FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tell your doctor if you are pregnant or intend to become pregnant.
Croatian: • Obavijestite svog liječnika ako ste trudni ili namjeravate zatrudnjeti.
English: It may also be harmful if this medicine is given to children
Croatian: Mogao bi biti štetan i ako se ovaj lijek daje djeci.
English: Not all pack sizes may be available.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakovanja.
English: In all cases of overdosage, general supportive measures should be followed and symptomatic treatment applied.
Croatian: U svim slučajevima predoziranja treba slijediti općenite suportivne mjere i primijeniti simptomatsku terapiju.
English: Motor polyneuropathy
Croatian: Motorna polineuropatija
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.
Croatian: Terapiju održavanja treba nastaviti najmanje 3 mjeseca (a po mogućnosti 6 mjeseci) prije nego što se doza postupno smanji na nulu do vremena od godine dana nakon transplantacije.
English: Therefore the simultaneous combination of ciclosporin and lercanidipine should be avoided.
Croatian: Stoga istodobnu kombinaciju ciklosporina i lerkanidipina treba izbjegavati.
English: A dispenser set is also provided.
Croatian: Priložen je i set za doziranje.
English: Subsequent use Commence at point 5.
Croatian: Sljedeća primjena Krenite od 5. točke.
English: Transplantation patients receiving this medicinal product should be managed in facilities with adequate laboratory and supportive medical resources.
Croatian: Transplantirani bolesnici koji primaju ovaj lijek moraju biti zbrinuti u ustanovama s odgovarajućim laboratorijskim i pomoćnim medicinskih resursima.
English: Your doctor will discuss with you the potential risks of taking Sandimmun during pregnancy.
Croatian: Liječnik će razgovarati s Vama o potencijalnim rizicima uzimanja Sandimmuna tijekom trudnoće.
English: The capsules should be left in the blister pack until required for use and stored at a temperature not exceeding 30°C.
Croatian: Kapsule treba ostaviti u blister pakovanju do uporabe i čuvati na temperaturi koja ne prelazi 30°C.
English: An aqueous solution of adrenaline 1:1000 and a source of oxygen should be available by the bedside.
Croatian: Vodena otopina adrenalina 1:1000 i izvor kisika moraju biti dostupni pored kreveta.
English: A decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal drug, taking into account the importance of the medicinal product to the mother.
Croatian: Treba odlučiti hoće li se majka suzdržati od dojenja ili od uzimanja lijeka, uzimajući u obzir važnost lijeka za majku.
English: Swallow the capsules whole with water.
Croatian: Progutajte kapsule cijele s vodom.
English: After the Commission Decision the National Competent Authorities will update the product information as required.
Croatian: Nakon Odluke Komisije, nacionalna nadležna tijela ažurirat će informacije o lijeku prema potrebi.
English: The glass must be rinsed well with some more diluent to ensure that all of the dose is taken.
Croatian: Čaša se mora dobro isprati s još tekućine za razrjeđivanje kako bi se osiguralo uzimanje cijele doze.
English: In general, Sandimmun should not be taken during pregnancy.
Croatian: Sandimmun općenito se ne bi smio uzimati tijekom trudnoće.
English: Never change your dose yourself, unless a doctor has told you to.
Croatian: Nikada sami ne mijenjajte dozu, osim ako Vam to kaže liječnik.
English: Ensure that the correct amount of medicine is in the syringe.
Croatian: Provjerite da je odgovarajuća količina lijeka u štrcaljki.
English: All metabolites identified so far contain the intact peptide structure of the parent compound; some possess weak immunosuppressive activity (up to one-tenth that of the unchanged drug).
Croatian: Svi dosad identificirani metaboliti sadrže netaknutu peptidnu strukturu matičnog spoja, a neki posjeduju slabu imunosupresivnu aktivnost (do jedne desetine aktivnosti nepromijenjenog lijeka).
English: This may affect your ability to drive and use machines.
Croatian: To može utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Everolimus and sirolimus had only a minor influence on ciclosporin pharmacokinetics.
Croatian: Everolimus i sirolimus imao je tek mali utjecaj na farmakokinetiku ciklosporina.
English: Carefully follow all the instructions given to you by your doctor.
Croatian: Pažljivo slijedite sve upute koje Vam je dao liječnik.
English: Signs of infection might be fever or sore throat.
Croatian: Znakovi infekcije mogu biti vrućica ili grlobolja.
English: To do this, your doctor may need to do some blood tests.
Croatian: Da bi to učinio, liječnik će možda morati obaviti neke krvne pretrage.
English: In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
Croatian: U plazmi se otprilike 90% veže na proteine, uglavnom lipoproteine.
English: It can also be used to maintain steroidinduced remission, allowing withdrawal of steroids.
Croatian: Može se koristiti i za održavanje remisije inducirane steroidima, omogućujući ustezanje steroida.
English: The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.
Croatian: Savjeti navedeni u ovoj uputi mogu se razlikovati ovisno o tome uzimate li lijek za presadak ili za autoimunu bolest.
English: The estimated glomerular filtration rate (eGFR) by the MDRD formula can be used for estimation of renal function in adults and an appropriate formula should be used to assess eGFR in paediatric patients.
Croatian: Procijenjena brzina glomerularne filtracije (eGFR) pomoću MDRD formule može se upotrijebiti za procjenu bubrežne funkcije u odraslih osoba, a odgovarajuću formulu treba upotrijebiti da bi se procijenio eGFR u pedijatrijskih bolesnika.
English: It may be stored at room temperature not exceeding 30°C.
Croatian: Može se čuvati na sobnoj temperaturi koja ne prelazi 30°C.
English: You will have regular blood tests and visits to the hospital, especially after a transplant.
Croatian: Obavljat ćete redovne krvne pretrage i posjete bolnici, osobito nakon transplantacije.
English: These functional changes are dose-dependent and are initially reversible, usually responding to dose reduction.
Croatian: Te su funkcionalne promjene ovisne o dozi i u početku su reverzibilne te obično odgovaraju na smanjenje doze.
English: The increased risk appears to be related to the degree and duration of immunosuppression rather than to the use of specific agents.
Croatian: Čini se da je povećani rizik povezan sa stupnjem i trajanjem imunosupresije, a ne s primjenom specifičnih tvari.
English: {e-mail}
Croatian: {Ime}
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.
Croatian: Kao posljedica viših početnih doza i dulje terapije održavanja potrebne nakon transplantacije, nuspojave su češće i obično teže u transplantiranih bolesnika, nego u bolesnika liječenih zbog drugih indikacija.
English: All indications
Croatian: Sve indikacije
English: In such cases, it is recommended to switch to oral administration as soon as feasible.
Croatian: U takvim slučajevima preporučuje se prijelaz na oralnu primjenu čim to bude izvedivo.
English: It must be remembered that the ciclosporin concentration in blood, plasma, or serum is only one of many factors contributing to the clinical status of the patient.
Croatian: Važno je zapamtiti da je koncentracija ciklosporina u krvi, plazmi ili serumu jedan od mnogih čimbenika koji doprinose kliničkom statusu bolesnika.
English: Endogenous uveitis
Croatian: Endogeni uveitis
English: Less than 1% of the administered dose is removed by dialysis.
Croatian: Manje od 1% primijenjene doze uklanja se dijalizom.
English: The normal route of administration is by mouth.
Croatian: Normalni način primjene je na usta.
English: • if you have kidney problems (except for nephrotic syndrome).
Croatian: • ako imate tegobe s bubrezima (osim nefrotskog sindroma).
English: Initial doses of 5 mg/kg/day are justified in patients whose condition requires rapid improvement.
Croatian: Početne doze od 5 mg/kg/dan su opravdane u bolesnika čije stanje zahtijeva brzo poboljšanje.
English: This belongs to a group of medicines known as immunosuppressive agents.
Croatian: Pripada skupini lijekova koji se nazivaju imunosupresivima.
English: Blister packs of double-sided aluminium consisting of aluminium foil on the bottom side and aluminium foil on the upper side.
Croatian: Blister pakovanja od dvostranog aluminija koja se sastoje od aluminijske folije na donjoj strani i aluminijske folije na gornjoj strani.
English: Plastic bottles should be used only if they conform to the requirements for “Sterile plastic containers for human blood and blood components” or “Empty sterile containers of plasticised polyvinyl chloride for human blood and blood components” of the current European Pharmacopoeia.
Croatian: Plastične boce smiju se koristiti samo ako zadovoljavaju uvjete za „Sterilne plastične spremnike za ljudsku krv i krvne sastavnice“ ili „Prazne sterilne spremnike od plastificiranog polivinilklorida za ljudsku krv i krvne sastavnice“ iz aktualne Europske farmakopeje.
English: The dose of this medicine will be carefully adjusted to your individual needs by your doctor.
Croatian: Liječnik će pažljivo prilagoditi dozu ovog lijeka Vašim individualnim potrebama.
English: • Leave your capsules in the foil.
Croatian: • Ostavite kapsule u foliji.
English: Effects of ciclosporin on other drugs
Croatian: Učinci ciklosporina na druge lijekove
English: Remove the black stopper and throw it away.
Croatian: Skinite crni čep i bacite ga.
English: This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.
Croatian: To će Vam dati mogućnost da razgovarate s liječnikom o svom liječenju i razgovarate o poteškoćama koje eventualno imate.
English: Then, take the syringe out of the bottle
Croatian: Zatim izvucite štrcaljku iz bočice
English: Store in the original package.
Croatian: Čuvati u originalnom pakovanju.
English: Diltiazem (at doses of 90 mg/day) can increase ciclosporin plasma concentrations by up to 50%.
Croatian: Diltiazem (u dozama od 90 mg/dan) može povećati koncentracije ciklosporina u plazmi za do 50%.
English: Your doctor might check the level of ciclosporin in your blood when starting or stopping treatment with other medicines.
Croatian: Liječnik će Vam možda provjeriti razinu ciklosporina u krvi kod započinjanja ili prekidanja liječenja drugim lijekovima.
English: Pull up the plunger until you have drawn up the correct amount of medicine.
Croatian: Povucite klip prema gore dok ne izvučete odgovarajuću količinu lijeka.
English: As with other long-term immunosuppressive treatments, an increased risk of lymphoproliferative disorders must be borne in mind.
Croatian: Kao i kod drugih dugoročnih imunosupresivnih terapija, mora se imati na umu povećani rizik limfoproliferativnih poremećaja.
English: Ciclosporin is distributed largely outside the blood volume, with an average apparent distribution volume of 3.5 l/kg.
Croatian: Ciklosporin se u velikoj mjeri distribuira izvan volumena krvi, uz prosječan prividni volumen distribucije od 3,5 l/kg.
English: In very severe cases, rapid and adequate control of the disease is more likely to occur with a starting dose of 5 mg/kg/day.
Croatian: U vrlo teškim slučajevima vjerojatnije je da će se brzo i odgovarajuće kontrolirati bolest s početnom dozom od 5 mg/kg/dan.
English: The medicine can be mixed just before it is taken.
Croatian: Lijek se može promiješati netom prije uzimanja.
English: Tell your doctor straight away if you notice any of the following serious side effects:
Croatian: Odmah se obratite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit.
Croatian: Ako slučajno uzmete previše lijeka, obavijestite svog liječnika ili otiđite na najbližu hitnu pomoć.
English: In non-transplant patients the relationship between blood level and clinical effects is less well established.
Croatian: U netransplantacijskih bolesnika odnos između razine u krvi i kliničkih učinaka nije tako dobro utvrđen.
English: In some patients, GVHD occurs after discontinuation of ciclosporin treatment, but usually responds favourably to re-introduction of therapy.
Croatian: U nekih bolesnika javlja se GVHD nakon prekida terapije ciklosporinom, ali obično pozitivno odgovara na ponovno uvođenje terapije.
English: If dose reduction is not successful in improving eGFR within one month, Sandimmun treatment should be discontinued (see section 4.4).
Croatian: Ako se smanjenjem doze ne uspije poboljšati eGFR u roku od mjesec dana, liječenje Sandimmunom treba prekinuti (vidjeti dio 4.4).
English: • Excessive hair growth.
Croatian: • Prekomjerni rast dlaka.
English: In the various indications the overall spectrum of side effects is essentially the same; there are, however, differences in incidence and severity.
Croatian: raznim indikacijama opći spektar nuspojava je u biti isti, ali postoje razlike u učestalosti i težini.
English: It is available in a 50 ml glass bottle, with two syringes for measuring the dose.
Croatian: Dostupna je u staklenoj bočici od 50 ml, s dvije štrcaljke za odmjeravanje doze.
English: Regular monitoring of blood pressure is required.
Croatian: Potrebno je redovito praćenje krvnog tlaka.
English: Clinical studies have included children from 1 year of age.
Croatian: Klinička ispitivanja obuhvaćala su djecu u dobi od 1 i više godina.
English: The dose can still be measured correctly with the syringe.
Croatian: Doza se još uvijek može točno izmjeriti pomoću štrcaljke.
English: Your doctor may give you magnesium supplements to take, especially just after your operation if you have had a transplant.
Croatian: Liječnik će Vam možda dati da uzimate nadoknadu magnezija, osobito nakon operacije ako ste imali transplantaciju.
English: In refractory cases, the dose can be increased to 7 mg/kg/day for a limited period.
Croatian: U refraktornim slučajevima doza se može povećati do 7 mg/kg/dan na ograničeno razdoblje.
English: • Medicines which may increase or decrease the level of ciclosporin (the active substance of Sandimmun) in your blood.
Croatian: • Lijekove koji mogu povećati ili smanjiti razinu ciklosporina (djelatne tvari Sandimmuna) u Vašoj krvi.
English: Combinations with increased risk for nephrotoxicity
Croatian: Kombinacije s povećanim rizikom od nefrotoksičnosti
English: This effect is often reversible with ciclosporin dose reduction.
Croatian: Taj je učinak često reverzibilan uz smanjenje doze ciklosporina.
English: Your daily doses should always be taken in 2 divided doses.
Croatian: Svoju dnevnu dozu uvijek morate uzimati u 2 podijeljene doze.
English: This summary of product characteristics, labelling and package leaflet is the version valid at the time of Commission Decision.
Croatian: Ovaj sažetak opisa svojstava lijeka, označavanje i uputa o lijeku predstavljaju verziju valjanu u vrijeme Odluke Komisije.
English: Control of serum magnesium levels is therefore recommended in the peri-transplant period, particularly in the presence of neurological symptom/signs.
Croatian: Stoga se preporučuje kontroliranje razina magnezija u serumu u pertitransplantacijskom razdoblju, osobito ako su prisutni neurološki simptomi/znakovi.
English: If NSAIDs with a low first-pass effect (e.g. acetylsalicylic acid) are given together with ciclosporin, no increase in their bioavailability is to be expected.
Croatian: Ako se NSAIL-ovi s niskim učinkom prvog prolaza (npr. acetilsalicilatna kiselina) daju zajedno s ciklosporinom, ne očekuje se nikakvo povećanje njihove bioraspoloživosti.
English: When to take Sandimmun Take Sandimmun at the same time every day.
Croatian: Kada uzimati Sandimmun Uzimajte Sandimmun u isto vrijeme svakoga dana.
English: - Stir and drink the whole contents of the glass straight away.
Croatian: Promiješajte i odmah popijte cjelokupni sadržaj čaše.
English: Food interactions
Croatian: Interakcije s hranom
English: Other medicines and Sandimmun
Croatian: Drugi lijekovi i Sandimmun
English: • if this medicine is being prescribed for a child.
Croatian: • ako je ovaj lijek propisan za dijete.
English: • Do not use this medicine after the expiry date which is stated on the package.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju.
English: Your doctor will check your blood pressure regularly and may give you a medicine to lower blood pressure if necessary.
Croatian: Liječnik će Vam redovito provjeravati krvni tlak, a može Vam i dati lijek za snižavanje krvnog tlaka ako bude potrebno.
English: A limited number of observations in children exposed to ciclosporin in utero are available, up to an age of approximately 7 years.
Croatian: Dostupan je ograničeni broj opažanja u djece izložene ciklosporinu in utero, do dobi od otprilike 7 godina.
English: Other side effects with frequency not known: Frequency cannot be estimated from the available data.
Croatian: Ostale nuspojave nepoznate učesalosti: Učestalost se ne može procijeniti iz dostupnih podataka.
English: Each mark on the syringe is 0.1 ml.
Croatian: Svaka oznaka na štrcaljki je 0,1 ml.
English: Do not take Sandimmun:
Croatian: Nemojte uzimati Sandimmun:
English: • Like other medicines that act on the immune system, ciclosporin may influence your body's ability to fight against infection and may cause tumours or other cancers, particularly of the skin.
Croatian: • Kao i drugi lijekovi koji djeluju na imunološki sustav, ciklosporin može utjecati na sposobnost Vašeg tijela da se bori protiv infekcije i može uzrokovati tumore ili druge vrste raka, osobito kože.
English: Macrolide antibiotics: Erythromycin can increase ciclosporin exposure 4- to 7-fold, sometimes resulting in nephrotoxicity.
Croatian: Makrolidni antibiotici: eritromicin može povećati izloženost ciklosporinu za 4 do 7 puta, što ponekad može rezultirati nefrotoksičnošću.
English: - The lower part of the plunger ring needs to be in front of the mark on the syringe which shows the amount of medicine.
Croatian: Donji dio klipa treba biti ispred oznake na štrcaljki koja pokazuje količinu lijeka.
English: If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun if your condition is particularly severe.
Croatian: Ako ste stariji od 65 godina i imate psorijazu ili atopijski dermatitis, smijete se liječiti Sandimmunom samo ako Vam je stanje osobito teško.
English: Monitoring during your treatment with Sandimmun Your doctor will check:
Croatian: Praćenje tijekom Vašeg liječenja Sandimmunom Liječnik će Vam provjeriti:
English: It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and in relation to meals.
Croatian: Preporučuje se da se Sandimmun primjenjuje po dosljednom rasporedu s obzirom na vrijeme dana i obroke.
English: Prevention of graft rejection following solid organ transplantation.
Croatian: Prevencija odbacivanja presatka nakon presađivanja solidnih organa.
English: It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
Croatian: Vaš vid zbog višeg tlaka u glavi (dobroćudna intrakranijska hipertenzija).
English: This can lead to symptomatic hypomagnesaemia, especially in the peri-transplant period.
Croatian: To može dovesti do simptomatske hipomagnezijemije, osobito u peritransplantacijskom razdoblju.
English: Experience with acute overdosage of ciclosporin is limited.
Croatian: Iskustvo s akutnim predoziranjem ciklosporinom je ograničeno.
English: This explains why, in rare cases, Sandimmun-associated structural kidney alterations have been observed without increases in serum creatinine.
Croatian: To objašnjava zašto su, u rijetkim slučajevima, uočene stukturne promjene bubrega povezane sa Sandimmunom bez povišenja serumskog kreatinina.
English: • Bleeding underneath the skin or purple skin patched, sudden bleeding with no apparent cause.
Croatian: • Krvarenje ispod kože ili ljubičaste mrlje na koži, iznenadno krvarenje bez vidljivog uzroka.
English: If you have been given more Sandimmun than you should Too much of the medicine can affect your kidneys.
Croatian: Ako uzmete više Sandimmuna nego što ste trebali Previše lijeka može utjecati na Vaše bubrege.
English: The combination of Sandimmun with low doses of oral corticosteroids is recommended if the effect of Sandimmun alone is not satisfactory, especially in steroid-resistant patients.
Croatian: Kombinacija Sandimmuna s niskim dozama oralnih kortikosteroida preporučuje se ako učinak samog Sandimmuna nije zadovoljavajući, osobito u bolesnika rezistentnih na steroide.
English: Elderly population (age 65 years and above) In elderly patients, renal function should be monitored with particular care.
Croatian: Starija populacija (u dobi od 65 i više godina) U starijih bolesnika bubrežnu funkciju treba pratiti osobito pozorno.
English: Paediatric population Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih osoba.
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.
Croatian: Stoga bolesnici koji primaju Sandimmun koncentrat za otopinu za infuziju moraju biti pod neprekidnim promatranjem tijekom najmanje prvih 30 minuta od početka infuzije te u učestalim intervalima nakon toga.
English: These conditions are often related to a high total immunosuppressive burden and should be considered in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Croatian: Ta stanja su često povezana s visokim ukupnim imunosupresivnim opterećenjem i treba ih uzeti u obzir u diferencijalnoj dijagnozi u imunosuprimiranih bolesnika s narušenom funkcijom bubrega ili neurološkim simptomima.
English: The syringe should not be rinsed, but wiped on the outside with a dry tissue to remove remaining drops of the solution (see section 6.6).
Croatian: Štrcaljka se ne smije ispirati, već obrisati izvana suhom maramicom da bi se uklonile preostale kapljice otopine (vidjeti dio 6.6).
English: In patients in whom within a given time (for specific information see below) no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with Sandimmun should be discontinued.
Croatian: U bolesnika u kojih se u određenom razdoblju (za specifične informacije vidjeti u nastavku) ne postigne primjereni odgovor ili učinkovita doza nije kompatibilna s utvrđenim smjernicama za sigurnost primjene, liječenje Sandimmunom potrebno je prekinuti.
English: It is used by your doctor or nurse to prepare a solution which will be given to you by slow intravenous infusion.
Croatian: Vaš liječnik ili medicinska sestra koriste je da bi pripremili otopinu koju ćete dobiti sporom intravenskom infuzijom.
English: If available, glass containers should be used for infusion.
Croatian: Ako su dostupni, potrebno je koristiti staklene spremnike za infuziju.
English: The absolute oral bioavailability following administration of Sandimmun is 20 to 50%.
Croatian: Apsolutna oralna bioraspoloživost nakon primjene Sandimmuna iznosi 20 do 50%.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće razviti kod svakoga.
English: Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis.
Croatian: Liječnik će Vas pažljivo motriti ako ste stariji i ako se liječite zbog psorijaze ili atopijskog dermatitisa.