FrancophonIA/ELRC3.0 huggingface dataset:
English: Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Slovenian: Takrolimus lahko podaljša interval QT, vendar za zdaj ni prepričljivih dokazov, da bi povzročal torsades de pointes.
English: Dose adjustment during post-transplant period in adults and children <Invented name> doses are usually reduced in the post-transplant period.
Slovenian: Prilagoditev odmerka med obdobjem po presaditvi pri odraslih in otrocih Odmerki <(Lastniško) ime zdravila> se med obdobjem po presaditvi ponavadi zmanjšajo.
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Slovenian: V literaturi objavljene koncentracije ter individualne vrednosti v klinični praksi je treba primerjati previdno in ob poznavanju uporabljene metode.
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Slovenian: Zdravljenje se mora začeti v 5 dneh po opravljeni operaciji, čim se bolnikovo stanje stabilizira.
English: In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Slovenian: Pri zdravih preiskovancih je povprečni razpolovni čas v polni krvi približno 43 ur.
English: <Invented name> is often used in combination with other medicines that also suppress the immune system.
Slovenian: <(Lastniško) ime zdravila> se pogosto uporablja v kombinaciji z drugimi zdravili, ki prav tako zavirajo imunski sistem.
English: Treatment with <Invented name> should not continue for more than 7 days.
Slovenian: Zdravljenje z <(Lastniško) ime zdravila> ne sme trajati več kot 7 dni.
English: Blood trough levels should be monitored approximately twice weekly during the early post-transplant period and then periodically during maintenance therapy.
Slovenian: Najmanjšo koncentracijo je treba med zgodnjim obdobjem po presaditvi nadzirati približno dvakrat na teden in potem redno med vzdrževalnim zdravljenjem.
English: Due to the need of treatment, tacrolimus can be considered in pregnant women when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
Slovenian: Ker je terapija potrebna, pride takrolimus v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
English: The other metabolites have only weak or no immunosuppressive activity.
Slovenian: Ostali presnovki imajo le šibko imunosupresijsko delovanje ali ga sploh nimajo.
English: The efficacy of tacrolimus for kidney transplantation has been investigated in a number of studies and different regimens and can nowadays be regarded as a well-established treatment option, both for primary immunosuppression and for rescue therapy.
Slovenian: Učinkovitost takrolimusa pri presaditvi ledvic je bila preučevana v številnih raziskavah in različnih shemah, zaradi česar danes velja za dobro uveljavljeno možnost zdravljenja, in sicer tako za doseganje primarne imunosupresije kot tudi za rešilno zdravljenje.
English: increased blood pressure common:
Slovenian: zvišan krvni tlak pogosti:
English: Hypersensitivity to tacrolimus or other macrolides.
Slovenian: Preobčutljivost za takrolimus ali druge makrolide.
English: Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Slovenian: Potransplantacijsko izboljšanje bolnikovega stanja lahko spremeni farmakokinetiko takrolimusa in potrebne utegnejo biti dodatne prilagoditve odmerka.
English: The incidences of acute rejection were numerically lower with tacrolimus in all three studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Slovenian: Incidenca akutnih zavrnitev je bila v vseh treh študijah številčno manjša s takrolimusom in v eni od teh študij so poročali o značilno manjši incidenci obliteracijskega bronhiolitisa s takrolimusom.
English: Heart transplantation in adults:
Slovenian: Presaditev srca pri odraslih:
English: However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).
Slovenian: Toda zaradi nefrotoksičnega potenciala takrolimusa je priporočljivo skrbno nadzirati delovanje ledvic (vključno z rednim določanjem koncentracije kreatinina v serumu, izračunavanjem očistka kreatinina in nadziranjem izločanja urina).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA [Izpolni država članica]
English: Limited knowledge of interactions between tacrolimus and statins is available.
Slovenian: Znanje o interakcijah med takrolimusom in statini je omejeno.
English: Caution is therefore necessary in patients who have previously received preparations containing polyoxyethylene castor oil derivatives either by intravenous injection or infusion, and in patients with an allergenic predisposition.
Slovenian: Zato je potrebna previdnost pri bolnikih, ki so kdaj dobili derivate polioksietilen ricinusovega olja v intravenski injekciji ali infuziji, in pri bolnikih z nagnjenostjo k alergijam.
English: - If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics.
Slovenian: - Če ste alergični na (preobčutljivi za) katerikoli antibiotik iz podskupine makrolidnih antibiotikov.
English: It would seem appropriate to recognise the de facto situation that tacrolimus is used in primary and rescue situations as an immunosupressant in liver transplantation and grant an appropriate therapeutic indication.
Slovenian: Kaže, da bi bilo primerno sprejeti de facto stanje, namreč da se takrolimus uporablja v primarni terapiji in v nujnih reševalnih situacijah kot imunosupresiv pri presaditvah jeter, ter podeliti ustrezno terapevtsko indikacijo.
English: As shown in both the published data and the ISHLT's annual report tacrolimus can substitute ciclosporin as primary immunosuppression therapy.
Slovenian: Kot kažejo objavljeni podatki in letno poročilo ISHLT, lahko takrolimus nadomesti ciklosporin v okviru primarnega imunosupresivnega zdravljenja.
English: Meteor Office Centre Park Sokolovská 100/94
Slovenian: Astellas Pharma s.r.o Meteor Office Centre Park Sokolovská 100/94
English: In head to head comparisons with ciclosporin it appears to have a modest efficacy advantage.
Slovenian: Na podlagi neposrednih primerjav s ciklosporinom se zdi, da ima manjšo prednost z vidika učinkovitosti.
English: Excretion Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Slovenian: Po intravenski in peroralni uporabi s 14C označenega takrolimusa se je večina radioaktivnosti izločila v blatu.
English: Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Slovenian: V urinu in blatu so našli manj kot 1 % nespremenjenega takrolimusa, kar kaže, da se takrolimus pred izločanjem skoraj povsem presnovi; glavna pot izločanja je žolč.
English: difficulty in sleeping common:
Slovenian: težave s spanjem pogosti:
English: In some patients, tacrolimus appears to be continuously absorbed over a prolonged period yielding a relatively flat absorption profile.
Slovenian: Pri nekaterih bolnikih se takrolimus stalno absorbira skozi daljše obdobje, tako da je absorpcijski profil razmeroma sploščen.
English: <Invented name> is taken orally twice daily, usually in the morning and evening.
Slovenian: <(Lastniško) ime zdravila> se zaužije dvakrat na dan, ponavadi zjutraj in zvečer.
English: - If you have diarrhoea for more than one day, please tell your doctor, because it might be necessary to adapt the dose of <Invented name> that you receive.
Slovenian: - Če imate drisko, ki traja več kot en dan, morate to povedati zdravniku, kajti potrebna utegne biti prilagoditev odmerka <(Lastniško) ime zdravila>, ki ga dobivate.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Slovenian: Obstajajo tudi dokazi o gastrointestinalni presnovi s CYP3A4 v črevesni steni.
English: Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml.
Slovenian: Klinično-raziskovalna analiza kaže, da je mogoče večino bolnikov uspešno voditi, če je najmanjša koncentracija takrolimusa v krvi vzdrževana pod 20 ng/ml.
English: Following oral administration of <Invented name> capsules peak concentrations (Cmax) of tacrolimus in blood are achieved in approximately 1 - 3 hours.
Slovenian: Po peroralni uporabi kapsul <(Lastniško) ime zdravila> doseže takrolimus največjo koncentracijo (Cmax) v krvi v približno 1 do 3 urah.
English: The effect of a high-carbohydrate meal is less pronounced.
Slovenian: Učinek obrokov, v katerih je veliko ogljikovih hidratov, je manj izrazit.
English: Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ.
Slovenian: Po presaditvi organa (npr. jeter, ledvic, srca) telo poskuša zavrniti novi organ.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta (vključno z izdelki rastlinskega izvora).
English: In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended (in particular the effects on the kidneys).
Slovenian: V primeru izpostavljenosti in utero je novorojenčka priporočljivo nadzirati glede možnih neželenih učinkov takrolimusa (zlasti učinki na ledvice).
English: Rejection therapy - adults and children
Slovenian: Zdravljenje zavrnitve - odrasli in otroci
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood including a semi-automated microparticle enzyme immunoassay (MEIA).
Slovenian: Kot pomoč za optimizacijo odmerjanja je na voljo več imunskih preskusov za določanje koncentracije takrolimusa v polni krvi, vključno s semiavtomatičnim encimskim imunskim preskusom z mikrodelci (MEIA).
English: In prospective published studies tacrolimus was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Slovenian: V prospektivnih objavljenih študijah so takrolimus raziskovali kot primarni imunosupresiv pri približno 175 bolnikih po presaditvi pljuč, 475 bolnikih po presaditvi pankreasa in 630 bolnikih po presaditvi črevesa.
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Slovenian: Ledvice in pankreas sta bila primarna organa, prizadeta v študijah toksičnosti pri podganah in opicah.
English: This medicinal product is authorised in the Member States of the EEA under the following name:
Slovenian: To zdravilo ima dovoljenje za promet v državah članicah EGP z naslednjim imenom: Prograf:
English: painful urination with blood in the urine Disorders affecting the body as a whole common:
Slovenian: boleče uriniranje s krvjo v urinu Bolezni, ki prizadenejo telo v celoti pogosti:
English: The half-life of tacrolimus is long and variable.
Slovenian: Razpolovni čas takrolimusa je dolg in variabilen.
English: For information on conversion from ciclosporin to <Invented name>, see below under “Dose adjustments in specific patient populations”.
Slovenian: Za informacije o prehodu s ciklosporina na <(Lastniško) ime zdravila> glejte v nadaljevanju, "Prilagoditve odmerjanja pri specifičnih populacijah bolnikov".
English: Paediatric liver transplant recipients have a TBC approximately twice that of adult liver transplant patients.
Slovenian: Pediatrični prejemniki jeter imajo CTO približno dvakrat tolikšen kot odrasli bolniki s presajenimi jetri.
English: Astellas Pharma Co. Ltd. 25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
Slovenian: Astellas Pharma Co. Ltd. 25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irska
English: Most cases have been reversible, occurring primarily in children with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Slovenian: Večina primerov je bila reverzibilna in pojavili so se v prvi vrsti pri otrocih, ki so imeli najmanjšo koncentracijo takrolimusa v krvi veliko večjo, kot je priporočena najvišja raven.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy (Bechstein et al., Transplantation 2004;77:1221).
Slovenian: V celoti je 34 bolnikov prešlo s ciklosporina na takrolimus, le 6 bolnikov na takrolimusu pa je potrebovalo drugo terapijo (Bechstein et al., Transplantation 2004;77:1221).
English: Like all medicines, <Invented name> can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo <(Lastniško) ime zdravila> neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Even the trials in liver and kidney transplantation were of only moderate size.
Slovenian: Celo preskušanja v zvezi s presaditvami ledvic in jeter so bile le zmernega obsega.
English: Overall, the safety profile of tacrolimus in these published studies appeared to be similar to what was reported in the large studies, where tacrolimus was used as primary treatment in liver, kidney and heart transplantation.
Slovenian: V celoti so bile varnostne značilnosti takrolimusa v teh objavljenih študijah podobne tistemu, kar je znano iz velikih študij, v katerih so takrolimus uporabljali kot primarno zdravljenje po presaditvi jeter, ledvic in srca.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving <Invented name>.
Slovenian: Ker ni mogoče izključiti zelo škodljivih učinkov na novorojenčka, ženske med uporabo <(Lastniško) ime zdravila> ne smejo dojiti.
English: Injury, poisoning and procedural complications common:
Slovenian: povečanje maščobnega tkiva Poškodbe, zastrupitve in postopkovni zapleti pogosti:
English: Via delle Industrie 1 20061 Carugate (Milano) Italy
Slovenian: Astellas Pharma S.p.A Via delle Industrie 1 20061 Carugate (Milano) Italija
English: A wording modification was introduced to section on pregnancy and lactation (4.6) in order to add clarity and to put it in line with the guideline on summary of product characteristics.
Slovenian: Sprememba je bila vključena v poglavje o nosečnosti in dojenju (4.6), da bi tako povečali njegovo jasnost ter ga uskladili s smernico o povzetku glavnih značilnosti zdravila.
English: changes in blood clotting, reduction in all blood cell counts rare:
Slovenian: spremembe v strjevanju krvi, zmanjšanje števila vseh krvnih celic redki:
English: dermatitis, photosensitivity rare:
Slovenian: dermatitis, fotosenzibilnost redki:
English: Fujisawa GmbH acting on behalf of all Marketing Authorisation holders (see Annex I) has applied for harmonisation according to Article 30 of Directive 2001/83/EC, as amended, of their products Prograf and associated names 0.5, 1 and 5 mg hard capsules (oral use) and Prograf and associated names 5 mg/ml concentrate for infusion (intravenous use).
Slovenian: Družba Fujisawa GmbH je v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I) vložila zahtevek za usklajevanje v skladu s členom 30 Direktive 2001/83/ES, kot je bila spremenjena, za svoje proizvode Prograf in z njim povezana imena 0,5, 1 in 5 mg trde kapsule (peroralna uporaba) ter Prograf in z njim povezana imena 5 mg/ml koncentrat za raztopino za infundiranje (intravenska uporaba).
English: hypertonia very rare:
Slovenian: hipertonija zelo redki:
English: Tacrolimus is extensively distributed in the body.
Slovenian: Takrolimus se izdatno razporedi po telesu.
English: The mean oral bioavailability of tarolimus is in the range of 20% - 25%.
Slovenian: Povprečna biološka uporabnost peroralno uporabljenega takrolimusa je od 20 do 25 %.
English: Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Slovenian: Opazni sta bili zmanjšanji AUC (27 %) in Cmax (50 %) ter povečanje tmax (173 %) v polni krvi.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Slovenian: Takrolimus zavira aktivacijo celic T in od celic T pomagalk odvisno proliferacijo celic B, pa tudi nastajanje limfokinov (npr. interlevkina-2, -3 in γ-interferona) ter izraženje receptorja za interlevkin-2.
English: primary graft dysfunction
Slovenian: primarna disfunkcija presadka
English: The presence of food decreases both the rate and extent of absorption of tacrolimus, the effect being most pronounced after a high-fat meal.
Slovenian: Prisotnost hrane zmanjša hitrost in stopnjo absorpcije takrolimusa; ta učinek je najizrazitejši po zelo mastnih obrokih.
English: If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Slovenian: Če so opazni klinični znaki zavrnitve, je treba razmisliti o spremembi imunosupresivne sheme.
English: Of note is the probable greater propensity of tacrolimus and ciclosporin to cause glucose intolerance and clinically manifest diabetes mellitus.
Slovenian: Omeniti je potrebno verjetno večjo nagnjenost takrolimusa in ciklosporina k povzročanju netolerance na glukozo ter klinično izraženega diabetesa mellitusa.
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Slovenian: Karbamazepin, metamizol in izoniazid lahko znižajo koncentracijo takrolimusa.
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Slovenian: Takrolimus se v veliki meri presnovi v jetrih, predvsem s citokromom P450-3A4.
English: Quality aspects do not form part of the current arbitration procedure.
Slovenian: V ta arbitražni postopek niso zajeti vidiki v zvezi s kakovostjo zdravila.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY (IES) OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Tatoiou Street Lamia National Road 14671 Nea Erythrea Greece
Slovenian: Tatoiou Street Lamia National Road 14671 Nea Erythrea Grčija
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Slovenian: Takrolimus je izredno močan imunosupresiv in njegovo delovanje je dokazano v poskusih in vitro in in vivo.
English: Not relevant.
Slovenian: Podatek ni potreben.
English: To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Slovenian: Za zavrtje zavrnitve presadka je treba imunosupresijo vzdrževati, zato trajanja peroralnega zdravljenja ni mogoče omejiti.
English: Therefore, metabolites do not contribute to pharmacological activity of tacrolimus.
Slovenian: Presnovki torej ne prispevajo k farmakološkemu delovanju takrolimusa.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the halflife of pentobarbital and antipyrine.
Slovenian: Pri živalih dobljeni podatki kažejo, da bi takrolimus lahko zmanjšal očistek in podaljšal razpolovni čas pentobarbitala in antipirina.
English: Patients should be converted to oral therapy as soon as clinically practicable.
Slovenian: Bolnik mora preiti na peroralno terapijo, čim je to klinično izvedljivo.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Slovenian: Omejeni podatki prejemnic presajenih organov ne kažejo, da bi med zdravljenjem s takrolimusom obstajalo večje tveganje za neželene učinke na potek in izid nosečnosti v primerjavi z drugimi imunosupresivnimi zdravili.
English: Other allografts (lung, pancreas and intestines)
Slovenian: Drugi alotransplantati (pljuča, pankreas in črevesje)
English: In addition, findings on clinical pharmacology were introduced in the sections on special warnings and precautions for use (4.4), interaction with other medicinal products and other forms of interaction (4.5) and the section on pharmacokinetic properties (5.2).
Slovenian: Poleg tega so bile v poglavja o posebnih opozorilih in previdnostnih ukrepih za uporabo (4.4), medsebojnem delovanju z drugimi zdravili in drugih oblikah interakcij (4.5) ter v poglavje o farmakokinetičnih lastnostih (5.2) vključene ugotovitve o klinični farmakologiji.
English: Target whole blood trough concentration recommendations Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient.
Slovenian: Priporočila za ciljno najnižjo koncentracijo v polni krvi Odmerjanje mora v prvi vrsti temeljiti na klinični oceni zavrnitve in prenašanju vsakega posameznega bolnika.
English: If you receive more <Invented name> than you should If you have received too much <Invented name>, your doctor will amend your next dose.
Slovenian: Če ste dobili večji odmerek zdravila <(Lastniško) ime zdravila>, kot bi smeli Če ste dobili preveč zdravila <(Lastniško) ime zdravila>, bo zdravnik prilagodil naslednji odmerek.
English: Conversion from ciclosporin
Slovenian: Prehod s ciklosporina
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo odobreno {MM/LLLL}.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Slovenian: Pri podganah je takrolimus povzročil toksične učinke na živčevju in očeh.
English: Results from published data in other primary organ transplantation <Invented name> has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
Slovenian: Rezultati iz objavljenih podatkov pri drugih primarnih presaditvah organov <(Lastniško) ime zdravila> se je uveljavil kot primarna imunosupresivna terapija po presaditvi pankreasa, pljuč in črevesa.
English: muscular weakness
Slovenian: šibkost mišic
English: An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Slovenian: Poročali so o alternativnem načinu, pri katerem so peroralni takrolimus uporabili v 12 urah po presaditvi.
English: When dosed orally, blood trough levels should be drawn approximately 12 hours post-dosing, just prior to the next dose.
Slovenian: Med peroralno uporabo je treba vzorce za določitev najmanjše koncentracije vzeti približno 12 ur po uporabi zdravila, tik pred naslednjim odmerkom.
English: Administration should commence approximately 12 hours after the completion of surgery.
Slovenian: Začeti se mora približno 12 ur po koncu operacije.
English: Tacrolimus may cause visual and neurological disturbances.
Slovenian: Takrolimus lahko povzroči motnje vida in nevrološke motnje.
English: Administration should commence within 24 hours after the completion of surgery.
Slovenian: Začeti se mora v 24 urah po koncu operacije.