FrancophonIA/ELRC3.0 huggingface dataset:
English: *Note: p-values not controlled for multiple testing.
Slovenian: *opomba: vrednosti p niso nadzorovane za večkratno testiranje.
English: Follow your doctor's instructions exactly, and never change the dose yourself.
Slovenian: Natančno upoštevajte navodila zdravnika in sami nikoli ne spreminjajte odmerka.
English: These may be symptoms of a serious allergic reaction.
Slovenian: To so lahko simptomi resne alergijske reakcije.
English: You may need to repeat step 3 more than once to deliver your dose.
Slovenian: Korak 3 boste morda morali ponoviti več kot enkrat, da boste pripravili vaš odmerek.
English: Frequency not known (cannot be estimated from available data)
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
English: Initial therapy (2 to 3 months post-transplantation)
Slovenian: Začetno zdravljenje (2 do 3 mesece po presaditvi)
English: The concentration values obtained by these different methodologies are not interchangeable.
Slovenian: Vrednosti koncentracij, dobljene s temi različnimi metodami, medsebojno niso zamenljive.
English: Date of first authorisation: 13 March 2001 Date of latest renewal: 13 March 2011
Slovenian: Datum prve odobritve: 13. marec 2001 Datum zadnjega podaljšanja: 13. marec 2011
English: Consequently your body will not be as good as normal at fighting infections.
Slovenian: Zato se vaše telo ne bo tako uspešno borilo proti okužbam kot ponavadi.
English: After that, continue to take your medicines as usual.
Slovenian: Po tem nadaljujte z jemanjem zdravila ob običajnem času.
English: All patients who developed PTLD were aged below 18 years.
Slovenian: Vsi bolniki, pri katerih se je razvila PTLD, so bili mlajši od 18 let.
English: Rapamune reduces your body's own defence mechanisms.
Slovenian: Zdravilo Rapamune oslabi lastne obrambne mehanizme vašega telesa.
English: For skin carcinoma, the median time to first occurrence was significantly delayed.
Slovenian: Pri karcinomu kože je bil mediani čas do prvega pojava pomembno odložen.
English: Use within 24 hours after filling the dosing syringe.
Slovenian: Uporabite v 24 urah po polnjenju odmerne brizge.
English: Thereafter, the difference between the two groups was not significant.
Slovenian: Nato razlika med obema skupinama ni bila več statistično pomembna.
English: The following list of adverse reactions is based on experience from clinical studies and on postmarketing experience.
Slovenian: Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnih študij in izkušnjah v obdobju trženja.
English: Therefore, absorption and the subsequent elimination of sirolimus may be influenced by substances that affect these proteins.
Slovenian: Absorpcija in poznejše izločanje sirolimusa sta torej lahko odvisna od snovi, ki vplivajo na omenjeni beljakovini.
English: Always take the labelled medicine bottle with you, even if it is empty.
Slovenian: S seboj vedno vzemite označeno steklenico zdravila, tudi če je prazna.
English: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG United Kingdom
Slovenian: Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG Velika Britanija
English: Do not take Rapamune:
Slovenian: Ne jemljite zdravila Rapamune:
English: Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
Slovenian: Zdravnik se bo odločil, kakšen odmerek zdravila Rapamune morate jemati in kako pogosto.
English: Stir well for one minute and drink immediately at once.
Slovenian: Dobro mešajte eno minuto in takoj vse popijte.
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).
Slovenian: Večina zavrnitev se je pojavila v prvih 6 mesecih po prehodu in je bila blagih; med študijo niso poročali o izgubi presadka (glejte poglavje 4.4).
English: At 12, 24 and 36 months, graft and patient survival were similar for both groups.
Slovenian: Po 12, 24 in 36 mesecih je bilo preživetje presadkov in bolnikov v obeh skupinah podobno.
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.
Slovenian: Vzdrževalni odmerki po 4 mg ali manj vsebujejo manjše količine etanola (100 mg ali manj), ki so verjetno premajhne, da bi lahko škodovale.
English: S-LAM is a rare progressive lung disease that affects predominantly women of childbearing age.
Slovenian: S-LAM je redka napredujoča bolezen pljuč, ki prizadene predvsem ženske v rodni dobi.
English: There was a large variability for individuals within the age groups.
Slovenian: Med posamezniki v posamezni starostni skupini je bila variabilnost velika.
English: Periodic quantitative monitoring of urinary protein excretion is recommended.
Slovenian: Priporočljivo je redno kvantitativno spremljanje izločanja beljakovin v urin.
English: Careful attention should be made to clinical signs/symptoms, tissue biopsies, and laboratory parameters.
Slovenian: Pozornost je treba nameniti tudi kliničnim znakom/simptomom, biopsijam tkiv in laboratorijskim parametrom.
English: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgium
Slovenian: Pfizer Service Company bvba Hoge Wei 10, B-1930 Zaventem Belgija
English: If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
Slovenian: Če sočasno jemljete tudi ciklosporin, morate ti dve zdravili vzeti približno 4 ure narazen.
English: The most common symptom of S-LAM is shortness of breath.
Slovenian: Najpogostejši simptom S-LAM je kratka sapa.
English: Use within 30 days after opening bottle.
Slovenian: Uporabite v 30 dneh po odprtju steklenice.
English: Hepatoxicity has been reported.
Slovenian: Poročali so o hepatotoksičnosti.
English: The rates of acute rejection, graft loss, and death were similar at 1 and 2 years.
Slovenian: Pogostnost akutne zavrnitve, izgube presadka in smrti je bila po 1 in 2 letih podobna.
English: Your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation.
Slovenian: Zdravnik vam bo predpisal začetni odmerek 6 mg čimprej po operaciji presaditve ledvice.
English: Do not crush, chew or split.
Slovenian: Ne drobite, žvečite ali delite.
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.
Slovenian: Podatki iz nadzorovanih študij zdravljenja S-LAM, ki traja več kot 1 leto, trenutno niso na voljo, zato je treba pri dolgotrajni uporabi zdravila ponovno oceniti korist zdravljenja s tem zdravilom.
English: 30 days for opened bottle.
Slovenian: 30 dni po odprtju steklenice
English: Undesirable effects observed with patients with S-LAM
Slovenian: Neželeni učinki, ki so jih opazili pri bolnikih s S-LAM
English: In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Slovenian: Na splošno so neželeni učinki pri prevelikem odmerjanju enaki tistim, ki so navedeni v poglavju 4.8.
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.
Slovenian: če imate veliko tveganje za zavrnitev ledvice, na primer, če ste že imeli predhoden presadek, ki ste ga izgubili zaradi zavrnitve.
English: Always take the labelled blister with you, even if it is empty.
Slovenian: S seboj vedno vzemite označen pretisni omot, tudi če je prazen.
English: Rapamune with food and drink
Slovenian: Zdravilo Rapamune skupaj s hrano in pijačo
English: You should contact your doctor if you experience symptoms that are serious, unusual, or prolonged.
Slovenian: Obvestite zdravnika, če se vam pojavijo simptomi, ki so resni, nenavadni ali dolgotrajni.
English: Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days.
Slovenian: Po odprtju steklenico shranjujte v hladilniku, njeno vsebino pa porabite v 30 dneh.
English: The incidence of ovarian cysts may be higher in premenopausal females compared to postmenopausal females.
Slovenian: Incidenca ovarijskih cist je lahko večja pri ženskah pred menopavzo, v primerjavi z ženskami v postmenopavzi.
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.
Slovenian: Če ste pozabili vzeti zdravilo Rapamune, ga vzemite takoj, ko se spomnite, vendar ne manj kot 4 ure pred naslednjim odmerkom ciklosporina.
English: Rapamune should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Rapamune se med nosečnostjo ne sme uporabljati, razen če je to nujno potrebno.
English: An abbreviated dosing schedule of daclizumab was used in one of the studies.
Slovenian: V eni od študij so uporabili skrajšano shemo odmerjanja daklizumaba.
English: The safety and efficacy of Rapamune for treatment of S-LAM were assessed in a randomised, double-blind, multicentre, controlled trial.
Slovenian: Varnost in učinkovitost zdravila Rapamune za zdravljenje S-LAM so ocenjevali v randomiziranem, dvojno slepem, multicentričnem, nadzorovanem preskušanju.
English: Once a stable dose is achieved, therapeutic drug monitoring should be performed at least every 3 months.
Slovenian: Ko dosežemo stabilen odmerek, je treba najmanj vsake 3 mesece opraviti terapevtsko spremljanje koncentracije zdravila.
English: Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant.
Slovenian: Ne prenehajte z jemanjem zdravila Rapamune, razen če vam to naroči zdravnik, ker s tem tvegate izgubo presadka.
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.
Slovenian: Te okužbe so pogosto povezane z velikim celotnim imunosupresivnim bremenom in lahko vodijo v resna ali smrtno nevarna stanja, ki jih morajo zdravniki upoštevati pri diferencialni diagnozi pri imunosuprimiranih bolnikih s slabšajočo se ledvično funkcijo ali nevrološkimi simptomi.
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).
Slovenian: Neželeni učinki so znotraj organskega sistema navedeni po pogostnosti (število bolnikov, pri katerih pričakujejo pojav neželenega učinka) z uporabo naslednjih kategorij: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Slovenian: Hrana lahko vpliva na količino zdravila, ki pride v vaš krvni obtok, zato jemanje vašega zdravila na vedno enak način pomeni, da bo koncentracija zdravila Rapamune v vaši krvi stabilnejša.
English: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Ireland
Slovenian: Pfizer Ireland Pharmaceuticals Little Connell, Newbridge, Co. Kildare Irska
English: if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na sirolimus ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju6).
English: Immunosuppressants may affect response to vaccination.
Slovenian: Imunosupresivi lahko vplivajo na odziv bolnika na cepljenje.
English: The maximum Rapamune dose administered on any day should not exceed 40 mg.
Slovenian: Največji dnevni odmerek zdravila Rapamune ne sme na noben dan preseči 40 mg.
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.
Slovenian: Vse koncentracije sirolimusa, navedene v tem povzetku glavnih značilnosti zdravila, so bile bodisi izmerjene s kromatografskimi metodami ali so bile pretvorjene v ekvivalente kromatografske metode.
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.
Slovenian: Po 3 mesecih vam zdravnik lahko ukine bodisi zdravilo Rapamune bodisi ciklosporin, ker ni priporočljivo, da bi ti dve zdravili skupaj jemali več kot 3 mesece.
English: Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Slovenian: Čeprav ni pričakovati, da bi zdravilo Rapamune vplivalo na vašo sposobnost vožnje, se v primeru dvoma posvetujte z zdravnikom.
English: Upon repeated administration, the average blood concentration of sirolimus is increased approximately 3-fold.
Slovenian: Po ponavljajočih se odmerkih se povprečna koncentracija sirolimusa v krvi poveča za približno 3-krat.
English: Please inform your doctor if you are taking any of these medicines.
Slovenian: Obvestite zdravnika, če jemljete katera od teh zdravil.
English: The presence of this haze does not affect the quality of Rapamune.
Slovenian: Prisotnost motnosti ne vpliva na kakovost zdravila Rapamune.
English: What Rapamune is and what it is used for
Slovenian: Kaj je zdravilo Rapamune in za kaj ga uporabljamo
English: Patients allergic to peanut or soya must not take this medicine.
Slovenian: Bolniki, ki so alergični na arašide ali sojo, ne smejo jemati tega zdravila.
English: These data indicate that younger children might require higher bodyweight-adjusted doses than adolescents and adults to achieve similar target concentrations.
Slovenian: Ti podatki kažejo, da utegnejo mlajši otroci za doseganje podobnih ciljnih koncentracij potrebovati večje odmerke, prirejene na telesno maso, kot mladostniki in odrasli.
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.
Slovenian: Absolutna razlika med skupinama v povprečni spremembi FEV1 v obdobju zdravljenja je bila 152 ml ali približno 11 % povprečnega FEV1 ob vključitvi v študijo.
English: The effect of CsA was also reflected by increases in sirolimus Cmax and tmax.
Slovenian: Učinek CsA se je kazal tudi s povečanjem vrednosti Cmax in tmax sirolimusa.
English: The recommended 24-hour trough concentration ranges for sirolimus are based on chromatographic methods.
Slovenian: Priporočeni razponi 24-urnih najmanjših koncentracij sirolimusa temeljijo na kromatografskih metodah.
English: If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away.
Slovenian: Če ste vzeli večji odmerek zdravila, kot vam je bilo predpisano, takoj obvestite zdravnika ali pojdite na urgentni oddelek najbližje bolnišnice.
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.
Slovenian: Čeprav izsledki študije medsebojnega delovanja enkratnega odmerka s peroralnim kontraceptivom ne kažejo farmakokinetičnega medsebojnega delovanja, ni izključena možnost sprememb farmakokinetike, ki bi lahko vplivale na učinkovitost zaščite pred zanositvijo pri dolgotrajnem zdravljenju z zdravilom Rapamune.
English: The primary endpoint was the difference between the groups in the rate of change (slope) in FEV1.
Slovenian: Primarni opazovani dogodek je bila razlika med skupinama v stopnji spremembe FEV1 (naklon).
English: Optimal therapy requires therapeutic concentration monitoring of the medicinal product in all patients.
Slovenian: Za optimalno zdravljenje je pri vseh bolnikih potrebno terapevtsko spremljanje koncentracije zdravila.
English: If you prefer to take Rapamune without food, then you should always take it without food.
Slovenian: Če ga rajši jemljete brez hrane, ga vedno jemljite brez hrane.
English: Following administration of radiolabelled sirolimus, radioactivity is excreted in the milk of lactating rats.
Slovenian: Po dajanju radioaktivno označenega sirolimusa se je radioaktivnost pojavila v mleku podganjih samic.
English: The effective half-life, however, is shorter and mean steady-state concentrations were achieved after 5 to 7 days.
Slovenian: Efektivni razpolovni čas pa je krajši in srednje koncentracije v stanju dinamičnega ravnovesja so bile dosežene po 5 do 7 dneh.
English: Undesirable effects observed with prophylaxis of organ rejection in renal transplantation
Slovenian: Neželeni učinki, ki so jih opazili pri preprečevanju zavrnitve organa pri presaditvi ledvic
English: Clear polyvinyl chloride (PVC)/polyethylene (PE)/polychlorotrifluoroethylene (Aclar) aluminium blister packages of 30 and 100 tablets.
Slovenian: Pretisni omoti iz prozornega polivinil-klorida (PVC)/polietilena (PE)/poliklorotrifluoroetilena (Aclar) in aluminija v škatlah s 30 in 100 tabletami.
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.
Slovenian: Pri 24 zdravih prostovoljcih, ki so zaužili zdravilo Rapamune tablete skupaj z obrokom z visoko vsebnostjo maščob, so se vrednosti Cmax, tmax in AUC povečale za 65 %, 32 % oziroma 23 %.
English: Cytomegalovirus (CMV) prophylaxis is recommended for 3 months after renal transplantation, particularly for patients at increased risk for CMV disease.
Slovenian: Profilaksa proti citomegalovirusu (CMV) je priporočljiva prve 3 mesece po presaditvi ledvic, še zlasti pri bolnikih z zvečanim tveganjem za bolezni, ki jih povzroča CMV.
English: HMG-CoA reductase inhibitors
Slovenian: Zaviralci reduktaze HMG-CoA
English: During treatment with immunosuppressants, including Rapamune, vaccination may be less effective.
Slovenian: Med zdravljenjem z imunosupresivi, tudi z zdravilom Rapamune, je učinkovitost cepiva lahko zmanjšana.
English: Prophylaxis of Organ Rejection
Slovenian: Preprečevanje zavrnitve organa
English: Rapamune must not be diluted in grapefruit juice or any other liquid other than water or orange juice (see section 6.6).
Slovenian: Zdravila Rapamune ne smemo redčiti s sokom grenivke niti s katerokoli drugo tekočino, razen z vodo ali pomarančnim sokom (glejte poglavje 6.6).
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.
Slovenian: Če ocenjeni dnevni odmerek zaradi dodatka polnilnega odmerka preseže 40 mg, je treba dati polnilni odmerek v obdobju 2 dni.
English: It is not known whether Rapamune passes into breast milk.
Slovenian: Ni znano, ali zdravilo Rapamune prehaja v materino mleko.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA10.
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti; oznaka ATC: L04AA10.
English: Among 89 patients known to be Epstein-Barr virus (EBV) seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Slovenian: Med 89 bolniki, ki so bili pred presaditvijo dokazano seronegativni za virus Epstein-Barr (EBV), se je PTLD razvila pri 13 (15,6 %) bolnikih.
English: There are no or limited amount of data from the use of sirolimus in pregnant women.
Slovenian: Podatkov o uporabi sirolimusa pri nosečnicah ni oziroma so omejeni.
English: The inhibition of mTOR results in blockage of several specific signal transduction pathways.
Slovenian: Zaviranje mTOR vodi v blokado številnih specifičnih poti za prenos signalov.
English: Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, poleg tega zdravilo Rapamune ter ciklosporin vzemite vedno vsaj 4 ure narazen.
English: As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Slovenian: Kot je običajno pri bolnikih z zvečanim tveganjem za kožnega raka, je treba omejiti izpostavljanje sončni svetlobi in ultravijolični (UV) svetlobi z zaščitnimi oblačili in kremo za sončenje z visokim zaščitnim faktorjem.
English: Treatment emergent adverse events occurred more frequently during the first 6 months after Rapamune conversion.
Slovenian: Neželeni učinki zaradi zdravljenja so se pogosteje pojavljali v prvih 6 mesecih po prehodu na zdravilo Rapamune.
English: The study also failed to demonstrate non-inferiority of the rate of combined graft loss, missing survival data, or death for the sirolimus conversion group compared to the CNI continuation group.
Slovenian: V študiji prav tako niso uspeli dokazati neinferiornosti glede pogostnosti kombinirane izgube presadka, manjkajočih podatkov o preživetju ali smrti za skupino s prehodom na sirolimus v primerjavi s skupino, ki je nadaljevala s CNI.
English: Once the contents of the dosing syringe have been diluted with water or orange juice, the preparation should be drunk immediately.
Slovenian: Ko ste vsebino odmerne brizge razredčili z vodo ali pomarančnim sokom, morate pripravek spiti takoj.
English: Therapeutic monitoring of the medicinal product should not be the sole basis for adjusting sirolimus therapy.
Slovenian: Terapevtsko spremljanje koncentracije zdravila naj ne bo edino merilo prilagajanja zdravljenja s sirolimusom.
English: Rapamune contains ethanol (alcohol)
Slovenian: Zdravilo Rapamune vsebuje etanol (alkohol)
English: However, the development of such special dosing recommendations for children requires more data to be definitely confirmed.
Slovenian: Vendar bo za razvoj in potrditev takih posebnih priporočil odmerjanja pri otrocih potrebno več podatkov.
English: Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
Slovenian: Rifampicin je povečal izločanje sirolimusa za približno 5,5-krat ter zmanjšal AUC za približno 82 % in Cmax za približno 71 %.
English: Focal segmental glomerulosclerosis has been reported.
Slovenian: Poročali so o fokalni segmentni glomerulosklerozi.
English: In patients with severe hepatic impairment, it is recommended that the maintenance dose of Rapamune be reduced by approximately one-half.
Slovenian: Pri bolnikih s hudo okvaro jeter je vzdrževalni odmerek zdravila Rapamune priporočljivo zmanjšati za približno polovico.
English: The target for trough concentrations was 10-20 ng/mL.
Slovenian: Ciljna najmanjša koncentracija učinkovine je bila 10-20 ng/ml.
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.
Slovenian: V odprti, randomizirani, primerjalni in multicentrični študiji, v kateri so bolniki s presadki ledvic prešli s takrolimusa na sirolimus 3 do 5 mesecev po presaditvi ali so ostali na takrolimusu, po 2 letih ni bilo pomembne razlike v ledvični funkciji.
English: The 0.5 mg and 2 mg tablets also contain yellow iron oxide (E172) and brown iron oxide (E172).
Slovenian: Tableti po 0,5 mg in 2 mg vsebujeta tudi rumeni železov oksid (E172) in rjavi železov oksid (E172).
English: Inform your doctor if you have difficulty taking the tablet.
Slovenian: Obvestite zdravnika, če imate težave pri jemanju tablet.