Hvad er oversættelsen af " FASTURTEC " på engelsk?

• fasturtec

Eksempler på brug af Fasturtec på Dansk og deres oversættelser til Engelsk

Hvad anvendes Fasturtec til?
What is Fasturtec used for?

Fasturtec leveres i en pakning med.
Fasturtec is supplied as a pack of.

Anvend ikke Fasturtec hvis du.
Do not use Fasturtec if you.

Hvilken risiko er der forbundet med Fasturtec?
What is the risk associated with Fasturtec?

Hvorfor blev Fasturtec godkendt?
Why has Fasturtec been approved?

Fasturtec indeholder den aktive ingrediens rasburikase.
Fasturtec contains the active ingredient rasburicase.

Andre oplysninger om Fasturtec.
Other information about Fasturtec.

Fasturtec gives i begyndelsen af den kemoterapeutiske behandling.
Fasturtec is given at the start of chemotherapy.

Den fuldstændige EPAR for Fasturtec findes her.
The full EPAR for Fasturtec is available here.

Methæmoglobinæmi er forekommet hos patienter, der får Fasturtec.
Methaemoglobinaemia has been reported in patients receiving Fasturtec.

Fasturtec er et lægemiddel, der indeholder det aktive stof rasburikase.
Fasturtec is a medicine containing the active substance rasburicase.

Efter rekonstitution indeholder 1 ml Fasturtec 1, 5 mg rasburikase.
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.

Fasturtec bør således ikke anvendes under graviditet eller amning.
Fasturtec should not be used during pregnancy or in breast- feeding women.

Det foreligger ingen data, der kan begrunde sekventiel brug af Fasturtec og allopurinol.
There is no data available to recommend the sequential use of Fasturtec and allopurinol.

Fasturtec skal gives inden eller i begyndelsen af dit kemoterapiforløb.
FASTURTEC is to be given to you before or during the start of your course of chemotherapy.

Det vides ikke, og risikoen for at udvikle en allergisk reaktion øges, hvis behandlingen med Fasturtec gentages.
It is not known whether the chance of developing an allergic reaction is increased if treatment with FASTURTEC is repeated.

Brug ikke Fasturtec, hvis opløsningen er uklar og/ eller indeholder partikler.
Do not use Fasturtec if you notice that the solution is unclear and/ or contains particles.

Tidsrummet frem til første bekræftede normalisering af urinsyreværdier hos patienter med hyperurikæmi er 4 timer for Fasturtec og 24 timer for allopurinol.
Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for Fasturtec and 24 hours for allopurinol.

Fasturtec virker ved at gøre det lettere for kroppen at fjerne denne urinsyre via nyrerne.
Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.

Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fasturtec til sanofi- aventis den 23. februar 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec to sanofi-aventis on 23 February 2001.

Fasturtec vil blive givet sammen med andre produkter, som også kan give bivirkninger.
FASTURTEC will be administered at the same time as other medicines that may also cause side effects.

En randomiseret komparativ fase III- undersøgelse baseret på den anbefalede dosis viste en signifikant hurtigere virkning af Fasturtec sammenlignet med allopurinol.
A randomised comparative phase III study, using the recommended dose, showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.

Fasturtec 1, 5 mg/ ml pulver til koncentrat til infusionsvæske, opløsning rasburikase Til intravenøs brug.
Fasturtec 1.5 mg/ ml powder for concentrate for solution for infusion rasburicase Intravenous use.

Endvidere er der nedenfor anført bivirkninger af grad 3 eller 4, der måske skyldes Fasturtec og er fremkommet under kliniske forsøg, opført efter systemorganklasse og hyppighed.
In addition, grade 3 or 4 adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.

Fasturtec er et rekombinant uratoxidaseenzym fremstillet i en genmanipuleret Saccharomyces cerevisiae- stamme.
Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.

Udseende og pakningsstørrelser Fasturtec leveres som pulver og solvens til koncentrat til infusionsvæske, opløsning.
Fasturtec is provided as a powder and solvent for concentrate for solution for infusion.

Fasturtec er ikke undersøgt hos patienter med hyperurikæmi i forbindelse med myeloproliferative sygdomme.
Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.

Hvordan anvender du Fasturtec” samt praktisk information om fremstilling og håndtering i det nedenstående.
See section 3“ How to use Fasturtec” and practical information on preparation and handling given below.

Fasturtec skal indgives under overvågning af en læge med erfaring i kemoterapi af hæmatologiske maligne tilstande.
Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.

Behandlingen med Fasturtec kan vare op til 7 dage, den præcise varighed skal baseres på fyldestgørende monitorering af urinsyre niveauet i plasma samt klinisk vurdering.
The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.

Hvordan man bruger "fasturtec" i en Dansk sætning

Fasturtec gives umiddelbart inden og under indledning af kemoterapeutisk behandling.

Fasturtec indgives som intravenøs infusion en gang daglig over 30 minutter i 50 ml natriumchloridopløsning 9 mg/ml (0,9%) (se pkt. 6.6).

Der er kun begrænsede kliniske erfaringer med fornyet behandling med Fasturtec, og behandlingen må derfor kun gentages med forsigtighed.

Hæmolyse er forekommet hos patienter, der får Fasturtec.

I så fald skal Fasturtec omgående seponeres permanent, og en passende behandling iværksættes.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstitution indeholder 1 ml Fasturtec 1,5 mg rasburikase.

LÆGEMIDLETS NAVN Fasturtec 1,5 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning. 2.

Hvordan man bruger "fasturtec" i en Engelsk sætning

Fasturtec may interact with other drugs and medicines, both script and over the counter.

As Fasturtec is only administered under the direct supervision of a specialized health care professional, an overdose with Fasturtec is unlikely.

Fasturtec may not be safe for use in patients that are or may become pregnant during the course of the therapy.

Other medical conditions may also affect your Fasturtec treatment.

Fasturtec is only administered in a clinic or hospital by a specialized health care professional.

Also, Fasturtec may not be suitable for use in patients that are breast feeding a baby.

Fasturtec has been sold under Health Canada´s Special Access Program since May 21, 2002.

Fasturtec may only be administered under the direct supervision of a health care professional, authorized and specialized in the manipulation and administration of chemotherapeutic agents.

Fasturtec may lead to the appearance of, or may aggravate pre-existing blood conditions such as hemolytic reactions or methemoglobinemia.

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