natgillin/translations-raw huggingface dataset:
1 fyldt injektionssprøjte med 0, 5 ml injektionsvæske, opløsning indeholder 20000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 0.5 ml solution for injection contains 20000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Opløsningen indeholder 40000 IU Epoetin zeta pr. ml.
The solution contains 40000 IU Epoetin zeta per ml.
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.
− 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.
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).
106 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).
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).
107 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).
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
108 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.
118 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
109 Method of administration
119 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
120 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.
111 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Ligesom med alle andre vækstfaktorer kan man frygte, at epoetiner kunne stimulere væksten af enhver type malign tumor.. 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.
As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy.
Flere kontrollerede kliniske forsøg, hvor epoetiner blev givet til patienter med en række forskellige almindelige tumorer, herunder planocellulær cancer i hoved og hals, lungecancer og brystcancer, har vist en uforklarlig overdødelighed.
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 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
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
121 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),
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.
112 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.
113 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
123 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.
114 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.
115 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.
125 Glycin Leucin Isoleucin Treonin Glutaminsyre Fenylalanin Vand til injektioner Natriumhydroxid (til justering af pH- værdien) Saltsyre (til justering af pH- værdien)
116 Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Hver pakning indeholder 1 eller 4 eller 6 fyldt injektionssprøjter.
Each pack contains 1 or 4 or 6 pre-filled syringes.
126 Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
117 Any unused product or waste material should be disposed of in accordance with local requirements.
Retacrit 30000 IU/ 0, 75 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 30000 IU/ 0.75ml solution for injection in pre-filled syringe
1 fyldt injektionssprøjte med 0, 75 ml injektionsvæske, opløsning indeholder 30000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Hver fyldt injektionssprøjte indeholder 0, 38 mg fenylalanin
Each pre-filled syringe contains 0.38 mg phenylalanine.
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).
119 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).
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).
120 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).
Den anbefalede dosis er angivet i følgende diagram:
121 The recommended dosing regimen is described in the following diagram:
132 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
122 Method of administration
133 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
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
134 anbefales der regelmæssig monitorering af reticulocyttal Hyperkalæmi er observeret i isolerede tilfælde.
Hyperkalaemia has been observed in isolated cases.
Serumelektrolytter skal monitoreres hos patienter med kronisk nyresvigt.
124 electrolytes should be monitored in chronic renal failure patients.
kortere samlet overlevelse og flere dødsfald, som tilskrives sygdomsprogression ved 4 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),
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
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.
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), 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.
I lyset af ovenstående er blodtransfusion i nogle kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
125 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.
136 cerebrovaskulær hændelse (cerebral blødning og cerebral infarkt), forbigående iskæmiske anfald, dyb venetrombose, arterietrombose, pulmonal emboli, aneurismer, retinal trombose samt tilstopning af en kunstig nyre hos patienter, der får erythropoietiske midler.
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.
Antistofforårsaget erytroblastopeni (PRCA) er blevet rapporteret efter måneder til års behandling med epoetin alfa.
126 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
137 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.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the
Hvorvidt disse rater også gælder for administration af rekombinant humant erytropoietin til patienter med cancer, som behandles med kemoterapi, for at opnå hæmoglobinkoncentrationer på mindre end 13 g/ dl, er uklart, fordi der i de gennemgåede data kun var få patienter med disse karakteristika.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Dinatriumfosfat- dihydrat Natriumdihydrogenfosfat- dihydrat Natriumklorid
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine
139 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)
129 Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Hver fyldt injektionssprøjte indeholder 0, 75 ml injektionsvæske, opløsning.
Each pre-filled syringe contains 0.75 ml solution for injection.
140 Dette medicinske produkt er kun til engangsbrug.
This medicinal product is for single use only.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
130 Any unused product or waste material should be disposed of in accordance with local requirements.
Retacrit 40000 IU/ 1, 0 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Retacrit 40000 IU/ 1.0ml solution for injection in pre-filled syringe
1 fyldt injektionssprøjte med 1, 0 ml injektionsvæske, opløsning indeholder 40000 internationale enheder (IU) epoetin zeta * (rekombinant humant erytropoietin).
1 pre-filled syringe with 1.0 ml solution for injection contains 40000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Det er nødvendigt, at en læge bedømmer den individuelle patients kliniske forløb og tilstand.
132 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.
Dosis (IU/ kg 3 gange ugentligt)
Dose (IU/ kg given 3x week)
Vægt (kg) < 10 10- 30 > 30
Weight (kg )< 10 10-30 > 30
Median 100 75 33
Median 100 75 33
Sædvanlig vedligeholdelsesdosis 75- 150 60- 150 30- 100
Usual maintenance dose 75-150 60-150 30-100
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
133 Adult patients on peritoneal dialysis The treatment is divided into two stages:
144 Hvis hæmoglobinet er steget med mindst 1 g/ dl (0, 62 mmol/ l), eller reticulocyttællingen er steget til ≥ 40. 000 celler/ µl over baseline efter 4 ugers behandling, bør der fortsættes med dosis på 150 IU/ kg 3 gange om ugen eller 450 IU/ kg 1 gang ugentligt.
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
134 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.
146 usammensat jern oralt dagligt) under hele behandlingen.
200 mg oral elemental iron daily) throughout the course of treatment.
Indgivelsesmåde
135 Method of administration
147 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
Hos patienter med kronisk nyerinsufficiens bør koncentrationen til vedligeholdelse af hæmoglobinniveauet ikke overstige den øvre grænse for den tilstræbte hæmoglobinkoncentration, som anbefales i afsnit 4. 2.
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously. 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.
148 anbefales der regelmæssig monitorering af reticulocyttal 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.
137 potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
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),
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), 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.
I lyset af ovenstående er blodtransfusion i nogle kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
138 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.
150 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 kunstig nyre hos patienter, der får erythropoietiske midler.
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.
Antistofforårsaget erytroblastopeni (PRCA) er blevet rapporteret efter måneder til års behandling med epoetin alfa.
139 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
151 Erytropoietin er et glykoprotein, der som mitosestimulerende faktor og differentierende hormon stimulerer dannelsen af erytrocytter ved at stimulere forstadier i knoglemarven.
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.
Erytropoietins biologiske effektivitet er påvist hos forskellige forsøgsdyr in vivo (normale og anæmiske rotter, polycytæmiske mus).
140 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
152 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.
Dinatriumfosfat- dihydrat
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine
153 Natriumdihydrogenfosfat- dihydrat Natriumklorid 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)
142 Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Retacrit må ikke bruges, hvis • blisterpakningens forsegling er brudt, eller blisterpakningen på nogen måde er beskadiget • væsken har farve, eller man kan se partikler flyde omkring i den • Der er sivet væske ud af den fyldte sprøjte, eller der er synlig kondens indeni den forseglede blisterpakning
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
155 BILAG II
144 ANNEX II
Norbitec GmbH Pinnauallee 4 D- 25436 Uetersen Tyskland
Norbitec GmbH Pinnauallee 4 D-25436 Uetersen Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Tyskland
STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
Produktresumé; pkt 4. 2).
Summary of Product Characteristics, section 4.2)