FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 5.1).
Croatian: U bolesnika sa slabim odgovorom hemoglobina na Silapo, potrebno je razmotriti druga moguća objašnjenja za slabi odgovor (vidjeti dijelove 4.4 i 5.1).
English: Your doctor may monitor your blood pressure regularly while you are using Silapo, particularly at the start of therapy.
Croatian: Vaš liječnik može redovno kontrolirati vaš krvni tlak dok uzimate Silapo, posebno na početku terapije.
English: If you experience headaches, particularly sudden, stabbing migraine-like headaches or feel confused or have fits, tell your doctor immediately.
Croatian: Ako osjetite glavobolju, posebice nagli početak jake glavobolje slične migreni ili se osjećate zbunjeno ili imate grčeve, odmah o tome obavijestite svog liječnika.
English: Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dl.
Croatian: Epoetin alfa u dozi od 300 IU/kg značajno je smanjio rizik od alogene transfuzije u bolesnika s razinom hemoglobina prije početka liječenja od > 10 do ≤ 13 g/dl.
English: A minimum of 4 weeks should elapse between dose increases.
Croatian: Između povećanja doze treba proći najmanje 4 tjedna.
English: • any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister
Croatian: • je tekućina curila iz napunjene štrcaljke ili se vidi kondenzacija unutar zatvorenog blistera
English: The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with erythropoietin for 3 years compared to a matched control group of dialysis patients who had not been treated with erythropoietin).
Croatian: U ispitivanjima provedenima na pacijentima na hemodijalizi incidencija fibroze koštane srži nije povećana kod onih koji su bili liječeni eritropoetinom tijekom 3 godine u odnosu na usklađenu kontrolnu skupinu pacijenata na dijalizi koji nisu bili liječeni s eritropoetinom).
English: 150 IU/kg 3x/week or 450 IU/kg once weekly for 4 weeks
Croatian: 150 IU/kg 3x/tjedno ili 450 IU/kg 1x/tjedno tijekom 4 tjedna
English: These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
Croatian: To uključuje: nedostatak željeza, folata ili vitamina B12, trovanje aluminijem, prolaznu infekciju, upalnu ili traumatsku epizodu, nevidljivo krvarenje, hemolizu i fibrozu koštane srži bilo kojeg uzroka.
English: Dose should not be increased over the maximum of 1 050 IU/kg (total dose 80 000 IU) per week.
Croatian: Dozu se ne smije povećati iznad maksimuma od 1050 IU/kg (ukupna doza iznosi 80 000 IU) na tjedan.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8 167 patients).
Croatian: Meta-analizom podataka o ukupnom preživljenju došlo se do procjene omjera rizika od 1,08 u korist kontrolne skupine (95% CI: 0,99, 1,18; 42 ispitivanja i 8 167 pacijenata).
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Croatian: Metaanaliza je pokazala konzistentan, značajno povećan relativni rizik tromboemboličkih događaja kod pacijenata koji primaju rekombinantni humani eritropoetin (vidjeti dio 4.4).
English: The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20 000 IU) once weekly or 480 IU/kg (up to a maximum of 40 000 IU) once every 2 weeks.
Croatian: Maksimalna doza ne bi trebala prelaziti 150 IU/kg 3 puta na tjedan, 240 IU/kg (do najviše 20 000 IU) jedanput na tjedan ili 480 IU/kg (do najviše 40 000 IU) jedanput svaka 2 tjedna.
English: Dose adjustment
Croatian: Prilagođavanje doze
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Croatian: Uključeno je 228 ispitanika s kroničnim zatajenjem bubrega liječenih epoetinom alfa u 4 ispitivanja kroničnog zatajenja bubrega (2 ispitivanja u bolesnika koji još nisu na dijalizi [N = 131 izloženih ispitanika s kroničnim zatajenjem bubrega] i 2 na dijalizi [N = 97 izloženih ispitanika s kroničnim zatajenjem bubrega]; 1 404 izloženih ispitanika s malignim bolestima u 16 ispitivanja anemije uslijed kemoterapije; 147 izloženih ispitanika u 2 ispitivanja autologne donacije krvi; 213 izloženih ispitanika u 1 ispitivanju u periodu prije operativnog zahvata i 102 izloženih ispitanika u 2 ispitivanja mijelodisplastičnog sindroma.
English: Dose hold and decrease
Croatian: Održavanje i smanjenje doze
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba.
English: The recommended starting dose is 50 IU/kg.
Croatian: Preporučena početna doza je 50 IU/kg.
English: Pure Red Cell Aplasia (PRCA) has been reported very rarely after months to years of subcutaneous treatment with other products containing erythropoietins and may not be ruled out with Silapo.
Croatian: Pure Red Cell Aplasia) mjesecima i godinama nakon supkutanog liječenja drugim lijekovima koji sadrže eritropoetin što se ne smije isključiti ni za Silapo.
English: - raised blood pressure which may require treatment with medicinal products or adjustment of the dosage of medicinal products you already take for high blood pressure.
Croatian: Bubrežni bolesnici - Povećan krvni tlak koji može zahtijevati liječenje lijekovima ili prilagođavanje doze lijekova koje već uzimate zbog visokog krvnog tlaka.
English: • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l),
Croatian: • skraćeno opće preživljenje i povećana smrtnost zbog napredovanja bolesti u 4 mjeseca kod pacijenata s metastatskim rakom dojke podvrgnutih kemoterapiji, kada se primjenjuju radi postizanja ciljne razine hemoglobina od 12-14 g/dl (7,5-8,7 mmol/l),
English: The solution contains 3 333 IU Epoetin zeta per ml.
Croatian: Otopina sadrži 3 333 IU epoetina zeta po ml.
English: In a randomised, double-blind, placebo-controlled study of 4 038 CRF patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dl, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dl or placebo (see section 4.4).
Croatian: U randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju 4 038 pacijenata s kroničnim zatajenjem bubrega koji nisu na dijalizi, s dijabetesom tipa 2 i razinom hemoglobina ≤11 g/dl, primali su ili darbopoetin alfa radi postizanja razine hemoglobina od 13 g/dl ili placebo (vidjeti dio 4.4).
English: Adult patients on peritoneal dialysis
Croatian: Odrasli pacijenti na peritonejskoj dijalizi
English: As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Silapo) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e.g. deep venous thrombosis or pulmonary embolism).
Croatian: S obzirom da je kod pacijenata s malignim bolestima koji primaju eritropoetske lijekove primijećena povećana incidencija trombotičkih vaskularnih događaja (vidjeti dio 4.8), potrebno je pažljivo odvagnuti rizik i dobrobit liječenja (Silapom), posebno kod pacijenata s malignim bolestima s povećanim rizikom od trombotičkih vaskularnih događaja kao što su pretili i pacijenti s prethodnim trombotičkim vaskularnim događajima (npr. duboka venska tromboza ili plućna embolija).
English: Injecting Silapo under the skin yourself
Croatian: Samostalno injiciranje Silapa pod kožu
English: Therefore, you should discuss the benefits of Silapo with your doctor, particularly if you are obese or have a history of blood clots/blood clotting disorders.
Croatian: Zbog toga trebate s liječnikom razgovarati o dobrobitima Silapa, pogotovo ukoliko ste pretili ili ste prethodno imali krvne ugruške/poremećaje zgrušavanja krvi.
English: Silapo is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Croatian: Silapo je bistra i bezbojna otopina za injekciju u napunjenoj štrcaljki s pričvršćenom injekcijskom iglom.
English: In two large, open-label studies, 2 697 cancer patients receiving non-platinum chemotherapy were included, 1 895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
Croatian: U dva velika otvorena ispitivanja bilo je uključeno 2 697 pacijenata s malignim bolestima koji su primali kemoterapiju koja nije bazirana na platini, 1 895 sa solidnim tumorima (683 dojka, 260 pluća, 174 ginekološki, 300 gastrointestinalni i 478 druge vrste tumora) i 802 s hematološkim malignim bolestima.
English: The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/dl or < 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or > 5 mmol/l).
Croatian: Dostupni klinički podaci pokazuju da pacijenti s vrlo niskim početnim vrijednostima hemoglobina (<6 g/dl ili <3,75 mmol/l) mogu zahtijevati veće doze održavanja nego oni kod kojih je početna anemija manje izražena (Hb >8 g/dl ili >5 mmol/l).
English: If you are receiving dialysis treatment when you begin treatment with Silapo, your dialysis regimen may need to be adjusted to maintain urea, creatinine and potassium levels in the desired range.
Croatian: Ukoliko ste na dijalizi dok primate Silapo, možda će biti potrebno prilagoditi parametre dijalize da bi se urea, kreatinin i kalij zadržali u željenom rasponu.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Croatian: Eritropoetin je faktor rasta koji primarno stimulira nastanak crvenih krvnih stanica.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I PRIMJENU
English: It could be shown with the aid of cell cultures of human bone marrow cells that erythropoietin stimulates erythropoiesis specifically and does not affect leukopoiesis.
Croatian: Na kulturama stanica ljudske koštane srži može se vidjeti da eritropoetin stimulira isključivo eritropoezu i da nema učinaka na leukopoezu.
English: The recommended starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Croatian: Preporučena početna doza Silapa je 50 IU/kg (internacionalne jedinice po kilogramu; eng. IUInternational Units).
English: At a rate of rise in haemoglobin of > 2 g/dl (> 1.25 mmol/l) per month the Silapo dose should be reduced by about 25-50%.
Croatian: Kod porasta hemoglobina za >2 g/dl (> 1,25 mmol/l) mjesečno, potrebno je smanjiti dozu Silapom za 25-50%.
English: Other causes of PRCA should be excluded, and appropriate therapy initiated.
Croatian: Treba isključiti druge uzroke čiste aplazije crvenih krvnih stanica i započeti prikladnu terapiju.
English: Reticulocyte count increase ≥ 40 000/μl or Hb increase ≥ 1 g/dl
Croatian: porast broja retikulocita ≥40 000/µl ili porast Hb ≥1 g/dl
English: Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Silapo treatment.
Croatian: Liječnik će zatražiti krvne pretrage i možda će Vam prilagoditi dozu, ovisno o tome kako u Vas Silapo djeluje na anemiju.
English: If you experience headaches, particularly sudden, stabbing migraine-like headaches or start to feel confused or have fits, tell your doctor or nursing staff immediately.
Croatian: Ukoliko osjetite glavobolju, pogotovo nagli početak jake glavobolje poput migrene ili počnete osjećati smušenost ili imate grčeve, odmah o tome obavijestite svog liječnika ili medicinsko osoblje.
English: Treatment of patients with chemotherapy induced anaemia
Croatian: - Liječenje pacijenata s anemijom uzrokovanom kemoterapijom
English: • If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
Croatian: • Ako postoji medicinska potreba za skraćenje vremena do kirurškog zahvata, dobivat ćete dnevne doze od 300 IU/kg do deset dana prije kirurškog zahvata, na sam dan kirurškog zahvata i tijekom prva četiri dana nakon kirurškog zahvata.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJI MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Chronic renal failure patients on erythropoietin should have their haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter to minimise the risk of an increase in blood pressure.
Croatian: Kod pacijenata s kroničnim zatajenjem bubrega koji primaju eritropoetin treba redovito mjeriti razinu hemoglobina sve dok se ne postigne stabilna razina, a zatim povremeno da bi se smanjio rizik od povećanja krvnog tlaka.
English: The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
Croatian: Ispitivanja su uključivala bilo pacijente koji su liječeni kemoterapijom (dva ispitivanja) bilo pacijente kojima nije indicirano liječenje sredstvima koja potiču eritropoezu: pacijenti s anemijom zbog maligne bolesti koji nisu primali kemoterapiju i pacijenti s malignim bolestima glave i vrata koji su primali radioterapiju.
English: The initial dose is 150 IU/kg given subcutaneously 3 times per week.
Croatian: Početna doza od 150 IU/kg daje se supkutano 3 puta na tjedan.
English: In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Croatian: U prospektivnom, randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju provedenom na 375 pacijenata s anemijom s različitim ne-mijeloidnim malignim bolestima koji su primali kemoterapiju koja se nije bazirala na platini, došlo je do značajnog smanjenja posljedica anemije (npr. umora, pada energije, smanjenje aktivnosti) mjerenih slijedećim uređajima i upitnicima: FACT-An skala općeg stanja (eng.
English: The recommended starting dose is 150 IU/kg.
Croatian: Preporučena početna doza je 150 IU/kg.
English: • Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.
Croatian: • začepljenost dišnog sustava, poput začepljenja nosa ili upale grla, je prijavljena u bolesnika s bolestima bubrega koji još nisu na dijalizi.
English: Moreover, in patients with a baseline haemoglobin of > 13 g/dl, the possibility that epoetin zeta treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Croatian: Štoviše, u bolesnika s početnom vrijednošću hemoglobina > 13 g/dl, ne može se isključiti mogućnost povezanosti liječenja epoetinom zeta s povećanim rizikom od postoperativnih trombotskih/vaskularnih događaja.
English: Haemoglobin concentration
Croatian: Koncentracija hemoglobina
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Silapo is used to provide adequate control of the symptoms of anaemiawhilst maintaininga haemoglobin concentrationbelowor at 12g/dl(7.5mmol/l).
Croatian: Pacijente treba pomno nadzirati kako bi se osigurala primjena najniže odobrene učinkovite doze Silapa za adekvatnu kontrolu simptoma anemije, uz istodobno održavanje koncentracije hemoglobina ispod ili na 12 g/dl (7,5 mmol/l).
English: An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
Croatian: U otvorenom ispitivanju na usporedbnim skupinama odraslih ispitanika koji nemaju nedostatak željeza s razinom hemoglobina prije početka liječenja od > 10 do ≤ 13 g/dl predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu uspoređena je primjena 300 IU/kg epoetina alfa na dan supkutano tijekom 10 dana prije operacije, na dan operacije i još 4 dana nakon operacije s primjenom 600 IU/kg epoetina alfa supkutano jednom tjedno, 3 tjedna prije operacije i na dan operacije.
English: • Bone or muscle pain
Croatian: • bol u kostima ili mišićima
English: All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
Croatian: Svi trombotički vaskularni događaji zabilježeni su u skupini koja je primala epoetin alfa te u prva 24 tjedna ispitivanja.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljne informacije dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: All patients being treated with Silapo should receive adequate iron supplementation (e.g. 200 mg oral elemental iron daily) throughout the course of treatment.
Croatian: Svi pacijenti koji se liječe Silapom trebaju primiti adekvatnu nadoknadu željeza za vrijeme liječenja (npr. peroralna primjena 200 mg željeza dnevno).
English: Good blood management practices should always be used in the perisurgical setting.
Croatian: U perioperacijskom okruženju uvijek treba primjenjivati dobru praksu postupanja s krvlju.
English: o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4).
Croatian: o Liječenje teške anemije bubrežnog porijekla praćene kliničkim simptomima kod odraslih pacijenata s bubrežnom insuficijencijom koji još nisu na dijalizi (vidjeti dio 4.4).
English: Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
Croatian: Vaš liječnik će zatražiti redovne krvne pretrage da bude siguran da lijek i dalje djeluje kako treba.
English: One pack contains 1, 4 or 6 pre-filled syringes.
Croatian: Jedno pakiranje sadrži 1, 4 ili 6 napunjenih štrcaljki.
English: If you develop a serious rash or another of these skin symptoms, stop taking Silapo and contact your doctor or seek medical attention immediately.
Croatian: U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati lijek Silapo i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: Adverse reactions during treatment with erythropoietin are observed predominantly in patients with chronic renal failure or underlying malignancies.
Croatian: Nuspojave za vrijeme liječenja eritropoetinom primijećene su pretežno kod pacijenata s kroničnim zatajenjem bubrega ili malignim bolestima.
English: If haemoglobin level exceeds 12 g/dl (7.5 mmol/l), discontinue therapy until it falls to 12 g/dl (7.5 mmol/l) or lower and then reinstitute Silapo therapy at a dose 25% below the previous dose.
Croatian: Ako razina hemoglobina prelazi 12 g/dl (7,5 mmol/l), potrebno je prekinuti terapiju dok vrijednosti ne padnu na 12 g/dl (7,5 mmol/l) ili niže i tada nastaviti s terapijom Silapom s 25% nižom dozom od prethodno primijenjene doze.
English: An increase in the dose of a particular blood-thinning medicine (heparin) during haemodialysis is often needed during the course of therapy with Silapo to minimise the risk of blood clotting.
Croatian: Za vrijeme terapije Silapom često je potrebno povećanje doze posebnih lijekova za razrjeđivanje krvi (heparin) tijekom hemodijalize da bi se smanjio rizik zgrušavanja krvi.
English: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l),
Croatian: • skraćeno vrijeme do napredovanja tumora kod pacijenata s napredovalim tumorom glave i vrata koji se liječe zračenjem kada se primjenjuju radi postizanja ciljne razine hemoglobina od 14 g/dl (8,7 mmol/l),
English: If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Croatian: Ukoliko se dijagnosticira čista aplazija crvenih krvnih stanica (PRCA), potrebno je odmah prekinuti terapiju Silapom i razmotriti testiranje za određivanje protutijela na eritropoetin.
English: in adult patients with renal insufficiency not yet on dialysis to treat severe anaemia associated with kidney disease accompanied by clinical symptoms.
Croatian: - kod odraslih pacijenata s renalnom insuficijencijom koji još nisu na dijalizi za liječenje jake anemije povezane s bubrežnom bolešću, praćene kliničkim simptomima.
English: Adult patients with renal insufficiency not yet undergoing dialysis
Croatian: Odrasli pacijenti s renalnom insuficijencijom koji još nisu na dijalizi
English: If the rate of increase in haemoglobin exceeds 2 g/dl (1.25 mmol/l) per month or the haemoglobin level exceeds 12 g/dl (7.5 mmol/l), the dose adjustment detailed in section 4.2 should be thoroughly performed to minimise the risk of thrombotic events (see section 4.2).
Croatian: Ako brzina povećanja hemoglobina prelazi 2 g/dl (1,25 mmol/l) mjesečno ili hemoglobin prelazi 12 g/dl (7,5 mmol/l) potrebno je u cijelosti primijeniti upute o prilagođavanju doze opisane u odjeljku 4.2 kako bi se smanjio rizik trombotičkih događaja (vidjeti dio 4.2).
English: Your doctor will order regular blood tests to see that this is being achieved.
Croatian: Vaš liječnik će zatražiti uobičajene krvne pretrage da vidi je li se to postiglo.
English: • the liquid is coloured or you can see particles floating in it
Croatian: • je tekućina obojana ili ukoliko vidite plutajuće čestice
English: Use in adult patients receiving peritoneal dialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl.
Croatian: Primjena kod odraslih pacijenata koji su na peritonejskoj dijalizi Vaš liječnik će održavati koncentraciju vašeg hemoglobina između 10 i 12 g/dl.
English: in adult patients on peritoneal dialysis to treat symptomatic anaemia associated with chronic renal failure (kidney disease).
Croatian: - kod odraslih pacijenata na peritonejskoj dijalizi za liječenje simptomatske anemije povezane s kroničnim zatajenjem bubrega (bubrežna bolest).
English: In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Croatian: U slučajevima u kojima je iz medicinskih razloga potrebno skratiti razdoblje do kirurškog zahvata na manje od tri tjedna, treba supkutano primijeniti 300 IU/kg Silapa dnevno tijekom 10 uzastopnih dana prije kirurškog zahvata, na sam dan kirurškog zahvata i tijekom četiri dana nakon kirurškog zahvata.