natgillin/translations-raw huggingface dataset:
Voksne og pædiatriske hæmodialysepatienter, voksne peritoneal- dialysepatienter og voksne med nyreinsufficiens, der endnu ikke er i dialyse.
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
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.
Der bør udvises særlig opmærksomhed over for pludseligt indsættende stikkende og migrænelignende hovedpine, da dette kan være et muligt forvarselstegn.
Particular attention should be paid to sudden stabbing migraine- like headaches as a possible warning signal.
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.).
Det anbefales at udføre tidlig shunt- revision og tromboseprofylakse, f. eks. i form af indgift af acetylsalicylsyre hos disse patienter.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
11 Voksne cancerpatienter med symptomatisk anæmi, der behandles med kemoterapi:
Adult cancer patients with symptomatic anaemia receiving chemotherapy
4. 4 og 4. 8 - Generelt) hos patienter, der får erythropoietiske midler.
11 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Operationspatienter i autologe prædonationsprogrammer
Surgery patients in autologous predonation programmes
Uafhængigt af erythropoietin- behandlingen kan der forekomme trombotiske og vaskulære hændelser hos operationspatienter med underliggende kardiovaskulær sygdom efter gentagne blodprøvetagninger.
Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Derfor skal der hos disse patienter foretages rutinemæssig erstatning af volumen.
Therefore, routine volume replacement should be performed in such patients.
Patienter, der er planlagt til større ortopædkirurgisk operation:
Patients scheduled for major elective orthopaedic surgery
Der er imidlertid kun begrænset klinisk erfaring.
In patients scheduled for major elective orthopaedic surgery, with a baseline haemoglobin of 10 to 13 g/ dl, the incidence of thrombotic/ vascular events (most of which were DVTs), in the overall patient population of the clinical trials, appeared to be similar across the different epoetin alfa dosing groups and placebo group, although the clinical experience is limited.
Desuden kan det ikke udelukkes, at behandlingen med epoetin alfa vil være forbundet med en øget risiko for postoperative trombotiske/ vaskulære hændelser hos patienter med en baseline- værdi af hæmoglobinkoncentration på > 13 g/ dl.
Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.
En overdosis med epoetin alfa kan give symptomer i form af en forstærket effekt af hormonets farmakologiske virkninger.
Overdose of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Åreladning skal foretages i tilfælde af usædvanligt høje hæmoglobinværdier.
Phlebotomy may be performed if excessively high haemoglobin levels occur.
Farmakoterapeutisk klassifikation: antianæmisk, ATC- kode:
Pharmacotherapeutic group: antianaemic, ATC code:
B03XA01.
B03XA01
Erythropoietin er et glykoprotein, der stimulerer dannelsen af erytrocytter fra erythrocyt- forstadier fra stamceller ved at stimulere mitose og ved at være et differentierende hormon.
Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Erythropoietins molekylevægt er 32. 000 til 40. 000 dalton.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
58% og består af 165 aminosyrer.
The protein fraction of the molecule contributes about 58% and consists of 165 amino acids.
De fire kulhydratkæder bindes til proteindelen med tre N- glykosid- bindinger og en O- glykosid- binding.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Genteknologisk fremstillet epoetin alfa er glykosyleret og identisk med erythropoietin, der er isoleret fra anæmiske patienters urin med hensyn til aminosyre - og kulhydratsammensætning.
Epoetin alfa obtained by gene technology is glycosylated and is identical in its amino acid and carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Abseamed har den højest mulige renhed i forhold til den nuværende teknologi.
Abseamed has the highest possible purity according to the present state of the art.
Ved de koncentrationer af det aktive stof, der anvendes hos mennesker, kan der således ikke spores nogen rester af den cellelinje, der er anvendt ved fremstillingen.
In particular, no residues of the cell line used for the production are detectable at the concentrations of the active ingredient that are used in humans.
Epoetin alfas biologiske effekt er påvist i forskellige dyr in vivo (normale og anæmiske rotter, polycytæmiske mus).
The biological efficacy of epoetin alfa has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
Efter indgift af epoetin alfa øges antallet af erytrocytter, hæmoglobinkoncentrationen, retikulocyttallet samt 59FE- optagelseshastigheden.
After administration of epoetin alfa, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Efter inkubation in vitro med epoetin alfa er der set en øget optagelse af 3 H- thymidin i erythroide kerneholdige celler i miltcellekulturer fra mus.
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
12 I kulturer af humane knoglemarvsceller er det påvist, at epoetin alfa specifikt stimulerer erythropoiesen og ikke påvirker leukopoiesen.
It could be shown with the aid of cell cultures of human bone marrow cells that epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Der blev ikke fundet cytotoksisk påvirkning af knoglemarvsceller for epoetin alfa.
Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
721 patienter, der blev behandlet med ikke- platinbaseret kemoterapi blev medregnet i tre placebokontrollerede undersøgelser, heraf 389 patienter med hæmatologiske maligniteter (221 myelomatose, 144 non- Hodgkin’ s lymfom og 24 andre hæmatologiske maligniteter) og 332 med alvorlige tumorer (172 bryst, 64 gynækologiske, 23 lunge, 22 prostata, 21 gastrointestinale og 30 andre tumortyper).
12 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
I to store åbne undersøgelser blev 2697 cancerpatienter, behandlet med ikke - platinbaserede kemoterapi, heraf havde 1895 alvorlige tumorer (683 bryst, 260 lunge, 174 gynækologiske, 300 gastrointestinale og 478 andre tumortyper) og 802 hæmatologiske maligniteter.
In two large, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastro-intestinal, and 478 other tumour types) and 802 with haematological malignancies.
I en prospektiv, randomiseret, dobbeltblind, placebokontrolleret undersøgelse med 375 anæmiske patienter med forskellige non- myeloide maligniteter, der var i behandling med ikke- platinholdig kemoterapi, sås en signifikant reduktion af anæmirelaterede følger (f. eks. træthed, nedsat energi og nedsat aktivitet) målt efter følgende klassificering:
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e. g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales:
Functional Assessment of Cancer Therapy- Anemia (FACT- An) general scale, FACT- An fatique scale, og Cancer Linear Analogue Scale (CLAS).
Functional Assessment of Cancer Therapy- Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
To andre, mindre, randomiserede placebokontrollerede undersøgelser viste ingen signifikant forbedring i livskvalitetsparametrene på skalaerne EORTC- QLQ- C30 og CLAS.
Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Erythropoietin er en vækstfaktor, som primært stimulerer produktionen af røde blodlegemer.
Erythropoietin is a growth factor that primarily stimulates red cell production.
Overlevelse og tumorprogression er undersøgt i fem store kontrollerede forsøg med i alt 2833 patienter, hvoraf fire var dobbeltblinde placebokontrollerede forsøg og et var et åbent forsøg.
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.
Forsøgene rekrutterede enten patienter, som var i behandling med kemoterapi (to forsøg) eller benyttede patientpopulationer, hvor erythropoiese- stimulerende stoffer ikke er indiceret: anæmi hos patienter med cancer, som ikke fik kemoterapi, og hoved - og halscancer hos patienter, som fik strålebehandling.
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.
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.
I de fire placebokontrollerede forsøg lå hazard ratio’ erne for samlet overlevelse imellem 1, 25 og 2, 47 til kontrolgruppens fordel.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Disse forsøg har vist en vedvarende uforklarlig statistisk signifikant overdødelighed hos patienter, som har anæmi i forbindelse med forskellige almindelige cancertyper, og som fik rekombinant humant erythropoietin sammenlignet med kontrolgrupper.
These studies have shown an consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Der er også foretaget en systematisk gennemgang af mere end 9000 cancerpatienter, som deltog i 57 kliniske forsøg.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Metaanalyse af data for samlet overlevelse gav et estimat af hazard ratio på 1, 08 til fordel for kontrolgruppen (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 undersøgelser og 8167 patienter).
0.99, 1,18; 42 trials and 8167 patients).
En øget relativ risiko for thromboemboliske hændelser (RR 1, 67, 95% konfidensinterval:
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
1, 35, 2, 06, 35 undersøgelser og 6769 patienter) sås hos patienter behandlet med rekombinant humant erythropoietin.
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Hvorvidt disse rater også gælder for administration af rekombinant humant erythropoietin 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.
13 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Intravenøs indgift
Intravenous route
Målinger af epoetin alfa efter gentagne intravenøse doser viser en halveringstid på omtrent 4 timer hos raske, frivillige forsøgspersoner samt en let forøget halveringstid på omtrent 5 timer hos patienter med nyresvigt.
Measurement of epoetin alfa following multiple dose intravenous administration revealed a half-life of approximately 4 hours in normal volunteers and a somewhat more prolonged half-life in renal failure patients, approximately 5 hours.
Hos børn er halveringstiden ca.
A half-life of approximately 6 hours has been reported in children.
6 timer.
Subcutaneous route
Subkutan indgift
Following subcutaneous injection, serum levels of epoetin alfa are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and
Serumværdierne øges langsomt og når deres maksimalværdi 12 til 18 timer efter injektionen.
13 18 hours postdose.
1/ 20 af værdien).
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
Der ses ingen akkumulation: niveauerne er de samme, hvadenten de bestemmes 24 timer efter den første injektion eller 24 timer efter den sidste injektion.
There 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.
Halveringstiden efter subkutan indgift er vanskelig at bestemme og er beregnet til omkring 24 timer.
The half-life is difficult to evaluate for the subcutaneous route and is estimated about 24 hours.
20%.
The bioavailability of subcutaneous injectable epoetin alfa is much lower than that of the intravenous medicinal product: approximately 20%.
Knoglemarvsfibrose er en kendt komplikation ved kronisk nyreinsufficiens hos mennesker, der kan relateres til sekundær hyperparathyroidisme eller ukendte faktorer.
In some preclinical toxicological studies in dogs and rats, but not in monkeys, epoetin alfa 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.
I et studie med hæmodialysepatienter, der blev behandlet med epoetin alfa i tre år, var forekomsten af knoglemarvsfibrose ikke højere end hos kontrolgruppens dialysepatienter, der ikke blev behandlet med epoetin alfa.
The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with epoetin alfa for 3 years compared to a matched control group of dialysis patients who had not been treated with epoetin alfa.).
20 gange den anbefalede ugentlige dosis til mennesker.
In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Disse ændringer fortolkes som sekundære til moderens nedsatte vægtøgning.
These changes are interpreted as being secondary to decreased maternal body weight gain.
I mutagenicitetstest af bakterie og pattedyrs cellekultur og en in vivo mikronukleus- test i mus viste epoetin alfa ingen ændringer.
Epoetin alfa did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Der er ikke udført langtids- karcinogenicitetsforsøg.
Long-term carcinogenicity studies have not been carried out.
Der er modstridende rapporter i litteraturen om, hvorvidt erythropoietiner kan spille en stor rolle som tumorproliferatorer.
There are conflicting reports in the literature regarding whether erythropoietins may play a major role as tumour proliferators.
Disse rapporter er baseret på in vitro- resultater fra humane tumorprøver, men det vides ikke med sikkerhed, om de er klinisk betydende.
These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Natriumdihydrogenphosphatdihydrat Dinatriumphosphatdihydrat Natriumchlorid Glycin Polysorbat 80 Vand til injektionsvæsker Saltsyre (til justering af pH- værdien) Natriumhydroxid (til justering af pH- værdien)
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Glycine Polysorbate 80 Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
14 6. 2 Uforligeligheder
6.2 Incompatibilities
Opbevares i køleskab og transporteres nedkølet (2°C – 8°C).
Store and transport refrigerated (2°C - 8°C).
I forbindelse med ambulant anvendelse kan patienten tage Abseamed ud af køleskabet og opbevare det under 25°C i én enkelt periode på op til 3 dage.
14 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Fyldte injektionssprøjter (type I- glas) med stempel (teflonbelagt gummi) og forseglet i en blisterpakning.
Pre-filled syringes (glass type I) with plunger (Teflon-faced rubber) sealed in a blister.
Sprøjterne indeholder 0, 5 ml (1000 IE) opløsning.
The syringes contain 0.5 ml (1000 IU) of solution.
Sprøjterne er påtrykt med delestreger og fyldningsvolumen er angivet med en klæbende mærkat, hvilket om nødvendigt muliggør delvis brug.
Syringes are embossed with graduation rings and the filling volume is indicated by a stick-on label in order to enable partial use if required.
Abseamed må ikke bruges,
Abseamed must not be used
- hvis opløsningen er uklar eller indeholder partikler
- if the solution is cloudy or there are particles in it.
- hvis forseglingen er brudt
- if the seal is broken.
- hvis opløsningen utilsigtet har været nedfrosset
- if the solution has been accidentally frozen.
Dosering og indgivelsesmåde).
The pre-filled syringes are ready to use (see section 4.2 – Method of administration).
Efter indsprøjtning af den nødvendige mængde opløsning fra den fyldte injektionssprøjte, skal resterende indhold bortskaffes.
After injection of the necessary amount of the solution from the pre-filled syringe, discard any remaining contents.
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D- 58638 Iserlohn Tyskland
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn
Abseamed 2000 IE/ 1 ml injektionsvæske, opløsning i en fyldt injektionssprøjte.
Abseamed 2000 IU/ 1 ml solution for injection in a pre-filled syringe
1 fyldt injektionssprøjte med 1 ml indeholder 2000 IE, svarende til 16, 8 mikrogram epoetin alfa.
Each ml of solution contains 2000 IU of epoetin alfa* corresponding to 16.8 micrograms per ml 1 pre-filled syringe of 1 ml contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa
17 Dosering
16 Posology
18 Korrigeringsfasen 50 IE/ kg intravenøst 3 gange ugentligt.
50 IU/ kg 3 times per week by the intravenous route.
Hæmoglobinvariabiliteten bør behandles via dosishåndtering under hensyntagen til det tilstræbte 19 hæmoglobinniveau 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).
Retningslinjer for, hvornår korrekt dosisjustering overholdes ved hæmoglobinværdier som overstiger 12 g/ dl (7, 5 mmol/ l), er beskrevet nedenfor.
18 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
20 150 IE/ kg 3 gange ugentligt eller 450 IE/ kg 1 gang ugentligt
19 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
21 Den anbefalede dosis er 600 IE/ kg epoetin alfa 1 gang om ugen i 3 uger (på dag ÷21, ÷14 og ÷7) forud for operationsdagen samt på selve operationsdagen (dag 0).
20 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
22 det er svært at regulere bør epoetin alfa anvendes med forsigtighed.
21 or poorly controllable hypertension.
23 Hæmoglobinniveauerne bør kontrolleres regelmæssigt, indtil et stabilt niveau er opnået og derefter periodevist.
Haemoglobin levels should be measured on a regular basis until a stable level is achieved and periodically thereafter.
1 g/ dl (0, 62 mmol/ l) pr. måned og bør ikke overstige 2 g/ dl (1, 25 mmol/ l) pr. måned.
22 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
24 Patienter, der er planlagt til større ortopædkirurgisk operation
23 Patients scheduled for major elective orthopaedic surgery
25 Som følge heraf:
Consequently:
26 Voksne cancerpatienter med symptomatisk anæmi, der behandles med kemoterapi:
Adult cancer patients with symptomatic anaemia receiving chemotherapy
4. 4 og 4. 8 - Generelt) hos patienter, der får erythropoietiske midler.
25 An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
27 I kulturer af humane knoglemarvsceller er det påvist, at epoetin alfa specifikt stimulerer erythropoiesen og ikke påvirker leukopoiesen.
It could be shown with the aid of cell cultures of human bone marrow cells that epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
721 patienter, der blev behandlet med ikke- platinbaseret kemoterapi blev medregnet i tre placebokontrollerede undersøgelser, heraf 389 patienter med hæmatologiske maligniteter (221 myelomatose, 144 non- Hodgkin’ s lymfom og 24 andre hæmatologiske maligniteter) og 332 med alvorlige tumorer (172 bryst, 64 gynækologiske, 23 lunge, 22 prostata, 21 gastrointestinale og 30 andre tumortyper).
26 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
28 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Serumværdierne øges langsomt og når deres maksimalværdi 12 til 18 timer efter injektionen.
27 18 hours postdose.
29 6. 2 Uforligeligheder
6.2 Incompatibilities