natgillin/translations-raw huggingface dataset:
For mere information om brug af Ogivri, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Ogivri, see the package leaflet or contact your doctor or pharmacist.
De hyppigste eller alvorligste bivirkninger ved Ogivri er hjerteproblemer, reaktioner i forbindelse med infusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
The most common or serious side effects with Ogivri are heart problems, reactions related to the infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Som for alle lægemidler bliver data vedrørende brug af Ogivri løbende overvåget.
As for all medicines, data on the use of Ogivri are continuously monitored.
En oversigt over Ogivri, og hvorfor det er godkendt i EU
An overview of Ogivri and why it is authorised in the EU
Referencelægemidlet for Ogivri er Herceptin.
The reference medicine for Ogivri is Herceptin.
Ved at bindes til HER2 aktiverer trastuzumab immunsystemets celler, som derefter dræber tumorcellerne.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Hvorfor blev Ogivri godkendt i EU?
Why is Ogivri authorised in the EU?
Endvidere viste et studie, der omfattede 500 patienter med metastatisk brystkræft og overekspression af HER2, at Ogivri var effektivt til at behandle tilstanden.
In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition.
Det aktive stof i Ogivri, trastuzumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde sig til HER2-proteinet.
The active substance in Ogivri, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Ogivri er et "biosimilært lægemiddel".
Ogivri is a ‘biosimilar medicine'.
Ogivri må ikke anvendes hos personer, der er overfølsomme (allergiske) over for trastuzumab, museproteiner eller andre af indholdsstofferne.
Ogivri must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Ved tumorer, som er lokalt fremskredne (herunder inflammatoriske tumorer), eller som er mere end 2 cm brede, anvendes Ogivri før operation i kombination med kemoterapi og så igen efter operation, hvor det gives alene
For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ogivri is used before surgery in combination with chemotherapy and then again after surgery on its own;
Hvad er Ogivri, og hvad anvendes det til?
What is Ogivri and what is it used for?
Sikkerheden ved Ogivri er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet Herceptin.
The safety of Ogivri has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Herceptin.
Da Ogivri er et biosimilært lægemiddel, behøver de studier af trastuzumabs virkning og sikkerhed, der er udført for Herceptin, ikke at blive gentaget for Ogivri.
Because Ogivri is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ogivri.
• tidlige stadier af brystkræft (når kræften har spredt sig inde i brystet eller til lymfeknuderne (kirtlerne) under armen, men ikke til andre dele af kroppen) efter eventuel operation, kemoterapi (lægemidler til behandling af kræft) eller strålebehandling.
• early breast cancer (when the cancer has spread within the breast or to the lymph nodes (‘glands') under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Patienterne fik Ogivri eller referencelægemidlet Herceptin sammen med andre kræftlægemidler (paclitaxel eller docetaxel).
Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel).
Det anvendes også i kombination med andre kræftlægemidler (paclitaxel eller docetaxel) eller sammen med en anden type lægemiddel kaldet en aromatasehæmmer
It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Ogivri har en struktur, renhed og biologisk aktivitet, der i høj grad svarer til Herceptin, og at det fordeles i kroppen på samme måde.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ogivri has a highly similar structure, purity and biological activity to Herceptin and is distributed in the body in the same way.
Hvilke risici er der forbundet med Ogivri?
What are the risks associated with Ogivri?
Ogivri må kun anvendes, hvis kræften har såkaldt overekspression af proteinet HER2, dvs. hvis der på overfladen af kræftcellerne produceres store mængder HER2.
Ogivri can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
I lyset af de samlede data vurderedes det, at forskellen ikke var relevant, og det blev konkluderet, at Ogivri vil have samme virkning som Herceptin i de godkendte indikationer.
In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Ogivri would behave in the same way as Herceptin in its approved indications.
Ogivri kan forårsage kardiotoksicitet (hjerteskade), herunder hjertesvigt (nedsat hjertefunktion).
Ogivri can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Studier har også vist, at en infusion af Ogivri giver samme niveau af det aktive stof i kroppen som en infusion af Herceptin.
Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.
Agenturet var derfor af den opfattelse, at fordelene ved Ogivri opvejer de identificerede risici som for Herceptin, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Herceptin, the benefit of Ogivri outweighs the identified risks and it can be authorised for use in the EU.
Hvordan anvendes Ogivri?
How is Ogivri used?
Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Ogivri vil have de samme egenskaber som intravenøs Herceptin, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
All these data were considered sufficient to conclude that Ogivri will behave in the same way as intravenous Herceptin in terms of effectiveness and safety in its authorised uses.
Laboratoriestudier, hvor Ogivri er blevet sammenlignet med Herceptin, har vist, at det aktive stof i Ogivri i høj grad svarer til det aktive stof i Herceptin, hvad angår struktur, renhed og biologisk aktivitet.
Laboratory studies comparing Ogivri with Herceptin have shown that the active substance in Ogivri is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Ca. en fjerdedel af alle brystkræfttilfælde og en femtedel af alle mavekræfttilfælde har overekspression af HER2.
HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Studier i metastatisk brystkræft med overekspression af HER2 har endvidere vist, at virkningen af infusion med Ogivri svarer til virkningen af infusion med Herceptin.
In addition, studies in metastatic breast cancer that overexpressed HER2 have shown that the effectiveness of Ogivri infusion is equivalent to that of Herceptin infusion.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ogivri.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ogivri have been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser studierne, at der er ved Ogivri?
What benefits of Ogivri have been shown in studies?
Alder < 65 år ≥ 65 år
Age < 65 years ≥ 65 years
Ingen rapporterede
None reported
Dato for første markedsføringstilladelse: 11. maj 2016
Date of first authorisation: 11 May 2016
Andre symptomer kan forekomme.
Other symptoms may occur as well.
European Group for Blood and Marrow Transplantation (EBMT) kriterier.
European Group for Blood and Marrow Transplantation (EBMT) criteria.
IRC-vurdering blev udført post-hoc.
IRC assessment was performed post-hoc.
Patienter skal monitoreres for udvikling af SPM.
Patients should be monitored for the development of SPMs.
ATC-kode: L01XC23.
ATC code: L01XC23.
Risikofaktorer Høj risiko
Risk factors High risk
De 8 timer er inklusive administrationsperioden.
This 8-hour period should be inclusive of the product administration period.
Den endelige OS-analyse opfyldte den protokolspecificerede grænse for statistisk signifikans (p ≤ 0,046).
The final OS analysis met the protocol-specified boundary for statistical significance (p ≤ 0.046).
Se tabel 8 og figur 2.
See Table 8 and Figure 2.
Elleve (9,4%) af patienterne havde høj-risiko myelom.
Eleven (9.4%) patients had high-risk myeloma.
Opfølgningsperioden var på mindst 70,6 måneder.
The minimum follow-up was 70.6 months.
Du må ikke forsøge at behandle dine symptomer med anden medicin.
Do not try to treat your symptoms with other medicines.
Alle patienter havde dokumenteret progression efter deres seneste behandling.
All patients had documented progression following their most recent therapy.
Samlet overlevelse (OS) var det et centralt sekundært endepunkt i studiet.
Overall survival (OS) was a key secondary study endpoint.
Eftersom du får Empliciti af sundhedspersonalet, er det usandsynligt, at du får for meget.
As Empliciti will be given to you by a healthcare professional, it is unlikely you will be given too much.
Resultaterne bør imidlertid fortolkes med forsigtighed, idet konsistens af effekt indenfor de forskellige undergrupper kunne ikke vurderes pga. det meget begrænsede antal patienter, der var inkluderet i de forskellige undergrupper.
However, results should be taken with caution as assessment of consistency of effect within the different subgroups was hampered by the very limited number of patients included in the different subgroups.
Følelse af træthed eller svaghed
Feeling tired or weak
I det usandsynlige tilfælde af en overdosis, vil lægen overvåge dig for bivirkninger.
In the unlikely case of an overdose, your doctor will monitor you for side effects.
Du vil få Empliciti under opsyn af erfarent sundhedspersonale.
You will receive Empliciti under the supervision of an experienced healthcare professional.
Det lyofiliserede pulver bør opløses på under 10 minutter.
The lyophilised powder should dissolve in less than 10 minutes.
Du vil blive overvåget for tegn på disse bivirkninger under og efter infusionen.
You will be monitored for signs of such effects during and after the infusion.
Median-OS blev ikke nået for E-Pd-behandlingsgruppen.
Median OS was not reached for E-Pd treatment group.
Dag 1-21
Days 1-21
* Denne hastighed fortsættes, indtil infusionen er afsluttet.
* Continue this rate until infusion is completed.
Paracetamol (650-1000 mg oralt).
Paracetamol (650-1000 mg orally).
Din læge vil behandle dig med Empliciti, så længe sygdommen bedres eller forbliver stabil, og bivirkningerne er tålelige.
Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.
Empliciti-infusionsvæske er kompatibel med:
Empliciti infusion is compatible with:
Klargøring og administration af Empliciti
Preparation and administration of Empliciti
Standardrisiko Cytogenetisk kategori Tilstedeværelse af del17p
Standard risk Cytogenetic category Presence of del17p
Så meget Empliciti skal du have Den mængde Empliciti, du skal have, vil blive beregnet ud fra din vægt.
How much Empliciti is given The amount of Empliciti you will be given will be calculated based on your body weight.
Empliciti anvendes hvis din kræft ikke har reageret på bestemte behandlinger eller er vendt tilbage efter disse behandlinger.
Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Administration af dexamethason foregår på følgende måde:
The administration of dexamethasone is as follows:
Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
These reactions are presented by system organ class and by frequency.
Der er ikke udført farmakokinetiske interaktionsstudier.
Pharmacokinetic interaction studies have not been conducted.
Dosis 2 og alle efterfølgende doser
Dose 2 and all subsequent doses
PVC- og polyolefinbeholdere
PVC and polyolefin containers
Patienten skal monitoreres, og infektioner skal behandles med standardbehandling.
Patients should be monitored and infections should be managed with standard treatment.
Børn og unge Brug af Empliciti frarådes til børn og unge under 18 år.
Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Tumorrespons blev evalueret hver 4. uge.
Assessment of tumour response was conducted every 4 weeks.
Du må ikke stoppe behandlingen, medmindre du har aftalt det med lægen.
Do not stop treatment unless you have discussed this with your doctor.
Patienten havde ingen symptomer, behøvede ikke behandling af overdoseringen og kunne fortsætte behandlingen med elotuzumab.
The patient had no symptoms, did not require any treatment for the overdose, and was able to continue on elotuzumab therapy.
Kaplan-Meier-kurve for PFS ifølge investigator er vist i Figur 3.
Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
b modificeret International Myeloma Working Group (IMWG)-kriterie.
b modified International Myeloma Working Group (IMWG) criteria.
Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies 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 available data).
Alle rapporterede infusionsreaktioner var ≤ grad 3.
All reports of infusion reaction were ≤ Grade 3.
Af de patienter, der oplevede en infusionsreaktion, fik 70% (23/33) reaktionen under den første dosis.
Of the patients who experienced an infusion reaction, 70% (23/33) had the reaction during the first dose.
PFS-resultater ifølge investigator og IRC er opsummeret i tabel 10 (minimum opfølgningsperiode på 9,1 måneder).
PFS results per the investigator and IRC are summarised in Table 10 (minimum follow-up of 9.1 months).
Som med alle terapeutiske proteiner er immunogenicitet for Empliciti mulig.
As with all therapeutic proteins, there is a potential for immunogenicity to Empliciti.
Den alvorligste bivirkning, som kan forekomme under behandling med elotuzumab, er pneumoni.
The most serious adverse reaction that may occur during elotuzumab treatment is pneumonia.
Fravær af del17p Tilstedeværelse af t(4;14) Fravær af t(4;14) ISS-stadium I
Absence of del17p Presence of t(4;14) Absence of t(4;14) ISS Stage I
Patienter med grad 2 eller højere perifer neuropati blev ekskluderet fra de kliniske studier med E-Pd.
Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
[6,54, NE (ikke estimerbar)]
[6.54, NE]
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Feber
Very common (may affect more than 1 in 10 people) Fever
Neutraliserende antistoffer blev detekteret hos 19 ud af 299 patienter i CA204004.
Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
De primære endepunkter i dette studie, progressionsfri overlevelse (PFS) baseret på hazard ratio, og samlet responsrate (ORR), blev fastlagt på grundlag af en vurdering foretaget af en blindet uafhængig review-komité (Independent Review Committee - IRC).
The primary endpoints of this study, progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR) were determined based on assessments made by a blinded Independent Review Committee (IRC).
Uanset den evaluerede undergruppe var PFS generelt i overensstemmelse med den observerede PFS hos ITT-populationen for behandlingsgrupperne.
Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for the treatment groups.
Progressionsfri overlevelse (måneder)
Progression free survival (Months)
Cyklus 1, Dosis 3 og 4 og alle efterfølgende cyklusser
Cycle 1, Dose 3 and 4 and all subsequent Cycles
Hos størstedelen af patienterne forekom immunogenicitet tidligt i behandlingen og var forbigående, idet den forsvandt efter 2-4 måneder.
In the majority of patients, immunogenicity occurred early in treatment and was transient resolving by 2 to 4 months.
Der blev observeret en statistisk signifikant fordel i OS hos patienter i E-Ld-armen sammenlignet med patienter i Ld-armen.
A statistically significant advantage in OS was observed in patients in the E-Ld arm compared to patients in the Ld arm.
OS-data fra den eksplorative analyse var ikke modnede på tidspunktet for data cut-off (29. november 2018) med en minimum opfølgningsperiode på 18,3 måneder.
The OS data from the exploratory analysis were not mature at the data cut-off (29 November 2018) with a minimum follow up of 18.3 months.
Nyrefunktion Baseline CrCl < 60 ml/min Baseline CrCl ≥ 60 ml/min
Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Mandlige patienter skal anvende effektiv prævention under og i 180 dage efter behandlingen, hvis deres partner er gravid eller er i den fertile alder og ikke anvender effektiv prævention.
Male patients must use effective contraception measures during and for 180 days following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.
Absorption Elotuzumab indgives intravenøst og derfor opnås omgående og fuldstændig biotilgængelighed.
Absorption Elotuzumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Den planlagte endelige OS-analyse blev udført efter 212 dødsfald i E-Ld-armen og 225 dødsfald i Ldarmen.
The pre-planned final OS analysis was performed after 212 deaths in the E-Ld arm and 225 deaths in the Ld arm.
Det skal du vide, før du begynder at bruge Empliciti 3.
What you need to know before you use Empliciti 3.
Sandsynlighed for progressionsfri overlevelse (%)
Probability progression free (%)
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natrium-fri.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
Derfor vil nedsat leverfunktion sandsynligvis ikke ændre dets clearance.
Thus, hepatic functional impairment is not likely to alter its clearance.
Patienter med kardiel amyloidose eller plasmacelleleukæmi blev udelukket fra dette studie.
Patients with cardiac amyloidosis or plasma cell leukemia were excluded from this study.
Patienter skulle komme sig i minimum 12 uger efter autolog stamcelletransplantation (SCT) og 16 uger efter allogen SCT.
Patients had to recover after transplant for a minimum of 12 weeks from autologous stem cell transplant (SCT), and 16 weeks from allogeneic SCT.
Det gives som drop (infusion) i en vene (intravenøst) over en periode på flere timer.
It will be given into a vein (intravenously) as a drip (infusion) over several hours.
De prækliniske sikkerhedsoplysninger stammer hovedsageligt fra begrænsede in vitro studier med humane celler/humant væv, hvor der ikke kunne identificeres sikkerhedsproblemer.
Non-clinical safety information primarily consists of limited in vitro human cell/tissue studies where no safety findings were identified.
Lenalidomid og pomalidomid forventes at være skadelige for det ufødte barn.
Lenalidomide and pomalidomide are expected to be harmful for an unborn baby.
Lenalidomid og pomalidomid findes i blod og sæd hos patienter, der får lægemidlerne.
Lenalidomide and pomalidomide are present in the blood and sperm of patients receiving the medicine.
Eftersom elotuzumab ikke genkender ikke humane typer af SLAMF7-proteinet, er in vivo sikkerhedsdata fra dyrestudier irrelevante.
Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant.
Hvis dosis af et af lægemidlerne i regimet udskydes, eller behandlingen afbrydes eller seponeres, kan behandlingen med de andre lægemidler fortsætte som planlagt.
If the dose of one medicine in the regimen is delayed, interrupted, or discontinued, the treatment with the other medicinal products may continue as scheduled.
Target-medieret clearance for elotuzumab steg ved højere serumM-proteinkoncentrationer.
Target-mediated clearance of elotuzumab increased with higher serum M-protein concentrations.
En præspecificeret analyse for PFS-rate ved år 3 blev udført baseret på en opfølgningsperiode på mindst 33 måneder.
A pre-specified analysis for 3-year PFS rate was performed based on a minimum follow-up time of 33 months.
Samlet overlevelse (OS) var et sekundært endepunkt, hvor den planlagte endelige OS-analyse udføres efter mindst 427 dødsfald.
Overall survival (OS) was a secondary endpoint with the pre-planned final OS analysis to occur after at least 427 deaths.
Den maksimale infusionshastighed bør ikke overstige 5 ml/min.
The maximum infusion rate should not exceed 5 mL/min.
Det kan være nødvendigt med mere end et Emplicitihætteglas for at kunne give patienten den totale dosis.
More than one vial of Empliciti may be needed to give the total dose for the patient.
En præspecificeret endelig analyse for OS blev udført baseret på mindst 427 dødsfald med en opfølgningsperiode på mindst 70,6 måneder.
A pre-specified final analysis for OS was performed based on at least 427 deaths with a minimum follow-up time of 70.6 months.
Denne interferens kan påvirke bestemmelsen af komplet respons og muligt recidiv fra komplet respons hos patienter med IgG kappa myelomprotein.
This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Effektresultater er vist i tabel 8 og figur 1.
Efficacy results are presented in Table 8 and Figure 1.
Når symptomerne er forsvundet eller aftaget, kan infusionen fortsættes med en langsommere hastighed, som gradvist øges, hvis symptomerne ikke vender tilbage.
When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur.
Andre primære maligniteter
Second Primary Malignancies
Patienter, der oplever infusionsreaktioner, bør frarådes at køre bil og betjene maskiner, indtil symptomerne er aftaget.
Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Komplet respons (CR) + stringent komplet respons (sCR).
Complete response (CR) + stringent complete response (sCR).
Ud af disse 19 patienter forekom antistoffer mod lægemidlet i løbet af de første 2 måneder efter opstart med behandling med Empliciti.
In these 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of Empliciti treatment.
Median-OS i E-Ldarmen var 48,30 måneder sammenlignet med 39,62 måneder i Ld-armen.
The median OS in the E-Ld arm was 48.30 months compared with 39.62 months in the Ld arm.
Efter fortynding skal infusionen være afsluttet inden for 24 timer.
After dilution, the infusion must be completed within 24 hours of preparation.
Forekomst (frekvens/100 patientår)
Rate (incidence rate/100 patient years)