FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility.
Danish: I dyreforsøg er der ikke set nogen klinisk betydningsfuld virkning af zanamivir på fertiliteten hos hanner eller hunner.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Nedsat nyrefunktion
English: Treatment emergent resistance is rare with zanamivir (see section 5.1).
Danish: Behandlingsrelateret resistens er sjælden med zanamivir (se pkt.
English: Following twice daily administration of 600 mg zanamivir solution for infusion, median trough zanamivir epithelial lining fluid concentrations ranged from 419 ng/mL to 584 ng/mL and were 47-66% of those in the initial bronchoalveolar sample following orally zanamivir inhalation powder 10 mg twice daily.
Danish: Efter administration af zanamivir 600 mg infusionsvæske, opløsning to gange dagligt, lå medianlavpunktet for koncentrationen af zanamivir i epitelvæske i intervallet 419 ng/ml til 584 ng/ml og udgjorde 47-66 % af koncentrationen i den indledende bronkoalveolære prøve efter oralt zanamivir inhalationspulver 10 mg to gange dagligt.
English: Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate.
Danish: Det er mere sandsynligt, at der forekommer selektion af influenzaresistente vira efter behandling med antivirale lægemidler hos immunkompromitterede patienter, herunder behandling med Dectova.
English: Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Danish: Børn og unge (6 år til under 18 år med en legemsvægt på mindre end 50 kg) samt spædbørn og børn (6 måneder til under 6 år) med kreatininclearance (CLcr) eller clearance via kontinuerlig nyresubstitutionsterapi (CLCRRT) < 80 ml/min skal have en initialdosis efterfulgt af en passende vedligeholdelsesdosis to gange dagligt som vist i tabel 3, 4 og 5.
English: Children Your doctor will decide on the correct dose of Dectova.
Danish: Lægen bestemmer den korrekte dosis Dectova.
English: Begin maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Danish: 48 timer efter initialdosis *CLcr- eller CLCRRT-enheder i ml/min for unge fra 13 år til under 18 år, eller i ml/min/1,73 m2 for børn fra 6 år til under 13 år.
English: A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg zanamivir twice daily intravenously in hospitalised patients (>16 years of age) with influenza.
Danish: Fase III-studie hos patienter med kompliceret influenza Der er udført et dobbeltblindet fase III-studie til vurdering af virkning, antiviral aktivitet og sikkerhed af zanamivir 600 mg intravenøst to gange dagligt sammenlignet med oral oseltamivir 75 mg to gange dagligt og 300 mg zanamivir intravenøst to gange dagligt hos indlagte patienter (> 16 år) med influenza.
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italy
Danish: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italien
English: It is supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off cap.
Danish: Det leveres i et 26 ml klart hætteglas med gummiprop og ekstra forsegling af aluminium med et fliplåg af plastik.
English: This substitution has no effect on zanamivir; therefore, viruses with the H275Y substitution retain full susceptibility to zanamivir.
Danish: Derfor bibeholder virusser med H275Y-substitutionen fuld følsomhed over for zanamivir.
English: Following twice-daily administration of zanamivir solution for infusion, pulmonary epithelial lining fluid concentrations were 60 - 65 % of the serum concentrations at the corresponding sampling time 12 hours after dosing.
Danish: Efter administration af zanamivir infusionsvæske, opløsning to gange dagligt var koncentrationen i lungeepitelvæske 60-65 % af serumkoncentrationen på det tilsvarende prøvetagningstidspunkt 12 timer efter dosisadministration.
English: • the in vitro activity of zanamivir;
Danish: • zanamivirs in vitro aktivitet
English: Marketing Authorisation Holder GlaxoSmithKline Trading Services Limited 12 Riverwalk
Danish: Indehaver af markedsføringstilladelsen GlaxoSmithKline Trading Services Limited 12 Riverwalk
English: Zanamivir solution for infusion 600 mg
Danish: Zanamivir infusionsvæske, opløsning 600 mg
English: Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
Danish: Voksne og børn (i alderen 6 år og derover med en legemsvægt på 50 kg eller mere) med kreatininclearance (CLcr) eller clearance via kontinuerlig nyresubstitutionsterapi (CLCRRT) < 80 ml/min skal have en initialdosis på 600 mg efterfulgt af en vedligeholdelsesdosis to gange dagligt i henhold til deres nyrefunktion (tabel 2).
English: What Dectova is and what it is used for What you need to know before you are given Dectova How Dectova is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Dectova Sådan får du Dectova
English: years mg/kg years mg/kg years mg years mg %CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available
Danish: mg %CVb = procent variationskoefficient, GM = geometrisk middel, NA=Ikke tilgængelig Nedsat nyrefunktion
English: How much Dectova is given
Danish: Hvor meget Dectova får du
English: CLcr or CLCRRT (mL/min/1.73 m
Danish: CLcr eller CLCRRT (ml/min/1,73 m2)
English: You can help by reporting any side effects you may get.
Danish: <De> <Du> kan hjælpe ved at indberette alle de bivirkninger, <De> <du> får.
English: Zanamivir solution for infusion 300 mg
Danish: Zanamivir infusionsvæske, opløsning 300 mg
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Danish: Den anbefalede dosis er 600 mg to gange dagligt i 5 til 10 dage.
English: Also contains sodium chloride, water for injections
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også natriumchlorid, vand til injektionsvæsker
English: 2D barcode carrying the unique identifier included
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Hætteglas med Dectova er kun til engangsbrug.
English: The potential for interactions with other medicines is low, based on the known elimination pathway of zanamivir.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Baseret på zanamivirs kendte eliminationsvej er potentialet for interaktion med andre lægemidler lavt.
English: • Each vial is for single use only; once the seal has been broken, the remaining volume must be discarded.
Danish: Når forseglingen er brudt, skal den resterende mængde bortskaffes.
English: Dectova 10 mg/mL solution for infusion zanamivir
Danish: Dectova 10 mg/ml infusionsvæske, opløsning zanamivir
English: dk-info@gsk.com
Danish: gskcyprus@gsk.com
English: • Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
Danish: • Bestem det volumen af natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, der skal anvendes til infusionsvæsken.
English: Solution for infusion A clear, colourless solution for infusion.
Danish: LÆGEMIDDELFORM Infusionsvæske, opløsning En klar, farveløs infusionsvæske, opløsning.
English: Each mL of Dectova contains 10 mg of zanamivir (as hydrate).
Danish: Hver ml Dectova indeholder 10 mg zanamivir (som hydrat).
English: Hepatic impairment No dose modification is required (see section 5.2).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in ICU-treated influenza patients, the MAH should submit the results of an observational chart review effectiveness study of IV zanamivir in ICU-treated influenza patients.
Danish: For at evaluere den kliniske virkning af behandlingen med zanamivir 10 mg/ml infusionsvæske, opløsning til ICU-behandlede influenzapatienter, skal indehaveren af markedsføringstilladelsen indsende resultaterne fra et observational chart review effectiveness study af IV zanamivir hos ICUbehandlede influenzapatienter.
English: Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously must be reduced in patients with renal impairment (see section 4.2).
Danish: Derfor skal dosis af Dectova reduceres hos patienter med nedsat nyrefunktion, når den administreres intravenøst (se pkt.
English: GlaxoSmithKline Trading Services Limited 12 Riverwalk
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Trading Services Limited 12 Riverwalk
English: CLcr or CLCRRT (mL/min or mL/min/1.73m
Danish: CLcr eller CLCRRT (ml/min eller ml/min/1,73 m2)*
English: • Using a sterile needle and syringe withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
Danish: • Med en steril kanyle og sprøjte trækkes volumen af Dectova op af hætteglasset/-glassene og tilføres infusionsposen.
English: Median difference between treatments, days (95% CI) p-value from Wilcoxon rank-sum 2-sided test Symptom onset 4 days subgroup, N Median TTCR, days
Danish: Influenzapositiv population, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-værdi fra Wilcoxons tosidede rangsumtest Intensivafdeling/mekanisk ventilationundergruppe, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-værdi fra Wilcoxons tosidede rangsumtest Symptomdebut ≤ 4 dage-undergruppe, N Median-TTCR, dage Medianforskel mellem behandlinger, dage (95 % CI) p-værdi fra Wilcoxons tosidede rangsumtest
English: A prospective observational study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection
Danish: Et prospektiv observationsstudie for at evaluere den kliniske virkning af behandlingen med zanamivir 10 mg/ml infusionsvæske, opløsning til patienter med kompliceret influenzainfektion.
English: A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection
Danish: Et retrospektiv observational chart review study for at evaluere den kliniske virkning af behandling med zanamivir 10 mg/ml infusionsvæske, opløsning i en kohorte af patienter behandlet på intensivafdeling (ICU patienter) med kompliceret influenzainfektion.
English: Initial Dose Maintenance Dose Maintenance Dose Schedule
Danish: Initialdosis Vedligeholdelsesdosis Vedligeholdelsesdoseringsplan
English: Begin twice daily maintenance dosing 48 hours after the initial dose
Danish: Påbegynd vedligeholdelsesdosering to gange dagligt 48 timer efter initialdosis
English: Begin maintenance dosing 24 hours after the initial dose
Danish: Påbegynd vedligeholdelsesdosering 24 timer efter initialdosis
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection, the MAH should submit the results of a prospective observational study in patients with complicated influenza infection.
Danish: For at evaluere den kliniske virkning af behandlingen med zanamivir 10 mg/ml infusionsvæske, opløsning til patienter med kompliceret influenzainfektion, skal indehaveren af markedsføringstilladelsen indsende resultaterne fra et prospektiv observationsstudie hos patienter med kompliceret influenzainfektion.
English: Begin maintenance dosing 12 hours after the initial dose
Danish: Påbegynd vedligeholdelsesdosering 12 timer efter initialdosis
English: The H275Y substitution is the most common neuraminidase resistance substitution and is associated with reduced susceptibility to peramivir and oseltamivir.
Danish: Substitutionen H275Y er den mest almindelige neuraminidaseresistenssubstitution.
English: Sodium chloride Water for injections
Danish: Vand til injektionsvæsker
English: Dectova 10 mg/mL solution for infusion
Danish: LÆGEMIDLETS NAVN Dectova 10 mg/ml infusionsvæske, opløsning
English: Nervous system disorders convulsions depressed level of consciousness not known
Danish: Krampeanfald Nedsat bevidsthedsniveau
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Danish: Hvert hætteglas indeholder 200 mg zanamivir (som hydrat) i 20 ml.
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Danish: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Danish: Forhøjet niveau af alaninaminotransferase (ALAT) og/eller aspartataminotransferase (ASAT)
English: If you have any questions on the use of Dectova, ask the doctor or nurse who is giving it you.
Danish: Brug af anden medicin sammen med Dectova Fortæl det altid til lægen hvis du tager anden medicin eller har gjort det for nylig.
English: Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Danish: Erythema multiforme Stevens-Johnsons syndrom Toksisk epidermal nekrolyse
English: Table 2: Initial and maintenance dose regimens for adults and children (6 years and over with a body weight of 50 kg or above) with renal impairment
Danish: Tabel 2: Initial- og vedligeholdelsesdoseringsregimer til voksne og børn (6 år og derover med en legemsvægt på 50 kg eller mere) med nedsat nyrefunktion
English: Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected.
Danish: Zanamivir metaboliseres ikke.
English: Begin twice daily maintenance dosing 12 hours after the initial dose
Danish: Påbegynd vedligeholdelsesdosering to gange dagligt 12 timer efter initialdosis
English: 600 mg 400 mg twice daily
Danish: 600 mg 400 mg to gange dagligt
English: What Dectova is and what it is used for
Danish: Hvornår og hvordan bliver Dectova givet
English: Each vial contains 200 mg of zanamivir (as hydrate).
Danish: Hvert hætteglas indeholder 200 mg zanamivir (som hydrat).
English: Česká republika GlaxoSmithKline, s.r.o.
Danish: GlaxoSmithKline, s.r.o.
English: Begin twice daily maintenance dosing 24 hours after the initial dose
Danish: Påbegynd vedligeholdelsesdosering to gange dagligt 24 timer efter initialdosis
English: 600 mg 150 mg twice daily
Danish: 600 mg 150 mg to gange dagligt
English: Table 5: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight less than 42.8 kg) with renal impairment
Danish: Tabel 5: Initial- og vedligeholdelsesdoseringsregimer til spædbørn og børn (6 måneder til under 6 år med en legemsvægt på mindre end 42,8 kg) med nedsat nyrefunktion
English: Hepatic impairment
Danish: Hepatocellulær skade
English: ANNEX II
Danish: Dublin 24
English: Table 3: Initial and maintenance dose regimens for children and adolescents (6 years to less than 18 years, with a body weight less than 50 kg) with renal impairment
Danish: Tabel 3: Initial- og vedligeholdelsesdoseringsregimer til børn og unge (6 år til under 18 år med en legemsvægt på mindre end 50 kg) med nedsat nyrefunktion
English: D.
Danish: (t)
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 200 mg zanamivir (som hydrat) i 20 ml (10 mg/ml).
English: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: Table 4: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight of 42.8 kg or above) with renal impairment
Danish: Tabel 4: Initial- og vedligeholdelsesdoseringsregimer til spædbørn og børn (6 måneder til under 6 år med en legemsvægt på 42,8 kg eller derover) med nedsat nyrefunktion
English: 12 mg/kg 8 mg/kg twice daily
Danish: 12 mg/kg 8 mg/kg to gange dagligt
English: 600 mg 250 mg twice daily
Danish: 600 mg 250 mg to gange dagligt
English: 12 mg/kg 5 mg/kg twice daily
Danish: 12 mg/kg 5 mg/kg to gange dagligt
English: Initial dose Maintenance Dose Maintenance Dose Schedule
Danish: Påbegynd vedligeholdelsesdosering
English: 12 mg/kg 3 mg/kg twice daily
Danish: 12 mg/kg 3 mg/kg to gange dagligt
English: 14 mg/kg twice daily
Danish: 14 mg/kg to gange dagligt
English: How to store Dectova
Danish: Sådan får du Dectova
English: MARKETING AUTHORISATION HOLDER
Danish: Dato for første markedsføringstilladelse:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mg/20 ml
English: Cmin (g/mL)
Danish: (µg/ml)
English: Tabulated list of adverse reactions
Danish: Anafylaktiske/anafylaktoide reaktioner
English: 14 mg/kg
Danish: 1 - < 2 år 14 mg/kg
English: ➔ Tell a doctor or nurse immediately.
Danish: Hvis du bemærker nogen af de ovenfornævnte symptomer: Fortæl det omgående til lægen eller sundhedspersonalet.
English: • acting strangely
Danish: • underlig adfærd
English: • Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL
Danish: • Med en steril kanyle og sprøjte trækkes et volumen natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning (svarende til volumen af Dectova) op fra infusionsposen og bortskaffes.
English: 1.4 mg/kg twice daily
Danish: 14 mg/kg 1,4 mg/kg to gange dagligt
English: Vials of Dectova are for single use only.
Danish: • Hvert hætteglas er kun til engangsbrug.
English: Begin twice daily maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Danish: Påbegynd vedligeholdelsesdosering to gange dagligt 48 timer efter initialdosis *CLcr eller CLCRRT enheder i ml/min.
English: 600 mg 60 mg twice daily
Danish: 60 mg to gange dagligt
English: 9.3 mg/kg twice daily
Danish: 14 mg/kg 9,3 mg/kg to gange dagligt
English: Date of first authorisation: 16 November 2017
Danish: Dato for første markedsføringstilladelse: 16 november 2017
English: It may cause allergic reactions.
Danish: Kan medføre allergiske reaktioner.
English: These can include:
Danish: De kan omfatte:
English: Table 5: Secondary endpoints*
Danish: Tabel 5: Sekundære endepunkter*
English: Age, weight and race
Danish: Alder, vægt og race
English: This medicine has not been studied in this age group.
Danish: Dette lægemiddel er ikke undersøgt til denne aldersgruppe.
English: Take Zejula at approximately the same time each day.
Danish: Tag Zejula på nogenlunde samme tidspunkt hver dag.
English: All clinical studies have only been performed in adults.
Danish: Alle kliniske studier er kun udført hos voksne.
English: Some infections can be serious and may lead to death.
Danish: Nogle infektioner kan være alvorlige og kan have dødelig udgang.
English: Children under 18 years of age should not be given Zejula.
Danish: Børn under 18 år må ikke få Zejula.
English: • Palpitations (feeling like your heart is skipping beats or beating harder than usual)
Danish: • Palpitationer (føles, som om hjertet springer slag over eller slår hårdere end normalt)
English: It is recommended that treatment should be continued until disease progression.
Danish: Behandlingen bør fortsættes indtil sygdomsprogression.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Danish: Patienterne skal opfordres til at tage deres dosis på nogenlunde samme tidspunkt hver dag.
English: Frequency of CTCAE grade 3 or 4
Danish: Hyppighed af CTCAE-grad 3 eller 4
English: There are no clinical data on fertility.
Danish: Der foreligger ingen kliniske data vedrørende fertilitet.
English: 1114 AB Amsterdam-Duivendrecht Netherlands
Danish: 1114 AB Amsterdam-Duivendrecht Holland
English: Zejula can cause high blood pressure, which in some cases, could be severe.
Danish: Zejula kan forårsage højt blodtryk, der i nogle tilfælde kan være alvorligt.
English: In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
Danish: I tilfælde af en overdosering skal læger følge generelle understøttende foranstaltninger og behandle symptomatisk.
English: There are limited clinical data in patients aged 75 or over.
Danish: Der er begrænsede kliniske data for patienter i alderen 75 år og derover.
English: Ask your doctor for advice before taking this medicine.
Danish: Spørg lægen til råds, før du tager dette lægemiddel.
English: Additionally, decreased spermatogenesis was seen in both species.
Danish: Desuden blev nedsat spermatogenese set hos begge arter.
English: p-value Hazard ratio (HR)
Danish: p-værdi Hazard ratio (HR)
English: Patients with low body weight
Danish: Patienter med lav legemsvægt
English: Zejula can be taken without regard to meals.
Danish: Zejula kan tages uden hensyn til måltider.
English: The clinical relevance of these findings is not known.
Danish: Den kliniske betydning af disse fund er ikke kendt.
English: There is no specific treatment in the event of Zejula overdose, and symptoms of overdose are not established.
Danish: Der er ingen specifik behandling i tilfælde af overdosering af Zejula, og symptomerne på overdosering er ikke fastlagt.
English: A starting dose of 200 mg for patients weighing less than 58 kg may be considered.
Danish: En startdosis på 200 mg hos patienter, som vejer mindre end 58 kg, kan overvejes.
English: Based on individual laboratory values, weekly monitoring for the second month may be warranted.
Danish: Baseret på individuelle laboratorieværdier kan der være behov for ugentlig overvågning i den anden måned.
English: Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Zejula skal iværksættes og overvåges af en læge med erfaring i brugen af kræftlægemidler.
English: In general, it is recommended to first interrupt the treatment (but no longer than 28 consecutive days) to allow the patient to recover from the adverse reaction and then restart at the same dose.
Danish: Det anbefales generelt først at afbryde behandlingen (men ikke i mere end 28 på hinanden følgende dage), så patienten kan komme sig over bivirkningen, og derefter starte igen ved samme dosis.
English: The hard capsules are packed in blister packs of
Danish: De hårde kapsler er pakket i blisterpakninger med
English: PFS was measured from the time of randomisation (which occurred up to 8 weeks after completion of the chemotherapy regimen) to disease progression or death.
Danish: PFS blev målt fra randomiseringstidspunktet (der lå op til 8 uger efter afslutning af kemoterapiregimet) til sygdomsprogression eller død.
English: No dose adjustment is necessary for elderly patients (≥ 65 years).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (≥ 65 år).