FrancophonIA/ELRC3.0 huggingface dataset:
English: 37.5 mg Prolonged-release capsules, hard
Danish: 37,5 mg Depotkapsler, hårde
English: NAME OF THE MEDICINAL PRODUCT Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules [See Annex I - To be completed nationally] Venlafaxine
Danish: Efexor Depot og tilhørende navne (se bilag I) 37.5 mg depotkapsler [Se bilag I - Udfyldes nationalt]
English: SE - 17124 Solna Sweden
Danish: P.O. Box 1822 SE - 17124 Solna Sverige
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container Not all pack sizes may be marketed.
Danish: 6.5 Emballagetype og pakningsstørrelser Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: BEFORE YOU TAKE EFEXOR DEPOT
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE EFEXOR DEPOT
English: 150 mg Prolonged release-Capsules
Danish: 150 mg Depotkapsler
English: Solvent: 10 ml Matrix: 2 x (2.5 x 5 cm)
Danish: Solvens: 10 ml Matrix: 2 x (2,5 x 5 cm)
English: Solvent: 10 ml Matrix: 7.5 x 10 cm
Danish: Matrix: 7,5 x 10 cm
English: 1 vial + 1 vial + 2 matrices + 2 syringes + 2 needles
Danish: 1 hætteglas + 1 hætteglas + 2 matrixer + 2 sprøjter + 2 nåle
English: 1 vial + 1 vial + 1 matrix + 2 syringes + 2 needles
Danish: 1 hætteglas + 1 hætteglas + 1 matrix + 2 sprøjter + 2 nåle
English: It is used on its own when other treatments have not worked or are not suitable.
Danish: Det anvendes alene, når andre behandlinger ikke har virket eller ikke er egnede.
English: Further information on Ogivri can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ogivri.
Danish: Yderligere information om Ogivri findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Ogivri.
English: The dose depends on the patient's body weight, on the condition being treated and on whether Ogivri is given every week or every 3 weeks.
Danish: Dosen afhænger af patientens kropsvægt, den tilstand, der skal behandles, og om Ogivri gives hver uge eller hver tredje uge.
English: This means that Ogivri is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Ogivri i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: A response to treatment after 24 weeks was seen in 70% of the patients given Ogivri (160 of 230) and 64% of the patients given Herceptin (146 of 228).
Danish: Efter 24 uger sås der virkning af behandlingen hos 70 % af de patienter, der fik Ogivri (160 of 230), og 64 % af de patienter, der fik Herceptin (146 of 228).
English: Ogivri is a cancer medicine used to treat the following conditions:
Danish: Ogivri er et kræftlægemiddel, der anvendes til behandling af følgende tilstande:
English: The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion for signs such as fever and chills.
Danish: Infusionen kan medføre allergiske reaktioner, og patienten bør derfor overvåges under og efter infusionen for symptomer såsom feber og kulderystelser.
English: What measures are being taken to ensure the safe and effective use of Ogivri?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ogivri?
English: Ogivri contains the active substance trastuzumab.
Danish: Ogivri indeholder det aktive stof trastuzumab.
English: Side effects reported with Ogivri are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ogivri vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Other information about Ogivri
Danish: Andre oplysninger om Ogivri
English: Ogivri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Danish: Ogivri udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i brug af kræftlægemidler.
English: For more information about using Ogivri, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ogivri, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: 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.
Danish: De hyppigste eller alvorligste bivirkninger ved Ogivri er hjerteproblemer, reaktioner i forbindelse med infusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
English: As for all medicines, data on the use of Ogivri are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Ogivri løbende overvåget.
English: An overview of Ogivri and why it is authorised in the EU
Danish: En oversigt over Ogivri, og hvorfor det er godkendt i EU
English: The reference medicine for Ogivri is Herceptin.
Danish: Referencelægemidlet for Ogivri er Herceptin.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Danish: Ved at bindes til HER2 aktiverer trastuzumab immunsystemets celler, som derefter dræber tumorcellerne.
English: Why is Ogivri authorised in the EU?
Danish: Hvorfor blev Ogivri godkendt i EU?
English: In addition, one study involving 500 patients with metastatic breast cancer that overexpressed HER2 showed that Ogivri was effective in treating the condition.
Danish: Endvidere viste et studie, der omfattede 500 patienter med metastatisk brystkræft og overekspression af HER2, at Ogivri var effektivt til at behandle tilstanden.
English: The active substance in Ogivri, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Danish: 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.
English: Ogivri is a ‘biosimilar medicine'.
Danish: Ogivri er et "biosimilært lægemiddel".
English: Ogivri must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Danish: Ogivri må ikke anvendes hos personer, der er overfølsomme (allergiske) over for trastuzumab, museproteiner eller andre af indholdsstofferne.
English: 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;
Danish: 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
English: What is Ogivri and what is it used for?
Danish: Hvad er Ogivri, og hvad anvendes det til?
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: Patients received Ogivri or the reference medicine Herceptin, together with other cancer medicines (paclitaxel or docetaxel).
Danish: Patienterne fik Ogivri eller referencelægemidlet Herceptin sammen med andre kræftlægemidler (paclitaxel eller docetaxel).
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another type of medicine called an aromatase inhibitor;
Danish: Det anvendes også i kombination med andre kræftlægemidler (paclitaxel eller docetaxel) eller sammen med en anden type lægemiddel kaldet en aromatasehæmmer
English: 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.
Danish: 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.
English: What are the risks associated with Ogivri?
Danish: Hvilke risici er der forbundet med Ogivri?
English: 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.
Danish: Ogivri må kun anvendes, hvis kræften har såkaldt overekspression af proteinet HER2, dvs. hvis der på overfladen af kræftcellerne produceres store mængder HER2.
English: 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.
Danish: 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.
English: Ogivri can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Danish: Ogivri kan forårsage kardiotoksicitet (hjerteskade), herunder hjertesvigt (nedsat hjertefunktion).
English: Studies have also shown that giving Ogivri infusion produces similar levels of the active substance in the body to giving an infusion of Herceptin.
Danish: Studier har også vist, at en infusion af Ogivri giver samme niveau af det aktive stof i kroppen som en infusion af Herceptin.
English: 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.
Danish: 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.
English: How is Ogivri used?
Danish: Hvordan anvendes Ogivri?
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Danish: Ca. en fjerdedel af alle brystkræfttilfælde og en femtedel af alle mavekræfttilfælde har overekspression af HER2.
English: 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.
Danish: Studier i metastatisk brystkræft med overekspression af HER2 har endvidere vist, at virkningen af infusion med Ogivri svarer til virkningen af infusion med Herceptin.
English: 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.
Danish: 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.
English: What benefits of Ogivri have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ogivri?
English: Age < 65 years ≥ 65 years
Danish: Alder < 65 år ≥ 65 år
English: None reported
Danish: Ingen rapporterede
English: Date of first authorisation: 11 May 2016
Danish: Dato for første markedsføringstilladelse: 11. maj 2016
English: Other symptoms may occur as well.
Danish: Andre symptomer kan forekomme.
English: European Group for Blood and Marrow Transplantation (EBMT) criteria.
Danish: European Group for Blood and Marrow Transplantation (EBMT) kriterier.
English: IRC assessment was performed post-hoc.
Danish: IRC-vurdering blev udført post-hoc.
English: Patients should be monitored for the development of SPMs.
Danish: Patienter skal monitoreres for udvikling af SPM.
English: ATC code: L01XC23.
Danish: ATC-kode: L01XC23.
English: Risk factors High risk
Danish: Risikofaktorer Høj risiko
English: This 8-hour period should be inclusive of the product administration period.
Danish: De 8 timer er inklusive administrationsperioden.
English: The final OS analysis met the protocol-specified boundary for statistical significance (p ≤ 0.046).
Danish: Den endelige OS-analyse opfyldte den protokolspecificerede grænse for statistisk signifikans (p ≤ 0,046).
English: See Table 8 and Figure 2.
Danish: Se tabel 8 og figur 2.
English: Eleven (9.4%) patients had high-risk myeloma.
Danish: Elleve (9,4%) af patienterne havde høj-risiko myelom.
English: The minimum follow-up was 70.6 months.
Danish: Opfølgningsperioden var på mindst 70,6 måneder.
English: Do not try to treat your symptoms with other medicines.
Danish: Du må ikke forsøge at behandle dine symptomer med anden medicin.
English: All patients had documented progression following their most recent therapy.
Danish: Alle patienter havde dokumenteret progression efter deres seneste behandling.
English: Overall survival (OS) was a key secondary study endpoint.
Danish: Samlet overlevelse (OS) var det et centralt sekundært endepunkt i studiet.
English: As Empliciti will be given to you by a healthcare professional, it is unlikely you will be given too much.
Danish: Eftersom du får Empliciti af sundhedspersonalet, er det usandsynligt, at du får for meget.
English: 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.
Danish: 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.
English: Feeling tired or weak
Danish: Følelse af træthed eller svaghed
English: In the unlikely case of an overdose, your doctor will monitor you for side effects.
Danish: I det usandsynlige tilfælde af en overdosis, vil lægen overvåge dig for bivirkninger.
English: You will receive Empliciti under the supervision of an experienced healthcare professional.
Danish: Du vil få Empliciti under opsyn af erfarent sundhedspersonale.
English: The lyophilised powder should dissolve in less than 10 minutes.
Danish: Det lyofiliserede pulver bør opløses på under 10 minutter.
English: You will be monitored for signs of such effects during and after the infusion.
Danish: Du vil blive overvåget for tegn på disse bivirkninger under og efter infusionen.
English: Median OS was not reached for E-Pd treatment group.
Danish: Median-OS blev ikke nået for E-Pd-behandlingsgruppen.
English: Days 1-21
Danish: Dag 1-21
English: * Continue this rate until infusion is completed.
Danish: * Denne hastighed fortsættes, indtil infusionen er afsluttet.
English: Paracetamol (650-1000 mg orally).
Danish: Paracetamol (650-1000 mg oralt).
English: Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.
Danish: Din læge vil behandle dig med Empliciti, så længe sygdommen bedres eller forbliver stabil, og bivirkningerne er tålelige.
English: Empliciti infusion is compatible with:
Danish: Empliciti-infusionsvæske er kompatibel med:
English: Preparation and administration of Empliciti
Danish: Klargøring og administration af Empliciti
English: Standard risk Cytogenetic category Presence of del17p
Danish: Standardrisiko Cytogenetisk kategori Tilstedeværelse af del17p
English: How much Empliciti is given The amount of Empliciti you will be given will be calculated based on your body weight.
Danish: Så meget Empliciti skal du have Den mængde Empliciti, du skal have, vil blive beregnet ud fra din vægt.
English: Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Danish: Empliciti anvendes hvis din kræft ikke har reageret på bestemte behandlinger eller er vendt tilbage efter disse behandlinger.
English: The administration of dexamethasone is as follows:
Danish: Administration af dexamethason foregår på følgende måde:
English: These reactions are presented by system organ class and by frequency.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
English: Pharmacokinetic interaction studies have not been conducted.
Danish: Der er ikke udført farmakokinetiske interaktionsstudier.
English: Dose 2 and all subsequent doses
Danish: Dosis 2 og alle efterfølgende doser
English: PVC and polyolefin containers
Danish: PVC- og polyolefinbeholdere
English: Patients should be monitored and infections should be managed with standard treatment.
Danish: Patienten skal monitoreres, og infektioner skal behandles med standardbehandling.
English: Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Danish: Børn og unge Brug af Empliciti frarådes til børn og unge under 18 år.
English: Assessment of tumour response was conducted every 4 weeks.
Danish: Tumorrespons blev evalueret hver 4. uge.
English: Do not stop treatment unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen, medmindre du har aftalt det med lægen.
English: The patient had no symptoms, did not require any treatment for the overdose, and was able to continue on elotuzumab therapy.
Danish: Patienten havde ingen symptomer, behøvede ikke behandling af overdoseringen og kunne fortsætte behandlingen med elotuzumab.
English: Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
Danish: Kaplan-Meier-kurve for PFS ifølge investigator er vist i Figur 3.
English: b modified International Myeloma Working Group (IMWG) criteria.
Danish: b modificeret International Myeloma Working Group (IMWG)-kriterie.
English: 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).
Danish: 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).
English: All reports of infusion reaction were ≤ Grade 3.
Danish: Alle rapporterede infusionsreaktioner var ≤ grad 3.
English: Of the patients who experienced an infusion reaction, 70% (23/33) had the reaction during the first dose.
Danish: Af de patienter, der oplevede en infusionsreaktion, fik 70% (23/33) reaktionen under den første dosis.
English: PFS results per the investigator and IRC are summarised in Table 10 (minimum follow-up of 9.1 months).
Danish: PFS-resultater ifølge investigator og IRC er opsummeret i tabel 10 (minimum opfølgningsperiode på 9,1 måneder).
English: As with all therapeutic proteins, there is a potential for immunogenicity to Empliciti.
Danish: Som med alle terapeutiske proteiner er immunogenicitet for Empliciti mulig.
English: The most serious adverse reaction that may occur during elotuzumab treatment is pneumonia.
Danish: Den alvorligste bivirkning, som kan forekomme under behandling med elotuzumab, er pneumoni.
English: Absence of del17p Presence of t(4;14) Absence of t(4;14) ISS Stage I
Danish: Fravær af del17p Tilstedeværelse af t(4;14) Fravær af t(4;14) ISS-stadium I
English: Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
Danish: Patienter med grad 2 eller højere perifer neuropati blev ekskluderet fra de kliniske studier med E-Pd.
English: [6.54, NE]
Danish: [6,54, NE (ikke estimerbar)]
English: Very common (may affect more than 1 in 10 people) Fever
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Feber
English: Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
Danish: Neutraliserende antistoffer blev detekteret hos 19 ud af 299 patienter i CA204004.
English: 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).
Danish: 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).
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for the treatment groups.
Danish: Uanset den evaluerede undergruppe var PFS generelt i overensstemmelse med den observerede PFS hos ITT-populationen for behandlingsgrupperne.
English: Progression free survival (Months)
Danish: Progressionsfri overlevelse (måneder)
English: Cycle 1, Dose 3 and 4 and all subsequent Cycles
Danish: Cyklus 1, Dosis 3 og 4 og alle efterfølgende cyklusser
English: In the majority of patients, immunogenicity occurred early in treatment and was transient resolving by 2 to 4 months.
Danish: Hos størstedelen af patienterne forekom immunogenicitet tidligt i behandlingen og var forbigående, idet den forsvandt efter 2-4 måneder.
English: A statistically significant advantage in OS was observed in patients in the E-Ld arm compared to patients in the Ld arm.
Danish: Der blev observeret en statistisk signifikant fordel i OS hos patienter i E-Ld-armen sammenlignet med patienter i Ld-armen.
English: 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.
Danish: 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.
English: Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Danish: Nyrefunktion Baseline CrCl < 60 ml/min Baseline CrCl ≥ 60 ml/min
English: 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.
Danish: 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.