koji su rizici povezani s lijekom Axumin?
English: In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling).
Croatian: U glavnom ispitivanju koje je uključivalo medicinske zapise 115 muškaraca, PET snimke uz korištenje lijeka Axumin koje su pokazale da se rak kod bolesnika vratio bile su točne u 79 % slučajeva, što je kasnije potvrđeno laboratorijskim ispitivanjima tkiva.
English: For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Axumin bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: What benefits of Axumin have been shown in studies?
Croatian: Koje su koristi od lijeka Axumin dokazane u ispitivanjima?
English: For the full list of side effects and restrictions reported with Axumin, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Axumin potražite u uputi o lijeku.
English: How is Axumin used?
Croatian: Kako se Axumin koristi?
English: How does Axumin work?
Croatian: Kako djeluje Axumin?
English: Furthermore, the risk from radiation is very low.
Croatian: Osim toga, rizik od zračenja vrlo je nizak i liječnicima se preporučuje da koriste najmanje potrebne doze.
English: The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin.
Croatian: Rezultate snimanja mora iščitati zdravstveni radnik osposobljen za tumačenje PET snimaka.
English: Axumin can only be obtained with a prescription.
Croatian: Axumin se izdaje samo na recept, a PET snimanje mora provoditi odgovarajuće kvalificirani zdravstveni radnik.
English: 1 pre-filled syringe with needle safety guard
Croatian: Veličina pakovanja napunjena štrcaljka (staklo) sa sigurnosnim štitnikom za iglu napunjena štrcaljka (staklo) sa sigurnosnim štitnikom za iglu
English: Pharmaceutical form Route of administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: 18 September 2013
Croatian: 18. rujna 2013.