natgillin/translations-raw huggingface dataset:
4. 4) − Ukontrolleret hypertension − Ved indikationen ” øgning af udbyttet af autologt blod ”: myokardial infarkt eller slagtilfælde i måneden forud for behandlingen, ustabil angina pectoris, øget risiko for dyb venetrombose, eksempelvis på grund af tromboembolisk venesygdom. − Patienter, som - uanset grund - ikke kan modtage tilstrækkelig antitrombotisk profylakse.
− Hypersensitivity to the active substance or to any of the excipients. − Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4). − Uncontrolled hypertension. − 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. − Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Som hos alle patienter, der får erytropoietin, kan blodtrykket stige under behandling med Silapo.
Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Silapo.
Hvis blodtrykket ikke kan kontrolleres, skal Silapo- behandlingen ophøre.
If blood pressure cannot be well controlled, Silapo treatment should be discontinued.
Alle andre årsager til anæmi (jernmangel, hæmolyse, blodtab, B12- vitamin - eller folatmangel) skal overvejes og behandles forud for påbegyndelse af og under terapi med Silapo.
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.
7 − Jerntilskud, fx 200- 300 mg/ dag peroralt (100- 200 mg/ dag for pædiatriske patienters vedkommende), anbefales til patienter med kronisk nyresvigt, hvis serumferritinniveau er under 100 ng/ ml. − Peroralt jerntilskud på 200- 300 mg/ dag anbefales til alle cancerpatienter, hvis transferrinmætning er under 20%.
6 − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose transferrin saturation is below 20%.
Immunogenicitetsdata for subkutan anvendelse af Silapo hos patienter med risiko for antistof - fremkaldt Pure Red Cell Aplasia (PRCA), dvs. patienter med renal anæmi, er ikke tilstrækkelige.
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.
Hvis der diagnosticeres PRCA, skal Silapo- terapien straks ophøre, og det skal overvejes at teste for antistoffer mod erytropoietin.
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
8 Hyperkalæmi er observeret i isolerede tilfælde.
7 Hyperkalaemia has been observed in isolated cases.
Ved vurderingen af om Silapo- terapi er hensigtsmæssig hos cancerpatienter i kemoterapi (risiko for, at patienten transfunderes), bør det tages i betragtning, at der går 2- 3 uger, fra administration af erytropoietin påbegyndes, til der viser sig erytropoietin- fremkaldte røde blodceller.
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).
4. 2)
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).
Dette er især vigtigt hos cancerpatienter med forhøjet risiko for vaskulær trombose, fx ved ovevægt, og patienter, som tidligere har oplevet TVE' er (fx dyb venetrombose eller pulmonal embolisme).
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).
9 måneder hos patienter med metastatisk brystcancer, som får kemoterapi, når stofferne gives for at tilstræbe et hæmoglobinniveau på 12- 14 g/ dl (7, 5- 8, 7 mmol/ l),
8
øget risiko for død, når stofferne gives for at tilstræbe et hæmoglobinniveau på 12 g/ dl (7, 5 mmol/ l) hos patienter med aktiv malign sygdom, som hverken får kemoterapi eller strålebehandling.
increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
5. 1).
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).
Silapo påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Silapo has no or negligible influence on the ability to drive and use machines.
Silapo er et biologisk lægemiddel.
Silapo is a biological medicinal product.
Data fra kliniske undersøgelser med Silapo stemmer overens med sikkerhedsprofilen for andre godkendte erytropoietiner.
Data from clinical studies with Silapo are in line with the safety profile of other authorized erythropoietins.
Der er rapporteret om trombotiske/ vaskulære hændelser, f. eks. myokardieiskæmi, myokardieinfarkt, cerebrovaskulær hændelse (cerebral blødning og cerebral infarkt), forbigående iskæmiske anfald, dyb
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.
Der er sjældne rapporter om overfølsomhedsreaktioner i forbindelse med epoetin alfa, herunder enkeltstående tilfælde af angioødemer og anafylaktiske reaktioner.
9 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Hos enkelte patienter med normalt eller lavt blodtryk er følgende reaktioner også set: hypertensive kriser med encefalopati- lignende symptomer (f. eks, hovedpine og konfusion) og generaliserede tonisk- kloniske kramper, hvilket kræver øjeblikkeligt lægetilsyn og igangsættelse af intensiv medicinsk behandling.
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.
Shunt- trombose kan opstå, især hos patienter med tendens til hypotension, eller hvis arteriovenøse fistler giver komplikationer (f. eks. stenose, aneurisme).
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
11 Erytropoietins tilsyneladende molekylvægt er 32000- 40000 Dalton.
10 The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
I to store åbne undersøgelser deltog 2697 cancerpatienter i behandling med ikke- platinbaseret kemoterapi, heraf 1895 med massive tumorer (683 med bryst -, 260 med lunge -, 174 med gynækologiske, 300 med gastrointetinale og 487 med andre typer tumorer) og 802 med hæmatologiske maligniteter.
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.
I en prospektiv, randomiseret, dobbeltblind, placebokontrolleret afprøvning, med 375 anæmipatienter med forskellige non- myeloide maligniteter, der var i behandling med ikke- platinbaseret kemoterapi, sås en signifikant reduktion af anæmirelaterede sequelae (fx træthed, nedsat energi og nedsat aktivitetsniveau), målt med anvendelse af følgende instrumenter og skalaer:
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:
Den tilstræbte hæmoglobinkoncentration i to forsøg var > 13 g/ dl, og i de øvrige tre forsøg var den 12- 14 g/ dl.
The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
1, 35, 2, 06, 35 undersøgelser og 6769 patienter) sås hos patienter behandlet med rekombinant humant erytropoietin.
There is an increased risk for
Der er en øget risiko for tromboemboliske hændelser hos patienter med cancer, som behandles med rekombinant humant erytropoietin, og en negativ virkning på samlet overlevelse kan ikke udelukkes.
11 thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hvorvidt disse rater også gælder for administration af rekombinant humant erytropoietin til patienter med cancer, som behandles med kemoterapi, for at opnå hæmoglobinkoncentrationer på mindre end 13 g/ dl, er uklart, fordi der i de gennemgåede data kun var få patienter med disse karakteristika.
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.
1/ 20 af værdien).
The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
Niveauerne er de samme, uanset om de bestemmes 4 timer efter første injektion eller 24 timer efter sidste injektion.
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.
Dinatriumfosfat- dihydrat Natriumdihydrogenfosfat- dihydrat Natriumklorid Kalciumklorid- dihydrat
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine
13 Polysorbat 20 Glycin Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
12 Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Silapo må ikke bruges, hvis • blisterpakningens forsegling er brudt, eller blisterpakningen på nogen måde er beskadiget • væsken har farve, eller man kan se partikler flyde omkring i den • Der er sivet væske ud af den fyldte sprøjte, eller der er synlig kondens indeni den forseglede blisterpakning • det ved et uheld er blevet frosset
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.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
13 Any unused product or waste material should be disposed of in accordance with local requirements.
Silapo 2000 IU/ 0, 6 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe
4. 4). − Behandling af anæmi og reduktion af transfusionsbehov hos voksne patienter i kemoterapi for massive tumorer, malignt lymfom eller multipelt myelom og med risiko ved transfusion vurderet ud fra patientens almentilstand (fx kardiovaskulær tilstand, præeksisterende anæmi ved kemoterapistart). − Silapo kan anvendes til at øge udbyttet af autologt blod fra patienterne i et prædonationsprogram.
− 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.
16 − Behandling af symptomatisk anæmi hos voksne og pædiatriske patienter med kronisk nyreinsufficiens
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
Der tilstræbes en hæmoglobinkoncentration på mellem 10 og 12 g/ dl (6, 2- 7, 5 mmol/ l) undtaget hos pædiatriske patienter, hvis hæmoglobinkoncentration bør ligge mellem 9, 5 og 11 g/ dl (5, 9 - 6, 8 mmol/ l).
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).
På grund af variabilitet hos den enkelte patient kan der af og til observeres individuelle hæmoglobinværdier for en patient, som ligger over og under det ønskede hæmoglobinniveau.
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.
Hæmoglobinvariabiliteten bør behandles via dosishåndtering under hensyntagen til det tilstræbte niveau for hæmoglobin på 10 g/ dl (6, 2 mmol/ l) til 12 g/ dl (7, 5 mmol/ l).
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).
Vejledning for passende dosisjustering, når der er observeret hæmoglobinværdier over 12 g/ dl (7, 5 mmol/ l), er beskrevet nedenfor.
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.
En stigning i hæmoglobin på mere en 2 g/ dl (1, 25 mmol/ l) over en 4 ugers periode bør undgås.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
50 IU/ kg 3 gange om ugen, intravenøst.
50 IU/kg 3 times per week by the intravenous route.
For hvert trin bør dosis hhv. øges eller nedsættes med 25 IU/ kg 3 gange om ugen.
At each step, the increase or reduction in dose should be of 25 IU/kg 3 times per week.
Hb mellem 10 og 12 g/ dl (6, 2- 7, 5 mmol/ l).
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Den anbefalede totale ugentlige dosis er mellem 75 og 300 IU/ kg, intravenøst.
The recommended total weekly dose is between 75 and 300 IU/kg by the intravenous route.
De tilgængelige kliniske data tyder på, at patienter med meget lavt initialt hæmoglobin (< 6 g/ dl eller < 3, 75 mmol/ l) kan kræve højere vedligeholdelsesdoser end patienter med mindre alvorlig initial anæmi (Hb > 8 g/ dl or > 5 mmol/ l).
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).
50 IU/ kg 3 gange om ugen intravenøst.
50 IU/kg, 3 times per week by the intravenous route.
Når en regulering af dosis er nødvendig, bør den ske i trin på 25 IU/ kg 3 gange om ugen med intervaller på mindst 4 uger, indtil det ønskede mål er nået.
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.
Hb mellem 9, 5 og 11 g/ dl (5, 9- 6, 8 mmol/ l).
Hb between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
17 Dosis (IU/ kg 3 gange ugentligt)
Dose (IU/kg given 3x week)
Vægt (kg) < 10 10- 30 > 30
Weight (kg) < 10 10-30 > 30
De tilgængelige kliniske data tyder på, at patienter med meget lavt initialt hæmoglobin (< 6, 8 g/ dl eller < 4, 25 mmol/ l) kan kræve højere vedligeholdelsesdoser end patienter med initialt hæmoglobin på > 6, 8 g/ dl eller > 4, 25 mmol/ l).
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).
Der startes med 50 IU/ kg 2 gange om ugen, intravenøst.
Starting dose of 50 IU/kg 2 times per week by the intravenous route.
(Hb mellem 10 og 12 g/ dl (6, 2- 7, 5 mmol/ l).
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Vedligeholdelsesdosis mellem 25 og 50 IU/ kg 2 gange om ugen i 2 lige store injektioner.
Maintenance dose between 25 and 50 IU/kg 2 times per week into 2 equal doses.
Startdosis på 50 IU/ kg 3 gange om ugen, intravenøst, om nødvendigt efterfulgt af en øgning af doseringen med 25 IU/ kg ad gangen (3 gange om ugen), indtil det ønskede mål er nået (dette bør ske i trin på minimum 4 uger).
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).
Vedligeholdelsesdosis mellem 17 og 33 IU/ kg 3 gange ugentligt indgivet intravenøst.
Maintenance dose between 17 and 33 IU/kg 3 times per week by the intravenous route.
Den maksimale dosering bør ikke overstige 200 IU/ kg 3 gange om ugen.
The maximum dose should not exceed 200 IU/kg 3 times per week.
Silapo skal indgives subkutant til patienter med anæmi (f. eks. hæmoglobinkoncentration ≤ 10 g/ dl (6, 2 mmol/ l).
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).
Hæmoglobinvariabilitet bør håndteres ved at styre dosis, med det tilstræbte hæmoglobininterval på 10 g/ dl (6, 2 mmol/ l) til 12 g/ dl (7, 5 mmol/ l) taget i betragtning.
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).
Vejledning for passende dosisjustering, når der er observeret hæmoglobinværdier over 12 g/ dl (7, 5 mmol/ l), er beskrevet nedenfor.
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.
Initialdosis er 150 IU/ kg indgivet subkutant 3 gange om ugen.
The initial dose is 150 IU/kg given subcutaneously 3 times per week.
Alternativt kan Silapo administreres med en initialdosis på 450 IU/ kg subkutant 1 gang ugentligt.
Alternatively, Silapo can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
18 Hvis hæmoglobinet er steget med mindst 1 g/ dl (0, 62 mmol/ l), eller reticulocyttællingen er steget til ≥ 40. 000 celler/ µl over baseline efter 4 ugers behandling, bør der fortsættes med dosis på 150 IU/ kg 3 gange om ugen eller 450 IU/ kg 1 gang ugentligt.
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.
Hvis hæmoglobinforøgelsen er < 1 g/ dl (< 0, 62 mmol/ l), og reticulocyttællingen er steget < 40000 celler/ µl over baseline, øges dosis til 300 IU/ kg 3 gange om ugen.
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.
Hvis hæmoglobinet er steget ≥ 1 g/ dl (0,. 62 mmol/ l), eller reticulocyttællingen er steget med 40000 celler/ µl efter endnu 4 ugers terapi med 300 IU/ kg 3 gange om ugen, skal dosis holdes på 300 IU/ kg 3 gange om ugen.
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.
Hvis hæmoglobinet er steget < 1 g/ dl (< 0, 62 mmol/ l), og reticulocyttællingen er steget < 40000 cells/ µl over baseline, er respons dog usandsynlig, og behandling bør ophøre.
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.
Retikulocyttalsstigning ≥ 40. 000/ mikroliter eller stigning i Hb med ≥ 1 g/ dl
17 Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
Stigning i retikulocyttal til < 40. 000/ mikroliter og stigning i Hb med < 1 g/ dl
Appropriate dose titration should be considered.
25- 50%.
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%.
Hvis hæmoglobinniveauet overstiger 12 g/ dl (7, 5 mmol/ l), ophøres der med terapi, indtil niveauet er faldet til 12 g/ dl (7, 5 mmol/ l) eller derunder, hvorefter Silapo- terapien genoptages med en dosis, som er 25% under den tidligere dosis.
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.
Let anæmiske patienter (hæmatokrit 33- 39%), som kræver en forudgående behandling med ≥ 4 enheder blod, skal behandles med Silapo med en dosis på 600 IU/ kg legemsvægt 2 gange ugentligt i 3 uger forud for operationen.
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.
Alle patienter, som behandles med Silapo, bør have et tilstrækkeligt jerntilskud (fx 200 mg
200 mg oral elemental iron daily) throughout the course of treatment.
Der bør startes med jerntilskud så tidligt som muligt, gerne flere uger før den autologe prædonation påbegyndes, således, at der opbygges store jerndepoter, før Silapo- behandling påbegyndes.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Silapo therapy.
a) Intravenøs injektion Dosis skal administreres over mindst 1- 5 minutter, afhængigt af den totale dosis.
18 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.