FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: CR=complete remission; CRp=complete remission with incomplete platelet recovery; CI=confidence interval; EFS=event-free survival; mITT=modified intent-to-treat; n=number; N=number; NE= not estimable; OS=overall survival; RFS=relapse-free survival.
Danish: Forkortelser: CR = komplet remission; CRp = komplet remission med ufuldstændig bedring af trombocyttal; CI = konfidensinterval; EFS = hændelsesfri overlevelse; mITT = modificeret intent-to-treat; n = tal; N = antal; NE = ikke estimerbart; OS = samlet overlevelse; RFS = relapsfri overlevelse.
English: When reconstituted to a 1 mg/mL concentration, the extractable content of one vial is 4.5 mg (4.5 mL).
Danish: Efter rekonstitution til en koncentration på 1 mg/ml er den ekstraherbare mængde i et hætteglas 4,5 mg (4,5 ml).
English: Gently invert the infusion container to mix the diluted solution.
Danish: Vend forsigtigt infusionsbeholderen om for at blande den fortyndede opløsning.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
Danish: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
English: • Complication known as tumour lysis syndrome Tell your doctor right away if you experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Danish: • Komplikation kaldet tumorlysesyndrom Fortæl straks din læge, hvis du oplever symptomer såsom svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, åndenød eller hjerterytmeforstyrrelser.
English: Mylotarg vials contain 5 mg of drug product with no overfill.
Danish: Mylotarg hætteglas indeholder 5 mg lægemiddel uden overskud.
English: • Gently invert the infusion container to mix the diluted solution.
Danish: • Hvirvl infusionsbeholderen forsigtigt for at blande den fortyndede opløsning.
English: a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Danish: Infektion omfatter sepsis og bakteriæmi (53,4 %), svampeinfektion (15,3 %), nedre luftvejsinfektion (5,3 %),
English: Each carton contains 1 amber, glass vial, with rubber stopper and crimp seal with flip-off cap.
Danish: Hver æske indeholder et ravgult hætteglas med en gummiprop og flip off-hætte med krympeforsegling.
English: In patients with hyperleukocytic (leukocyte count ≥ 30,000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of MYLOTARG.
Danish: 3) AML anbefales cytoreduktion enten med leukaferese, oral hydroxyurea eller AraC med eller uden hydroxyurea for at reducere antallet af perifere hvide blodlegemer 48 timer inden administration af MYLOTARG.
English: Dose modifications for haematological toxicities Haematological toxicities
Danish: Dosisændringer på grund af hæmatologisk toksicitet Hæmatologisk toksicitet
English: Τηλ: +357 22 817690
Danish: (Cyprus Branch) Τηλ: +357 22 817690
English: Dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Danish: Dextran 40, saccharose, natriumchlorid, natriumdihydrogenphosfatmonohydrat, dinatriumphosphat, vandfri.
English: Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, either before or after an haematopoietic stem cell transplant (HSCT), and patients with moderate or severe hepatic impairment are at increased risk for developing VOD (see section 4.8).
Danish: Baseret på en analyse over potentielle risikofaktorer er der en øget risiko for udvikling af VOD hos voksne patienter, der har fået MYLOTARG som monoterapi, enten før eller efter en hæmatopoietisk stamcelletransplantation (HSCT), samt hos patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma, and subdural haematoma).
Danish: Dødelig blødning/hæmoragiske reaktioner blev indberettet for 3 (2,3 %) patienter (cerebralt hæmatom, intrakranialt hæmatom og subduralt hæmatom).
English: b. Based on the Cox Proportional Hazards Model Versus daunorubicin+cytarabine.
Danish: Baseret på Cox proportional hazards-model versus daunorubicin + cytarabin.
English: • Abnormalities in liver blood tests (which can be indicators of liver injury)
Danish: • Unormale leverblodprøver (som kan antyde leverskade)
English: MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).
Danish: MYLOTARG kan ikke bruges til patienter med den type kræft, som hedder promyelocyt leukæmi.
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous
Danish: Natriumdihydrogenphosfatmonohydrat Dinatriumphosfat, vandfri
English: • Inspect the reconstituted solution for particulates and discolouration.
Danish: • Se efter, om den rekonstituerede opløsning indeholder partikler eller er misfarvet.
English: In toxicity studies, rats developed preneoplastic lesions (minimal to slight oval cell hyperplasia) in the liver approximately 54 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Danish: I toksicitetsstudierne udviklede rotter præ-neoplastiske læsioner (minimal til svag oval celle hyperplasi) i leveren ved ca. 54 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m baseret på AUC168.
English: For patients being treated with MYLOTARG in combination with daunorubicin and cytarabine for newly diagnosed de novo AML, when cytogenetics testing results become available it should be considered whether the potential benefit of continuing treatment with MYLOTARG outweighs the risks for the individual patient (see section 5.1).
Danish: Når de cytogenetiske resultaterne bliver tilgængelige hos patienter med nydiagnosticeret de novo AML i kombinationsbehandling med MYLOTARG sammen med daunorubicin og cytarabin, bør den potentielle fordel af forsat behandling med MYLOTARG vurderes i forhold til risikoen for den enkelte patient (se pkt.
English: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin.
Danish: Gemtuzumab ozogamicin er et antistof-lægemiddelkonjugat (ADC) sammensat af det CD33-rettede monoklonale antistof (hP67.6; rekombinant humaniseret immunoglobulin [Ig] G4, kappa-antistof fremstillet af pattedyrcellekultur i NS0-celler), som er kovalent bundet til det cytotoksiske stof Nacetyl-gamma-calicheamicin.
English: Haemoglobin decreased Platelets decreased White blood cells decreased Lymphocytes (absolute) decreased
Danish: Nedsat hæmoglobin Nedsat antal trombocytter Nedsat antal hvide blodlegemer Nedsat antal (absolutte) lymfocytter Nedsat antal neutrofile Hyperglykæmi
English: Unopened vial: Store in a refrigerator (2°C-8°C).
Danish: Uåbnede hætteglas: Opbevares i køleskab (2 °C - 8 °C).
English: Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemic or other agents for treatment of hyperuricaemia should be taken (see section 4.4).
Danish: Der bør træffes passende foranstaltninger til forebyggelse af udvikling af tumorlyserelateret hyperurikæmi, såsom hydrering, administration af antihyperurikæmiske eller andre midler til behandling af hyperurikæmi (se pkt.
English: MYLOTARG + daunorubicin + cytarabine (N=131)
Danish: MYLOTARG + daunorubicin + cytarabin (N=131)
English: • infusion reaction: experience during or shortly after MYLOTARG infusion symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome).
Danish: • infusionsreaktion: oplever symptomer, under eller kort efter infusion med MYLOTARG, såsom svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, åndenød eller hjerterytmeforstyrrelser (dette kan skyldes en mulig livstruende komplikation, som kaldes tumorlysesyndrom).
English: Abbreviat ion: P T =preferred t erm.
Danish: Forkortelse: FT = Foretrukken term a.
English: Discontinue MYLOTARG (see section 4.4).
Danish: Seponering af MYLOTARG (se pkt.
English: How MYLOTARG will be given 4.
Danish: Sådan administreres MYLOTARG 4.
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection.
Danish: De hyppigste (≥1 %) bivirkninger, der førte til permanent seponering i kombinationsbehandlingsstudiet, var trombocytopeni, VOD, blødning og infektion.
English: A systematic literature review of studies was conducted to evaluate MYLOTARG in paediatric patients with relapsed or refractory AML, which included 454 patients receiving MYLOTARG either as a monotherapy (single or fractionated dosing) or combination therapy from 16 published papers plus the US Expanded Access Study (see section 4.8).
Danish: Der blev udført en systematisk litteraturgennemgang af studier fra 16 publicerede artikler plus US Expanded Access Study, som omfattede 454 patienter, for at evaluere MYLOTARG hos pædiatriske patienter med recidiverende eller refraktær AML, der fik MYLOTARG som enten monoterapi (enkelt eller fraktioneret dosering) eller kombinationsbehandling (se pkt.
English: Relapse-free survival (by Investigator)
Danish: Relapssfri overlevelse (ved investigator)
English: • Toxic waste disposal procedures prescribed for anticancer medicinal products must be used.
Danish: • Der skal anvendes procedurer for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler.
English: Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see section 4.2).
Danish: Behandling af patienter med svær infektion, blødning/hæmoragi eller andre virkninger af knoglemarvssuppression, herunder svær neutropeni eller vedvarende trombocytopeni, kan gøre det nødvendigt at udsætte dosering eller permanent seponere behandlingen med MYLOTARG (se pkt.
English: t. Hepatic function abnormal includes the following reported PTs: Liver function test abnormal and Hepatic function abnormal.
Danish: Unormal leverfunktion omfatter følgende indberettede FT'er: unormal leverfunktionstest og unormal hepatisk funktion.
English: In a female rat fertility study slightly lower numbers of corpora lutea and increased embryolethality were observed in the presence of maternal toxicity (approximately 9.7 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Danish: I et fertilitetsstudie hos hunrotter blev der observeret lidt lavere antal corpora lutea og øget embryomortalitet med maternel toksicitet (ved ca. 9,7 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m2 baseret på AUC168).
English: The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone.
Danish: ALFA-0701-studie hos tidligere ubehandlede patienter med de novo AML Sikkerhed og virkning af MYLOTARG er blevet vurderet i et multicenter, randomiseret, open-label fase 3-studie, hvor man sammenlignede tilføjelse af MYLOTARG til et standard kemoterapiinduktionsregimen med daunorubicin og cytarabin (DA) kontra DA alene.
English: MYLOTARG daunorubicin cytarabine hydroxyurea
Danish: MYLOTARG daunorubicin cytarabin hydroxyurea
English: Effect of other medicinal products on gemtuzumab ozogamicin
Danish: Gemtuzumab ozogamicins virkninger på andre lægemidler
English: • Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)
Danish: • Lungebetændelse, som giver hoste og besværet vejrtrækning
English: Effect on drug transporter substrates
Danish: Virkning på lægemiddel-transportsubstrater
English: In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice.
Danish: Hvis patienten oplever VOD/SOS, bør MYLOTARG afbrydes og patienten behandles iht.
English: Management of signs or symptoms of hepatic toxicity may require a dose interruption, or discontinuation of MYLOTARG (see section 4.2).
Danish: Behandling af symptomer på levertoksicitet kan kræve dosisafbrydelse eller seponering af MYLOTARG (se pkt.
English: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of CD33-directed monoclonal antibody (hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin.
Danish: Gemtuzumab ozogamicin er et antistof-lægemiddelkonjugat (ADC) sammensat af det CD33-rettede monoklonale antistof (hP67.6), der er kovalent bundet til det cytotoksiske stof N-acetyl-gammacalicheamicin.
English: m. Hypertension includes the following reported PTs: Hypertension and Blood pressure increased.
Danish: Hypertension omfatter følgende indberettede FT'er: hypertension og forhøjet blodtryk.
English: Consolidation Course 1a,b
Danish: Konsolideringsforløb 1
English: Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemics (e.g., allopurinol) or other agents for treatment of hyperuricaemia (e.g., rasburicase) must be taken.
Danish: Der bør træffes passende foranstaltninger til forebyggelse af udvikling af tumorlyserelateret hyperurikæmi, såsom hydrering, administration af antihyperurikæmiske (fx allopurinol) midler eller andre midler til behandling af hyperurikæmi (fx rasburikase).
English: Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population)
Danish: Hændelsesfri overlevelse (investigators vurdering) i forhold til AML risikoklassifikation fra studie ALFA-0701 (mITT Population)
English: • Excessive accumulation of fluid in the abdomen/stomach
Danish: • Omfattende væskeansamling i underlivet/maven
English: In the completed randomised paediatric Phase 3 Study AAML0531 (see section 5.1) of gemtuzumab ozogamicin combined with intensive first-line therapy in 1,063 newly diagnosed children (93.7% of patients <18 years of age), and young adults (6.3% of patients) with de novo AML aged 0 to 29 years, the safety profile was similar with that observed in the other studies of gemtuzumab ozogamicin combined with intensive chemotherapy in adult patients with de novo AML.
Danish: 5.1) med gemtuzumab ozogamicin kombineret med intensiv førstelinjebehandling hos 1.063 nyligt diagnosticerede børn (93,7 % af patienterne <18 år) og unge (6,3 % af patienterne) med de novo AML i alderen 0 til 29 år, var sikkerhedsprofilen den samme som den, der blev observeret i andre studier med gemtuzumab ozogamicin kombineret med intensiv kemoterapi hos voksne patienter med de novo AML.
English: Safety information on myelosuppression, infections, VOD overall and VOD post-HSCT, and death, which are known adverse events for MYLOTARG (see section 4.8 and Table 7), was obtained from literature.
Danish: Sikkerhedsoplysninger vedrørende myelosuppression, infektioner, samlet VOD og VOD efter HSCT samt dødsfald, som er kendte bivirkninger af MYLOTARG (se pkt.
English: Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test. Efficacy data from ALFA-0701 study are summarised in Table 8, and the Kaplan-Meier plot for EFS is shown in Figure 1.
Danish: Medianen for hændelsesfri overlevelse var 17,3 måneder (95 % CI: 13,4-30,0) i MYLOTARG-armen sammenlignet med 9,5 måneder (95 % CI: 8,1-12,0) i DA-armen alene; hazardratio (HR) 0,562 (95 % CI: 0,415-0,762); dobbeltsidet p=0,0002 med log-rank test.
English: Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage, and pulmonary alveolar haemorrhage [2 patients]).
Danish: Grad 4 blødning/hæmoragiske reaktioner blev indberettet for 4 (3,1 %) patienter (gastrointestinal blødning, blødning og lungealveolarblødning (2 patienter)).
English: MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Danish: MYLOTARG indeholder det aktive stof gemtuzumab ozogamicin, et lægemiddel mod kræft.
English: Effects on liver, kidney and male reproductive organs in rats, and on lymphoid tissues in monkeys (approximately 18 times for rats, and 36 times for monkeys, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168) were not reversible.
Danish: Virkning på rotters lever, nyre, hanrotters reproduktive organer og abers lymfevæv (ved ca. 18 gange større hos rotter og 36 gange større hos aber end human klinisk eksponering efter tredje humane dosis på 3 mg/m baseret på AUC) var ikke reversibel.
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 3, 6, and 9
Danish: 3 mg/m2/dosis (op til højst et hætteglas af 5 mg) på dag 3, 6, og 9
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1
Danish: 3 mg/m2/dosis (op til højst et hætteglas af 5 mg) på dag 1
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også håndkøbsmedicin og naturlægemidler.
English: Consolidation Course 2a,b
Danish: Konsolideringsforløb 2
English: • Prior to reconstitution, allow the vial to reach room temperature (below 25°C) for approximately 5 minutes.
Danish: • Lad hætteglasset nå stuetemperatur (under 25 °C) inden rekonstitution i ca. 5 minutter.
English: • Budd-Chiari syndrome, which includes pain in the upper right part of the belly, an abnormally large liver, and/or accumulation of fluid in the belly associated with blood clots in the liver.
Danish: • Smerter i øverste højre side af maven, unormal stor lever og/ eller ophobning af væske i bughulen forbundet med blodpropper i leveren (Budd-Chiaris syndrom).
English: During the induction phase, 121 (92.4%) and 118 (90.1%) patients had a documented neutrophil recovery to ANC of 500/mm3 and 1,000/mm3, respectively.
Danish: Under induktionsfasen havde 121 (92,4 %) og 118 (90,1 %) patienter dokumenteret restitution af neutrofiltal til ANC på henholdsvis 500/mm 3 og 1.000/mm 3.
English: VOD was also reported in 2 patients who received MYLOTARG as a follow-up therapy following relapse of AML after chemotherapy treatment in the control arm of the combination therapy study.
Danish: I kombinationsbehandlingsstudiets kontrolarm blev VOD også indberettet hos 2 patienter, som fik gemtuzumab ozogamicin som opfølgningsterapi efter tilbagefald af AML efter kemoterapibehandling.
English: Women of childbearing potential, or partners of females of childbearing potential should be advised to use 2 methods of effective contraception during treatment with MYLOTARG for at least 7 months (females) or 4 months (males) after the last dose.
Danish: Kvinder i den fertile alder eller mænd med kvindelige partnere i den fertile alder skal rådes til at anvende 2 effektive kontraceptionsmetoder under behandlingen med MYLOTARG og i mindst 7 måneder (for kvinder) eller 4 måneder (for mænd) efter den sidste dosis.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving MYLOTARG.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Kvinder i den fertile alder skal rådes til at undgå at blive gravide, mens de får MYLOTARG.
English: o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness.
Danish: Abdominalsmerter omfatter følgende indberettede FT'er: mavesmerter, smerter i lavere abdomen, smerter i øvre abdomen, ubehag i abdomen og ømhed i abdomen.
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours.
Danish: Hvis opløsningen ikke anvendes straks, kan den opbevares ved stuetemperatur (under 25°C) i op til 6 timer.
English: f. Pancytopenia includes the following reported PTs: Pancytopenia and Bone marrow failure.
Danish: Pancytopeni omfatter følgende indberettede FT'er: Pancytopeni og knoglemarvssvigt.
English: • Liver venoocclusive disease (VOD), which includes signs of enlarged liver, pain in the upper right belly, yellowing of the skin and the whites of the eyes, accumulation of fluid in the abdomen, weight gain, abnormal liver blood tests
Danish: • Symptomer på forstørret lever, smerter i øverste højre side af maven, gulfarvning af huden og det hvide i øjnene, ophobning af væske i bughulen, vægtøgning, unormale levertest (venookklusiv leversygdom)
English: Abbreviations: AML =acute myeloid leukaemia; CI=confidence interval; EFS=event-free survival; ELN=European LeukaemiaNet; mIT T =modified intent-to-treat; n=number; N=number; NE=not estimable.
Danish: Forkortelser: AML= akut myeloid leukæmi; CI=konfidenceinterval; EFS= hændelsesfri overlevelse; ELN=European LeukaemiaNet; mITT=modificeret intent-to-treat; n=antal; N=antal.
English: Table 10.
Danish: Skema 10.
English: Myelosuppression
Danish: Myelosuppressi on
English: Interactions with other medicinal products
Danish: Lægemiddelinteraktioner
English: Infusion lines made of PVC (DEHP- or non-DEHP-containing), or polyethylene are recommended.
Danish: Det anbefales at bruge infusionsslanger fremstillet af PVC (med eller uden DEHP) eller polyætylen.
English: In the combination therapy study, in patients with de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy (N=131), 102 (77.9%) patients experienced all causality severe (Grade ≥ 3) infections.
Danish: I kombinationsbehandlingsstudiet oplevede 102 (77,9 %) patienter med de novo AML behandlet med fraktionerede doser gemtuzumab ozogamicin kombineret med kemoterapi (N=131) alvorlige (grad ≥3) infektioner af alle årsager.
English: • If platelet count recovers to < 100,000/mm3 and ≥ 50,000/mm3 within 14 days following the planned start date of the consolidation course: MYLOTARG should not be re-introduced and consolidation therapy should consist of DNR and AraC only.
Danish: 3 inden for 14 dage efter konsolideringsforløbets planlagte startdato: Bør MYLOTARG ikke genstartes, og konsolideringsterapien bør kun bestå af DNR og AraC.
English: In clinical studies, TLS was reported (see section 4.8).
Danish: Der er set TLS i kliniske studier (se pkt.
English: In the consolidation 1 phase of therapy, 94 (96.9%) patients had neutrophil recovery to counts of 500/mm3, and 91 (94%) patients recovered to counts of 1,000/mm3.
Danish: Under konsolideringsfase 1 af behandlingen havde 94 (96,9 %) patienter forbedret neutrofiltallet til 500/mm 3, og 91 (94 %) patienter forbedrede tallet til
English: Women of childbearing potential, or partners of females of childbearing potential should be advised to use 2 methods of effective contraception during treatment with MYLOTARG for at least 7 months (females) or 4 months (males) after the last dose (see section 4.6).
Danish: Kvinder i den fertile alder eller mænd med kvindelige partnere i den fertile alder skal rådes til at anvende 2 effektive kontraceptionsmetoder under behandlingen med MYLOTARG og i mindst 7 måneder (for kvinder) eller 4 måneder (for mænd) efter sidste dosis (se pkt.
English: MYLOTARG is a powder for concentrate for solution for infusion.
Danish: MYLOTARG er et pulver til koncentrat til infusionsvæske, opløsning.
English: How to store MYLOTARG
Danish: Sådan administreres MYLOTARG