FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of rilpivirine in antiretroviral treatment-naïve HIV-1 infected adolescent subjects receiving EDURANT 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving EDURANT 25 mg once daily.
Croatian: Pedijatrijska populacija (mlađi od 18 godina starosti) Farmakokinetika rilpivirina u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i koji su primali EDURANT u dozi od 25 mg jedanput dnevno bila je usporediva s onom u odraslih zaraženih virusom HIV-1 koji prethodno nisu bili liječeni te su primali EDURANT u dozi od 25 mg jedanput dnevno.
English: In THRIVE, the BR consisted of 2 investigator-selected N(t)RTIs: tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.
Croatian: U ispitivanju THRIVE, prateće liječenje sastojalo se od 2 N(t)RTI-ja po izboru ispitivača: tenofovir dizoproksil fumarat plus emtricitabin ili zidovudin plus lamivudin ili abakavir plus lamivudin.
English: Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 56 mg laktoze hidrata.
English: Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
Croatian: Famotidin* jedna doza od 40 mg uzeta 4 sata nakon rilpivirina rilpivirin AUC ↑ 13% rilpivirin Cmin NP rilpivirin Cmax ↑ 21%
English: No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze rilpivirina u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Croatian: U ispitivanju ECHO, prateće liječenje bilo je fiksirano na N(t)RTI-je, tenofovir dizoproksil fumarat plus emtricitabin.
English: Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Croatian: Famotidin* jedna doza od 40 mg uzeta 2 sata prije rilpivirina rilpivirin AUC ↓ 76% rilpivirin Cmin NP rilpivirin Cmax ↓ 85%
English: (Hypericum perforatum)
Croatian: BILJNI PRIPRAVCI gospina trava (Hypericum perforatum)
English: Laboratory abnormalities
Croatian: Laboratorijski poremećaji
English: 400 mg once daily didanosine AUC ↑ 12% didanosine Cmin NA didanosine Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Croatian: 400 mg jedanput dnevno didanozin AUC ↑ 12% didanozin Cmin NP didanozin Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Croatian: Deksametazon (za sustavnu primjenu, osim za primjenu jedne doze)
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Croatian: pojavilo se 24 (3,5%) i 14 (2,1%) dodatnih viroloških neuspjeha u skupini ispitanika liječenih rilpivirinom odnosno efavirenzom.
English: When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25 mg once daily.
Croatian: Nakon prestanka istodobne primjene s rifabutinom, doza rilpivirina mora se smanjiti na 25 mg jedanput dnevno
English: This observation was the same in the efavirenz arm.
Croatian: Isto je primijećeno u skupini koja je primala efavirenz.
English: HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
Croatian: Nepojačani inhibitori proteaze (atazanavir, fosamprenavir, indinavir, nelfinavir)
English: Discontinued for non-AE reason
Croatian: Prekid liječenja zbog nekog drugog razloga a ne nuspojave
English: edurant 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU edurant 25 mg
English: A strict dosing schedule, with intake of H2-receptor antagonists at least 12 hours before or at least 4 hours after rilpivirine should be used.
Croatian: H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon rilpivirina.
English: A risk for increases in dabigatran plasma concentrations cannot be excluded.
Croatian: Ne može se isključiti rizik za povećanja koncentracije dabigatrana u plazmi. (inhibicija crijevnog P-gp)
English: Tell your doctor immediately if you are pregnant or if you plan to become pregnant.
Croatian: Ako ste trudni ili planirate imati dijete, odmah o tome obavijestite liječnika.
English: Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Croatian: Jedna tableta EDURANTA sadrži 25 mg rilpivirina u obliku rilpivirinklorida.
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.
Croatian: Antacidi se smiju primijeniti najmanje 2 sata prije ili najmanje 4 sata poslije rilpivirina.
English: There is limited information regarding the use of EDURANT in patients > 65 years of age.
Croatian: > 65 godina postoje ograničeni podaci.
English: The combination of rilpivirine and H2-receptor antagonists should be used with particular caution.
Croatian: H2-receptora treba primjenjivati s posebnim oprezom.
English: In the pooled analysis for ECHO and THRIVE, demographics and baseline characteristics were balanced between the rilpivirine arm and the efavirenz arm. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.
Croatian: U analizi objedinjenih podataka iz ispitivanja ECHO i THRIVE, demografske i početne značajke bile su ravnomjerno raspoređene između skupine koja je primala rilpivirin i skupine koja je primala efavirenz.
English: At week 96, the mean change from baseline in CD4+ cell count was +228 × 10
Croatian: U analizi objedinjenih podataka u 96. tjednu ispitivanja ECHO i THRIVE, srednja promjena broja stanica CD4+ u odnosu na početne vrijednosti iznosila je +228 × 10
English: 25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
Croatian: 300 mg jedanput dnevno rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-dezacetil-rifabutin AUC ↔ 25-O-dezacetil-rifabutin Cmin ↔ 25-O-dezacetil-rifabutin Cmax ↔
English: 6 cells/l Percentage of subjects with: hepatitis B/C virus co-infection Percentage of patients with the following background regimens: tenofovir disoproxil fumarate plus emtricitabine zidovudine plus lamivudine abacavir plus lamivudine
Croatian: Postotak bolesnika na sljedećim osnovnim režimima: tenofovir dizoproksil fumarat plus emtricitabin zidovudin plus lamivudin abakavir plus lamivudin
English: ANTIMYCOBACTERIALS Rifabutin*
Croatian: Rifabutin*
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Croatian: Kad su u zdravih odraslih ispitanika ispitivane doze rilpivirina više od preporučenih, 75 mg jedanput dnevno odnosno 300 mg jedanput dnevno, maksimalne srednje vremenski usklađene (95% gornja granica pouzdanosti) razlike u QTcF intervalu u odnosu na placebo nakon početne korekcije bile su
English: Interaction Geometric mean change (%)
Croatian: Geometrijska sredina promjene
English: These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Croatian: Ove mutacije povezane s rezistencijom na rilpivirin trebaju služiti samo kao smjernice u primjeni EDURANTA u bolesnika koji prethodno nisu bili liječeni.
English: ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Croatian: Nukleozidni i nukleotidni inhibitori reverzne transkriptaze (NRTI / N[t]RTI) HIV-a Didanozin*
English: Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.
Croatian: Zbog nuspojava, u 96. tjednu, bilo je više prekida liječenja u skupini liječenoj efavirenzom nego u skupini liječenoj rilpivirinom.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Croatian: Podaci o primjeni rilpivirina u trudnica (vidjeti dijelove 4.4, 5.1 i 5.2) su ograničeni (manje od 300 trudnoća).
English: rilpivirine AUC ↑ 16%* rilpivirine Cmin ↔* rilpivirine Cmax ↑ 43%*
Croatian: rilpivirin AUC ↑ 16%* rilpivirin Cmin ↔* rilpivirin Cmax ↑ 43%* * u usporedbi s 25 mg rilpivirina samog,
English: Study TMC278-C204 enrolled 368 HIV-1 infected treatment-naïve adult patients who had a plasma HIV-1 RNA ≥ 5,000 copies/ml, previously received ≤ 2 weeks of treatment with an N(t)RTI or protease inhibitor, had no prior use of NNRTIs and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Croatian: Ispitivanje TMC278-C204 uključilo je 368 odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni i imali su u plazmi HIV-1 RNK ≥ 5 000 kopija/ml, prethodno su primali
English: Rilpivirine should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Croatian: Rilpivirin se ne smije primjenjivati u kombinaciji s deksametazonom za sustavnu primjenu (osim kao jednostruke doze), jer istovremena primjena može rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
English: No dose adjustment of EDURANT is required in patients with mild or moderate hepatic impairment.
Croatian: Prilagodba doze EDURANTA nije potrebna u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Resistance to emtricitabine/lamivudine % (n/N)
Croatian: Liječeni efavirenzom Rezistencija na emtricitabin/lamivudin % (n/N)
English: Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 25 mg rilpivirina u obliku rilpivirinklorida.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOČICI
English: 800/100 mg once daily darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
Croatian: Inhibitori proteaze (IP) HIV-a - uz istovremenu primjenu niske doze ritonavira Darunavir/ritonavir* 800/100 mg jedanput dnevno darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79%
English: 50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5) Sildenafil* jedna doza od 50 mg sildenafil AUC ↔ sildenafil Cmin NP sildenafil Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Croatian: Tablica 3: Početne značajke bolesti u odraslih ispitanika zaraženih s HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanjima ECHO i THRIVE (analiza objedinjenih podataka) Objedinjeni podaci iz ispitivanja ECHO i THRIVE Rilpivirin + BR N = 686
English: Triacetin
Croatian: ANTACIDI
English: At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.
Croatian: Prilagodba doze nije potrebna, kad se rilpivirin primjenjuje u preporučenoj dozi od 25 mg jedanput dnevno istovremeno s ketokonazolom.
English: Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Croatian: Rilpivirin se ne smije primjenjivati u kombinaciji s inhibitorima protonske pumpe, jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
English: The bottle comes with a child resistant cap.
Croatian: Otvaranje sigurnosnog zatvarača za djecu Boca ima sigurnosni zatvarač za djecu.
English: Rilpivirine must not be used in combination with these anticonvulsants as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Croatian: Rilpivirin se ne smije primjenjivati u kombinaciji s ovim antikonvulzivima, jer njihova istovremena primjena može dovesti do gubitka terapijskog učinka rilpivirina (vidjeti dio 4.3).
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Croatian: Prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega nije potrebna.
English: Dose dependent decreases in rilpivirine plasma concentrations are expected.
Croatian: Očekuju se smanjenja koncentracije rilpivirina u plazmi ovisna o dozi. (indukcija enzima CYP3A)
English: Cardiovascular
Croatian: ANTIDIJABETICI
English: Increased exposure of rilpivirine is expected.
Croatian: Očekuje se povećana izloženost rilpivirinu. (inhibicija enzima CYP3A)
English: Contact your doctor if uncertain about what to do if you miss a dose or vomit.
Croatian: Ako niste sigurni što učiniti u slučaju da zaboravite uzeti dozu ili povraćate, obratite se svom liječniku.
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole
Croatian: Pantoprazol Esomeprazol
English: Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Croatian: Rilpivirin se ne smije primjenjivati u kombinaciji s rifampicinom, jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
English: No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Croatian: Kad se započinje primjena metadona istovremeno s rilpivirinom, nije potrebna prilagodba doze.
English: HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
Croatian: Inhibitori proteaze (IP) HIV-a - bez istovremene primjene niske doze ritonavira
English: Zidovudine/lamivudine
Croatian: Nuspojave (Rilpivirin + BR)
English: Rilpivirine must not be used in combination with rifapentine as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Croatian: Rilpivirin se ne smije primjenjivati u kombinaciji s rifapentinom jer će istovremena primjena vjerojatno rezultirati gubitkom terapijskog učinka rilpivirina (vidjeti dio 4.3).
English: Silicified microcrystalline cellulose Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat karmelozanatrij, umrežena povidon K30 polisorbat 20 mikrokristalična celuloza, silicirana magnezijev stearat
English: Resistance to efavirenz % (n/N) * The number of patients with virologic failure and paired genotypes (baseline and failure) were 71, 11, and 4 for rilpivirine and 30, 10,
Croatian: Broj bolesnika s virološkim neuspjehom i sparenim genotipom (početni i neuspjeh) iznosio je 71 uz tenofovir/emtricitabin, 11 uz zidovudin/lamivudin i 4 uz abakavir/lamivudin u skupini koja je primala rilpivirin te 30 uz tenofovir/emtricitabin, 10 uz zidovudin/lamivudin i 2 uz abakavir/lamivudin u skupini koja je primala efavirenz.
English: Idelvion albutrepenonacog alfa
Croatian: Idelvion albutrepenonakog alfa
English: It must also not be used in patients allergic to hamster proteins.
Croatian: Također se ne smije upotrebljavati u bolesnika alergičnih na proteine hrčka.
English: This is a summary of the European public assessment report (EPAR) for Idelvion.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Idelvion.
English: Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) mogu se rijetko pojaviti tijekom primjene lijeka Idelvion te obuhvaćaju: oticanje, žarenje i peckanje na mjestu injekcije, zimicu, navalu crvenila, osip praćen svrbežom, glavobolju, koprivnjaču, niski krvni tlak, letargiju, mučninu i povraćanje, nemir, brzo kucanje srca, stezanje u prsima i piskanje pri disanju.
English: In a study in 80 adults and adolescents and another study in 27 children aged less than 12 years, Idelvion was effective at preventing bleeding, with most patients experiencing no bleeding while on preventive treatment.
Croatian: U ispitivanju provedenom na 80 odraslih i adolescenata te drugom ispitivanju provedenom na 27 djece mlađe od 12 godina, Idelvion je bio učinkovit u sprečavanju krvarenja, pri čemu većina bolesnika nije krvarila tijekom preventivnog liječenja.
English: Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.
Croatian: Nadalje, Idelvion je bio učinkovit u liječenju epizoda krvarenja kada je do njih došlo; otprilike 93 % epizoda krvarenja zaustavljeno je jednom injekcijom lijeka Idelvion.
English: What measures are being taken to ensure the safe and effective use of Idelvion?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Idelvion?
English: Other information about Idelvion
Croatian: Ostale informacije o lijeku Idelvion
English: The full EPAR for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Idelvion nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Idelvion was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Croatian: Budući da je broj bolesnika s hemofilijom B nizak, bolest se smatra „rijetkom” te se Idelvion označava kao lijek za liječenje rijetkih bolesti od 4. veljače 2010.
English: Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or other ingredients of the medicine.
Croatian: Idelvion se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar ili druge sastojke lijeka.
English: Idelvion is available as powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Idelvion je dostupan kao prašak i otapalo koji se miješaju kako bi se pripremila otopina za injekciju u venu.
English: A risk management plan has been developed to ensure that Idelvion is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Idelvion.
English: Why is Idelvion approved?
Croatian: Zašto je Idelvion odobren?
English: Idelvion can only be obtained with a prescription, and treatment should be supervised by a doctor with experience in treating haemophilia.
Croatian: Idelvion se izdaje samo na liječnički recept, a liječenje treba nadzirati liječnik s iskustvom u liječenju hemofilije.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Idelvion dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Idelvion and what is it used for?
Croatian: Što je Idelvion i za što se koristi?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Idelvion nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is not intended to provide practical advice on how to use Idelvion.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Idelvion.
English: What are the risks associated with Idelvion?
Croatian: Koji su rizici povezani s lijekom Idelvion?
English: Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Croatian: U nekih bolesnika koji uzimaju lijekove za faktor IX također se mogu razviti inhibitori (protutijela) faktora IX koji zaustavljaju djelovanje lijeka i dovode do gubitka kontrole krvarenja.
English: For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije o upotrebi ovog lijeka pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: For more information about treatment with Idelvion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Idelvion pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Croatian: Bolesnicima s hemofilijom B nedostaje faktor IX, bjelančevina potrebna za normalno zgrušavanje krvi, pa stoga lako krvare.
English: The dose and the frequency of the injections depend on the patient's bodyweight and whether Idelvion is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Croatian: Doza i učestalost ubrizgavanja injekcijom ovise o tome koristi li se Idelvion za liječenje ili sprečavanje krvarenja te o težini manjka faktora IX u bolesnika, količini i mjestu krvarenja te dobi i zdravstvenom stanju bolesnika.
English: Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Croatian: Lijekovi za liječenje nedostatka faktora IX također potencijalno mogu prouzročiti probleme zbog stvaranja krvnih ugrušaka u krvnim žilama.
English: Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Croatian: Idelvion je lijek koji se koristi za sprečavanje i liječenje krvarenja u bolesnika s hemofilijom B, nasljednim poremećajem krvarenja prouzročenim manjkom proteina za zgrušavanje krvi koji se naziva faktor IX. Može se primjenjivati u bolesnika svih dobi.
English: For practical information about using Idelvion, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Idelvion pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Idelvion used?
Croatian: Kako se Idelvion koristi?
English: Idelvion contains the active substance albutrepenonacog alfa.
Croatian: Lijek sadrži djelatnu tvar albutrepenonakog alfa.
English: What benefits of Idelvion have been shown in studies?
Croatian: Koje su koristi lijeka Idelvion utvrđene u ispitivanjima?
English: How does Idelvion work?
Croatian: Kako djeluje Idelvion?
English: For the full list of side effects reported with Idelvion, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Idelvion potražite u uputi o lijeku.