FrancophonIA/ELRC3.0 huggingface dataset:
English: A 100 mg dose of Sandimmun contains 556 mg ethanol.
Croatian: Sandimmuna od 100 mg sadrži 556 mg etanola.
English: Additional precautions in nephrotic syndrome
Croatian: Dodatne mjere opreza kod nefrotskog sindroma
English: Preference should be given to an antihypertensive agent that does not interfere with the pharmacokinetics of ciclosporin, e.g. isradipine (see section 4.5).
Croatian: Prednost treba dati antihipertenzivima koji ne ometaju farmakokinetiku ciklosporina, npr. isradipinu (vidjeti dio 4.5).
English: Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g. bosentan, dabigatran etexilate and aliskiren (see section 4.5).
Croatian: Kombinacija s lijekovima koji su supstrati P-glikoproteina, efluksnog transportera za protok više lijekova, ili organskih anionskih prijenosnih proteina (OATP) i za koje su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima, npr. bosentan, dabigatran eteksilat i aliskiren (vidjeti dio 4.5).
English: In two published research studies, rabbits exposed to ciclosporin in utero (10 mg/kg/day subcutaneously) demonstrated reduced numbers of nephrons, renal hypertrophy, systemic hypertension, and progressive renal insufficiency up to 35 weeks of age.
Croatian: U dva objavljena ispitivanja zečevi izloženi ciklosporinu in utero (10 mg/kg/dan potkožno) imali su smanjene brojeve nefrona, bubrežnu hipertrofiju, sistemsku hipertenziju te progresivnu bubrežnu insuficijenciju do dobi od 35 tjedana.
English: In the 24-month rat study conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate at the low dose level.
Croatian: U 24-mjesečnom ispitivanju na štakorima provedenom uz doze od 0,5, 2 i 8 mg/kg/dan, adenomi Langerhansovih otočića značajno su premašivali kontrolnu stopu pri niskoj dozi.
English: • Inflammation of the pancreas with severe upper stomach pain.
Croatian: • Upala gušterače s teškim bolovima u gornjem dijelu trbuha.
English: Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations.
Croatian: Liječenje Behçetovog uveitisa s opetovanim upalnim napadajima koji uključuju mrežnicu u bolesnika bez neuroloških mainfestacija.
English: There is limited experience with Sandimmun in elderly patients.
Croatian: Postoji ograničeno iskustvo sa Sandimmunom u starijih bolesnika.
English: • Low level of red blood cells, low level of platelets in your blood which could increase the risk of bleeding.
Croatian: • Niska razina eritrocita, niska razina trombocita u krvi koja bi mogla povećati rizik od krvarenja.
English: Non-transplantation indications
Croatian: Netransplantacijske indikacije
English: In 9 liver transplant patients aged 0.65-6 years, clearance was 9.3±5.4 ml/min/kg (assay: HPLC).
Croatian: U 9 bolesnika s jetrenim presatkom u dobi od 0,65-6 godina, klirens je bio 9,3±5,4 ml/min/kg (test: HPLC).
English: The 4-ml syringe is used to measure doses greater than 1 ml and up to 4 ml (each graduation of 0.1 ml corresponds to 10 mg of ciclosporin).
Croatian: Štrcaljka od 4 ml koristi se za odmjeravanje doza većih od 1 ml i do 4 ml (svaka oznaka od 0,1 ml odgovara 10 mg ciklosporina).
English: - Leave the white stopper and tube in the bottle.
Croatian: Ostavite bijeli čep i cjevčicu u bočici.
English: It is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants of skin, heart, kidney, pancreas, bone marrow, small intestine or lung.
Croatian: Snažan je imunosupresivni agens koji u životinja produljuje preživljavanje alogenih presadaka kože, srca, bubrega, gušterače, koštane srži, tankog crijeva i pluća.
English: Polyethoxylated castor oil: 650 mg/ml.
Croatian: Polietoksilirano ricinusovo ulje: 650 mg/ml.
English: Renal function must be assessed frequently throughout therapy to allow dosage adjustment (see section 4.2).
Croatian: Bubrežna se funkcija mora učestalo ocjenjivati tijekom liječenja kako bi se omogućilo prilagođavanje doze (vidjeti dio 4.2).
English: Like other immunosuppressants, ciclosporin increases the risk of developing lymphomas and other malignancies, particularly those of the skin.
Croatian: Kao i drugi imunosupresivi, ciklosporin povećava rizik od razvoja limfoma i drugih zloćudnih bolesti, osobito kožnih.
English: • The 1 ml syringe is used to measure doses of 1 ml or smaller.
Croatian: • Štrcaljka od 1 ml koristi se za odmjeravanje doza od 1 ml ili manjih.
English: Additional precautions in non-transplantation indications
Croatian: Dodatne mjere opreza kod netransplantacijskih indikacija
English: • Medicines which may affect your kidneys.
Croatian: • Lijekove koji mogu utjecati na bubrege.
English: disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements.
Croatian: nesanicu, dezorijentiranost, poremećaj vida, nesvijest, osjećaj slabosti u udovima, narušene pokrete.
English: • High blood pressure.
Croatian: • Visoki krvni tlak.
English: Keep taking Sandimmun for as long as your doctor tells you.
Croatian: Uzimajte Sandimmun onoliko dugo koliko Vam to kaže liječnik.
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.
Croatian: Iako bi ciklus terapije od 8 tjedana mogao biti dostatan za poboljšanje, pokazalo se da je terapija do 1
English: Unlike cytostatic agents, it does not depress haemopoiesis and has no effect on the function of phagocytic cells.
Croatian: Za razliku od citostatika, on ne potiskuje hemopoezu i nema učinka na funkciju fagocitskih stanica.
English: Doses available Fold change in exposure with ciclosporin
Croatian: Dostupne doze Koliko se puta mijenja izloženost uz ciklosporin
English: Sandimmun oral solution is provided with two syringes for measuring the doses.
Croatian: Sandimmun oralna otopina isporučuje se s dvije štrcaljke za odmjeravanje doza.
English: For maintenance treatment, doses have to be titrated individually to the lowest effective level, and should not exceed 5 mg/kg/day.
Croatian: Za terapiju održavanja dozu treba individualno titrirati do najniže učinkovite razine, a doza ne bi smjela prelaziti 5 mg/kg/dan.
English: Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and co-medications with hepatotoxic potential.
Croatian: Većina izvješća uključivala je bolesnike sa značajnim komorbiditetima, podležećim bolestima i drugim zbunjujućim čimbenicima uključujući infektivne komplikacije i istodobnu primjenu lijekova s hepatotoksičnim potencijalom.
English: Drugs that increase ciclosporin levels
Croatian: Lijekovi koji povećavaju razinu ciklosporina
English: Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents.
Croatian: Liječenje staničnog odbacivanja presatka u bolesnika koji su prethodno primali druge imunosupresivne lijekove.
English: What Sandimmun is and what it is used for
Croatian: Što je Sandimmun i za što se koristi
English: Fertility There is limited data on the effect of Sandimmun on human fertility (see section 5.3).
Croatian: Postoje ograničeni podaci o učinku Sandimmuna na plodnost u ljudi (vidjeti dio 5.3).
English: Experience with Sandimmun in children with atopic dermatitis is limited.
Croatian: Iskustvo sa Sandimmunom u djece s atopijskim dermatitisom je ograničeno.
English: In psoriatic patients on ciclosporin, as in those on conventional immunosuppressive therapy, development of malignancies (in particular of the skin) has been reported.
Croatian: U bolesnika s psorijazom koji primaju ciklosporin, kao i u onih na konvencionalnoj imunosupresivnoj terapiji, zabilježen je razvoj zloćudnih bolesti (osobito kožnih).
English: Combination with products containing Hypericum perforatum (St John´s Wort) (see section 4.5).
Croatian: Kombinacija s proizvodima koji sadrže Hypericum perforatum (gospinu travu) (vidjeti dio 4.5).
English: Capsule,soft
Croatian: OBLIK Kapsula, meka
English: Sandimmun 50 mg/ml concentrate for solution for infusion contains around 34% v/v ethanol (27.8% m/v ethanol).
Croatian: Sandimmun 50 mg/ml koncentrat za otopinu za infuziju sadrži oko 34% V/V etanola (27,8% m/V etanola).
English: Drugs that decrease ciclosporin levels
Croatian: Lijekovi koji smanjuju razinu ciklosporina
English: Once mixed it should be taken immediately after preparation.
Croatian: Nakon što se promiješa, lijek treba uzeti odmah nakon pripreme.
English: Infusion is continued at this dose level during the immediate post-transplant period of up to 2 weeks, before a change is made to oral maintenance therapy with Sandimmun at daily doses of about 12.5 mg/kg given in 2 divided doses.
Croatian: Infuzija se nastavlja u toj dozi tijekom razdoblja nakon transplantacije u trajanju do 2 tjedna, prije nego što se promijeni u oralnu terapiju održavanja lijekom Sandimmun u dnevnoj dozi od 12,5 mg/kg dano u 2 podijeljene doze.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Patients receiving immunosuppressive therapies, including ciclosporin and ciclosporin containing regimens, are at increased risk of developing lymphomas or lymphoproliferative disorders and other malignancies, particularly of the skin.
Croatian: Benigne, maligne i nespecifične neoplazme (uključujući ciste i polipe) Bolesnici koji primaju imunosupresivne terapije, uključujući ciklosporin i protokole koji sadrže ciklosporin, izloženi su povećanom riziku od razvoja limfoma ili limfoproliferativnih poremećaja i drugih zloćudnih bolesti, osobito kožnih.
English: Patients receiving calcineurin inhibitor (CNI) therapies, including ciclosporin and ciclosporincontaining regimens, are at increased risk of acute or chronic nephrotoxicity.
Croatian: Bolesnici koji primaju terapije inhibitorom kalcineurina (CNI), uključujući ciklosporin i protokole koji sadrže ciklosporin, izloženi su povećanom riziku od akutne ili kronične nefrotoksičnosti.
English: A treatment regimen containing multiple immunosuppressants (including ciclosporin) should therefore be used with caution as this could lead to lymphoproliferative disorders and solid organ tumours, some with reported fatalities.
Croatian: Režime liječenja s više imunosupresiva (uključujući ciklosporin) treba koristiti s oprezom jer to može dovesti do limfoproliferativnih poremećaja i tumora solidnih organa, od kojih su neki završili smrću.
English: During the remission phases, this should not exceed 5 mg/kg/day.
Croatian: Tijekom faza remisije ta doza ne bi smjela prelaziti 5 mg/kg/dan.
English: For maintenance treatment the lowest effective and well tolerated dosage should be determined individually.
Croatian: Za terapiju održavanja najniža učinkovita doza koja se dobro podnosi treba se individualno odrediti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Skin lesions not typical for psoriasis, but suspected to be malignant or pre-malignant should be biopsied before Sandimmun treatment is started.
Croatian: Treba napraviti biopsiju kožnih lezija koje nisu tipične za psorijazu, ali za koje se sumnja da su maligne ili predmaligne, prije početka liječenja Sandimmunom.
English: These reactions can consist of flushing of the face and upper thorax, and non-cardiogenic pulmonary oedema, with acute respiratory distress, dyspnoea, wheezing, blood pressure changes and tachycardia.
Croatian: Te se reakcije mogu sastojati od crvenila lica i gornjeg dijela grudnog koša te nekardiogenog plućnog edema, s akutnim respiratornim distresom, dispnejom, piskanjem, promjenama krvnog tlaka i tahikardijom.
English: Ciclosporin may reduce the clearance of digoxin, colchicine, HMG-CoA reductase inhibitors (statins) and etoposide.
Croatian: Ciklosporin može smanjiti klirens digoksina, kolhicina, inhibitora HMG-CoA reduktaze (statina) i etopozida.
English: In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight.
Croatian: U bolesnika s bubrežnim tegobama, prva doza koja se uzima svakoga dana ne smije biti veća od 2,5 mg po kilogramu tjelesne težine.
English: Ciclosporin
Croatian: ciklosporin
English: The concentrate is used to prepare a solution which is administered by intravenous infusion.
Croatian: Koncentrat se koristi u pripremi otopine koja se primjenjuje putem infuzije u venu.
English: Treatment with Sandimmun should be initiated within 12 hours before surgery at a dose of 10 to 15 mg/kg given in 2 divided doses.
Croatian: Liječenje Sandimmunom treba započeti unutar 12 sati prije operacije u dozi od 10 to 15 mg/kg dano u 2 podijeljene doze.
English: • Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness,
Croatian: • Simptomi moždanih poremećaja koji uključuju iznenadne napadaje, duševnu smetenost,
English: All inhibitors of CYP3A4 and/or P-glycoprotein may lead to increased levels of cyclosporine.
Croatian: Svi inhibitori CYP3A4 i/ili P-glikoproteina mogu dovesti do povišenih razina ciklosporina.
English: Sandimmun contains ethanol
Croatian: Sandimmun sadrži etanol
English: Once an ampoule is opened, the contents should be used immediately.
Croatian: Nakon što se ampula otvori, sadržaj treba odmah upotrijebiti.
English: Frequent monitoring of renal function is therefore required according to local guidelines for the indication in question (see sections 4.2 and
Croatian: Stoga je potrebno učestalo praćenje bubrežne funkcije u skladu s lokalnim smjernicama za relevantnu indikaciju (vidjeti dijelove 4.2 i 4.8).
English: If you forget to take Sandimmun
Croatian: Ako ste zaboravili uzeti Sandimmun
English: Paediatric use in non-transplantation indications
Croatian: Pedijatrijska primjena kod netransplantacijskih indikacija
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.
Croatian: U ispitivanju provedenom u bolesnika s terminalnim zatajenjem bubrega, sistemski klirens iznosio je otprilike dvije trećine srednjeg sistemskog klirensa u bolesnika s bubrezima normalne funkcije.
English: Occasional monitoring of ciclosporin blood levels may be relevant in non-transplant indications, e.g. when Sandimmun is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
Croatian: Povremeno praćenje razina ciklosporina u krvi moglo bi biti relevantno kod netransplantacijskih indikacija, npr. kada se Sandimmun primjenjuje istodobno s tvarima koje bi mogle ometati farmakokinetiku ciklosporina, ili u slučaju neuobičajenog kliničkog odgovora (npr. nedostatak djelotvornosti ili povećana intolerancija na lijek kao što je bubrežna disfunkcija).
English: If there is no improvement after 1 month, the daily dose may be gradually increased, but should not exceed 5 mg/kg.
Croatian: Ako nema poboljšanja nakon 1 mjeseca, dnevna se doza može postupno povisiti, ali ne bi trebala prelaziti
English: Caution is recommended when co-administering ciclosporin with lercanidipine (see section 4.4).
Croatian: Preporučuje se oprez kada se ciklosporin primjenjuje istodobno s lerkanidipinom (vidjeti dio 4.4).
English: Rifampicin induces ciclosporin intestinal and liver metabolism.
Croatian: Rifampicin inducira metabolizam ciklosporina u crijevima i jetri.
English: Subsequent relapse may be managed with a further course of Sandimmun.
Croatian: Naknadni relaps može se kontrolirati dodanim ciklusom primjene Sandimmuna.
English: Initial use of Sandimmun oral solution Raise the flap in the centre of the metal sealing ring.
Croatian: Prva primjena Sandimmun oralne otopine Podignite kapicu koja se nalazi u središtu metalnog sigurnosnog prstena.
English: • Serious liver problems both with and without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark coloured urine, swelling of the face, feet, hands and/or the whole body.
Croatian: • Ozbiljne tegobe s jetrom sa ili bez žutila očiju ili kože, mučnina, gubitak apetita, mokraća tamne boje, oticanje lica, stopala, ruku i/ili cijelog tijela.
English: Do not take Sandimmun and tell your doctor if the above applies to you.
Croatian: Nemojte uzimati Sandimmun i obavijestite svog liječnika ako se gore navedeno odnosi na Vas.
English: If your doctor switches you from one oral formulation of ciclosporin to another After you change from one oral formulation of ciclosporin to another:
Croatian: Ako Vas liječnik prebaci s jedne oralne formulacije ciklosporina na drugu
English: All inducers of CYP3A4 and/or P-glycoprotein are expected to decrease ciclosporin levels.
Croatian: Za sve induktore CYP3A4 i/ili P-glikoproteina očekuje se da će smanjiti razine ciklosporina.
English: Ciclosporin appears to block the resting lymphocytes in the G0 or G1 phase of the cell cycle, and inhibits the antigen-triggered release of lymphokines by activated T-cells.
Croatian: Čini se da ciklosporin blokira limfocite u mirovanju u fazama G0 ili G1 staničnog ciklusa te inhibira antigenom potaknuto otpuštanje limfokina iz aktiviranih T-stanica.
English: What Sandimmun contains
Croatian: Što Sandimmun sadrži
English: The ethanol content of the Sandimmun formulations should also be taken into account in women who are breast-feeding (see section 4.4).
Croatian: Sadržaj etanola u formulacijama Sandimmuna također treba uzeti u obzir kod žena koje doje (vidjeti dio 4.4).
English: The oral solution should not be refrigerated.
Croatian: Oralna otopina se ne smije stavljati u hladnjak.
English: Caution is required with concomitant use of potassium-sparing medicinal products (e.g. potassiumsparing diuretics, ACE inhibitors, angiotensin II receptor antagonists) or potassium-containing medicinal products since they may lead to significant increases in serum potassium (see section 4.4).
Croatian: Potreban je oprez kod istodobne primjene lijekova koji štede kalij (npr. diuretika koji štede kalij, ACE inhibitora, antagonista angiotenzin II receptora) ili lijekova koji sadrže kalij budući da oni mogu dovesti do značajnih povišenja kalija u serumu (vidjeti dio 4.4).
English: - with products containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure).
Croatian: - s lijekovima koji sadrže dabigatran eteksilat (koji se primjenjuje radi sprečavanja stvaranja krvnih ugrušaka nakon kirurškog zahvata) ili bosentan i aliskiren (koji se koriste za snižavanje povišenog krvnog tlaka).
English: • Medicines that may affect your potassium levels.
Croatian: • Lijekove koji mogu utjecati na razinu kalija.
English: The concentrate should be diluted 1:20 to 1:100 with normal saline or 5% glucose, and given as a slow intravenous infusion over approximately 2 to 6 hours.
Croatian: Koncentrat je potrebno razrijediti u omjeru 1:20 do 1:100 s normalnom fiziološkom otopinom ili 5%tnom glukozom te primijeniti kao sporu intravensku infuziju tijekom otprilike 2 do 6 sati.
English: Ciclosporin undergoes minimal renal elimination and its pharmacokinetics are not extensively affected by renal impairment (see section 5.2).
Croatian: Ciklosporin prolazi kroz minimalnu bubrežnu eliminaciju i oštećenje bubrega nema veliki utjecaj na njegovu farmakokinetiku (vidjeti dio 5.2).
English: Cases of acute nephrotoxicity reported disorders of ion homeostasis, such as hyperkalaemia, hypomagnesaemia, and hyperuricaemia.
Croatian: U slučajevima akutne nefrotoksičnosti zabilježeni su poremećaji homeostaze iona, kao što su hiperkalijemija, hipomagnezijemija i hiperuricemija.
English: Co-administration of ciclosporin and aliskiren is not recommended (see section 4.3).
Croatian: Istodobna primjena ciklosporina i aliskirena se ne preporučuje (vidjeti dio 4.3).
English: • Feeling numb or tingling.
Croatian: • Osjećaj obamrlosti ili trnaca.
English: These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics and some medicines which lower your blood pressure.
Croatian: To uključuje lijekove koji sadrže kalij, dodatke kalija, tablete za izmokravanje (diuretike) koji se nazivaju tabletama koje štede kalij i neke lijekove koji snižavaju krvni tlak.
English: Sandimmun 25 mg soft capsules Sandimmun 50 mg soft capsules Sandimmun 100 mg soft capsules ciclosporin
Croatian: Sandimmun 25 mg meke kapsule Sandimmun 50 mg meke kapsule Sandimmun 100 mg meke kapsule ciklosporin
English: Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.
Croatian: Takve bolesti uključuju tegobe s očima koje prijete Vašem vidu (endogeni uveitis, uključujući Behçetov uveitis), teške slučajeve određenih kožnih bolesti (atopijski dermatitis, ili ekcem i psorijaza), teški reumatoidni artritis i bolest bubrega koja se zove nefrotski sindrom.
English: Within the therapeutic dose range the peak plasma concentration and the area under the plasma concentration/time curve are proportional to the dose; for whole blood, however, the relationship is non-linear.
Croatian: Unutar terapijskog raspona doze, vršna koncentracija u plazmi i površina pod krivuljom koncentracije u plazmi/vremena proporcionalne su dozi.
English: This is because this medicine contains alcohol (see section below “Sandimmun contains ethanol”).
Croatian: Razlog tome je što ovaj lijek sadrži alkohol (vidjeti dio u nastavku „Sandimmun sadrži etanol“).
English: • Acne, hot flushes.
Croatian: • Akne, navale vrućine.
English: • The 4 ml syringe is used to measure doses bigger than 1 ml and up to 4 ml.
Croatian: • Štrcaljka od 4 ml koristi se za odmjeravanje doza većih od 1 ml i do 4 ml.
English: Elderly patients should be treated only in the presence of disabling psoriasis, and renal function should be monitored with particular care.
Croatian: Stariji se bolesnici smiju liječiti samo ako je prisutna onesposobljavajuća psorijaza, a bubrežnu funkciju valja osobito pažljivo pratiti.
English: What Sandimmun looks like and contents of the pack Sandimmun concentrate for solution for infusion is supplied in ampoules containing 1 ml or 5 ml concentrate.
Croatian: Sandimmun koncentrat za otopinu za infuziju dostupan je u ampulama koje sadrže 1 ml ili 5 ml koncentrata.
English: • Usually, higher doses are used before and just after your transplant.
Croatian: • Veće se doze uobičajeno primjenjuju prije i neposredno nakon presađivanja.
English: Ethanol: 100 mg/ml.
Croatian: Etanol: 100 mg/ml.
English: Ciclosporin enhances the risk of hyperkalaemia, especially in patients with renal dysfunction.
Croatian: Ciklosporin povećava rizik od hiperkalemije, osobito u bolesnika s bubrežnom disfunkcijom.
English: - For more than 1 ml of medicine, use the 4 ml syringe.
Croatian: Za više od 1 ml lijeka, upotrijebite štrcaljku od 4 ml.
English: In the event of increased lipids being found, restriction of dietary fat and, if appropriate, a dose reduction, should be considered.
Croatian: U slučaju nalaza povišenih lipida, treba razmotriti ograničavanje unosa masnoća putem hrane te, ako je primjereno,
English: Co-administration of bosentan and ciclosporin in healthy volunteers increases the bosentan exposure several-fold and there was a 35% decrease in ciclosporin exposure.
Croatian: Istodobna primjena bosentana i ciklosporina u zdravih dobrovljaca povećava nekoliko puta izloženost bosentanu, a došlo je i do smanjenja izloženosti ciklosporinu za 35%.
English: • Rash.
Croatian: • Osip.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Croatian: DODATAK III SAŽETAK OPISA SVOJSTAVA LIJEKA, OZNAČAVANJE I UPUTA O LIJEKU