FrancophonIA/ELRC3.0 huggingface dataset:
English: This amount of alcohol may be harmful for those suffering from alcoholism as well as for pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Croatian: Ta količina alkohola može štetiti osobama koje boluju od alkoholizma, trudnicama ili dojiljama, djeci i visokorizičnim skupinama bolesnika kao što su oni s bolešću jetre ili epilepsijom.
English: Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after renal transplantation, particularly for patients at increased risk for CMV disease.
Croatian: Preporučuje se profilaksa infekcije citomegalovirusom (CMV) tijekom 3 mjeseca nakon transplantacije bubrega, posebice u bolesnika s povećanim rizikom od CMV infekcije.
English: If you have taken more medicine than you were told to, contact a doctor or go to the nearest hospital emergency department as soon as possible.
Croatian: Ako ste uzeli više lijeka nego što Vam je rečeno, čim prije se obratite liječniku ili odite na hitnu službu u najbližu bolnicu.
English: The safety and efficacy of Rapamune in children and adolescents less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Rapamune u djece i adolescenata starosti ispod 18 godina nisu ustanovljene.
English: HMG-CoA reductase inhibitors
Croatian: Inhibitori HMG-CoA reduktaze
English: Rapamune oral solution contains soya oil.
Croatian: Rapamune oralna otopina sadrži sojino ulje.
English: Some medicines can interfere with the action of Rapamune and, therefore, dose adjustment of Rapamune may be required.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Rapamune pa će možda biti potrebno prilagoditi dozu lijeka Rapamune.
English: It is not known whether Rapamune passes into breast milk.
Croatian: Nije poznato prelazi li Rapamune u majčino mlijeko.
English: Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections, and sepsis.
Croatian: Pretjerana supresija imunološkog sustava također može povećati sklonost infekcijama, uključujući oportunističke infekcije (bakterijama, gljivicama, virusima i protozoama), infekcije sa smrtnim ishodom i sepsu.
English: Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the level of the oral solution is even with the appropriate mark on the dosing syringe.
Croatian: Izvucite točnu količinu oralne otopine Rapamune koju Vam je propisao liječnik tako što ćete nježno izvlačiti klip dozirne štrcaljke sve dok se razina oralne otopine ne poravna s odgovarajućom oznakom na dozirnoj štrcaljki.
English: The primary endpoint was the difference between the groups in the rate of change (slope) in FEV1.
Croatian: Mjera primarnog ishoda bila je razlika između skupina u stopi promjene (nagibu) u FEV1.
English: 30 dosing syringes 1 syringe adapter 1 carrying case
Croatian: 30 dozirnih štrcaljki 1 nastavak za štrcaljku 1 kutijica za nošenje
English: Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Croatian: Smanjen broj spermija povezan s primjenom lijeka Rapamune obično se vrati na normalu nakon prestanka liječenja.
English: In clinical studies, the concomitant administration of Rapamune and HMG-CoA reductase inhibitors and/or fibrates was well-tolerated.
Croatian: U kliničkim se ispitivanjima istodobna primjena Rapamunea i inhibitora HMG-CoA reduktaze i/ili fibrata dobro podnosila.
English: Since half-life is prolonged in these patients, therapeutic monitoring of the medicinal product after a loading dose or a change of dose should be performed for a prolonged period of time until stable concentrations are reached (see sections 4.2 and 5.2).
Croatian: Budući da je u tih bolesnika produžen poluvijek, terapijsko praćenje lijeka nakon udarne doze ili promjene doze mora se provoditi kroz duže vrijeme sve dok se ne postignu stabilne koncentracije (vidjeti dijelove 4.2 i 5.2).
English: The mean Cmax was decreased by 35%, and mean tmax increased by 82%.
Croatian: Prosječni Cmax bio je smanjen za 35%, dok je prosječni tmax bio povećan za 82%.
English: Information directly related to the tablet formulation is summarised specifically in the Oral tablet section.
Croatian: Informacije koje se odnose izravno na oblik tableta sažete su posebno u dijelu Tablete za peroralnu primjenu.
English: The absolute between-group difference in the mean change in FEV1 during the treatment period was 152 mL, or approximately 11% of the mean FEV1 at enrollment.
Croatian: Apsolutna razlika između skupina u srednjoj vrijednosti promjene u FEV1 iznosila je 152 ml tijekom razdoblja liječenja ili približno 11% srednje vrijednosti FEV1 kod uključivanja u ispitivanje.
English: (1) in patients with hepatic impairment (2) when inducers or inhibitors of CYP3A4 are concurrently administered and after their discontinuation (see section 4.5) and/or (3) if ciclosporin dosing is markedly reduced or discontinued, as these populations are most likely to have special dosing requirements.
Croatian: (1) u bolesnika s oštećenjem jetre (2) prilikom istodobne primjene induktora ili inhibitora CYP3A4 i nakon njihovog ukidanja (vidjeti dio 4.5); i/ili (3) ako je doziranje ciklosporina značajno smanjeno ili je davanje prekinuto, budući da je u ove skupine najvjerojatnije potrebno posebno prilagoditi doziranje.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Croatian: Unutar skupina organskog sustava, nuspojave su prikazane po učestalosti (broj bolesnika za koje se očekuje da će imati reakciju) prema sljedećim kategorijama: vrlo često (1/10), često (1/100 i <1/10); manje često (1/1000 i <1/100), rijetko (10 000 i <1/1000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you experience symptoms such as bruising or rash, changes in your urine, or changes in behaviour or any others that are serious, unusual or prolonged, contact your doctor.
Croatian: Ako dobijete simptome kao što su modrice ili osip, promjena boje mokraće ili promjene ponašanja ili bilo koje druge ozbiljne, neobične ili dugotrajne simptome, obratite se liječniku.
English: The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
Croatian: Istodobna oralna primjena 10 mg Rapamune oralne otopine i 120 mg diltiazema značajno je utjecala na bioraspoloživost sirolimusa.
English: The rate at which the dose of sirolimus is increased should correspond to the rate of ciclosporin elimination.
Croatian: Brzina kojom se povećava doza sirolimusa mora odgovarati brzini eliminacije ciklosporina.
English: Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.
Croatian: Morate ograničiti izlaganje sunčanom svjetlu i UV zračenju tako što ćete zaštititi kožu nošenjem odjeće i primjenom sredstava s visokim faktorom zaštite od sunca, zato što postoji povećan rizik od raka kože.
English: 30 coated tablets 100 coated tablets
Croatian: 30 obloženih tableta 100 obloženih tableta
English: Data from controlled studies for treatment of S-LAM longer than one year are currently not available, therefore the benefit of treatment should be reassessed when used long-term.
Croatian: Trenutno nisu dostupni podaci iz kontroliranih ispitivanja o liječenju S-LAM-a dulje od jedne godine te je potrebno ponovno procijeniti korist u slučaju dugoročnog liječenja.
English: In an open-label, randomised, comparative, multi-centre study where renal transplant patients were either converted from tacrolimus to sirolimus 3 to 5 months post-transplant or remained on tacrolimus, there was no significant difference in renal function at 2 years.
Croatian: U otvorenom, randomiziranom, usporednom, multicentričnom ispitivanju u kojemu su bolesnici s presatkom bubrega prebačeni s takrolimusa na sirolimus 3 do 5 mjeseci nakon transplantacije ili su ostali na takrolimusu, nije bilo značajne razlike u bubrežnoj funkciji za 2 godine.
English: The pharmacokinetics of sirolimus were similar in various populations with renal function ranging from normal to absent (dialysis patients).
Croatian: Farmakokinetika sirolimusa bila je slična u različitim populacijama s funkcijom bubrega u rasponu od normalne do odsutne (bolesnika na dijalizi).
English: Most patients were on immunosuppressive regimens, which included Rapamune in combination with other immunosuppressive agents.
Croatian: Većina bolesnika bila je na imunosupresivnom liječenju koje je uključivalo Rapamune u kombinaciji s drugim imunosupresivnim lijekovima.
English: Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and possibly your liver function, during treatment with Rapamune.
Croatian: Liječnik će također raditi pretrage kojima će pratiti funkciju Vaših bubrega, razinu masnoća u krvi (kolesterol i/ili trigliceride) i po mogućnosti funkciju jetre dok se liječite lijekom Rapamune.
English: Partly reversible reductions in sperm counts were reported in a 13-week rat study.
Croatian: Opisano je djelomično reverzibilno smanjenje broja spermija u ispitivanju na štakorima u trajanju od 13 tjedana.
English: Loss of TSC gene function activates the mTOR signaling pathway, resulting in cellular proliferation and release of lymphangiogenic growth factors.
Croatian: Gubitak funkcije TSC gena aktivira signalni put mTOR što rezultira proliferacijom stanica i oslobađanjem limfangiogenih čimbenika rasta.
English: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Ireland
Croatian: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA10.
Croatian: Farmakoterapijska skupina: Imunosupresivi, selektivni imunosupresivni lijekovi,ATK oznaka: L04AA10.
English: This medicine contains approximately 350 mg propylene glycol (E1520) in each mL.
Croatian: Ovaj lijek sadrži približno 350 mg propilenglikola (E1520) u jednom ml.
English: Once Rapamune maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring.
Croatian: Nakon što je prilagođena doza održavanja lijeka Rapamune, bolesnici moraju nastaviti primjenjivati novu dozu održavanja najmanje 7 do 14 dana prije daljnje prilagodbe doze, uz praćenje koncentracije.
English: In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Croatian: U 24 zdrava dobrovoljca koji su primali tablete Rapamunea s obrokom bogatim mastima došlo je do porasta Cmax za 65%, tmax za 32% i AUC za 23%.
English: Food can affect the amount of medicine that gets into your bloodstream, and taking your medicine in a consistent way means that the blood levels of Rapamune remain more stable.
Croatian: Hrana može utjecati na količinu lijeka koja ulazi u krvotok pa će razine lijeka Rapamune u krvi biti stabilnije kad se lijek uzima uvijek na isti način.
English: There are no or limited amount of data from the use of sirolimus in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni sirolimusa u trudnica ograničeni.
English: Once in the syringe the medication may be kept at room temperature (not exceeding 25C) or refrigerated and should be used within 24 hours.
Croatian: Nakon što se lijek uvuče u štrcaljku, može se čuvati na sobnoj temperaturi (koja ne prelazi 25C) ili u hladnjaku i mora se primijeniti u roku od 24 sata.
English: Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Croatian: 30 ili 100 tableta u prozirnim polivinilklorid (PVC)/polietilen (PE) /poliklorotrifluoroetilen (Aclar) aluminijskim blister pakiranjima.
English: The target for trough concentrations was 10-20 ng/mL.
Croatian: Ciljna vrijednost najniže koncentracije iznosila je 10-20 ng/ml.
English: Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
Croatian: Koncentracije sirolimusa nakon primjene tableta Rapamune (5 mg) zdravim osobama u jednokratnoj dozi, razmjerno proporcionalne su dozi između 5 i 40 mg.
English: Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist.
Croatian: Liječenje mora započeti i voditi odgovarajuće obučen specijalist.
English: Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis).
Croatian: Lijekovi koji se zovu „statini“ i „fibrati“ i primjenjuju se za liječenje povišenog kolesterola i triglicerida povezani su s povećanim rizikom od razgradnje mišića (rabdomioliza).
English: Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
Croatian: Rifampicin je povećao klirens sirolimusa za približno 5,5 puta i smanjio AUC za otprilike 82% te Cmax za 71%.
English: To minimise variability, Rapamune should be taken at the same time in relation to ciclosporin, 4 hours after the ciclosporin dose, and consistently either with or without food (see section 5.2).
Croatian: Kako bi se smanjile promjene koncentracije u krvi, Rapamune se mora uzimati uvijek u isto vrijeme u odnosu na ciklosporin, i to 4 sata nakon doze ciklosporina te uvijek na isti način - ili s hranom ili bez nje (vidjeti dio 5.2).
English: Rapamune oral solution contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Croatian: Rapamune oralna otopina sadrži polisorbat-80, za koji se zna da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilklorida (PVC).
English: Inform your doctor if you have difficulty taking the tablet.
Croatian: Obratite se liječniku ako imate poteškoća s gutanjem tableta.
English: If you forget to take Rapamune
Croatian: Ako ste zaboravili uzeti Rapamune
English: New onset nephrosis (nephrotic syndrome) was also reported in 2% of the patients in the study (see section 4.8).
Croatian: Novonastala nefroza (nefrotski sindrom) također je opisana u 2% bolesnika u tom ispitivanju (vidjeti dio 4.8).
English: Based upon the analysis of data from 36 months and beyond, which showed a growing difference in graft survival and renal function, as well as significantly lower blood pressure in the ciclosporin elimination group, it was decided to discontinue subjects from the Rapamune with ciclosporin group.
Croatian: Na temelju analize podataka nakon 36 mjeseci i kasnije, koja je pokazala sve veću razliku u preživljenju presatka i funkciji bubrega, kao i značajno niži krvni tlak u skupini kojoj je isključen ciklosporin, odlučeno je da skupina bolesnika liječenih Rapamuneom i ciklosporinom prekine ispitivanje.
English: In patients with severe hepatic impairment, it is recommended that the maintenance dose of Rapamune be reduced by approximately one-half.
Croatian: Bolesnicima s teškim oštećenjem jetre preporučuje se smanjiti dozu održavanja Rapamunea na otprilike polovicu.
English: Patients can be switched from Rapamune oral solution to the tablet formulation on a mg per mg basis.
Croatian: Bolesnici se mogu prebaciti s oralne otopine Rapamunea na formulaciju u obliku tableta na temelju odnosa miligram za miligram.
English: If you prefer to take Rapamune with food, then you should always take it with food.
Croatian: Ako Vam više odgovara uzimati Rapamune s hranom, onda ga uvijek uzimajte s hranom.
English: Much of the general pharmacokinetic information was obtained using the Rapamune oral solution, which is summarised first.
Croatian: Većina općih farmakokinetičkih informacija dobivena je primjenom Rapamune oralne otopine, što je sažeto u prvom dijelu.
English: LAM involves lung tissue infiltration with smooth muscle-like cells that harbour inactivating mutations of the tuberous sclerosis complex (TSC) gene (LAM cells).
Croatian: LAM uključuje infiltraciju plućnog tkiva stanicama sličnim glatkim mišićnim stanicama koje nose inaktivirajuće mutacije TSC (engl. tuberous sclerosis complex) gena (stanice LAM-a).
English: Your doctor will give you 2 mg of Rapamune each day, until otherwise directed by your doctor.
Croatian: Liječnik će Vam davati 2 mg Rapamunea svaki dan dok ne dobijete drugačije upute.
English: Renal function was not better in the treatment arms with de novo sirolimus without a calcineurin inhibitor.
Croatian: Funkcija bubrega nije bila bolja u skupinama de novo liječenima Rapamuneom bez inhibitora kalcineurina.
English: Co. Kildare
Croatian: Kildare
English: You should see your doctor immediately if you experience symptoms, such as swollen face, tongue and/or back of the mouth (pharynx) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis).
Croatian: Morate se odmah obratiti liječniku ako osjetite simptome kao što su oticanje lica, jezika i/ili stražnjeg dijela usne šupljine (ždrijela) i/ili otežano disanje (angioedem) ili dobijete kožne promjene s guljenjem kože (eksfolijativni dermatitis).
English: An abbreviated dosing schedule of daclizumab was used in one of the studies.
Croatian: U jednom od ispitivanja primijenjen je skraćeni protokol doziranja daklizumaba.
English: Because of the potential for adverse reactions in breast-fed infants from sirolimus, breast-feeding should be discontinued during treatment with Rapamune.
Croatian: Zbog mogućih nuspojava u dojenčadi majki koje uzimaju sirolimus, mora se prekinuti dojenje tijekom liječenja Rapamuneom.
English: A lower incidence of squamous cell carcinoma of the skin was observed in the sirolimus group (0% vs. 4.9%).
Croatian: Niža incidencija karcinoma pločastih stanica kože uočena je u skupini koja je primala sirolimus (0% naspram 4,9%).
English: General supportive measures should be initiated in all cases of overdose.
Croatian: U svim slučajevima predoziranja potrebno je uvesti opće potporne mjere.
English: Date of first authorisation: 13 March 2001 Date of latest renewal: 13 March 2011
Croatian: Datum prvog odobrenja: 13. ožujka 2001.
English: TEXT FOR 60 mL OUTER CARTON (CONTAINING SYRINGES/BOTTLE IN CARTON)
Croatian: TEKST ZA VANJSKO PAKIRANJE OD 60 ml (SADRŽI ŠTRCALJKE/BOCU
English: Once the dosing syringe has been filled with Rapamune oral solution, it should be kept at room temperature, but not above 25C, for maximum 24 hours.
Croatian: Nakon što se dozirna štrcaljka napuni oralnom otopinom Rapamune, treba se čuvati na sobnoj temperaturi, ali ne iznad 25C, najdulje 24 sata.
English: The safety and efficacy of Rapamune for treatment of S-LAM were assessed in a randomised, double-blind, multicentre, controlled trial.
Croatian: Sigurnost primjene i djelotvornost Rapamunea u liječenju LAM-a procijenjene su u randomiziranom, dvostruko slijepom, multicentričnom, kontroliranom ispitivanju.
English: Refill the glass with at least 120 mL of water or orange juice, stir well, and drink immediately.
Croatian: Ponovno napunite čašu s najmanje 120 ml vode ili narančinog soka, dobro promiješajte i odmah popijte.
English: If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away.
Croatian: Ako ste uzeli više lijeka nego što Vam je rečeno, odmah se obratite liječniku ili otiđite na hitnu službu u najbližu bolnicu.
English: If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it - the cap should snap into place.
Croatian: Ako zbog toga morate nositi lijek sa sobom, napunite dozirnu štrcaljku do odgovarajuće oznake i čvrsto je zatvorite zatvaračem, tako da škljocne na mjesto.
English: Ciclosporin inhibits the metabolism of sirolimus, and consequently sirolimus levels will decrease when ciclosporin is discontinued, unless the sirolimus dose is increased.
Croatian: Ciklosporin inhibira metabolizam sirolimusa pa će se posljedično tome razine sirolimusa sniziti nakon prekida terapije ciklosporinom, osim ako se doza sirolimusa ne povisi.
English: The treatment regimen studied (continuous use of Rapamune in combination with calcineurin inhibitor) is not indicated for adult or paediatric patients (see section 4.1).
Croatian: Ispitivana shema liječenja (kontinuirana primjena Rapamunea u kombinaciji s inhibitorom kalcineurina) nije indicirana u odraslih ili pedijatrijskih bolesnika (vidjeti dio 4.1).
English: Rapamune contains up to 3.17 vol % ethanol (alcohol).
Croatian: Rapamune sadrži do 3,17 vol % etanola (alkohola).
English: In rat, testicular interstitial cell adenomas were likely indicative of a species-dependent response to lutenising hormone levels and are usually considered of limited clinical relevance.
Croatian: Pojava testikularnih adenoma intersticijskih stanica u štakora vrlo vjerojatno upućuje na utjecaj ovisan o vrsti, na koncentracije luteinizirajućeg hormona i obično se smatra da je od ograničene kliničke važnosti.
English: The use of live vaccines should be avoided during treatment with Rapamune.
Croatian: Mora se izbjegavati primjena živih cjepiva tijekom liječenja Rapamuneom.
English: The concomitant administration of Rapamune and angiotensin-converting enzyme (ACE) inhibitors has resulted in angioneurotic oedema-type reactions.
Croatian: Istodobna primjena Rapamunea i inhibitora angiotenzin-konvertirajućeg enzima (ACE inhibitora) rezultirala je reakcijama tipa angioneurotskog edema.
English: In most patients, dose adjustments can be based on simple proportion: new Rapamune dose=current dose x (target concentration/current concentration).
Croatian: Prilagodbe doza u većine se bolesnika mogu temeljiti na jednostavnom omjeru: nova doza lijeka Rapamune = trenutna doza x (ciljna koncentracija/trenutna koncentracija).
English: Rapamune oral solution contains up to 3.17 vol % ethanol (alcohol).
Croatian: Rapamune oralna otopina sadrži do 3,17 vol % etanola (alkohol).
English: If necessary, you may store the bottle at room temperature up to 25C for a short period of time, but no longer than 24 hours.
Croatian: Po potrebi, bocu možete čuvati na sobnoj temperaturi do 25C tijekom kratkog razdoblja, ali ne dulje od 24 sata.
English: Treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation.
Croatian: Liječenje mora započeti i voditi odgovarajuće obučen specijalist u području transplantacijske medicine.
English: If you prefer to take Rapamune without food, then you should always take it without food.
Croatian: Ako Vam više odgovara uzimati Rapamune bez hrane, onda ga uvijek trebate uzimati bez hrane.
English: When switching patients between oral solution and tablet formulations, it is recommended to give the same dose and to verify the sirolimus trough concentration 1 to 2 weeks later to assure that it remains within recommended target ranges.
Croatian: Prilikom prelaska bolesnika s oralne otopine na formulaciju tableta i obrnuto, preporučuje se davanje iste doze i provjera najniže koncentracije sirolimusa 1 do 2 tjedna kasnije kako bi se osigurala vrijednost unutar preporučenog ciljnog raspona.
English: It is recommended that sirolimus whole blood trough levels be closely monitored in patients with impaired hepatic function (see Therapeutic monitoring of the medicinal product and dose adjustment).
Croatian: Preporučuje se pažljivo pratiti najnižu koncentraciju sirolimusa u punoj krvi u bolesnika s oštećenom funkcijom jetre (vidjeti Terapijsko praćenje lijeka i prilagodba doze).