FrancophonIA/ELRC3.0 huggingface dataset:
English: Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone.
Danish: Ixazomib udviste in vitro-cytotoksicitet over for myelomceller fra patienter, som havde fået tilbagefald efter flere tidligere behandlinger, herunder bortezomib, lenalidomid og dexamethason.
English: Ixazomib is a low affinity substrate of P-gp.
Danish: Ixazomib er et P-gp-substrat med lav affinitet.
English: The recommended dose of lenalidomide is 25 mg taken every day for the first 3 weeks of the cycle.
Danish: Den anbefalede dosis af lenalidomid er 25 mg, der skal tages hver dag i de første 3 uger af cyklussen.
English: Pre- and post-dialyzer concentrations of ixazomib measured during the haemodialysis session were similar, suggesting that ixazomib is not dialyzable (see section 4.2).
Danish: Ixazomib-koncentrationerne før og efter dialysatoren, målt under hæmodialysesessionen, var stort set ens, hvilket tyder på, at ixazomib ikke er dialyserbart (se pkt.
English: Male and female patients who are able to have children must use effective contraceptive measures during and for 90 days following treatment.
Danish: Fertile mandlige og kvindelige patienter skal benytte sikker kontraception under behandling og i mindst 90 dage efter behandlingsophør.
English: Discontinue treatment regimen.
Danish: Seponer behandlingen.
English: • numbness, tingling or burning of the hands or feet (peripheral neuropathy)
Danish: • følelsesløshed eller en prikkende eller brændende fornemmelse i hænder eller fødder (perifer neuropati)
English: Concomitant medicinal products, such as antiemetic, antiviral, and antihistamine medicinal products were given to patients at the physician's discretion as prophylaxis and/or management of symptoms.
Danish: Efter lægens skøn fik patienterne samtidig lægemidler, f.eks. antiemetika, antivirale midler og antihistaminer, som forebyggelse mod og/eller håndtering af symptomer.
English: Ixazomib + Lenalidomide and Dexamethasone (N = 360)
Danish: ixazomib + lenalidomid og dexamethason (N = 360)
English: • rare blood condition resulting from blood clots that may cause fatigue, fever, bruising, nose bleeds, decreased urination (thrombotic thrombocytopenic purpura)
Danish: • sjælden blodsygdom som følge af blodpropper, hvilket kan forårsage træthed, feber, blå mærker, næseblod, nedsat vandladning (trombotisk trombocytopenisk purpura).
English: Rash Grade† 2 or 3
Danish: Udslæt Grad† 2 eller 3
English: The ixazomib dose reduction steps are presented in Table 1 and the dose modification guidelines are provided in Table 2.
Danish: Dosisreduktionstrinnene for ixazomib kan ses i Tabel 1, og retningslinjerne for dosisjustering ses i Error!
English: See the package leaflets for lenalidomide and dexamethasone for additional information on pregnancy and breast-feeding
Danish: Læs indlægssedlen for lenalidomid og dexamethason for at få yderligere oplysninger om graviditet og amning.
English: NINLARO is used to treat adults with multiple myeloma.
Danish: NINLARO anvendes til behandling af voksne med myelomatose.
English: In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma.
Danish: In vivo udviste ixazomib antitumoraktivitet i forskellige tumor-xenograftmodeller, herunder modeller af myelomatose.
English: What NINLARO is NINLARO is a cancer medicine that contains ixazomib, a ‘proteasome inhibitor'.
Danish: NINLARO er et lægemiddel mod kræft, der indeholder ixazomib, som er en såkaldt proteasomhæmmer.
English: Refer to the lenalidomide SmPC, section 4.2 for the dose reduction steps for these toxicities.
Danish: 4.2 i produktresuméet for lenalidomid vedrørende dosisreduktionstrin ved disse bivirkninger.
English: *For additional occurrences, alternate dose modification of lenalidomide and ixazomib †Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03
Danish: †Klassificering baseret på National Cancer Institute Common Terminology Criteria (CTCAE) version 4.03
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Danish: Kvinder, der anvender hormonel kontraception, skal derudover anvende en barrieremetode.
English: What you need to know before you take NINLARO
Danish: Det skal du vide, før du begynder at tage NINLARO
English: Table 4: Progression free survival and response Results in multiple myeloma patients treated with ixazomib or placebo in combination with lenalidomide and dexamethasone (intent-to-treat population)
Danish: Tabel 4: Progressionsfri overlevelse og responsresultater hos patienter med myelomatose behandlet med ixazomib eller placebo i kombination med lenalidomid og dexamethason (ITT-population)
English: If contact occurs, wash thoroughly with soap and water.
Danish: Vask grundigt med sæbe og vand, hvis der opstår kontakt.
English: Ixazomib is not recommended in women of childbearing potential not using contraception.
Danish: ixazomib frarådes til kvinder i den fertile alder, som ikke benytter kontraception.
English: • Non-haematologic toxicities should, at the physician's discretion, generally be recovered to patient's baseline condition or ≤ Grade 1
Danish: • Ikke-hæmatologiske toksiciteter skal generelt være restitueret til patientens baseline-niveau eller ≤ grad 1, efter lægens skøn
English: The PK of ixazomib was characterized at a dose of 3 mg in patients with normal renal function (creatinine clearance ≥ 90 mL/min, N=18), severe renal impairment (creatinine clearance < 30 mL/min, N=14), or ESRD requiring dialysis (N=6).
Danish: Ixazomibs PK blev bestemt ved en dosis på 3 mg hos patienter med normal nyrefunktion (kreatininclearance ≥ 90 ml/min., N = 18), alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min., N = 14) eller dialysekrævende ESRD (N = 6).
English: • Withhold ixazomib.
Danish: • Udsæt ixazomib.
English: There was no discernible relationship between ixazomib concentration and the RR interval suggesting no clinically meaningful effect of ixazomib on heart rate.
Danish: Der kunne ikke konstateres nogen sammenhæng mellem ixazomibkoncentration og RR-interval, hvilket tyder på, at ixazomib ikke har nogen klinisk relevant indvirkning på hjerterytmen.
English: Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients given the ixazomib, lenalidomide and dexamethasone combination.
Danish: Fungal og viral pneumoni med dødelig udgang blev sjældent rapporteret hos patienter, der fik en kombination af ixazomib, lenalidomid og dexamethason.
English: Ixazomib is 99% bound to plasma proteins and distributes into red blood cells with a blood-to-plasma AUC ratio of 10.
Danish: Ixazomib er 99% bundet til plasmaproteiner og fordeles i røde blodlegemer med en blod:plasma AUC-ratio på 10. Ved steady state er fordelingsvolumenet 543 l.
English: NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma.
Danish: Du vil få NINLARO sammen med lenalidomid og dexamethason, som også er lægemidler, der bruges til behandling af myelomatose.
English: Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 24% in patients in the ixazomib regimen and 15% of patients in the placebo regimen.
Danish: Øjenlidelser blev indberettet under mange forskellige foretrukne termer, men samlet under et var hyppigheden 24% i ixazomib-gruppen og 15% i placebogruppen.
English: Table 3: Adverse reactions in patients treated with ixazomib in combination with lenalidomide and dexamethasone (all grades, grade 3 and grade 4) System organ class /
Danish: Tabel 3: Bivirkninger hos patienter, der fik ixazomib i kombination med lenalidomid og dexamethason (alle grader, grad 3 og grad 4) Systemorganklasse/bivirkning Bivirkninger
English: Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Danish: Perifer motorisk neuropati blev rapporteret hos < 1% i begge grupper.
English: Absolute neutrophil count < 500/mm3
Danish: Neutropeni (absolut neutrofiltal) Absolut neutrofiltal < 500/mm3
English: Rash should be managed with supportive care or with dose modification if Grade 2 or higher (see section 4.2).
Danish: Udslæt skal håndteres med understøttende pleje og med dosisændringer ved grad 2 eller højere (se pkt.
English: Women of childbearing potential must use highly effective contraception while taking ixazomib and for 90 days after stopping treatment (see sections 4.5 and 4.6).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception, mens de tager ixazomib, og i mindst 90 dage efter behandlingsophør (se pkt.
English: NINLARO must be prescribed to you by a doctor with experience of treating multiple myeloma.
Danish: NINLARO skal ordineres af en læge med erfaring i behandling af myelomatose.
English: Peripheral neuropathy Grade 1 peripheral neuropathy with pain or Grade 2 peripheral neuropathy
Danish: Perifer neuropati Grad 1 perifer neuropati med smerter og grad 2 perifer neuropati
English: C16019: In order to further investigate the efficacy the MAH should provide additional OS/PFS2 data when approximately 200 death events have occurred from the Phase 3, randomized, placebo-controlled, double-blind study of ixazomib in maintenance therapy in patients with multiple myeloma following SCT.
Danish: C16019: Med henblik på at undersøge virkningen yderligere skal indehaveren af markedsføringstilladelsen levere yderligere OS/PFS2-data, når omtrent 200 dødshændelser har fundet sted fra det randomiserede, placebokontrollerede, dobbeltblindede fase 3-studie af ixazomib givet som vedligeholdelsesbehandling til patienter med myelomatose efter SCT.
English: • lowered white blood cells called neutrophils (neutropenia) that may increase the risk of infection
Danish: • nedsat antal af de hvide blodlegemer, der kaldes neutrofiler (neutropeni).
English: Co-administration of ixazomib with clarithromycin, a strong CYP3A inhibitor, did not result in a clinically meaningful change in the systemic exposure of ixazomib.
Danish: Samtidig behandling med ixazomib og clarithromycin, en potent CYP3A-hæmmer, resulterede ikke i en klinisk relevant ændring i den systemiske eksponering af ixazomib.
English: Table 2: Dose modifications guidelines for ixazomib in combination with lenalidomide and dexamethasone
Danish: Tabel 2: Retningslinjer for dosisjustering for ixazomib i kombination med lenalidomid og dexamethason
English: C16014: In order to further investigate the efficacy the MAH should conduct a phase 3, randomized, double-blind, multicenter study comparing ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone in adult patients with newly diagnosed multiple myeloma not eligible for stem cell transplantation (SCT) and provide the final report for primary endpoint PFS.
Danish: C16014: Med henblik på at undersøge virkningen yderligere skal indehaveren af markedsføringstilladelsen gennemføret et randomiseret, dobbeltblindt fase 3-multicenterstudie, hvor ixazomib plus lenalidomid og dexamethason bliver sammenlignet med placebo plus lenalidomid og dexamethason hos voksne patienter med nyligt diagnosticeret myelomatose, der ikke er egnede til stamcelletransplantation (SCT), og frembringe den endelige rapport for det primære endepunkt progressionsfri overlevelse.
English: Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (see section 4.2).
Danish: Leverenzymer skal monitoreres regelmæssigt, og dosis skal justeres ved grad 3- eller 4-symptomer (se pkt.
English: Dosing schedule: Ixazomib taken with lenalidomide and dexamethasone 28-day cycle (a 4-week cycle)
Danish: Doseringsskema: ixazomib taget sammen med lenalidomid og dexamethason 28-dages cyklus (en 4-ugers cyklus)
English: • muscle weakness, loss of feelings of the toes and feet or loss of leg movement (transverse myelitis)
Danish: • muskelsvaghed, manglende følesans i tæer og fødder eller lammelse af benene (transversel myelitis)
English: Overall Response Rate‡, n (%) 282 (78.3) Response Category, n (%) Complete Response
Danish: Responskategori, n (%) Komplet respons Meget god partiel respons Partiel respons
English: There was no clinically meaningful effect of age (23-91 years), sex, body surface area (1.2-2.7 m2), or race on the clearance of ixazomib based on the results of a population PK analysis.
Danish: Baseret på resultaterne af en populationsfarmakokinetisk analyse har alder (23-91 år), køn, kropsoverfladeareal (1,2-2,7 m2) og race ingen klinisk relevant indvirkning på ixazomibs clearance.
English: If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected.
Danish: Der forventes en teratogen virkning hos mennesker, hvis lenalidomid tages under graviditet.
English: An alternating dose modification approach is recommended for ixazomib and lenalidomide for overlapping toxicities of thrombocytopenia, neutropenia and rash.
Danish: Der anbefales en successiv dosisjustering for henholdsvis ixazomib og lenalidomid i tilfælde af overlappende toksicitet i form af trombocytopeni, neutropeni og udslæt.
English: The capsule should not be removed until just prior to dosing.
Danish: Kapslen må først tages ud af emballagen lige før dosering.
English: • Withhold lenalidomide until rash recovers to ≤ Grade 1.
Danish: Udsæt lenalidomid, indtil udslættet er bedret til ≤ grad 1.
English: 1 hard capsule.
Danish: 1 hård kapsel.
English: Avoid becoming pregnant or breast-feeding while being treated with NINLARO.
Danish: Undgå at blive gravid eller amme, mens du får NINLARO.
English: Do not take a missed dose if it is within 3 days or 72 hours of your next scheduled dose.
Danish: Du må ikke tage en manglende dosis, hvis der er under 3 dage eller 72 timer til den næste planlagte dosis.
English: Cardiac arrhythmias in patients > 75 years of age were observed in 10 patients (21%) in the ixazomib regimen and 9 patients (15%) in the placebo regimen.
Danish: Blandt patienter > 75 år blev der observeret hjertearytmier hos 10 patienter (21%) i ixazomib-gruppen og hos 9 patienter (15%) i placebogruppen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO 2.3 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING NINLARO 2,3 mg kapsler, hårde
English: After administration of a single oral dose of 14C-ixazomib to 5 patients with advanced cancer, 62% of the administered radioactivity was excreted in urine and 22% in the faeces.
Danish: Udskillelse Efter indgivelse af en enkelt oral dosis 14C-ixazomib til 5 patienter med fremskreden cancer blev 62%
English: Takeda Pharmaceuticals Croatia d.o.o.
Danish: Hrvatska Takeda Pharmaceuticals Croatia d.o.o.
English: Ixazomib will be given in combination with lenalidomide and breast-feeding should be stopped because of the use of lenalidomide.
Danish: Ixazomib gives i kombination med lenalidomid, og amning skal ophøre på grund af lenalidomid.
English: • skin rash that may be itchy and in a few areas or all over the body
Danish: • hududslæt, der kan klø og forekommer pletvist på kroppen eller over hele kroppen.
English: Grade 2 peripheral neuropathy with pain or Grade 3 peripheral
Danish: Grad 2 perifer neuropati med smerter og grad 3 perifer neuropati
English: NINLARO is used to treat a cancer of the bone marrow called multiple myeloma.
Danish: NINLARO anvendes til behandling af en kræfttype i knoglemarven, der hedder myelomatose.
English: Strong inducers may reduce the efficacy of ixazomib, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see sections 4.5 and 5.2).
Danish: Derfor skal samtidig brug af potente CYP3A-induktorer, f.eks. carbamazepin, phenytoin, rifampicin og perikon (Hypericum perforatum), undgås (se pkt.
English: The recommended starting dose of ixazomib is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.
Danish: Den anbefalede startdosis af ixazomib er 4 mg, som gives oralt én gang om ugen på dag 1, 8 og 15 i en 28-dages behandlingscyklus.
English: • If Grade 2 or 3 rash occurs again, withhold ixazomib and lenalidomide until rash recovers to ≤ Grade 1.
Danish: Hvis der atter opstår udslæt af grad 2 eller 3, udsæt ixazomib og lenalidomid, indtil udslættet er bedret til ≤ grad 1.
English: No dose adjustment of ixazomib is required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min).
Danish: Dosisjustering af ixazomib er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min.).
English: Discontinuations in patients > 75 years of age were reported in 13 patients (28%) in the ixazomib regimen and 10 patients (16%) in the placebo regimen.
Danish: Blandt patienter > 75 år blev det rapporteret, at 13 patienter (28%) i ixazomib-gruppen og 10 patienter (16%) i placebogruppen seponerede behandlingen.
English: The most common type of rash reported in both regimens was maculo-papular and macular rash.
Danish: Den hyppigste form for udslæt rapporteret i begge grupper var makulopapuløst og makuløst udslæt.
English: • shortness of breath or persistent coughing or wheezing (heart failure)
Danish: • stakåndethed, vedvarende hoste eller pibende vejrtrækning (hjertesvigt)
English: The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Danish: Den anbefalede startdosis af dexamethason er 40 mg, som indgives dag 1, 8, 15 og 22 i en 28-dages behandlingscyklus.
English: The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle.
Danish: Den anbefalede startdosis af lenalidomid er 25 mg, som gives dagligt dag 1 til 21 i en 28-dages behandlingscyklus.
English: Breast-feeding should be stopped when taking NINLARO.
Danish: Du skal stoppe med at amme, når du tager NINLARO.
English: CYP inducers
Danish: CYP-induktorer
English: No dose adjustment of ixazomib is required for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin > 1-1.5 x ULN and any AST).
Danish: Dosisjustering af ixazomib er ikke nødvendig hos patienter med let nedsat leverfunktion (total-bilirubin ≤ øvre grænse for normalområdet (ULN) og aspartat-aminotransferase (ASAT) > ULN eller total-bilirubin > 1-1,5 x ULN og enhver ASAT).
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER
English: Treatment with ixazomib in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited (see section 5.1).
Danish: Behandling med ixazomib i kombination med lenalidomid og dexamethason i mere end 24 cyklusser bør ske på grundlag af en individuel benefit/risk-vurdering, da data vedr.
English: Toxicities should, at the physician's discretion, generally recover to patient's baseline condition or at most Grade 1 prior to resuming ixazomib.
Danish: Generelt skal toksiciteten bedres til patientens baseline-niveau eller højst grad 1 efter lægens skøn, før dosering af ixazomib genoptages.
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Danish: Propylenglycol Kaliumhydroxid Sort jernoxid (E 172)
English: Nervous system disorders Peripheral neuropathies* Very common
Danish: Nervesystemet Perifere neuropatier*
English: The reduced dose of 3 mg is recommended in patients with moderate (total bilirubin > 1.5-3 x ULN) or severe (total bilirubin > 3 x ULN) hepatic impairment (see section 5.2).
Danish: Den reducerede dosis på 3 mg anbefales til patienter med moderat nedsat leverfunktion (total-bilirubin > 1,5-3 x ULN) eller alvorligt nedsat leverfunktion (total-bilirubin > 3 x ULN) (se pkt.
English: Rash resulted in discontinuation of one or more of the three medicinal products in < 1% of patients in both regimens.
Danish: Udslæt resulterede i seponering af et eller flere af de tre lægemidler hos < 1% af patienterne i begge grupper.
English: Peripheral neuropathy occurred in 25% of patients in the ixazomib regimen compared to 20% of patients in the placebo regimen.
Danish: Perifer neuropati forekom hos 25% af patienterne i ixazomib-gruppen sammenlignet med 20% i placebogruppen.
English: Fertility studies have not been conducted with ixazomib (see section 5.3).
Danish: Der er ikke udført fertilitetsstudier med ixazomib (se pkt.
English: For each adverse reaction, one or more of the three medicinal products was discontinued in ≤ 1% of patients in the ixazomib regimen.
Danish: For hver bivirkning blev et eller flere af de tre lægemidler seponeret hos ≤ 1% af patienterne i ixazomib-gruppen.
English: Therefore, co-administration of strong CYP3A inducers with ixazomib is not recommended (see section 4.4).
Danish: Derfor frarådes samtidig behandling med potente CYP3A-induktorer og ixazomib (se pkt.
English: Please refer to the current lenalidomide SmPC.
Danish: Der henvises til det aktuelle produktresumé for lenalidomid.
English: Therefore, no dose modification is required for ixazomib with co-administration of strong CYP1A2 inhibitors.
Danish: Dosisjustering er derfor ikke nødvendig ved samtidig behandling med ixazomib og potente CYP1A2-hæmmere.
English: • Withhold ixazomib and lenalidomide until absolute neutrophil count is ≥ 500/mm3.
Danish: • Udsæt ixazomib og lenalidomid, indtil det absolutte neutrofiltal er ≥ 500/mm3.
English: Refer to the lenalidomide SmPC for dosing recommendations in patients with renal impairment.
Danish: Se produktresuméet for lenalidomid vedrørende anbefalede doser til patienter med nedsat nyrefunktion.
English: Do not remove the capsule until you need to take a dose.
Danish: Kapslen må først tages ud af emballagen lige inden, at du skal tage en dosis.
English: Grade 3 adverse reactions of peripheral neuropathy were reported in 2% of patients in both regimens.
Danish: I begge grupper blev perifer neuropati rapporteret som grad 3-bivirkning hos 2% af patienterne.
English: • vision conditions including blurred vision, dry eye and pink eye (conjunctivitis)
Danish: • problemer med øjnene, herunder sløret syn, tørre øjne og øjenbetændelse.
English: Unbound AUC was 38% higher in patients with severe renal impairment or ESRD requiring dialysis as compared to patients with normal renal function.
Danish: Ikke-bundet dosis-normaliseret AUC var 38% højere hos patienter med alvorligt nedsat nyrefunktion eller dialysekrævende ESRD
English: • If platelet count falls to < 30,000/mm3 again, withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Danish: • Hvis trombocyttallet atter falder til < 30.000/mm3, udsættes ixazomib og lenalidomid, indtil trombocyttallet er ≥ 30.000/mm3.
English: If a dose is missed or delayed, you should take the dose as long as the next scheduled dose is more than 3 days or 72 hours away.
Danish: Hvis du glemmer en dosis eller ikke kan tage den til tiden, skal du tage dosis, hvis der er mindst 3 dage eller 72 timer til den næste planlagte dosis.
English: Other adverse reactions
Danish: Kutane reaktioner
English: Rash occurred in 18% of patients in the ixazomib regimen compared to 10% of patients in the placebo regimen.
Danish: Udslæt forekom hos 18% af patienterne i ixazomib-gruppen sammenlignet med 10% i placebogruppen.
English: Patients experiencing new or worsening peripheral neuropathy may require dose modification (see section 4.2).
Danish: Dosisjustering kan være nødvendig hos patienter med nyopstået eller forværring af perifer neuropati (se pkt.
English: What multiple myeloma is
Danish: Om myelomatose
English: Three single blister wallet packs are packaged in one carton.
Danish: Tre mapper i karton med hver én enkelt blister pakket i en yderpakning.
English: In the event of an overdose, monitor the patient for adverse reactions (section 4.8) and provide appropriate supportive care.
Danish: I tilfælde af en overdosis skal patienten overvåges for bivirkninger (pkt.