natgillin/translations-raw huggingface dataset:
Temybric Ellipta bør bruges med forsigtighed hos patienter med krampelidelser eller tyreotoksikose og hos patienter, der reagerer i usædvanlig høj grad på beta2-adrenerge agonister.
Temybric Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Temybric Ellipta indeholder lactose
Temybric Ellipta contains lactose
Letal pneumoni forekom hos 12 af 4.151 patienter (3,5 pr. 1.000 patientår), som fik Temybric Ellipta, 5 af 4.134 patienter (1,7 pr. 1.000 patientår), som fik fluticasonfuroat/vilanterol og 5 af 2.070 patienter (2.9 pr. 1.000 patientår), som fik umeclidinium/vilanterol.
Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Temybric Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Patienter med moderat til svært nedsat leverfunktion, som får Temybric Ellipta, bør monitoreres for bivirkninger relateret til kortikosteroiders systemiske virkninger (se pkt.
Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1378/001
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/001
Temybric Ellipta kan ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
Temybric Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
INFORMATION I BRAILLESKRIFT temybric ellipta
INFORMATION IN BRAILLE temybric ellipta
I IMPACT medførte Temybric Ellipta en signifikant forbedring (p < 0,001) i lungefunktionen sammenlignet med FF/VI og UMEC/VI over en 52-ugers periode (se tabel 2).
In IMPACT, Temybric Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Administration af Temybric Ellipta samtidig med andre langtidsvirkende muskarine antagonister eller langtidsvirkende beta2-adrenerge agonister er ikke blevet undersøgt og anbefales ikke, da det kan forstærke bivirkningerne (se pkt.
Co-administration of Temybric Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Hos i alt 1.810 patienter med fremskreden KOL (gennemsnitlig postbronkodilator FEV1 ved screening på 45 % af det forventede, standardafvigelse (SD) 13 %), hvoraf 65 % havde haft en moderat/svær eksacerbation af KOL i året før indtrædelse i studiet (studie CTT116853), blev der indberettet en højere forekomst af pneumonitilfælde op til 24 uger hos patienter, der fik Temybric Ellipta (20 patienter, 2 %), end hos patienter, der fik budesonid/formoterol (7 patienter, < 1 %).
In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Temybric Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Temybric Ellipta indeholder De aktive stoffer er fluticasonfuroat, umeclidiniumbromid og vilanterol.
What Temybric Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
I IMPACT reducerede behandlingen med Temybric Ellipta den årlige frekvens af svære eksacerbationer (dvs. der krævede hospitalsindlæggelse eller resulterede i død) med 13 % sammenlignet med FF/VI (95 % CI: -1, 24; p = 0,064).
In IMPACT, treatment with Temybric Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Temybric Ellipta bør derfor anvendes med forsigtighed til patienter med ustabil eller livstruende kardiovaskulær sygdom.
Therefore, Temybric Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
IMPACT (CTT116855) var et 52-ugers studie (n = 10.355), der sammenlignede Temybric Ellipta (92/55/22 mikrogram) med fluticasonfuroat/vilanterol 92/22 mikrogram (FF/VI) og umeclidinium/vilanterol 55/22 mikrogram (UMEC/VI).
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Temybric Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1378/003
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/003
I IMPACT medførte Temybric Ellipta en signifikant reduktion (p < 0,001) i brugen af akutmedicin (tilfælde pr. dag) i hver periode på 4 uger sammenlignet med FF/VI og UMEC/VI.
In IMPACT, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
Temybric Ellipta bør administreres med forsigtighed til patienter med lungetuberkulose og til patienter med kroniske eller ubehandlede infektioner.
Temybric Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Temybric Ellipta bør anvendes med forsigtighed hos patienter med snævervinklet glaukom eller urinretention.
Temybric Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Behandling med Temybric Ellipta medførte en signifikant reduktion i den årlige frekvens af svære eksacerbationer med 34 % sammenlignet med UMEC/VI (95 % CI: 22,44; p <0,001).
Treatment with Temybric Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Studie 200812 var et 24-ugers non-inferiorstudie (n = 1.055), der sammenlignede Temybric Ellipta (92/55/22 mikrogram) med FF/VI (92/22 mikrogram) + UMEC (55 mikrogram), der blev administreret samtidig som en multi-inhalatorbehandling én gang dagligt hos patienter med moderate eller svære eksacerbationer inden for de seneste 12 måneder.
Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Temybric Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Hvis du har glemt at bruge Temybric Ellipta
If you forget to use Temybric Ellipta
I FULFIL medførte Temybric Ellipta et signifikant fald i risikoen for en moderat/svær eksacerbation sammenlignet med BUD/FOR over 24 uger (33 %; 95% CI: 12; 48; p =
In FULFIL, Temybric Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
I FULFIL medførte Temybric Ellipta en signifikant reduktion (p < 0,001) i brugen af akutmedicin mellem uge 1-24 sammenlignet med BUD/FOR (behandlingsforskel: -0,2 tilfælde pr. dag; 95 % CI:
In FULFIL, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Temybric Ellipta medførte en signifikant forbedring (p < 0,001) i helbredsrelateret livskvalitet (målt ved hjælp af SGRQ-score [St. George's Respiratory Questionnaire]) i både FULFIL (uge 24) når sammenlignet med BUD/FOR (-2,2 enheder; 95 % CI: -3,5; -1,0) og IMPACT (uge 52) når sammenlignet med FF/VI (-1,8 enheder; 95 % CI: -2,4; -1,1) og UMEC/VI (-1,8 enheder; 95 % CI:
Temybric Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Andelen af respondenter i uge 21-24 var signifikant højere (p < 0,001) for patienter behandlet med Temybric Ellipta sammenlignet med BUD/FOR (henholdsvis 47 % og 37 %; OR 1,59; 95 % CI: 1,30; 1,94).
The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
I IMPACT var andelen af respondenter også signifikant højere (p < 0,001) for Temybric Ellipta (36 %) sammenlignet med FF/VI (29 %; OR 1,36; 95 % CI: 1,19; 1,55) og UMEC/VI (30 %; OR 1,33; 95 % CI: 1,13; 1,57).
In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Temybric Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
I IMPACT medførte Temybric Ellipta en signifikant forlængelse i tiden til første moderate/svære eksacerbation og et signifikant fald (p < 0,001) i risikoen for moderate/svære eksacerbationer målt ved tid til første eksacerbation, sammenlignet med både FF/VI (14,8 %; 95 % CI: 9,3; 19,9) og UMEC/VI (16,0 %; 95% CI: 9,4; 22,1).
In IMPACT, Temybric Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
I et 52-ugers studie med i alt 10.355 KOL-patienter og moderate eller svære eksacerbationer inden for de seneste 12 måneder (gennemsnitlig postbronkodilator FEV1 ved screening på 46 % af forventede, standardafvigelse (SD) 15 %) (studie CTT116855) var forekomsten af pneumoni på 8 % (317 patienter) for Temybric Ellipta (n = 4.151), 7 % (292 patienter) for fluticasonfuroat/vilanterol (n = 4.134) og 5 % (97 patienter) for umeclidinium/vilanterol (n = 2.070).
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Temybric Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
I IMPACT medførte Temybric Ellipta en statistisk signifikant reduktion i det gennemsnitlige antal natlige opvågninger som følge af KOL sammenlignet med FF/VI (-0,05; 95 % CI: -0,08; -0,01; p = 0,005) og med UMEC/VI (-0,10; 95 % CI: -0,14; -0,05; p < 0,001) i uge 49 til 52.
In IMPACT, Temybric Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
I undergruppen med 430 patienter i op til 52 uger var forekomsten af indberettet pneumoni for både Temybric Ellipta- og budesonid/formoterol-gruppen 2 %.
In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Temybric
I IMPACT var andelen af patienter, der var CAT-respondenter i uge 52, signifikant højere (p < 0,001) for patienter behandlet med Temybric Ellipta (42 %) sammenlignet med FF/VI (37 %; OR 1,24; 95 % CI: 1,14; 1,36) og UMEC/VI (36 %; OR 1,28; 95 % CI: 1,15; 1,43).
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Temybric Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
FULFIL (CTT116853) var et 24-ugers studie (n = 1.810) med forlængelse op til 52 uger i en undergruppe af forsøgspersoner (n = 430), der sammenlignede Temybric Ellipta (92/55/22 mikrogram)
FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Temybric Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Det er ikke nødvendigt at kontrollere, om Temybric Ellipta-inhalatoren virker korrekt, før du bruger den første gang.
The first time you use Temybric Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Temybric Ellipta bør anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt.
Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Det skal du vide, før du begynder at bruge Temybric Ellipta
What you need to know before you use Temybric Ellipta
Æsken med Temybric Ellipta-inhalatoren indeholder
Your Temybric Ellipta inhaler carton contains
LÆGEMIDLETS NAVN Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Indlægsseddel: Information til patienten Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
Package leaflet: Information for the patient Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Tel: + 39 050 971011
Laboratori Guidotti S.p.A. Tel: + 39 050 971011
I FULFIL medførte Temybric Ellipta en signifikant reduktion (p = 0,002) i den årlige frekvens af moderate/svære eksacerbationer på 35 % (95 % CI: 14; 51) sammenlignet med BUD/FOR, baseret på data op til 24 uger.
In FULFIL, based upon data up to 24 weeks, Temybric Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
I FULFIL var andelen af respondenter ifølge TDI (defineret som mindst 1 enhed) signifikant højere (p < 0,001) for Temybric Ellipta sammenlignet med BUD/FOR (61 % ift.
In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Temybric Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
I FULFIL var andelen af patienter, der var CAT-respondenter (defineret som 2 enheder under baseline eller lavere) i uge 24, signifikant højere (p < 0,001) for patienter behandlet med Temybric Ellipta sammenlignet med BUD/FOR (53 % ift.
In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temybric Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Sådan skal du bruge Temybric Ellipta
How to use Temybric Ellipta
Hvis du har brugt for meget Temybric Ellipta
If you stop using Temybric Ellipta
I løbet af 52 uger i IMPACT medførte Temybric Ellipta en signifikant reduktion (p < 0,001) i den årlige frekvens af moderate/svære eksacerbationer på 15 % (95 % CI: 10; 20) sammenlignet med FF/VI (frekvens; 0,91 ift.
In IMPACT, over 52 weeks, Temybric Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
(n = 4.151)
Temybric Ellipta (N = 4,151
Det skal du vide, før du begynder at bruge Temybric Ellipta Sådan skal du bruge Temybric Ellipta Bivirkninger
What you need to know before you use Temybric Ellipta 3.
Ellipta
Elderly
Sammenligning Temybric ift.
How to use Temybric Ellipta 4.
UMEC/VI
Comparison Temybric vs. UMEC/VI
• Risiko for reaktivering af latent tuberkulose og information om screening for tuberkulose ifølge den lokale vejledning;
• Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
• Lokal vejledning i tuberkulose-screening;
• Local Guidance for tuberculosis screening;
• Egnede teknikker til selvadministration af Stelara, inklusive brug af den fyldte injektionssprøjte.
• Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
Medlemsstaterne skal sikre sig, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor implementeres:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
• Uddannelsepakke til sundhedspersonale • Informationspakke til patienter
Healthcare Professional educational pack • Patient information pack
Indehaverne af markedsføringstilladelsen (MAH) skal sikre sig, at alt sundhedspersonale, som forventes at udskrive/anvende Stelara, før lanceringen af den fyldte Stelara-injektionssprøjte bliver forsynet med undervisningsmateriale, som indeholder følgende:
The Marketing authorisation Holder (MAH) shall ensure that prior to launch of the prefilled syringe form of Stelara, all healthcare professionals who are expected to prescribe/use Stelara are provided with educational materials containing the following:
• Risiko for maligniteter.
• Risk of malignancies.
Hovedbudskaberne og de vigtigste komponenter inkluderet i uddannelsepakken til sundhedspersonale er defineret som følger:
The key messages and components included in the Healthcare Professional educational pack are defined as follows:
• Mulig risiko for maligniteter
• Potential risk of malignancies;
Hovedbudskaberne i informationspakken til patienter er defiveret som følger:
The key messages in the patient information pack are defined as follows:
• Indlægsseddel
• Patient Information Leaflet
N: antal patienter i en behandlingsgruppe.
N: number of patients in a treatment group.
Performance-status og BMI
Performance status and BMI
(Del af den ydre karton)
(Part of the Outer Carton)
Tid (dage) til hændelse
Time (days) to event
Børn og teenagere Removab må ikke anvendes til børn og teenagere under 18 år.
Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Den samlede behandlingsperiode må ikke overstige 20 dage.
The overall treatment period should not exceed 20 days.
Desuden skal der bruges følgende materialer:
In addition the following is required:
• Begrundelse for en ekstra fornyelse
• Grounds for one additional renewal
Estimeret sandsynlighed for at være punkturfri (%)
Estimated Probability of Being Puncture-free (%)
Det kan fjernes dagen efter den sidste infusion.
It can be removed the day after the last infusion.
Patienter af ikke-kaukasisk oprindelse har ikke været inkluderet i disse kliniske studier.
Patients of nonCaucasian origin have not been included in these clinical studies.
Nødvendige materialer og udstyr
Material and equipment required
Nogle af disse bivirkninger kan kræve lægebehandling.
Some of these side effects may require medical treatment.
Slutvolumen til administration
Final volume for administration
• Usikkerhed om kendskabet til de sjældne, ufavorable virkninger, da sikkerhedsdatabasen stadig er meget begrænset på grund af det lille antal patienter, der er blevet behandlet med Removab.
• Uncertainty in the knowledge about the rare unfavourable effects since the safety database is still very limited due to the low number of patients treated with Removab.
Derefter kan kateteret fjernes.
Subsequently, the catheter can be removed.
Kun i tilfælde af klinisk relevant eller vedvarende forhøjelse bør yderligere diagnostik eller behandling overvejes.
Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Plasmaniveauet havde tendens til at falde efter at have nået et maksimum efter hver dosis.
Plasma levels tended to decline after achieving a maximum after each dose.
Særlige populationer Der er ikke foretaget nogen studier.
Special populations No studies have been conducted.
Ved den første af de fire doser kan en infusionstid på 6 timer overvejes, afhængigt af patientens sundhedstilstand.
For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Disse reaktioner svandt under symptomatisk behandling.
These reactions resolved under symptomatic treatment.
Administration af prednisolon som præmedicinering medførte ingen reduktion af disse bivirkninger.
Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Tyskland
Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Det er ukendt, om catumaxomab/metabolitter udskilles i human mælk.
It is unknown whether catumaxomab/metabolites are excreted in human milk.
Efter studiets afslutning blev patienterne yderligere observeret indtil deres død for at bedømme den samlede overlevelse (Tabel 4).
After completion of the study, patients were further observed until the end of their lifetime to assess overall survival (Table 4).
Bivirkningerne er afledt af en integreret sikkerhedsanalyse, der omfattede 12 kliniske studier.
Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
82166 Graefelfing Tyskland
82166 Graefelfing
Intervallet mellem infusionsdagene kan forlænges i tilfælde af relevante bivirkninger.
The interval between the infusion days can be prolonged in case of relevant adverse reactions.
Disse symptomer reflekterer catumaxomabs virkningsmekanisme og er generelt fuldt reversible.
These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Der er ingen eller utilstrækkelige data fra anvendelse af catumaxomab til gravide kvinder.
There are no or limited amount of data from the use of catumaxomab in pregnant women.
Under og efter infusionen med Removab vil mere end 1 ud af 10 patienter (meget almindelig) sandsynligvis opleve infusionsrelaterede bivirkninger.
During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Resume over sikkerhedsprofil
Summary of the safety profile
Patientpopulationen svarede til den fra det pivotale studie.
The patient population was comparable to the pivotal study.
Figur 3: Skematisk illustration af infusionssystemet
Figure 3 Schematic illustration of the infusion system
Hvis disse symptomer opstår, skal De straks kontakte lægen, da disse bivirkninger kræver omgående undersøgelse og behandling.
If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Følgende komponenter skal bruges til opløsning og administration af Removab, da Removab kun er kompatibel med:
The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
I pivotal-studiet IP-REM-AC01 var 98,1 % af patienterne indlagt i gennemsnitligt 11 dage.
In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Endometrie *= lobulær brystcancer
Endometrial *= lobular breast cancer
I kliniske studier blev infusionstider på 3 timer og 6 timer undersøgt.
In clinical studies infusion times of 3 hours and 6 hours were investigated.