natgillin/translations-raw huggingface dataset:
Ved det 1. år efter transplantationen var 14 af 216 patienter (6,5%), som fik Zenapax og 4 af 207 patienter (1,9%), som fik placebo døde af en infektion; en forskel på 4,6% (95% CI: 0,3%, 8,8%).
At 1 year post-transplant 14 of 216 patients (6.5%) who received Zenapax and 4 of 207 (1.9%) patients who received placebo died of an infection, a difference of 4.6% (95% CI: 0.3%, 8.8%).
Der er ingen farmakokinetisk interaktion mellem Zenapax og mycophenolsyre, mycophenolatmofetils aktive metabolit (CellCept).
There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
Daclizumab bindes til et antigen som ligger på overfladen af specielle hvide blodlegemer, T-lymfocytter.
Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes.
Ialt havde 16% (10 af 64 patienter) af placebo behandlede og 32% (28 af 88 patienter) af Zenapax behandlede patienter høje fastende blodsukker værdier.
A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
En af 18 aber fik en anafylaktisk reaktion efter daclizumab.
One of 18 monkeys had an anaphylactic reaction to daclizumab.
Hyperglycæmi: Der observeredes ingen forskelle i abnorme hæmatologiske eller klinisk-kemiske laboratorieprøve resultater mellem placebo behandlede og Zenapax behandlede grupper med undtagelse af fastende blodsukker.
Hyperglycaemia: No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose.
Hvis fortyndingen er sket aseptisk kan infusionsvæsken opbevares i 24 timer i køleskab ved 2 °C - 8 °C eller i 4 timer ved 25 °C.
If diluted aseptically it may be stored for 24 hours when refrigerated between 2 °C - 8 °C or for 4 hours at 25 °C.
Et præklinisk reproduktionstoxicitetsstudie med daclizumab har vist en øget risiko for tidlig prænatal død hos cynomolgusaber i forhold til placebo.
A non-clinical reproduction toxicity study with daclizumab has shown an increased risk of early prenatal loss in cynomolgus monkeys compared to placebo.
Det anbefalede daclizumabregime vil opretholde serumkoncentrationer som hos de fleste patienter er tilstrækkelige til at mætte IL-2R alfareceptorer på aktiverede T-lymfocytter i mere end 90 dage efter transplantationen.
The recommended regimen of daclizumab will maintain serum concentrations sufficient to saturate IL-2R alpha receptors on activated T lymphocytes for more than 90 days post transplantation in the majority of patients.
Incidens af maligniteter: Tre år efter behandling var incidensen af maligniteter 7,8% i placebogruppen sammenlignet med 6,4% i Zenapaxgruppen.
Incidence of malignancies: Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group.
Daclizumab binder sig med høj specificitet til alfa- eller Tac subdelen af højaffinitets IL-2 receptorkomplekset (udtrykt på aktiverede T celler) og hæmmer IL-2 bindingen og den biologiske aktivitet.
Daclizumab binds with high specificity to the alpha or Tac subunit of the high affinity IL-2 receptor complex (expressed on activated T cells), and inhibits IL-2 binding and biological activity.
Opløsningen blandes ved at vende posen forsigtigt op og ned for at undgå skumning.
For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
I fase III undersøgelserne blev Zenapax givet sammen med et standard immunsuppressivt regime bestående af ciclosporin (5 mg/kg) og steroider (prednison eller metylprenisolon) med eller uden tillæg af azathioprin (4 mg/kg).
In Phase III trials Zenapax was added to a standard immunosuppressive regimen of cyclosporine (5 mg/kg) and steroids (prednisone or methylprednisolone), with or without addition of azathioprine (4 mg/kg).
Fastende blodsukker blev målt hos et mindre antal placebo- og Zenapax behandlede patienter.
Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.
1 hætteglas á 5 ml indeholder 25 mg daclizumab* (5 mg/ml).
One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml).
Der er ikke fundet nogen maksimal tolererbar Zenapax dosis hos patienter og den kunne ikke bestemmes på dyr.
A maximum tolerated dose has not been determined in patients and could not be achieved in animals that received Zenapax.
Den overordnede anvendelse af polyklonal antilymfocyt antistofterapi (OKT3, ATG, ATGAM) var ens hos patienter, som fik Zenapax og hos patienter, som fik placebo, henholdsvis 18,5 og 17,9%.
Overall, use of polyclonal antilymphocyte antibody therapy (OKT3, ATG, ATGAM) was similar in patients who received Zenapax and in patients who received placebo, 18.5% and 17.9%, respectively.
Peak serum koncentrationer (peak ± SD) øgedes mellem den første dose (16 ± 12 µg/ml) og den femte dose (21 ± 14 µg/ml).
Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ml) and the fifth dose (21 + 14 µg/ml).
Der opretholdtes acceptable daclizumabkoncentrationer hos alle 18 aber bortset fra 2 som udviklede anti-daclizumabantistoffer.
Appreciable daclizumab serum levels were maintained except in 2 out of 18 monkeys that developed anti-daclizumab antibodies.
Tillæg af Zenapax øgede ikke antallet af posttransplantations lymfomer, som forekom med en frekvens på 1,5% i placebogruppen og 0,7% i Zenapax gruppen.
Addition of Zenapax did not increase the number of post-transplant lymphomas, which occurred with a frequency of 1.5% in the placebotreated group and 0.7% in the Zenapax-treated group.
Insomni Depression
Very common Insomnia Depression
Daclizumab tolereredes godt af mus, rotte og kanine efter enkelt-bolusdoser, intravenøst eller subkutant, i doser fra 50 til 125 mg/kg og efter 28 dages administration af 15 mg/kg til aber.
Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys.
Cytomegalovirus infektion rapporteredes hos 16% af patienterne i placebogruppen og hos 13% af patienterne i Zenapax gruppen.
Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group.
De vil få yderligere 4 doser med 14 dages mellemrum.
You will receive 4 subsequent doses which are spaced 14 days apart from each other.
Hvad Zenapax indeholder
What Zenapax contains
MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Hypertension (inkl.
Very common Hypertension(incl.
Samtidig anvendelse af Zenapax med en anden antilymfocyt antistofterapi i forbindelse med en intensiv immunosuppression med cyclosporin, mycophenolat mofetil og kortikosteroider kan være en faktor, der fører til fatal infektion.
Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.
I alt får De 5 doser svarende til en komplet behandling.
In total you should receive 5 doses of Zenapax for a complete treatment course.
Der er ingen holdepunkter for at antage, at Zenapax påvirker evnen til at føre motorkøretøj eller betjene maskiner.
There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery.
Zenapax indeholder daclizumab, et rekombinant humaniseret IgG 1 anti-Tac antistof, og virker som en interleukin (IL-2) receptor antagonist.
Zenapax contains daclizumab, a recombinant, humanized IgG1 anti-Tac antibody, and functions as an interleukin 2 (IL-2) receptor antagonist.
Diabetes mellitus Ophobning af væske
Diabetes mellitus Fluid overload
Klar til let opaliserende, farveløs til svagt gullig væske.
Clear to slightly opalescent, colourless to slightly yellowish liquid.
Et forsøg med cynomolgusaber har ikke vist teratogen effekt, men viste en øgning i tidlig prænatal død, som er indenfor grænserne af tidligere rapporteret hyppighed for spontane aborter for arten (se pkt.5.3).
A study in cynomolgus monkeys has not shown teratogenic effects but did show an increase of early prenatal loss which remains in the historical spontaneous abortion rate (see section 5.3).
Følgende transplantationslægemidler er anvendt i kliniske undersøgelser sammen med Zenapax uden interaktioner: ciclosporin, mycophenolatmofetil, ganciclovir, aciclovir, tacrolimus, azathioprin, antithymocyt immunglobulin, muromonab-CD3 (OKT3) og kortikosteroider.
The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
• BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
● CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
En dosis på 1,5 mg/kg blev givet til knoglemarvstranplanterede patienter uden der forekom uønskede hændelser.
A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.
Pædiatriske patienter: Farmakokinetiske og farmakodynamiske egenskaber blev vurderet på 61 pædiatriske patienter behandlet med en dosis Zenapax på 1 mg/kg i.v.
Paediatric Patients: Pharmacokinetic and pharmacodynamic properties were evaluated in 61 paediatric patients treated with 1 mg/kg IV dose of Zenapax every 14 days for a total of 5 doses.
- vejrtrækningsproblemer - forstoppelse; diarré; opkastning; kvalme; eller halsbrand - smerter i led og muskler - overskud af væske i kroppen (ødem); opsvulmede arme og ben (perifere ødemer); - problemer med sårheling
- difficulty breathing - constipation; diarrhoea; vomiting; nausea; or heartburn - pain in joints and muscles - excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema) - problems with wound healing
Deres læge bør informere Dem om at bruge prævention, før behandlingen med Zenapax starter, under behandlingen med Zenapax og i yderligere 4 måneder efter den sidste dosis af Zenapax.
Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax.
Nogle bivirkninger forekommer oftere hos børn end hos voksne, og det drejer sig om diarré, smerter efter operation, feber, opkastning, forhøjet blodtryk, kløende hud, infektioner i næse og svælg og infektioner i urinen.
Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.
Tre års transplantatoverlevelse var ikke signifikant forskellig mellem placebo og daclizumab i det tredobbelte immunosuppressive forsøg (83% vs. 84%) eller i det dobbelte immunosuppressive forsøg (78% vs. 82%).
The three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs. 84%) or the double immunosuppressant trial (78% Vs. 82%).
Zenapax's sikkerhedsprofil blev undersøgt overfor placebo hos patienter som samtidigt fik immunosuppressiv behandling indeholdende ciclosporin og kortikosteroider alene, med tillæg af azathioprin eller med tillæg af mycophenolatmofetil.
The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
I det samme prækliniske reproduktionstoxicitetsstudie med daclizumab, hvor cynomolgusaberne fik doser, der svarer til 5-10 gange normal human dosis (10 mg /kg), udskilte fire ud af syv aber meget lave koncentrationer af daclizumab (0,17 % - 0,28 % af maternelt serum niveau) i brystmælk.
In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating cynomolgus monkeys given a 5 - 10 fold multiple (10 mg/kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 - 0.28% of maternal serum levels) in breast milk.
Tre års patientoverlevelsesgraden var signifikant forskellig mellem placebo og daclizumab i det dobbelte immunosuppressive forsøg (88% vs. 96%; p=0,017) men ikke i det tredobbelte immunosuppressive forsøg (94% vs. 92%).
The three year patient survival rate was significantly different between placebo and daclizumab in the double immunosuppressant trial (88% Vs. 96%; p = 0.017), but not in the triple immunosuppressant trial (94% Vs. 92%).
Svækket sårheling (uden infektion) Brystsmerter
Impaired healing (without infection) Chest pain
Daclizumab*………… 5 mg pr. 1 ml infusionsvæske
Daclizumab*…………5 mg per 1 ml infusion
Reaktioner på injektionsstedet Pyreksi
Application site reaction Pyrexia
Zenapax øger ikke denne risiko, , når det anvendes sammen med andre immunosuppresive lægemidler, inklusive ciclosporin og corticosteroider.
Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
I sjældne tilfælde er overfølsomhedsreaktioner efter administration af Zenapax blevet rapporteret (se pkt.
In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4).
Der kan optræde anafylaktiske reaktioner efter anvendelse af proteiner.
Anaphylactic reactions following the administration of proteins can occur.
Hyppigheden af dødfødte, kejsersnit og sædefødsler var sammenlignelig mellem kontrolgruppen og behandlingsgrupperne.
The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups.
Opbevares i køleskab (2 °C - 8 °C) Må ikke nedfryses
Store in a refrigerator (2 °C - 8 °C) Do not freeze
Zenapax er kontraindiceret til patienter med kendt overfølsomhed overfor daclizumab eller ethvert af dets andre indholdsstoffer (se pkt.
Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
Alvorlige bivirkninger rapporteredes af 44,4% af patienterne i den placebobehandlede gruppe og af 39,9% af de behandlede patienter i Zenapaxgruppen.
Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group.
Instruktion i hvordan Zenapax infusioner fremstilles, er beskrevet i pkt.
Instructions for the preparation of Zenapax infusions are described in section 6.6.
De bør ikke anvende Zenapax anvendes: - hvis De er allergisk (overfølsom) over for daclizumab eller et af de øvrige indholdsstoffer i
Do not use Zenapax - if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax.
I en enkel randomiseret kontrolleret klinisk undersøgelse hos hjertetransplanterede patienter, der sammenlignede Zenapax overfor placebo, begge anvendt i kombination med mycophenolat mofetil (CellCept 1,5 g to gange daglig), cyclosporin og kortikosteroider var der flere infektionsrelaterede dødsfald hos patienter, der fik Zenapax.
In a single randomized controlled clinical trial in cardiac transplant recipients which compared Zenapax to placebo, each used in combination with mycophenolate mofetil (CellCept 1.5 g bid), cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax.
Hos de 40 patienter, der fik både Zenapax og antilymfocytterapi, var der 8 der døde (20,0%) mens hos de 37 patienter, der fik både placebo og antilymfocytterapi, var der 2 der døde (5,4%).
However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the 37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Zenapax 5 mg/ml koncentrat til infusionsvæske, opløsning er en klar, farveløs til svagt gullig opløsning som leveres i hætteglas indeholdende 5 ml opløsning.
Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution.
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 February 1999
Et volumen Zenapax indeholdende den nødvendige dosis sættes til 50 ml 0,9% steril natriumchloridopløsning og indgives intravenøst i løbet af 15 minutter.
The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period.
I kliniske undersøgelser med nyretransplanterede patienter som blev behandlet med 1 mg/kg Zenapax hver anden uge, i alt 5 doser, steg gennemsnit peak-serumkoncentrationen (middel ± SD) fra den første dosis (21 ± 14 µg/ml) til den femte dosis (32 ± 22 µg/ml).
In clinical trials involving renal allograft patients-treated with 1 mg/kg of Zenapax every 14 days for a total of 5 doses, average peak serum concentrations (mean ± standard deviation) rose between the first dose (21 ± 14 µg/ml) and fifth doses (32 ± 22 µg/ml).
Sjældent forekommer allergiske reaktioner (overfølsomhedsreaktioner) overfor Zenapax.
Rarely, allergic reactions (hypersensitivity) to Zenapax may occur.
Zenapax anvendes sammen med andre immunosuppressive lægemidler, inklusive ciclosporin og kortikosteroider.
Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
De kliniske tegn på disse reaktioner inkluderer hypotension, takykardi, hypoxi, dyspnø, hiven efter vejret, larynxødem, lungeødem, rødmen, diaforese, temperaturstigning, udslæt og kløe.
The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus.
12 måneders mortaliteten var 4,4% i placebogruppen og 1,5% i Zenapax gruppen.
The twelve months mortality was 4.4% in the placebo- and 1.5% in the Zenapax-treated groups.
- Opbevares i den originale emballage for at beskytte mod lys.
- Store in the original package in order to protect from light.
Abdominalsmerter Øvre abdominalsmerter (epigastrisk smerte)
Abdominal pain upper (epigastric pain) Haemorrhoids
Dødsfald, der forekom i de første 6 måneder efter transplantationen, rapporteredes hos 3,4% i placebogruppen og hos 0,6% i Zenapax gruppen.
Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Kombinationsbehandling hos renal allotransplanterede
Combination Therapy in Renal Allograft Recipients
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/098/001
MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001
ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intravenøs infusion efter fortynding Læs indlægssedlen inden brug
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, for infusion after dilution Read the package leaflet before use
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/098/002
MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/002
HVORDAN DE ANVENDER ZENAPAX
HOW TO USE ZENAPAX
I de undersøgte standard tests var daclizumab ikke genotoksisk.
Daclizumab was not genotoxic in standard tests.
* Rekombinant humaniseret IgG1 anti-Tac antistof fremstillet i en murin NSO myelom cellelinje under anvendelse af glutamin synthease (GS) ekspressions system (NS_GSO) ved rekombinant DNA teknologi.
* Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Den gennemsnitlige trough serumkoncentration ± SD før femte dosis var 7.6 ± 4.0 µg/ml.
The mean ± standard deviation trough serum concentration prior to fifth dose was 7.6 ± 4.0 µg/ml.
Dosisjustering er ikke nødvendig ved svær nedsat nyrefunktion.
No dosage adjustment is necessary for patients with severe renal impairment.
Zenapax er kontraindiceret ved amning (se pkt.
Zenapax is contraindicated during lactation (see section 4.6).
Patienter med svær nedsat nyrefunktion
Patients with severe renal impairment
Infektionstyperne var de samme i Zenapax- og placebogruppen.
The type of infections reported was similar in both the Zenapax- and the placebo-treated groups.
ANVENDELSESMÅDE Til intravenøs anvendelse efter fortynding Læs indlægssedlen inden brug
METHOD OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Skader og forgiftninger Almindelig Post-traumatisk smerte
Injury and poisoning Common
Daclizumab er et humaniseret monoklonalt antistof fremstilles i en murin NSO myelom cellelinje under anvendelse af glutamin synthetase (GS) ekspressions system (NS_GSO) ved rekombinant DNA teknologi.
Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Ængstelse Rysten
Anxiety Tremor
Der er ingen erfaringer med behandling nr. 2 eller efterfølgende behandlinger hos transplantatmodtagere.
In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax.
Dyspepsi (inkl.halsbrand) Udspilet abdomen Gastritis
pyrosis) Abdominal distension Gastritis
Det skal fortyndes med 50 ml steril 0,9% natriumkloridopløsning før det gives intravenøst.
It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before intravenous administration to the patients.
Et hætteglas med 5 ml koncentrat til infusionsvæske, opløsning indeholder 25 mg daclizumab.
One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
- Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør de fortælle det til Deres læge eller apotek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 hætteglas á 5 ml
PHARMACEUTICAL FORM AND CONTENTS 1 vial of 5 ml
Efter fortynding anbefales det, at den tilberedte infusionsvæske anvendes med det samme.
After dilution an immediate use is recommended.
HVORDAN DE OPBEVARER ZENAPAX
HOW TO STORE ZENAPAX
I en enkeltdosis toksikologisk undersøgelse på mus var der ingen tegn på toksicitet efter intravenøs indgift af 125 mg/kg.
In a single dose toxicity study a dose of 125 mg/kg was administered intravenously to mice and showed no evidence of toxicity.
Renal tubulær nekrose Hydronephros Nyrelidelser (skader) Urinvejsblødning Urinretention
Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria
Middel trough serum koncentrationen var 5,0 ± 2,7 µg/ml før den femte dose.
The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ml.
Der findes ingen data ved svær nedsat leverfunktion.
No data are available for patients with severe hepatic impairment.
Natriumdihydrogenphosphat, vandfri Dinatriumphosphat, vandfri Saltsyre, koncentreret Natriumhydroxid
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide
Polysorbat 80; natriumchlorid; natriumdihydrogenphosphat, vandfri; dinatriumphosphat, vandfri; saltsyre, koncentreret; natriumhydroxid; vand til injektionsvæsker.
Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection.