FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported organ cancer in the placebo-controlled clinical trials was lung cancer 0.17 (0.05, 0.43) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients and 0.12 (0.08, 0.17) per 100 patient-years in the cumulative period.
Danish: Den hyppigst rapporterede organcancer i de placebokontrollerede kliniske studier var lungecancer 0,17 (0,05, 0,43) pr. 100 patientår hos abatacept-behandlede patienter, 0 hos placebobehandlede patienter og 0,12 (0,08, 0,17) pr. 100 patientår i den samlede periode.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion 2.
Danish: ORENCIA 250 mg pulver til koncentrat til infusionsvæske, opløsning 2.
English: In study VI, ACR responses were assessed at 2 years in 232 patients with 85% ACR 20 responses, 74% ACR 50 responses, and 54% ACR 70 responses.
Danish: I studie VI blev ACR-responset vurderet efter 2 år hos 232 patienter; heraf opnåede 85% ACR 20-respons, 74% opnåede ACR 50-respons, og 54% opnåede ACR 70-respons.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled pen contains 125 mg abatacept in one mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 125 mg abatacept i en ml.
English: Abataceptf IV +MTX n=678
Danish: Abataceptf s.c. +MTX n=693
English: MRI Osteitis/Bone Oedema Score
Danish: Osteitis/knogleødem-score ved MR-scanning
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med ORENCIA Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: ORENCIA 125 mg solution for injection in pre-filled syringe The active substance is abatacept.
Danish: ORENCIA 125 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Aktivt stof: abatacept.
English: In placebo-controlled clinical trials, malignancies were reported in 1.2% (31/2,653) of abatacepttreated patients and in 0.9% (14/1,485) of placebo-treated patients.
Danish: Der er i placebokontrollerede kliniske studier rapporteret om maligniteter hos 1,2% (31/2.653) af abatacept-behandlede patienter.
English: ORENCIA SC PATIENT ALERT CARD TEXT
Danish: TEKST PÅ ADVARSELSKORT TIL PATIENTER
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Danish: ORENCIA 250 mg pulver til koncentrat til infusionsvæske, opløsning abatacept
English: In placebo-controlled clinical trials, malignancies were reported in 1.2% (31/2,653) of abatacepttreated patients, and in 0.9% (14/1,485) of placebo-treated patients.
Danish: Der er i placebokontrollerede kliniske studier rapporteret om maligniteter hos 1,2% (31/2.653) ud af de abatacept-behandlede patienter.
English: However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive, cycle or operate any machinery.
Danish: Anvendelse af ORENCIA forventes ikke at påvirke evnen til at føre motorkøretøj eller betjene maskiner, men hvis du føler dig træt eller utilpas efter behandling med ORENCIA, må du ikke føre motorkøretøj eller arbejde med maskiner.
English: Physical Function Response
Danish: Ændring i fysisk funktion
English: ORENCIA powder for concentrate for solution for infusion for intravenous administration is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
Danish: ORENCIA pulver til koncentrat til infusionsvæske, opløsning til intravenøs administration er tilgængelig for pædiatriske patienter i alderen 6 år og derover til behandlingen af pJIA (see produktresumé for OENCIA pulver til koncentrat til infusionsvæske, opløsning).
English: Expiry Date
Danish: UDLØBSDATO
English: The most common hematologic malignancy was lymphoma 0.04 (0, 0.24) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients and 0.06 (0.03, 0.1) per 100 patient-years in the cumulative period.
Danish: Den hyppigste hæmatologiske malignitet var lymfomer 0,04 (0, 0,24) pr. 100 patientår hos abatacept-behandlede patienter, 0 hos placebobehandlede patienter og 0,06 (0,03, 0,1) pr. 100 patientår i den samlede periode.
English: Liquid
Danish: Klik
English: In the cumulative period in clinical trials in 7,044 patients treated with abatacept during 20,510 patient-years, the incidence rate of serious infections was 2.4 per 100 patient-years, and the annualised incidence rate remained stable.
Danish: I den samlede periode i de kliniske studier blev 7.044 patienter behandlet med abatacept i 20.510 patientår.
English: Structural joint damage was assessed radiographically over a two-year period in studies II, VI, and SC-II.
Danish: Studie II, VI og SC-II vurderede strukturel ledskade radiografisk over en periode på 2 år.
English: DON'T recap the needle.
Danish: Du må ikke sætte kanylehætten på igen.
English: Proceed to Step 2
Danish: Fortsæt til Trin 2
English: Packs of 4 pre-filled syringes with needle guard.
Danish: Pakninger med 4 fyldte injektionssprøjter med kanylebeskyttelse.
English: Uncommon Basal cell carcinoma, skin papilloma Rare
Danish: Basalcellekarcinom, hudpapillom
English: Number of Vialsb
Danish: Antal hætteglasb
English: ORENCIA powder for concentrate for solution for infusion is used in children and adolescents aged 6 to 17 years when a previous disease-modifying medicine has not worked well enough or is not suitable for them.
Danish: ORENCIA pulver til koncentrat til infusionsvæske, opløsning, anvendes til børn og unge i alderen 617 år når en tidligere sygdomsmodificerende medicin ikke har virket godt nok eller ikke er passende til dem. ORENCIA anvendes sædvanligvis sammen med methotrexat, selvom ORENCIA også kan bruges alene i tilfælde af overfølsomhed overfor methotrexat, eller hvis behandling med methotrexat ikke er passende.
English: A randomised, single(investigator)-blinded, non-inferiority study was conducted to assess the safety and efficacy of weekly subcutaneous (SC) abatacept without an abatacept intravenous (IV) loading dose versus every-other-weekly subcutaneous adalimumab, both with background MTX, in patients with an inadequate response to methotrexate (study SC-II).
Danish: Et randomiseret, enkelt (investigator)-blindet, non-inferioritetsstudie blev udført med henblik på at vurdere sikkerhedsprofil og effekt ved ugentlig subkutan (s.c.) administration af abatacept administreret uden en intravenøs (i.v.)
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 125 mg solution for injection in pre-filled pen 2.
Danish: ORENCIA 125 mg injektionsvæske, opløsning, i fyldt pen 2.
English: Baseline (Mean)
Danish: og intravenøs (i.v.)
English: 3 pre-filled syringes with needle guard
Danish: 3 fyldte injektionssprøjter med kanylebeskyttelse
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 125 mg abatacept in one mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt injektionssprøjte indeholder 125 mg abatacept i en ml.
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe
Danish: ORENCIA 87,5 mg injektionsvæske, opløsning, i fyldt injektionssprøjte abatacept
English: If the expiry date has passed, do not use the syringes.
Danish: Hvis udløbsdatoen er overskredet, må du ikke bruge injektionssprøjten.
English: In study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous IV infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
Danish: infunderet abatacept hvad angår ACR 20-respons op til 6 måneders behandling.
English: If you use more ORENCIA than you should
Danish: Hvis du har brugt for meget ORENCIA
English: ORENCIA 125 mg solution for injection in pre-filled syringe
Danish: ORENCIA 125 mg injektionsvæske abatacept
English: Dose
Danish: Leddegigt
English: What ORENCIA is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Study SC-I was a randomised, double-blind, double-dummy noninferiority study administered to patients stratified by body weight (< 60 kg, 60 to 100 kg, > 100 kg) that compared the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis (RA), receiving background methotrexate (MTX), and experiencing an inadequate response to MTX (MTX-IR).
Danish: Studie SC-I var et randomiseret, dobbeltblindt, dobbeltdummy non-inferioritetsstudie, som blev gennemført med patienter, der blev stratificeret efter kropsvægt (< 60 kg, 60-100 kg, > 100 kg).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION ORENCIA 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING ORENCIA 50 mg injektionsvæske, opløsning, i fyldt injektionssprøjte.
English: In study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous (IV) infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
Danish: I studie SC-I var subkutant (s.c.) administreret abatacept non-inferiør sammenlignet med intravenøst (i.v.)
English: It may also be helpful to write down any questions or concerns about the injection so you can ask your doctor, nurse or pharmacist.
Danish: indsprøjtningen ned, så du kan spørge lægen, sundhedspersonalet eller på apoteket.
English: ORENCIA solution for injection in pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA solution for injection in pre-filled syringe).
Danish: ORENCIA injektionsvæske, opløsning, i fyldt injektionssprøjte til subkutan administration er tilgængelig for pædiatriske patienter som er 2 år og derover til behandling af pJIA (se Produktresumé for ORENCIA injektionsvæske, opløsning, i fyldt injektionssprøjte).
English: You can discard the cap in your household waste after the injection.
Danish: Efter injektionen smides hætten i skraldespanden.
English: Cough
Danish: Kanyle
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe 2.
Danish: Hver fyldt injektionssprøjte indeholder 87,5 mg abatacept i 0,7 ml ORENCIA 125 mg injektionsvæske, opløsning, i fyldt injektionssprøjte.
English: Caregiver ONLY
Danish: KUN omsorgsperson
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACK OF 1 VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL PAKNING MED 1 HÆTTEGLAS 1.
English: ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
Danish: ORENCIA 125 mg pulver til injektionsvæske, opløsning, i fyldt injektionssprøjte abatacept
English: ORENCIA solution for injection pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA Solution for Injection pre-filled syringe).
Danish: ORENCIA injektionsvæske, opløsning, fyldt injektionssprøjte til subkutan administration er tilgængelig for pædiatriske patienter i alderen 2 år og derover til behandling af pJIA (se produktresumé for ORENCIA injektionsvæske, opløsning, fyldt injektionssprøjte).
English: What is in this leaflet
Danish: Foran på lårene
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 87.5 mg solution for injection in pre-filled syringe abatacept
Danish: ORENCIA 87,5 mg injektionsvæske abatacept s.c.
English: Breast-feeding
Danish: ORENCIA-dosisa
English: Remove Needle Cover
Danish: Fjern kanylehætten
English: Do not inject if the liquid is cloudy, discoloured, or has particles.
Danish: DU MÅ IKKE tage injektionen, hvis væsken er uklar, misfarvet eller indeholder synlige partikler.
English: respectively
Danish: TILLADELSEN
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning, i fyldt injektionssprøjte 4 fyldte injektionssprøjter med kanylebeskyttelse
English: ORENCIA solution for injection pre-filled syringe is available for subcutaneous administration for paediatric patients 2 years of age and older.
Danish: ORENCIA injektionsvæske, opløsning, i fyldt injektionssprøjte er tilgængelig til subkutan anvendelse til børn i alderen 2 år og opefter.
English: Multipack: 12 ClickJect pre-filled pens (3 packs of 4) 5.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning, i fyldt pen (ClickJect) Multipakning: 12 fyldte ClickJect-penne (3 pakninger med hver 4) 5.
English: These measures will help to protect the environment.
Danish: Det kan medvirke til at bedre din generelle livskvalitet.
English: With your other hand, pinch the cleaned skin.
Danish: Brug den anden hånd til at klemme sammen om det rensede hudområde.
English: ORENCIA 50 mg solution for injection in pre-filled syringe
Danish: ORENCIA 50 mg injektionsvæske, opløsning, i fyldt injektionssprøjte abatacept
English: Have your additional injection supplies ready before you inject.
Danish: lægge de ting, du skal bruge frem, inden du foretager injektionen.
English: Remove the needle from the skin and let go of the surrounding skin.
Danish: Træk kanylen ud og slip huden.
English: 4 pre-filled syringes with needle guard
Danish: 4 fyldte injektionssprøjter med kanylebeskyttelse
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Eventuelle rester fra infusionsvæsken må ikke gemmes til senere brug.
English: Should you have any questions, ask your pharmacist.
Danish: Spørg apotekspersonalet, hvis der er noget, du er i tvivl om.
English: 30 June 2024
Danish: 30 Juni 2024
English: These secondary endpoints were not adjusted for multiplicity
Danish: Disse sekundære endepunkter blev ikke justeret for multiplicitet
English: See Table 6 and Figure 1.
Danish: Se tabel 6 og figur 1.
English: · You will be given one infusion every 3 weeks.
Danish: · Du vil få en infusion hver 3. uge.
English: Patients should have either:
Danish: Patienterne bør enten:
English: · Risk Management Plan (RMP)
Danish: ● Risikostyringsplan (RMP)
English: · Heart problems can occur.
Danish: ● Hjerteproblemer kan opstå.
English: Repeat LVEF assessment within 3 weeks.
Danish: Gentag LVEF-vurdering inden for 3 uger.
English: ** The interim analysis for OS was conducted when 331 events were observed.
Danish: ** Der udførtes interimanalyse for samlet overlevelse, da der var observeret 331 hændelser.
English: Delayed or missed dose
Danish: Forsinket eller glemt dosis
English: The data are from an open-label study and no firm conclusions can be drawn.
Danish: Disse data er fra et åbent studie, og der kan ikke drages sikre konklusioner.
English: Your doctor will calculate the correct dose for you.
Danish: Lægen vil beregne den korrekte dosis.
English: · you have already received the medicine trastuzumab and a medicine known as a taxane.
Danish: · du allerede har fået behandling med lægemidlet trastuzumab og et lægemiddel, der kaldes et taxan.
English: In most cases you will not have any symptoms.
Danish: I de fleste tilfælde vil du ikke have symptomer.
English: Do not wait until your next planned visit.
Danish: Du må ikke vente til næste planlagte behandling.
English: A change of 5 points in the TOI-B is considered clinically significant.
Danish: En ændring på 5 point i TOI-B anses for klinisk signifikant.
English: In this patient population:
Danish: I denne patientpopulation var:
English: (treatment after surgery is called adjuvant therapy).
Danish: (behandling efter operation kaldes adjuverende behandling).
English: Hierarchical testing applied for IDFS and OS 2.
Danish: Der er anvendt hierakisk test for IDFS og OS 2.
English: In general, these symptoms were not severe (see section 4.8).
Danish: Generelt var disse symptomer ikke alvorlige (se pkt.
English: If a planned dose is missed, it should be administered as soon as possible; without waiting until the next planned cycle.
Danish: Hvis en planlagt dosis glemmes, skal den gives så hurtigt som muligt og ikke vente til næste planlagte cyklus.
English: Appropriate procedures for the preparation of chemotherapeutic medicinal products should be used.
Danish: Relevante procedurer for tilberedning af kemoterapeutiske lægemidler skal anvendes.
English: Only patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 were eligible.
Danish: Kun patienter, som havde Eastern Cooperative Oncology Group (ECOG)-performancestatus 0 eller 1 kunne deltage.
English: Appropriate aseptic technique should be used.
Danish: Der skal anvendes relevant aseptisk teknik.
English: You should not be given Kadcyla if the above applies to you.
Danish: Du må ikke få Kadcyla, hvis ovenstående gælder for dig.
English: Since the efficacy boundary was crossed at this analysis, this is considered the definitive analysis.
Danish: Da virkningsgrænserne var nået ved denne analyse, betragtes denne analyse som endelig.
English: Lapatinib + Capecitabine n = 496
Danish: Lapatinib + Capecitabin n = 496
English: Read all of this leaflet carefully before you start being given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: Emtansine refers to the MCC-DM1 complex.
Danish: Emtansin refererer til MCC-DM1-komplekset.
English: Kadcyla can make some existing conditions worse, or cause side effects.
Danish: Kadcyla kan forværre nogle tilstande eller give bivirkninger.
English: · The total number of infusions that you will be given depends on how you respond to the treatment and which indication is treated.
Danish: · Antallet af infusioner, du vil få, afhænger af, hvordan du reagerer på behandlingen og årsagen til at du får behandlingen.
English: It must not be administered as an intravenous push or bolus.
Danish: Det må ikke administreres som intravenøs stød- eller bolus.
English: · Do not use this medicine after the expiry date which is stated on the outer carton and vial after EXP.
Danish: · Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP.
English: · Additional risk minimisation measures
Danish: ● Yderligere risikominimeringsforanstaltninger
English: Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use.
Danish: Lægemidler til behandling af sådanne reaktioner samt akutudstyr skal være umiddelbart tilgængelige.
English: See section 4 for more details about what side effects to look out for.
Danish: Se afsnit 4 for yderligere oplysninger om bivirkninger, du skal holde øje med.
English: Patients may have received more than one HER2-targeted therapy.
Danish: Patienterne kunne have fået mere end én HER2-rettet behandling.
English: Most patients will not have symptoms from the heart problems.
Danish: De fleste patienter vil ikke opleve symptomer ved hjerteproblemer.
English: These symptoms may indicate nerve damage.
Danish: Disse symptomer kan tyde på nerveskade.
English: If a CE-marked IVD is not available, the HER2-status should be assessed by an alternate validated test.
Danish: Hvis CE-mærket IVD-udstyr ikke er tilgængeligt, bør HER2-status vurderes ved en anden valideret test.
English: There are insufficient data to establish the safety and efficacy in patients ≥ 75 years due to limited data in this subgroup.
Danish: Data er utilstrækkelige til at vurdere sikkerhed og virkning hos patienter ≥75 år pga. begrænsede data i denne subgruppe.
English: Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvenser defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til < 1/1000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra nuværende data).
English: In clinical studies, patients had a LVEF ³ 50% at baseline.
Danish: I de kliniske studier havde patienterne LVEF ³50% ved baseline.
English: The next dose should be administered in accordance with the dosing recommendations above.
Danish: Den næste dosis bør gives i overensstemmelse med doseringsanbefalingerne ovenfor.
English: Male patients or their female partners should also use effective contraception.
Danish: Mandlige patienter eller deres kvindelige partner skal ligeledes anvende sikker prævention.
English: The results of this descriptive follow-up analysis are consistent with the confirmatory OS analysis.
Danish: Resultaterne af denne deskriptive opfølgningsanalyse er i overensstemmelse med den bekræftende analyse af samlet overlevelse.
English: Talk to your doctor before stopping your contraception.
Danish: Tal med lægen, før du holder op med at bruge prævention.
English: Kadcyla is for intravenous use.
Danish: Kadcyla er til intravenøs anvendelse.
English: All of the patients had received taxanes as part of neoadjuvant chemotherapy.
Danish: Alle patienter modtog taxaner som del af neoadjuverende kemoterapi.
English: Consideration for re-treatment should be based on clinical assessment of the severity of the reaction.
Danish: Eventuel genoptagelse af behandlingen kan overvejes på basis af en klinisk vurdering af reaktionens sværhedsgrad.
English: If a pregnant woman is treated with trastuzumab emtansine, close monitoring by a multidisciplinary team is recommended.
Danish: Hvis en gravid kvinde behandles med trastuzumabemtansin, anbefales tæt monitorering ved et multidisciplinært team.
English: · The first infusion will be given to you over 90 minutes.
Danish: · Den første infusion gives i løbet af 90 minutter.
English: However, based on results from general animal toxicity studies, adverse effects on fertility can be expected.
Danish: Baseret på resultaterne fra generelle toksicitetsstudier hos dyr må negativ påvirkning af fertilitet dog forventes.
English: · Received prior therapy for locally advanced or metastatic disease, or
Danish: ● tidligere have fået behandling for lokalt fremskreden sygdom eller metastatisk sygdom, eller
English: No dose adjustment is required in patients aged ≥ 65 years.
Danish: Dosisjustering er ikke nødvendig til patienter ≥65 år.
English: Trastuzumab emtansine n = 495
Danish: Trastuzumabemtansin n = 495
English: HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth.
Danish: HER2 findes i store mængder på overfladen af nogle kræftceller og stimulerer deres vækst.
English: Glucose (5%) solution should not be used for reconstitution or dilution since it causes aggregation of the protein.
Danish: Glucoseinfusionsvæske (5%) må ikke anvendes til rekonstitution eller fortynding, da det forårsager aggregering af proteinet.
English: · If you experience side effects, your doctor may decide to continue your treatment but lower your dose, delay the next dose or stop the treatment.
Danish: · Hvis du oplever bivirkninger, kan lægen vælge at fortsætte behandlingen ved en lavere dosis, udsætte næste dosis eller helt stoppe behandlingen.
English: It is not expected that Kadcyla will affect your ability to drive, cycle, use tools or machines.
Danish: Kadcyla forventes ikke at påvirke evnen til at køre bil, cykle, bruge værktøj eller maskiner.
English: The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of breast cancer .
Danish: Sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt, da det ikke er relevant at anvende trastuzumabemtansin i den pædiatriske population på indikationen brystkræft.
English: Patients should be observed closely for infusion-related reactions, especially during the first infusion.
Danish: Patienterne skal observeres tæt for infusionsrelaterede reaktioner, særligt under den første infusion.