FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50% inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Danish: In vitro-data indikerer, at ambrisentan ved 300 μM resulterede i mindre end 50% hæmning af UGT1A1, UGT1A6, UGT1A9, UGT2B7 (op til 30%) eller af cytokrom P450 - enzymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4 (op til 25%).
English: The effects of repeat dosing of ketoconazole (400 mg once daily) on the pharmacokinetics of a single dose of 10 mg ambrisentan were investigated in 16 healthy volunteers.
Danish: Virkningen af gentagne doser ketoconazol (400 mg en gang dagligt) på farmakokinetikken af en enkelt 10 mg-dosis ambrisentan blev undersøgt hos 16 raske frivillige.
English: (N=247)
Danish: Monoterapi, puljede (N=247)
English: Severe hepatic impairment (with or without cirrhosis) (see section 4.2).
Danish: Svært nedsat leverfunktion (med eller uden cirrose) (se pkt.
English: Phosphodiesterase inhibitors
Danish: Fosfodiesterasehæmmere
English: It is recommended that the tablet is swallowed whole and it can be taken with or without food.
Danish: Tabletten kan tages med eller uden mad.
English: In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI:
Danish: ARIES-2 viste, at ambrisentan (kombineret dosis-gruppe) i signifikant grad udsatte tiden til klinisk forværring af PAH sammenlignet med placebo (p < 0,001).
English: In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2).
Danish: I et klinisk studie med raske personer påvirkede steady state-dosering (10 mg ambrisentan én gang dagligt) ikke signifikant enkeltdosis-farmakokinetikken af et oralt kombinationsantikonceptionsmiddel indeholdende ethinylestradiol og norethindron (se pkt.
English: However, caution should be used in patients with severe renal impairment (see section 4.2).
Danish: Der skal dog udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion (se pkt.
English: Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Danish: Næsebenshyperplasi af siben er set i næsehulen hos rotter, der var blevet behandlet med ambrisentan ved eksponeringer på 3 gange det kliniske AUC.
English: Therefore, ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Danish: Ambrisentan må derfor ikke indledes hos patienter med svært nedsat leverfunktion eller med klinisk signifikant forhøjede niveauer af leveraminotransferaser (> 3 x ULN) (se pkt.
English: • a runny nose
Danish: • løbende næse
English: Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Danish: Kvinder, der behandles med ambrisentan, skal informeres om risikoen for fosterskader, og anden behandling skal igangsættes, hvis kvinden bliver gravid (se pkt.
English: Peripheral oedema has been observed with ERAs including ambrisentan.
Danish: Der er set perifere ødemer ved anvendelse af ERA'er, herunder ambrisentan.
English: Similarly, co-administration with warfarin did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Danish: På samme måde påvirker samtidig administration af warfarin ikke farmakokinetikken af ambrisentan (se pkt.
English: Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Danish: Gentagne doser ambrisentan har ingen indvirkning på ciclosporin A's eksponering, og dosisjustering af ciclosporin A er ikke påkrævet.
English: Ambrisentan Mylan 5 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. lægemidlet er i det væsentlige natrium-frit.
English: This is a very common side effect that may affect more than one in 10 people.
Danish: Dette er en meget almindelig bivirkning, der kan forekomme hos flere end 1 ud af 10 patienter.
English: • feeling tired
Danish: • træthed.
English: Similarly, co-administration with tadalafil did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Danish: På samme måde påvirker samtidig administration af tadalafil ikke farmakokinetikken af ambrisentan (se pkt.
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no
Danish: Tid til første hospitalsindlæggelse for forværret PAH (evalueret)
English: Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Danish: Patienter, som er i ambrisentanbehandling, skal nøje overvåges, når behandling med rifampicin påbegyndes (se pkt.
English: The effect of 7-day dosing of sildenafil (20 mg three times daily) on the pharmacokinetics of a single dose of ambrisentan, and the effects of 7-day dosing of ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of sildenafil were investigated in 19 healthy volunteers.
Danish: Virkningen af 7 dages indgift af sildenafil (20 mg tre gange dagligt) på farmakokinetikken af en enkelt dosis ambrisentan, og virkningen af 7 dages indgift af ambrisentan (10 mg en gang dagligt) på farmakokinetikken ved en enkelt dosis sildenafil blev undersøgt hos 19 raske frivillige.
English: No specific drug-drug interactions with soluble guanylate cyclase stimulators or prostanoids are anticipated based on the known biotransformation data (see section 5.2).
Danish: Baseret på data fra den kendte biotransformation forventes ingen specifikke lægemiddelinteraktioner med opløselige guanylatcyklase-stimulatorer eller prostanoider (se pkt.
English: However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Danish: Administration af flere doser ambrisentan har imidlertid ingen klinisk relevant virkning på ciclosporin A eksponering, og dosisjustering af ciclosporin A er ikke påkrævet.
English: Ambrisentan Mylan 10 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Danish: Ambrisentan Mylan 10 mg filmovertrukne tabletter indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. lægemidlet er i det væsentlige natrium-frit.
English: Ambrisentan was not shown to be an inhibitor of bile acid transport or to produce overt hepatotoxicity.
Danish: Det er ikke vist, at ambrisentan hæmmer galdesyretransporten eller er åbenlyst hepatotoksisk.
English: (N=121)
Danish: Tadalafilmonoterapi (N=121)
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Danish: Virkningen af steady state-ambrisentan (10 mg en gang dagligt) på farmakokinetikken og farmakodynamikken af en enkelt dosis warfarin (25 mg) (målt vha. PT og INR) blev undersøgt hos 20 raske frivillige.
English: Monthly pregnancy tests during treatment with ambrisentan are recommended (see sections 4.3 and 4.6).
Danish: Det anbefales, at der tages graviditetstest hver måned under behandling med ambrisentan (se pkt.
English: Ambrisentan Mylan 10 mg film-coated tablets contain lactose.
Danish: Ambrisentan Mylan 10 mg filmovertrukne tabletter indeholder lactose.
English: Ambrisentan Mylan 5 mg film-coated tablets contain lactose.
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter indeholder lactose.
English: The potential for ambrisentan to induce CYP3A4 activity was explored in healthy volunteers with results suggesting a lack of inductive effect of ambrisentan on the CYP3A4 isoenzyme.
Danish: Resultaterne tyder på, at ambrisentan ikke har induktiv effekt på CYP3A4-isoenzymet.
English: Nasal bone hyperplasia has not been observed with ambrisentan in mice or dogs.
Danish: Næsebenshyperplasi er ikke set efter administration af ambrisentan til mus og hunde.
English: The placeboadjusted mean improvement in 6MWD was 44.6 m (95% CI: 24.3 to 64.9; p<0.001) for the 5 mg dose, and 52.5 m (95% CI: 28.8 to 76.2; p<0.001) for the 10 mg dose.
Danish: Den placebojusterede middelforbedring i 6MWD var for 5 mg-dosis: 44,6 m (95% CI: 24,3 til 64,9; p < 0,001) og for 10 mg-dosis: 52,5 m (95% CI: 28,8 til 76,2; p < 0,001).
English: This is a common side effect that may affect up to one in 10 people.
Danish: Dette er en almindelig bivirkning, der kan forekomme hos op til 1 ud af 10 patienter.
English: Ambrisentan Mylan 5 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter indeholder azo-farvestoffet Allura Red AC Aluminium Lake (E129), som kan fremkalde allergiske reaktioner.
English: What Ambrisentan Mylan is and what it is used for What you need to know before you take Ambrisentan Mylan How to take Ambrisentan Mylan Possible side effects
Danish: Det skal du vide, før du begynder at tage Ambrisentan Mylan Sådan skal du tage Ambrisentan Mylan Bivirkninger
English: • nose bleed
Danish: • næseblod
English: Therefore at concentrations observed in the plasma (approximately 4% relative to parent ambrisentan), 4-hydroxymethyl ambrisentan is not expected to contribute to pharmacological activity of ambrisentan.
Danish: 4-hydroxymetyl-ambrisentan forventes derfor ikke at bidrage til den farmakologiske aktivitet for ambrisentan i de koncentrationer, der ses i plasma (ca. 4 % i forhold til oprindelig ambrisentan).
English: Swallow the tablet whole, with a glass of water, do not split, crush or chew the tablet.
Danish: Du må ikke dele, knuse eller tygge tabletten.
English: No clinically meaningful effects on the pharmacokinetics of ambrisentan or sildenafil were seen during a drug-drug interaction study in healthy volunteers, and the combination was well tolerated.
Danish: Der sås ingen klinisk betydende effekt på farmakokinetikken for hverken ambrisentan eller sildenafil, og kombinationen blev tålt godt.
English: Ambrisentan also undergoes oxidative metabolism mainly by CYP3A4 and to a lesser extent by CYP3A5 and CYP2C19 to form 4-hydroxymethyl ambrisentan (21%) which is further glucuronidated to 4-hydroxymethyl ambrisentan glucuronide (5%).
Danish: Ambrisentan gennemgår også oxidativ metabolisme, hovedsagelig via CYP3A4 og i mindre grad CYP3A5 og CYP2C19.
English: If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
Danish: Hvis der udvikles klinisk signifikant væskeretention under behandling med ambrisentan, med eller uden vægtøgning, skal der foretages en yderligere vurdering for at fastlægge årsagen.
English: Generics (UK) Limited, Potters Bar,
Danish: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL,
English: Nervous system disorders Headache (including sinus headache, migraine)
Danish: sinushovedpine, migræne)
English: Ambrisentan Mylan tablets contain a colouring agent called Allura red AC Aluminium Lake (E129) which may cause allergic reactions.
Danish: Ambrisentan Mylan tabletter indeholder et farvestof, der hedder Allura red AC Aluminium Lake (E129), som kan medføre allergiske reaktioner.
English: Ambrisentan Mylan 10 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Danish: Ambrisentan Mylan 10 mg filmovertrukne tabletter indeholder azo-farvestoffet Allura Red AC Aluminium Lake (E129), som kan fremkalde allergiske reaktioner.
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of tadalafil, and the effects of steady-state tadalafil (40 mg once daily) on the pharmacokinetics of a single dose of ambrisentan were studied in 23 healthy volunteers.
Danish: Virkningen af ambrisentan ved steady state (10 mg en gang dagligt) på farmakokinetikken af en enkeltdosis tadalafil, og virkningen af tadalafil ved steady state (40 mg en gang dagligt) på farmakokinetikken ved en enkeltdosis ambrisentan blev undersøgt hos 23 raske frivillige.
English: Taken together, the in vitro data suggest ambrisentan at clinically relevant concentrations (plasma Cmax up to 3.2 μM) would not be expected to have an effect on UGT1A1, UGT1A6, UGT1A9, UGT2B7 or cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3, or NTCP.
Danish: Samlet set antyder in vitro-data, at ambrisentan ikke kan forventes at have en effekt på UGT1A1, UGT1A6, UGT1A9, UGT2B7 eller cytokrom P450enzymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 eller transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3 eller NTCP ved klinisk relevante koncentrationer (plasma-Cmax op til 3,2 μM).
English: • chest pain/discomfort.
Danish: • smerter eller ubehag i brystet.
English: Decreased haemoglobin
Danish: Lavt hæmoglobin
English: The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p<0.001).
Danish: For 10 mg-gruppen i ARIES-1 var den placebojusterede forbedring i middel-6MWD efter 12 uger 51,4 m (95% CI: 26,6 til 76,2; p < 0,001).
English: In addition to the above, except abnormal blood test results for liver function:
Danish: I tillæg til ovenstående, med undtagelse af blodprøver, der viser unormal leverfunktion: • ringen for ørerne (tinnitus) kun ved anvendelse af kombinationsbehandlingen.
English: Women of child-bearing potential
Danish: Kvinder i den fertile alder
English: Ambrisentan Mylan 5 mg film-coated tablets Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter Ambrisentan Mylan 10 mg filmovertrukne tabletter ambrisentan
English: → If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Ambrisentan Mylan.
Danish: → Du skal bruge en sikker præventionsform, hvis der er mulighed for, at du kan blive gravid, mens du er i behandling med Ambrisentan Mylan.
English: → If you become pregnant or think that you may be pregnant while you're taking Ambrisentan Mylan, see your doctor immediately.
Danish: → Du skal omgående kontakte lægen, hvis du bliver gravid eller har mistanke om, at du er gravid, mens du er i behandling med Ambrisentan Mylan.
English: The incidence of nasal congestion was dose related during ambrisentan therapy.
Danish: Hyppigheden af tilstoppet næse under behandling med ambrisentan var dosisafhængig.
English: The excretion of ambrisentan in milk has not been studied in animals.
Danish: Det er ikke undersøgt i dyrestudier, om ambrisentan udskilles i mælk.
English: Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
Danish: In vitro- og in vivo-non-kliniske undersøgelser har vist, at ambrisentan hverken hæmmer eller fremmer fase I- eller II-lægemiddelmetaboliserende enzymer ved klinisk relevante koncentrationer.
English: Chest pain/discomfort
Danish: Smerter/ubehag i brystet
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in ARIES-1 and 2 respectively.
Danish: For 5 mg-gruppen i ARIES-1 og -2 var den placebojusterede forbedring i middel-6MWD efter 12 uger henholdsvis 30,6 m (95% CI: 2,9 til 58,3; p = 0,008) og 59,4 m (95% CI: 29,6 til 89,3; p < 0,001) sammenlignet med baseline.
English: How to take Ambrisentan Mylan
Danish: Sådan skal du tage Ambrisentan Mylan
English: Each tablet contains 10 mg ambrisentan
Danish: Hver tablet indeholder 10 mg ambrisentan
English: Each tablet contains 5 mg ambrisentan
Danish: Hver tablet indeholder 5 mg ambrisentan
English: • dizziness
Danish: • udslæt.
English: The effects of acute and repeat dosing of rifampicin (600 mg once daily) on the steady-state pharmacokinetics of ambrisentan (10 mg once daily) were studied in healthy volunteers.
Danish: Virkningen på steady state-farmakokinetikken af ambrisentan (10 mg en gang dagligt) efter akutte og gentagne doser rifampicin (600 mg en gang daglig) er undersøgt hos raske frivillige personer.
English: Uncommon side effects:
Danish: Ikke almindelige bivirkninger:
English: The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
Danish: respektive ublindede forlængelser) var 17 ud af 483 personer i løbet af en middel eksponeringsvarighed på 79,5 uger.
English: However, there was no clinically relevant effect on ambrisentan exposure by day 8, following administration of multiple doses of rifampicin.
Danish: Efter administration af adskillige doser rifampicin var der dog ingen klinisk relevant virkning på ambrisentan-eksponeringen på dag 8.
English: Each tablet contains 5 mg of ambrisentan.
Danish: Hver tablet indeholder 5 mg ambrisentan.
English: There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan.
Danish: Behandlingen skal derfor indledes med forsigtighed hos disse patienter, og der skal udvises særlig forsigtighed, hvis dosis øges til 10 mg ambrisentan.
English: Each tablet contains 10 mg of ambrisentan.
Danish: Hver tablet indeholder 10 mg ambrisentan.
English: Ambrisentan Mylan 10 mg film-coated tablets
Danish: Ambrisentan Mylan 10 mg filmovertrukne tabletter
English: Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study (see section 5.2).
Danish: I en undersøgelse med raske frivillige påvirkede ambrisentan ikke steady state-farmakokinetikken og antikoagulationsaktiviteten af warfarin (se pkt.
English: Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Danish: Ambrisentan Mylan 10 mg filmovertrukne tabletter ambrisentan
English: Teratogenicity is a suspected class effect of ERAs.
Danish: Der er mistanke om, at alle ERA'er er teratogene.
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Danish: Risk/benefit-profilen for ambrisentan kan ikke fastslås hos patienter med PAH WHOfunktionsklasse I, da ambrisentan ikke er undersøgt hos et tilstrækkeligt antal af disse patienter.
English: Pack sizes of 30 film-coated tablets and unit dose blisters of 30x1 film-coated tablets Not all pack sizes may be marketed.
Danish: Pakningsstørrelser: 30 filmovertrukne tabletter og enkeltdosisblister med 30x1 filmovertrukne tabletter.
English: NR
Danish: NN:
English: CI: 1.05, 2.32
Danish: Odds ratio 1,56; 95% CI: 1,05 - 2,32
English: Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan.
Danish: De hyppigste bivirkninger, der blev observeret med ambrisentan, var perifert ødem, væskeretention og hovedpine (inkl.
English: Ambrisentan Mylan 5 mg film-coated tablets ambrisentan
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter ambrisentan
English: Time to First Clinical Failure Event (Adjudicated) Clinical failure, no.
Danish: Tid til første hændelse af klinisk behandlingssvigt (evalueret)
English: Ambrisentan Mylan 5 mg film-coated tablets
Danish: Ambrisentan Mylan 5 mg filmovertrukne tabletter
English: Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Danish: Igennem de 12-ugers placebokontrollerede fase 3-studier faldt middel-hæmoglobinkoncentrationerne for patienterne i ambrisentan-grupperne.
English: Ambrisentan does not undergo significant renal metabolism or renal clearance (excretion).
Danish: Ambrisentan metaboliseres eller udskilles ikke i signifikant grad via nyrerne.
English: Fluid retention
Danish: Væskeretention
English: Dizziness
Danish: • hudrødme
English: 47% to 92%).
Danish: 4.2 og 4.4).
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Liste over bivirkninger
English: → Don't take two doses at the same time to make up for a forgotten dose Don't stop taking Ambrisentan Mylan without your doctor's advice Ambrisentan Mylan is a treatment that you will need to keep on taking to control your PAH.
Danish: Ambrisentan Mylan er en behandling, som du skal blive ved med at tage for at holde din PAH under kontrol.
English: (N=253)
Danish: Ambrisentan + tadalafil (N=253)
English: • flushing (redness of the skin)
Danish: Amning (se pkt.
English: Elderly (≥65 years of age)
Danish: Ældre (≥65 år)
English: t½ (days)
Danish: t½ (dage)
English: 10 to 12
Danish: 10 til 12
English: • if you have had heart problems,
Danish: • hvis du har haft problemer med hjertet,
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes øjeblikkeligt.
English: Complete resolution of constitutional symptoms b
Danish: Komplet resolution af konstitutionelle symptomer b
English: Date of first authorisation: 19 April 2010 Date of latest renewal: 17 February 2015
Danish: Dato for første markedsføringstilladelse: 19. april 2010 Dato for seneste fornyelse af tilladelsen: 17. februar 2015
English: The disease can also affect other organs in your body.
Danish: Sygdommen kan også påvirke andre af kroppens organer.
English: You will be checked closely and if you do have any reactions these will be treated.
Danish: Du vil blive overvåget nøje, og hvis du får reaktioner, vil de blive behandlet.
English: Ask your doctor for advice if you are planning to become pregnant after this period.
Danish: Spørg din læge til råds, hvis du planlægger at blive gravid efter denne periode.
English: No case of overdose has been reported.
Danish: Der er ikke rapporteret om tilfælde af overdosering.
English: There are no adequate and well-controlled studies in pregnant women to inform a product-associated risk.
Danish: Der er ingen tilstrækkelige eller velkontrollerede studier hos gravide kvinder til at fortælle om en produktrelateret risiko.
English: 1) Cycle for which the pharmacokinetic parameters are presented in this table.
Danish: 1) Cyklus, for hvilken de farmakokinetiske værdier er præsenteret i denne tabel.
English: Number at risks at
Danish: Antal i risiko for
English: Improvements also were demonstrated in components of the NCI-WG response criteria.
Danish: Der blev også påvist forbedringer i komponenter af responskriterierne fra NCI-WG.
English: Best response is a clinical response that did not improve with 3 additional cycles of treatment.
Danish: Bedste respons er et klinisk respons, som ikke forbedres efter yderligere 3 behandlingscyklusser.
English: In rare cases, these reactions may lead to death.
Danish: I sjældne tilfælde kan disse reaktioner være dødelige.
English: Medicines given before each infusion
Danish: Medicin, der gives før hver infusion