FrancophonIA/ELRC3.0 huggingface dataset:
English: If available, glass containers should be used for infusion.
Slovenian: Če je mogoče, je treba za infuzije uporabljati steklene vsebnike.
English: The physician responsible for maintenance therapy should receive complete information for the follow-up of the patient.
Slovenian: Zdravnik, odgovoren za vzdrževalno zdravljenje, mora prejeti vse informacije, ki so potrebne za nadaljnje spremljanje bolnika.
English: The increased risk appears to be related to the degree and duration of immunosuppression rather than to the use of specific agents.
Slovenian: Kaže, da je to povečano tveganje povezano s stopnjo in trajanjem imunosupresije, ne pa z uporabo specifičnega zdravila.
English: This belongs to a group of medicines known as immunosuppressive agents.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo imunosupresivna zdravila.
English: After 2 months, you should use a new bottle.
Slovenian: Po 2 mesecih je treba odpreti novo steklenico.
English: During treatment with ciclosporin, vaccination may be less effective.
Slovenian: Med zdravljenjem s ciklosporinom je lahko cepljenje manj učinkovito.
English: Lower doses are used once your transplanted organ or bone marrow has stabilised.
Slovenian: Nižje odmerke uporabljamo kasneje, ko se presajeni organ ali kostni mozeg stabilizira.
English: • Tell your doctor if you are pregnant or intend to become pregnant.
Slovenian: • Zdravniku povejte, če ste noseči ali nameravate zanositi.
English: After 6 months of therapy, renal function needs to be assessed every 4 to 8 weeks depending on the stability of the disease, its co- medication, and concomitant diseases.
Slovenian: Po 6 mesecih zdravljenja je treba ledvično funkcijo ocenjevati vsake 4 do 8 tednov, glede na stabilnost bolezni, sočasno zdravljenje z drugimi zdravili in druge sočasne bolezni.
English: - Stir and drink the whole contents of the glass straight away.
Slovenian: Premešajte in takoj spijte celotno vsebino kozarca.
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Interakcijske študije so izvajali samo pri odraslih.
English: If hypertension develops, appropriate antihypertensive treatment must be instituted.
Slovenian: Če se razvije hipertenzija, je treba uvesti primerno antihipertenzivno zdravljenje.
English: All available evidence suggests that ciclosporin acts specifically and reversibly on lymphocytes.
Slovenian: Vsi razpoložljivi dokazi kažejo, da ciklosporin deluje specifično in reverzibilno na limfocite.
English: Endogenous uveitis
Slovenian: Endogeni uveitis
English: OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally]
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [izpolni država članica]
English: Push down and pull up the plunger a few times.
Slovenian: Bat nekajkrat potisnite gor in dol.
English: It can also be used to maintain steroidinduced remission, allowing withdrawal of steroids.
Slovenian: Zdravilo je mogoče uporabljati tudi za vzdrževanje s steroidi inducirane remisije, kar omogoča ukinitev zdravljenja s steroidi.
English: Maintenance treatment should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation.
Slovenian: Z vzdrževalnim odmerkom je treba nadaljevati še najmanj 3 mesece (še bolje 6 mesecev), nato pa je treba odmerek postopno znižati na nič do konca 1. leta po presaditvi.
English: However, there are no adequate and well-controlled studies in pregnant women and therefore Sandimmun should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Slovenian: Pri nosečnicah pa niso opravili primernih in ustrezno kontroliranih študij, zato se zdravila Sandimmun med nosečnostjo ne sme uporabljati, razen v primeru, da pričakovana možna korist za mater presega potencialno tveganje za plod.
English: This interaction can occur for a long time after withdrawal of amiodarone, due to its very long half-life (about 50 days).
Slovenian: Do te interakcije lahko pride še dolgo časa po prekinitvi zdravljenja z amiodaronom, ker ima ta dolg razpolovni čas (približno 50 dni).
English: You should limit your exposure to sunlight and UV light by:
Slovenian: Izpostavljenost sončni in ultravijolični (UV) svetlobi omejite tako, da:
English: Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids.
Slovenian: Ciklosporin (znan tudi pod imenom ciklosporin A) je cikličen polipeptid, sestavljen iz 11 aminokislin.
English: Ensure that the correct amount of medicine is in the syringe.
Slovenian: Prepričajte se, da je v brizgi prava količina zdravila.
English: • if you have or have had alcohol-related problems.
Slovenian: • če imate ali ste imeli kdaj prej težave z alkoholom,
English: Pravastatin 20-80 mg Rosuvastatin 5-40 mg Pitavastatin 1-4 mg
Slovenian: 20-40 mg pravastatin 20-80 mg rosuvastatin 5-40 mg pitavastatin 1-4 mg
English: Consultation with a physician with experience of use of ciclosporin is recommended.
Slovenian: Priporočeno se je posvetovati z zdravnikom, ki ima izkušnje z uporabo ciklosporina.
English: If plasma or serum is used, a standard separation protocol (time and temperature) should be followed.
Slovenian: Za meritve v plazmi ali serumu je treba upoštevati predpise standardnega protokola za postopek separacije (glede časa in temperature).
English: Clinical studies have included children from 1 year of age.
Slovenian: V klinične študije so vključili otroke, stare najmanj 1 leto.
English: Follow all your doctor's instructions carefully.
Slovenian: Natančno upoštevajte navodila svojega zdravnika.
English: This summary of product characteristics, labelling and package leaflet is the version valid at the time of Commission Decision.
Slovenian: Povzetek glavnih značilnosti zdravila, Označevanja in Navodilo za uporabo so podani v različici, ki je veljavna v času, ko Odbor izda odločbo.
English: Everolimus and sirolimus had only a minor influence on ciclosporin pharmacokinetics.
Slovenian: Everolimus in sirolimus sta le malo vplivala na farmakokinetiko ciklosporina.
English: The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
Slovenian: Prisotnost nekaj majhnih mehurčkov je nepomembna in nikakor ne bo vplivala na velikost odmerka.
English: In a study performed in patients with terminal renal failure, the systemic clearance was approximately two thirds of the mean systemic clearance in patients with normally functioning kidneys.
Slovenian: V študiji, ki so izvajali pri bolnikih s končno ledvično odpovedjo, je sistemski očistek znašal približno dve tretjini povprečnega sistemskega očistka pri bolnikih z normalnim delovanjem ledvic.
English: • if this medicine is being prescribed for a child.
Slovenian: • če je zdravilo predpisano otroku.
English: if you have epilepsy.
Slovenian: • če imate epilepsijo,
English: The medicine can be mixed just before it is taken.
Slovenian: Zdravilo lahko zmešate tik preden ga zaužijete.
English: In such cases, it is recommended to switch to oral administration as soon as feasible.
Slovenian: V takih primerih je priporočljivo preiti na peroralen vnos takoj, ko je to mogoče.
English: Prevention or treatment of graft-versus-host disease (GVHD).
Slovenian: Preprečevanje ali zdravljenje reakcije presadka proti prejemniku (angl. graft-versus-host disease,
English: If a starting dose of 2.5 mg/kg/day does not achieve a satisfactory response within 2 weeks, the daily dose may be rapidly increased to a maximum of 5 mg/kg.
Slovenian: Če začetni odmerek 2,5 /kg/dan ne doseže zadovoljivega odziva v 2 tednih, je mogoče dnevni odmerek hitro zvišati na največ 5 mg/kg.
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease.
Slovenian: Segajo od 6,3 ure pri zdravih prostovoljcih do 20,4 ure pri bolnikih s hudo boleznijo jeter.
English: During treatment with ciclosporin, vaccination may be less effective and the use of live attenuated vaccines should be avoided.
Slovenian: Med zdravljenjem s ciklosporinom je lahko cepljenje manj učinkovito, uporabi živih atenuiranih cepiv pa se je treba izogibati.
English: Diluted infusion solutions must be discarded after 24 hours.
Slovenian: Že pripravljeno raztopino za infundiranje je treba po 24 urah zavreči.
English: Diltiazem (at doses of 90 mg/day) can increase ciclosporin plasma concentrations by up to 50%.
Slovenian: Diltiazem (v odmerku 90 mg/dan) lahko zviša koncentracijo ciklosporina v plazmi za do 50 %.
English: When using Sandimmun in any of the established non-transplantation indications, the following general rules should be adhered to:
Slovenian: Pri uporabi zdravila Sandimmun za katerokoli od uveljavljenih indikacij, ki niso povezane s presaditvijo, je treba upoštevati naslednja splošna pravila:
English: As with other long-term immunosuppressive treatments, an increased risk of lymphoproliferative disorders must be borne in mind.
Slovenian: Kot pri drugih vrstah dolgotrajnega imunosupresivnega zdravljenja se je treba zavedati povečanega tveganja za limfoproliferativne bolezni.
English: Both generalised and localised infections can occur.
Slovenian: Lahko pride tako do generaliziranih kot do lokalnih okužb.
English: In general, Sandimmun should not be taken during pregnancy.
Slovenian: Na splošno velja, da zdravila Sandimmun ne smete jemati med nosečnostjo.
English: Sandimmun can be used to induce and maintain remissions.
Slovenian: Zdravilo Sandimmun je mogoče uporabljati za indukcijo in vzdrževanje remisije.
English: Although an 8-week course of therapy may be sufficient to achieve clearing, up to 1 year of therapy has been shown to be effective and well tolerated, provided the monitoring guidelines are followed.
Slovenian: 8-tedensko zdravljenje sicer lahko zadošča za odpravo simptomov, vendar se je pokazalo, da je zdravljenje v trajanju do enega leta učinkovito in ga bolniki dobro prenašajo ob upoštevanju smernic glede spremljanja bolnika.
English: Special excipients: Sorbitol
Slovenian: Posebne pomožne snovi: sorbitol
English: Clinical studies have included children from 1 year of age using standard ciclosporin dosage with a comparable safety profile to adults.
Slovenian: V klinične študije so vključili otroke, stare najmanj 1 leto, in pri njih uporabljali standardne odmerke ciklosporina, pri čemer je bil varnostni profil primerljiv s profilom pri odraslih.
English: Once satisfactory response is achieved, the dose should be reduced gradually and, if possible, Sandimmun should be discontinued.
Slovenian: Ko pride do zadovoljivega odziva, je treba odmerek postopoma znižati in, če je mogoče, zdravilo Sandimmun povsem ukiniti.
English: When a blister is opened, a characteristic smell is noticeable; this is normal and does not mean that there is anything wrong with the capsule.
Slovenian: Pri odpiranju pretisnega omota se pojavi značilen vonj, kar je normalno in ne pomeni, da bi bilo s kapsulami kaj narobe.
English: Lymphomas and other malignancies
Slovenian: Limfomi in druge maligne bolezni
English: • Often applying a sunscreen with a high protection factor.
Slovenian: • na kožo pogosto nanašate sredstva z visokim zaščitnim faktorjem.
English: Paediatric population: Ciclosporin has been shown to be efficacious in steroid-dependent nephrotic syndrome.
Slovenian: Pediatrična populacija: Pokazalo se je, da je ciklosporin učinkovit pri od steroidov odvisnem nefrotskem sindromu.
English: However, the pharmacokinetic profile of ciclosporin was not significantly altered.
Slovenian: Farmakokinetične lastnosti ciklosporina se pri tem niso bistveno spremenile.
English: <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known
Slovenian: občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000); pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Your doctor will discuss with you the potential risks of taking Sandimmun during pregnancy.
Slovenian: Vaš zdravnik vam bo pojasnil možna tveganja, ki so povezana z jemanjem zdravila Sandimmun med nosečnostjo.
English: Azole antibiotics: Ketoconazole, fluconazole, itraconazole and voriconazole could more than double ciclosporin exposure.
Slovenian: Azolni antibiotiki: Ketokonazol, flukonazol, itrakonazol in vorikonazol lahko več kot podvojijo izpostavljenost ciklosporinu.
English: Thus, patients receiving Sandimmun concentrate for solution for infusion should be under continuous observation for at least the first 30 minutes after the start of the infusion and at frequent intervals thereafter.
Slovenian: Iz tega razloga je treba vse bolnike, ki prejemajo zdravilo Sandimmun koncentrat za raztopino za infundiranje, vsaj prvih 30 minut po začetku infuzije opazovati neprekinjeno, nato pa v krajših presledkih.
English: As a consequence of the higher initial doses and longer maintenance therapy required after transplantation, side effects are more frequent and usually more severe in transplant patients than in patients treated for other indications.
Slovenian: Zaradi višjih začetnih odmerkov, ki so potrebni pri presaditvenih indikacijah in potrebe po daljšem vzdrževalnem zdravljenju, so neželeni učinki pogostejši in bolj izraženi pri bolnikih po presaditvi kot pri bolnikih, ki zdravilo prejemajo zaradi drugih indikacij.
English: After 3 months, the dose of corticosteroids may be tapered to the lowest effective dose.
Slovenian: Po 3 mesecih je mogoče odmerek kortikosteroida postopoma znižati do najnižjega še učinkovitega odmerka.
English: In a study performed in severe liver disease patients with biopsy-proven cirrhosis, the terminal half-life was 20.4 hours (range between 10.8 to 48.0 hours) compared to 7.4 to 11.0 hours in healthy subjects.
Slovenian: V študiji, ki so jo izvajali pri bolnikih s hudo jetrno boleznijo in s cirozo jeter, potrjeno z biopsijo, je bil končni razpolovni čas 20,4 ure (v razponu od 10,8 do 48,0 ur ) v primerjavi s 7,4 do 11,0 ur pri zdravih preiskovancih.
English: This explains why, in rare cases, Sandimmun-associated structural kidney alterations have been observed without increases in serum creatinine.
Slovenian: To pojasnjuje, zakaj so v redkih primerih opažali z zdravilom Sandimmun povezane strukturne spremembe ledvic brez zvišanja koncentracije kreatinina v serumu.
English: The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.
Slovenian: Nasveti, ki jih najdete v tem navodilu, so lahko različni glede na to ali jemljete zdravilo zaradi presaditve ali zaradi avtoimunske bolezni.
English: The daily doses of Sandimmun should be given in two divided doses equally distributed throughout the day.
Slovenian: Dnevni odmerek zdravila Sandimmun je treba vzeti v dveh deljenih odmerkih, enakomerno razporejenih preko dneva.
English: If anaphylaxis occurs, the infusion should be discontinued.
Slovenian: Če pride do anafilaksije, je treba infuzijo prekiniti.
English: The frequency of malignancies increases with the intensity and duration of therapy (see section 4.4).
Slovenian: Pogostnost malignih bolezni narašča z intenzivnostjo in trajanjem zdravljenja (glejte poglavje 4.4).
English: Some side effects could be serious.
Slovenian: Nekateri neželeni učinki so lahko resni
English: Ciclosporin is distributed largely outside the blood volume, with an average apparent distribution volume of 3.5 l/kg.
Slovenian: Ciklosporin se porazdeljuje pretežno po ekstravaskularnem prostoru s povprečnim navideznim volumnom porazdelitve 3,5 l/kg.
English: It may also be harmful if this medicine is given to children.
Slovenian: Škodljiv je lahko tudi v primeru, če zdravilo prejema otrok.
English: This increases your risk of developing cancers, particularly of the skin and lymphoid system.
Slovenian: To lahko poveča tveganje za razvoj raka, zlasti raka kože in limfatičnega sistema.
English: If you forget to take Sandimmun If you forget to take a dose, take it as soon as you remember it.
Slovenian: Če ste pozabili vzeti zdravilo Sandimmun • Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite nanj.
English: In non-transplant patients the relationship between blood level and clinical effects is less well established.
Slovenian: Pri drugih bolnikih, ki niso prejemniki presadkov, povezanost med koncentracijo v krvi in kliničnim učinkom ni tako dobro opredeljena.
English: A dispenser set is also provided.
Slovenian: Priložen je tudi set za pripravljanje odmerkov.
English: Ciclosporin passes into breast milk.
Slovenian: Ciklosporin prehaja v materino mleko.
English: Macrolide antibiotics: Erythromycin can increase ciclosporin exposure 4- to 7-fold, sometimes resulting in nephrotoxicity.
Slovenian: Makrolidni antibiotiki: Eritromicin lahko 4 do 7-krat poveča izpostavljenost ciklosporinu, kar včasih povzroči toksično delovanje na ledvice.
English: Pharmacotherapeutic group: Immunosuppressive agents, calcineurin inhibitors, ATC code: L04AD01
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci kalcinevrina, oznaka ATC: L04AD01
English: Your doctor will check your blood pressure regularly and may give you a medicine to lower blood pressure if necessary.
Slovenian: Zdravnik vam bo redno meril krvni tlak in vam predpisal zdravilo za zniževanje krvnega tlaka, če bo potrebno.
English: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na ciklosporin ali katero koli sestavino tega zdravila (navedeno v poglavju 6;
English: This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.
Slovenian: Tako boste imeli priložnost, da se z zdravnikom pogovorite o zdravljenju in o težavah, če bi do njih prišlo.
English: Unlike cytostatic agents, it does not depress haemopoiesis and has no effect on the function of phagocytic cells.
Slovenian: Za razliko od citostatičnih zdravil ne zavira hematopoeze in ne vpliva na funkcijo fagocitov.
English: Remove the black stopper and throw it away.
Slovenian: Odstranite črni zamašek in ga zavrzite.
English: if you need to have a vaccination.
Slovenian: • če morate prejeti cepivo.
English: Food interactions
Slovenian: Interakcije s hrano
English: A limited number of observations in children exposed to ciclosporin in utero are available, up to an age of approximately 7 years.
Slovenian: Na voljo je omejeno število opazovanj do starosti približno 7 let pri otrocih, ki so bili izpostavljeni ciklosporinu in utero.
English: Your doctor should monitor how well your kidneys work.
Slovenian: Zdravnik mora spremljati delovanje vaših ledvic.
English: Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis.
Slovenian: Zdravnik bo natančno nadzoroval vaše zdravljenje, če ste starejši in se zdravite zaradi luskavice ali zaradi atopijskega dermatitisa.
English: Another well-established use of the concentrate for solution for infusion is the initial treatment of patients undergoing bone marrow transplantation.
Slovenian: Druga dobro uveljavljena možnost uporabe koncentrata za raztopino za infundiranje je začetno zdravljenje bolnikov po presaditvi kostnega mozga.
English: Elderly population (age 65 years and above) In elderly patients, renal function should be monitored with particular care.
Slovenian: Populacija starejših (starih 65 let ali več) Pri starejših bolnikih je potrebno še posebej pozorno spremljati delovanje ledvic.
English: This combination should therefore be given with caution with an interval of at least 3 hours.
Slovenian: Pri uporabi kombinacije teh dveh zdravil je torej potrebna previdnost, med odmerjanjem enega in drugega pa morajo preteči najmanj 3 ure.
English: The doses need to be adjusted individually according to efficacy (proteinuria) and safety, but should not exceed 5 mg/kg/day in adults and 6 mg/kg/day in children.
Slovenian: Odmerke je treba prilagoditi vsakemu bolniku posamezno glede na učinkovitost (proteinurijo) in varnost zdravila, pri tem pa odmerki ne smejo presegati 5 mg/kg/dan pri odraslih oziroma 6 mg/kg/dan pri otrocih.
English: The use of live attenuated vaccines should be avoided (see section 4.5).
Slovenian: Uporabi živih atenuiranih cepiv se je treba izogibati (glejte poglavje 4.5).
English: Therefore the simultaneous combination of ciclosporin and lercanidipine should be avoided.
Slovenian: Iz tega razloga se je treba sočasni uporabi ciklosporina in lerkadipina izogibati.
English: Additional side effects in children and adolescents There are no additional side effects to be expected in children and adolescents compared to adults.
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih Pri otrocih in mladostnikih ni pričakovati dodatnih neželenih učinkov v primerjavi z odraslimi.
English: Benign lymphadenopathy is commonly associated with flares in atopic dermatitis and invariably disappears spontaneously or with general improvement in the disease.
Slovenian: Benigna limfadenopatija je pogosto povezana z izbruhi pri atopijskem dermatitisu in vedno izzveni spontano oziroma s splošnim izboljšanjem simptomov bolezni.
English: Carcinogenicity studies were carried out in male and female rats and mice.
Slovenian: Raziskave kancerogenosti so opravili na mišjih in podganjih samcih in samicah.
English: Ethanol: 278 mg/ml.
Slovenian: Etanol: 278 mg/ml.
English: Talk to your doctor before taking Sandimmun: if you have or have had alcohol-related problems.
Slovenian: Posvetujte se z zdravnikom, preden začnete jemati zdravilo Sandimmun: • če imate ali ste imeli kdaj prej težave z alkoholom,
English: It is used by your doctor or nurse to prepare a solution which will be given to you by slow intravenous infusion.
Slovenian: Iz te tekočine bosta vaš zdravnik ali vaša medicinska sestra pripravila raztopino, ki jo boste prejemali s počasno intravensko infuzijo.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani {Ime države članice/Agencije}.
English: Skin infections with Staphylococcus aureus are not an absolute contraindication for Sandimmun therapy, but should be controlled with appropriate antibacterial agents.
Slovenian: Okužbe kože z bakterijo Staphylococcus aureus niso absolutna kontraindikacija za zdravljenje z zdravilom Sandimmun, treba pa jih je zdraviti z ustreznimi antibiotiki.
English: It is available in a 50 ml glass bottle, with two syringes for measuring the dose.
Slovenian: Na voljo je v 50-mililitrski rjavi steklenici z dvema priloženima brizgama za pripravljanje pravilnega odmerka.
English: Stopping your treatment with Sandimmun may increase the risk of your transplanted organ being rejected.
Slovenian: Prekinitev zdravljenja z zdravilom Sandimmun lahko poveča tveganje za zavrnitev presajenega organa.
English: You will have regular blood tests and visits to the hospital, especially after a transplant.
Slovenian: Redno boste opravljali krvne preiskave in obiskovali svojega zdravnika, zlasti po presaditvi.
English: In the various indications the overall spectrum of side effects is essentially the same; there are, however, differences in incidence and severity.
Slovenian: Celoten spekter neželenih učinkov je na splošno enak pri vseh indikacijah, obstajajo pa razlike glede pogostosti in izraženosti.
English: The syringe should not come in contact with the diluent.
Slovenian: Brizga ne sme priti v stik s tekočino za razredčenje.
English: Contains ethanol (see leaflet for further information).
Slovenian: Vsebuje etanol (za več podatkov glejte Navodilo za uporabo).
English: Alcohol may be harmful if you have alcohol-related problems, epilepsy, brain injury, liver problems or if you are pregnant or breast-feeding.
Slovenian: Alkohol vam lahko škoduje, če imate težave z uživanjem alkohola, epilepsijo, poškodbo možganov, težave z jetri ali če ste noseči ali dojite.