FrancophonIA/ELRC3.0 huggingface dataset:
English: Draw up the prescribed volume of solution (position the lower part of the plunger ring in front of the graduation corresponding to the prescribed volume).
Croatian: Povucite prema gore propisani volumen otopine (postavite donji dio klipa štrcaljke ispred oznake koja odgovara propisanom volumenu).
English: If you have questions about how long to take Sandimmun, talk to your doctor or your pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Sandimmun, obratite se svom liječniku ili ljekarniku.
English: If anaphylaxis occurs, the infusion should be discontinued.
Croatian: Ako dođe do anafilakse, infuziju treba prekinuti.
English: Stopping your treatment with Sandimmun may increase the risk of your transplanted organ being rejected.
Croatian: Ako prekinete liječenje Sandimmunom, može se povećati rizik od odbacivanja presađenog organa.
English: The concurrent administration of nifedipine with ciclosporin may result in an increased rate of gingival hyperplasia compared with that observed when ciclosporin is given alone.
Croatian: Istodobna primjena nifedipina s ciklosporinom može rezultirati povišenom stopom hiperplazije gingive u usporedbi sa stopom uočenom kada se ciklosporin daje sam.
English: In the 78-week mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
Croatian: U 78-tjednom ispitivanju na miševima, pri dozama od 1, 4 i 16 mg/kg/dan, pronađeni su dokazi statistički značajnog trenda limfocitnih limfoma u ženki, a incidencija hepatocelularnih karcinoma u mužjaka koji su primali srednje doze značajno je premašivala kontrolnu vrijednost.
English: Transplantation Solid organ transplantation
Croatian: Transplantacija solidnih organa
English: Oral erythromycin, which is known to have the potential to increase the blood concentration of ciclosporin (see section 4.5), should be avoided.
Croatian: Oralni eritromicin, za koji je poznato da ima potencijal povišenja koncentracije ciklosporina u krvi (vidjeti dio 4.5), treba izbjegavati.
English: This depends on whether you are taking it after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome.
Croatian: To ovisi o tome uzimate li ga nakon transplantacije ili za liječenje teških kožnih bolesti, reumatoidnog artritisa, uveitisa ili nefrotskog sindroma.
English: The inter- and intrasubject variability ranges between 18 to 74%.
Croatian: Varijabilnost kod pojedinačnog ispitanika te između ispitanika kreće se u rasponu od 18 do 74%.
English: • Nerve problems with numbness or tingling in fingers and toes.
Croatian: • Problemi sa živcima uz obamrlost ili trnce u prstima na rukama i nogama.
English: The recommended intravenous dose is 3 to 5 mg/kg/day.
Croatian: Preporučena intravenska doza je 3 do 5 mg/kg/dan.
English: If the concentrate for solution for infusion is used, careful consideration should be given to administering an adequate intravenous dose that corresponds to the oral dose.
Croatian: Ako se koristi koncentrat za otopinu za infuziju, potrebno je pažljivo razmotriti primjenu odgovarajuće intravenske doze koja odgovara oralnoj dozi.
English: This medicinal product does not require any special temperature storage conditions.
Croatian: Ovaj lijek ne zahtijeva čuvanje na određenoj temperaturi.
English: Clarithromycin has been reported to double the exposure of ciclosporin.
Croatian: Zabilježeno je da klaritromicin udvostručuje izloženost ciklosporina.
English: Interactions
Croatian: Interakcije
English: Sandimmun can be given in combination with low-dose corticosteroids and/or non-steroidal antiinflammatory drugs (NSAIDs) (see section 4.4).
Croatian: Sandimmun se može davati u kombinaciji s niskim dozama kortikosteroida i/ili nesteroidnih antiinflamatornih lijekova (NSAIL) (vidjeti dio 4.4).
English: Another well-established use of the concentrate for solution for infusion is the initial treatment of patients undergoing bone marrow transplantation.
Croatian: Još jedna dobro utvrđena primjena koncetrata za otopinu za infuziju odnosi se na početno liječenje bolesnika koji se podvrgavaju presađivanju koštane srži.
English: Special caution should be observed if Sandimmun is used in combination with methotrexate due to nephrotoxic synergy.
Croatian: Poseban je oprez potreban ako se Sandimmun primjenjuje u kombinaciji s metotreksatom zbog nefrotoksične sinergije.
English: Switching between oral ciclosporin formulations The switch from one oral ciclosporin formulation to another should be made under physician supervision, including monitoring of blood levels of ciclosporin for transplantation patients.
Croatian: Prebacivanje između oralnih formulacija ciklosporina Prijelaz s jedne oralne formulacije ciklosporina na drugu mora biti proveden pod nadzorom liječnika, što uključuje i praćenje koncentracije ciklosporina u krvi u bolesnika s presatkom.
English: About 37% increase in AUC Cmax was observed when Sandimmun was administered with high-fat meal.
Croatian: Uočeno je povećanje AUC i Cmax od oko 37% kada se Sandimmun primjenjivao uz obrok bogat masnoćama.
English: Clinical studies have included children from 1 year of age using standard ciclosporin dosage with a comparable safety profile to adults.
Croatian: Klinička ispitivanja uključivala su djecu u dobi od 1 godine naviše koja su uzimala doze ciklosporina sa sigurnosnim profilom usporedivim s onim u odraslih osoba.
English: Imatinib could increase ciclosporin exposure and Cmax by around 20%.
Croatian: Imatinib bi mogao povećati izloženost ciklosporinu i Cmax za oko 20%.
English: The syringe should not come in contact with the diluent.
Croatian: Štrcaljka ne smije doći u kontakt s tekućinom za razrjeđivanje.
English: Haemolytic uraemic syndrome, microangiopathic haemolytic anaemia
Croatian: Hemolitički uremijski sindrom, mikroangiopatska hemolitička anemija
English: Due to the variability of this condition, treatment must be individualised.
Croatian: Zbog raznolikosti ovog stanja, liječenje mora biti prilagođeno bolesniku.
English: In rheumatoid arthritis clinical trials with ciclosporin, patients aged 65 or older were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥50% above the baseline after 3 to 4 months of therapy.
Croatian: U kliničkim ispitivanjima reumatoidnog artritisa s ciklosporinom, u bolesnika u dobi od 65 i više godina postojala je veća vjerojatnost razvoja sistoličke hipertenzije tijekom liječenja te veća vjerojatnost povišenja serumskog kreatinina ≥50% iznad početne vrijednosti nakon 3 do 4 mjeseca terapije.
English: Ciclosporin is not dialysable to any great extent, nor is it well cleared by charcoal haemoperfusion.
Croatian: Ciklosporin se ne dijalizira u velikoj mjeri niti se dobro uklanja hemoperfuzijom ugljenom.
English: - Then, put the syringe back in its cover.
Croatian: Zatim vratite štracljku u njezin spremnik.
English: Monitoring ciclosporin levels (see section 4.2)
Croatian: Praćenje razina ciklosporina (vidjeti dio 4.2)
English: More frequent checks are necessary when the Sandimmun dose is increased, or concomitant treatment with an NSAID is initiated or its dosage increased.
Croatian: Učestalije provjere nužne su kada se povećava doza Sandimmuna ili kada se započinje istodobno liječenje nekim NSAILom ili se povećava njegova doza.
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja lijekom ili njegove primjene Za upute o razrijeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: Its use in children under 16 years of age for non-transplantation indications other than nephrotic syndrome cannot be recommended.
Croatian: Njegova primjena u djece mlađe od 16 godina za netransplantacijske indikacije osim nefrotskog sindroma ne može se preporučiti.
English: Pregnant rats which received 12 mg/kg/day of ciclosporin intravenously (twice the recommended human intravenous dose) had foetuses with an increased incidence of ventricular septal defect.
Croatian: Skotne ženke štakora koje su primale 12 mg/kg/dan ciklosporina intravenski (što je dvaput više od preporučene intravenske doze za ljude) imale su fetuse s povećanom incidencijom defekta ventrikularnog septuma.
English: Close monitoring of parameters that assess hepatic function is required and abnormal values may necessitate dose reduction (see sections 4.2 and 5.2).
Croatian: Potrebno je pažljivo pratiti parametre kojima se procjenjuje jetrena funkcija, a u slučaju abnormalnih vrijednosti moglo bi biti potrebno smanjenje doze (vidjeti dijelove 4.2 i 5.2).
English: At the cellular level it inhibits production and release of lymphokines including interleukin 2 (T-cell growth factor, TCGF).
Croatian: Na staničnoj razini inhibira proizvodnju i oslobađanje limfokina, uključujući interleukin 2 (čimbenik rasta T-stanica, TCGF).
English: In some patients, it may be difficult to detect Sandimmun-induced renal dysfunction because of changes in renal function related to the nephrotic syndrome itself.
Croatian: U nekih bolesnika može biti teško uočiti bubrežnu disfunkciju uzrokovanu Sandimmunom zbog promjena u bubrežnoj funkciji povezanih sa samim nefrotskim sindromom.
English: Like other immunosuppressants, ciclosporin predisposes patients to the development of a variety of bacterial, fungal, parasitic and viral infections, often with opportunistic pathogens.
Croatian: Kao i drugi imunosupresivi, ciklosporin u bolesnika stvara predispozicije za razvoj raznih bakterijskih, gljivičnih, parazitskih i virusnih infekcija, često s oportunističkim patogenima.
English: However, due to its nephrotoxic potential (see section 4.8), careful monitoring of renal function is recommended (see section 4.4).
Croatian: Međutim, zbog njegovog nefrotoksičnog potencijala (vidjeti dio 4.8), preporučuje se pažljivo praćenje bubrežne funkcije (vidjeti dio 4.4).
English: Additional precautions in psoriasis
Croatian: Dodatne mjere opreza kod psorijaze
English: • if you develop high blood pressure.
Croatian: • ako razvijete visoki krvni tlak.
English: if you have an infection which is not under control with medication.
Croatian: • ako imate infekciju koja se ne kontrolira lijekom.
English: To achieve initial remission, or to counteract inflammatory ocular attacks, systemic corticosteroid treatment with daily doses of 0.2 to 0.6 mg/kg prednisone or an equivalent may be added if Sandimmun alone does not control the situation sufficiently.
Croatian: Da bi se postigla incijalna remisija ili da bi se suzbili upalni okularni napadaji može se dodati liječenje sistemskim kortikosteroidima u dnevnim dozama od 0,2 do 0,6 mg/kg prednizona ili ekvivalenta ako sam Sandimmun ne kontrolira dostatno situaciju.
English: • if you have gout.
Croatian: • ako imate giht.
English: Special excipients: Ethanol
Croatian: Posebne pomoćne tvari: etanol
English: Do not take Sandimmun: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Sandimmun: - ako ste alergični na ciklosporin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6;
English: Special caution is therefore necessary in patients who have previously received preparations containing polyethoxylated castor oil (e.g. a preparation containing Cremophor® EL) by intravenous injection or infusion, and in patients with an allergic predisposition.
Croatian: Stoga je potreban poseban oprez u bolesnika koji se ranije primali pripravke koji sadrže polietoksilirano ricinusovo ulje (npr. pripravak koji sadrži Cremophor® EL) intravenskom injekcijom ili infuzijom te u bolesnika s predispozicijama za alergiju.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranicama {naziv države članice/ nadležnog tijela}
English: Ethanol: 278 mg/ml.
Croatian: Etanol: 278 mg/ml.
English: The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Croatian: Poluvijek eliminacije u bolesnika s bubrežnim presatkom iznosio je otprilike 11 sati, s rasponom između 4 i 25 sati.
English: Breast-feeding is not recommended during treatment with Sandimmun.
Croatian: Dojenje se ne preporučuje tijekom liječenja Sandimmunom.
English: There is a high variability in the data reported on the terminal elimination half-life of ciclosporin, depending on the assay applied and the target population.
Croatian: Postoji visoka varijabilnost u zabilježenim podacima o terminalnom poluvijeku eliminacije za ciklosporin, ovisno o testu koji se primijenio na ciljanu populaciju.
English: Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally).
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Ciklosporin nije dao nikakve dokaze mutagenih ili teratogenih učinaka u standardnim testnim sustavima uz oralnu primjenu (štakori do 17 mg/kg/dan i zečevi do 30 mg/kg/dan oralno).
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranicama {naziv države članice/ nadležnog tijela}.
English: Co-administration with telaprevir resulted in approximately 4.64-fold increase in ciclosporin dose normalised exposure (AUC).
Croatian: Istodobna primjena s telaprevirom rezultirala je povećanjem od otprilike 4,64 puta u normaliziranoj izloženosti dozi ciklosporina (AUC).
English: • If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Sandimmun is to control your body's immune system.
Croatian: • Ako Vam je presađen organ, koštana srž ili matične stanice, funkcija Sandimmuna je da kontrolira imunološki sustav Vašeg tijela.
English: The concomitant use of diclofenac and ciclosporin has been found to result in a significant increase in the bioavailability of diclofenac, with the possible consequence of reversible renal function impairment.
Croatian: Otkriveno je da istodobna primjena diklofenaka i ciklosporina rezultira značajnim povećanjem bioraspoloživosti diklofenaka, uz moguću posljedicu reverzibilnog oštećenja bubrežne funkcije.
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.
Croatian: Dodatne mjere opreza kod reumatoidnog artritisa Nakon 6 mjeseci terapije bubrežnu je funkciju potrebno procjenjivati svakih 4 do 8 tjedana ovisno o stabilnosti bolesti, istodobno primijenjenim lijekovima i pridruženim bolestima.
English: Optic disc oedema, including papilloedema, with possible visual impairment secondary to benign intracranial hypertension
Croatian: Edemi optičkog diska uključujući papiloedeme, s mogućim poremećajima vida, sekundarno uslijed benigne intrakranijalne hipertenzije
English: This dose should be maintained as the daily dose for 1 to 2 weeks post-operatively, being gradually reduced in accordance with blood levels according to local immunosuppressive protocols until a recommended maintenance dose of about 2 to 6 mg/kg given in 2 divided doses is reached.
Croatian: Ovu dozu treba održavati kao dnevnu dozu tijekom 1 do 2 tjedna postoperativno te potom postupno smanjivati prema razinama u krvi u skladu s lokalnim protokolima imunosupresije dok se ne dostigne preporučena doza održavanja od oko 2 do 6 mg/kg dano u 2 podijeljene doze.
English: When Sandimmun is given with other immunosuppressants (e.g. with corticosteroids or as part of a triple or quadruple medicinal product therapy), lower doses (e.g. 3 to 6 mg/kg given in 2 divided doses for the initial treatment) may be used.
Croatian: Kada se Sandimmun daje s drugim imunosupresivnim lijekovima (npr. s kortikosteroidima ili kao dio trostruke ili četverostruke terapije), mogu se primjenjivati niže doze (npr. 3 do 6 mg/kg dano u 2 podijeljene doze za uvođenje liječenja).
English: Multiple dose administration of ambrisentan and ciclosporin in healthy volunteers resulted in an approximately 2-fold increase in ambrisentan exposure, while the ciclosporin exposure was marginally increased (approximately 10%).
Croatian: Primjena višestrukih doza ambrisentana i ciklosporina u zdravih dobrovoljaca rezultirala je povećanjem izloženosti ambrisentanu od otprilike 2 puta, dok se izloženost ciklosporinu marginalno povećala (otprilike 10%).
English: Psoriasis and atopic dermatitis
Croatian: Psorijaza i atopijski dermatitis
English: If there is no alternative, it is recommended to closely monitor blood levels of ciclosporin, renal function, and for side effects of ciclosporin.
Croatian: Ako nema alternative, preporučuje se pažljivo praćenje razina ciklosporina u krvi, bubrežne funkcije i nuspojava ciklosporina.
English: For inducing remission, initially 5 mg/kg/day orally given in 2 divided doses are recommended until remission of active uveal inflammation and improvement in visual acuity are achieved.
Croatian: Za induciranje remisije za početak se preporučuje 5 mg/kg/dan dano u 2 podijeljene doze dok se ne postigne remisija aktivne uvealne upale i poboljšanje vidne oštrine.
English: The use of live attenuated vaccines should be avoided (see section 4.5).
Croatian: Primjenu živih atenuiranih cjepiva treba izbjegavati (vidjeti dio 4.5).
English: • High level of sugar in your blood.
Croatian: • Visoka razina šećera u krvi.
English: Exposure changes of commonly used statins with ciclosporin are summarised in Table 1.
Croatian: Promjene izloženosti često korištenih statina s ciklosporinom sažete su u Tablici 1.
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.
Croatian: U ispitivanju provedenom u bolesnika s teškom bolešću jetre s cirozom dokazanom biopsijom, terminalni poluvijek bio je 20,4 sati (raspon između 10,8 i 48,0 sati) u usporedbi sa 7,4 do 11,0 sati u zdravih ispitanika.
English: Yellow to brownish yellow liquid, clear or with a small amount of very fine sediment.
Croatian: Žuta do smećkasto žuta tekućina, bistra ili s malom količinom vrlo finog taloga.
English: In addition if you are taking Sandimmun for a non-transplant disease (intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Sandimmun:
Croatian: Osim toga, ako uzimate Sandimmun za netransplantacijsku bolest (intermedijarni ili posteriorni uveitis i Behçetov uveitis, atopijski dermatitis, teški reumatoidni artritis ili nefrotski sindrom), nemojte uzimati Sandimmun:
English: During the concomitant use of a drug that may exhibit nephrotoxic synergy, close monitoring of renal function should be performed.
Croatian: Tijekom istodobne primjene lijeka koji može pokazivati nefrotoksičnu sinergiju potrebno je pažljivo pratiti bubrežnu funkciju.
English: Following oral administration of Sandimmun peak blood concentrations are reached within 1 to 6 hours.
Croatian: Nakon peroralne primjene Sandimmuna vršne koncentracije u krvi postižu se u roku od 1 do 6 sati.
English: Nephrotic syndrome
Croatian: Nefrotski sindrom
English: A 500 mg dose of Sandimmun contains 500 mg ethanol, equivalent to nearly 15 ml beer or 5 ml wine.
Croatian: Doza Sandimmuna od 500 mg sadrži 500 mg etanola, što je ekvivalentno količini od gotovo 15 ml piva ili 5 ml vina.
English: In such cases an initial oral loading dose of 10 to 12.5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory.
Croatian: U takvim slučajevima treba dati početnu oralnu udarnu dozu od 10 do 12,5 mg/kg , nakon čega će uslijediti svakodnevna oralna primjena doze održavanja za koju je prethodno utvrđeno da je zadovoljavajuća.
English: What you need to know before you take Sandimmun
Croatian: Što morate znati prije nego počnete uzimati Sandimmun
English: Pharmacokinetic data from paediatric patients given Sandimmun Neoral or Sandimmun are very limited.
Croatian: Farmakokinetički podaci od pedijatrijskih bolesnika koji su primali Sandimmun Neoral ili Sandimmun vrlo su ograničeni.
English: Sandimmun contains around 12% vol. ethanol.
Croatian: Sandimmun sadrži oko 12 vol. % etanola.
English: • Gum tissue overgrowing and covering your teeth.
Croatian: • Desni koje prekomjerno rastu i prekrivaju Vam zube.
English: Sandimmun prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Croatian: Sandimmun sprečava odbacivanje presađenih organa tako što blokira razvoj određenih stanica koje obično napadaju presađeno tkivo.
English: At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day orally), ciclosporin was embryo- and foetotoxic as indicated by increased prenatal and postnatal mortality, and reduced foetal weight together with related skeletal retardations.
Croatian: Pri toksičnim dozama (štakori pri 30 mg/kg/dan i zečevi pri 100 mg/kg/dan oralno), ciklosporin je bio embrio- i fetotoksičan na što upućuje povećana prenatalna i postnatalna smrtnost te smanjena fetalna težina zajedno s povezanim retardacijama skeleta.
English: Flakes or small bits (sediments) in the medicine do not affect how the medicine works or how safe it is to use.
Croatian: Pahuljice ili mali komadići (talog) u lijeku ne utječu na djelovanje lijeka ili na sigurnost primjene.
English: Sandimmun may also cause dose-dependent, reversible increases in serum bilirubin and in liver enzymes (see section 4.8).
Croatian: Sandimmun može uzrokovati i o dozi ovisna, reverzibilna povišenja serumskog bilirubina i jetrenih enzima (vidjeti dio 4.8).
English: Ciclosporin may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycaemia.
Croatian: Ciklosporin može povisiti koncentracije repaglinida u plazmi i time povećati rizik od hipoglikemije.
English: Sandimmun oral solution and soft gelatin capsules are bioequivalent.
Croatian: Sandimmun oralna otopina i meke želatinske kapsule su bioekvivalentne.
English: If medicinal products known to increase ciclosporin levels are given concomitantly, frequent assessment of renal function and careful monitoring for ciclosporin-related side effects may be more appropriate than blood level measurement.
Croatian: Ako se lijekovi za koje se zna da povećavaju razine ciklosporina primjenjuju istodobno, učestale procjene bubrežne funkcije i pažljivo praćenje nuspojava povezanih s ciklosporinom moglo bi biti primjerenije od mjerenja razine u krvi.
English: Since Sandimmun has been reported to induce a reversible slight increase in blood lipids, it is advisable to perform lipid determinations before treatment and after the first month of therapy.
Croatian: Budući da je za Sandimmun zabilježeno da inducira reverzibilno blago povišenje lipida u krvi, preporučuje se utvrditi razine lipida prije liječenja te nakon prvog mjeseca terapije.
English: It prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Croatian: On sprečava odbacivanje presađenih organa tako što blokira razvoj određenih stanica koje bi inače napale presađeno tkivo.
English: Amiodarone substantially increases the plasma ciclosporin concentration concurrently with an increase in serum creatinine.
Croatian: Amiodaron znatno povećava koncentraciju ciklosporina u plazmi istodobno s povišenjem serumskog kreatinina.
English: • if you have high blood pressure (hypertension) which is not under control with medication.
Croatian: • ako imate visoki krvni tlak (hipertenziju) koja se ne kontrolira lijekom.