FrancophonIA/ELRC3.0 huggingface dataset:
English: b. Meningitis is a composite term that includes meningitis and meningitis aseptic.
Danish: b. Meningitis er en sammensat term, der omfatter meningitis og aseptisk meningitis.
English: Withhold LIBTAYO Initiate symptomatic management
Danish: Pauser LIBTAYO Initiér symptomatisk behandling
English: For patients with externally visible target lesions (locally advanced CSCC and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria).
Danish: Hos patienter med eksterne, synlige mållæsioner (lokalt avanceret CSCC og metastatisk CSCC) blev ORR bestemt ved et sammensat endepunkt, som integrerede ICR-evaluering af radiologiske data (RECIST 1.1) og digitale fotografier (WHO-kriterier).
English: However, systemic corticosteroids or other immunosuppressants can be used after starting cemiplimab to treat immune-related adverse reactions (see sections 4.2).
Danish: Dog kan systemiske kortikosteroider eller andre immunosuppressiva anvendes efter opstart med cemiplimab til behandling af immunrelaterede bivirkninger (se pkt.
English: Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2).
Danish: Cemiplimab er ikke undersøgt hos patienter med CLcr <25 ml/min (se pkt.
English: Dosing delay or discontinuation may be required based on individual safety and tolerability.
Danish: På baggrund af sikkerhed og tolerance hos den enkelte patient kan udsættelse af dosis eller seponering være nødvendig.
English: Immune-related skin reaction or other immune-related adverse reactions in patients with prior treatment with idelalisib
Danish: Immunrelateret hudreaktion eller andre immunrelaterede bivirkninger hos patienter, der tidligere er behandlet med idelalisib
English: Any unused portion of the infusion solution should not be re-used and should be disposed in accordance with local requirements.
Danish: Eventuelt resterende infusionsvæske må ikke genanvendes og skal bortskaffes i henhold til lokale retningslinjer.
English: The MAH shall ensure that in each Member State where LIBTAYO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use LIBTAYO have access to/are provided with the following educational package: - A patient guide - A patient alert card
Danish: Indehaveren af markedsføringstilladelsen skal, i hver medlemsstat, hvor LIBTAYO markedsføres sikre, at alle sundhedspersoner og patienter/omsorgspersoner, som forventes at udskrive og anvende LIBTAYO, har adgang til/har modtaget følgende uddannelsesmateriale:
English: Similar exposures to cemiplimab are achieved with the doses of 350 mg every 3 weeks and 3 mg/kg every 2 weeks.
Danish: Tilsvarende eksponering opnås med cemiplimab ved doser på 350 mg hver 3. uge og 3 mg/kg hver 2. uge.
English: • a cancer medicine called idelalisib • medicines that make your immune system weak - examples include corticosteroids, such as prednisone.
Danish: • medicin, der svækker dit immunsystem - f.eks. kortikosteroider som prednison.
English: All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immunerelated adverse reactions and infusion-related reactions.
Danish: Alle læger, der ordinerer LIBTAYO, skal være bekendt med uddannelsesmaterialet, fortælle patienten om patientkortet og forklare hvad patienten skal gøre, hvis han/hun får et eller flere symptomer på en immunrelateret eller infusionsrelateret bivirkning.
English: Thyroid disorders (Hypothyroidism/Hyperthyroidism) Immune-related thyroid disorders have been observed in patients receiving cemiplimab.
Danish: Thyroideasygdomme (hypothyreoidisme/hyperthyreoidisme) Immunrelaterede thyroideasygdomme er observeret hos patienter, der har fået cemiplimab.
English: Store in a refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: Progression free survival (PFS)
Danish: Progressionsfri overlevelse (PFS)a, c
English: The safety of cemiplimab has been evaluated in 591 patients with advanced solid malignancies including 219 advanced CSCC patients who received cemiplimab monotherapy in 2 clinical studies (R2810-ONC-1423 and R2810-ONC-1540).
Danish: Cemiplimabs sikkerhed er blevet undersøgt hos 591 patienter med fremskredne solide maligniteter, inklusive 219 patienter med avanceret kutant planocellulært karcinom, der fik cemiplimab som monoterapi i 2 kliniske studier (R2810-ONC-1423 og R2810-ONC-1540).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer.
English: There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).
Danish: Der findes kun begrænsede data for LIBTAYO hos patienter med svært nedsat nyrefunktion CLcr <30 ml/min (se pkt.
English: h. Pruritus is a composite term that includes pruritus and pruritus allergic.
Danish: h. Pruritus er en sammensat term, der omfatter pruritus og allergisk pruritus.
English: The most common immune-related adverse reactions were hypothyroidism (7.1%), pneumonitis (3.7%), immune-related skin adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) (see “Description of selected adverse reactions” below, Special warnings and precautions for use in section 4.4 and Recommended treatment modifications in section 4.2).
Danish: De hyppigste immunrelaterede bivirkninger var hypothyreoidisme (7,1 %), pneumonitis (3,7 %), immunrelaterede hudreaktioner (2,0 %), hyperthyreoidisme (1,9 %) og hepatitis (1,9 %) (se ”Beskrivelse af udvalgte bivirkninger” nedenfor, Særlige advarsler og forsigtighedsregler i pkt.
English: The solution may contain trace amounts of translucent to white particles in a single-use vial.
Danish: Opløsningen kan indeholde spormængder af gennemsigtige til hvide partikler i hætteglas til engangsbrug.
English: Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Danish: Cemiplimab forstærker T-celleresponset, herunder anti-tumorresponset, ved at blokere bindingen imellem PD-1 og liganderne PD-L1 og PD-L2.
English: Initiate symptomatic management
Danish: Initiér symptomatisk behandling
English: How you are given LIBTAYO • LIBTAYO will be given to you in a hospital or clinic - supervised by a doctor experienced in cancer treatment.
Danish: • Du får LIBTAYO på et hospital eller en klinik under tilsyn af en læge med erfaring i behandling af kræft.
English: LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Danish: LIBTAYO fås i et 10 ml klart glas (type 1) hætteglas med en grå chlorbutylprop med FluroTec overtræk og flip-off-låg.
English: Listed in Table 2 are adverse reactions by system organ class and by frequency.
Danish: Bivirkninger er anført efter systemorganklasse og hyppighed i nedenstående tabel 2.
English: • increased liver enzymes in blood, abnormal kidney function test
Danish: • forhøjet indhold af leverenzymer i blodet, unormalt resultat af leverfunktionstest
English: • Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose.
Danish: • Du må ikke amme dit barn, mens du behandles med LIBTAYO og i mindst 4 måneder efter den sidste dosis.
English: Tumour response assessments were performed every 8 or 9 weeks (for patients receiving 3 mg/kg every 2 weeks or 350 mg every 3 weeks, respectively).
Danish: Vurdering af tumorrespons blev udført hver 8. eller 9. uge (hos patienter der fik henholdsvis 3 mg/kg hver 2. uge eller 350 mg hver 3. uge).
English: No studies have been performed to test the potential of cemiplimab for carcinogenicity or genotoxicity.
Danish: Der er ikke udført studier for at undersøge cemiplimabs karcinogene og genotoksiske potentiale.
English: Do not shake the solution.
Danish: Opløsningen må ikke rystes.
English: A total of 161 (83.4 %) patients were male, and 187 (96.9%) patients were White; the ECOG performance score was 0 (44.6%) or 1 (55.4%).
Danish: I alt 161 (83,4 %) patienter var mænd, og 187 (96,9 %) patienter var kaukasere; ECOG-performance-score var 0 (44,6 %) eller 1 (55,4 %).
English: It is unknown whether cemiplimab is secreted in human milk.
Danish: Det vides ikke, om cemiplimab udskilles i modermælk.
English: Uncommon General disorders and administration site conditions Fatigue k
Danish: Ikke almindelig Almene symptomer og reaktioner på administrationsstedet Træthed k
English: Resolution of immune-related diarrhoea or colitis had occurred in 4 (57.1%) of the 7 patients at the time of data cut-off.
Danish: Immunrelateret diarré eller colitis havde fortaget sig hos 4 (57,1 %) af de 7 patienter på tidspunktet for data cut-off.
English: Grade 3 or 4 (hyperglycaemia)
Danish: Type 1-diabetes mellitus Grad 3 eller 4 (hyperglykæmi)
English: Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2).
Danish: Afhængigt af bivirkningens sværhedsgrad bør cemiplimab pauseres eller seponeres permanent (se pkt.
English: Permanently discontinue
Danish: Permanent seponering
English: Cemiplimab should be withheld and anti-hyperglycaemics or insulin should be administered in patients with severe or life-threatening (Grade ≥ 3) hyperglycaemia.
Danish: Cemiplimab skal pauseres og anti-hyperglykæmika eller insulin administreres til patienter med svær eller livstruende (grad ≥ 3) hyperglykæmi.
English: Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8).
Danish: Tilfælde af SJS, letal TEN og stomatitis forekom efter den første dosis cemiplimab hos patienter, der tidligere var behandlet med idelalisib, som deltog i et klinisk studie, der undersøgte cemiplimab til Non-Hodgkin lymfom (NHL), og som for nyligt havde været behandlet med sulfa-holdige antibiotika (se pkt.
English: Version v.4.03 of NCI CTCAE was used to grade toxicity.
Danish: Toksicitet er klassificeret i henhold til version v.4.03 af NCI CTCAE.
English: • Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Danish: • Træk 7 ml (350 mg) ud af hætteglasset med LIBTAYO og overfør dem til en infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning eller glucose 50 mg/ml (5 %) injektionsvæske.
English: • If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
Danish: • Hvis du ammer eller planlægger at amme dit barn, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Immune-related adverse reactions can occur with cemiplimab.
Danish: Der kan forekomme immunrelaterede bivirkninger med cemiplimab.
English: Diarrhoea is a composite term that includes diarrhoea and colitis.
Danish: Diarré er en sammensat term, der omfatter diarré og colitis.
English: Animal reproduction studies have not been conducted with cemiplimab.
Danish: Der er ikke udført reproduktionsstudier med cemiplimab i dyr.
English: Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term
Danish: Tabel over bivirkninger hos patienter behandlet med cemiplimab Systemorganklasse
English: What LIBTAYO contains The active substance is cemiplimab:
Danish: LIBTAYO indeholder Aktivt stof: Cemiplimab.
English: Other medicinal products should not be co-administered through the same infusion line.
Danish: Der må ikke administreres andre lægemidler i samme infusionsslange.
English: 22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22).
Danish: Blandt 22 patienter med avanceret CSCC med PD-L1 < 1 % var ORR ifølge uafhængig central vurdering 40,9 % (9/22).
English: Each carton contains 1 glass vial with 7 ml of concentrate.
Danish: En kartonæske indeholder 1 hætteglas med 7 ml koncentrat.
English: Eye disorders: Keratitis Gastrointestinal disorders: Stomatitis a includes meningitis and meningitis aseptic b includes encephalitis and noninfective encephalitis c includes autoimmune myocarditis and myocarditis d includes arthritis and polyarthritis
Danish: Øjne: keratitis Mave-tarm-kanalen: stomatitis a omfatter meningitis og aseptisk meningitis b omfatter encefalitis og ikke-infektiøs encefalitis c omfatter autoimmun myocarditis og myocarditis d omfatter artritis og polyartritis
English: concentrate for solution for infusion 350 mg/7 ml
Danish: Koncentrat til infusionsvæske, opløsning 350 mg/7 ml
English: Interrupt or slow rate of infusion
Danish: Afbryd infusion eller nedsæt infusionshastigheden
English: Among 53 advanced CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53).
Danish: Blandt 53 patienter med avanceret CSCC med PD-L1 ≥ 1 % var ORR 54,7 % (29/53).
English: The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab.
Danish: Følgende klinisk signifikante, immunrelaterede bivirkninger forekom med en hyppighed på mindre end 1 % af de 591 patienter, der fik cemiplimab.
English: Musculoskeletal pain is a composite term that includes back pain, musculoskeletal pain, myalgia, neck pain and pain in extremity.
Danish: Muskuloskeletale smerter er en sammensat term, der omfatter rygsmerter, muskuloskeletale smerter, myalgi, nakkesmerter og smerter i arme og ben.
English: Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids.
Danish: Immunrelaterede bivirkninger bør behandles med modifikationer i cemiplimab-behandlingen, hormonsubstitutionsbehandling (hvis det er klinisk indiceret) og kortikosteroid.
English: Musculoskeletal pain i
Danish: Muskuloskeletale smerter i
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: Dispose of any unused medicinal product or waste material in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Arthritis is a composite term that includes arthritis and polyarthritis.
Danish: Artritis er en sammensat term, der omfatter artritis og polyartritis.
English: • you have lung or breathing problems
Danish: • hvis du har problemer med dine lunger eller din vejrtrækning
English: This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion
Danish: Dette inkluderer opbevaringstid for infusionsvæsken i den intravenøse infusionspose ved stuetemperatur og tid til administration af infusionsvæsken
English: Cemiplimab should be resumed when metabolic control is achieved on insulin replacement or anti-hyperglycaemics (see section 4.2).
Danish: Cemiplimab bør genoptages, når metabolisk kontrol er opnået med insulin eller anti-hyperglykæmika (se pkt.
English: Hepatobiliary disorders Hepatitis f
Danish: Lever og galdeveje Hepatitis f
English: The most common symptoms of infusion-related reaction were nausea, pyrexia, vomiting, abdominal pain, chills and flushing.
Danish: De hyppigste symptomer på en infusionsrelateret reaktion var kvalme, pyreksi, opkastning, mavesmerter, kulderystelser og ansigtsrødme.
English: LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC.
Danish: LIBTAYO anvendes til behandling af den type hudkræft, der hedder fremskreden kutant planocellulært karcinom eller CSCC hos voksne.
English: Cemiplimab can cause severe or life-threatening infusion-related reactions (see section 4.8).
Danish: Cemiplimab kan forårsage alvorlige eller livstruende infusionsrelaterede reaktioner (se pkt.
English: Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off.
Danish: Hepatitis havde fortaget sig hos 8 (72,7 %) af de 11 patienter på tidspunktet for data cut-off.
English: • inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain
Danish: • betændelse i hjertemusklen, som kan vise sig som åndenød, uregelmæssig hjerterytme, træthed eller smerter i brystkassen
English: Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).
Danish: Cemiplimab-eksponering er sammenlignelig på tværs af alle aldersgrupper (se pkt.
English: laCSCC cemiplimab: 3 mg/kg Q2W (Group 2) (N = 78)
Danish: laCSCC cemiplimab: 3 mg/kg hver anden uge (Gruppe 2) (N = 78)
English: No dose adjustment of LIBTAYO is recommended for patients with renal impairment.
Danish: Der er ikke behov for dosisjustering af LIBTAYO til patienter med nedsat nyrefunktion.
English: (including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b
Danish: (inklusive men ikke begrænset til meningitis, paraneoplastisk encefalomyelitis, artritis, Guillain-Barré syndrom, encefalitis, kronisk inflammatorisk demyeliniserende polyradikuloneuropati, inflammation i centralnervesystemet, autoimmun myocarditis og immun trombocytopenisk purpura, myalgi, Sjögrens syndrom, vasculitis, myasthenia gravis)b
English: This includes room temperature storage of the infusion solution in the intravenous container and time for administration of the infusion.
Danish: Dette omfatter opbevaringstid for infusionsvæsken i den intravenøse beholder ved stuetemperatur og tid til administration af infusionsvæsken.
English: Patients should be monitored for changes in thyroid function at the start of treatment and periodically during the treatment as indicated based on clinical evaluation (see section 4.8).
Danish: Patienterne bør monitoreres for ændringer i thyroideafunktionen ved behandlingsstart og regelmæssigt under behandlingen, hvis indiceret på baggrund af klinisk evaluering (se pkt.
English: Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older.
Danish: Af de 219 patienter med mCSCC og laCSCC, som blev behandlet med cemiplimab, var 25,1 % (55/219) under 65 år, 34,2 % (75/219) var mellem 65 og 75 år og 40,6 % (89/219) var 75 år eller derover.
English: Renal and urinary disorders Nephritis
Danish: Nyrer og urinveje Nefritis
English: The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.
Danish: Øvrige indholdsstoffer: L-Histidin, L-Histidinmonohydrochloridmonohydrat, L-prolin, saccharose, polysorbat 80 og vand til injektionsvæsker.
English: • Do not co-administer other medicinal products through the same infusion line.
Danish: • Der må ikke administreres andre lægemidler i samme infusionsslange.
English: Uncommon Respiratory, thoracic and mediastinal disorders Pneumonitis
Danish: Luftveje, thorax og mediastinum Pneumonitis
English: LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Danish: LIBTAYO som monoterapi er indiceret til behandling af voksne patienter med metastatisk kutant planocellulært karcinom (CSCC) eller lokalt avanceret CSCC, som ikke er egnede til kurativ kirurgi eller kurativ strålebehandling.
English: The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years.
Danish: Gennemsnitsalderen var 72 år (interval: 38 til 96): 78 (40,4 %) patienter var 75 år eller derover, 66 patienter (34,2 %) var 65 til 75 år, og 49 patienter (25,4 %) var under 65 år.
English: Five out of 398 patients (1.3%) administered cemiplimab developed treatment-emergent antibodies, with 1 out of 398 patients (0.3%) exhibiting persistent antibody responses.
Danish: Fem ud af 398 patienter (1,3 %), der fik cemiplimab, udviklede behandlingsudløste antistoffer, og 1 ud af 398 patienter (0,3 %) udviste vedvarende antistofrespons.
English: Grades 1-5
Danish: Grad 1-5
English: Resolution of pneumonitis had occurred in 14 (63.6%) of the 22 patients at the time of data cut-off.
Danish: Pneumonitis havde fortaget sig hos 14 (63,6 %) af de 22 patienter på tidspunktet for data cut-off.
English: • you have liver problems
Danish: • hvis du har problemer med din lever
English: Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients.
Danish: Immunrelaterede bivirkninger medførte permanent seponering af cemiplimab hos 4,4 % af patienterne.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne angivet i pkt.
English: Grade 3 or 4 or recurrent Grade 2
Danish: Grad 3 eller 4 eller tilbagevendende grad 2
English: Hyperthyroidism
Danish: Hyperthyreoidisme
English: Malta Sanofi S.p.A
Danish: Sanofi S.p.A.
English: o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
Danish: o En beskrivelse af de vigtigste tegn eller symptomer på immunrelaterede bivirkninger (pneumonitis, colitis, hepatitis, endokrinopatier, immunrelaterede hudreaktioner, nefritis og andre immunrelaterede bivirkninger) og infusionsrelaterede reaktioner samt vigtigheden af straks at kontakte den behandlende læge, hvis der opstår et eller flere symptomer.
English: LIBTAYO has not been studied in patients with moderate or severe hepatic impairment.
Danish: LIBTAYO er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
English: Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret type 1-diabetes mellitus, inklusive diabetisk ketoacidose, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Nervous system disorders Paraneoplastic encephalomyelitis
Danish: Nervesystemet Paraneoplastisk encefalomyelitis
English: You should not be given LIBTAYO if:
Danish: Du må ikke få LIBTAYO:
English: (Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral.
Danish: (grad 4), paraneoplastisk encefalomyelitis (grad 5), Guillain-Barré syndrom, inflammation i centralnervesystemet, kronisk inflammatorisk demyeliniserende polyradikuloneuropati, encefalitisb, myasthenia gravis, perifer neuropati Hjerte: myocarditis c, pericarditis
English: Unopened vial Store in a refrigerator (2°C to 8°C).
Danish: Uåbnet hætteglas Opbevares i køleskab (2°C - 8°C).
English: Immune system disorders Infusion-related reaction
Danish: Immunsystemet Infusionsrelateret reaktion
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter anbrud eller fortynding af lægemidlet, se pkt.