FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare blood creatine phosphokinase increased insomnia includes: insomnia, initial insomnia and sleep disorder depression includes: depression, depressed mood, major depression, and persistent depressive disorder anxiety includes: anxiety and generalised anxiety disorder abdominal pain includes: abdominal pain, and abdominal pain upper abdominal discomfort includes: abdominal discomfort, and epigastric discomfort faeces soft includes: faeces soft and abnormal faeces gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury
Danish: Sjælden forhøjet kreatinfosfokinase i blodet insomni inkluderer: insomni, initial insomni og søvnforstyrrelser depression inkluderer: depression, forsænket stemningsleje, major depression (moderat til svær depression) og vedvarende depressive lidelser angst inkluderer: angst og generaliseret angst abdominalsmerter inkluderer: abdominalsmerter og øvre abdominalsmerter abdominalt ubehag inkluderer: abdominalt ubehag og epigastrisk ubehag blød afføring inkluderer: blød afføring og unormal afføring gastrointestinale motilitetsforstyrrelser inkluderer: gastrointestinale motilitetsforstyrrelser og hyppig afføring.
English: No dose adjustment of doravirine is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis af doravirin hos patienter med let nedsat (Child-Pugh-klasse A) eller moderat nedsat (Child-Pugh-klasse B) leverfunktion.
English: Expected: ↔ canagliflozin ↔ liraglutide ↔ sitagliptin
Danish: Forventet: ↔ canagliflozin ↔ liraglutid ↔ sitagliptin
English: Other medicines and Pifeltro
Danish: Brug af anden medicin sammen med Pifeltro
English: Antiviral activity in combination with other HIV antiviral medicinal products The antiviral activity of doravirine was not antagonistic when combined with the NNRTIs delavirdine, efavirenz, etravirine, nevirapine, or rilpivirine; the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir disoproxil, or zidovudine; the PIs darunavir or indinavir; the fusion inhibitor enfuvirtide; the CCR5 co-receptor antagonist maraviroc; or the integrase strand transfer inhibitor raltegravir.
Danish: Doravirins antivirale aktivitet var ikke antagonistisk ved kombination med non-nukleosid revers transkriptasehæmmerne delavirdin, efavirenz, etravirin, nevirapin eller rilpivirin; nukleosid revers transkriptasehæmmerne abacavir, didanosin, emtricitabin, lamivudin, stavudin, tenofovirdisoproxil eller zidovudin; proteasehæmmerne darunavir eller indinavir; fusionshæmmeren enfuvirtid; CCR5-co-receptorantagonisten maraviroc eller integrasehæmmeren af genomoverførsel raltegravir.
English: In the DRIVE-SHIFT trial, an immediate switch to DOR/3TC/TDF was demonstrated to be noninferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL.
Danish: I DRIVE-SHIFT-studiet blev øjeblikkeligt skift til DOR/3TC/TDF påvist at være non-inferiørt ved uge 48 i forhold til at fortsætte på baseline-regimet ved uge 24, som det blev vurderet hos den del af forsøgspersonerne, der havde hiv-1 RNA < 40 kopier/ml.
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets).
Danish: • 90 filmovertrukne tabletter (3 flasker a 30 filmovertrukne tabletter).
English: If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart).
Danish: Hvis administration sammen med andre moderate CYP3A-induktorer (f.eks. dabrafenib, lesinurad, bosentan, thioridazin, nafcillin, modafinil, telotristatethyl) ikke kan undgås, skal en 100 mg tablet Pifeltro tages to gange dagligt (med ca. 12 timers mellemrum).
English: Expected:  doravirine daclatasvir
Danish: Forventet:  doravirin daclatasvir
English: Clinical isolates containing the Y188L substitution or V106 substitutions in combination with A98G, H221Y, P225H, F227C or Y318F showed a greater than 100-fold reduced susceptibility to doravirine.
Danish: Kliniske isolater med Y188L-substitutionen eller V106-substitutioner i kombination med A98G, H221Y, P225H, F227C eller Y318F viste en større end 100-gange reduktion i følsomhed over for doravirin.
English: • increased levels of creatine phosphokinase
Danish: • forhøjet indhold af kreatinfosfokinase.
English: See also “Other Medicines and Pifeltro” section.
Danish: Se også punktet “Brug af anden medicin sammen med Pifeltro”.
English: Renal and urinary disorders Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis General disorders and administration site conditions Common fatigue
Danish: Nyrer og urinveje Sjælden akut nyreskade, nyresygdom, sten i urinvejene, nefrolitiasis Almene symptomer og reaktioner på administrationsstedet Almindelig træthed
English: Expected:  doravirine glecaprevir, pibrentasvir
Danish: Forventet:  doravirin glecaprevir, pibrentasvir
English: Pifeltro 100 mg film-coated tablets.
Danish: Pifeltro 100 mg filmovertrukne tabletter.
English: Expected: ↔ doravirine ↔ raltegravir ritonavir †-boosted elvitegravir
Danish: Forventet: ↔ doravirin ↔ raltegravir ritonavir †-boostet elvitegravir
English: If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart).
Danish: Hvis lægen beslutter, at du skal tage disse lægemidler sammen med Pifeltro, skal du tage 1 tablet Pifeltro to gange dagligt (med ca. 12 timers mellemrum).
English: Recommendation Concerning Co-administration with doravirine dasabuvir
Danish: Anbefalinger vedrørende administration sammen med doravirin dasabuvir
English: HIV-1 RNA < 40 copies/mL 32 (80) Treatment differences (95 % CI)
Danish: Hiv-1-RNA < 40 kopier/ml Behandlingsforskelle (95% CI)
English: If you get any side effects, talk to your doctor,pharmacist, or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Danish: Hvis administration sammen med andre moderate CYP3A-induktorer (f.eks. dabrafenib, lesinurad, bosentan, thioridazin, nafcillin, modafinil, telotristatethyl) ikke kan undgås, skal dosis af doravirin øges til 100 mg to gange dagligt (doserne skal tages med ca. 12 timers mellemrum) (se pkt.
English: • decreased levels of phosphate
Danish: • nedsat indhold af fosfat
English: Recommendation Concerning Co-administration with doravirine
Danish: Anbefalinger vedrørende administration sammen med doravirin
English: When used with other medicines, Pifeltro works by preventing HIV from making more viruses in your body.
Danish: Når Pifeltro anvendes sammen med andre lægemidler, virker det ved at hæmme hiv-virusets evne til at formere sig (lave kopier af sig selv) i kroppen.
English: Skin and subcutaneous tissue disorders Common rash
Danish: Hud og subkutane væv Almindelig udslæt
English: Gastrointestinal disorders Common nausea, diarrhoea, flatulence, abdominal pain vomiting
Danish: Mave-tarm-kanalen Almindelig kvalme, diarré, flatulens, abdominalsmerter opkastning
English: As a precautionary measure, it is preferable to avoid the use of doravirine during pregnancy.
Danish: For en sikkerheds skyld bør doravirin undgås under graviditeten.
English: Expected:  norgestimate/ethinyl oestradiol
Danish: Forventet:  norgestimat/ethinylestradiol
English: The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects.
Danish: Doravirins farmakokinetik blev undersøgt hos raske forsøgspersoner og hiv-1-inficerede forsøgspersoner.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Tabletterne indeholder lactosemonohydrat og bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Mutagenesis Doravirine was not genotoxic in a battery of in vitro or in vivo assays.
Danish: Doravirin var ikke genotoksisk i en række in vitro- og in vivo-analyser.
English: Croscarmellose sodium (E468) Hypromellose acetate succinate Lactose monohydrate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551)
Danish: Croscarmellosenatrium (E468) Hypromelloseacetatsuccinat Lactosemonohydrat Magnesiumstearat (E470b) Mikrokrystallinsk cellulose (E460) Silica, kolloid vandfri (E551)
English: • feeling tired
Danish: • træthedsfølelse.
English: Pifeltro 100 mg film-coated tablets doravirine
Danish: Pifeltro 100 mg filmovertrukne tabletter doravirin
English: Expected: ↔ doravirine ↔ maraviroc
Danish: Forventet: ↔ doravirin ↔ maraviroc
English: If you stop taking Pifeltro Do not run out of this medicine.
Danish: Sørg for ikke at løbe tør for dette lægemiddel.
English: Protease Inhibitors ritonavir
Danish: Proteasehæmmere ritonavir
English: Biotransformation Based on in vitro data, doravirine is primarily metabolized by CYP3A.
Danish: På baggrund af in vitro-data metaboliseres doravirin primært via CYP3A.
English: No dose adjustment of doravirine is needed in elderly patients (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis af doravirin hos ældre patienter (se pkt.
English: • The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal anhydrous E551.
Danish: • Øvrige indholdsstoffer: croscarmellosenatrium (E468), hypromelloseacetatsuccinat, lactosemonohydrat, magnesiumstearat (E470b), mikrokrystallinsk cellulose (E460) og silica, kolloid vandfri (E551).
English: Expected: ↔ doravirine ↔ enfuviritide maraviroc
Danish: Forventet: ↔ doravirin ↔ enfuviritid maraviroc
English: If you are not sure, talk to your doctor, pharmacist, or nurse before taking Pifeltro.
Danish: Hvis du er i tvivl, så kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Pifeltro.
English: HIV Antiviral Agents Fusion and Entry Inhibitors enfuvirtide
Danish: Hiv-antivirale midler Fusions- og CCR5-hæmmere enfuvirtid
English: The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171; and triacetin E1518.
Danish: Tabletterne er filmovertrukket med et overtræksmateriale med følgende indholdsstoffer: carnaubavoks (E903), hypromellose (E464), lactosemonohydrat, titandioxid (E171) og triacetin (E1518).
English: Doravirine has not been studied in patients with end-stage renal disease and has not been studied in dialysis patients (see section 5.2).
Danish: Doravirin er ikke undersøgt hos patienter med terminal nyresygdom (ESRD) og er ikke undersøgt hos dialysepatienter (se pkt.
English: Doravirine should not be coadministered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine (see sections 4.3 and 5.2).
Danish: Doravirin må ikke administreres sammen med lægemidler, der er potente CYP3A-enzyminduktorer, da der forventes at forekomme et signifikant fald i plasmakoncentrationen af doravirin, hvilket kan nedsætte doravirins virkning (se pkt.
English: ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
Danish: ledipasvir + sofosbuvir (90 mg ledipasvir enkeltdosis + 400 mg sofosbuvir enkeltdosis, doravirin 100 mg enkeltdosis)
English:  doravirine AUC 0.12 (0.10, 0.15) Cmax 0.43 (0.35, 0.52) C24 0.03 (0.02, 0.04) (Induction of CYP3A)
Danish: AUC 0,12 (0,10; 0,15) Cmax 0,43 (0,35; 0,52) C24 0,03 (0,02; 0,04) (CYP3A-induktion)
English: •bosentan (a medicine to treat lung disease) •dabrafenib (a medicine to treat skin cancer)
Danish: • dabrafenib (et lægemiddel til behandling af hudkræft)
English: If doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (approximately 12 hours apart).
Danish: Hvis doravirin administreres samtidigt med rifabutin, skal dosis af doravirin øges til 100 mg to gange dagligt (med ca. 12 timers mellemrum).
English: If Pifeltro is co-administered with rifabutin, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart) (see section 4.5).
Danish: Hvis Pifeltro administreres sammen med rifabutin, skal en 100 mg tablet Pifeltro tages to gange dagligt (med ca. 12 timers mellemrum) (se pkt.
English: Film-coating Carnauba wax (E903) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171)
Danish: Filmovertræk Carnaubavoks (E903) Hypromellose (E464) Lactosemonohydrat Titandioxid (E171) Triacetin (E1518)
English: When doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Danish: Når doravirin administreres sammen med rifabutin, skal dosis af doravirin øges til 100 mg to gange dagligt (doserne skal tages med ca. 12 timers mellemrum) (se pkt.
English: indigestion, soft stools, stomach spasms
Danish: fordøjelsesproblemer, blød afføring, mavekramper
English: What Pifeltro contains
Danish: Pifeltro indeholder:
English: Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of Pifeltro (see sections 4.4 and 4.5).
Danish: Samtidig administration med lægemidler, der er potente CYP3A-enzyminduktorer, er kontraindiceret, da der forventes at forekomme et signifikant fald i plasmakoncentrationen af doravirin, hvilket kan nedsætte Pifeltros virkning (se pkt.
English: How to take Pifeltro
Danish: Sådan skal du tage Pifeltro
English: • increased levels of liver enzymes (AST)
Danish: • forhøjet indhold af leverenzymer (ASAT)
English: Expected: ↔ doravirine ↔ abacavir
Danish: Forventet: ↔ doravirin ↔ abacavir emtricitabin
English: Musculoskeletal and connective tissue disorders Uncommon myalgia, arthralgia
Danish: Knogler, led, muskler og bindevæv Ikke almindelig myalgi, artralgi
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1 infected subjects.
Danish: På baggrund af en farmakokinetisk populationsanalyse af doravirin hos raske og hiv-1-inficerede forsøgspersoner er der ikke identificeret klinisk relevante racemæssige forskelle i doravirins farmakokinetik.
English: Doravirine 25 mg
Danish: Doravirin 25 mg
English: Expected: ↔ doravirine ↔ emtricitabine tenofovir alafenamide
Danish: Forventet: ↔ doravirin ↔ emtricitabin tenofoviralafenamid
English:  doravirine AUC 0.50 (0.45, 0.55) Cmax 0.99 (0.85, 1.15) C24 0.32 (0.28, 0.35) (Induction of CYP3A)
Danish: AUC 0,50 (0,45; 0,55) Cmax 0,99 (0,85; 1,15) C24 0,32 (0,28; 0,35) (CYP3A-induktion)
English:  doravirine AUC 3.06 (2.85, 3.29) Cmax 1.25 (1.05, 1.49) C24 2.75 (2.54, 2.98) (Inhibition of CYP3A)
Danish: AUC 3,06 (2,85; 3,29) Cmax 1,25 (1,05; 1,49) C24 2,75 (2,54; 2,98) (CYP3A-hæmning)
English:  doravirine AUC 1.15 (1.07, 1.24) Cmax 1.11 (0.97, 1.27) C24 1.24 (1.13, 1.36)
Danish: AUC 1,15 (1,07; 1,24) Cmax 1,11 (0,97; 1,27) C24 1,24 (1,13; 1,36)
English:  doravirine AUC 3.54 (3.04, 4.11) Cmax 1.31 (1.17, 1.46) C24 2.91 (2.33, 3.62) (Inhibition of CYP3A)
Danish: AUC 3,54 (3,04; 4,11) Cmax 1,31 (1,17; 1,46) C24 2,91 (2,33; 3,62) (CYP3A-hæmning)
English: Doravirine 200 mg
Danish: Doravirin 200 mg
English:  dolutegravir AUC 1.36 (1.15, 1.62) Cmax 1.43 (1.20, 1.71) C24 1.27 (1.06, 1.53) (Inhibition of BCRP)
Danish:  dolutegravir AUC 1,36 (1,15; 1,62) Cmax 1,43 (1,20; 1,71) C24 1,27 (1,06; 1,53) (BCRP-hæmning)
English: Doravirine 50 mg
Danish: Doravirin 50 mg
English: Expected: ↔ doravirine ↔ tenofovir alafenamide
Danish: Forventet: ↔ doravirin ↔ tenofoviralafenamid
English: Doravirine 100 mg
Danish: Doravirin 100 mg
English:  doravirine AUC 1.56 (1.45, 1.68) Cmax 1.41 (1.25, 1.58) C24 1.61 (1.45, 1.79) (Inhibition of CYP3A)
Danish: AUC 1,56 (1,45; 1,68) Cmax 1,41 (1,25; 1,58) C24 1,61 (1,45; 1,79) (CYP3A-hæmning)
English: • trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality sleep
Danish: • koncentrationsbesvær, hukommelsesproblemer, prikken og snurren i hænder og fødder,
English: lamivudine + tenofovir disoproxil (300 mg lamivudine SD + 245 mg tenofovir disoproxil SD, doravirine 100 mg SD)
Danish: lamivudin + tenofovirdisoproxil (300 mg lamivudin enkeltdosis +
English: No dose adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment.
Danish: Det er ikke nødvendigt at justere dosis af doravirin hos patienter med let nedsat, moderat nedsat eller svært nedsat nyrefunktion.
English: ↔ boosted PIs cobicistat-boosted PIs (darunavir, atazanavir)
Danish: ↔ boostede proteasehæmmere cobicistat-boostede proteasehæmmere (darunavir, atazanavir)
English:  lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
Danish:  lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
English: What Pifeltro is and what it is used for What you need to know before you take Pifeltro How to take Pifeltro
Danish: Det skal du vide, før du begynder at tage Pifeltro Sådan skal du tage Pifeltro Bivirkninger
English: 20-200 mg QD individualised dose, doravirine 100 mg QD
Danish: Opioidanalgetika methadon individualiseret dosis på 20-200 mg en gang dagligt, doravirin 100 mg en gang dagligt
English:  doravirine AUC 1.00 (0.89, 1.12) Cmax 1.06 (0.88, 1.28) C24 0.98 (0.88, 1.09)
Danish:  doravirin AUC 1,00 (0,89; 1,12) Cmax 1,06 (0,88; 1,28) C24 0,98 (0,88; 1,09)
English: Nucleoside Reverse Transcriptase Inhibitors tenofovir disoproxil (245 mg QD, doravirine 100 mg SD)
Danish: Nukleosid revers transkriptasehæmmere tenofovirdisoproxil (245 mg en gang dagligt, doravirin 100 mg enkeltdosis)
English: Interactions table
Danish: Interaktionstabel
English: Integrase Strand Transfer Inhibitors dolutegravir (50 mg QD, doravirine 200 mg QD)
Danish: Integrasehæmmere af genomoverførsel dolutegravir (50 mg en gang dagligt, doravirin 200 mg en gang dagligt)
English: Expected:  doravirine (Inhibition of CYP3A4)
Danish: Forventet:  doravirin (CYP3A4-hæmning)
English:  doravirine AUC 0.74 (0.61, 0.90) Cmax 0.76 (0.63, 0.91) C24 0.80 (0.63, 1.03)
Danish: AUC 0,74 (0,61; 0,90) Cmax 0,76 (0,63; 0,91) C24 0,80 (0,63; 1,03)
English: • kidney damage, kidney problems, kidney stones
Danish: • nyreskade, nyreproblemer, nyresten
English: Pharmacokinetic Enhancers ritonavir (100 mg BID, doravirine 50 mg SD)
Danish: Farmakokinetiske forstærkere ritonavir (100 mg to gange dagligt, doravirin 50 mg enkeltdosis)
English: Multiple dose rifampicin (600 mg QD, doravirine 100 mg SD)
Danish: Flere doser rifampicin (600 mg en gang dagligt, doravirin 100 mg enkeltdosis)
English:  doravirine AUC 0.83 (0.76, 0.91) Cmax 0.88 (0.76, 1.01) C24 0.84 (0.77, 0.92)
Danish: AUC 0,83 (0,76; 0,91) Cmax 0,88 (0,76; 1,01) C24 0,84 (0,77; 0,92)
English: Difference (95 % CI) 4.2 % (-1.4%, 9.7 %)
Danish: Forskel (95% CI)
English: Expected:  doravirine (CYP3A inhibition)
Danish: Forventet:  doravirin (CYP3A-hæmning)
English: abacavir
Danish:  doravirin
English: omeprazole
Danish: søvngængeri
English: Opioid Analgesics methadone
Danish: Antineoplastiske midler mitotan
English: Minimum, maximum
Danish: Minimum, maksimum
English: 50 to < 65
Danish: 50 til < 65
English: Black or African American White
Danish: Sort eller afroamerikansk
English: The next prescribed dose should be taken at the usual time.
Danish: Den næste ordinerede dosis skal tages på det sædvanlige tidspunkt.
English: Talzenna could harm an unborn baby.
Danish: Talzenna kan skade et ufødt barn.
English: Swallow the capsule whole with a glass of water.
Danish: Synk kapslen hel med et glas vand.
English: Symptoms of overdose are not established.
Danish: Symptomer på overdosering er ikke fastlagt.
English: There is no information on fertility in patients.
Danish: Der foreligger ingen informationer om fertilitet hos patienterne.
English: Overall survival (interim analysis)c
Danish: Overall survival (interimanalyse)
English: The OS interim analysis was performed at 51% for the total number of planned events.
Danish: OS-interimanalyse blev udført ved 51 % for det samlede antal planlagte hændelser.
English: 90537 Feucht Germany
Danish: 90537 Feucht Tyskland
English: If you stop taking Talzenna Do not stop taking Talzenna unless your doctor tells you to.
Danish: Hvis du holder op med at tage Talzenna Du må ikke stoppe med at tage Talzenna, medmindre din læge fortæller dig det.
English: Not reported
Danish: Ikke indberettet
English: Recommended dose reductions are indicated in Table 1.
Danish: Anbefalede dosisreduktioner fremgår af tabel 1.
English: Urgent treatment may be necessary.
Danish: Det kan være nødvendigt at du får akut behandling.
English: Age, sex, and body weight
Danish: Alder, køn og kropsvægt
English: Patients should be treated until disease progression or unacceptable toxicity occurs.
Danish: Patienterne skal behandles indtil sygdomsprogression eller uacceptabel toksicitet.
English: No deaths were reported due to myelosuppression-related adverse reactions.
Danish: Der blev ikke indberettet dødsfald som følge af bivirkninger relateret til myelosuppression.
English: Objective response by investigatord,e
Danish: Objektivt respons ifølge investigator d,e
English: Tell your doctor straight away if you notice any of the following symptoms which could be a sign of serious blood disorder:
Danish: Kontakt straks til din læge, hvis du bemærker nogen af følgende symptomer, som kan være tegn på en alvorlig blodsygdom:
English: Talzenna is used when the cancer has spread beyond the original tumour or to other parts of the body.
Danish: Talzenna bruges når kræften har spredt sig ud over den oprindelige tumor eller til andre dele af kroppen.
English: Duration of response by investigatord
Danish: Varighed af respons ifølge investigator
English: Talk to your doctor if you get any other side effects.
Danish: Tal med din læge, hvis du får andre bivirkninger.
English: There are no data from the use of Talzenna in pregnant women.
Danish: Der er ingen data fra anvendelse af Talzenna hos gravide kvinder.
English: Number of patients at risk
Danish: Antal risikopatienter
English: Most of the histopathologic findings were generally reversible while the testes findings were partially reversible after 4 weeks of dosing cessation.
Danish: De fleste af de histopatologiske fund var generelt reversible, hvorimod fundene i testiklerne var delvist reversible efter 4 ugers ophør med dosering.
English: If you have taken more Talzenna than your normal dose, contact your doctor or nearest hospital right away.
Danish: Hvis du har taget mere Talzenna end din normale dosis, skal du straks kontakte din læge eller nærmeste hospital.
English: Do not open the capsules.
Danish: Undlad at åbne kapslerne.
English: Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Danish: - tal med din læge om prævention, hvis der er mulighed for, at du eller din partner kan blive gravid.
English: Dose modification and management Withhold Talzenna until levels resolve to
Danish: Dosisændring og -håndtering Tilbagehold Talzenna, indtil værdierne er