FrancophonIA/ELRC3.0 huggingface dataset:
English: Most rejections occurred within the first six months following conversion and were mild in severity; no graft losses were reported during the study (see section 4.4).
Croatian: Većina odbacivanja dogodila se unutar prvih šest mjeseci nakon prelaska i bila su manje teška; tijekom ispitivanja nisu prijavljeni gubitci presadaka (vidjeti dio 4.4).
English: In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Croatian: Općenito, nuspojave predoziranja odgovaraju onima navedenima u dijelu 4.8.
English: The use of Rapamune is not recommended in this population.
Croatian: Ne preporučuje se primjenjivati Rapamune u ove populacije.
English: If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin.
Croatian: Ako ste zaboravili uzeti Rapamune, uzmite ga čim se sjetite, ali ne ako do sljedeće doze ciklosporina ima manje od 4 sata.
English: Rapamune contains ethanol (alcohol)
Croatian: Rapamune sadrži etanol (alkohol)
English: Since results are assay and laboratory dependent, and the results may change over time, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used.
Croatian: Budući da rezultati ovise o metodi i laboratoriju i da se rezultati mogu mijenjati tijekom vremena, prilagodba doze ciljnom terapijskom rasponu mora biti učinjena uz detaljno poznavanje specifičnosti metode koja je upotrijebljena.
English: Use within 30 days after opening bottle.
Croatian: Primijeniti u roku od 30 dana nakon otvaranja boce.
English: Do not crush, chew, or split the tablets.
Croatian: Nemojte drobiti, žvakati niti lomiti tablete.
English: This leaflet was last revised in MM/YYYY
Croatian: Uputa je zadnji puta revidirana u MM/GGGG
English: Always take the labelled blister with you, even if it is empty.
Croatian: Obavezno ponesite sa sobom blister s naljepnicom, čak i ako je prazan.
English: The efficacy and safety data are too limited to allow specific recommendations for use of sirolimus in Black recipients.
Croatian: Trenutno su podaci o djelotvornosti i sigurnosti previše ograničeni da bi se mogle dati posebne preporuke za primjenu sirolimusa u primatelja crne rase.
English: Immunosuppressants may affect response to vaccination.
Croatian: Imunosupresivi mogu utjecati na odgovor na cijepljenje.
English: Always take the labelled medicine bottle with you, even if it is empty.
Croatian: Obavezno ponesite sa sobom bocu lijeka s naljepnicom, čak i ako je prazna.
English: Rapamune should be given with corticosteroids.
Croatian: Rapamune se mora davati s kortikosteroidima.
English: Hepatoxicity has been reported.
Croatian: Zabilježena je hepatotoksičnost.
English: You may have been instructed to take your Rapamune oral solution at a particular time of day.
Croatian: Možda su Vam dali uputu da uzimate oralnu otopinu Rapamune u određeno doba dana.
English: Grapefruit juice should be avoided (see section 4.5).
Croatian: Mora se izbjegavati sok od grejpa (vidjeti dio 4.5).
English: Rapamune should not be taken with grapefruit juice.
Croatian: Rapamune se ne smije uzimati sa sokom od grejpa.
English: S-LAM is a rare progressive lung disease that affects predominantly women of childbearing age.
Croatian: S-LAM je rijetka progresivna plućna bolest koja se pretežno javlja u žena koje su u dobi kada mogu zatrudnjeti.
English: If you take more Rapamune than you should
Croatian: Ako uzmete više lijeka Rapamune nego što ste trebali
English: The inhibition of mTOR results in blockage of several specific signal transduction pathways.
Croatian: Inhibicija mTOR-a dovodi do blokade nekoliko specifičnih puteva prijenosa signala.
English: Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart.
Croatian: Jednokratna doza sirolimusa nije utjecala na farmakokinetiku ciklosporina (mikroemulzije) u zdravih dobrovoljaca kad je davana istodobno ili u razmaku od 4 sata.
English: Talk to your doctor or pharmacist before taking Rapamune
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Rapamune
English: Pale yellow to yellow solution.
Croatian: Blijedožuta do žuta otopina.
English: The blood to plasma ratio (B/P) of 36 indicates that sirolimus is extensively partitioned into formed blood elements.
Croatian: Omjer u krvi prema plazmi (B/P) od 36 ukazuje na to da sirolimus u značajnoj mjeri ulazi i u stanične elemente krvi.
English: After 3 months, your doctor may discontinue either Rapamune or ciclosporin, as it is not recommended that these medicines be taken together beyond this period.
Croatian: Nakon 3 mjeseca, liječnik može prekinuti primjenu lijeka Rapamune ili ciklosporina, jer se ne preporučuje uzimati ta dva lijeka zajedno dulje od 3 mjeseca.
English: Maintenance doses of 4 mg or less contain small amounts of ethanol (100 mg or less) that are likely to be too low to be harmful.
Croatian: Doze održavanja od 4 mg ili manje sadrže male količine etanola (100 mg ili manje) koje su najvjerojatnije premale da bi mogle biti štetne.
English: Rapamune must not be diluted in grapefruit juice or any other liquid other than water or orange juice (see section 6.6).
Croatian: Rapamune se ne smije razrjeđivati u soku od grejpa ili nekoj drugoj tekućini, nego samo u vodi ili soku od naranče (vidjeti dio 6.6).
English: It is recommended that Rapamune be administered 4 hours after ciclosporin (microemulsion).
Croatian: Preporučuje se davati Rapamune 4 sata nakon ciklosporina (mikroemulzija).
English: Stir vigorously and drink at once.
Croatian: Žustro promiješajte i odmah popijte.
English: If you are considered to be at high risk for kidney rejection, such as if you had a previous transplant that was lost to rejection.
Croatian: Ako se smatra da je kod Vas rizik od odbacivanja bubrega velik, na primjer, ako ste već izgubili prethodni presađeni organ zbog odbacivanja.
English: Do not crush, chew or split.
Croatian: Ne drobiti, žvakati niti lomiti.
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Croatian: Ove su infekcije često povezane s visokim ukupnim opterećenjem imunosupresivima te mogu dovesti do ozbiljnih ili smrtonosnih stanja o kojima liječnici moraju voditi računa pri razmatranju diferencijalne dijagnoze u imunosuprimiranih bolesnika s pogoršanjem funkcije bubrega ili neurološkim simptomima.
English: If an estimated daily dose exceeds 40 mg due to the addition of a loading dose, the loading dose should be administered over 2 days.
Croatian: Ako je procijenjena dnevna doza veća od 40 mg zbog dodavanja udarne doze, udarnu dozu treba dati tijekom 2 dana.
English: The effective half-life, however, is shorter and mean steady-state concentrations were achieved after 5 to 7 days.
Croatian: Međutim, efektivni poluvijek je kraći i srednja vrijednost koncentracije u stanju dinamičke ravnoteže bila je postignuta nakon 5 do 7 dana.
English: Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Croatian: Iako se ne očekuje da bi liječenje lijekom Rapamune moglo utjecati na Vašu sposobnost upravljanja vozilima, obratite se svom liječniku ako imate ikakvih pitanja.
English: The systemic availability of sirolimus in combination with simultaneously administered ciclosporin (Sandimune) is approximately 14%.
Croatian: Sistemska raspoloživost sirolimusa u kombinaciji s istodobno primijenjenim ciklosporinom (Sandimune) iznosi približno 14%.
English: If you miss a dose of Rapamune completely, you should inform your doctor.
Croatian: Ako potpuno propustite uzeti dozu lijeka Rapamune, obavijestite o tome svog liječnika.
English: What you need to know before you take Rapamune
Croatian: Što morate znati prije nego počnete uzimati Rapamune
English: One patient experienced an episode of atrial fibrillation after ingestion of 150 mg of Rapamune.
Croatian: Jedan bolesnik doživio je fibrilaciju atrija nakon unosa 150 mg Rapamunea.
English: The Rapamune group failed to demonstrate superiority to the control group in terms of the first occurrence of biopsy confirmed acute rejection, graft loss, or death.
Croatian: Skupina s Rapamuneom nije postigla bolje rezultate od kontrolne skupine obzirom na prvi nastup akutnog odbacivanja potvrđenog biopsijom, gubitak presatka ili smrt.
English: Date of latest renewal: 13 March 2011
Croatian: Datum posljednje obnove odobrenja: 13. ožujka 2011.
English: Please inform your doctor if you are taking medicines to lower your blood fats.
Croatian: Molimo da obavijestite liječnika ako uzimate lijekove za snižavanje masnoća u krvi.
English: Focal segmental glomerulosclerosis has been reported.
Croatian: Opisana je fokalna segmentalna glomeruloskleroza.
English: Patients with symptomatic ovarian cysts should be referred for further evaluation.
Croatian: Bolesnici sa simptomatskim ovarijskim cistama moraju biti upućeni na daljnju obradu.
English: Please inform your doctor if you are taking any of these medicines.
Croatian: Obavijestite svog liječnika ako uzimate neke od ovih lijekova.
English: Patients initiated on ramipril 10 mg had a higher rate of BCAR (15%) compared to patients initiated on ramipril 5 mg (5%).
Croatian: Bolesnici koji su započeli s ramiprilom 10 mg imali su veću stopu BCAR-a (15%) u usporedbi s bolesnicima koju su započeli s ramiprilom 5 mg (5%).
English: These data indicate that younger children might require higher bodyweight-adjusted doses than adolescents and adults to achieve similar target concentrations.
Croatian: Ovi podaci upućuju na to da mlađa djeca vjerojatno zahtijevaju veće doze prilagođene tjelesnoj težini u usporedbi s adolescentima i odraslim osobama kako bi postigla slične ciljne koncentracije.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane po padajućoj ozbiljnosti.
English: The rates of acute rejection, graft loss, and death were similar at 1 and 2 years.
Croatian: Stope akutnog odbacivanja, gubitka presatka i smrti bile su slične nakon 1 i 2 godine.
English: In particular, you should inform your doctor or pharmacist if you are taking any of the following:
Croatian: Osobito je važno da obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova:
English: Patients receiving sirolimus should be monitored closely if taking ACE inhibitors concomitantly.
Croatian: Bolesnike koji primaju sirolimus treba pozorno pratiti ako istodobno uzimaju ACE inhibitore.
English: It is not necessary to modify the Rapamune loading dose.
Croatian: Nije potrebno prilagođavati udarnu dozu Rapamunea.
English: There was no significant between-group difference in this interval in the change in functional residual capacity, 6-minute walk distance, diffusing capacity of the lung for carbon monoxide, or general well-being score in patients with S-LAM.
Croatian: Nije postojala značajna razlika među skupinama u ovom intervalu u promjeni funkcionalnog rezidualnog kapaciteta, prijeđene udaljenosti tijekom 6-minutnog hoda, difuzijskom kapacitetu pluća za ugljikov monoksid ili rezultatu općeg zadovoljstva u bolesnika sa S-LAM-om.
English: Careful attention should be made to clinical signs/symptoms, tissue biopsies, and laboratory parameters.
Croatian: Mora se obratiti posebna pažnja na kliničke znakove i simptome, nalaze biopsije tkiva te laboratorijske parametre.
English: If this occurs, simply bring your Rapamune oral solution to room temperature and shake gently.
Croatian: Ako se to dogodi, jednostavno stavite oralnu otopinu Rapamune na sobnoj temperaturi i nježno je protresite.
English: The incidence of ovarian cysts may be higher in premenopausal females compared to postmenopausal females.
Croatian: Incidencija ovarijskih cista može biti viša u žena prije menopauze u usporedbi sa ženama u postmenopauzi.
English: Rapamune should not be used during pregnancy unless clearly necessary.
Croatian: Rapamune se ne smije uzimati tijekom trudnoće osim kad za time postoji jasna potreba.
English: After dilution, the preparation should be used immediately.
Croatian: Nakon razrjeđenja, pripravak se mora odmah primijeniti.
English: The 0.5 mg and 2 mg tablets also contain yellow iron oxide (E172) and brown iron oxide (E172).
Croatian: Tablete od 0,5 mg i 2 mg također sadrže žuti željezov oksid (E172) i smeđi željezov oksid (E172).
English: Once a stable dose is achieved, therapeutic drug monitoring should be performed at least every 3 months.
Croatian: Kada se postigne stabilna doza, potrebno je pratiti koncentracije lijeka tijekom terapije najmanje svaka 3 mjeseca.
English: The recommended 24-hour trough concentration ranges for sirolimus are based on chromatographic methods.
Croatian: Preporučeni raspon 24-satnih najnižih koncentracija sirolimusa temelji se na kromatografskim metodama.
English: No clinically significant pharmacokinetic interaction was observed between Rapamune oral solution and 0.3 mg norgestrel/0.03 mg ethinyl estradiol.
Croatian: Nije opažena klinički značajna farmakokinetička interakcija između Rapamune oralne otopine i 0,3 mg norgestrela / 0,03 mg etinilestradiola.
English: If you stop taking Rapamune
Croatian: Ako prestanete uzimati Rapamune
English: Treatment emergent adverse events occurred more frequently during the first 6 months after Rapamune conversion.
Croatian: Nuspojave proizašle iz liječenja bile su češće tijekom prvih 6 mjeseci nakon prebacivanja na Rapamune.
English: It is important to follow the instructions to drink Rapamune oral solution at once when a plastic container is used for the dilution and/or administration (see section 6.6).
Croatian: Važno je pridržavati se uputa da se Rapamune oralna otopina mora popiti odjednom kad se za razrjeđivanje i/ili primjenu koristi plastični spremnik (vidjeti dio 6.6).
English: When given 2 hours before CsA administration, sirolimus Cmax and AUC were not affected.
Croatian: Kad se davao 2 sata prije ciklosporina A, Cmax i AUC sirolimusa nisu se promijenile.
English: However, the development of such special dosing recommendations for children requires more data to be definitely confirmed.
Croatian: Međutim, razvoj ovakvih konkretnih preporuka o doziranju u djece nije moguć bez potvrde na temelju dodatnih podataka.
English: Patients who had both antibody-mediated rejection and T-cell-mediated rejection on the same biopsy were counted once for each category.
Croatian: Bolesnici koji su imali i protutijelima posredovano odbacivanje i T-stanicama posredovano odbacivanje na istom bioptatu bili su uračunati po jedanput u svaku kategoriju.
English: Consequently your body will not be as good as normal at fighting infections.
Croatian: Posljedično tome, Vaše se tijelo neće moći obraniti od infekcija kao što to inače može.
English: Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.
Croatian: Ispitivanja su pokazala da su njegovi učinci posredovani mehanizmom koji je drugačiji od mehanizma ciklosporina, takrolimusa i drugih imunosupresivnih lijekova.
English: Among 89 patients known to be Epstein-Barr virus (EBV) seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Croatian: Od 89 bolesnika za koje je poznato da su bili seronegativni na Epstein-Barrov virus (EBV) prije transplantacije, u 13 (15,6%) se razvio posttransplantacijski limfoproliferativni poremećaj.
English: The combined use of Rapamune with angiotensin-converting enzyme (ACE) inhibitors (a type of medicine used to lower blood pressure) may result in allergic reactions.
Croatian: Kombinirana primjena lijeka Rapamune s inhibitorima angiotenzin-konvertirajućeg enzima (ACE) (vrsta lijekova za snižavanje povišenog krvnog tlaka) može dovesti do alergijske reakcije.
English: In reproduction toxicity studies decreased fertility in male rats was observed.
Croatian: U ispitivanjima reproduktivne toksičnosti opažena je smanjena plodnost u mužjaka štakora.
English: Upon repeated administration, the average blood concentration of sirolimus is increased approximately 3-fold.
Croatian: Nakon opetovane primjene prosječna koncentracija sirolimusa u krvi poveća se otprilike 3 puta.
English: Although the results of a single-dose interaction study with an oral contraceptive suggest the lack of a pharmacokinetic interaction, the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long-term treatment with Rapamune.
Croatian: Iako rezultati ispitivanja interakcije jednokratne doze lijeka s oralnim kontraceptivom upućuju na to da nema farmakokinetičke interakcije, ti rezultati ne mogu isključiti mogućnost promjena u farmakokinetici koje bi mogle utjecati na djelotvornost oralnog kontraceptiva tijekom dugotrajnog liječenja Rapamuneom.
English: The active substance is sirolimus.
Croatian: Djelatna tvar je sirolimus.
English: Once the contents of the dosing syringe have been diluted with water or orange juice, the preparation should be drunk immediately.
Croatian: Nakon što se sadržaj dozirne štrcaljke razrijedi vodom ili narančinim sokom, treba ga odmah popiti.
English: 24 hours in the dosing syringe (at room temperature, but not to exceed 25C).
Croatian: 24 sata u dozirnoj štrcaljki (na sobnoj temperaturi, ali koja ne prelazi 25C).
English: There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
Croatian: Nema dovoljno iskustva na temelju kojeg bi bilo moguće preporučiti primjenu Rapamunea u djece i adolescenata (vidjeti dio 4.2).
English: In patients for whom ciclosporin withdrawal is either unsuccessful or cannot be attempted, the combination of ciclosporin and Rapamune should not be maintained for more than 3 months post-transplantation.
Croatian: U bolesnika u kojih ukidanje ciklosporina nije bilo uspješno ili izvedivo, kombinaciju ciklosporina i Rapamunea ne smije se nastaviti duže od 3 mjeseca nakon transplantacije.
English: The 0.5 mg tablet is not fully bioequivalent to the 1 mg, 2 mg and 5 mg tablets when comparing Cmax.
Croatian: Tableta od 0,5 mg nije u potpunosti bioekvivalentna onima od 1 mg, 2 mg i 5 mg, kada se uspoređuju Cmax.
English: Rapamune, like other immunosuppressive medicines, may decrease your body's ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
Croatian: Kao i drugi imunosupresivni lijekovi, Rapamune može smanjiti sposobnost Vašeg tijela da se obrani od infekcije i može povećati rizik od razvoja raka limfnog tkiva i kože.
English: Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor.
Croatian: Potom ćete morati uzimati 2 mg lijeka Rapamune svaki dan, sve dok liječnik ne odredi drugačije.
English: Also, when switching between different tablet strengths, verification of trough concentrations is recommended.
Croatian: Također, pri prelasku na tablete druge jačine, preporučuje se provjera najniže koncentracije.
English: Caution should be exercised when co-administering other agents that are known to have a deleterious effect on renal function.
Croatian: Potreban je oprez kad se istodobno primjenjuju drugi lijekovi za koje je poznato da imaju štetan učinak na funkciju bubrega.
English: All sirolimus concentrations reported in this Summary of Product Characteristics were either measured using chromatographic methods or have been converted to chromatographic method equivalents.
Croatian: Sve koncentracije sirolimusa koje se navode u ovom sažetku opisa svojstava lijeka mjerene su kromatografskom metodom ili su pretvorene u ekvivalentne vrijednosti kromatografske metode.
English: Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to 3 months) with ciclosporin.
Croatian: Rapamune se primjenjuje u odraslih za sprječavanje odbacivanja presađenog bubrega i obično se uzima s drugim imunosupresivnim lijekovima koji se zovu kortikosteroidi, a u početku (prva 2 do 3 mjeseca) se uzima s ciklosporinom.
English: Physicians should therefore remain continuously informed by responsible representatives for their local laboratory on the performance of the locally used method for concentration determination of sirolimus.
Croatian: Odgovorni predstavnici područnog laboratorija moraju stoga stalno obavještavati liječnike o korištenim metodama određivanja koncentracije sirolimusa.
English: Sirolimus trough concentrations should be monitored at least 3 to 4 days after a loading dose(s).
Croatian: Najniže koncentracije sirolimusa moraju se pratiti najmanje 3 do 4 dana nakon udarne(ih) doze(a).
English: If necessary, the patient may store the bottles at room temperatures up to 25C for a short period of time (24 hours).
Croatian: Po potrebi, bolesnik može čuvati boce na sobnoj temperaturi do 25C tijekom kratkog razdoblja (24 sata).
English: Special populations Black population
Croatian: Populacija crne rase
English: The following list of adverse reactions is based on experience from clinical studies and on postmarketing experience.
Croatian: U sljedećoj tablici prikazane su nuspojave na temelju iskustva iz kliničkih ispitivanja i praćenja lijeka nakon stavljanja u promet.
English: Rapamune contains the active substance sirolimus, which belongs to a group of medicines called immunosuppressants.
Croatian: Rapamune sadrži djelatnu tvar sirolimus, koja pripada skupini lijekova po imenu imunosupresivi.
English: The presence of this haze does not affect the quality of Rapamune.
Croatian: Blaga zamućenost ne utječe na kvalitetu otopine Rapamune.
English: There is limited information indicating that Black renal transplant recipients (predominantly African-American) require higher doses and trough levels of sirolimus to achieve the same efficacy as observed in non-Black patients.
Croatian: Ograničeni podaci ukazuju na to da primatelji presatka bubrega koji su crne rase (uglavnom Afroamerikanci) trebaju više doze sirolimusa i više najniže koncentracije lijeka za postizanje iste djelotvornosti kao u bolesnika koji nisu crne rase.
English: In mouse, chronic ulcerative skin lesions were increased.
Croatian: U miševa je bio povećan broj kroničnih ulceroznih lezija kože.
English: So if you are taking Rapamune, you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract (see list below).
Croatian: Stoga ćete, dok uzimate Rapamune, možda češće nego obično dobivati infekcije kao što su infekcije kože, usta, želuca i crijeva, pluća i mokraćnog sustava (vidjeti popis dolje).
English: Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in patients receiving therapeutic doses of Rapamune.
Croatian: Iako sirolimus in vitro inhibira ljudski jetreni mikrosomalni citokrom P450 CYP2C9, CYP2C19, CYP2D6, i CYP3A4/5, ne očekuje se da će djelatna tvar inhibirati aktivnost navedenih izoenzima in vivo, budući da su koncentracije sirolimusa potrebne za postizanje inhibicije značajno više od onih koje su opažene u bolesnika koji su primali terapijske doze Rapamunea.
English: Optimally, adjustments in Rapamune dose should be based on more than a single trough level obtained more than 5 days after a previous dosing change.
Croatian: U najboljem slučaju, prilagodbe doza Rapamunea moraju se temeljiti na više od jednog određivanja najnižih koncentracija lijeka dobivenih više od 5 dana nakon prethodne promjene doziranja.
English: During treatment with immunosuppressants, including Rapamune, vaccination may be less effective.
Croatian: Tijekom liječenja imunosupresivima, uključujući i Rapamune, cijepljenje može imati oslabljeni učinak.