FrancophonIA/ELRC3.0 huggingface dataset:
English: In long term safety studies, an analysis of data from 867 paediatric patients (mean age 7.3 years, range 0 to17) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
Danish: I langtidssikkerhedsstudier viste en analyse af data fra 867 pædiatriske patienter (gennemsnitsalder 7,3 år, aldersgruppe 0 til 17), som blev behandlet med rasburikase 0,20 mg/kg/dag i 1 til 24 dage (hovedsagelig 1 til 4 dage), resultater, der er i overensstemmelse med kliniske pivotalstudier med hensyn til effekt og sikkerhed.
English: In healthy volunteers, a marked dose-related decrease in plasma uric acid levels was observed across the dose range 0.05 mg/kg to 0.20 mg/kg of Fasturtec.
Danish: Hos raske personer er der observeret et markant dosisafhængigt fald i urinsyres plasmaniveauer i dosisintervallet 0,05 mg/kg til 0,20 mg/kg.
English: Store in the original package in order to protect from light
Danish: Opbevares i den originale yderpakning for at beskytte mod lys
English: The acute increase in plasma levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive chemotherapy may lead to impairment of renal function and renal failure resulting from the precipitation of crystals of uric acid in renal tubules.
Danish: Den akutte stigning i urinsyres plasmaniveauer efter destruktion af et større antal celler, som det ses ved maligne sygdomme og under kemoterapi med cytostatika, kan føre til nedsat nyrefunktion og nyresvigt, hvilket henføres til udfældning af urinsyrekrystaller i tubuli renales.
English: - Anaphylaxis - Anaphylactic shock*
Danish: -Anafylaktisk shock*
English: Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.
Danish: Da rasburikase er et enzym, anses risikoen for lægemiddelinteraktioner usandsynlig.
English: In pivotal clinical studies, 246 paediatric patients ( mean age 7 years, range 0 to17) were treated with rasburicase at doses of 0.15 mg/kg/day or 0.20 mg/kg/day for 1 to 8 days (mainly 5 to 7 days).
Danish: I kliniske pivotalstudier blev 246 pædiatriske patienter i (gennemsnitsalder 7 år, aldersgruppe 0 til 17 år) behandlet med rasburikase i doser på 0,15 mg/kg/dag eller 0,20 mg/kg/dag i 1 til 8 dage (hovedsagelig 5 til 7 dage).
English: If you get any side effects, talk to your doctor, nurse or hospital pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller sygehusfarmaceuten.
English: Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section
Danish: Fasturtec indgives som intravenøs infusion en gang daglig over 30 minutter i 50 ml natriumchloridopløsning 9 mg/ml (0,9%) (se pkt.
English: Very common side effects (may affect more than 1 in 10 people): - diarrhoea - vomiting - nausea
Danish: Meget almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): − Diarre
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT/AMPOULE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SOLVENS/AMPUL
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1,5 mg
English: Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate).
Danish: Pulver og solvens til koncentrat til infusionsvæske, opløsning (pulver til sterilt koncentrat).
English: The increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients.
Danish: Den øgede forekomst af hydrogenperoxid elimineres af endogene antioxidanter og en øget risiko for hæmolyse ses udelukkende hos personer med G6PD mangel eller medfødt anæmi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER/VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PULVER/HÆTTEGLAS
English: Reconstitution required with the entire contents of the 1 ml solvent ampoule Intravenous use
Danish: Rekonstitution nødvendig med hele ampullens indhold af solvens (1 ml) Til intravenøs brug
English: If use of a separate line is not possible, the line should be flushed out with saline solution between infusion of chemotherapeutic agents and rasburicase.
Danish: Hvis det ikke er muligt at anvende en separat dropslange, skal slangen gennemskylles med en saltvandsopløsning mellem infusion af kemoterapeutiske midler og rasburikase.
English: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Danish: dinatriumphosphatdihydrat, natriumdihydrogenphosphatdihydrat.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: For single-use only, any unused solution should be discarded.
Danish: Ikke anvendt opløsning bør bortskaffes.
English: Tell your doctor, nurse or hospital pharmacist immediately as these may be signs of a serious allergic reaction (anaphylaxis).
Danish: − Udslæt, kløe eller nældefeber Fortæl det omgående til din læge, sygeplejerske eller kliniske farmaceut, da dette kan være tegn på en alvorlig allergisk reaktion (anafylaksi).
English: - Convulsion**
Danish: -Kramper**
English: Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Danish: Fasturtec gør det lettere for kroppen at fjerne denne urinsyre via nyrerne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/170/001
English: Fasturtec is not directly effective in the treatment of these abnormalities.
Danish: Fasturtec er ikke effektiv i behandlingen af disse tilstande, hvorfor sådanne patienter skal monitoreres tæt.
English: Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
Danish: Da rasburikase in vitro kan nedbryde urinsyre, skal der tages specielle forholdsregler ved bestemmelse af plasmaurinsyre hos patienter behandlet med Fasturtec, se pkt.
English: - Headache +
Danish: -Kvalme ++
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/170/001-002
English: STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 1.5 mg/1 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
Danish: ANGIVELSE AF AKTIVT STOF rasburikase 1,5 mg/1 ml rasburikase er produceret ved genteknologi i Saccharomyces cervisiae-stammer
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/170/002
English: In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec.
Danish: I kliniske forsøg har Fasturtec forårsaget hæmatologiske sygdomme såsom hæmolyse, hæmolytisk anæmi og methæmoglobinæmi med frekvensen ”Ikke almindelig”.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 1 vial and 1 ampoule
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE Pulver og solvens til koncentrat til infusionsvæske, opløsning 1 hætteglas og 1 ampul.
English: Uric acid levels were <2 mg/dl in 96% of patients in the two arms containing rasburicase and 5% of patients in the allopurinol arm at 4 hours of the day 1 dose.
Danish: 4 timer efter doseringen på dag 1 var urinsyrekoncentrationen <2 mg/dl (<0,11 mmol/l) hos 96% af patienterne i de to arme, som fik rasburikase, og hos 5% af patienterne i allopurinolarmen.
English: Caution should be used in patients with a history of atopic allergies.
Danish: Forsigtighed tilrådes ved administration til patienter der lider af, eller har lidt af, atopiske allergier.
English: After reconstitution or dilution an immediate use is recommended.
Danish: Det anbefales at anvende opløsningen umiddelbart efter rekonstitution eller fortynding.
English: How to use Fasturtec
Danish: Sådan får du Fasturtec
English: Talk to your doctor, nurse or hospital pharmacist if you have a history of any kind of allergy.
Danish: Kontakt lægen, den kliniske farmaceut eller sundhedspersonalet, hvis du tidligere har haft allergiske reaktioner.
English: Reconstitution results in a solution with a concentration of 1.5 mg/ml rasburicase to be further diluted with sodium chloride 9 mg/ml (0.9%) intravenous solution.
Danish: Rekonstitutionen giver en opløsning med en koncentration på 1,5 mg/ml rasburikase, som skal fortyndes yderligere med natriumchlorid 9 mg/ml (0,9%) infusionsopløsning.
English: Methaemoglobinaemia has been reported in patients receiving Fasturtec.
Danish: Methæmoglobinæmi er forekommet hos patienter, der får Fasturtec.
English: Rasburicase must be reconstituted with the entire volume of the supplied solvent ampoule (1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Danish: Rasburikase skal opløses i hele indholdet i den medfølgende ampul med solvens (hætteglasset med 1,5 mg rasburikase skal rekonstitueres med 1 ml ampul med solvens - hætteglasset med 7,5 mg rasburikase skal rekonstitueres med 5 ml ampul med solvens).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNING MED 3 PULVERHÆTTEGLAS OG 3 SOLVENS AMPULLER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 1 PULVERHÆTTEGLAS OG 1 SOLVENS AMPUL
English: STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 7.5 mg/5 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
Danish: ANGIVELSE AF AKTIVT STOF rasburikase 7,5 mg/ 5 ml rasburikase er produceret ved genteknologi i Saccharomyces cervisiae-stammer.
English: Common Uncommon
Danish: Almindelig Ikke almindelig Sjælden Ikke kendt
English: • rash, itching or hives (nettle-type rash) on the skin
Danish: • udslæt, kløe eller nældefeber på huden
English: Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.
Danish: Administration af Fasturtec medfører en reduktion i koncentrationen af urinsyre til niveauer under normalområdet, hvorved risikoen for nyresvigt som følge af udfældning af urinsyrekrystaller i nyretubuli reduceres.
English: Reconstitution of the solution:
Danish: Fremstilling (rekonstitution) af opløsning:
English: Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Danish: Fasturtec skal fremstilles (rekonstitueres) med hele voluminet af den medfølgende solvens (f.eks. skal indholdet af en 1,5 mg rasburikaseampul opløses i 1 ml fra solvensampullen; og 7,5 mg rasburikase fra en ampul skal opløses i de 5 ml solvens fra 5 ml solvensampullen).
English: During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid and decide how long you will be treated for.
Danish: Urinsyreniveauet i blodet vil blive kontrolleret og din læge vil bestemme den præcise varighed af behandlingen.
English: No interaction studies have been performed.
Danish: Der er ikke foretaget undersøgelser af rasburikases interaktion.
English: Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Danish: Et hætteglas med rasburikase tilsættes indholdet fra en solvensampul under kontrollerede og validerede aseptiske forhold, hvorefter glasset vippes forsigtigt.
English: NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN Fasturtec 1,5 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning.
English: G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Danish: G6PD-mangel og andre metaboliske sygdomme, der medfører hæmolytisk anæmi, idet konvertering af urinsyre til allantoin medfører dannelse af biproduktet hydrogenperoxid.
English: If you notice any of these, tell your doctor, nurse or hospital pharmacist.
Danish: Hvis du opdager nogle af disse bivirkninger, skal du fortælle det til lægen, sygeplejersken eller sygehusfarmaceuten.
English: The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ml (0.9%) solution to make a total volume of 50 ml.
Danish: Den nødvendige mængde færdigblandet opløsning fra et eller flere hætteglas skal fortyndes yderligere med en natriumchloridopløsning 9 mg/ml (0,9%) op til et volumen på i alt 50 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 7.5 mg
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til rasburikase 7,5 mg
English: Methaemoglobina emia
Danish: Methæmoglobin æmi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fasturtec 1.5 mg/ml powder for sterile concentrate rasburicase
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fasturtec 1,5 mg/ml pulver til sterilt koncentrat rasburicase i.v.
English: Haemolysis has been reported in patients receiving Fasturtec.
Danish: Hæmolyse er forekommet hos patienter, der får Fasturtec.
English: Reconstitution results in a solution with a concentration of 1.5 mg/ml to be further diluted with sodium chloride 9 mg/ml (0.9%).
Danish: Rekonstitutionen resulterer i en opløsning på 1,5 mg/ml, der skal fortyndes yderligere med natriumchlorid 9 mg/ml (0,9%).
English: What Fasturtec is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 3 POWDER VIALS and 3 SOLVENT AMPOULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 3 PULVER HÆTTEGLAS OG 3 SOLVENS AMPULLER
English: - The other ingredients of the solvent are: poloxamer 188, water for injection.
Danish: - Øvrige indholdsstoffer i solvensen: poloxamer 188, vand til injektionvæske.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Fasturtec, skal du henvende dig til den lokale repræsentant:
English: (frequency not known) which may be fatal - low blood pressure (hypotension) - wheezing or difficulty in breathing (bronchospasm) - blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels
Danish: − Blodsygdomme, såsom sygdomme, hvor de røde blodlegemer nedbrydes (hæmolyse) eller ødelægges (hæmolytisk anæmi), eller unormalt niveau af blodpigment (methæmoglobinæmi)
English: Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Danish: Øvrige indholdsstoffer i pulver: alanin, mannitol, dinatriumphosphatdodecahydrat, dinatriumphosphatdihydrat, natriumdihydrogenphosphatdihydrat.
English: Reconstitution required with the entire contents of the 5 ml solvent ampoule Intravenous use
Danish: Rekonstitution nødvendig med hele ampullens indhold af solvens (5 ml).
English: Fasturtec is injected slowly into a vein, which should take about 30 minutes.
Danish: Lægemidlet indgives i en vene (intravenøst) som en infusion, der i gennemsnit varer 30 minutter.
English: - Diarrhoea + - Vomiting++ - Nausea++
Danish: -Diarré + -Opkastning
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ Andre informationskilder
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 1.5 mg
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til rasburikase 1,5 mg
English: Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Fasturtec Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Do not use any glucose solution for dilution due to potential incompatibility.
Danish: På grund af potentiel inkompatibilitet må glucoseinfusionsvæske ikke anvendes til fortynding.
English: Solvent: poloxamer 188 water for injection
Danish: Solvens: poloxamer 188 vand til injektionsvæsker
English: - Haemolysis - Haemolytic anaemia
Danish: -Hæmolyse -Hæmolytisk anæmi
English: - headache - fever
Danish: − Feber
English: Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Pulver: alanin mannitol dinatriumphosphatdodecahydrat dinatriumphosphatdihydrat natriumdihydrogenphosphatdihydrat.
English: The reconstituted solution contains no preservative.
Danish: Den rekonstituerede opløsning indeholder ikke konserveringsmiddel, derfor skal den fortyndede infusionsopløsning indgives omgående.
English: What Fasturtec looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.
Danish: Da solvensen ikke indeholder konserveringsmiddel, skal fortynding af den fremstillede opløsning ske under kontrollerede og validerede aseptiske forhold.
English: Solvent: poloxamer 188, water for injection
Danish: Solvens: poloxamer 188, vand til injektionsvæske
English: Therapeutic indications
Danish: 4.1 Terapeutiske indikationer
English: Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility.
Danish: For at forebygge eventuel lægemiddeluforligelighed skal rasburikase opløsningen indgives som infusion gennem en anden dropslange end den, der anvendes til infusion af kemoterapeutiske midler.
English: Solvent: poloxamer 188, water for injection.
Danish: Solvens: poloxamer 188, vand til injektionsvæsker.
English: 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Danish: 1 hætteglas à 7,5 mg rasburikase og 1 ampul à 5 ml solvens.
English: If you suddenly notice: - a swelling of the face, lips, tongue or other part of your body - a shortness of breath, wheezing or breathing problems - a rash, itching or hives
Danish: − Hævelse af ansigtet, læberne, tungen eller andre dele af kroppen
English: 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Danish: 3 hætteglas à 1,5 mg rasburikase og 3 ampuller à 1 ml solvens.
English: • coughing or wheezing
Danish: • hoste eller hvæsende vejrtrækning
English: NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Danish: Fasturtec 1,5 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning Rasburikase
English: Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Danish: Pakning med 1 hætteglas á 7,5 mg rasburikase og 1 ampul med 5 ml solvens.
English: Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Danish: Pakninger med 3 hætteglas á 1,5 mg rasburikase og 3 ampuller med 1 ml solvens.
English: Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses.
Danish: Fasturtec gives umiddelbart inden og under indledning af kemoterapeutisk behandling.
English: The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Danish: Pulveret leveres i 10 ml hætteglas af klart glas (type I) med gummiprop og solvensen i 5 ml klar glasampul (type I).
English: The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.
Danish: Pulveret leveres i 10 ml klare hætteglas med gummilukker og solvensen i en 5 ml klar glas ampul (type I).
English: The powder is supplied in 3 ml clear glass vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule.
Danish: Pulveret leveres i 3 ml klare hætteglas med gummilukker og solvensen i en 2 ml klar glas ampul (type I).
English: The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
Danish: Pulveret leveres i 3 ml hætteglas af klart glas (type I) med gummiprop og solvensen i 2 ml klar glasampul (type I).
English: C.
Danish: Тел.
English: Package leaflet: Information for the user Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Danish: Fasturtec 1,5 mg/ml pulver og solvens til koncentrat til infusionsvæske, opløsning rasburikase
English: Uncommon side effects (may affect up to 1 in 100 people): - severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock
Danish: − Alvorlige allergiske reaktioner som for eksempel anafylaksi (sjælden) inklusive anafylaktisk shock (hyppighed ikke kendt), som kan være dødelig
English: Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
Danish: Rasburikase produceres ved hjælp af genteknologi i en mikroorganisme der hedder Saccharomyces cervisiae - Øvrige indholdsstoffer i pulveret: alanin, mannitol, dinatriumphosphatdodecahydrat,
English: - if you are pregnant or if there is a possibility that you may be pregnant (see below).
Danish: - hvis De er gravid, eller hvis der er mulighed for, at De er gravid (se nedenfor).
English: Up to 12 days from the date of manufacture.
Danish: Op til 12 dage fra fremstillingsdatoen.
English: However, should this occur, you will receive appropriate treatment from your doctor.
Danish: Skulle dette alligevel forekomme, vil De modtage passende behandling af Deres læge.
English: Intravenous administration should not be protracted over more than 2 hours.
Danish: Intravenøs indgivelse bør ikke strække sig over mere end to timer.
English: The risk to receive a possible overdose is small.
Danish: Risikoen for at få en eventuel overdosering er lille.
English: These complexes are rapidly eliminated by the kidneys.
Danish: Disse komplekser elimineres hurtigt af nyrerne.
English: Please tell your doctor if there is any possibility that you are pregnant.
Danish: Fortæl det til lægen, hvis der er mulighed for, at De er gravid.
English: Like all medicines, Yttriga can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Yttriga have bivirkninger, selvom ikke alle får disse bivirkninger.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/01/2006
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse:19/01/2006
English: WHAT YTTRIGA IS AND WHAT IT IS USED FOR
Danish: HVAD YTTRIGA ER, OG HVAD DET ANVENDES TIL
English: Yttriga is contraindicated in Pregnancy.
Danish: Yttriga er kontraindiceret under graviditet.
English: Date of renewal: 06/01/2011
Danish: Dato for fornyelse af tilladelsen: 06/01/2011
English: Activity may be measured using an ionisation chamber.
Danish: Aktiviteten kan måles ved hjælp af et ionkammer.
English: Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.
Danish: Målingsintervallerne var på 5 minutter samt 1, 6, 24, 96 og 360 timer.