natgillin/translations-raw huggingface dataset:
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).
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).
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
55 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
56 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.
62 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
57 Method of administration
63 erytropoietin skal det sikres, at der er tilstrækkelige jerndepoter. − 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%.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose
64 Hyperkalæmi er observeret i isolerede tilfælde.
Hyperkalaemia has been observed in isolated cases.
Hvis der observeres forhøjet (eller stigende) serum- kaliumniveau, skal det overvejes at ophøre med administrationen af erytropoietin, indtil hyperkalæmien er korrigeret.
59 potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
I adskillige kontrollerede studier er det ikke påvist at Epoetin kan forbedre den overordnede overlevelse eller mindske risikoen for tumorprogression hos patienter med cancerrelateret anæmi..
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
I lyset af ovenstående er blodtransfusion i nogle kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
60 In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Antistofforårsaget erytroblastopeni (PRCA) er blevet rapporteret efter måneder til års behandling med epoetin alfa.
61 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
67 Erytropoietins tilsyneladende molekylvægt er 32000- 40000 Dalton.
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Erytropoietins biologiske effektivitet er påvist hos forskellige forsøgsdyr in vivo (normale og anæmiske rotter, polycytæmiske mus).
62 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
5. 2 Farmakokinetiske egenskaber
63 5.2 Pharmacokinetic properties
69 Kalciumklorid- dihydrat Polysorbat 20 Glycin Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
64 Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Hver fyldt injektionssprøjte indeholder 0, 5 ml injektionsvæske, opløsning.
Each pre-filled syringe contains 0.5 ml solution for injection.
70 Må ikke rystes.
Do not shake.
EU/ 1 / 07/ 431/ 009 EU/ 1 / 07/ 431/ 010
MARKETING AUTHORISATION NUMBER(S) EU/ 1/ 07/ 431/ 009 EU/ 1/ 07/ 431/ 010
Retacrit 6000 IU/ 0, 6 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 6000 IU/ 0.6ml solution for injection in pre-filled syringe
1 fyldt injektionssprøjte med 0, 6 ml injektionsvæske, opløsning indeholder 6000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 0.6 ml solution for injection contains 6000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Opløsningen indeholder 10000 IU Epoetin zeta pr. ml.
The solution contains 10000 IU Epoetin zeta per ml. *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
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).
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).
Det er nødvendigt, at en læge bedømmer den individuelle patients kliniske forløb og tilstand.
67 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
68 Adult patients on peritoneal dialysis The treatment is divided into two stages:
74 (< 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.
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
69 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.
76 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
70 Method of administration
77 erytropoietin skal det sikres, at der er tilstrækkelige jerndepoter. − 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%.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose
78 Hyperkalæmi er observeret i isolerede tilfælde.
Hyperkalaemia has been observed in isolated cases.
Ordineringen af dialyse skal måske justeres periodisk for at holde urinstof -, kreatinin - og kalium- niveauerne indenfor det ønskede område.
72 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
79 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),
73 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.
Der er sjældne rapporter om overfølsomhedsreaktioner i forbindelse med epoetin alfa, herunder enkeltstående tilfælde af angioødemer og anafylaktiske reaktioner.
74 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
81 Erytropoietins tilsyneladende molekylvægt er 32000- 40000 Dalton.
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
De fire kulhydratkæder er bundet til proteinet via tre N- glykosidbindinger og en O- glykosidbinding.
75 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Metaanalyse af data for samlet overlevelse gav et estimat af hazard ratio på 1, 08 til
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
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.
76 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.
Dinatriumfosfat- dihydrat Natriumdihydrogenfosfat- dihydrat Natriumklorid Kalciumklorid- dihydrat Polysorbat 20
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine
83 Glycin Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
77 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
84 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1 / 07/ 431/ 011 EU/ 1 / 07/ 431/ 012
MARKETING AUTHORISATION NUMBER(S) EU/ 1/ 07/ 431/ 011 EU/ 1/ 07/ 431/ 012
Retacrit 8000 IU/ 0, 8 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 8000 IU/ 0.8ml solution for injection in pre-filled syringe
1 fyldt injektionssprøjte med 0, 8 ml injektionsvæske, opløsning indeholder 8000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 0.8 ml solution for injection contains 8000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Hver fyldt injektionssprøjte indeholder 0, 40 mg fenylalanin
Each pre-filled syringe contains 0.40 mg phenylalanine.
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). − Retacrit kan anvendes til at øge udbyttet af autologt blod fra patienterne i et prædonationsprogram.
4.1 Therapeutic indications − 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). − Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme.
86 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).
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).
Det er nødvendigt, at en læge bedømmer den individuelle patients kliniske forløb og tilstand.
80 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
81 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
82 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.
90 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
83 Method of administration
91 erytropoietin skal det sikres, at der er tilstrækkelige jerndepoter. − 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%.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose
92 Hyperkalæmi er observeret i isolerede tilfælde.
Hyperkalaemia has been observed in isolated cases.
Ordineringen af dialyse skal måske justeres periodisk for at holde urinstof -, kreatinin - og kalium- niveauerne indenfor det ønskede område.
85 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
93 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),
86 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.
Der er sjældne rapporter om overfølsomhedsreaktioner i forbindelse med epoetin alfa, herunder enkeltstående tilfælde af angioødemer og anafylaktiske reaktioner.
87 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
95 Erytropoietins tilsyneladende molekylvægt er 32000- 40000 Dalton.
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
De fire kulhydratkæder er bundet til proteinet via tre N- glykosidbindinger og en O- glykosidbinding.
88 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
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.
89 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.
97 Polysorbat 20 Glycin Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
90 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Hver fyldt injektionssprøjte indeholder 0, 8 ml injektionsvæske, opløsning.
Each pre-filled syringe contains 0.8 ml solution for injection.
98 Må ikke rystes.
Do not shake.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
91 Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1 / 07/ 431/ 013 EU/ 1 / 07/ 431/ 014
MARKETING AUTHORISATION NUMBER(S) EU/ 1/ 07/ 431/ 013 EU/ 1/ 07/ 431/ 014
Retacrit 10000 IU/ 1, 0 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 10000 IU/ 1.0ml solution for injection in pre-filled syringe
1 fyldt injektionssprøjte med 1, 0 ml injektionsvæske, opløsning indeholder 10000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 1.0 ml solution for injection contains 10000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Hver fyldt injektionssprøjte indeholder 0, 50 mg fenylalanin
Each pre-filled syringe contains 0.50 mg phenylalanine.
Det er nødvendigt, at en læge bedømmer den individuelle patients kliniske forløb og tilstand.
93 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
94 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
95 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.
104 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
96 Method of administration
105 erytropoietin skal det sikres, at der er tilstrækkelige jerndepoter. − 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%.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose
For at detektere en eventuel forekomst af manglende effektivitet hos patienter med kronisk nyresvigt anbefales der regelmæssig monitorering af reticulocyttal Hyperkalæmi er observeret i isolerede tilfælde.
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
Hos patienter med kronisk nyresvigt kan korrektion af
Hyperkalaemia has been observed in isolated cases.
106 blodmangel medføre øget appetit og indtag af kalium og protein.
Dialysis prescriptions may
Ordineringen af dialyse skal måske justeres periodisk for at holde urinstof -, kreatinin - og kalium- niveauerne indenfor det ønskede område.
98 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
I kontrollerede kliniske forsøg har brug af epoetin alfa og andre erytropoiese- stimulerende stoffer (ESA' er) vist: • kortere tid til tumorprogression hos patienter med fremskreden hoved - og halscancer, som får strålebehandling, når stofferne administreres for at tilstræbe et hæmoglobinniveau, som er højere end 14 g/ dl (8, 7 mmol/ l), • kortere samlet overlevelse og flere dødsfald, som tilskrives sygdomsprogression ved 4 måneder hos patienter med metastatisk brystcancer, som får kemoterapi, når stofferne gives
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l),
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.
99 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.
Der er rapporteret om trombotiske/ vaskulære hændelser, f. eks. myokardieiskæmi, myokardieinfarkt, cerebrovaskulær hændelse (cerebral blødning og cerebral infarkt), forbigående iskæmiske anfald, dyb venetrombose, arterietrombose, pulmonal emboli, aneurismer, retinal trombose samt tilstopning af en
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.
100 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Erytropoietins tilsyneladende molekylvægt er 32000- 40000 Dalton.
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
De fire kulhydratkæder er bundet til proteinet via tre N- glykosidbindinger og en O- glykosidbinding.
101 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
En
0.99, 1,18; 42 trials and 8167 patients).
110 øget relativ risiko for thromboemboliske hændelser (RR 1, 67, 95% konfidensinterval:
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
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.
102 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.
Dinatriumfosfat- dihydrat Natriumdihydrogenfosfat- dihydrat Natriumklorid Kalciumklorid- dihydrat Polysorbat 20 Glycin
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine
111 Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
103 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Hver fyldt injektionssprøjte indeholder 1, 0 ml injektionsvæske, opløsning.
Each pre-filled syringe contains 1.0 ml solution for injection.
112 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
104 Any unused product or waste material should be disposed of in accordance with local requirements.
EU/ 1 / 07/ 431/ 015 EU/ 1 / 07/ 431/ 016
MARKETING AUTHORISATION NUMBER(S) EU/ 1/ 07/ 431/ 015 EU/ 1/ 07/ 431/ 016
Retacrit 20000 IU/ 0, 5 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 20000 IU/ 0.5ml solution for injection in pre-filled syringe