FrancophonIA/ELRC3.0 huggingface dataset:
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Croatian: Jednogodišnja stopa preživljenja bila je 73,1% u skupini koja je primala takrolimus i 79,2% u skupini koja je primala ciklosporin.
English: Hypersensitivity to tacrolimus, or to any of the excipients listed in section 6.1 Hypersensitivity to other macrolides
Croatian: Preosjetljivost na takrolimus ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Croatian: Nepažljiva, slučajna ili nenadzirana međusobna zamjena formulacije takrolimusa s trenutnim oslobađanjem i formulacije takrolimusa s produljenim oslobađanjem nije sigurna.
English: Blood trough levels of tacrolimus should also be closely monitored following conversion from Prograf to Advagraf, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Croatian: Najniže koncentracije takrolimusa u krvi moraju se pažljivo pratiti i nakon zamjene Prografa Advagrafom, nakon prilagodbe doze te nakon promjene u imunosupresijskom režimu ili istodobne primjene tvari koje mogu promijeniti koncentracije takrolimusa u punoj krvi (vidjeti dio 4.5).
English: Do not swallow the desiccant contained in the foil wrapper.
Croatian: Pazite da ne progutate sredstvo za sušenje koje se nalazi u omotu od folije.
English: Absorption is variable and the mean oral bioavailability of tacrolimus (investigated with the Prograf formulation) is in the range of 20% - 25% (individual range in adult patients 6% - 43%).
Croatian: Prograf) kreće se u rasponu od 20% do 25% (individualni raspon u odraslih bolesnika 6% - 43%).
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Croatian: Bolesnicima se mora davati ista formulacija takrolimusa uz odgovarajući dnevni režim doziranja; naizmjenične primjene različitih formulacija ili režima doziranja dopuštene su samo pod strogim nadzorom specijaliste transplantacijske medicine (vidjeti dio 4.4 i 4.8).
English: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Croatian: Odmah obavijestite liječnika ako tijekom liječenja primijetite: probleme s vidom kao što su zamagljen vid, promjene vida u boji, otežano uočavanje detalja, ili ako Vam vidno polje postane ograničeno.
English: As tacrolimus is a substance with low clearance, following adjustments to the Advagraf dose regimen it may take several days before the targeted steady state is achieved.
Croatian: Budući da je takrolimus tvar s niskim klirensom, nakon prilagodbe režima doziranja Advagrafa može proći i nekoliko dana prije nego što se postigne stanje dinamičke ravnoteže.
English: Advagraf therapy should commence at a dose of 0.10 - 0.20 mg/kg/day administered once daily in the morning.
Croatian: Liječenje Advagrafom treba započeti dozom od 0,10 do 0,20 mg/kg na dan koja se primjenjuje jedanput na dan, ujutro.
English: The 12-month patient survival rates were 98.6% for Advagraf, 95.7% for Prograf and 97.6% for ciclosporin; in the Advagraf arm 3 patients died (all male), in the Prograf arm 10 patients died (3 female, 7 male) and in the ciclosporin arm 6 patients died (3 female, 3 male).
Croatian: Dvanaestomjesečna stopa preživljenja bolesnika iznosila je 98,6% za Advagraf, 95,7% za Prograf i 97,6% za ciklosporin; u skupini koja je primala Advagraf umrlo je 3 bolesnika (svi muškarci), u skupini koja je primala Prograf umrlo je 10 bolesnika (3 žene, 7 muškaraca) i u skupini koja je primala ciklosporin umrlo je 6 bolesnika (3 žene, 3 muškarca).
English: Caution should be exercised in patients with risk factors for QT prolongation, including patients with a personal or family history of QT prolongation, congestive heart failure, bradyarrhythmias and electrolyte abnormalities.
Croatian: uključujući bolesnike koji u osobnoj ili obiteljskoj anamnezi imaju produženje QT-a, kongestivno zatajenje srca, bradiaritmije i poremećaje elektrolita.
English: gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stools uncommon:
Croatian: gastrointestinalni znakovi i simptomi, povraćanje, gastrointestinalni bolovi i bolovi u trbuhu, upalna stanja probavnog sustava, krvarenje u probavni sustav, ulceracije i perforacije probavnog sustava, ascites, stomatitis i ulceracije, konstipacija, dispeptički znakovi i simptomi, flatulencija, nadutost i distenzija, meka stolica manje često:
English: thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders uncommon:
Croatian: tromboembolički i ishemijski događaji, hipotenzivni vaskularni poremećaji, krvarenje, periferni vaskularni poremećaji manje često:
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Advagraf.
Croatian: Ako nakon uzimanja Advagrafa imate omaglicu, osjećate pospanost ili Vam je zamućen vid, nemojte voziti, koristiti alate ili upravljati strojevima.
English: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Croatian: U liječenju epizoda odbacivanja alogenog presatka koristile su se više doze takrolimusa, dodatna terapija kortikosteroidima i uvođenje kratkotrajnih primjena mono-/poliklonalnih protutijela.
English: The initial oral per protocol dose of tacrolimus was 0.2 mg/kg/day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ml by Day 5 and 5 to 10 ng/ml after Month 6.
Croatian: Prema protokolu je početna oralna doza takrolimusa iznosila 0,2 mg/kg/dan uz naknadno prilagođivanje doze ciljnoj najnižoj vrijednosti od 8 do 15 ng/ml do 5. dana i 5 do 10 ng/ml nakon 6 mjeseci.
English: Conversion from ciclosporin to tacrolimus
Croatian: Zamjena ciklosporina takrolimusom
English: rash, pruritus, alopecias, acne, sweating increased uncommon:
Croatian: osip, pruritus, alopecije, akne, pojačano znojenje manje često:
English: coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal rare:
Croatian: koagulopatije, pancitopenija, neutropenija, poremećen nalaz koagulacije i krvarenja rijetko:
English: Advagraf therapy should commence at a dose of 0.20 - 0.30 mg/kg/day administered once daily in the morning.
Croatian: Liječenje Advagrafom treba započeti dozom od 0,20 do 0,30 mg/kg na dan koja se primjenjuje jedanput na dan, ujutro.
English: diarrhoea, nausea common:
Croatian: proljev, mučnina često:
English: Treatment of allograft rejection after heart transplantation In adult patients converted to Advagraf, an initial oral dose of 0.15 mg/kg/day should be administered once daily in the morning.
Croatian: U odraslih bolesnika u kojih se liječenje zamjenjuje Advagrafom, primjenjuje se početna oralna doza od 0,15 mg/kg/dan, jedanput na dan, ujutro.
English: febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed uncommon:
Croatian: febrilni poremećaji, bol i neugoda, astenička stanja, edem, poremećna percepcija tjelesne temperature,
English: Capsule shell: Titanium dioxide (E171), yellow iron oxide (E 172), red iron oxide (E 172), sodium laurilsulfate, gelatin.
Croatian: Ovojnica kapsule: titanijev dioksid (E171), žuti željezov oksid (E 172), crveni željezov oksid (E 172), natrijev laurilsulfat, želatina.
English: deafness neurosensory very rare:
Croatian: senzorna gluhoća vrlo rijetko:
English: Treatment of allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily Advagraf, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection.
Croatian: Kad se drugi imunosupresivi zamjenjuju Advagrafom koji se uzima jedanput na dan, liječenje je potrebno započeti početnom oralnom dozom Advagrafa koja se preporučuje za sprječavanje odbacivanja presatka nakon presađivanja bubrega odnosno jetre.
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera.
Croatian: nikardipinom, diltiazemom, verapamilom, amiodaronom, danazolom, etinilestradiolom, omeprazolom, nefazodonom i (kineskim) biljnim pripravcima koji sadrže ekstrakte biljke Schisandra sphenanthera.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Croatian: Utvrđeno je nekoliko metabolita, no samo je jedan od njih pokazao in vitro da ima imunosupresivno djelovanje slično takrolimusu.
English: bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice rare:
Croatian: poremećaji žučnih puteva, hepatocelularno oštećenje i hepatitis, kolestaza i žutica rijetko:
English: Advagraf is taken orally once daily in the morning.
Croatian: Advagraf se uzima kroz usta svakog jutra jedanput na dan.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Croatian: EKG-om), bubrežne funkcije i drugih nuspojava, kad god se istodobno primjenjuju tvari koje mogu promijeniti njegov metabolizam putem CYP3A4 ili na neki drugi način utjecati na koncentraciju takrolimusa u krvi i prekid ili prilagođavanje doze takrolimusa na odgovarajući način kako bi se održala slična izloženost takrolimusu (vidjeti dio 4.2 i 4.4).
English: Liver failure
Croatian: zatajenje jetre
English: Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Croatian: Doziranje se prvenstveno mora temeljiti na kliničkoj procjeni odbacivanja organa i podnošljivosti lijeka u pojedinog bolesnika; u toj procjeni pomaže određivanje najnižih koncentracija takrolimusa u punoj krvi.
English: The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and
Croatian: Potrebno je izbjegavati kombiniranu primjenu ciklosporina i takrolimusa, a oprez je potreban i kada se takrolimus primjenjuje u bolesnika koji su prethodno uzimali ciklosporin (vidjeti dio 4.2 i 4.5).
English: Printing ink: Shellac, lecithin (soya), simeticone, red iron oxide (E 172), hydroxypropylcellulose.
Croatian: Tinta za označavanje: šelak, lecitin (soja), simetikon, crveni željezov oksid (E 172), hidroksipropilceluloza.
English: Human data show that tacrolimus crosses the placenta.
Croatian: Podaci iz ispitivanja u ljudi pokazuju da takrolimus prolazi kroz posteljicu.
English: Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Croatian: Nakon zamjene jedne formulacije drugom potrebno je tijekom liječenja pratiti koncentraciju lijeka i prilagođivati dozu kako bi se održala jednaka sistemska izloženost takrolimusu.
English: Excipients with known effect: Each capsule contains 102.17 mg lactose.
Croatian: Jedna kapsula sadrži 102,17 mg laktoze.
English: Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Croatian: Druge interakcije koje mogu povećati koncentraciju takrolimusa u krvi Takrolimus se velikim dijelom veže za proteine plazme pa je potrebno uzeti u obzir moguće interakcije s drugim djelatnim tvarima koje imaju visok afinitet za proteine plazme (npr. nesteroidni protuupalni lijekovi - NSAIL, oralni antikoagulansi ili oralni antidijabetici).
English: Frequent trough level monitoring in the initial two weeks post transplantation is recommended, followed by periodic monitoring during maintenance therapy.
Croatian: U prva dva tjedna nakon presađivanja organa preporučuje se često određivanje najnižih koncentracija, dok se poslije toga određivanje koncentracije za vrijeme terapije održavanja može raditi povremeno.
English: Advagraf 0.5 mg prolonged-release hard capsules Advagraf 1 mg prolonged-release hard capsules Advagraf 3 mg prolonged-release hard capsules Advagraf 5 mg prolonged-release hard capsules
Croatian: Advagraf 0,5 mg tvrde kapsule s produljenim oslobađanjem Advagraf 1 mg tvrde kapsule s produljenim oslobađanjem Advagraf 3 mg tvrde kapsule s produljenim oslobađanjem Advagraf 5 mg tvrde kapsule s produljenim oslobađanjem takrolimus
English: Limited knowledge of interactions between tacrolimus and statins is available.
Croatian: Interakcije između takrolimusa i statina nisu dovoljno poznate.
English: During subsequent maintenance therapy, blood concentrations have generally been in the range of 5 - 15 ng/ml in liver, kidney and heart transplant recipients.
Croatian: Tijekom terapije održavanja, koncentracije takrolimusa u krvi primatelja presadaka jetre, bubrega i srca općenito se kreću u rasponu između 5 - 15 ng/ml.
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Croatian: - ako ste alergični (preosjetljivi) na takrolimus ili neki drugi sastojak lijeka Advagraf (vidjeti dio - ako ste alergični na sirolimus ili neki makrolidni antibiotik (npr. eritromicin, klaritromicin,
English: 12-month graft survival was 91.5% for Advagraf and 92.8% for Prograf.
Croatian: Dvanaestomjesečno preživljenje presatka iznosilo je 91,5% u skupini koja je primala Advagraf i 92,8% u skupini koja je primala Prograf.
English: Hypromellose Ethylcellulose Lactose monohydrate Magnesium stearate.
Croatian: Sadržaj kapsule: hipromeloza etilceluloza laktoza hidrat magnezijev stearat.
English: Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Croatian: Farmakokinetika takrolimusa može se promijeniti zbog poboljšanja stanja bolesnika nakon presađivanja, zbog čega može biti potrebna daljnja prilagodba doze.
English: The 12-month patient survival rates were 96.9% for Advagraf and 97.5% for Prograf; in the Advagraf arm 10 patients died (3 female, 7 male) and in the Prograf arm 8 patients died (3 female, 5 male).
Croatian: Dvanaestomjesečna stopa preživljenja bolesnika iznosila je 96,9% za skupinu koja je primala Advagraf i 97,5% za skupinu koja je primala Prograf; u skupini koja je primala Advagraf, 10 je bolesnika umrlo (3 žene, 7 muškaraca), dok je u skupini koja je primala Prograf umrlo 8 bolesnika (3 žene, 5 muškaraca).
English: psychotic disorder Nervous system disorders very common:
Croatian: Poremećaji živčanog sustava vrlo često:
English: Advagraf is a once-a-day oral formulation of tacrolimus.
Croatian: Advagraf je oralna formulacija takrolimusa koja se uzima jedanput na dan.
English: CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically the following substances have been shown to increase tacrolimus blood levels:
Croatian: Induktori CYP3A4 koji mogu smanjiti koncentraciju takrolimusa u krvi Klinički se pokazalo da sljedeće tvari smanjuju koncentraciju takrolimusa u krvi:
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Croatian: Sprječavanje odbacivanja alogenog presatka bubrega ili jetre u odraslih primatelja.
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Croatian: Potreban je oprez i poznavanje postupaka testiranja koji su se koristili pri uspoređivanju koncentracija objavljenih u radovima s vrijednostima koncentracija u pojedinog bolesnika u kliničkoj praksi.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Croatian: Razinu ciklosporina u krvi potrebno je određivati i nakon zamjene terapije, jer se klirens ciklosporina može promijeniti.
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/kg/day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/kg/day.
Croatian: Takrolimus se počeo davati u obliku kontinuirane intravenske infuzije u dozi od 0,01 do 0,03 mg/kg/dan, a oralni takrolimus primjenjivao se u dozi od 0,05 do 0,3 mg/kg/dan.
English: Significantly more ciclosporintreated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Croatian: (p = 0,02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
English: hearing impaired
Croatian: oštećen sluh
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Advagraf.
Croatian: Pri stanju dinamičke ravnoteže koncentracije Advagrafa postoji jaka korelacija između AUC i najnižih koncentracija takrolimusa u punoj krvi.
English: In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for Advagraf on Day 1 was 30% and 50% lower respectively, when compared with that for the immediate release capsules (Prograf) at equivalent doses.
Croatian: AUC0-24 takrolimusa iz Advagrafa u usporedbi s kapsulama s trenutnim oslobađanjem takrolimusa (Prograf) pri ekvivalentnim dozama bila je prvog dana 30% niža u bolesnika koji su de novo primili presadak bubrega i 50% niža u bolesnika koji su de novo primili presadak jetre.
English: diabetes mellitus, hyperglycaemic conditions, hyperkalaemia common:
Croatian: šećerna bolest, hiperglikemijska stanja, hiperkalijemija često:
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Croatian: Zabilježena je niža incidencija akutnih epizoda odbacivanja u bolesnika liječenih takrolimusom nasuprot onih liječenih ciklosporinom (11,5% nasuprot 22,6%) i niža incidencija kroničnog odbacivanja,
English: These may worsen kidney or nervous system problems when taken together with Advagraf.
Croatian: Ako se uzmu zajedno s Advagrafom, ti lijekovi mogu pogoršati probleme s bubrezima ili živčanim sustavom.
English: Excipients with known effect: Each capsule contains 51.09 mg lactose.
Croatian: Jedna kapsula sadrži 51,09 mg laktoze.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC 0-24) is similar between the two formulations Advagraf and Prograf.
Croatian: Dvije formulacije takrolimusa, Advagraf i Prograf, imaju sličan odnos između najnižih izmjerenih koncentracija (C24) i sistemske izloženosti (AUC 0-24).
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful, if used shortly after intake.
Croatian: (poput aktivnog ugljena) mogu biti od pomoći ako se primijene ubrzo nakon uzimanja takrolimusa.
English: arthralgia, back pain, muscle spasms, pain in extremity uncommon:
Croatian: artralgija, križobolja, spazam mišića, bol u ekstremitetima manje često:
English: Marketing Authorisation Holder: Astellas Pharma Europe B.V. Sylviusweg 62
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Astellas Pharma Europe B.V.
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Croatian: U bolesnika crne rase može biti potrebna viša doza takrolimusa nego u bolesnika bijele rase da bi se postigle slične vrijednosti najniže koncentracije.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.
Croatian: U bolesnika koji su se liječili imunosupresivima, uključujući Advagraf, zabilježeni su slučajevi nefropatije povezane s BK virusom i progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Sodium laurilsulfate Gelatin.
Croatian: Ovojnica kapsule: titanijev dioksid (E 171) željezov oksid, žuti (E 172) željezov oksid, crveni (E 172) natrijev laurilsulfat želatina.
English: : +370 37 408 681 Faks.
Croatian: Biocodex UAB Tel.: +370 37 408 681 Faks.: +370 37 408 682
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Croatian: farmakokinetika statina uglavnom nije promijenjena pri istodobnoj primjeni takrolimusa.
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 ng/ml.
Croatian: Takrolimus se počeo davati u obliku kontinuirane intravenske infuzije u dozi od 0,025 mg/kg na dan, a oralni takrolimus se primjenjivao u dozi od 0,15 mg/kg na dan uz naknadne prilagodbe doze do najnižih ciljnih vrijednosti od 10 do 20 ng/ml.
English: The incidence of efficacy failure at 12 months (defined as death, graft loss, biopsy-confirmed acute rejection, or lost to follow-up) was 14.0% in the Advagraf group (N=214), 15.1% in the Prograf group (N=212) and 17.0% in the ciclosporin group (N=212).
Croatian: iznosila je 14,0% u skupini koja je primala Advagraf (N=214), 15,1% u skupini koja je primala Prograf (N=212) i 17,0% u skupini koja je primala ciklosporin (N=212).
English: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Croatian: dismenoreja i uterino krvarenje
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Croatian: potrebno je izbjegavati visok unos kalija ili diuretike koji štede kalij (npr. amilorid, triamteren ili spironolakton) (vidjeti dio 4.4).
English: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia Psychiatric disorders very common:
Croatian: dehidracija, hipoglikemija, hipoproteinemija, hiperfosfatemija
English: Other factors observed to increase the risk of these clinical conditions included preexisting heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
Croatian: Drugi čimbenici za koje se primijetilo da povećavaju rizik od razvoja takvih kliničkih stanja bili su postojeća srčana bolest, primjena kortikosteroida, hipertenzija,
English: EU/1/07/387/004 EU/1/07/387/005 EU/1/07/387/006 EU/1/07/387/017 EU/1/07/387/018 EU/1/07/387/019 EU/1/07/387/020
Croatian: EU/1/07/387/003 EU/1/07/387/004 EU/1/07/387/005 EU/1/07/387/006 EU/1/07/387/017 EU/1/07/387/018 EU/1/07/387/019 EU/1/07/387/020