natgillin/translations-raw huggingface dataset:
Classification and terminology were amended according to the MedDRA system organ class.
Klasifikacija in terminologija sta bili dopolnjeni v skladu s klasifikacijo organov v sistemu MedDRA.
• Safety issues
• Varnostni vidiki
The long-term safety profile of tacrolimus has not been systematically studied.
Dolgoročni varnostni profil takrolimusa ni bil sistematično raziskan.
2350 AC Leiderdorp The Netherlands
2350 AC Leiderdorp Nizozemska
Distribution and elimination
Porazdelitev in izločanje
Many of the adverse drug reactions stated below are reversible and/or respond to dose reduction.
Številne spodaj navedene neželene reakcije na zdravilo so reverzibilne in/ali se odzovejo na zmanjšanje odmerka.
Based on these data the efficacy of tacrolimus appears to be well established.
Na podlagi teh podatkov je učinkovitost takrolimusa dobro potrjena.
114 rue Victor Hugo 92300 Levallois Perret France
114 rue Victor Hugo 92300 Levallois Perret Francija
Most of the data supporting this indication are as expected retrospective.
Večina podatkov, ki podpirajo to indikacijo, je v skladu s pričakovanji retrospektivna.
Benefit/Risk considerations
Razmerje med koristmi in tveganji
Middlesex TW18 3AZ United Kingdom
Middlesex, TW18 3AZ Združeno kraljestvo
If you have forgotten to take your <Invented name> capsules, wait until it is time for the next dose, and then continue as before.
Če ste pozabili vzeti kapsule <(Lastniško) ime zdravila>, počakajte, da bo čas za naslednji odmerek, in potem nadaljujte kot prej.
insufficient function of your transplanted organ
nezadostno delovanje presajenega organa
The ISHLT's annual report therefore adds important information to the use of heart transplantation in children.
Zato letno poročilo ISHLT nudi pomembne dodatne informacije o uporabi zdravila pri presaditvi srca pri otrocih.
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
Astellas Farma Limitada Edifício Cinema Rua José Fontana, n°1, 1° andar 2770-101 Paço de Arcos Portugalska
Clinically significant interactions have also been observed with phenobarbital.
Klinično pomembne interakcije so opažali tudi s fenobarbitalom.
But in a scenario where re-transplantation or death is a likely outcome a more liberal attitude toward the indication is in place.
Vendar pa je pri scenariju, pri katerem je verjeten rezultat ponovna presaditev ali smrt, upravičeno bolj liberalno stališče v povezavi s to indikacijo.
If overdosage occurs, general supportive measures and symptomatic treatment should be conducted.
Če pride do prevelikega odmerjanja, je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
The safety database for tacrolimus is fragmented and uncertain.
Baza podatkov o varnosti takrolimusa je fragmentarna in nezanesljiva.
There is no evidence currently available to indicate that dosing should be adjusted in elderly patients.
Trenutno ni dokazov, da bi bila pri starejših bolnikih potrebna prilagoditev odmerjanja.
During treatment, careful monitoring with EBV-PCR is recommended.
Med zdravljenjem je potrebno natančno nadziranje z EBV-PCR.
There is a risk for premature delivery (<37 week) as well as for hyperkalaemia in the newborn, which, however, normalizes spontaneously.
Obstaja tveganje za prezgoden porod (< 37 tednov) in za hiperkaliemijo pri novorojenčku, ki pa se normalizira sama od sebe.
The frequency of blood level monitoring should be based on clinical needs.
Pogostnost nadziranja koncentracije v krvi mora temeljiti na kliničnih potrebah.
very rare:
zelo redki:
Due to the fact that the original product Prograf and associated names does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union and due to divergent national decisions, a harmonisation of the SPC for Prograf and associated names, throughout Europe became necessary.
Ker originalni proizvod Prograf in z njim povezana imena nima istega Povzetka glavnih značilnosti zdravila (SPC) v vseh državah članicah EU in ker se posamezne nacionalne odločitve medsebojno razlikujejo, se je pojavila potreba bo uskladitvi Povzetka glavnih značilnosti zdravila Prograf in z njim povezanih imen po celotni Evropi.
Dosage adjustments in specific patient populations Patients with liver impairment
Prilagoditve odmerjanja pri specifičnih populacijah bolnikov Bolniki z okvaro jeter
Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Neželene reakcije na zdravilo so naštete spodaj v padajočem zaporedju pogostnosti pojavljanja: zelo pogoste (> 1/10), pogoste (> 1/100, < 1/10), občasne (> 1/1.000, < 1/100), redke (> 1/10.000, < 1/1.000), zelo redke (< 1/10.000, vključno s posameznimi primeri).
Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Zdravnik vam bo redno naročil preiskave krvi, da bo določil pravi odmerek in da ga bo od časa do časa prilagodil.
As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Tako kot pri drugih močnih imunosupresivih tudi pri tem zdravilu tveganje za sekundarnega raka ni znano (glejte poglavje 4.8).
Severe effects have been reported, including allergic and anaphylactic reactions.
Poročali so o hudih učinkih, vključno z alergijskimi in anafilaktičnimi reakcijami.
You will receive <Invented name> as a continuous 24-hour infusion and never as a short injection.
<(Lastniško) ime zdravila> boste dobili kot stalno 24-urno infuzijo, nikoli kot hitro vbrizgano injekcijo.
Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Pozitivna EBV-PCR lahko traja še mesece in sama po sebi ne nakazuje limfoproliferativne bolezni ali limfoma.
The consequences of long-term immunosuppression, infections and tumour formation, are likely to increase with time, but this issue was not addressed.
Posledice dolgotrajne imunosupresije, okužbe in tvorbe tumorjev, se s časom povečujejo, vendar pa to vprašanje ni bilo obravnavano.
Corresponding data based on whole blood averaged 47.6 l.
Ustrezni podatek na podlagi polne krvi je povprečno 47,6 l.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Začetni odmerek za preprečitev zavrnitve presajenega organa bo določil zdravnik na podlagi vaše telesne mase.
If you have previously had such a problem, please inform your doctor.
Če ste kdaj prej imeli takšne težave, morate o tem obvestiti zdravnika.
If signs of toxicity are noted (e.g. pronounced adverse reactions - see section 4.8) the dose of <Invented name> may need to be reduced.
Če se pojavijo znaki toksičnosti (npr. izrazite neželene reakcije - glejte poglavje 4.8), utegne biti potrebno zmanjšanje odmerka <(Lastniško) ime zdravila>.
• the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
• je so bili Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi posredovane dokumentacije in znanstvene razprave znotraj Odbora,
Section on undesirable effects (4.8) was brought in line with the guideline on summary of product characteristics.
Poglavje o neželenih učinkih (4.8) je bilo usklajeno s smernico o povzetku glavnih značilnosti zdravila.
• the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
• je bil namen napotitve uskladitev Povzetkov glavnih značilnosti zdravila,
This is quite normal and will help your doctor to decide on the most appropriate dose of <Invented name> for you.
To je povsem običajno in bo zdravniku pomagalo, da izbere odmerek zdravila <(Lastniško) ime zdravila>, ki bo za vas najprimernejši.
The concentrate should be used for intravenous infusion only after it is diluted with suitable carrier media (see section 6.6).
Koncentrat smete uporabiti za intravensko infundiranje, šele ko je razredčen s primernim vehiklom (glejte poglavje 6.6).
This should be dealt with as a follow-up request.
To vprašanje bo potrebno rešiti z zahtevo po spremljanju zdravljenja.
Only anecdotal descriptions of isolated patients or small numbers of patients in differing organ transplant indications were provided.
Podani so bili le anekdotični opisi izoliranih primerov bolnikov ali manjšega števila bolnikov z različnimi presajenimi organi.
- If you need to have any vaccinations, please inform your doctor beforehand.
- Če morate opraviti kakšno cepljenje, o tem predhodno obvestite svojega zdravnika.
One pitfall for the renal paediatric indication is, however, the lack of longterm data.
Pomanjkljivost v indikaciji za zdravljenje ledvic pri pediatričnih bolnikih pa je odsotnost dolgoročnih podatkov.
Inconsistencies between section 4.6 (Pregnancy and lactation) and section 5.3 (Preclinical safety data) have been corrected and more information has been included on male fertility.
Neskladnosti med poglavjema 4.6 (Nosečnost in dojenje) ter 5.3 (Predklinični podatki o varnosti) so bile odpravljene, vključenih je bilo tudi več podatkov o moški plodnosti.
This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Ta način je pridržan za bolnike brez motene funkcije organov (npr. motenega delovanja ledvic).
Your doctor will then prescribe <Invented name> capsules for you instead.
Potem vam bo zdravnik namesto tega predpisal kapsule <(Lastniško) ime zdravila>.
Data on cardiac transplantation in children are sparse due to the low number of transplantations performed each year.
Podatki o presaditvah srca pri otrocih so skromni, kar je posledica majhnega števila letno izvedenih presaditev.
If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Če nameravate zanositi ali mislite, da ste noseči, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
Patients should be converted from intravenous to oral medication as soon as individual circumstances permit.
Bolnik mora preiti z intravenskega na peroralno zdravilo, čim to dopuščajo individualne okoliščine.
<Invented name> therapy requires careful monitoring by adequately qualified and equipped personnel.
Zdravljenje s <(Lastniško) ime zdravila> mora natančno nadzorovati ustrezno usposobljeno in opremljeno osebje.
Take special care with <Invented name> - You will need to take <Invented name> every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Bodite posebno pozorni pri jemanju zdravila <(Lastniško) ime zdravila> - <(Lastniško) ime zdravila> boste morali jemati vsak dan, dokler potrebujete imunosupresijo za preprečitev zavrnitve presajenega organa.
Metabolism and biotransformation
Presnova in biotransformacija
Consequently, your body will not be as good as usual at fighting infections.
Zaradi tega telo ne more premagovati okužb tako dobro kot ponavadi.
Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Kontroliranje najmanjše koncentracije v polni krvi zato omogoča dobro oceno sistemske izpostavljenosti.
Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Imunosupresivi lahko poslabšajo odziv na cepljenje in cepljenje je med zdravljenjem s takrolimusom lahko manj učinkovito.
In practice, <Invented name> therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
V praksi so zdravljenje s <(Lastniško) ime zdravila> začenjali od 12 do 24 ur po prekinitvi ciklosporina.
Heart transplantation in paediatric patients:
Presaditev srca pri pediatričnih bolnikih:
In systemic circulation only one of the inactive metabolites is present at low concentrations.
V sistemskem obtoku je v majhni koncentraciji prisoten le eden od neaktivnih presnovkov.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROGRAF / PROGRAFT HARD CAPSULES AND CONCENTRATE FOR INFUSION
SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVILA PROGRAF / PROGRAFT TRDE KAPSULE IN KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG preand post-transplant (e.g. initially at three months and then at 9-12 months).
Glede na to je treba zelo ogrožene bolnike, zlasti mlade otroke in tiste, ki prejemajo precejšnjo 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).
Pharmacotherapeutic group: Macrolide immunosuppressant, ATC code: L04A A05
Farmakoterapevtska skupina: Zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC: L04A A05
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.
V takšnem primeru so uporabili začetni peroralni odmerek takrolimusa od 2 do 4 mg na dan v kombinaciji z mofetilmikofenolatom in kortikosteroidi ali v kombinaciji s sirolimusom in kortikosteroidi.
Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Takrolimus lahko podaljša interval QT, vendar za zdaj ni prepričljivih dokazov, da bi povzročal torsades de pointes.
Dose adjustment during post-transplant period in adults and children <Invented name> doses are usually reduced in the post-transplant period.
Prilagoditev odmerka med obdobjem po presaditvi pri odraslih in otrocih Odmerki <(Lastniško) ime zdravila> se med obdobjem po presaditvi ponavadi zmanjšajo.
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.
V literaturi objavljene koncentracije ter individualne vrednosti v klinični praksi je treba primerjati previdno in ob poznavanju uporabljene metode.
Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Zdravljenje se mora začeti v 5 dneh po opravljeni operaciji, čim se bolnikovo stanje stabilizira.
In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Pri zdravih preiskovancih je povprečni razpolovni čas v polni krvi približno 43 ur.
<Invented name> is often used in combination with other medicines that also suppress the immune system.
<(Lastniško) ime zdravila> se pogosto uporablja v kombinaciji z drugimi zdravili, ki prav tako zavirajo imunski sistem.
Treatment with <Invented name> should not continue for more than 7 days.
Zdravljenje z <(Lastniško) ime zdravila> ne sme trajati več kot 7 dni.
Blood trough levels should be monitored approximately twice weekly during the early post-transplant period and then periodically during maintenance therapy.
Najmanjšo koncentracijo je treba med zgodnjim obdobjem po presaditvi nadzirati približno dvakrat na teden in potem redno med vzdrževalnim zdravljenjem.
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.
Ker je terapija potrebna, pride takrolimus v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
The other metabolites have only weak or no immunosuppressive activity.
Ostali presnovki imajo le šibko imunosupresijsko delovanje ali ga sploh nimajo.
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.
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.
increased blood pressure common:
zvišan krvni tlak pogosti:
Hypersensitivity to tacrolimus or other macrolides.
Preobčutljivost za takrolimus ali druge makrolide.
Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Potransplantacijsko izboljšanje bolnikovega stanja lahko spremeni farmakokinetiko takrolimusa in potrebne utegnejo biti dodatne prilagoditve odmerka.
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.
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.
Heart transplantation in adults:
Presaditev srca pri odraslih:
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).
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).
QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
KAKOVOSTNA IN KOLIČINSKA SESTAVA [Izpolni država članica]
Limited knowledge of interactions between tacrolimus and statins is available.
Znanje o interakcijah med takrolimusom in statini je omejeno.
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.
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.
- If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics.
- Če ste alergični na (preobčutljivi za) katerikoli antibiotik iz podskupine makrolidnih antibiotikov.
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.
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.
As shown in both the published data and the ISHLT's annual report tacrolimus can substitute ciclosporin as primary immunosuppression therapy.
Kot kažejo objavljeni podatki in letno poročilo ISHLT, lahko takrolimus nadomesti ciklosporin v okviru primarnega imunosupresivnega zdravljenja.
In head to head comparisons with ciclosporin it appears to have a modest efficacy advantage.
Na podlagi neposrednih primerjav s ciklosporinom se zdi, da ima manjšo prednost z vidika učinkovitosti.
Excretion Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Po intravenski in peroralni uporabi s 14C označenega takrolimusa se je večina radioaktivnosti izločila v blatu.
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.
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.
difficulty in sleeping common:
težave s spanjem pogosti:
In some patients, tacrolimus appears to be continuously absorbed over a prolonged period yielding a relatively flat absorption profile.
Pri nekaterih bolnikih se takrolimus stalno absorbira skozi daljše obdobje, tako da je absorpcijski profil razmeroma sploščen.
<Invented name> is taken orally twice daily, usually in the morning and evening.
<(Lastniško) ime zdravila> se zaužije dvakrat na dan, ponavadi zjutraj in zvečer.
- 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.
- 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.
There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Obstajajo tudi dokazi o gastrointestinalni presnovi s CYP3A4 v črevesni steni.
Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml.
Klinično-raziskovalna analiza kaže, da je mogoče večino bolnikov uspešno voditi, če je najmanjša koncentracija takrolimusa v krvi vzdrževana pod 20 ng/ml.
Following oral administration of <Invented name> capsules peak concentrations (Cmax) of tacrolimus in blood are achieved in approximately 1 - 3 hours.
Po peroralni uporabi kapsul <(Lastniško) ime zdravila> doseže takrolimus največjo koncentracijo (Cmax) v krvi v približno 1 do 3 urah.
The effect of a high-carbohydrate meal is less pronounced.
Učinek obrokov, v katerih je veliko ogljikovih hidratov, je manj izrazit.
Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ.
Po presaditvi organa (npr. jeter, ledvic, srca) telo poskuša zavrniti novi organ.
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.
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).
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).
V primeru izpostavljenosti in utero je novorojenčka priporočljivo nadzirati glede možnih neželenih učinkov takrolimusa (zlasti učinki na ledvice).
Rejection therapy - adults and children
Zdravljenje zavrnitve - odrasli in otroci
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).
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).
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.
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.
The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Ledvice in pankreas sta bila primarna organa, prizadeta v študijah toksičnosti pri podganah in opicah.
This medicinal product is authorised in the Member States of the EEA under the following name:
To zdravilo ima dovoljenje za promet v državah članicah EGP z naslednjim imenom: Prograf:
painful urination with blood in the urine Disorders affecting the body as a whole common:
boleče uriniranje s krvjo v urinu Bolezni, ki prizadenejo telo v celoti pogosti: