FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections.
Danish: Hjælpestoffer: L-histidin, L-histidinmonohydrochloridmonohydrat, L-prolin, polysorbat 80, saccharose og vand til injektionsvæsker.
English: Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%.
Danish: Blandt 21 patienter med mCSCC var ORR 60 % (3/5) hos patienter med PD-L1 < 1 % og 56,3 % (9/16) blandt patienter med PD-L1 ≥ 1 %.
English: • Lung problems (pneumonitis) such as new or worsening cough, being short of breath and chest pain.
Danish: • Lungeproblemer (lungebetændelse) som f.eks. ny eller forværret hoste, åndenød og smerter i brystkassen.
English: • feeling tired
Danish: vægttab og træthed
English: • The patient guide shall contain the following key messages 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: • Patientvejledningen skal indeholde følgende hovedelementer 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: Severity a
Danish: Sværhedsgrad a
English: • Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat, such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding.
Danish: • Problemer i andre dele af kroppen som f.eks. hovedpine eller stivhed i nakken, feber, træthed eller svaghedsfølelse, forvirring, svækket hukommelse eller søvnighed, anfald (krampeanfald), man ser eller hører ting, der ikke er virkelige (hallucinationer), synsforstyrrelser, øjensmerter eller røde øjne, kraftige muskelsmerter, ændret hjerterytme som f.eks. hurtigere hjerterytme, følelse af at hjertet springer et slag over eller hjertebanken samt blå mærker på huden eller blødning.
English: Grade 4 or recurrent Grade 3
Danish: Grad 4 eller tilbagevendende grad 3
English: Initiate thyroid hormone replacement as clinically indicated
Danish: Initiér substitutionsbehandling med thyroideahormon hvis klinisk indiceret
English: Hypophysitis
Danish: Hypofysitis
English: In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older.
Danish: Hos de 193 patienter i effektanalysen var den objektive responsrate ved ICR (95 % CI) 40,8 % (27,0 %; 55,8 %) hos patienterne under 65 år, 48,5 % (36,0 %; 61,1 %) hos patienterne mellem 65 og 75 år og 42,3 % (31,2 %; 54,0 %) hos patienterne i alderen 75 år eller derover.
English: LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles.
Danish: LIBTAYO er en klar til let opaliserende, farveløs til svagt gul opløsning, der kan indeholde spormængder af gennemsigtige til hvide partikler.
English: The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540).
Danish: Cemiplimabs sikkerhed og virkning er blevet undersøgt hos patienter med metastatisk (lymfemetastaser eller fjernmetastaser) CSCC (mCSCC) og lokalt avanceret CSCC (laCSCC), der ikke var egnede til kurativ kirurgi eller kurativ strålebehandling, i et klinisk studie R2810-ONC-1540 (Studie 1540).
English: If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.
Danish: Hætteglassene og/eller de intravenøse infusionsposer skal nå stuetemperatur inden brug, hvis de har været opbevaret i køleskab.
English: Sími: +354 535 7000
Danish: Vistor hf. Sími: +354 535 7000
English: Endocrine disorders Hypothyroidism
Danish: Det endokrine system Hypothyreoidisme
English: Cemiplimab has not been studied in patients with moderate or severe hepatic impairment.
Danish: Cemiplimab er ikke undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
English: Among the 4 patients with type 1 diabetes mellitus, the median time to onset was 2.3 months (range: 28 days to 6.2 months).
Danish: Blandt de 4 patienter med type 1-diabetes mellitus var tid til indtræden 2,3 måneder (interval: 28 dage til 6,2 måneder).
English: Among 54 patients with laCSCC, ORR was 35.3% (6/17) in patients with PD-L1 < 1% and 54.1% (20/37) among patients with PD-L1 ≥ 1%.
Danish: Blandt 54 patienter med laCSCC var ORR 35,3 % (6/17) hos patienter med PD-L1 < 1 % og 54,1 % (20/37) blandt patienter med PD-L1 ≥ 1 %.
English: In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should provide interim data of a single-arm trial in the same population [study 1540 group 6].
Danish: Med henblik på at bekræfte cemiplimabs virkning og sikkerhed til behandling af metastatisk kutant planocellulært karcinom eller lokalt avanceret kutant planocellulært karcinom hos patienter, som ikke er egnede til kurativ kirurgi eller kurativ strålebehandling, skal indehaveren af markedsføringstilladelsen fremlægge foreløbige data fra et studie med en enkelt behandlingsarm i samme population [studie 1540 gruppe 6].
English: • Gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness.
Danish: • Tarmproblemer (tyktarmsbetændelse) som f.eks. hyppig diarré ofte med blod eller slim, hyppigere afføring end normalt, sort eller tjærelignende afføring og kraftige mavesmerter eller ømhed i maven.
English: • inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid
Danish: • betændelse i hypofysen som sidder på bunden af hjernen, nedsat hormonudskillelse fra binyrerne, betændelse i bugspytkirtlen
English: mCSCC cemiplimab: 350 mg Q3W (Group 3) (N = 56)
Danish: mCSCC cemiplimab: 350 mg hver tredje uge (Gruppe 3) (N = 56)
English: • Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas
Danish: • Problemer med de hormonproducerende kirtler - især skjoldbruskkirtlen, hypofysen, binyrerne og bugspytkirtlen
English: Eighteen patients (3.0%) received high-dose corticosteroids for a median of 8.5 days (range: 1 day to 5.9 months).
Danish: Atten patienter (3,0 %) fik højdosis-kortikosteroid i gennemsnitligt 8,5 dage (interval: 1 dag til 5,9 måneder).
English: • Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane.
Danish: • Hudproblemer som f.eks. udslæt eller kløe, blæredannelse på huden og sår i mund eller andre slimhinder.
English: Cemiplimab should be interrupted or the rate of infusion slowed for mild or moderate infusion-related reactions.
Danish: Ved milde eller moderate infusionsrelaterede reaktioner bør cemiplimab afbrydes eller infusionshastigheden nedsættes.
English: • at room temperature up to 25°C for no more than 8 hours from the time of preparation.
Danish: • Ved stuetemperatur op til 25°C i højst 8 timer fra tidspunktet for klargøring.
English: Four patients (0.7%) with immune-related diarrhoea or colitis received high-dose corticosteroids for a median of 29 days (range: 19 days to 2.0 months).
Danish: Fire patienter (0,7 %) med immunrelateret diarré eller colitis fik højdosis-kortikosteroid i gennemsnitligt 29 dage (interval: 19 dage til 2,0 måneder).
English: At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 mg every 3 weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway over the dosing interval.
Danish: Ved dosering på 1 mg/kg til 10 mg/kg hver 2. uge og 350 mg hver 3. uge udviste cemiplimab lineær og dosisproportionel farmakokinetik, hvilket tyder på mætning af den targeterede omsætning i hele doseringsintervallet.
English: • Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than a few translucent-to-white particles.
Danish: • Kassér hætteglasset, hvis opløsningen er uklar, misfarvet eller indeholder andre synlige partikler end nogle få delvist gennemsigtige eller hvide partikler.
English: In order to confirm the efficacy and safety of cemiplimab for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, the MAH should submit the final study report for Groups 1-3 in the phase 2 pivotal study 1540.
Danish: Med henblik på at bekræfte cemiplimabs virkning og sikkerhed til behandling af metastatisk kutant planocellulært karcinom eller lokalt avanceret kutant planocellulært karcinom hos patienter, som ikke er egnede til kurativ kirurgi eller kurativ strålebehandling, skal indehaveren af markedsføringstilladelsen indsende den endelige studierapport for gruppe 1-3 i fase-II hovedstudiet 1540.
English: mCSCC cemiplimab: 3 mg/kg Q2W (Group 1) (N = 59)
Danish: mCSCC cemiplimab: 3 mg/kg hver anden uge (Gruppe 1) (N = 59)
English: Immune-related adverse reactions occurred in 20.1% of patients treated with cemiplimab in clinical trials including Grade 5 (0.7%), Grade 4 (1.2%) and Grade 3 (6.1%).
Danish: Immunrelaterede bivirkninger forekom hos 20,1 % af de patienter, der blev behandlet med cemiplimab i kliniske undersøgelser, inklusive grad 5 (0,7 %), grad 4 (1,2 %) og grad 3 (6,1 %).
English: For a full list of patients excluded from clinical trials, see section 5.1.
Danish: 5.1 for listen over patienter, der blev ekskluderet fra de kliniske studier.
English: LIBTAYO 350 mg sterile concentrate cemiplimab
Danish: LIBTAYO 350 mg sterilt koncentrat cemiplimab i.v.
English: Grades 3-5
Danish: Grad 3-5
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see section 4.4).
Danish: Der er rapporteret svære kutane bivirkninger (SCARs), inklusive Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), i forbindelse med cemiplimab-behandling (se pkt.
English: Patients should be managed with hormone replacement therapy (if indicated) and cemiplimab treatment modifications.
Danish: Patienterne bør behandles med hormonsubstitutionsbehandling (hvis det er klinisk indiceret) og justeringer i cemiplimabbehandlingen.
English: Hypothyroidism
Danish: Hypothyreoidisme
English: Other fatal and life-threatening immune-related adverse reactions have been observed in patients receiving cemiplimab including paraneoplastic encephalomyelitis and meningitis (see section 4.8 for other immune-related adverse reactions).
Danish: Der er observeret andre letale og livstruende immunrelaterede bivirkninger hos patienter, der har fået cemiplimab, herunder paraneoplastisk encefalomyelitis og meningitis (se pkt.
English: No effects on fertility assessment parameters or in the male and female reproductive organs were observed in a 3-month repeat dose fertility assessment study with sexually mature cynomolgus monkeys.
Danish: I et studie af 3 måneders varighed, der undersøgte fertilitet efter gentagne doser hos kønsmodne cynomolgusaber, blev der ikke observeret nogen effekt på fertilitetsparametre eller på hanners eller hunners reproduktionsorganer.
English: LIBTAYO is for intravenous use.
Danish: LIBTAYO er til intravenøs anvendelse.
English: • inflammation of brain and spinal cord membranes usually caused by infection • dryness in many parts of the body, from mouth to eyes, nose, throat and the top layers of skin
Danish: • tørhed flere steder på kroppen, lige fra munden til øjne, næse, svælg og det øverste hudlag
English: Sjogren's syndrome
Danish: Sjögrens syndrom
English: Median (range) (months)
Danish: Responsvarighed (DOR)a, Median (interval) (måneder)
English: Patient Alert Card
Danish: Patientkort
English: o The contact details of their LIBTAYO prescriber.
Danish: o Kontaktoplysninger på den læge, der har ordineret LIBTAYO.
English: • Do not shake the vial.
Danish: • Hætteglasset må ikke rystes.
English: Among the 42 patients with hypothyroidism, the median time to onset was 4.2 months (range: 15 days to 18.9 months).
Danish: Blandt de 42 patienter med hypothyreoidisme var mediantid til indtræden 4,2 måneder (interval: 15 dage til 18,9 måneder).
English: There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2).
Danish: Data fra patienter med moderat eller svært nedsat leverfunktion er for begrænsede til at kunne give dosisanbefalinger (se pkt.
English: • you have any other medical conditions.
Danish: • hvis du har en sygdom af enhver art.
English: Or
Danish: Eller
English: Among the 11 patients with hyperthyroidism, the median time to onset was 1.9 months (range: 28 days to 14.8 months).
Danish: Blandt de 11 patienter med hyperthyreoidisme var mediantid til indtræden 1,9 måned (interval: 28 dage til 14,8 måneder).
English: Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Danish: Initial dosis prednison på 12 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning samt hormonsubstitutionsbehandling hvis klinisk indiceret
English: Immune-related skin adverse reactions, defined as requiring use of systemic corticosteroids with no clear alternate aetiology, including severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (some cases with fatal outcome), and other skin reactions such as rash, erythema multiforme, pemphigoid, have been reported in association with cemiplimab treatment (see section 4.8).
Danish: I forbindelse med cemiplimab-behandlingen er der rapporteret immunrelaterede hudreaktioner, defineret som behandlingskrævende med systemisk kortikosteroid og uden klar alternativ ætiologi, inklusive svære kutane bivirkninger (SCARs) som f.eks. Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) (i nogle tilfælde med dødelig udgang) og andre hudreaktioner som f.eks. udslæt, erythema multiforme, pemfigoid (se pkt.
English: • LIBTAYO is for intravenous use.
Danish: • LIBTAYO er til intravenøs anvendelse.
English: Fatigue has been reported following treatment with cemiplimab (see section 4.8).
Danish: Træthed er rapporteret efter behandling med cemiplimab (se pkt.
English: • Lung problems (pneumonitis)
Danish: • Lungeproblemer (lungebetændelse)
English: Storage of diluted solution
Danish: Opbevaring af fortyndet opløsning
English: What you need to know before you use LIBTAYO 3.
Danish: Det skal du vide, før du begynder at få LIBTAYO
English: Skin and subcutaneous skin disorders Rashg
Danish: Hud og subkutane væv Udslæt g
English: Other immune-related adverse reactions
Danish: Andre immunrelaterede reaktioner
English: Immune-related hypophysitis occurred in 1 (0.2%) of 591 patients receiving cemiplimab.
Danish: Immunrelateret hypofysitis forekom hos 1 (0,2 %) af de 591 patienter, der fik cemiplimab.
English: Immune-related nephritis
Danish: Immunrelateret nefritis
English: Animal reproduction studies have not been conducted with cemiplimab (see section 4.6).
Danish: Der er ikke udført reproduktionsstudier med cemiplimab i dyr (se pkt.
English: LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody.
Danish: Det indeholder det aktive stof cemiplimab, som er et monoklonalt antistof.
English: Patients should be managed with cemiplimab treatment modifications and corticosteroids as described above (see section 4.2).
Danish: Patienterne bør behandles med justeringer i cemiplimab-behandlingen og kortikosteroid som beskrevet ovenfor (se pkt.
English: • Type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Danish: • Type 1-diabetes som kan omfatte øget sultfølelse eller øget tørst, hyppigere vandladning, vægttab og træthed.
English: LIBTAYO 350 mg concentrate for solution for infusion cemiplimab
Danish: LIBTAYO 350 mg koncentrat til infusionsvæske, opløsning cemiplimab
English: Resolution had occurred in 6 (50%) of 12 patients at the time of data cut-off.
Danish: Immunrelaterede hudreaktioner havde fortaget sig hos 6 (50 %) af 12 patienter på tidspunktet for data cut-off.
English: Grade 2 or 3
Danish: Grad 2 eller 3
English: Once prepared, administer the diluted solution immediately.
Danish: Den fortyndede opløsning skal administreres umiddelbart efter klargøring.
English: Infusion-related reaction led to permanent discontinuation of cemiplimab in 2 (0.3%) patients.
Danish: Infusionsrelateret reaktion medførte permanent seponering af cemiplimab hos 2 (0,3 %) patienter.
English: What LIBTAYO looks like and contents of the pack LIBTAYO concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles.
Danish: LIBTAYO koncentrat til infusionsvæske, opløsning (sterilt koncentrat) er en klar til let opaliserende, farveløs til svagt gul steril opløsning, der kan indeholde spormængder af gennemsigtige til hvide partikler.
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Danish: sanofi-aventis Pharma Slovakia s.r.o.
English: At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway.
Danish: Ved et dosisregime på 1 mg/kg til 10 mg/kg hver 2. uge udviste cemiplimab lineær og dosisrelateret farmakokinetik, hvilket tyder på mætning af den targeterede omsætning.
English: Patients should be monitored for hyperglycaemia and signs and symptoms of diabetes as indicated based on clinical evaluation and managed with oral anti-hyperglycaemics or insulin and cemiplimab treatment modifications (see section 4.2).
Danish: Patienterne bør monitoreres for hyperglykæmi og tegn og symptomer på diabetes, hvis indiceret på baggrund af klinisk evaluering og behandles med et oral antihyperglykæmisk præparat eller insulin og justeringer i cemiplimab-behandlingen (se pkt.
English: • under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation.
Danish: • I køleskab ved 2°C - 8°C i højst 24 timer fra tidspunktet for klargøring.
English: • LIBTAYO must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Danish: • LIBTAYO skal administreres som en intravenøs infusion over en periode på 30 minutter gennem en infusionsslange med et sterilt, ikke-pyrogent in-line- eller add-on-filter med lav proteinbinding (porestørrelse på 0,2-5 mikron).
English: Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and skin reaction.
Danish: Udslæt er en sammensat term, der omfatter makulopapuløst udslæt, udslæt, dermatitis, generaliseret udslæt, bulløs dermatit, medikamentelt udslæt, erytem, pemfigoid, psoriasis, erytematøst udslæt, makuløst udslæt, kløende udslæt og hudreaktion.
English: Ten (1.7%) patients with immune-related hepatitis received high-dose corticosteroids for a median of 10.5 days (range: 2 days to 1.9 months).
Danish: Ti (1,7 %) patienter med immunrelateret hepatitis fik højdosiskortikosteroid i gennemsnitligt 10,5 dage (interval: 2 dage til 1,9 måned).
English: Withhold LIBTAYO
Danish: Pauser LIBTAYO
English: • Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than trace amounts of translucent-to-white particles.
Danish: • Kassér hætteglasset, hvis opløsningen er uklar, misfarvet eller indeholder andre synlige partikler end nogle få delvist gennemsigtige eller hvidlige partikler.
English: Among the 22 patients with immune-related pneumonitis, the median time to onset was 3.8 months (range: 7 days to 18 months) and the median duration of pneumonitis was 21.5 days (range: 5 days to 6.5 months).
Danish: Blandt de 22 patienter med immunrelateret pneumonitis var mediantid til indtræden 3,8 måneder (interval: 7 dage til 18 måneder) og median varighed af pneumonitis var 21,5 dage (interval: 5 dage til 6,5 måneder).
English: Among the 12 patients with immune-related skin adverse reactions, the median time to onset was 1.5 months (range: 2 days to 10.9 months) and the median duration was 4.4 months (range: 14 days to 9.6 months).
Danish: Blandt de 12 patienter med immunrelaterede hudreaktioner var mediantid til indtræden 1,5 måneder (interval: 2 dage til 10,9 måneder), og median varighed var 4,4 måneder (interval: 14 dage til 9,6 måneder).
English: Two (0.3%) patients with immune-related nephritis received high-dose corticosteroids for a median of 1.5 months (range: 16 days to 2.6 months).
Danish: To (0,3 %) patienter med immunrelateret nefritis fik højdosis-kortikosteroid i gennemsnitligt 1,5 måneder (interval: 16 dage til 2,6 måneder).
English: Among the 11 patients with immune-related hepatitis, the median time to onset was 1.0 month (range: 7 days to 4.2 months) and the median duration of hepatitis was 15 days (range: 8 days to 2.7 months).
Danish: Blandt de 11 patienter med immunrelateret hepatitis var mediantid til indtræden 1,0 måned (interval: 7 dage til 4,2 måneder) og median varighed af hepatitis var 15 dage (interval: 8 dage til 2,7 måneder).
English: fast heartbeat, increased sweating, feeling cold, very tired, dizzy or fainting, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, constipation, your voice gets deeper, very low blood pressure, passing water more often than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful).
Danish: • Problemer med de hormonproducerende kirtler som f.eks. vedvarende eller usædvanlig hovedpine, hurtig puls, øget svedtendens, følelse af at fryse, udmattelse, svimmelhed eller besvimelse, vægtstigning eller vægttab, øget sultfølelse eller tørst, hårtab, forstoppelse, dybere stemme, meget lavt blodtryk, hyppigere vandladning, kvalme eller opkastning, mavesmerter, ændret humør eller adfærd (f.eks. nedsat sexlyst, irritabilitet eller glemsomhed).
English: It must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Danish: Det skal administreres som en intravenøs infusion over en periode på 30 minutter gennem en infusionsslange med et sterilt, ikke-pyrogent inline- eller add-on-filter med lav proteinbinding (porestørrelse på 0,2-5 mikron).