FrancophonIA/ELRC3.0 huggingface dataset:
English: - The role of the patient card in ensuring that patients are aware of the product they are taking and the recommendations for safe and effective use in particular once daily dose and the importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of your doctor
Slovenian: - Vloga opozorilne kartice za bolnika pri zagotavljanju, da se bolnik zaveda, kakšno zdravilo uporablja, in priporočilu za varno in učinkovito uporabo, zlasti odmerka, ki se uporablja enkrat na dan, in da je pomembno, da ne pride do menjavanja z drugimi zdravili, ki vsebujejo takrolimus, razen po nasvetu in pod nadzorom zdravnika.
English: If you need to have any vaccinations, please tell your doctor before.
Slovenian: Če se morate cepiti s katerim koli cepivom, o tem predhodno obvestite zdravnika.
English: Injury, poisoning and procedural complications primary graft dysfunction
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih primarna disfunkcija presadka
English: - The importance of avoiding inadvertent switching between tacrolimus containing products and the risk of under and overdosing if monitoring is inadequate.
Slovenian: - Pomembnost preprečitve nenamernih zamenjav med zdravili, ki vsebujejo takrolimus, in tveganje premajhnega ali prevelikega odmerjanja, če spremljanje ni ustrezno.
English: In the de novo liver transplant study, 29 subjects were treated with Envarsus.
Slovenian: V študiji bolnikov z na novo presajenimi jetri je bilo 29 preiskovancev, zdravljenih z zdravilom Envarsus.
English: Stopping your treatment with Envarsus may increase the risk of rejection of your transplanted organ.
Slovenian: Prekinitev zdravljenja z zdravilom Envarsus lahko poveča tveganje za zavrnitev presajenega organa.
English: As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Slovenian: Perforacija prebavil je zdravstveno pomemben dogodek, ki lahko povzroči življenjsko nevarna ali resna stanja, zato je treba razmisliti o ustreznem zdravljenju takoj, ko se pojavijo domnevni simptomi ali znaki.
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: 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: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Slovenian: Podatki zbrani na živalih kažejo, da bi takrolimus lahko zmanjšal očistek in podaljšal razpolovni čas pentobarbitala in antipirina.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Envarsus.
Slovenian: Ker ni mogoče izključiti škodljivih učinkov na novorojenčka, ženske med uporabo zdravila Envarsus ne smejo dojiti.
English: Envarsus is used to control your body's immune response, enabling your body to accept the transplanted organ.
Slovenian: Zdravilo Envarsus se uporablja za obvladovanje telesnega imunskega odziva, kar omogoči, da telo sprejme presajeni organ.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Slovenian: Izogibati se je treba uporabi živih oslabljenih cepiv (glejte poglavje 4.4).
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Slovenian: - če ste alergični na sirolimus ali kateri koli makrolidni antibiotik (npr. eritromicin, klaritromicin,
English: Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.
Slovenian: Vse tablete s podaljšanim sproščanjem morate porabiti v 45 dneh po odprtju ovitka iz aluminijaste folije.
English: Data from clinical studies suggest that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/mL.
Slovenian: Analize kliničnih študij kažejo, da je mogoče večino bolnikov uspešno voditi, če je najmanjša koncentracija takrolimusa v krvi vzdrževana pod 20 ng/ml.
English: Tacrolimus reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Slovenian: Takrolimus zavira obrambni mehanizem telesa (imunski sistem), zato se manj učinkovito bojuje proti okužbam.
English: It is recommended that the oral daily dose of Envarsus is administered once daily in the morning.
Slovenian: Priporočeno je jemanje peroralnega odmerka zdravila Envarsus enkrat na dan zjutraj.
English: Limited knowledge of interactions between tacrolimus and statins is available.
Slovenian: O interakcijah med takrolimusom in statini je na voljo malo podatkov.
English: Contents of the pack and other information What Envarsus contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Envarsus
English: Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Slovenian: Pri bolnikih, zdravljenih s takrolimusom, so poročali o razvoju sindroma posteriorne reverzibilne encefalopatije (PRES).
English: In case of in utero exposure, monitoring of the newborn for potential adverse events of tacrolimus is recommended (in particular, effects on the kidneys).
Slovenian: V primeru izpostavljenosti in utero je novorojenčka priporočljivo nadzirati glede možnih neželenih učinkov takrolimusa (zlasti učinki na ledvice).
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Slovenian: Presnovki torej ne prispevajo k farmakološkemu delovanju takrolimusa.
English: As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Slovenian: Enako kot pri drugih imunosupresivnih sredstvih obstaja potencialno tveganje za maligne kožne spremembe, zato je treba izpostavljenost sončni in ultravijolični svetlobi omejiti: bolnik naj nosi varovalna oblačila in naj uporablja sredstvo za sončenje z visokim zaščitnim faktorjem.
English: Initial daily doses just after transplantation will generally be in the range of: 0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ.
Slovenian: Začetni dnevni odmerki tik po presaditvi so običajno v razponu: 0,11 - 0,17 mg na kg telesne mase na dan, odvisno od presajenega organa.
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 izražanje receptorja za interlevkin-2.
English: If you have accidentally taken too much Envarsus, contact your doctor or nearest hospital emergency department immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Envarsus, kot bi smeli Če ste po nesreči vzeli preveč zdravila Envarsus, takoj pojdite k svojemu zdravniku ali na urgentni oddelek najbližje bolnišnice.
English: This is because immunosuppressants could increase the risk of skin cancer.
Slovenian: Med imunosupresivnim zdravljenjem se lahko namreč poveča tveganje za razvoj raka na koži.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Slovenian: Farmakoterapevtska skupina: imunosupresivi, zaviralci kalcinevrina, oznaka ATC: L04AD02 Mehanizem delovanja
English: No studies have been conducted with conversion of patients from Advagraf to Envarsus; however, data from healthy volunteers would suggest that the same conversion rate is applicable as with the conversion from Prograf to Envarsus.
Slovenian: Študij prehoda bolnikov z zdravila Advagraf na zdravilo Envarsus niso opravili, vendar podatki pri zdravih prostovoljcih kažejo, da velja enaka stopnja prehoda kot pri prehodu z zdravila Prograf na zdravilo Envarsus.
English: It should be noted that black patients may require a higher dose to achieve the targeted trough levels.
Slovenian: Treba je pripomniti, da bodo morda bolniki črne rase potrebovali višje odmerke za doseganje ciljnih najnižjih koncentracij.
English: Human data demonstrate that tacrolimus is excreted in breast milk.
Slovenian: Podatki pri ljudeh kažejo, da se takrolimus izloča v materino mleko.
English: Following the initiation of your treatment with this medicine, frequent blood tests will be taken by your doctor to define the correct dose.
Slovenian: Po uvedbi zdravljenja s tem zdravilom bo zdravnik pogosto opravljal krvne preiskave in tako določil ustrezni odmerek.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Slovenian: Pred prihodom zdravila na trg se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva.
English: The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Envarsus pri otrocih, starih do 18 let, še nista bili dokazani.
English: The other metabolites have only weak or no immunosuppressive activity.
Slovenian: Ostali presnovki imajo le šibko imunosupresvno delovanje ali ga sploh nimajo.
English: Immunosuppressants may affect the response to vaccination, and vaccination during treatment with tacrolimus may be less effective.
Slovenian: Imunosupresivi lahko poslabšajo odziv na cepljenje, zato je cepljenje med zdravljenjem s takrolimusom lahko manj učinkovito.
English: • Patient cards to be given to patients with the product
Slovenian: • Opozorilno kartico za bolnika, ki jo bolnik prejme skupaj z zdravilom
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood.
Slovenian: Kot pomoč za optimizacijo odmerjanja je na voljo več imunskih preskusov za določanje koncentracije takrolimusa v polni krvi.
English: Patients should be advised to report changes in visual acuity, changes in colour vision, blurred vision, or visual field defect, and in such cases, prompt evaluation is recommended with referral to an ophthalmologist as appropriate.
Slovenian: Bolnikom je treba naročiti, da morajo sporočiti vsako spremembo ostrine vida, spremembo barvnega vida, zamegljen vid ali izpad vidnega polja; v takšnih primerih je priporočljiva takojšnja obravnava in napotitev k oftalmologu, če je potrebno.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Slovenian: Druge možne interakcije, ki lahko povečajo sistemsko izpostavljenost takrolimusu, vključujejo prokinetične učinkovine (kot sta metoklopramid in cisaprid), cimetidin in magnezij-aluminijev hidroksid.
English: Post-transplant changes 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: Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Slovenian: Po prehodu na katero koli alternativno farmacevtsko obliko je potrebno terapevtsko nadziranje zdravila in prilagoditev odmerka, da se zagotovi stalna sistemska izpostavljenost takrolimusu.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse events 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 pojav neželenih učinkov na potek in izid nosečnosti v primerjavi z drugimi imunosupresivnimi zdravili.
English: Other medicines and Envarsus
Slovenian: Druga zdravila in zdravilo Envarsus
English: What you need to know before you take Envarsus Do not take Envarsus:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Envarsus Ne jemljite zdravila Envarsus:
English: What Envarsus is and what it is used for
Slovenian: Kaj je zdravilo Envarsus in za kaj ga uporabljamo
English: Tacrolimus is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Slovenian: Takrolimus se v začetnem pooperacijskem obdobju uporablja rutinsko skupaj z drugimi imunosupresivi.
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Slovenian: Če se ugotovi prisotnost PRES, je potreben ustrezen nadzor krvnega tlaka in epileptičnih napadov ter takojšnja prekinitev sistemske uporabe takrolimusa.
English: In clinical practice, whole blood trough levels have generally been in the range of 5-20 ng/mL in kidney transplant patients in the early post-transplant period, and 5-15 ng/mL during subsequent maintenance therapy.
Slovenian: V klinični praksi so bile najmanjše koncentracije v polni krvi v zgodnjem obdobju po presaditvi pri prejemnikih ledvic na splošno v območju od 5 do 20 ng/ml in v območju od 5 do 15 ng/ml pri poznejšem vzdrževalnem zdravljenju.
English: Envarsus is supplied in PVC blisters containing 10 tablets.
Slovenian: Zdravilo Envarsus je na voljo v pretisnih omotih iz PVC, ki vsebujejo po 10 tablet.
English: Mean values for Cmax, percentage degree of fluctuation and percentage degree of swing were significantly lower with administration of Envarsus tablets.
Slovenian: Povprečne vrednosti Cmax, odstotna stopnja fluktuacije in odstotna stopnja nihanja so bile značilno nižje pri uporabi zdravila Envarsus tablete.
English: To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Slovenian: Za preprečitev zavrnitve presadka je treba imunosupresijo vzdrževati, zato trajanja peroralnega zdravljenja ni mogoče omejiti.
English: A number of associated cases of transplant rejection have been reported.
Slovenian: Poročali so o več povezanih primerih zavrnitve presadka.
English: Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure.
Slovenian: Previdnost je potrebna pri prehodu s kombiniranega zdravljenja s ciklosporinom, ki ovira enterohepatično kroženje mikofenolne kisline, na takrolimus, ki tega učinka nima, kajti takšen prehod lahko spremeni izpostavljenost mikofenolni kislini.
English: What Envarsus is and what it is used for 2.
Slovenian: Kaj je zdravilo Envarsus in za kaj ga uporabljamo 2.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Slovenian: Večina primerov je bila reverzibilna in se je pojavila v primerih, ko je bila najmanjša koncentracija takrolimusa v krvi veliko večja, kot je priporočena najvišja raven.
English: Avoid grapefruit (also as juice) while on treatment with Envarsus, since it can affect its levels in the blood.
Slovenian: Med zdravljenjem z zdravilom Envarsus se morate izogibati uživanju grenivk (tudi soka), saj lahko vpliva na ravni zdravila v krvi.
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful if used shortly after intake.
Slovenian: Pri peroralni intoksikaciji lahko pomaga izpiranje želodca in/ali uporaba adsorbentov (npr. aktivnega oglja), če so uporabljeni kmalu po zaužitju.
English: Tacrolimus passes into breast milk.
Slovenian: Takrolimus prehaja v materino mleko.
English: All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medicinal product associated with PRCA.
Slovenian: Pri vseh bolnikih so poročali o dejavnikih tveganja za PRCA, kot so okužba s parvovirusom B19, osnovna bolezen ali sočasno jemanje zdravil, povezanih s PRCA.
English: It is not recommended that Envarsus is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Slovenian: Jemanje zdravila Envarsus skupaj s ciklosporinom (drugo zdravilo, ki se uporablja za preprečevanje zavrnitve presadka) se ne priporoča.
English: This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-exposure to tacrolimus.
Slovenian: To je povzročilo hude neželene učinke, vključno z zavrnitvijo presadka, ali druge neželene učinke, ki so lahko posledica premajhne ali prevelike izpostavljenosti takrolimusu.
English: Mycophenolic acid
Slovenian: Mikofenolna kislina
English: This can lead to graft rejection or increased incidence of adverse reactions, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Slovenian: To lahko povzroči zavrnitev presadka ali poveča incidenco neželenih učinkov, vključno s premajhno ali preveliko imunosupresijo zaradi klinično pomembnih razlik v sistemski izpostavljenosti takrolimusu.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1,300 L (healthy subjects).
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je glede na koncentracijo v plazmi približno 1.300 litrov (zdravi preiskovanci).
English: PVC blisters containing 10 prolonged-release tablets.
Slovenian: Pretisni omoti iz PVC, ki vsebujejo 10 tablet s podaljšanim sproščanjem.
English: Experience with overdose is limited.
Slovenian: Izkušenj s prevelikim odmerjanjem je malo.
English: If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures and visual disturbances, a radiological procedure (e.g. MRI) should be performed.
Slovenian: Če se pri bolnikih, ki jemljejo takrolimus, pojavijo znaki, ki kažejo na PRES, kot so glavobol, spremenjeno duševno stanje, krči in motnje vida, je treba izvesti radiološko slikanje (npr. MRS).
English: Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Slovenian: Zdravljenje s takrolimusom je treba začeti upoštevaje koncentracijo ciklosporina v krvi in bolnikovo klinično stanje.
English: In vitro test results indicate that there is no risk of in vivo dose dumping related to alcohol intake.
Slovenian: Rezultati testov in vitro kažejo, da in vivo ni tveganja za takojšnjo sprostitev odmerka, povezano z uživanjem alkohola.
English: How should I take the Envarsus tablets Envarsus is taken orally once daily, generally on an empty stomach.
Slovenian: Zdravilo Envarsus se jemlje peroralno enkrat na dan, načeloma na prazen želodec.
English: If abnormalities develop, dose reduction of tacrolimus or change of treatment to another immunosuppressive agent should be considered.
Slovenian: Če se pojavijo nenormalnosti, je treba razmisliti o zmanjšanju odmerka takrolimusa ali o prehodu na drugo imunosupresivno zdravilo.
English: The oral bioavailability is approximately 40% higher for Envarsus as compared to the same dose of tacrolimus immediate-release formulation (Prograf) in kidney transplant patients.
Slovenian: Peroralna biološka razpoložljivost je približno 40 % večja za zdravilo Envarsus v primerjavi z enakim odmerkom takrolimusa v farmacevtski obliki s takojšnjim sproščanjem (zdravilo Prograf) pri bolnikih po presaditvi ledvice.
English: The treatment difference (Envarsus-Prograf) was 0% (95% confidence interval [4.21%, 4.21%]).
Slovenian: Razlika v zdravljenju (zdravilo Envarsuszdravilo Prograf) je bila 0 % (95-odstotni interval zaupanja [-4,21 %; 4,21 %]).
English: If you stop taking Envarsus
Slovenian: Če ste prenehali jemati zdravilo Envarsus
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Slovenian: Biotransformacija Takrolimus se v veliki meri presnovi v jetrih, predvsem s citokromom P450-3A4.
English: In adult liver, kidney, and heart transplant patients, values of 4.1 L/h, 6.7 L/h, and 3.9 L/h, respectively, have been observed.
Slovenian: Pri odraslih bolnikih so po presaditvi jeter opazili vrednost 4,1 l/h, po presaditvi ledvice 6,7 l/h in po presaditvi srca 3,9 l/h.
English: The pharmacokinetics, efficacy and safety of Envarsus and tacrolimus immediate-release capsules, both in combination with corticosteroids were compared in 117 liver transplant recipients, of whom 88 received treatment with Envarsus.
Slovenian: Primerjali so farmakokinetiko, učinkovitost in varnost zdravila Envarsus in kapsul takrolimusa s takojšnjim sproščanjem, oboje v kombinaciji s kortikosteroidi pri 117 bolnikih po presaditvi jeter, od katerih jih je 88 prejemalo zdravilo Envarsus.
English: When converting from tacrolimus immediate-release products (e.g. Prograf capsules) or from Advagraf prolonged-release capsules to Envarsus, trough levels should be measured prior to conversion and within two weeks after conversion.
Slovenian: Pri prehodu s takrolimusa s takojšnjim sproščanjem (npr. zdravila Prograf kapsule) ali z zdravila Advagraf kapsule s podaljšanim sproščanjem na zdravilo Envarsus je treba najnižje vrednosti takrolimusa izmeriti pred prehodom in nato dva tedna po prehodu.
English: Pharmacokinetics studies have indicated that the increase in blood levels is mainly a result of increase in oral bioavailability of tacrolimus owing to the inhibition of gastrointestinal metabolism.
Slovenian: Farmakokinetične študije so pokazale, da je zvišanje koncentracije v krvi v glavnem posledica večje biološke uporabnosti peroralnega takrolimusa zaradi zaviranja presnove v prebavilih.
English: • Envarsus 4 mg tablets:
Slovenian: • Envarsus 4 mg tablete:
English: Envarsus is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to maximum blood concentration (Cmax) of approximately 6 hours (tmax) at steady state.
Slovenian: Zdravilo Envarsus je farmacevtska oblika takrolimusa s podaljšanim sproščanjem in posledičnim podaljšanim profilom peroralne absorpcije s povprečnim časom do največje koncentracije v krvi (Cmax) približno 6 ur (tmax) v stanju dinamičnega ravnovesja.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Slovenian: Pri podganah in kuncih je takrolimus povzročil embriofetalne toksične učinke v odmerkih, ki so imeli toksične učinke pri materah (glejte poglavje 5.3).
English: You may also be given Envarsus for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Slovenian: Zdravilo Envarsus lahko dobite tudi zaradi zavračanja presajenih jeter, ledvic, srca ali drugega organa, če zdravila, ki ste jih jemali pred tem, niso obvladala imunskega odziva po presaditvi.