natgillin/translations-raw huggingface dataset:
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Te študije so pokazale dosledno nepojasnjen statistično pomemben presežek smrtnosti pri bolnikih, katerih anemija je povezana z različnimi običajnimi vrstami raka in ki so za razliko od kontrol prejeli rekombinantni humani eritropoetin.
Some patients with more extended dosing intervals (greater than once weekly) of epoetin may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin dose.
Nekateri bolniki z daljšimi odmernimi intervali epoetina (daljšimi kot enkrat tedensko) morda ne bodo ohranili ustreznih nivojev hemoglobina (glejte poglavje 5.1) in bodo morda potrebovali višji odmerek epoetina.
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Če pride do diagnoze PRCA, je treba zdravljenje z zdravilom Silapo takoj prekiniti in razmisliti o testiranju na protitelesa za eritropoetin.
• Swelling of the ankles, feet or fingers
• Otekanje gležnjev, stopal ali prstov.
The pre-filled syringes contain between 0.3 and 1 ml solution, depending on the content of epoetin zeta (see “What Silapo contains”).
Vnaprej napolnjene brizge vsebujejo med 0,3 in 1 ml raztopine, odvisno od vsebnosti epoetin zeta (glejte "Kaj vsebuje zdravilo Silapo").
Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anaemia.
Bolnike morate pozorno nadzorovati, da bi zagotovili uporabo najnižjega odobrenega odmerka zdravila Silapo za primeren nadzor simptomov anemije.
Based on the results from clinical trials with other authorised erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Na osnovi kliničnih preskušanj z drugimi eritropoetini z dovoljenjem za prometje pričakovati, da bo do neželenih učinkov prišlo pri približno 8% bolnikov, ki se jih zdravi z eritropoetinom.
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.
V študije so vključili bolnike, ki so bili deležni kemoterapije (dve študiji) ali pa so uporabljali populacije bolnikov, pri katerih zdravila za stimulacijo eritropoeze niso bila indicirana: anemija pri bolnikih z rakom, ki ne prejemajo kemoterapije ter bolniki z rakom glave in vratu, ki prejemajo terapijo z obsevanjem.
Treatment with Silapo has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
Zdravljenje z zdravilom Silapo je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z zgoraj navedenimi indikacijami.
• Severe allergic reaction that may include: o a swollen face, lips, mouth, tongue or throat o difficulty swallowing or breathing o itchy rash (hives)
• Hude alergijske reakcije, ki lahko vključujejo: o otekanje obraza, ustnic, ust, jezika ali žrela, o težave pri požiranju ali dihanju, o srbeč izpuščaj (koprivnica).
If blood pressure cannot be well controlled, Silapo treatment should be discontinued.
Če krvnega tlaka ni mogoče obvladati, je treba zdravljenje z zdravilom Silapo prekiniti.
PRCA may be caused by the production of antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
Do PRCA lahko pride zaradi tvorjenja protiteles proti eritropoetinu v zdravilu in posledično proti Vašemu lastnemu eritropoetinu.
Maintenance phase: During the maintenance phase, Silapo can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Vzdrževalna faza: Med vzdrževalno fazo se zdravilo Silapo lahko daje bodisi trikrat tedensko in v primeru subkutanega dajanja enkrat tedensko ali enkrat na vsaka dva tedna.
All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Silapo.
Vse druge vzroke anemije (pomanjkanje železa, hemoliza, izguba krvi, pomanjkanje folne kisline ali vitamina B12) je treba izključiti oziroma zdraviti pred začetkom zdravljenja in med zdravljenjem z zdravilom Silapo.
Median time from baseline to first transfusion was statistically significantly longer in the epoetin alfa group compared to placebo (49 vs. 37 days; p=0.046).
Mediani čas od izhodišča do prve transfuzije je bil statistično značilno daljši v skupini, ki je prejemala epoetin alfa, v primerjavi s skupino, ki je prejemala placebo (49 dni v primerjavi s 37 dnevi; p = 0,046).
After 4 weeks of treatment the time to first transfusion was further increased in the epoetin alfa group (142 vs. 50 days, p=0.007).
Po 4 tednih zdravljenja se je čas do prve transfuzije v skupini, ki je prejemala epoetin alfa, še dodatno podaljšal (142 dni v primerjavi s 50 dnevi; p = 0,007).
• you are at risk of blood clots in the veins (deep venous thrombosis) - for example, if you have had clots before.
• če pri vas obstaja tveganje za nastanek krvnih strdkov v venah (globoka venska tromboza) - na primer, če ste imeli krvne strdke že v preteklosti.
Use in children and adolescents up to 18 years receiving haemodialysis In children the doctor will maintain the haemoglobin concentration between 9.5 and 11 g/dl
Uporaba pri otrocih in mladostnikih do 18 leta na hemodializi Zdravnik bo koncentracijo hemoglobina pri otrocih vzdrževal med 9,5 in 11 g/dl.
• The recommended dose is 600 IU per kilogram bodyweight once a week.
• Priporočeni odmerek je 600 i.e.na kilogram telesne mase enkrat na teden.
Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Silapo treatment.
Vaš zdravnik bo naročil krvne preiskave in morda prilagodil odmerek, odvisno od tega, kako se anemija odziva na zdravljenje z zdravilom Silapo.
• have recently had a heart attack or stroke
• ste pred kratkim imeli srčno ali možgansko kap,
- Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if you have low blood pressure or if your arteriovenous fistula has complications.
- Možna je obstrukcija spoja med arterijo in veno (tromboza šanta), še posebej, če imate nizek krvni tlak ali se na vaši arteriovenski fistuli kažejo zapleti.
• Silapo is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
• Zdravilo Silapo se injicira pod kožo vsak teden tri tedne pred kirurškim posegom in na dan kirurškega posega.
• Cerebral haemorrhages.
• Krvavitve v možganih.
In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
Bolnikom na hemodializi lahko med dializo injicirate bolus skozi ustrezni venski dostop na dializni liniji.
• Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness.
• Gripi podobni simptomi, kot so glavobol, bolečine v sklepih, občutek šibkosti, mrzlica, utrujenost in omotica.
As with other haematopoietic growth factors, erythropoietin has shown in vitro stimulating properties on human endothelial cells.
Kot pri drugih hematopoetskih rastnih faktorjih je eritropoetin in vitro imel stimulativne učinke na celice človeškega endotelija.
Blood pressure should be closely monitored and adequately controlled in all epoetin treatment naïve as well as pre-treated patients before, at initiation of, and during treatment with Silapo.
Krvni tlak je treba skrbno preverjati in ustrezno nadzorovati pri vseh bolnikih, ki še niso bili zdravljeni z epoetinom, ter tudi pri bolnikih, ki so z njim že bili zdravljeni, ob začetku in med zdravljenjem z zdravilom Silapo.
These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Ta poročila slonijo na in vitro rezultatih vzorcev človeških tumorjev, njih klinična pomembnost pa ni gotova.
Patients should not be switched to another medicinal product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Bolnikom se ne sme začeti dajati kakšno drugo zdravilo, ker eritropoetinska protitelesa navzkrižno reagirajo z drugimi eritropoetini.
Patients were stratified according to their baseline haemoglobin (≤ 10 g/dl, > 10 to ≤ 13 g/dl and > 13 g/dl).
Bolniki so bili stratificirani glede na njihov izhodiščni hemoglobin (≤ 10 g/dl, > 10 do ≤ 13 g/dl in > 13 g/dl).
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Pri indikaciji "povečanje količine avtologne krvi": miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska tromboembolična bolezen v anamnezi.
Therefore your haemoglobin-levels and your blood pressure should be controlled.
Zato je treba nadzorovati nivo hemoglobina in krvni tlak.
Epoetin zeta is identical in its amino acid sequence and similar in carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Epoetin zeta je, kar se zaporedja amino kislin in sestave ogljikovodikov tiče, identičen endogenemu humanemu eritropoetinu, ki so ga izolirali iz seča slabokrvnih bolnikov.
This medicine contains up to 0.5 mg phenylalanine in each dosage unit.
To zdravilo vsebuje do 0,5 mg fenilalanin v enoti odmerka.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
V nekaterih predkliničnih toksikoloških študijah na psih in mačkah, ne pa na opicah, je eritropietinsko terapijo spremljala subklinična fibroza kostnega mozga (fibroza kostnega mozga je pri ljudeh znan zaplet kronične ledvične odpovedi, ki je lahko povezana s sekundarnim hiperparatiroidizmom ali neznanimi faktorji.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično ledvično okvaro vzdrževalna koncentracija hemoglobina ne sme presegati zgornje meje priporočene ciljne koncentracije hemoglobina, ki je podana v poglavju 4.2.
Its use in this indication must be balanced against the reported risk of thromboembolic events.
Uporabo pri tej indikaciji moramo ovrednotiti glede na povečano tveganje tromboemboličnih zapletov.
Based on information available to date, correction of anaemia with erythropoietin in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Na osnovi podatkov, ki so trenutno na razpolago, popravki anemije z eritropoetinom pri odraslih bolnikih z ledvično nezadostnostjo, ki še niso na dializi, razvoja ledvične nezadostnosti ne pospešujejo.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Silapo, your doctor will check your dose of Silapo because repeatedly increasing your dose of Silapo if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Če ste bolnik s kronično ledvično okvaro; zlasti, če se na zdravilo Silapo ne odzivate ustrezno, bo zdravnik spremljal vaš odmerek zdravila Silapo, ker ponavljajoče se zviševanje odmerka zdravila Silapo, če se na zdravljenje ne odzivate, lahko poveča tveganje za težave s srcem ali krvnimi žilami in lahko poveč tveganje za srčni infarkt, možgansko kap in smrt.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Zaradi razlik med posameznimi bolniki je pri bolnikih občasno mogoče opaziti individualne vrednosti hemoglobina, ki so nad ali pod želeno koncentracijo hemoglobina.
This is characterised by a sustained decrease in haemoglobin despite an increase in Silapo dosage.
Značilno je tudi trajno zmanjšanje hemoglobina kljub povečanju odmerka zdravila Silapo.
Your doctor may decide that it is better for you to receive Silapo by injection under the skin (subcutaneous) rather than into a vein (intravenous).
Vaš zdravnik bo odločil, ali je za vas bolje, če zdravilo Silapo dobivate pod kožo (subkutano) injekcijo ali z injekcijo v veno (intravensko).
A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
V randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji so ocenjevali učinkovitost in varnost epoetina alfa pri odraslih anemičnih preskušancih z MDS z nizkim ali srednjim-1 tveganjem.
If the solution is given into a vein, it should be injected over 1-5 minutes.
Če se raztopino daje v veno, naj injiciranje traja 1 - 5 minut.
Hyperkalaemia has been observed in isolated cases.
V posameznih primerih so opazili hiperkalemijo.
Epoetins are growth factors that primarily stimulate red blood cell production.
Epoetini so rastni dejavniki, ki primarno stimulirajo nastajanje rdečih krvničk.
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.
Zato se morate o koristih zdravila Silapo pogovoriti s svojim zdravnikom, posebno če ste debeli ali če ste že imeli krvne strdke ali motnje strjevanja krvi.
Other medicines and Silapo
Druga zdravila in zdravilo Silapo
If PRCA, a very rare condition, occurs, the Silapo therapy will be stopped and your doctor will determine the best course of action to treat the anaemia.
Če pride do PRCA, zelo redkega stanja, se bo zdravljenje z zdravilom Silapo prekinilo in vaš zdravnik bo odločil, kaj bo najboljši način za zdravljenje anemije.
In patients with chronic renal failure and clinically evident ischaemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration.
Pri bolnikih s kronično ledvično okvaro in klinično jasno ishemično boleznijo srca ali s kongestivno srčno okvaro vzdrževana koncentracija hemoglobina ne sme presegati zgornje ciljne meje za koncentracijo hemoglobina.
In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
V randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji je pri 4 (4,7 %) preskušancih prišlo do TVE (nenadna smrt, ishemična kap, embolija in flebitis).
in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous pre-donation).
za zmerno slabokrvne bolnike, ki so pred operacijo in v ta namen pred njo darujejo kri, tako da jim bodo med operacijo dajali lastno kri (predhodno darovanje avtologne krvi).
Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p<0.001).
Eritroidni odziv v prvih 24 tednih študije so dokazali pri 27/85 (31,8 %) preskušancev iz skupine, ki je prejemala epoetin alfa, v primerjavi z 2/45 (4,4 %) preskušancev iz skupine, ki je prejemala placebo (p < 0,001).
Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Preskušance so stratificirali glede na raven eritropoetina v serumu (sEPO) in podatke o predhodnih transfuzijah ob presejanju.
The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Učinek epoetina alfa (300 i.e./kg ali 100 i.e./kg) na izpostavljenjost alogenski transfuziji krvi so ocenili v s placebom nadzorovnem, dvojno slepem kliničnem preskušanju pri odraslih bolnikih brez pomanjkanja železa, ki imajo načrtovan večji elektivni ortopedski kirurški poseg na kolku ali kolenu.
If erythropoietin is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose of ciclosporin adjusted as the haematocrit rises.
Če se uporablja eritropoetin hkrati z ciklosporinom, je treba nadzorovati koncentracije ciklosporina v krvi in odmerek ciklosporina prilagajati s porastom hematokrita.
These may be the warning signs of a sudden rise in blood pressure, which requires urgent treatment.
To so lahko opozorilni znaki za nenadno zvišanje krvnega tlaka, ki zahteva takojšnje zdravljenje.
You will receive Silapo during the 3 weeks before your surgery.
Zdravilo Silapo boste dobivali tri tedne pred operacijo.
Tell your doctor or nurse immediately if you notice any of the effects in this list.
Takoj obvestite svojega zdravnika ali medicinsko sestro, če opazite katerega koli izmed naštetih učinkov.
Treatment of adult patients with low- or intermediate-1-risk MDS
Zdravljenje odraslih bolnikov z MDS z nizkim ali srednjim-1 tveganjem
Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Eritropoetin v testih mutagenosti na kulturah bakterij in sesalskih celic ni pokazal nobenih sprememb, ravno tako ne v mikrojedrskem testu na miših.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/kg body weight 2 times weekly for 3 weeks prior to surgery.
Blago anemičnim bolnikom (hematokrit 33-39%), ki potrebujejo zalogo ≥ 4 enot krvi, je treba dajati zdravilo Silapo v odmerku 600 i.e./kg telesne mase dvakrat tedensko, 3 tedne pred operacijo.
When a dose adjustment is necessary, this should be done in steps of 25 IU/kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Kadar je potrebno spremeniti odmerek, je treba spremembo izvesti v korakih po 25 i.e./ kg, 3 krat na teden s presledki najmanj 4 tednov, dokler se ne doseže zadana vrednost.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
SJS/TEN je sprva lahko videti kot rdečkaste, tarčam podobne lise ali okrogle zaplate na trupu s pogostimi mehurčki v njihovem središču.
Tumour growth potential
Možnost za rast tumorja
The recommended total weekly dose is between 75 and 300 IU/kg.
Priporočen tedenski odmerek je med 75 in 300 i.e/kg.
In case Silapo is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Če se zdravilo Silapo injicira pod kožo (subkutano), si lahko injekcije dajete tudi sami, ko vam pokažejo kako.
If this occurs it can result in severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
Če pride do tega, je posledica resna anemija, s simptomi, kot so neobičajna utrujenost, vrtoglavica in pomanjkanje sape.
Once the haemoglobin level is <11 g/dl the dose can be restarted on the same dosing step or one dosing step down based on physician judgement.
Ko je raven hemoglobina < 11 g/dl, lahko nadaljujete zdravljenje z enakim odmerkom ali za en korak manjšim odmerkom, odvisno od presoje zdravnika.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The following reactions have also occurred in isolated patients with normal or low blood pressure: hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state) and generalised tonoclonal seizures, requiring the immediate attention of a physician and intensive medical care.
Pri posameznih bolnikih z normalnim ali nizkim krvnim tlakom so se pojavile naslednje reakcije: hipertenzivna kriza s simptomi, podobnimi encefalopatiji (npr. glavoboli, stanje zmedenosti), in generalizirani tonično-klonični epileptični napadi, pri katerih je potrebna takojšnja zdravniška pomoč in intenzivna zdravstvena nega.
• the liquid is coloured or you can see particles floating in it
• če je tekočina obarvana ali če je videti v njej plavati delce
Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
Injiciranje se lahko opravi tudi ob koncu dialize skozi arteriovensko fistulo, ki mu sledi injiciranje natrijevega klorida 9 mg/ml (0,9%) raztopine za injiciranje, da se cevke splaknejo in da se zagotovi zadovoljiv vnos zdravila v obtok.
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Pri bolnikih, pri katerih pride nenadoma do zmanjšanja učinkovitosti, definiranega kot zvišanje hemoglobina (1-2 g/dl na mesec) ob povečani potrebi po transfuzijah, je treba izmeriti število retikulocitov in raziskati tipične vzroke za zmanjšanje učinkovitosti (npr. pomanjkanje železa, folata, vitamina B12, zastrupitev z aluminijem, okužbe ali vnetja, izguba krvi in hemoliza).
If you stop using Silapo
Če ste prenehali uporabljati zdravilo Silapo
Screening sEPO <200 mU/ml (N) Haemoglobin (g/l)
Skupaj (n) sEPO ob presejanju < 200 mU/ml (n) Hemoglobin (g/l)
In clinical trials, an increased risk of death, serious cardiovascular events or cerebrovascular events including stroke were observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
V kliničnih preskušanjih so opazili povečano tveganje za smrt, resne kardiovaskularne dogodke ali možganskožilne dogodke, vključno s kapjo, kadar so ESA dajali, da bi dosegli ciljno koncentracijo hemoglobina, ki presega 12 g/dl (7,5 mmol/l).
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Pri ambulantni uporabi lahko bolnik zdravilo vzame iz hladilnika in ga nato hrani pri sobni temperaturi (do 25 ºC), vendar največ 3 dni.
Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
Zdravilo Silapo se lahko uporablja za povečanje količine avtologne krvi pri bolnikih v programu avtologne transfuzije.
Intravenous injection
Intravensko injiciranje
• have severe disorders of the veins and arteries
• imate hude motnje ven ali arterij,
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Silapo, treatment with Silapo must not be restarted in this patient at any time.
Če je pri bolniku zaradi uporabe zdravila Silapo prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z zdravilom Silapo ni dovoljeno ponovno začeti.
Discontinue therapy soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Silapo therapy.
Z dodajanjem železa je treba začeti čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Silapo bolnik imel visoke zaloge železa.