FrancophonIA/ELRC3.0 huggingface dataset:
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Croatian: U sistemskoj cirkulaciji samo jedan od nedjelatnih metabolita je prisutan u niskim koncentracijama.
English: Children and adolescents will receive doses of Modigraf calculated in the same way as adults.
Croatian: Djeca i adolescenti će primati doze Modigrafa koje su izračunate na isti način kao i odraslima.
English: Suspend the granules in water.
Croatian: Pomiješajte granule u vodi.
English: In addition, synergistic/additive nephrotoxic effects can occur.
Croatian: Osim toga, mogu nastupiti sinergistički/aditivni nefrotoksični učinci.
English: What Modigraf is and what it is used for
Croatian: Što je Modigraf i za što se koristi
English: Pack size: carton box containing 50 sachets.
Croatian: Veličina pakiranja: kartonska kutija koja sadrži 50 vrećica.
English: Materials containing polyvinyl chloride (PVC) should not be used (see section 6.2).
Croatian: Ne smiju se koristiti materijali koji sadrže polivinil klorid (PVC) (vidjeti dio 6.2).
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.
Croatian: Liječenje takrolimusom može se razmotriti u trudnica kada nema sigurnije alternative i kada očekivana korist opravdava mogući rizik za fetus.
English: Other medicines and Modigraf
Croatian: Drugi lijekovi i Modigraf
English: 50 sachets containing granules for oral suspension.
Croatian: 50 vrećica koje sadrže granule za oralnu suspenziju.
English: Clinically significant interactions have also been observed with phenobarbital.
Croatian: Klinički značajne interakcije također su bile opažene s fenobarbitalom.
English: Available tacrolimus is generally rapidly absorbed.
Croatian: Dostupni takrolimus općenito se brzo apsorbira.
English: Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).
Croatian: Vrećice koje se sastoje od slojeva polietilentereftalata (PET), aluminija (Al) i polietilena (PE).
English: toxic epidermal necrolysis (Lyell's syndrome)
Croatian: toksična epidermalna nekroliza (Lyellov sindrom)
English: If the physical appearance has changed from the normal white granules, or if dose instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Croatian: Ako se izgled lijeka promijenio od normalnih bijelih granula ili ako su se upute za doze promijenile, obratite se čim prije liječniku ili ljekarniku kako biste provjerili uzimate li pravi lijek.
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Croatian: Nema dokaza da bolesnici muškog i ženskog spola zahtijevaju različite doze da bi se postigle slične najniže razine.
English: When treating rejection, these same doses may be used.
Croatian: Za liječenje odbacivanja organa mogu se koristiti iste doze.
English: The course of pre-existing infections may be aggravated.
Croatian: Tijek već postojećih infekcija može se pogoršati.
English: In case of sun exposure, wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Croatian: U slučaju izlaganja suncu nosite odgovarajuću zaštitnu odjeću i koristite sredstva s visokim faktorom zaštite od sunca.
English: Materials used to prepare and administer the suspension, e.g. drinking vessels, cups, or tubing, must not contain PVC.
Croatian: Materijali koji se koriste za pripremu i primjenu suspenzije, npr. posude za piće, šalice ili cjevčice ne smiju sadržavati PVC.
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.
Croatian: Usporedbe koncentracija u objavljenoj literaturi s pojedinačnim vrijednostima u kliničkoj praksi treba procijeniti s pažnjom i poznavanjem metode korištenog testa.
English: Children and adolescents may experience the same side effects as adults.
Croatian: Djeca i adolescenti mogu iskusiti iste nuspojave kao i odrasli.
English: Clinical efficacy and safety of tacrolimus administered twice daily in other primary organ transplantation
Croatian: Klinička djelotvornost i sigurnost takrolimusa primijenjenog dvaput na dan kod primarne transplantacije drugih organa
English: The effect of a high-carbohydrate meal is less pronounced.
Croatian: Učinak obroka bogatog ugljikohidratima manje je izražen.
English: - If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na takrolimus ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Modigraf.
Croatian: Nemojte voziti niti koristiti alate ili strojeve ako osjećate omaglicu ili pospanost ili imate zamagljen vid nakon uzimanja Modigrafa.
English: The required dose is calculated from the weight of the patient, using the minimum number of sachets possible.
Croatian: Potrebna doza izračunava se na temelju tjelesne težine bolesnika koristeći najmanji mogući broj vrećica.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Croatian: Nadziranje najnižih razina u punoj krvi stoga daje dobru procjenu sistemske izloženosti.
English: If you need to have any vaccinations, please tell your doctor before.
Croatian: Ako morate primiti bilo kakvo cjepivo, molimo prije toga obavijestite svog liječnika.
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Croatian: Doza će Vam ovisiti o općem stanju i o drugim imunosupresivnim lijekovima koje uzimate.
English: In general children need higher doses per kg of body weight to achieve the same effective levels in the blood as adults.
Croatian: Općenito, djeca će trebati više doze po kg tjelesne težine kako bi se dostigla ista djelotvorna razina u krvi kao u odraslih.
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Croatian: Doza se može razlikovati ovisno o odabranom imunosupresivnom režimu.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Croatian: Početnu dozu za sprječavanje odbacivanja presađenog organa odredit će Vaš liječnik tako što će je izračunati prema Vašoj tjelesnoj težini.
English: Modigraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Croatian: Modigraf slabi obrambeni mehanizam (imunološki sustav) Vašeg tijela koji zato više neće biti tako dobar u borbi protiv infekcija.
English: Limited knowledge of interactions between tacrolimus and statins is available.
Croatian: Dostupno je ograničeno poznavanje interakcija takrolimusa i statina.
English: Tacrolimus is not compatible with PVC (polyvinylchloride) plastics.
Croatian: Takrolimus nije kompatibilan s plastikom od PVC-a (polivinilklorid).
English: This is because immunosuppressants like Modigraf could increase the risk of skin cancer.
Croatian: Razlog je taj što imunosupresivi kao što je Modigraf mogu povećati rizik od raka kože.
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.
Croatian: Nemojte koristiti šalice ili žlice napravljene od PVC-a (polivinilklorida) za uzimanje Modigrafa zato što se djelatna tvar u Modigrafu može zalijepiti za PVC.
English: Not known (frequency cannot be estimated from the available data): Abnormality of the optic nerve (optic neuropathy)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): poremećaj vidnog živca (optička neuropatija)
English: Efficacy results of the largest studies in each indication are summarised below.
Croatian: Rezultati djelotvornosti u najvećim ispitivanjima u svakoj od ovih indikacija sažeti su u nastavku.
English: Your doctor may need to adjust your dose of Modigraf.
Croatian: Liječnik će Vam možda trebati prilagoditi dozu Modigrafa.
English: If you have accidentally taken too much Modigraf, contact your doctor or nearest hospital emergency department immediately.
Croatian: Ako ste slučajno uzeli previše Modigrafa, odmah se javite liječniku ili otiđite na hitnu službu u najbližu bolnicu.
English: You will need to take Modigraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Croatian: Modigraf ćete morati uzimati svaki dan onoliko dugo koliko Vam je potrebna imunosupresija zbog sprečavanja odbacivanja presađenog organa.
English: It is normal that some granules stay behind; the sachet was designed that way.
Croatian: Normalno je da nešto granula zaostane u vrećici, vrećica je tako napravljena.
English: Tacrolimus may cause visual and neurological disturbances.
Croatian: Takrolimus može prouzročiti vidne i neurološke poremećaje.
English: You should keep in regular contact with your doctor.
Croatian: Trebate se redovito javljati liječniku.
English: If you take Modigraf during pregnancy, it may pass into your baby through the placenta.
Croatian: Ako uzmete Modigraf tijekom trudnoće, on može proći kroz posteljicu do Vašeg djeteta.
English: Carefully open the prescribed number of sachets, e.g. with a pair of scissors at the point indicated with an arrow.
Croatian: Pažljivo otvorite propisani broj vrećica, npr. pomoću škara na točki koju pokazuje strelica.
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.
Croatian: S obzirom da je gastrointestinalna perforacija medicinski važan događaj koji može dovesti do ozbiljnog stanja ili stanja opasnog po život, trebalo bi provesti adekvatno liječenje odmah nakon sumnje na simptome ili znakove koji se pojave.
English: This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Croatian: Ovaj je pristup bio rezerviran za bolesnike bez poremećaja funkcije organa (npr. poremećaja funkcije bubrega).
English: Modigraf is used to control your body's immune response enabling your body to accept the transplanted organ.
Croatian: Modigraf se primjenjuje za kontrolu imunološkog odgovora što Vašem tijelu omogućuje da prihvati presađeni organ.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus.
Croatian: Budući da se štetni učinci na novorođenče ne mogu isključiti, žene ne smiju dojiti za vrijeme primanja takrolimusa.
English: The half-life of tacrolimus is long and variable.
Croatian: Poluvijek takrolimusa je dug i raznolik.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Croatian: EBV-PCR može biti prisutan mjesecima i sam po sebi ne upućuje na limfoproliferativnu bolest ili limfom.
English: Data on oral bioavailability of Modigraf in other indications is not available.
Croatian: Podaci o peroralnoj bioraspoloživosti Modigrafa u drugim indikacijama nisu dostupni.
English: In healthy subjects, the mean half-life in whole blood was approximately 43 hours.
Croatian: U zdravih ispitanika srednji poluvijek u punoj krvi iznosio je približno 43 sata.
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.
Croatian: Ako se opaze znakovi toksičnosti kao što su teške nuspojave (vidjeti dio 4.8), dozu Modigrafa možda će trebati sniziti.
English: The liquid should be drunk immediately after preparation.
Croatian: Tekućinu treba popiti odmah nakon pripreme.
English: What Modigraf looks like and contents of the pack
Croatian: Kako Modigraf izgleda i sadržaj pakiranja
English: For accurate measuring the volume of water you can use a syringe or graduated cylinder.
Croatian: Za točno mjerenje volumena vode možete uporabiti štrcaljku ili mjernu posudu.
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definira se na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Croatian: Dozu treba prilagoditi kako bi se osiguralo održanje slične sistemske izloženosti.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Croatian: U štakora je takrolimus prouzročio toksične učinke na živčani sustav i oči.
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.
Croatian: U slučajevima peroralnog otrovanja, ispiranje želuca i/ili primjena adsorbensa (kao što je aktivni ugljen) mogu biti od pomoći ako se primijene ubrzo nakon gutanja.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Croatian: U praksi se terapija na bazi takrolimusa započinje 12 do 24 sata nakon prekida ciklosporina.
English: Therefore, you may be more prone to infections while you are taking Modigraf.
Croatian: Stoga možete biti skloniji infekcijama dok uzimate Modigraf.
English: Hold the opened sachet between thumb and index finger above the cup with the open side of the sachet facing downwards.
Croatian: Držite otvorenu vrećicu palcem i kažiprstom iznad šalice tako da otvorena strana vrećice gleda prema dolje.
English: No studies on the effects of tacrolimus (Modigraf) on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka takrolimusa (Modigraf) na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pour the prescribed volume of water (at room temperature) into a glass or cup, up to a maximum of 50 ml.
Croatian: Natočite propisani volumen vode (sobne temperature) u čašu ili šalicu do najviše 50 ml.
English: It is not recommended that Modigraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Croatian: Ne preporučuje se uzimati Modigraf s ciklosporinom (drugi lijek koji se koristi za prevenciju odbacivanja organa prilikom transplantacije).
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood.
Croatian: Kao pomoć u optimizaciji doziranja dostupno je nekoliko imunotestova za određivanje koncentracije takrolimusa u punoj krvi.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Croatian: Kao i za druge jake imunosupresivne spojeve, nije poznat rizik od sekundarnog karcinoma (vidjeti dio 4.8).
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Croatian: Volumen distribucije pri dinamičkoj ravnoteži koncentracije u plazmi iznosi približno 1300 l (zdravi ispitanici).
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.
Croatian: Također možete primati Modigraf zbog odbacivanja presađene jetre, bubrega, srca ili drugog organa koje je u tijeku ili ako se liječenjem koje ste prije uzimali nije mogao kontrolirati Vaš imunološki odgovor nakon presađivanja organa.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze-galaktoze ne smiju uzimati ovaj lijek.
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).
Croatian: Određene kombinacije takrolimusa s lijekovima za koje se zna da imaju nefrotoksične ili neurotoksične učinke mogu povećati rizik od nastanka tih učinaka (vidjeti dio 4.5).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Elderly patients There is no evidence currently available to indicate that dosing should be adjusted in older people.
Croatian: Trenutno nema dostupnih podataka koji bi pokazivali da je u starijih osoba potrebno prilagoditi dozu.
English: Modigraf granules for oral suspension are white granules supplied in sachets.
Croatian: Modigraf granule za oralnu suspenziju bijele su granule koje se nalaze u vrećicama.
English: There are no safety data available on the use of Modigraf granules following a temporary switch from Prograf or Advagraf in critically ill patients.
Croatian: Nema dostupnih podataka o sigurnosti primjene Modigraf granula nakon privremenog prelaska s Prografa ili Advagrafa u kritično bolesnih bolesnika.
English: Take Modigraf on an empty stomach or 2 to 3 hours after a meal.
Croatian: Uzmite Modigraf na prazan želudac ili 2 do 3 sata nakon obroka.
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Croatian: Pazite da svaki put kad podižete lijek na recept dobijete isti lijek s takrolimusom, osim ako se Vaš liječnik specijalist transplantacijske medicine složio s time da se lijek koji uzimate zamijeni drugim lijekom s takrolimusom.
English: An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Croatian: Objavljena je i alternativna strategija gdje se takrolimus davao peroralno u roku od 12 sati nakon transplantacije.
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.
Croatian: Ukupno se sigurnosni profil peroralnog takrolimusa u ovim objavljenim ispitivanjima činio sličnim onome zabilježenom u velikim ispitivanjima u kojima se takrolimus primjenjivao kao primarno liječenje kod transplantacije jetre, bubrega i srca.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Croatian: U slučaju predoziranja potrebno je uvesti opće potporne mjere i simptomatsko liječenje.
English: very rare:
Croatian: Vrlo rijetko:
English: Modigraf is taken orally twice daily, usually in the morning and evening.
Croatian: Modigraf se uzima kroz usta dvaput na dan, obično ujutro i navečer.
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Croatian: 5 dana nakon završetka operacije, čim se kliničko stanje bolesnika stabilizira.
English: Severe effects may occur, including allergic and anaphylactic reactions (a very serious type of allergic reaction with fainting and difficulty breathing, which needs immediate medical attention).
Croatian: Mogu nastupiti teški učinci, uključujući alergijske reakcije i anafilaktične reakcije (vrlo ozbiljna vrsta alergijske reakcije s nesvjesticom i otežanim disanjem koju treba odmah liječiti).
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.
Croatian: Sniženje doze može biti potrebno u bolesnika s teškim oštećenjem jetre kako bi se najniže razine u krvi održale unutar preporučenog ciljnog raspona.
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.
Croatian: Podaci iz kliničkih ispitivanja pokazuju da se većina bolesnika može uspješno liječiti ako se najniže razine takrolimusa u krvi održavaju ispod 20 nanogram/ml.
English: Tacrolimus is extensively distributed in the body.
Croatian: Takrolimus se opsežno distribuira u tijelu.
English: What Modigraf contains
Croatian: Što Modigraf sadrži
English: In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.
Croatian: Pedijatrijska populacija Pedijatrijski bolesnici uglavnom zahtijevaju doze 1½ do 2 puta više od doza za odrasle da bi se postigle slične razine u krvi.
English: Grapefruit and grapefruit juice should be avoided while taking Modigraf, since it can affect its levels in the blood.
Croatian: Grejp i sok od grejpa bi trebali izbjegavati dok uzimate Modigraf, budući da može utjecati na razinu lijeka u krvi.
English: In adult and paediatric liver transplant patients, it averaged 11.7 hours and 12.4 hours, respectively, compared with 15.6 hours in adult kidney transplant recipients.
Croatian: U odraslih i pedijatrijskih bolesnika s presatkom jetre prosječno je iznosio 11,7 sati odnosno 12,4 sati u usporedbi s 15,6 sati u odraslih bolesnika s presatkom bubrega.
English: Modigraf granules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Croatian: Modigraf granule općenito treba primijeniti na prazan želudac ili najmanje 1 sat prije ili 2 do 3 sata poslije obroka da bi se postigla najveća apsorpcija (vidjeti dio 5.2).
English: In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Croatian: U ženki štakora bila je oštećena reproduktivna funkcija uključujući rađanje pri toksičnim dozama i potomstvo je pokazivalo smanjenu porođajnu tjelesnu težinu, sposobnost za život i rast.
English: Tacrolimus blood trough levels should be determined approximately 12 hours post-dosing of Modigraf granules, just prior to the next dose.
Croatian: Najniže razine takrolimusa u krvi potrebno je odrediti otprilike 12 sati nakon davanja Modigraf granula, neposredno prije sljedeće doze.
English: Therefore, metabolites do not contribute to pharmacological activity of tacrolimus.
Croatian: Stoga metaboliti ne pridonose farmakološkom djelovanju takrolimusa.
English: As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.
Croatian: Budući da takrolimus može smanjiti klirens kontraceptiva na bazi steroida i tako dovesti do povećane izloženosti hormonima, potreban je poseban oprez kod odlučivanja o kontracepcijskim mjerama.
English: Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Croatian: Terapiju takrolimusom treba započeti nakon razmatranja koncentracija ciklosporina u krvi i kliničkog stanja bolesnika.
English: Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Croatian: Smanjenje AUC (27%) i Cmax (50%) te povećanje tmax (173%) u puno krvi bili su očiti.
English: Pure Red Cell Aplasia
Croatian: PRCA - Pure Red Cell Aplasia).
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).
Croatian: Međutim, zbog nefrotoksičnog potencijala takrolimusa, preporučuje se pažljivo pratiti funkciju bubrega (uključujući niz mjerenja koncentracije kreatinina u serumu, izračunavanje klirensa kreatinina i praćenje diureze).