natgillin/translations-raw huggingface dataset:
På grund af intra- patientvariabilitet kan der hos en patient til tider observeres individuelle hæmoglobinværdier over og under det ønskede hæmoglobinniveau.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Hvis hæmoglobinniveauet efter fire ugers behandling er steget med mindst 1 g/ dl (0, 62 mmol/ l), bør den anvendte dosis bibeholdes.
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/ dl (0.62 mmol/ l), the current dose should be continued.
Hvis hæmoglobinniveauet ikke er steget med mindst 1 g/ dl (0, 62 mmol/ l), bør det overvejes at fordoble den ugentlige dosis.
If the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), a doubling of the weekly dose should be considered.
Hvis hæmoglobinniveuaet efter otte ugers behandling ikke er steget med mindst 1 g/ dl (0, 62 mmol/ l), anses respons for usandsynligt, og behandlingen bør afbrydes.
If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), response is unlikely and treatment should be discontinued.
Den maksimale dosis bør ikke overstige 60. 000 IE/ uge.
The maximum dose should not exceed 60,000 IU per week.
Når den enkelte patient har nået det terapeutiske mål, bør dosis reduceres med 25- 50% for at fastholde hæmoglobinniveauet.
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.
Hvis hæmoglobinkoncentrationen overstiger 12 g/ dl (7, 5 mmol/ l) bør dosis reduceres med cirka 25 - 50%.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Behandling med NeoRecormon bør midlertidigt afbrydes, hvis hæmoglobinniveauet overstiger 13 g/ dl (8, 1 mmol/ l).
Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Efter hæmoglobinniveauet er faldet til 12 g/ dl (7, 5 mmol/ l) eller lavere, bør behandlingen genoptages med en cirka 25% lavere dosis end den tidligere dosis.
Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) or below.
Hvis stigningen i hæmoglobinniveauet er højere end 2 g/ dl (1, 3 mmol/ l) på fire uger, bør dosis reduceres med 25- 50%.
If the rise in haemoglobin is greater than 2 g/ dl (1.3 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Behandling for at øge udbyttet ved autolog blodtransfusion:
Treatment for increasing the amount of autologous blood:
I de situationer, hvor patientens hæmatokrit tillader blodtapning, dvs. hæmatokrit over 33% administreres NeoRecormon umiddelbart efter blodtapning.
PCV ≥ 33%, NeoRecormon is administered at the end of blood donation.
Igennem hele behandlingsperioden må man ikke overskride en hæmatokrit på 48%.
During the entire treatment period, a PCV of 48% should not be exceeded.
Denne mængde bør svare til, hvad der forventes at være sufficient for at undgå homolog blodtransfusion.
4 This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
4 2.
2.
100
Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100
Kvinder:
Women:
blodvolumen (ml) = 41 (ml/ kg) x legemsvægt (kg) + 1200 (ml) blodvolumen (ml) = 44 (ml/ kg) x legemsvægt (kg) + 1600 (ml) > 45 kg)
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
Mænd
Male patients
Krævede mængde prædoneret blod [enheder]
Required amount of pre-donated blood [units]
Endogen reserve af røde blodlegemer [ml]
Endogenous red cell reserve [ml]
Den på ovennævnte måde beregnede dosis indgives
The single dose thus determined is administered twice weekly over 4 weeks.
overstige 1600 IE/ kg legemsvægt pr. uge ved intravenøs eller 1200 IE/ kg pr. uge ved subkutan administration.
The maximum dose should not exceed 1600 IU/ kg body weight per week for intravenous or 1200 IU/ kg per week for subcutaneous administration.
Myokardieinfarkt eller slagtilfælde i den forudgående måned af behandlingen, ustabil angina pectoris, øget risiko for dyb venetrombose såsom venøs trombolytisk sygdom i anamnesen.
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.
NeoRecormon Flerdosis indeholder benzylalkohol som konserveringsmiddel og må derfor ikke gives til spædbørn og små børn mindre end 3 år.
NeoRecormon Multidose contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
Folinsyre og vitamin B12 mangel bør udelukkes, da de nedsætter NeoRecormon' s virkning.
Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
Behandling med jernsupplement kan blive nødvendig og skal i så fald udføres i henhold til gældende terapeutiske retningslinjer.
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines.
Erythroblastopeni forårsaget af neutraliserende antierythropoietin antistoffer er blevet rapporteret i forbindelse med erythropoietinterapi, herunder NeoRecormon.
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Disse antistoffer har vist sig at kunne krydsreagere med alle erythropoietinproteiner, og patienter, for hvem der er mistanke om eller påvist neutraliserende antistoffer overfor erythropoietin, skal ikke skifte til NeoRecormon (se afsnit 4. 8).
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
Hos patienter med kronisk nyresvigt kan en stigning i blodtrykket eller en forværring af eksisterende forhøjet blodtryk, især i tilfælde af hurtig stigning i hæmatokrit, forekomme.
In chronic renal failure patients an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
Hypertensive kriser med encephalopati- lignende symptomer kan forekomme, hvilket kræver umiddelbar opmærksomhed af en læge og intensiv medicinsk behandling.
Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care.
Hos patienter med kronisk nyresvigt bør hæmoglobinkoncentrationen til vedligeholdelse ikke overstige den øvre grænse for den anbefalede tilstræbte hæmoglobinkoncentration, som anbefalet i pkt. 4. 2.
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.
I kliniske studier blev der observeret en øget risiko for dødsfald og alvorlige cardiovaskulære hændelser, når erythropoiesisstimulerende stoffer (ESAs) blev administreret for at opnå en hæmoglobinkoncentration større end 12 g/ dl (7, 5 mmol/ l).
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).
Når hæmoglobinkoncentrationen øges over niveauet, som er nødvendigt for at kontrollere anæmisymptomerne og for at undgå blodtransfusioner, har der i kliniske studier ikke været vist signifikante fordele, som er tilskrevet administration af epoetiner.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Virkninger på tumorvækst Epoetiner er vækstfaktorer, som primært stimulerer produktionen af røde blodceller.
Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production.
- At tiden til tumorprogression var forkortet hos patienter, som har fremskreden hoved - og
- shortened time to tumour progression in patients with advanced head and neck cancer receiving
halscancer, og som får strålebehandling, når disse stoffer blev administreret for at opnå en hæmoglobinkoncentration højere end 14 g/ dl (8, 7 mmol/ l)
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
- At total overlevelse var mindsket, og dødsfald var øget pga. sygdomsprogression efter 4
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
måneder hos patienter, som har metastaserende brystkræft, og som får kemoterapi, når disse stoffer blev administreret for at opnå en hæmoglobinkoncentration på 12 – 14 g/ dl (7, 5 - 8, 7 mmol/ l)
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l),
- At risiko for dødsfald var øget hos patienter, som har en aktiv malign sygdom, og som hverken
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
får kemoterapi eller strålebehandling, når disse stoffer blev administreret for at opnå en hæmoglobinkoncentration på 12 g/ dl (7, 5 mmol/ l).
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Analysen bør tage hensyn til den specifikke kliniske kontekst.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
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)
Hos patienter i et autologt blod- prædoneringsprogram kan der forekomme en stigning i trombocyttallet, for det meste indenfor referenceområdet.
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
Hvis trombocyttallet stiger med mere end 150 x 109/ l, eller hvis trombocyttallet stiger til over øvre referencegrænse, skal behandlingen med NeoRecormon afbrydes.
If there is an increase in platelets of more than 150 x 109/ l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
Tidlig fistelomlægning og tromboseprofylakse ved administration af f. eks. acetylsalicylsyre bør overvejes hos patienter med kronisk nyresvigt, hvor der er risiko for fisteltrombose.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
Kalium - og phosphatværdien i serum skal kontrolleres regelmæssigt under behandlingen med NeoRecormon.
Serum potassium and phosphate levels should be monitored regularly during NeoRecormon therapy.
Ved anvendelse af NeoRecormon i et autologt prædonationsprogram skal de officielle retningslinjer for principper ved blodtransfusion følges i særdeleshed:
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
- kun patienter med hæmatokrit ≥ 33% (hæmoglobin ≥ 11 g/ dl [6, 83 mmol/ l]) bør behandles,
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/ dl [6.83 mmol/ l]) should donate;
- specielle hensyn skal tages til patienter med en legemsvægt under 50 kg,
- special care should be taken with patients below 50 kg weight;
- den enkelte udtagne portion blod bør ikke overstige ca.
- the single volume drawn should not exceed approx.
12% af patientens estimerede
12% of the patient's estimated blood
blodvolumen.
volume.
Behandlingen bør reserveres patienter for hvem, det betragtes som særdeles vigtigt at undgå homolog blodtransfusion, idet man vurderer fordele/ ulemper ved homolog blodtransfusion.
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/ benefit assessment for homologous transfusions.
Misbrug hos raske personer kan føre til en udbredt stigning i hæmatokrit.
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
NeoRecormon Flerdosis indeholder op til 5, 0 mg phenylalanin/ hætteglas som hjælpestof.
NeoRecormon Multidose contains up to 5.0 mg phenylalanine/ vial as an excipient.
NeoRecormon i rekonstitueret flerdosisopløsning indeholder benzylalkohol, som kan forårsage toksiske reaktioner og anafylaktiske reaktioner hos spædbørn og børn op til 3 år.
NeoRecormon in reconstituted multidose solution contains benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas og kan derfor betragtes som ” fri for natrium ”.
7 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”.
NeoRecormon påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
NeoRecormon has no influence on the ability to drive and use machines.
Baseret på kliniske studier, der inkluderede 1725 patienter, forventes omkring 8% af de patienter, der bliver behandlet med NeoRecormon at opleve bivirkninger.
Based on results from clinical trials including 1725 patients approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.
- Anæmiske patienter med kronisk nedsat nyrefunktion
- Anaemic patients with chronic renal failure
Den hyppigste bivirkning ved behandling med NeoRecormon er en stigning i blodtrykket eller forværring af eksisterende hypertension, specielt i tilfælde med hurtig øgning af hæmatokrit (se pkt.
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4).
4. 4).
Hypertensive crisis with encephalopathy-like symptoms (e. g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
4. 4.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e. g. stenoses, aneurisms), see section 4.4.
4. 4).
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Der er rapporteret om isolerede tilfælde af neutraliserende antierythropoietin antistofmedieret erythroblastopeni i forbindelse med NeoRecormonbehandling.
In isolated cases, neutralising anti erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
4. 4).
In case anti-erythropoietin antibody- mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4).
Forekomsten af bivirkninger i kliniske forsøg, som anses for at være relaterede til behandling med NeoRecormon, er vist i tabellen nedenfor.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Inden for hver frekvensgruppe, er de uønskede hændelser præsenteret i forhold til faldende alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Systemorganklasse Vaskulære sygdomme
System Organ Class
Bivirkning Hypertensiv krise
Adverse Drug Reaction
Hyppighed Ikke almindelig (> 0, 1%, < 1%)
Vascular disorders
Hypertension
Hypertensive crisis Hypertension
Almindelig (> 1%, < 10%)
Uncommon (> 0.1% ,< 1%) Common (> 1% ,< 10%)
Nervesystemet Blod - og lymfesystem
Nervous system disorders Blood and the lymphatic system disorders
Hovedpine Shunttrombose Trombocytose
Headache Shunt thrombosis Thrombocytosis
Almindelig (> 1%, < 10%) Sjælden (> 0, 01%, < 0, 1%) Meget sjælden (< 0, 01%)
Common (> 1% ,< 10%) Rare (> 0.01% ,< 0.1%) Very rare (< 0.01%)
- Cancerpatienter
Patients with cancer
4. 4).
8 Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
4. 4).
In some patients, a fall in serum iron parameters is observed (see section 4.4).
Der er ingen forøget tromboembolisk mortalitet i forhold til kontrolgruppen.
In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
Forekomsten af uønskede hændelser i kliniske forsøg, som anses for at være relaterede til NeoRecormonbehandlingen, er vist i tabellen nedenfor.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Systemorganklasse Vaskulære sygdomme Blod - og lymfesystem
Vascular disorders Blood and the lymphatic system disorders
Bivirkning Hypertension Tromboemboliske hændelser
Hypertension Thromboembolic event
Hyppighed Almindelig (> 1%, < 10%) Almindelig (> 1%, < 10%)
Common (> 1% ,< 10%) Common (> 1% ,< 10%)
Almindelig (> 1%, < 10%)
Common (> 1%, < 10%)
- Patienter i autologt blodprædonationsprogram
- Patients in an autologous blood predonation programme
Patienter i autologt blodprædonationsprogram, udviser en lille forøget frekvens i forekomsten af tromboemboliske hændelser.
Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
4. 4).
In placebo controlled trials temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4).
Forekomsten af uønskede hændelser i kliniske forsøg, som anses for at være relaterede til behandlingen, er vist i tabellen nedenfor.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Systemorganklasse Nervesystemet
System Organ Class
Bivirkning Hovedpine
Adverse Drug Reaction
Hyppighed Almindelig (> 1%, < 10%)
Nervous system disorders
- Alle indikationer
- All indications
I sjældne tilfælde (≥1/ 10. 000 til ≤1/ 1000) kan der opstå hudreaktioner såsom udslæt, pruritus, urticaria eller reaktioner ved injektionsstedet i forbindelse med epoetin betabehandling.
Rarely (≥ 1/ 10.000 to ≤ 1/ 1.000), epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
Der er i meget sjældne tilfælde (≤1/ 10. 000) rapporteret om overfølsomhedsreaktioner i forbindelse med epoetin betabehandling.
In very rare cases (≤ 1/ 10.000), epoetin beta treatment- related anaphylactoid reactions have been reported.
I kontrollerede kliniske undersøgelser blev der imidlertid ikke fundet nogen øgning i forekomsten af overfølsomhedsreaktioner.
However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
I meget sjældne tilfælde (≤1/ 10. 000), især i starten af behandlingen, er influenza- lignende symptomer såsom feber, kulderystninger, hovedpine, smerter i ekstremiteterne, utilpashed og/ eller knoglesmerter blevet rapporteret i forbindelse med epoetin betabehandling.
In very rare cases (≤ 1/ 10.000), particularly when starting treatment, epoetin beta treatment-related flu- like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/ or bone pain have been reported.
NeoRecormon' s terapeutiske margen er meget bred.
The therapeutic margin of NeoRecormon is very wide.
Antianæmisk, ATC- kode:
9 Pharmacotherapeutic group: antianaemic, ATC code:
Epoetin beta er identisk i dets aminosyre - og kulhydratsammensætning med erythropoietin, som er isoleret fra urinen hos patienter med blodmangel.
Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
9 Erythropoietin er et glycoprotein, der stimulerer dannelsen af erytrocytter fra særlige stamceller.
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors.
Efter indgift af epoetin beta øges antallet af erytrocytter, Hb- værdien og retikulocytantallet såvel som 59Fe - optagelseshastigheden.
After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
En forhøjet 3H- thymidin optagelse i miltens erythroide forstadier er blevet fundet in vitro (musemiltcelle - kultur) efter inkubation med epoetin beta.
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Efter en enkelt administration af epoetin beta kunne der ikke konstateres nogen virkninger på adfærd eller lokomotorisk aktivitet hos mus og kredsløbs - eller respirationsfunktion hos hunde.
After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Heraf var fire studier dobbelt- blindede placebo- kontrollerede studier, og et studie var et ublindet studie.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Den tilstræbte hæmoglobinkoncentration i to studier var > 13 g/ dl; i de øvrige studier 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.
0, 87, 1, 46).
An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95% CI 0.87, 1.46).
Hos patienter med en baseline hæmoglobinkoncentration på ≤ 10 g/ dl (n=899) var hazard ratioen for overlevelse 0, 89 (95% konfidensinterval:
In patients with baseline haemoglobin ≤ 10 g/ dl (n=899), the hazard ratio point estimate for survival was 0.98 (95% CI 0.68 to 1.40).
En øget relativ risiko for tromboemboliske hændelser blev observeret i den samlede population (RR:
An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95% CI:
1, 62, 95% konfidensinterval; 1, 13, 2, 31).
1.13, 2.31).
En systematisk gennemgang har også været foretaget af 57 kliniske studier, som har involveret mere end 9000 cancerpatienter.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
En meta- analyse af data for total overlevelse viste en estimeret hazard ratio på 1, 08 i kontrolgruppens favør (95% konfidensinterval:
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 studier og 8167 patienter).
0.99, 1.18; 42 trials and 8167 patients).
For patienter behandlet med recombinant human erytropoietin blev der observeret en øget relativ risiko for tromboeboliske hændelser (RR:
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
1, 35, 2, 06; 35 studier og 6769 patienter).
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.