FrancophonIA/ELRC3.0 huggingface dataset:
English: Some side effects could be serious.
Croatian: Neke nuspojave mogu biti ozbiljne
English: Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids.
Croatian: Ciklosporin (također poznat kao ciklosporin A) je ciklički polipeptid koji se sastoji od 11
English: Ciclosporin is extensively metabolised to approximately 15 metabolites.
Croatian: Ciklosporin se u velikoj mjeri metabolizira na približno 15 metabolita.
English: In several studies, paediatric patients required and tolerated higher doses of ciclosporin per kg body weight than those used in adults.
Croatian: U nekoliko su ispitivanja pedijatrijski bolesnici trebali i podnosili više doze ciklosporina po kg tjelesne težine od onih koje se primjenjuju u odraslih osoba.
English: Transplantation
Croatian: Transplantacija
English: A slight precipitate that may occur during storage does not affect the efficacy and safety of the drug.
Croatian: Lagani talog koji se može pojaviti tijekom čuvanja ne utječe na djelotvornost i sigurnost lijeka.
English: Convulsions, paraesthesia
Croatian: Konvulzije, parestezije
English: When Sandimmun is used in transplant patients, routine monitoring of ciclosporin blood levels is an important safety measure.
Croatian: Kada se Sandimmun koristi u transplantiranih bolesnika, rutinsko praćenje razina ciklosporina u krvi važna je sigurnosna mjera.
English: Alcohol may be harmful if you have alcohol-related problems, epilepsy, brain injury, liver problems or if you are pregnant or breast-feeding.
Croatian: Alkohol može biti štetan ako imate tegobe povezane s alkoholom, epilepsiju, ozljedu mozga, probleme s jetrom ili ako ste trudni ili dojite.
English: Types of containers suitable for the infusion solution are mentioned in section 6.2.
Croatian: Vrste spremnika prikladnih za otopinu za infuziju navedene su u dijelu 6.2.
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.
Croatian: Doze se moraju individualno prilagoditi prema djelotvornosti (proteinurija) i sigurnosti primjene, ali ne smiju premašivati 5 mg/kg/dan u odraslih osoba i 6 mg/kg/dan u djece.
English: Lower doses are used once your transplanted organ or bone marrow has stabilised.
Croatian: Niže se doze koriste nakon što se presađeni organ ili koštana srž stabiliziraju.
English: Push the medicine out of the syringe into a small glass with some liquid (not grapefruit juice).
Croatian: Istisnite lijek iz štrcaljke u malu čašu u nešto tekućine (ali ne u sok od grejpa).
English: Except for the treatment of nephrotic syndrome, there is no adequate experience available with Sandimmun.
Croatian: Osim za liječenje nefrotskog sindroma, nema odgovarajućeg iskustva sa Sandimmunom.
English: This is because these can affect how Sandimmun works.
Croatian: To je zato što oni mogu utjecati na djelovanje Sandimmuna.
English: Additional side effects in children and adolescents There are no additional side effects to be expected in children and adolescents compared to adults.
Croatian: Ne očekuju se nikakve dodatne nuspojave u djece i adolescenata u usporedbi s odraslim osobama.
English: • Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body.
Croatian: • Slabost mišića, gubitak mišićne snage, bol u mišićima nogu i ruku ili bilo gdje na tijelu.
English: Benign lymphadenopathy is commonly associated with flares in atopic dermatitis and invariably disappears spontaneously or with general improvement in the disease.
Croatian: Dobroćudna limfoadenopatija obično je povezana s egzacerbacijama atopijskog dermatitisa i redovito nestaju spontano ili s općim poboljšanjem stanja bolesti.
English: Pregnancy Animal studies have shown reproductive toxicity in rats and rabbits.
Croatian: Trudnoća Ispitivanja na životinjama pokazala su reproduktivnu toksičnost u štakora i zečeva.
English: No data exist on the effects of Sandimmun on the ability to drive and use machines.
Croatian: Nema podataka o učincima Sandimmuna na sposobnost upravljanja vozilima i rada sa strojevima.
English: Sandimmun suppresses the immune system and may also affect your body's ability to fight against infection.
Croatian: Sandimmun oslabljuje imunološki sustav i mogao bi utjecati na sposobnost Vašeg tijela da se bori protiv infekcije.
English: Prevention or treatment of graft-versus-host disease (GVHD).
Croatian: Prevencije ili liječenje dokazane reakcije presatka protiv primatelja (GVHD).
English: The absorption of ciclosporin is variable and may be influenced by intake of food.
Croatian: Apsorpcija ciklosporina je promjenjiva i može biti pod utjecajem unosa hrane.
English: Dose reduction may be necessary in patients with severe liver impairment to maintain blood levels within the recommended target range (see sections 4.4 and 5.2) and it is recommended that ciclosporin blood levels are monitored until stable levels are reached.
Croatian: Moglo bi biti potrebno smanjiti dozu u bolesnika s teškim oštećenjem jetre da bi se održale razine u krvi koje su unutar preporučenog ciljnog raspona (vidjeti dijelove 4.4 i 5.2) te se preporučuje praćenje razina ciklosporina u krvi dok se ne postignu stabilne razine.
English: Acne, hypertrichosis
Croatian: Akne, hipertrihoza
English: If you think you have been given too much Sandimmun, tell your doctor immediately.
Croatian: Ako mislite da ste dobili previše Sandimmuna, odmah obavijestite svog liječnika.
English: You will have regular blood tests and visits to the hospital.
Croatian: Redovno ćete imati krvne pretrage i dolaziti u bolnicu.
English: Patients with malignant or pre-malignant alterations of the skin should be treated with Sandimmun only after appropriate treatment of such lesions, and if no other option for successful therapy exists.
Croatian: Bolesnike s malignim ili predmalignim promjenama na koži smije se liječiti Sandimmunom samo nakon odgovarajućeg liječenja takvih lezija te ako ne postoji druga mogućnost za uspješnu terapiju.
English: If no improvement has been observed after this time to improvement period, Sandimmun therapy should be discontinued.
Croatian: Ako nije uočeno nikakvo poboljšanje nakon tog razdoblja vremena do poboljšanja, potrebno je prekinuti terapiju Sandimmunom.
English: Remove the capsules from the blister.
Croatian: Izvadite kapsule iz blistera.
English: Your doctor will carry out regular blood tests and may change your dose if necessary.
Croatian: Liječnik će Vam redovito obavljati krvne pretrage i može Vam promijeniti dozu ako bude potrebno.
English: Pharmacotherapeutic group: Immunosuppressive agents, calcineurin inhibitors, ATC code: L04AD01
Croatian: Farmakoterapijska grupa: Imunosupresivi, inhibitori kalcineurina, ATC oznaka: L04AD01
English: Elevations in serum creatinine were observed in the studies using everolimus or sirolimus in combination with full-dose ciclosporin for microemulsion.
Croatian: Povišenja serumskog kreatinina uočena su u ispitivanjima u kojima se koristio everolimus ili sirolimus u kombinaciji s ciklosporinom za mikroemulziju u punoj dozi.
English: Treatment should be discontinued in patients in whom sufficient response of psoriatic lesions cannot be achieved within 6 weeks on 5 mg/kg/day, or in whom the effective dose is not compatible with the established safety guidelines (see section 4.4).
Croatian: Liječenje treba prekinuti u bolesnika u kojih se ne može postići dostatan odgovor psorijatičnih lezija unutar 6 tjedana s dozom od 5 mg/kg/dan, ili ako učinkovita doza nije kompatibilna sa smjernicama za sigurnost primjene (vidjeti dio 4.4).
English: In comparison to adult transplant populations, the differences in bioavailability between Sandimmun Neoral and Sandimmun in paediatrics are comparable to those observed in adults.
Croatian: U usporedbi s odraslom transplantiranom populacijom, razlike u bioraspoloživosti između Sandimmun Neorala i Sandimmuna u pedijatriji usporedive su s onima uočenima u odraslih osoba.
English: This increases your risk of developing cancers, particularly of the skin and lymphoid system.
Croatian: To Vas izlaže povećanom riziku od razvoja raka, osobito kože i limfnog sustava.
English: Renal biopsy should be considered for patients with steroid-dependent minimal-change nephropathy, in whom Sandimmun therapy has been maintained for more than 1 year.
Croatian: Valja razmotriti biopsiju bubrega za bolesnike s nefropatijom minimalnih promjena ovisnom o steroidima kod kojih se terapija Sandimmunom održavala više od 1 godine.
English: Beneficial effects of ciclosporin therapy have also been shown in a variety of conditions that are known, or may be considered to be of autoimmune origin.
Croatian: Blagotvorni učinci terapije ciklosporinom pokazali su se i u raznim bolestima za koje je poznato ili se može smatrati da su autoimunog porijekla.
English: • Migraine or severe headache often with feeling and being sick (nausea, vomiting) and being sensitive to light.
Croatian: • Migrena ili teška glavobolja često uz osjećaj mučnine (povraćanje) i osjetljivost na svjetlo.
English: Your doctor will adjust your dose to one that is ideal for you.
Croatian: Liječnik će Vam prilagoditi dozu na onu koja je idealna za Vas.
English: Your doctor will work out the correct dose of Sandimmun for you.
Croatian: Vaš liječnik će odrediti pravilnu dozu Sandimmuna za Vas.
English: This is divided in two doses.
Croatian: To je podijeljeno u dvije doze.
English: Prophylactic administration of an antihistamine (H1 + H2 blocker) prior to Sandimmun concentrate for solution for infusion has also been successfully employed to prevent the occurrence of anaphylactoid reactions.
Croatian: Profilaktička primjena antihistaminika (H1 + H2 blokatora) prije Sandimmun koncentrata za otopinu za infuziju također se uspješno koristila za sprečavanje pojave anafilaktoidnih reakcija.
English: The determination of bilirubin and parameters that assess hepatic function are required prior to starting therapy and close monitoring during treatment is recommended.
Croatian: Određivanje bilirubina i parametara kojima se procjenjuje funkcija jetre potrebno je prije početka terapije, a tijekom terapije se preporučuje pažljivo praćenje.
English: Once satisfactory response is achieved, Sandimmun may be discontinued and subsequent relapse managed with re-introduction of Sandimmun at the previous effective dose.
Croatian: Nakon što se postigne zadovoljavajući odgovor može se prekinuti primjena Sandimmuna, a naknadni relaps može se kontrolirati ponovnim uvođenjem Sandimmuna pri prethodnoj učinkovitoj dozi.
English: CARTON AND BOTTLE LABEL
Croatian: KUTIJA I NALJEPNICA ZA BOČICU
English: Lymphomas and other malignancies
Croatian: Limfomi i druge zloćudne bolesti
English: If any of these drugs are used concurrently with ciclosporin, close clinical observation is required in order to enable early detection of toxic manifestations of the medicinal products, followed by reduction of its dosage or its withdrawal.
Croatian: Ako se bilo koji od tih lijekova koristi istodobno s ciklosporinom, potrebno je pažljivo kliničko promatranje da bi se mogle rano uočiti toksične manifestacije lijekova, nakon čega će uslijediti smanjenje doze ili ustezanje lijeka.
English: - This will get rid of any large air bubbles.
Croatian: Tako ćete izbaciti velike mjehure zraka.
English: The oral LD50 of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and > 1,000 mg/kg in rabbits.
Croatian: Oralni LD50 ciklosporina je 2,329 mg/kg u miševa, 1,480 mg/kg u štakora i >1000 mg/kg u zečeva.
English: <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known
Croatian: (≥1/1000, <1/100), rijetko (≥1/10 000, <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Too much of the medicine can affect your kidneys.
Croatian: Previše lijeka može utjecati na Vaše bubrege.
English: If eGFR decreases by more than 25% below baseline at more than one measurement, the dosage of Sandimmun should be reduced by 25 to 50%.
Croatian: Ako se eGFR smanji za više od 25% ispod početne vrijednosti kod više od jednog mjerenja, dozu Sandimmuna potrebno je smanjiti za 25 do 50%.
English: Ciclosporin was tested in a number of in vitro and in vivo tests for genotoxicity with no evidence for a clincally relevant mutagenic potential.
Croatian: Ciklosporin je bio ispitan u brojnim in vitro i in vivo testovima genotoksičnosti i nije bilo dokaza klinički relevantnog mutagenog potencijala.
English: The frequency of malignancies increases with the intensity and duration of therapy (see section 4.4).
Croatian: Učestalost zloćudnih bolesti povećava se s intenzitetom i trajanjem terapije (vidjeti dio 4.4).
English: Carcinogenicity studies were carried out in male and female rats and mice.
Croatian: Ispitivanja kancerogenosti provedena su u mužjaka i ženki štakora i miševa.
English: The white stopper and tube should remain in the bottle.
Croatian: Bijeli čep i cjevčica trebaju ostati u bočici.
English: You might get swollen gums that might grow over your teeth if you are taking nifedipine during your treatment with ciclosporin.
Croatian: Mogle bi Vam oteknuti desni i rasti preko zubi ako uzimate nifedipin tijekom liječenja ciklosporinom.
English: Lymphadenopathy which persists despite improvement in disease activity should be examined by biopsy as a precautionary measure to ensure the absence of lymphoma.
Croatian: Limfoadenopatiju koja ustraje usprkos poboljšanju u aktivnosti bolesti treba ispitati biopsijom kao mjeru predostrožnosti da bi se utvrdilo nepostojanje limfoma.
English: Active herpes simplex infections should be allowed to clear before treatment with Sandimmun is initiated, but are not necessarily a reason for treatment withdrawal if they occur during therapy unless infection is severe.
Croatian: Aktivne infekcije herpes simplexom treba pustiti da se povuku prije početka liječenja Sandimmunom, ali nisu nužno razlog za ustezanje liječenja ako se jave tijekom terapije, osim ako je infekcija teška.
English: LABELLING
Croatian: OZNAČAVANJE
English: Sandimmun oral solution should be diluted in a glass (not plastic) container with cold chocolate drink, milk, fruit juice or cola immediately before being taken, stirred well and drunk at once.
Croatian: Sandimmun oralnu otopinu potrebno je razrijediti u staklenoj (ne plastičnoj) čaši s hladnim čokoladnim napitkom, mlijekom, voćnim sokom ili kolom neposredno prije uzimanja, dobro promiješati i odmah popiti.
English: Azole antibiotics: Ketoconazole, fluconazole, itraconazole and voriconazole could more than double ciclosporin exposure.
Croatian: Azolni antibiotici: ketokonazol, flukonazol, itrakonazol i vorikonazol mogu više nego udvostručiti izloženost ciklosporinu.
English: Many side effects associated with ciclosporin therapy are dose-dependent and responsive to dose reduction.
Croatian: Mnoge nuspojave povezane s terapijom ciklosporinom ovise o dozi i reagiraju na smanjenje doze.
English: During treatment with ciclosporin, vaccination may be less effective and the use of live attenuated vaccines should be avoided.
Croatian: Tijekom liječenja ciklosporinom cijepljenje bi moglo biti manje učinkovito, a uporabu živih atenuiranih cjepiva valja izbjegavati.
English: During long-term treatment, some patients may develop structural changes in the kidney (e.g. interstitial fibrosis) which, in renal transplant patients, must be differentiated from changes due to chronic rejection.
Croatian: Tijekom dugoročnog liječenja u nekih bi se bolesnika mogle razviti strukturne promjene u bubrezima (npr. intersticijska fibroza) koje se, u bolesnika s bubrežnim presatkom, moraju razlikovati od promjena uzrokovanih kroničnim odbacivanjem.
English: Your doctor will tell you how long you need to take Sandimmun for.
Croatian: Liječnik će Vam reći koliko dugo morate uzimati Sandimmun.
English: Forced emesis and gastric lavage may be of value within the first few hours after oral intake.
Croatian: Prisilno povraćanje i ispiranje želuca mogu biti korisni u prvih nekoliko sati nakon oralnog unosa.
English: If considered necessary, magnesium supplementation should be given.
Croatian: Ako se smatra potrebnim, treba dati nadoknadu magnezij.
English: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na ciklosporin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If Sandimmun concentrate for solution for infusion is used, the recommended dose is approximately one-third of the corresponding Sandimmun oral dose, and it is recommend that patients be switched to oral therapy as soon as possible.
Croatian: Ako se primjenjuje Sandimmun koncentrat za otopinu za infuziju, preporučena doza je otprilike jedna trećina odgovarajuće oralne doze Sandimmuna, a preporučuje se da bolesnici čim prije prijeđu na oralnu terapiju.
English: Metabolism mainly takes place in the liver via cytochrome P450 3A4 (CYP3A4), and the main pathways of metabolism consist of mono- and dihydroxylation and N-demethylation at various positions of the molecule.
Croatian: Metabolizam se uglavnom odvija u jetri putem citokroma P450 3A4 (CYP3A4), a glavni putovi metabolizma sastoje se od monoi dihidroksilacije i N-demetilacije na raznim položajima u molekuli.
English: This depends on your body weight and what you are taking the medicine for.
Croatian: To ovisi o Vašoj tjelesnoj težini i razlogu zbog kojeg uzimate lijek.
English: Choose the syringe depending on how much medicine you need to measure: - For 1 ml or less of medicine, use the 1 ml syringe.
Croatian: Mjerenje doze Odaberite štrcaljku ovisno o tome koliko lijeka trebate izmjeriti: Za 1 ml ili manje lijeka, upotrijebite štrcaljku od 1 ml.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines before or during Sandimmun treatment:
Croatian: Osobito obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova prije ili tijekom liječenja Sandimmunom:
English: The intravenous LD50 is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in rabbits.
Croatian: Intravenski LD50 je 148 mg/kg u miševa, 104 mg/kg u štakora i 46 mg/kg u zečeva.
English: The daily doses of Sandimmun should be given in two divided doses equally distributed throughout the day.
Croatian: Dnevne doze Sandimmuna trebaju se primjenjivati u dvije podijeljene doze koje će biti ravnomjerno raspoređene tijekom dana.
English: However, serious symptoms of intoxication have been reported following accidental parenteral overdosage with ciclosporin in premature neonates.
Croatian: Međutim, ozbiljni simptomi trovanja zabilježeni su nakon slučajnog parenteralnog predoziranja ciklosporinom u prijevremeno rođene novorođenčadi.
English: Sandimmun capsules should be swallowed whole.
Croatian: Peroralna primjena Sandimmun kapsule trebaju se progutati cijele.
English: Successful solid organ and bone marrow transplantations have been performed in man using ciclosporin to prevent and treat rejection and GVHD.
Croatian: Uspješne transplantacije solidnih organa i koštane srži obavljene su u ljudi uz uporabu ciklosporina za sprečavanje i liječenje odbacivanja i GVHD-a.
English: Contains ethanol (see leaflet for further information).
Croatian: Sadrži etanol (vidjeti Uputu o lijeku za dodatne informacije).
English: Containers and stoppers should be free of silicone oil and fatty substances.
Croatian: Spremnici i čepovi ne smiju sadržavati silikonsko ulje i masne tvari.
English: After 3 months, the dose of corticosteroids may be tapered to the lowest effective dose.
Croatian: Nakon 3 mjeseca doza kortikosteroida može se postupno smanjivati do najniže učinkovite doze.
English: Ciclosporin doses may need to be increased 3- to 5-fold during co-administration.
Croatian: Doze ciklosporina možda će trebati povećati 3 do 5 puta tijekom istodobne primjene.
English: Usually, higher doses are used before and just after your transplant.
Croatian: Obično se više doze koriste prije i odmah nakon transplantacije.
English: During treatment with ciclosporin, vaccination may be less effective.
Croatian: Tijekom liječenja ciklosporinom cijepljenje bi moglo biti manje učinkovito.
English: • Changes in your sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness.
Croatian: • Promjene vida, gubitak koordinacije, nespretnost, gubitak pamćenja, poteškoće u govorenju ili razumijevanju onoga što drugi govore te slabost mišića.
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.
Croatian: Ako se početnom dozom od 2,5 mg/kg/dan ne postigne dobar početni odgovor unutar 2 tjedna, doza se može brzo povećati do najviše 5 mg/kg.
English: This is because ciclosporin, the active substance, passes into breast milk.
Croatian: To je zato što ciklosporin, djelatna tvar, prelazi u majčino mlijeko.
English: Low doses of Sandimmun should be used to treat mild, chronic GVHD.
Croatian: Niske doze Sandimmuna trebaju se koristiti za liječenje blagog, kroničnog GVHD-a.
English: • Changes in menstrual cycle, breast enlargement in men.
Croatian: • Promjene u menstrualnom ciklusu, povećanje grudi u muškaraca.
English: Sandimmun suppresses your immune system.
Croatian: Sandimmun oslabljuje Vaš imunološki sustav.
English: Sandimmun contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Croatian: Sandimmun sadrži otprilike 12,0 vol. % etanola (alkohola), što odgovara količini do 500 mg po dozi u transplantiranih bolesnika.
English: Psoriasis Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective.
Croatian: Liječenje teške psorijaze u bolesnika u kojih je konvencionalna terapija neučinkovita ili neodgovarajuća.
English: The increase in the bioavailability of diclofenac is most probably caused by a reduction of its high first-pass effect.
Croatian: Povećanje bioraspoloživosti diklofenaka najvjerojatnije je uzrokovano smanjenjem učinka njegovog prvog prolaza kroz jetru.
English: Tear off the sealing ring completely.
Croatian: Potpuno otkinite cijeli sigurnosni prsten.
English: Except in patients with sight-threatening endogenous uveitis and in children with nephrotic syndrome, the total daily dose must never exceed 5 mg/kg.
Croatian: Osim u bolesnika s po vid prijetećim endogenim uveitisom i u djece s nefrotskim sindromom, ukupna dnevna doza nikada ne smije biti veća od 5 mg/kg.
English: Paediatric population: Ciclosporin has been shown to be efficacious in steroid-dependent nephrotic syndrome.
Croatian: Pedijatrijska populacija: pokazalo se da je ciklosporin djelotvoran kod nefrotskog sindroma ovisnog o steroidima.
English: Sandimmun should be administered with caution in patients with neurological Behcet`s syndrome.
Croatian: Sandimmun se mora oprezno primjenjivati u bolesnika s neurološkim Behcetovim sindromom.
English: Expel any large bubbles by depressing and withdrawing the plunger a few times before removing the syringe containing the prescribed dose from bottle.
Croatian: Izbacite sve velike mjehure zraka tako da pritisnete i povučete klip nekoliko puta prije nego izvadite štrcaljku s propisanom dozom iz bočice.
English: In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100,
Croatian: Osim toga, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji (CIOMS III): vrlo često (≥1/10), često (≥1/100, <1/10), manje često
English: Do not take Sandimmun if any of the above applies to you.
Croatian: Nemojte uzimati Sandimmun ako se bilo što od navedenog odnosi na Vas.
English: Owing to its possible interference with the cytochrome P450 enzyme system, grapefruit juice should be avoided for dilution (see section 4.5).
Croatian: Zbog moguće interferencije s enzimskim sustavom citokroma P450, valja izbjegavati sok od grejpa za razrjeđivanje (vidjeti dio 4.5).