FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risks of these effects (see section 4.5).
Slovenian: Določene kombinacije takrolimusa z zdravili, za katere je znano, da imajo nefrotoksične ali nevrotoksične učinke, lahko povečajo tveganje za te učinke (glejte poglavje 4.5).
English: Materials containing polyvinyl chloride (PVC) should not be used (see section 6.2).
Slovenian: Ne uporabljajte materialov, ki vsebujejo polivinilklorid (PVC) (glejte poglavje 6.2).
English: Other medicines and Modigraf
Slovenian: Druga zdravila in zdravilo Modigraf
English: The required dose is calculated from the weight of the patient, using the minimum number of sachets possible.
Slovenian: Potrebni dnevni odmerek se preračuna iz bolnikove telesne mase, in tako, da se uporabi najmanjše možno število vrečk.
English: Pour the prescribed volume of water (at room temperature) into a glass or cup, up to a maximum of 50 ml.
Slovenian: Predpisano količino vode (pri sobni temperaturi) zlijte v kozarec ali lonček, vendar ne več kot 50 ml.
English: Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).
Slovenian: Vrečke so iz plasti polietilen tereftalata (PET), aluminija (Al) in polietilena.
English: Carefully open the prescribed number of sachets, e.g. with a pair of scissors at the point indicated with an arrow.
Slovenian: Previdno odprite predpisano število vrečk, npr. s škarjami, na mestu, označenem s puščico.
English: In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
Slovenian: V tem primeru je začetni peroralni odmerek takrolimusa 2 do 4 mg na dan, uporabljen v kombinaciji z mofetilijevim mikofenolatom in kortikosteroidi ali v kombinaciji s sirolimusom in kortikosteroidi.
English: Clinical efficacy and safety of tacrolimus administered twice daily in other primary organ transplantation
Slovenian: Objavljene študije o klinični učinkovitosti in varnosti jemanja takrolimusa dvakrat dnevno pri primarnih presaditvah drugih organov
English: What Modigraf is and what it is used for
Slovenian: Kaj je zdravilo Modigraf in za kaj ga uporabljamo
English: Packs containing 50 sachets are available.
Slovenian: Na voljo je pakiranje s 50 vrečkami.
English: Tacrolimus treatment 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: Zdravljenje s takrolimusom pride v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
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: Vendar je zaradi nefrotoksičnega potenciala takrolimusa priporočljivo skrbno nadziranje delovanja ledvic (vključno z rednim določanjem koncentracije kreatinina v serumu, izračunavanjem očistka kreatinina in nadziranjem izločanja urina).
English: Pain in extremity has been described in a number of published case reports as part of CalcineurinInhibitor Induced Pain Syndrome (CIPS).
Slovenian: Bolečina v okončini je bila opisana v številnih objavljenih poročilih o primerih kot del bolečinskega sindroma, izzvanega z zaviralci kalcinevrina (CIPS - Calcineurin-Inhibitor Induced Pain Syndrome).
English: An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Slovenian: Objavljena je bila tudi alternativna strategija, pri kateri je bil takrolimus uveden v roku 12 ur po presaditvi.
English: Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ.
Slovenian: Prekinitev zdravljenja z zdravilom Modigraf lahko poveča tveganje za zavrnitev presajenega organa.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Slovenian: V praksi so zdravljenje s takrolimusom začenjali od 12 do 24 ur po ukinitvi ciklosporina.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Slovenian: Farmakoterapevtska skupina: imunosupresivi, zaviralci kalcinevrina, oznaka ATC: L04AD02
English: Pack size: carton box containing 50 sachets.
Slovenian: Velikost pakiranja: kartonasta škatla s 50 vrečkami.
English: The other metabolites have only weak or no immunosuppressive activity.
Slovenian: Ostali presnovki imajo le šibko imunosupresivno delovanje ali ga sploh nimajo.
English: Modigraf 1 mg granules for oral suspension EU/1/09/523/002
Slovenian: Modigraf 1 mg zrnca za peroralno suspenzijo EU/1/09/523/002
English: The incidences of acute rejection were numerically lower with tacrolimus in all 3 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 pri uporabi takrolimusa.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus.
Slovenian: Ker ni mogoče izključiti škodljivih učinkov na novorojenčka, ženske med zdravljenjem s takrolimusom ne smejo dojiti.
English: If signs of toxicity such as severe adverse reactions are noted (see section 4.8), the dose of Modigraf may need to be reduced.
Slovenian: Če se pojavijo znaki toksičnosti, na primer resni neželeni učinki (glejte poglavje 4.8), bo odmerek zdravila Modigraf morda treba zmanjšati.
English: Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''EXP''.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Modigraf.
Slovenian: Zdravnik vam bo od časa do časa moral narediti preiskave krvi, urina, srca in vida, da bo določil pravi odmerek zdravila Modigraf.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Slovenian: Kontroliranje najnižje koncentracije v polni krvi zato omogoča dobro oceno sistemske izpostavljenosti.
English: If you take Modigraf during pregnancy, it may pass into your baby through the placenta.
Slovenian: Če jemljete zdravilo Modigraf med nosečnostjo, lahko ta preide skozi posteljico v vašega otroka.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions.
Slovenian: Ventrikularno hipertrofijo ali hipertrofijo septuma, opisani kot kardiomiopatije, so opazili v redkih primerih.
English: It is normal that some granules stay behind; the sachet was designed that way.
Slovenian: Normalno je, da nekaj zrnc ostane v vrečki; vsebina vrečk je temu prilagojena.
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 pavianih.
English: Overall, the safety profile of oral 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 peroralni obliki v teh objavljenih študijah podobne tistemu, kar je znano iz velikih študij, v katerih so takrolimus v peroralni obliki uporabljali kot primarno zdravljenje po presaditvi jeter, ledvic in srca.
English: - The other ingredients are: lactose monohydrate, hypromellose (E464) and croscarmellose sodium (E468).
Slovenian: - Druge sestavine zdravila so: laktoza monohidrat, hipromeloza (E464) in premrežen natrijev karmelozat (E468).
English: febrile neutropenia
Slovenian: febrilna nevtropenija
English: The half-life in paediatric transplant patients averages approximately 12 hours.
Slovenian: Povprečen razpolovni čas pri pediatričnih bolnikih s presadki je približno 12 ur.
English: Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Slovenian: Glede na to je treba zelo ogrožene bolnike, še posebej male otroke in tiste, ki se zdravijo z intenzivno imunosupresijo, nadzorovati s preiskavami, kot sta ehokardiografija ali EKG, in sicer pred presaditvijo in po njej (npr. uvodoma po 3 mesecih in potem pri 9-12 mesecih).
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: 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 krčev ter takojšnja prekinitev sistemske uporabe takrolimusa.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Slovenian: Izogniti se je treba uporabi živih oslabljenih cepiv (glejte poglavje 4.4).
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Modigraf.
Slovenian: Pri tej skupini bolnikov je pred začetkom zdravljenja z zdravilom Modigraf treba izvesti serološko testiranje na EBV-VCA.
English: Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Slovenian: Takrolimus lahko podaljša interval QT in lahko povzroči Torsades de Pointes.
English: Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Slovenian: Evidentno je bilo zmanjšanje AUC (27 %) in Cmax (50 %) ter povečanje tmax (173 %) v polni krvi.
English: Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water.
Slovenian: Narahlo udarite po zaprtem delu vrečke in stresite vsebino vsake vrečke v kozarec ali lonček z vodo.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy.
Slovenian: V celoti je 34 bolnikov prešlo s ciklosporina na takrolimus, le 6 bolnikov na takrolimusu pa je potrebovalo drugo terapijo.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions 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: Tell your doctor immediately if during treatment you suffer from: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Slovenian: Nemudoma obvestite zdravnika, če se vam med zdravljenjem pojavijo: težave z vidom, npr. zamegljen vid, spremembe barvnega vida, težave pri videnju podrobnosti ali zožitev vidnega polja.
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 hepatic or renal function or neurological symptoms.
Slovenian: Te okužbe so pogosto povezane z visoko skupno obremenitvijo z imunosupresivi in lahko vodijo do resnih ali smrtno nevarnih stanj, kar morajo zdravniki upoštevati pri diferencialni diagnostiki pri bolnikih, ki se zdravijo z imunosupresivi in ki imajo oslabljeno delovanje jeter ali ledvic ali nevrološke simptome.
English: Tacrolimus is not compatible with PVC (polyvinylchloride) plastics.
Slovenian: Takrolimus ni kompatibilen z umetnimi masami iz polivinilklorida (PVC).
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. interlevkin-2, -3 in γ-interferon) ter izražanje receptorja za interlevkin-2.
English: headache, tremor common:
Slovenian: glavobol, tremor pogosti:
English: Decreases in AUC (2 to 12%) and Cmax (15 to 38%), and an increase in tmax (38 to 80%) in whole blood were evident.
Slovenian: Evidentno je bilo zmanjšanje AUC (od 2 do 12 %) in Cmax (od 15 do 38 %) ter povečanje tmax (od 38 do 80 %) v polni krvi.
English: In a study of stable renal transplant patients who were administered tacrolimus immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced.
Slovenian: V študiji s stabilnimi bolniki po presaditvi ledvic, ki so zaužili takrolimus takoj po standardnem kontinentalnem zajtrku, je bil učinek na biološko uporabnost po peroralni aplikaciji manj izrazit.
English: In healthy subjects, the mean half-life in whole blood was approximately 43 hours.
Slovenian: Pri zdravih preiskovancih je povprečni razpolovni čas v polni krvi približno 43 ur.
English: The suspension should be administered immediately after preparation.
Slovenian: Suspenzijo je treba zaužiti takoj po pripravi.
English: You may also be given Modigraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
Slovenian: Zdravilo Modigraf lahko dobite tudi zaradi zavračanja presajenih jeter, ledvic, srca ali drugega organa, oziroma če zdravila, ki ste jih jemali pred tem, niso obvladala imunskega odziva po presaditvi.
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s takrolimusom, so poročali o pojavu z Epstein-Barr virusom (EBV) povezanih limfoproliferativnih bolezni (glejte poglavje 4.8).
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. MRI).
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: Ker je perforacija prebavil medicinsko pomemben dogodek, ki lahko privede do življenjsko nevarnega ali resnega stanja, je pri pojavu simptomov ali znakov potrebno nemudoma uvesti ustrezno zdravljenje.
English: Dose adjustment during post-transplant period in adults and paediatric patients Tacrolimus doses are usually reduced in the post-transplant period.
Slovenian: Prilagoditve odmerka pri odraslih in pediatričnih bolnikih med obdobjem po presaditvi V obdobju po presaditvi se odmerki takrolimusa ponavadi zmanjšajo.
English: Patients are also at an increased risk of infections with viral hepatitis (for example, hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Slovenian: Pri bolnikih je tudi večje tveganje za pojav okužb z virusnim hepatitisom (na primer reaktivacija okužbe s hepatitisom B ali C ali prva okužba z njima, kot tudi s hepatitisom E, ki lahko postane kronična).
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je glede na koncentracijo v plazmi približno 1.300 l (zdravi preiskovanci).
English: Patients should be converted to oral therapy as soon as clinically practicable.
Slovenian: Zdravljenje je treba zamenjati s peroralnim takoj, ko je to klinično izvedljivo.
English: What Modigraf is and what it is used for What you need to know before you take Modigraf How to take Modigraf
Slovenian: Kaj je zdravilo Modigraf in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Modigraf Kako jemati zdravilo Modigraf Možni neželeni učinki
English: Blood trough levels should be monitored at least twice weekly during the early post-transplant period and then periodically during maintenance therapy.
Slovenian: Najnižje koncentracije v krvi je treba v zgodnjem potransplantacijskem obdobju nadzirati najmanj dvakrat tedensko in nato redno med vzdrževalnim zdravljenjem.
English: This effect may be enhanced if tacrolimus is administered in association with alcohol.
Slovenian: Ta učinek se lahko stopnjuje, če se takrolimus uporablja skupaj z alkoholom.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and phenazone.
Slovenian: Podatki, zbrani na živalih, kažejo, da bi takrolimus lahko zmanjšal očistek in podaljšal razpolovni čas pentobarbitala in fenazona.
English: Data from clinical studies suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 nanogram/ml.
Slovenian: Podatki iz kliničnih študij kažejo, da je mogoče večino bolnikov uspešno nadzirati, če je najnižja koncentracija takrolimusa v krvi vzdrževana pod 20 ng/ml.
English: Published clinical experience from a single centre on the use of oral tacrolimus for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Slovenian: Objavljene klinične izkušnje enega samega centra o uporabi peroralne oblike takrolimusa pri primarnem zdravljenju po presaditvi črevesa kažejo, da je bilo aktuarsko preživetje 155 bolnikov (65 samo črevo, 75 jetra in črevo, 25 multivisceralno), ki so dobivali takrolimus in prednizon, po 1 letu 75 %, po 5 letih 54 % in po 10 letih 42 %.
English: Human data demonstrate that tacrolimus is excreted into breast milk.
Slovenian: Podatki pri ljudeh kažejo, da se takrolimus izloča v materino mleko.
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Modigraf granules may commence orally.
Slovenian: Tok žolča ne vpliva na absorpcijo takrolimusa, zato se zdravljenje z zrnci Modigraf lahko začne peroralno.
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 analiz za določanje koncentracije takrolimusa v polni krvi.
English: This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus.
Slovenian: Ta se tipično pojavi kot obojestranska in simetrična, huda, ascendentna bolečina v spodnjih okončinah ter je lahko povezana s supraterapevtsko koncentracijo takrolimusa.
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 obseg absorpcije takrolimusa; ta učinek je največji po zelo mastnih obrokih.
English: Do not use cups or spoons that are made of PVC (polyvinylchloride) to take Modigraf because the active substance in Modigraf may stick to PVC.
Slovenian: Za jemanje zdravila Modigraf ne uporabljajte lončkov ali žlic, ki so narejeni iz PVC (polivinilklorida), ker se lahko zdravilna učinkovina zdravila Modigraf prilepi na PVC.
English: Tacrolimus blood trough levels should be determined approximately 12 hours post-dosing of Modigraf granules, just prior to the next dose.
Slovenian: Najnižjo koncentracijo takrolimusa je treba določiti približno 12 ur po uporabi zrnc Modigraf, tik pred naslednjim odmerkom.
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES) Poročali so, da se je pri bolnikih, ki se zdravijo s takrolimusom, razvil sindrom posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome).
English: Modigraf can be used with antibody induction (allowing for delayed start of tacrolimus therapy) or alternatively in clinically stable patients without antibody induction.
Slovenian: Zdravilo Modigraf se lahko uporablja z indukcijo protiteles, kar omogoča zakasnjen začetek terapije s takrolimusom, ali alternativno pri klinično stabilnih bolnikih brez indukcije protiteles.
English: In prospective published studies oral tacrolimus (given as Prograf capsules) was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Slovenian: V objavljenih prospektivnih študijah so takrolimus v peroralni obliki (Prograf kapsule) raziskovali kot primarni imunosupresiv pri približno 175 bolnikih po presaditvi pljuč, 475 bolnikih po presaditvi pankreasa in 630 bolnikih po presaditvi črevesa.
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: Results of a single dose bioequivalence study with adult healthy volunteers showed that Modigraf granules were approximately 20% more bioavailable than the Prograf capsules.
Slovenian: Rezultati bioekvivalenčne študije z enkratnim odmerjanjem pri zdravih moških prostovoljcih so pokazali, da je biološka uporabnost zrnc Modigraf približno za 20 % večja od tiste pri kapsulah Prograf.
English: The liquid should be drunk immediately after preparation.
Slovenian: Tekočino je treba zaužiti takoj po pripravi.
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 absorbira nepretrgoma skozi daljše obdobje, kar se kaže v relativno ploskem absorpcijskem profilu.
English: Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Slovenian: Številčno je bilo akutnih zavrnitvenih epizod na 100 bolnikovih dni v skupini s takrolimusom manj (0,85 epizode) kot v skupini s ciklosporinom (1,09 epizode).
English: The interim analysis of a recent multicentre study discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Slovenian: Vmesna analiza novejše multicentrične študije obravnava 110 bolnikov, ki so bili v razmerju 1 : 1 randomizirani na takrolimus ali ciklosporin.