FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional precautions in atopic dermatitis
Croatian: Dodatne mjere opreza kod atopijskog dermatitisa
English: Elderly patients should be treated only in the presence of disabling atopic dermatitis and renal function should be monitored with particular care.
Croatian: Stariji bolesnici smiju se liječiti samo u slučaju onesposobljavajućeg atopijskog dermatitisa, a bubrežnu funkciju potrebno je posebno oprezno pratiti.
English: Talk to your doctor before taking Sandimmun:
Croatian: Obratite se svom liječniku prije nego uzmete lijek Sandimmun:
English: • Excessive growth of body and facial hair.
Croatian: • Prekomjerni rast dlaka na tijelu i licu.
English: Activation of latent polyomavirus infections that may lead to polyomavirus associated nephropathy (PVAN), especially to BK virus nephropathy (BKVN), or to JC virus associated progressive multifocal leukoencephalopathy (PML), have been observed in patients receiving ciclosporin.
Croatian: Aktivacija latentnih infekcija poliomavirusom koje mogu dovesti do nefropatije povezane s poliomavirusom (eng. polyomavirus associated nephropathy, PVAN), osobito do BK virusne nefropatije (BKVN) ili do progresivne multifokalne leukoencefalopatije (PML) povezane s JC
English: What Sandimmun is used for and how Sandimmun works
Croatian: Za što se Sandimmun kroisti i kako Sandimmun djeluje
English: In view of the potential risk of skin malignancy, patients on Sandimmun, in particular those treated for psoriasis or atopic dermatitis, should be warned to avoid excess unprotected sun exposure and should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Croatian: S obzirom na potencijalni rizik zloćudne bolesti kože, bolesnike koji primaju Sandimmun, osobito one koji se liječe zbog psorijaze ili atopijskog dermatitisa, treba upozoriti da izbjegavaju prekomjerno izlaganje suncu bez zaštite te da se ne smiju istodobno liječiti ultraljubičastim
English: • Your doctor will adjust your dose to one that is ideal for you.
Croatian: • Vaš će liječnik prilagoditi Vašu dozu lijeka tako da ona bude idealna upravo za Vas.
English: Acute and chronic nephrotoxicity
Croatian: Akutna i kronična nefrotoksičnost
English: For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Croatian: Za terapiju održavanja dozu treba postupno smanjivati do najniže učinkovite razine.
English: Before initiation of treatment a reliable baseline level of renal function should be established by at least two measurements.
Croatian: Prije početka liječenja potrebno je pomoću najmanje dva mjerenja odrediti pouzdanu početnu razinu bubrežne funkcije.
English: Ciclosporin is extensively metabolised by the liver.
Croatian: Ciklosporin se uvelike metabolizira putem jetre.
English: What Sandimmun is used for and how it works Sandimmun is used to control the body's immune system following an organ transplant, including bone marrow and stem cell transplantation.
Croatian: Sandimmun se koristi za kontroliranje imunološkog sustava tijela nakon presađivanja organa, uključujući koštanu srž i matične stanice.
English: Caution should be observed when co-administering ciclosporin with drugs that substantially increase or decrease ciclosporin plasma concentrations, through inhibition or induction of CYP3A4 and/or Pglycoprotein (see section 4.5).
Croatian: Potreban je oprez kod istodobne primjene ciklosporina i lijekova koji značajno povisuju ili snižavaju koncentracije ciklosporina u plazmi, kroz inhibiciju ili indukciju CYP3A4 i/ili P-glikoproteina (vidjeti dio 4.5).
English: Special excipients: Polyoxyl 40 hydrogenated castor oil Sandimmun contains polyoxyl 40 hydrogenated castor oil, which may cause stomach upsets and diarrhoea.
Croatian: Posebne pomoćne tvari: polioksil 40 hidrogenirano ricinusovo ulje Sandimmun sadrži polioksil 40 hidrogenirano ricinusovo ulje koje može uzrokovati želučane tegobe i proljev.
English: Insert the nozzle of the syringe into the white stopper.
Croatian: Umetnite vrh štrcaljke u bijeli čep.
English: If any of these affects you severely, tell your doctor.
Croatian: Ako se bilo koja od ovih nuspojava pojavi u teškom obliku, obavijestite svog liječnika.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 100 mg ciclosporin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 ml oralne otopine sadržava 100 mg ciklosporina.
English: Sandimmun contains castor oil and ethanol
Croatian: Sandimmun sadrži ricinusovo ulje i etanol
English: For the initial monitoring of liver transplant patients, either the specific monoclonal antibody should be used, or parallel measurements using both the specific monoclonal antibody and the non-specific monoclonal antibody should be performed, to ensure a dosage that provides adequate immunosuppression.
Croatian: Za početno praćenje bolesnika s jetrenim presatkom treba koristiti ili specifično monoklonalno protutijelo ili obaviti paralelna mjerenja u kojima se koristi i specifično monoklonsko protutijelo i nespecifično monoklonalno protutijelo, kako bi se osiguralo da doza pruža odgovarajuću imunosupresiju.
English: The signs include pale skin, feeling tired, being breathless, having dark urine (this is a sign of the breakdown of red blood cells), bruising or bleeding with no obvious reasons, feeling confused, feeling disorientated, being less alert and having kidney problems.
Croatian: Znakovi uključuju blijedu kožu, osjećaj umora, nedostatak zraka, tamnu mokraću (to je znak raspadanja eritrocita), podljeve ili krvarenje bez očiglednog razloga, osjećaj smetenosti, osjećaj dezorijentiranosti, manja razina budnosti i tegobe s bubrezima.
English: Hirsutism
Croatian: Hirzutizam
English: The concentrate for solution for infusion should be diluted 1:20 to 1:100 with normal saline or 5% glucose and given as a slow intravenous infusion over 2 to 6 hours.
Croatian: Koncentrat za otopinu za infuziju potrebno je razrijediti u omjeru 1:20 do 1:100 s normalnom fiziološkom otopinom ili 5-postotnom glukozom te dati kao sporu intravensku infuziju tijekom 2 do 6 sati.
English: Studies suggest that ciclosporin inhibits the development of cell-mediated reactions, including allograft immunity, delayed cutaneous hypersensitivity, experimental allergic encephalomyelitis, Freund's adjuvant arthritis, graft-versushost disease (GVHD), and also T-cell dependent antibody production.
Croatian: Ispitivanja upućuju na to da ciklosporin inhibira razvoj reakcija kojima posreduju stanice, uključujući imunitet alogenog presatka, odgođenu preosjetljivost kože, eksperimentalni alergijski encefalomijelitis, Freundov adjuvantni artritis, reakciju presatka protiv primatelja (GVHD), te isto tako proizvodnju protutijela ovisnih o T-stanicama.
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Upitajte svog liječnika ili ljekarnika za savjet prije nego što uzmete ovaj lijek.
English: Following concomitant administration of ciclosporin and lercanidipine, the AUC of lercanidipine was increased three-fold and the AUC of ciclosporin was increased 21%.
Croatian: Nakon istovremene primjene ciklosporina i lerkanidipina, AUC lerkanidipina povećao se tri puta, a AUC ciklosporina povećao se za 21%.
English: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders Very common
Croatian: Trombotska mikroangiopatija, trombotska trombocitopenička purpura Poremećaji metabolizma i prehrane Vrlo često
English: If hypertension develops, appropriate antihypertensive treatment must be instituted.
Croatian: mora se započeti odgovarajuće antihipertenzivno liječenje.
English: Sandimmun should be prescribed only by physicians who are experienced in immunosuppressive therapy and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure and control of laboratory safety parameters.
Croatian: Sandimmun smiju propisivati samo liječnici koji imaju iskustva s imunosupresivnom terapijom i mogu osigurati odgovarajuće naknadno praćenje, koje uključuje redovne potpune fizikalne preglede,
English: If this affects you severely, tell your doctor.
Croatian: Ako se ova nuspojava pojavi u teškom obliku, obavijestite svog liječnika.
English: Sandimmun concentrate for solution for infusion contains castor oil which may cause severe allergic reactions.
Croatian: Sandimmun koncentrat za otopinu za infuziju sadrži ricinusovo ulje koje može uzrokovati teške alergijske reakcije.
English: The concomitant intake of grapefruit and grapefruit juice has been reported to increase the bioavailability of ciclosporin.
Croatian: Zabilježeno je da istodobni unos grejpa i soka od grejpa povećava bioraspoloživost ciklosporina.
English: if you have low levels of magnesium in your body.
Croatian: • ako imate niske razine magnezija u krvi.
English: Additional precautions in endogenous uveitis
Croatian: Dodatne mjere opreza kod endogenog uveitisa
English: If you are not sure, talk to your doctor before taking Sandimmun.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego što uzmete Sandimmun.
English: What Sandimmun is
Croatian: Što je Sandimmun
English: There is only limited experience with the use of Sandimmun in children with psoriasis.
Croatian: Postoji tek ograničeno iskustvo s primjenom Sandimmuna u djece s psorijazom.
English: The principal adverse reactions observed in clinical trials and associated with the administration of ciclosporin include renal dysfunction, tremor, hirsutism, hypertension, diarrhoea, anorexia, nausea and vomiting.
Croatian: Glavne nuspojave koje su bile uočene u kliničkim ispitivanjima i povezane s primjenom ciklosporina uključuju bubrežnu disfunkciju, tremor, pojačanu dlakavost, hipertenziju, proljev, anoreksiju, mučninu i povraćanje.
English: Sandimmun concentrate for solution for infusion contains macrogolglycerol ricinoleate/polyethoxylated castor oil, which can cause phathalate stripping from polyvinyl chloride.
Croatian: Sandimmun koncentrat za otopinu za infuziju sadrži makrogolglicerolricinoleat/polietoksilirano ricinusovo ulje, koje može uzrokovati otpuštanje ftalata iz polivinilklorida.
English: Severe rheumatoid arthritis
Croatian: Teški reumatoidni artritis
English: Regular monitoring of blood pressure is required during Sandimmun therapy.
Croatian: Hipertenzija Tijekom terapije Sandimmunom potrebno je redovito pratiti krvni tlak.
English: Hyperglycaemia, anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia Nervous system disorders
Croatian: Hiperglikemija, anoreksija, hiperuricemija, hiperkalijemija, hipomagnezijemija
English: Polyethoxylated castor oil and anaphylactoid reactions Sandimmun concentrate for solution for infusion contains polyethoxylated castor oil, which has been reported to cause anaphylactoid reactions following intravenous administration.
Croatian: Polietoksilirano ricinusovo ulje i anafilaktoidne reakcije Sandimmun koncentrat za otopinu za infuziju sadrži polietoksilirano ricinusovo ulje, za koje je zabilježeno da uzrokuje anafilaktoidne reakcije nakon intravenske primjene.
English: Organ, bone marrow and stem cell transplantation The total dose each day is usually between 2 mg and 15 mg per kilogram body weight.
Croatian: Transplantacija organa, koštane srži i matičnih stanica Ukupna doza svakoga dana obično je između 2 mg i 15 mg po kilogramu tjelesne težine.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene redom od najozbiljnijih prema manje ozbiljnima.
English: Sandimmun oral solution contains 12.6% v/v ethanol (10.0% m/v ethanol).
Croatian: Sandimmun oralna otopina sadrži 12,6% V/V etanola (10,0% m/V etanol).
English: • If you have an autoimmune disease, in which your body's immune response attacks your body's own cells, Sandimmun stops this immune reaction.
Croatian: • Ako imate autoimunu bolest, u kojoj imunološki odgovor Vašeg tijela napada vlastite stanice
English: Concomitant use of ciclosporin and tacrolimus should be avoided (see section 4.5).
Croatian: Istovremenu primjenu ciklosporina i takrolimusa treba izbjegavati (vidjeti dio 4.5).
English: Sandimmun soft capsules contain 12.8% v/v ethanol (10.2% m/v).
Croatian: Sandimmun meke kapsule sadrži 12,8% V/V etanola (10,2% m/V).
English: Pyrexia, fatigue
Croatian: Pireksija, umor
English: Sandimmun 100 mg soft capsules are dusty rose and oblong.
Croatian: Sandimmun 100 mg meke kapsule su prljavo ružičaste i duguljaste.
English: How much Sandimmun to take
Croatian: Koliko Sandimmuna uzimati
English: Live-attenuated vaccines
Croatian: Živa atenuirana cjepiva
English: In some cases, mainly in transplant patients, fatal outcomes have been reported (see section 4.4).
Croatian: U nekim slučajevima, uglavnom u transplantiranih bolesnika, zabilježeni su smrtni ishodi (vidjeti dio
English: • High level of uric acid or potassium in your blood, low levels of magnesium in your blood.
Croatian: • Visoka razina mokraćne kiseline ili kalija u krvi, niske razine magnezija u krvi.
English: There is only limited experience with the use of Sandimmun in children with endogenous uveitis.
Croatian: Postoji samo ograničeno iskustvo s primjenom Sandimmuna u djece s endogenim uveitisom.
English: - with products containing Hypericum perforatum (St John´s Wort).
Croatian: - s proizvodima koji sadrže Hypericum perforatum (gospinu travu).
English: It contains the active substance ciclosporin.
Croatian: Sadrži djelatnu tvar ciklosporin.
English: • The other ingredients are: ethanol anhydrous, macrogolglycerol ricinolate/polyethoxynolated castor oil.
Croatian: • Drugi sastojci su: bezvodni etanol, makrogolglicerolricinolat/polietoksilirano ricinusovo ulje.
English: For inducing remission, the recommended initial dose is 2.5 mg/kg/day orally given in 2 divided doses.
Croatian: Za postizanje remisije preporučena početna doza je 2,5 mg/kg/dan dano oralno u 2 podijeljene doze.
English: Nicardipine, metoclopramide, oral contraceptives, methylprednisolone (high dose), allopurinol, cholic acid and derivatives, protease inhibitors, imatinib, colchicine, nefazodone.
Croatian: Primjeri su: nikardipin, metoklopramid, oralni kontraceptivi, metilprednizolon (visoka doza), alopurinol, kolna kiselina i derivati, inhibitori proteaze, imatinib, kolhicin, nefazodon.
English: In a study of 7 renal transplant patients aged 2-16 years, the ciclosporin clearance ranged from 9.8 to15.5 ml/min/kg.
Croatian: U ispitivanju 7 bolesnika s bubrežnim presatkom u dobi od 2-16 godina, klirens ciklosporina bio je u rasponu od 9,8 do15,5 ml/min/kg.
English: If you are taking Sandimmun following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases.
Croatian: Što morate znati prije nego počnete uzimati Sandimmun Ako uzimate Sandimmun nakon presađivanja, smije Vam ga propisati samo liječnik koji ima iskustva s presađivanjem i/ili autoimunim bolestima.
English: The 1-ml syringe is used to measure doses less than or equal to 1 ml (each graduation of 0.05 ml corresponds to 5 mg of ciclosporin).
Croatian: Štrcaljka od 1 ml koristi se za odmjeravanje doza koje su manje od ili jednake 1 ml (svaka oznaka od 0,05 ml odgovara
English: There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin.
Croatian: Postoje poticane i spontane prijave o hepatotoksičnosti i ozljedi jetre koja uključuju kolestazu, žuticu, hepatitis i zatajenje jetre u bolesnika liječenih ciklosporinom.
English: For maintenance treatment the dose has to be titrated individually to the lowest effective level according to tolerability.
Croatian: Doza održavanja treba se individualno titrirati do najniže učinkovite doze u skladu s podnošljivošću.
English: • The total dose each day is usually between 3 to 5 mg per kilogram of your weight.
Croatian: • Ukupna doza svakog dana obično je između 3 do 5 mg po kilogramu Vaše težine.
English: For volume greater than 1 ml, use the 4-ml syringe.
Croatian: Za volumen veći od 1 ml, upotrijebite štrcaljku od 4 ml.
English: How long to take Sandimmun
Croatian: Kako dugo uzimati Sandimmun
English: Once an ampoule has been opened, the contents should be used immediately.
Croatian: Nakon što se ampula otvori sadržaj se mora odmah upotrijebiti.
English: Migraine
Croatian: Migrene
English: Leucopenia
Croatian: Leukopenija
English: For volume less than 1 ml or equal to 1 ml, use the 1-ml syringe.
Croatian: Za volumen manji ili jednak 1 ml, upotrijebite štrcaljku od 1 ml.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih dodatnih pitanja o primjeni ovog lijeka, obratite se svojem liječniku ili ljekarniku.
English: Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis.
Croatian: Terapiju statinima treba privremeno ustezati ili prekinuti u bolesnika sa znakovima i simptomima miopatije ili u onih s čimbenicima rizika koji ih predisponiraju za tešku ozljedu bubrega, što uključuje zatajenje bubrega uslijed rabdomiolize.
English: The recommended dose range is 2.5 to 5 mg/kg/day given in 2 divided oral doses.
Croatian: Preporučeni raspon doza kreće se između 2,5 i 5 mg/kg/dan dano u 2 podijeljene oralne doze.
English: How to take Sandimmun
Croatian: Kako uzimati Sandimmun
English: Pink, oval soft gelatin capsules Corn yellow, oblong soft gelatin capsules Dusty rose, oblong soft gelatin capsules
Croatian: Kukuruzno žute, duguljaste meke želatinske kapsule
English: Hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure with some fatal outcome (see section 4.4) Skin and subcutaneous tissue disorders Very common
Croatian: Hepatotoksičnost i ozljeda jetre uključujući kolestazu, žuticu, hepatitis i zatajenje jetre ponekad uz smrtni ishod (vidjeti dio 4.4)
English: Caution should be observed while co-administering ciclosporin with such drugs or concomitant use should be avoided (see section 4.5).
Croatian: Potreban je oprez kod istodobne primjene ciklosporina s takvim lijekovima ili izbjegavanje istovremene primjene (vidjeti dio 4.5).
English: Sandimmun should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive therapy and/or organ transplantation.
Croatian: Sandimmun smiju propisivati samo liječnici koji imaju iskustva s imunosupresivnom terapijom i/ili presađivanjem organa ili drugi liječnici u uskoj suradnji s njima.
English: ml.
Croatian: U
English: Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis (see section
Croatian: Terapiju statinima treba privremeno ustezati ili prekinuti u bolesnika sa znakovima i simptomima miopatije ili u onih koji imaju čimbenike rizika zbog kojih su predisponirani za tešku ozljedu bubrega, uključujući zatajenje bubrega uslijed rabdomiolize (vidjeti dio 4.5).
English: Take off the black stopper and throw it away.
Croatian: S bočice skinite crni gumeni čep i pažljivo ga bacite.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su poredane prema učestalosti, počevši od najučestalijih.
English: Verapamil increases ciclosporin blood concentrations 2- to 3-fold.
Croatian: Verapamil povećava koncentracije ciklosporina u krvi za 2 do 3 puta.
English: Discontinuation of Sandimmun may also become necessary if hypertension developing during treatment cannot be controlled by appropriate therapy.
Croatian: Prekid liječenja Sandimmunom također bi mogao biti nužan ako se hipertenzija koja se razvije tijekom liječenja ne može kontrolirati odgovarajućom terapijom.
English: [See Annex I - To be completed nationally]
Croatian: [Vidjeti Dodatak I - Ispunjava država članica]
English: If you are not sure, talk to your doctor or pharmacist before taking Sandimmun.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije uzimanja Sandimmuna.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Skin infections with Staphylococcus aureus are not an absolute contraindication for Sandimmun therapy, but should be controlled with appropriate antibacterial agents.
Croatian: Kožne infekcije bakterijom Staphylococcus aureus nisu apsolutna kontraindikacija za terapiju
English: Nausea, vomiting, abdominal discomfort/pain, diarrhoea, gingival hyperplasia, peptic ulcer
Croatian: Mučnina, povraćanje, nelagoda/bol u abdomenu, proljev, hiperplazija gingive,
English: LIST OF EXCIPIENTS Also contains: Ethanol anhydrous, macrogolglycerol ricinoleate/polyethoxylated castor oil
Croatian: POPIS POMOĆNIH TVARI Također sadrži: etanol, bezvodni, makrogolglicerolricinoleat/polietoksilirano ricinusovo ulje
English: How to store Sandimmun Contents of the pack and other information
Croatian: Kako Sandimmun izgleda i sadržaj pakiranja
English: High level of lipids in your blood.
Croatian: • Visoka razina lipida u krvi.
English: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, intravenous sulfadimidine, probucol, orlistat, hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan.
Croatian: Primjeri lijekova koji smanjuju razine ciklosporina su: barbiturati, karbamazepin, okskarbazepin, fenitoin; nafcilin, intravenski sulfadimidin, probukol, orlistat, Hypericum perforatum (gospina trava), tiklopidin, sulfinpirazon, terbinafin, bosentan.
English: Sandimmun and associated names (see Annex I) 25 mg soft capsules Sandimmun and associated names (see Annex I) 50 mg soft capsules Sandimmun and associated names (see Annex I) 100 mg soft capsules [See Annex I - To be completed nationally]
Croatian: Sandimmun i pridružena imena (vidjeti Dodatak I) 25 mg meke kapsule Sandimmun i pridružena imena (vidjeti Dodatak I) 50 mg meke kapsule Sandimmun i pridružena imena (vidjeti Dodatak I) 100 mg meke kapsule
English: if you have any liver problems.
Croatian: • ako imate bilo kakve tegobe s jetrom.
English: Renal toxicity should be monitored when initiating ciclosporin use together with active substances that increase ciclosporin levels or with substances that exhibit nephrotoxic synergy (see section 4.5).
Croatian: Bubrežnu toksičnost treba pratiti kada se započinje liječenje ciklosporinom zajedno s djelatnim tvarima koje povećavaju razine ciklosporina ili s tvarima koje pokazuju nefrotoksičnu sinergiju
English: Thrombocytopenia, anaemia
Croatian: Trombocitopenija, anemija
English: For the first 6 weeks of treatment the recommended dose is 3 mg/kg/day orally given in 2 divided doses.
Croatian: Reumatoidni artritis Za prvih 6 tjedana liječenja preporučena doza iznosi 3 mg/kg/dnevno dano oralno u 2 podijeljene doze.
English: Experience with Sandimmun in pregnancy is limited.
Croatian: Iskustvo sa Sandimmunom u trudnoći je ograničeno.
English: The total dose each day for children is usually 6 mg per kilogram body weight.
Croatian: Ukupna doza svakoga dana za djecu je obično 6 mg po kilogramu tjelesne težine.
English: Ethanol: 25 mg/capsule.
Croatian: Etanol: 25 mg/kapsula.
English: • Tell your doctor if you are breast-feeding.
Croatian: • Obavijestite svog liječnika ako dojite.
English: Anaphylactoid reactions have been observed following intravenous administration (see section 4.4).
Croatian: Nakon intravenske primjene uočene su anafilaktoidne reakcije (vidjeti dio 4.4).
English: SPECIAL STORAGE CONDITIONS [To be completed nationally]
Croatian: POSEBNE MJERE ČUVANJA [Ispunjava država članica]
English: if you have high levels of potassium in your blood.
Croatian: • ako imate visoke razine kalija u krvi.
English: This is equivalent to nearly 15 ml beer or 5 ml wine.
Croatian: To je ekvivalentno količini od gotovo 15 ml piva ili