natgillin/translations-raw huggingface dataset:
Methoxypolyethylenglycol- epoetin betas farmakokinetik blev undersøgt hos raske frivillige og hos anæmiske patienter med kronisk nyreinsufficiens, inklusive patienter med og uden dialyse.
The pharmacokinetics of methoxy polyethylene glycol-epetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
7 Efter subkutan administration til kronisk nyreinsufficiente patienter, som ikke var i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 95 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Den absolutte biotilgængelighed af methoxypolyethylenglycol - epoetin beta efter subkutan administration var 54%.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Efter subkutan administration til patienter med kronisk nyreinsufficiens i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 72 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Den observerede, terminale eliminationshalveringstid var 139 timer hos patienter med kronisk nyreinsufficiens i dialyse.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Efter intravenøs administration til kronisk nyreinsufficiente patienter i dialyse var den totale systemiske clearance 0, 494 ml/ time/ kg.
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/ h per kg.
Eliminationshalveringstiden efter intravenøs administration af methoxypolyethylenglycol- epoetin beta er 134 timer.
The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
En sammenligning af serumkoncentrationerne af methoxypolyethylenglycol- epoetin beta hos 41 patienter med kronisk nyreinsufficiens, bestemt før og efter hæmodialyse, viste at hæmodialyse ingen effekt har på farmakokinetikken af dette lægemiddel.
7 A comparison of serum concentrations of methoxy polyethylene glycol-epetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Analyse af 126 patienter med kronisk nyreinsufficiens viste ingen farmakokinetisk forskel mellem patienter i dialyse og patienter, som ikke var i dialyse.
An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis and patients not on dialysis.
4. 2).
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Methoxypolyethylenglycol- epoetin betas carcinogene potentiale er ikke undersøgt i langtidsdyreforsøg.
The carcinogenic potential of methoxy polyethylene glycol-epetin beta has not been evaluated in long- term animal studies.
Det inducerede ikke et proliferativt respons i non- hæmatologiske tumorcellelinier in vitro.
It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
I et 6- måneders toksicitetsstudie hos rotter blev der ikke observeret tumorigent eller uventet mitogent respons i non- hæmatologisk væv.
In a six-month rat toxicity study no tumorigenic or unexpected mitogenic responses were observed in non-haematological tissues.
Endvidere blev in vitro bindingen af methoxypolyethylenglycol- epoetin beta undersøgt i et panel af humane vævstyper, og den blev kun observeret hos målceller (progenitorceller i knoglemarven).
In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epetin beta was only observed in target cells (bone marrow progenitor cells).
Der observeredes ingen signifikant passage af methoxypolyethylenglycol- epoetin beta over placenta hos rotter, og dyreforsøg har ikke vist skadelige virkninger på graviditet, embryoets/ fostrets udvikling, fødslen eller den postnatale udvikling.
No significant placental transfer of methoxy polyethylene glycol-epetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Den fysiske, kognitive eller seksuelle udvikling hos afkom af moderdyr, der fik methoxypolyethylenglycol- epoetin beta under drægtighed og diegivning, blev ikke påvirket.
Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epetin beta during gestation and lactation were not affected.
Når methoxypolyethylenglycol- epoetin beta blev administreret subkutant til han - og hunrotter før og under parring, blev parametre til vurdering af forplantningsevne, fertilitet og sæd ikke påvirket.
When methoxy polyethylene glycol-epetin beta was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Natriumdihydrogenphosphatmonohydrat Natriumsulfat Mannitol (E421) Methionin Poloxamer 188 Vand til injektionsvæsker
Sodium dihydrogen phosphate monohydrate Sodium sulphate Mannitol (E421) Methionine Poloxamer 188 Water for injections
Må ikke nedfryses.
Store in a refrigerator (2°C – 8°C) Do not freeze
Den sidste bruger må tage lægemidlet ud af køleskabet og opbevare det ved stuetemperatur i en måned, dog ikke over 25º C.
8 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Hætteglas (type I glas) med grå, lamineret hætte (brombutylgummi) og afrivningslåg (aluminium og polypropylen- plastik).
Vial (type I glass) with grey laminated stopper (bromobutyl rubber material) and flip-off cap (aluminium and polypropylene plastic material).
Fås i en pakning med 1 hætteglas.
Pack size of 1.
Det sterile hætteglas indeholder ikke konserveringsmidler og må kun anvendes til en enkelt injektion.
The sterile vial does not contain any preservative and is to be used for a single injection only.
Der må kun gives en dosis fra hvert hætteglas.
Only one dose should be administered per vial.
Der må kun injiceres klare, farveløse til let gullige opløsninger, som er fri for synlige partikler.
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Lad hætteglasset opnå stuetemperatur før injiceringen.
Allow the vial to reach room temperature before injecting.
23. januar 2009
23 January 2009
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
MIRCERA 100 mikrogram/ ml, injektionsvæske, opløsning
MIRCERA 100 micrograms/ ml solution for injection
1 ml (et hætteglas) indeholder 100 mikrogram methoxypolyethylenglycol- epoetin beta *.
1 ml (one vial) contains 100 micrograms of methoxy polyethylene glycol-epoetin beta*.
* protein, som fremstilles ved rekombinant DNA- teknologi i ovarieceller fra kinesisk hamster og konjugeres kovalent til et lineært methoxypolyethylenglycol (PEG).
* Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
11 Patienter bør nøje monitoreres for at sikre, at den lavest godkendte dosis MIRCERA anvendes til at sørge for tilstrækkelig kontrol af de anæmiske symptomer.
10 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
Når der er nået en hæmoglobinkoncentration på over 10 g/ dl (6, 21 mmol/ l) for den enkelte patient, kan MIRCERA administreres én gang månedlig i en dosis, som er dobbelt så stor som den dosis, der tidligere blev givet hver 2. uge.
If the haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every- two-weeks dose.
Patienter, som i øjeblikket er i behandling med et ESA, kan omstilles til MIRCERA administreret én gang månedlig som en intravenøs eller subkutan injektion.
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Startdosis af methoxypolyethylenglycol - epoetin beta baseres på den tidligere beregnede ugentlige dosis af darbepoetin alfa eller epoetin på tidspunktet for udskiftningen, som beskrevet i tabel 1.
The starting dose of methoxy polyethylene glycol- epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Det er derfor nødvendigt med regelmæssig hæmoglobinkontrol og streng overholdelse af vejledningen for justering af dosis hos denne patientgruppe.
11 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
5. 2).
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairmented patients (see section 5.2).
Tilstødende infektioner, inflammatoriske eller traumatiske episoder, okkult blodtab, hæmolyse, svær aluminium toksicitet, underliggende hæmatologiske sygdomme eller knoglemarvsfibrose kan også kompromittere det erythropoietiske respons.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
13 Hæmoglobinkoncentration:
Haemoglobin concentration:
Blodtrykskontrol:
12 Blood pressure monitoring:
To kontrollerede, kliniske studier, i hvilke epoetiner blev administreret til patienter med forskellige kræfttyper, inklusive hoved- halskræft og brystkræft, viste en uforklaret, øget mortalitet.
Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Misbrug af MIRCERA hos raske mennesker kan medføre overdreven stigning i hæmoglobin.
Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin.
14 4. 8 Bivirkninger
4.8 Undesirable effects
Sikkerhedsdatabasen fra de kliniske studier omfatter 2737 patienter med kronisk nyreinsufficiens, inklusive 1789 patienter behandlet med MIRCERA og 948 behandlet med et andet ESA.
The safety data base from clinical trials comprised 2’ 737 CKD patients, including 1’ 789 patients treated with MIRCERA and 948 with another ESA.
Tabel 2:
13 Table 2:
Hud og subkutane væv Traumer, forgiftninger og behandlingskomplikationer
Skin and subcutaneous tissue disorders
Sjælden Ikke almindelig
Rare
Makulo- papuløst udslæt Trombose efter anlæggelse af karadgang
Injury, poisoning and procedural complications
15 MIRCERA stimulerer erythropoiesen ved interaktion med erythropoietinreceptoren på progenitorceller i knoglemarven.
MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
Som primær vækstfaktor for erythroid udvikling dannes det naturlige hormon erythropoietin i nyrerne og udskilles i blodet som respons på hypoxi.
As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.
Data fra korrektionsstudier viser at hæmoglobin responsraterne i MIRCERA armen var høje (93, 3% og 97, 5% i studier med patienter henholdsvis i dialyse og ikke i dialyse) sammenlignet med komparator (henholdsvis 91, 3% og 96, 3%).
14 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Der er udført fire randomiserede, kontrollerede studier med dialysepatienter, som ved studiestart blev behandlet med enten darbepoetin alfa eller epoetin.
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetinat the time of enrollment.
To af studierne rekruterede patienter, som var i kemoterapibehandling.
Two of the studies recruited patients who were being treated with chemotherapy.
Methoxypolyethylenglycol- epoetin betas farmakokinetik blev undersøgt hos raske frivillige og hos anæmiske patienter med kronisk nyreinsufficiens, inklusive patienter med og uden dialyse.
The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Efter subkutan administration til patienter med kronisk nyreinsufficiens, som ikke var i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 95 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Den observerede terminale eliminationshalveringstid var 142 timer hos kronisk nyreinsufficiens- patienter, som ikke var i dialyse.
The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
16 Efter subkutan administration til patienter med kronisk nyreinsufficiens i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 72 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Den observerede terminale eliminationshalveringstid var 139 timer hos kronisk nyreinsufficiente patienter i dialyse.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Efter intravenøs administration til patienter med kronisk nyreinsufficiens i dialyse var den totale systemiske clearance 0, 494 ml/ time/ kg.
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/ h per kg.
En sammenligning af serumkoncentrationerne af methoxypolyethylenglycol- epoetin beta hos 41 kronisk nyreinsufficiente patienter, bestemt før og efter hæmodialyse, viste at hæmodialyse ingen effekt har på farmakokinetikken af dette lægemiddel.
15 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
4. 2).
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Methoxypolyethylenglycol- epoetin betas carcinogene potentiale er ikke undersøgt i langtidsdyreforsøg.
The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Endvidere blev in vitro bindingen af methoxypolyethylenglycol- epoetin beta undersøgt i et panel af humane vævstyper, og den blev kun observeret hos målceller (progenitorceller i knoglemarven).
In addition, using a panel of human tissues, the in vitro binding of methoxy polyethylene glycol-epoetin beta was only observed in target cells (bone marrow progenitor cells).
Der observeredes ingen signifikant passage af methoxypolyethylenglycol- epoetin beta over placenta hos rotter, og dyreforsøg har ikke vist skadelige virkninger på graviditet, embryoets/ fostrets udvikling, fødslen eller den postnatale udvikling.
No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Den fysiske, kognitive eller seksuelle udvikling hos afkom af moderdyr, der fik methoxypolyethylenglycol- epoetin beta under drægtighed og diegivning, blev ikke påvirket.
Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
Når methoxypolyethylenglycol- epoetin beta blev administreret subkutant til han - og hunrotter før og under parring, blev parametre til vurdering af forplantningsevne, fertilitet og sæd ikke påvirket.
When methoxy polyethylene glycol-epoetin beta was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Opbevares i køleskab (2º C - 8º C) Må ikke nedfryses Opbevar hætteglasset i den ydre pakning for at beskytte mod lys Den sidste bruger må tage lægemidlet ud af køleskabet og opbevare det ved stuetemperatur i en måned, dog ikke over 25º C.
16 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
MIRCERA 200 mikrogram/ ml, injektionsvæske, opløsning
MIRCERA 200 micrograms/ ml solution for injection
1 ml (et hætteglas) indeholder 200 mikrogram methoxypolyethylenglycol- epoetin beta *.
1 ml (one vial) contains 200 micrograms of methoxy polyethylene glycol-epoetin beta*.
Styrken angiver mængden af proteinindholdet i methoxypolyethylenglycol- epoetin beta- molekylet uden hensyn til glycosyleringen.
The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
For yderligere informationer se pkt 5. 1.
For more information, see section 5.1.
Behandling af symptomatisk anæmi hos voksne patienter med kronisk nyreinsufficiens Behandling med Mircera skal påbegyndes under supervision af en læge med erfaring med behandling af patienter med kronisk nyreinsufficiens.
Treatment of symptomatic anaemia in adult chronic kidney disease patients Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
20 Patienter bør nøje monitoreres for at sikre, at den lavest godkendte dosis MIRCERA anvendes til at sørge for tilstrækkelig kontrol af de anæmiske symptomer
18 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
Når der er nået en hæmoglobinkoncentration på over 10 g/ dl (6, 21 mmol/ l) for den enkelte patient, kan Mircera administreres én gang månedlig i en dosis, som er dobbelt så stor som den dosis, der tidligere blev givet hver 2. uge.
If the haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every- two-weeks dose.
0. 35 g/ dl (0, 22 mmol/ l) pr. uge.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
Det er derfor nødvendigt med regelmæssig hæmoglobinkontrol og streng overholdelse af vejledningen for justering af dosis hos denne patientgruppe.
19 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
22 Hæmoglobinkoncentration:
Haemoglobin concentration:
I kliniske studier blev der observeret en øget risiko for dødsfald og alvorlige cardiovaskulære hændelser, når erythropoietinstimulerende stoffer (ESAs) blev administreret for at opnå en hæmoglobinkoncentration over 12 g/ dl (7, 45 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 12g/ dl (7.5 mmol/ l).
Blodtrykskontrol:
20 Blood pressure monitoring:
23 4. 8 Bivirkninger
4.8 Undesirable effects
Tabel 2:
21 Table 2:
En overdosis kan medføre manifestationer på en overdreven farmakodynamisk virkning, fx overdreven erythropoiese.
Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e. g. excessive erythropoiesis.
24 MIRCERA stimulerer erythropoiesen ved interaktion med erythropoietinreceptoren på progenitorceller i knoglemarven.
MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
Data fra korrektionsstudier viser at hæmoglobin responsraterne i MIRCERA armen var høje (93, 3% og 97, 5% i studier med patienter henholdsvis i dialyse og ikke i dialyse) sammenlignet med komparator (henholdsvis 91, 3% og 96, 3%).
22 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
I det ublindede studiet var der ingen forskel på total ovelevelse for patienter, der blev behandlet med rekombinant human erythropoietin og kontrolgruppen.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Det er uklart i hvilket omfang disse resultater også kan forbindes med administration af rekombinant human erythropoietin til patienter med cancer, som bliver behandlet med kemoterapi for at opnå hæmoglobin koncentrationer på mindre end 13 g/ dl, fordi få patienter med disse karakteristika var inkluderet i de gennemgåede data.
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.
Efter subkutan administration til kronisk nyreinsufficiente patienter, som ikke var i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 95 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) after administration.
Den observerede terminale eliminationshalveringstid var 142 timer hos patienter med kronisk nyreinsufficiens, som ikke var i dialyse.
The observed terminal elimination half-life was 142 hours in CKD patients not on dialysis.
25 Efter subkutan administration til kronisk nyreinsufficiente patienter i dialyse, observeredes de maksimale serumkoncentrationer af methoxypolyethylenglycol- epoetin beta 72 timer (median) efter administrationen.
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Den observerede terminale eliminationshalveringstid var 139 timer hos patienter med kronisk nyreinsufficiens i dialyse.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.