natgillin/translations-raw huggingface dataset:
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml
200- 300 mg na dan peroralno (100- 200 mg na dan za pediatrične bolnike) se priporoča za bolnike s kronično odpovedjo ledvic, ki imajo nivoje feritina v serumu pod 100 ng/ ml. − peroralno nadomeščanje železa z 200- 300 mg/ dan se priporoča za vse bolnike z rakom, pri katerih je nasičenost transferina pod 20%.
Immunogenicity data for subcutaneous use of Silapo in patients at risk for antibody-induced Pure Red Cell Aplasia (PRCA), i. e. patients with renal anaemia, are not sufficient.
Imunogenski podatki za subkutano uporabo zdravila Silapo pri bolnikih, s tveganjem za s protitelesi povzročene čiste aplazije rdečih krvnih celic (PRCA), t. j. pri bolnikih z ledvično anemijo, so nezadostni.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (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 in resne kardiovaskularne dogodke, kadar so zdravila za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agents) dajali, da bi dosegli ciljno koncentracijo hemoglobina, ki presega 12 g/ dl (7, 5 mmol/ l).
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
7 Če pride do diagnoze PRCA, je treba zdravljenje z zdravilom Silapo takoj prekiniti in razmisliti o testiranju na protitelesa za eritropoetin.
7 Hyperkalaemia has been observed in isolated cases.
V posameznih primerih so opazili hiperkalemijo.
In cancer patients receiving chemotherapy, the 2-3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if Silapo therapy is appropriate (patient at risk of being transfused).
Pri rakavih bolnikih na kemoterapiji je treba pri vprašanju, ali je zdravljenje z zdravilom Silapo primerno (bolniki s povečanim tveganjem pri transfuzijah), upoštevati 2- 3 tedenski zamik med začetkom dajanja eritropoetina in pojavom eritrocitov, ki jih eritropoetin inducira.
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).
Če hitrost naraščanja hemoglobina presega 2 g/ dl (1, 25 mmol/ l) na mesec ali če nivo hemoglobina presega 12 g/ dl (7, 5 mmol/ l), je potrebno opraviti korenito spremembo odmerka, kot je navedeno v poglavju 4. 2, da bi se zmanjšalo riziko tveganja za trombotične zaplete (glejte poglavje 4. 2)
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).
Posebna pozornost je potrebna pri bolnikih z rakom, pri katerih je prisoto povečano tveganje ta trombotične vaskularne zaplete, na primer zaradi debelosti, ali pa zaradi trombotičnih vaskularnih zapletov v anamnezi (npr. globoka venozna tromboza ali pljučna embolija):
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • 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), • 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),
8 V kontroliranih kliničnih študijah je prišlo pri uporabi epoetina alfa in drugih zdravil za stimulacijo eritropoeze (ESA) do: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/ dl (8, 7 mmol/ l), • skrajšanega časa skupnega preživetja in povečanja števila smrti, ki jih pripisujejo napredovanju bolezni po 4 mesecih pri bolnikih z metastaznim rakom dojk na kemoterapiji, pri katerih so z uporabo sredstev za stimulacijo eritropoeze želeli doseči ciljne koncentracije hemoglobina od 12– 14 g/ dl (7, 5– 8, 7 mmol/ l), • povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/ dl (7, 5 mmol/ l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Dejavnike, ki bi jih morali upoštevati pri tej oceni morajo vključevati tip tumorja in njegov stadij, stopnjo anemičnosti, pričakovano življenjsko dobo, okolje v katerem se bolnika zdravi in prednosti za bolnika (glejte poglavje 5. 1).
Silapo is a biological medicinal product.
Zdravilo Silapo je biološko zdravilo.
"Flu-like" symptoms such as headaches, joint pains, feelings of weakness, dizziness, and tiredness may occur, especially at the start of treatment.
9 Zlasti na začetku zdravljenja se lahko pojavijo » gripi podobni « simptomi, kot so glavobol, bolečine v sklepih, občutek šibkosti, omotica in utrujenost.
Thrombotic/vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetine, so poročali o trombotičnih/ vaskularnih dogodkih, kot so miokardna ishemija, miokardni infarkt, cerebrovaskularni dogodki (možganska krvavitev in možganska kap), tranzitorne ishemične atake, globoka venska tromboza, arterijska tromboza, pljučna embolija, anevrizme, retinalna tromboza in zamašitev umetne ledvice.
9 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Pri bolnikih, ki so prejemali epoetin alfa, so poročali tudi o redkih preobčutljivostnih reakcijah, vključno s posameznimi primeri angioedemov in anafilaktičnih reakcij.
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.
Adult cancer patients with symptomatic anaemia receiving chemotherapy
Odrasli bolniki z rakom in s simptomatsko anemijo, ki se zdravijo s kemoterapijo Pri bolnikih, ki se zdravijo z epoetinom alfa, se lahko pojavi hipertenzija.
Pharmacotherapeutic group:
10 Farmakoterapevtska skupina:
10 The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Navidezna molekularna masa eritropoetina je med 32. 000 in 40. 000 Daltoni.
In two l arge, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
V dve veliki odprti študiji je bilo vključeno 2. 697 bolnikov z rakom na kemoterapiji brez platine, 1. 895 s čvrstimi tumorji (683 dojke, 260 pljuč, 174 ginekološki, 300 gastrointestinalni, in 478 s tumorji drugih vrst) in 802 s hematološkimi malignimi obolenji.
The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Ciljna koncentracija hemoglobina je bila v dveh študijah > 13 g/ dl, v preostalih treh študijah pa od 12 do 14 g/ dl.
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
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Izvedli so tudi sistemsko ocenjevanje, ki je vključevalo več kot 9000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
There is an increased risk for
1, 35, 2, 06, 35 preskušanj in 6769 bolnikov) so opazili pri bolnikih, ki so jih zdravili z rekombinantnim humanim eritropoetinom.
11 thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin, obstaja povečano tveganje za tromboembolijske dogodke, negativnega vpliva na skupno preživetje pa ni mogoče izključiti.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/ dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
Vrh je vedno bistveno niže kot v primeru intravenskega dajanja (približno 1/ 20 te vrednosti).
The re is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
Do akumulacije ne prihaja: koncentracije ostajajo enake, če se merijo 24 ur po prvi ali 24 ur po zadnjem injiciranju.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine
Natrijev fosfat dihidrat Natrijev dihidrogenfosfat dihidrat Natrijev klorid Kalcijev klorid dihidrat Polisorbat 20 Glicin Levcin Izolevcin Treonin Glutamatna kislina Fenilalanin Voda za injekcije Natrijev hidroksid (za prilagoditev pH) Klorovodikova kislina (za prilagoditev pH)
Silapo must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
Zdravila Silapo se ne sme uporabljati, • če je pečat na ovojnini pretrgan ali če je ovojnina na kakršenkoli način poškodovana • če je tekočina obarvana ali če je videti v njej plavati delce • če je iz vnaprej napolnjene brizge iztekla tekočina ali če je v zavarjenem blistru videti
13 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe
Silapo 2. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). 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). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
− Zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic pri odraslih in pediatričnih bolnikih: o zdravljenje anemije pri odraslih in pediatričnih bolnikih s kronično odpovedjo ledvic na hemodializi ali odraslih bolnikov na peritonealni dializi (glejte poglavje 4. 4). o zdravljenje hude anemije ledvičnega izvora s spremljajočimi kliničnimi znaki, pri odraslih bolnikih z ledvično insuficienco, ki se jih še ne zdravi z dializo (glejte poglavje 4. 4). − zdravljenje anemije in zmanjšanje potrebe po transfuzijah pri odraslih bolnikih, ki prejemajo kemoterapijo zaradi čvrstih tumorje, malignega limfoma ali multiplega mieloma, in za katere je transfuzija glede na splošno stanje bolnika tvegana (npr. kardiovaskularni status, anemičnost ob začetku kemoterapije). − Zdravilo Silapo se lahko uporablja za povečanje količine avtologne krvi pri bolnikih v programu avtologne transfuzije.
15 The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
15 Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Zdravnik mora opraviti ocenjevanje poteka bolezni in stanja bolnika.
Silapo should be administered intravenously in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L) 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.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Izogibajte se trajni koncentraciji hemoglobina, ki presega 12 g/ dl.
A sustained haemoglobin level of greater than 12 g/dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Navodila za primerno prilagajanje odmerka v primeru ugotovljenih vrednosti hemoglobina, ki presegajo 12 g/ dl (7, 5 mmol/ l), so navedena spodaj.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
V času štirih tednov se morate izogibati dvigu koncentracije hemoglobina, ki presega 2 g/ dl (1, 25 mmol/ l).
50 IU/kg 3 times per week by the intravenous route.
50 i. e. / kg trikrat tedensko, intravensko.
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Hb med 10 in 12 g/ dl (6, 2- 7, 5 mmol/ l).
The recommended total weekly dose is between 75 and 300 IU/kg by the intravenous route.
Priporočen tedenski odmerek je med 75 in 300 i. e/ kg, intravensko.
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).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6 g/ dl ali < 3, 75 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 8 g/ dl ali > 5 mmol/ l).
50 IU/kg, 3 times per week by the intravenous route.
50 i. e. / kg trikrat tedensko, intravensko.
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.
Hb between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Hb med 9, 5 in 11 g/ dl (5, 9- 6, 8 mmol/ l).
Dose (IU/kg given 3x week)
Odmerek (i. e. / kg 3x na teden)
Weight (kg) < 10 10-30 > 30
< 10 10- 30 > 30
16 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
Starting dose of 50 IU/kg 2 times per week by the intravenous route.
začetni odmerek 50 i. e. / kg dvakrat tedensko, intravensko.
Maintenance dose between 25 and 50 IU/kg 2 times per week into 2 equal doses.
Vzdrževalni odmerek med 25 in 50 i. e. / kg dvakrat tedensko v dveh enakih odmerkih.
Starting dose of 50 IU/kg 3 times per week by the intravenous route, followed if necessary by a dose increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
začetni odmerek je 50 i. e. / trikrat tedensko, intravensko, ki se ga po potrebi veča s koraki po 25 i. e. / kg (trikrat tedensko), dokler se ne doseže zadana vrednost (koraki naj si sledijo s presledkom najmanj štirih tednov):
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
(Hb med 10 in 12 g/ dl (6, 2- 7, 5 mmol/ l).
Maintenance dose between 17 and 33 IU/kg 3 times per week by the intravenous route.
Vzdrževalni odmerek med 17 in 33 i. e. / kg trikrat tedensko, intravensko.
The maximum dose should not exceed 200 IU/kg 3 times per week.
Največji odmerek ne sme preseči 200 i. e. / kg 3 krat na teden.
Treatment of patients with chemotherapy induced anaemia Silapo should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l).
Bolnikom z anemijo (npr. koncentracije hemoglobina ≤ 10 g/ dl (6, 2 mmol/ l)) je treba zdravilo Silapo dajati subkutano.
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Izogibajte se trajni koncentraciji hemoglobina, ki presega 12 g/ dl.
A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Navodila za primerno prilagajanje odmerka v primeru ugotovljenih vrednosti hemoglobina, ki presegajo 12 g/ dl (7, 5 mmol/ l), so navedena spodaj.
The initial dose is 150 IU/kg given subcutaneously 3 times per week.
Začetni odmerek 150 i. e. / kg dajemo subkutano trikrat tedensko.
Alternatively, Silapo can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Zdravilo Silapo se lahko daje tudi enkrat tedensko subkutano z začetnim odmerkom 450 i. e. / kg.
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
Če se po 4 tednih zdravljenja hemoglobin zviša za najmanj 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo ≥40. 000 celic/ µl nad osnovno vrednostjo, naj odmerek ostane pri 150 i. e. / kg trikrat tedensko ali 450 i. e. / kg enkrat tedensko.
If the haemoglobin increase is < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40,000 cells/µl above baseline, increase the dose to 300 IU/kg 3 times per week.
Če se je hemoglobina zvišal < 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo < 40. 000 celic/ µl nad osnovno vrednost, zvišamo odmerek na 300 i. e. / kg trikrat tedensko.
If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin has increased ≥ 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl the dose should remain at 300 IU/kg 3 times per week.
Če se po dodatnih 4 tednih zdravljenja z 300 i. e. / kg trikrat tedensko hemoglobin zviša za najmanj 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo ≥40. 000 celic/ µl, naj odmerek ostane pri 300 i. e. / kg trikrat tedensko.
However, if the haemoglobin has increased < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40,000 cells/µl above baseline, response is unlikely and treatment should be discontinued.
Če pa se je hemoglobina zvišal < 1 g/ dl (0, 62 mmol/ l) ali če se je število retikulocitov dvignilo < 40. 000 celic/ µl nad osnovno vrednost, odziva
The recommended dosing regimen is described in the following diagram:
17 verjetno ni in je treba zdravljenje prekiniti.
Dose adjustment 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%.
150 i. e. / kg, 3- krat na teden ali 450 i. e. / kg, enkrat na teden
Silapo should be given by the intravenous route.
300 i. e. / kg
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.
All patients being treated with Silapo should receive adequate iron supplementation (e.g.
Vsem bolnikom, ki dobivajo zdravilo Silapo, je treba ves čas zdravljenja dodajati ustrezn dodatek z železom (npr.
18 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Intravensko injiciranje Odmerek je treba injicirati najmanj 1 do 5 minut, odvisno od celotnega odmerka.
A lternatively, 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.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
19 V času zdravljenja z eritropoetinom lahko pride znotraj normalnih mej do, od odmerka odvisnega, zvišanja trombocitov.
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: − iron supplementation, e.g.
Da je odziv na eritropoetin optimalen, je treba poskrbeti za ustrezne zaloge železa: − dodajanje železa, npr.