FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and TYSABRI
Danish: Brug af anden medicin sammen med TYSABRI
English: In general, anti-JCV antibody prevalence did not appear to be affected by prior immunosuppressant use, prior exposure to TYSABRI, or duration of TYSABRI exposure.
Danish: Generelt synes tidligere brug af immunsupprimerende lægemidler, tidligere eksponering for TYSABRI eller varigheden af eksponering for TYSABRI ikke at have indvirkning på prævalensen af anti-JCV-antistoffer.
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML.
Danish: Hos anti-JCV-antistof-positive, TYSABRI-behandlede patienter, som ikke tidligere er blevet behandlet med immunsupprimerende lægemidler, er niveauet af anti-JCV-antistof-respons (indeks) korreleret til risikoen for udvikling af PML.
English: Relapses in previous 12 months, median (range)
Danish: Attakker i forudgående 12 måneder, median (område) EDSS-baseline, median (område)
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Danish: Der er ikke gennemført studier til undersøgelse af virkningerne ved nyre- eller leverinsufficiens.
English: • Present data from PK/PD/efficacy modelling from clinical trial data that suggests efficacy of 6 week dosing more similar to 4 weeks if occurs >1 year of 4 weekly treatment
Danish: • Fremlægge data fra farmakokinetisk/farmakodynamisk/virkningsrelateret modellering fra kliniske studiedata, der tyder på en mere ensartet virkning ved dosering hver 6. uge i forhold til dosering hver 4. uge, hvis der skiftes efter >1 års behandling med dosering hver 4. uge.
English: The treatment discontinuation form • Inform patient that PML has been reported up to 6 months after stopping Tysabri
Danish: • Informere patienten om, at der er rapporteret om PML op til 6 måneder efter ophør med
English: Combination with other DMTs.
Danish: Kombination med anden sygdomsmodificerende behandling (DMT).
English: o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Description of Immune Reconstitution Inflammatory Syndrome (IRIS) is provided
Danish: − Et patientinformationskort, der indeholder en basistekst aftalt med CHMP o Hvis behandlingen skal fortsætte længere end 24 måneder: Nødvendigheden af at informere patienterne om den øgede risiko for PML og nødvendigheden af at forsyne patienterne med en kopi af formularen til fortsat behandling o Beskrivelse af immunrekonstitutionssyndrom (IRIS) udleveres
English: Estimates of the total natalizumab removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Danish: Estimeringer af den totale fjernelse af natalizumab efter tre plasmafereser (over en periode på 5-8 dage) var cirka 70-80 % sammenlignet med 40 % i tidligere studier, hvor målingerne blev foretaget efter afbrydelse af natalizumab over en lignende observationsperiode.
English: • Progressive multifocal leukoencephalopathy (PML)
Danish: • Progressiv multifokal leukoencefalopati (PML)
English: If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Danish: Hvis du har glemt din sædvanlige dosis TYSABRI, skal du aftale med din læge at få den så hurtigt som muligt.
English: Diluted solution After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Danish: Efter fortynding med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske anbefales omgående anvendelse.
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least
Danish: Cirka 6 % af patienterne udviklede persisterende anti-natalizumab antistoffer (én positiv test bekræftet ved gentagelse af testen mindst 6 uger senere).
English: Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
Danish: o Anbefalingen, at patienterne bør MR-scannes på følgende tidspunkter: Inden for 3 måneder inden behandlingsstart med TYSABRI Årligt under behandling med TYSABRI Hyppigere MR-scanninger (f.eks. hver 3. til 6. måned) af patienter med høj risiko for udvikling af PML Ved det første tegn på ethvert symptom, der indikerer muligheden for PML.
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI
Danish: • Information om PML og IRIS herunder risikoen for at udvikle PML under TYSABRIbehandlingen, stratificeret i forhold til tidligere behandling med immunsupprimerende lægemidler og JCV-infektion
English: How to use TYSABRI
Danish: Sådan skal du bruge TYSABRI
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: • Tilfør de 15 ml koncentrat til infusionsvæske, opløsning til 100 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a higher risk of PML.
Danish: Patienter, som har alle tre risikofaktorer for PML (dvs. er anti-JCV-antistof-positive og har fået mere end 2 års behandling med TYSABRI og tidligere har fået immunsuppressiv behandling), har en højere risiko for PML.
English: Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Tilfør de 15 ml koncentrat til infusionsvæske, opløsning til 100 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Danish: • Patienter med et højt anti-JCV-antistof-indeks, som er blevet behandlet i mere end 2 år med TYSABRI, og som ikke tidligere er blevet behandlet med immunsupprimerende lægemidler.
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for natalizumab eller over for et eller flere af hjælpestofferne anført i pkt.
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Danish: Biogen Netherlands B.V.
English: Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Danish: Din læge kan ved hjælp af en blodprøve finde ud af, om TYSABRI ikke virker, som det skal for dig.
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI, see MRI screening for PML).
Danish: Disse patienter bør derfor overvåges hyppigere (dvs. som patienter, der skifter fra immunsupprimerende lægemidler til TYSABRI, se screening med MR-scanning for PML).
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Efter at infusionen er gennemført, gennemskylles i.v.-slangen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Diluted solution:
Danish: Fortyndet opløsning:
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o Opportunistic infections (other than PML):
Danish: • Information om, at atypiske/opportunistiske infektioner, især PML, kan optræde i forbindelse med TYSABRI-behandling, herunder: o Opportunistiske infektioner (andre end PML): o TYSABRI øger risikoen for udvikling af encephalitis, meningitis og akut retinal nekrose (ARN) forårsaget af herpes simplex- og varicella zoster-vira o Vejledning i screening for ARN.
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI).
Danish: Disse patienter bør derfor overvåges hyppigere (dvs. som patienter, der skifter fra immunsupprimerende lægemidler til TYSABRI).
English: What TYSABRI is and what it is used for What you need to know before you use TYSABRI How to use TYSABRI
Danish: Det skal du vide, før du begynder at bruge TYSABRI Sådan skal du bruge TYSABRI Bivirkninger
English: − Weight loss
Danish: − Synsnedsættelse
English: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate
Danish: Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatheptahydrat Natriumchlorid
English: However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Danish: Der foreligger ingen studier af TYSABRIs indvirkning på evnen til at føre motorkøretøj og betjene maskiner, men hvis du oplever svimmelhed, som er en almindelig bivirkning, må du ikke føre motorkøretøj eller betjene maskiner.
English: Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI.
Danish: Inden du påbegynder behandling med TYSABRI, vil lægen muligvis tage en blodprøve for at undersøge, om du har antistoffer mod JC-virus i blodet.
English: Currently available data are described in sections 4.8 and 5.1
Danish: 4.8 og 5.1.
English: • Reminder of PML symptoms • When MRI imaging may be warranted
Danish: • Hvornår MR-scanning kan være indiceret
English: The efficacy of re-administration has not been established, for safety see section 4.4.
Danish: Effekten af readministration er ikke blevet klarlagt.
English: − Pain or redness of the eye(s)
Danish: − Smertende eller rødt øje/øjne
English: − Impaired vision
Danish: − Voldsom diaré
English: • Shivering
Danish: TYSABRI
English: 1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
Danish: 1 >106,3 og < 108,3 CFU af levende Bordetella bronchiseptica bakterie stamme B-C2 pr. dosis
English: Packaging Content Package size
Danish: Indgivelsesvej Emballage Indhold
English: Vial (type I glass) in carton box
Danish: Hætteglas (type I glas) i karton
English: Vial (type I glass) in plastic box
Danish: Hætteglas (type I glas) i plastikæske
English: Strength Pharmaceutical Form
Danish: EU-nummer Særnavn Styrke Lægemiddel¬ form
English: EU Number
Danish: Pakningsstørrelse
English: Target Species
Danish: Dyrearter, som læge-midlet er beregnet til
English: Pack size l t o r
Danish: Pakningsstørrelse t r
English: Packaging Content (concentration)
Danish: Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: Route of administration
Danish: Særnavn Styrke
English: • or through an evaluation of individual case reports.
Danish: • eller ved evaluering af individuelle rapporter.
English: The results of these pre-specified analyses are as follows:
Danish: Resultaterne fra disse præspecificerede analyser er følgende:
English: • epidemiological studies/non-interventional or observational studies,
Danish: • epidemiologiske studier/non-interventionsstudier eller observationsstudier,
English: • you are pregnant.
Danish: • hvis du er gravid.
English: You will be treated with MVASI once every 2 or 3 weeks.
Danish: Du vil blive behandlet med MVASI én gang hver 2. eller 3. uge.
English: Discuss with your doctor to make sure that you do not combine these medicine.
Danish: Tal med din læge for at sikre, at du ikke kombinerer disse lægemidler.
English: 25-75 percentile (months)
Danish: 25-75 percentil (måneder)
English: Overall survival (final analysis)***
Danish: Samlet overlevelse (endelig analyse)***
English: Blinded independent review (protocol-defined primary analysis).
Danish: ^ Blindet uafhængig vurdering (protokol-defineret primær analyse).
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Danish: Du kan eventuelt også selv skrive disse oplysninger ned for det tilfælde, at du i fremtiden bliver bedt om dem.
English: • spontaneous reporting,
Danish: • spontane indberetninger,
English: Based on a substudy from NSABP C-08 with 295 patients.
Danish: Baseret på et substudie fra NSABP C-08 med 295 patienter.
English: Kaplan-Meier estimates.
Danish: Kaplan-Meier-estimater.
English: Oxaliplatin on day 1
Danish: Oxaliplatin på dag 1
English: Intravitreal use
Danish: Intravitreal anvendelse
English: Patients older than 65 years have an increased risk of experiencing the following side effects:
Danish: Patienter over 65 år har øget risiko for at få følgende bivirkninger:
English: Observed in paediatric population only.
Danish: Kun observeret i den pædiatriske population.
English: Interferon alfa-2a 9 MIU 3x/week.
Danish: Interferon alfa-2a 9 MIE 3x/ugentlig.
English: MVASI may also cause changes in laboratory tests carried out by your doctor.
Danish: MVASI kan også forårsage ændringer i de laboratorieundersøgelser, som din læge foretager.
English: Subject to a p-value boundary of 0.0116.
Danish: Underlagt en p-værdigrænse på 0,0116.
English: Before you are given MVASI or while you are being treated with MVASI:
Danish: Før du får MVASI, eller imens du bliver behandlet med MVASI:
English: Treatment regimens in trial NO16966 (mCRC)
Danish: Behandlingsregimer i studie NO16966 (mCRC) Behandling
English: Further details on the study and the results are provided below.
Danish: Nærmere detaljer om studiet og resultaterne heraf er beskrevet nedenfor.
English: MVASI is for single-use only, as the product contains no preservatives.
Danish: MVASI er udelukkende til engangsbrug, da produktet ikke indeholder konserveringsmidler.
English: The incidence varied between 10% (4/40) and 20%
Danish: Hyppigheden varierede mellem 10 % (4/40) og 20 % (3/15).
English: 6 - 12 months (n = 202) Median
Danish: 6 - 12 måneder (n = 202) Median
English: Post-marketing adverse reactions are included in both tables 1 and 2, where applicable.
Danish: Postmarketing-bivirkninger er inkluderet i både tabel 1 og 2, hvis relevant.
English: This does not necessarily mean that these side effects were strictly caused by MVASI.
Danish: Det betyder ikke, at disse bivirkninger nødvendigvis kun skyldes MVASI.
English: Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Danish: Oral capecitabin to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
English: • your doctor will decide when you should be given your next dose of MVASI.
Danish: • Din læge beslutter, hvornår du skal have den næste dosis MVASI.
English: log-rank test (stratified).
Danish: log-rank-test (stratificeret).
English: ** Primary analysis at clinical cut-off 31 January 2006.
Danish: ** Primær analyse ved klinisk cut-off 31. januar 2006.
English: Do not stop treatment with MVASI unless you have discussed this with your doctor.
Danish: Stop ikke behandlingen med MVASI før, du har diskuteret det med din læge.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018
Danish: Dato for første markedsføringstilladelse: 15. januar 2018
English: In Part II, treatment assignment was double-blind with respect to bevacizumab.
Danish: I del 2 var tildeling af behandling dobbeltblindet i forhold til bevacizumab.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Danish: Hvis det er påkrævet, skal behandlingen enten seponeres permanent eller afbrydes midlertidigt, som beskrevet i pkt.
English: Very rare Frequency not known
Danish: Hyppighed ikke kendt
English: MVASI may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Danish: MVASI kan skade det ufødte barn, da det kan standse dannelsen af nye blodkar.
English: Name and address of the manufacturer of the biological active substance Amgen Inc
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Amgen Inc
English: Pre-specified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Danish: Præspecificerede PFS-analyser blev udført, alle med en cut-off den 29. september 2009.
English: Caution should be taken when treating these patients with MVASI.
Danish: Der skal iagttages forsigtighed, når disse patienter behandles med MVASI.
English: MVASI is a biosimilar medicinal product.
Danish: MVASI er et biosimilært lægemiddel.
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Danish: Tillæg af bevacizumab til FOLFOX-4 gav en statistisk signifikant forlængelse af overlevelse.
English: • you may develop a severe migraine.
Danish: • Du kan få svær migræne.
English: When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur:
Danish: Hvis bevacizumab injiceres direkte i øjet (ikke-godkendt brug), kan følgende bivirkninger forekomme:
English: However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR = 0.91).
Danish: Stigningen i det primære endepunkt, samlet overlevelse på 2 måneder, var ikke signifikant (HR = 0,91).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes øjeblikkelig, er holdbarheden under anvendelse og opbevaringsbetingelserne før anvendelsen brugerens ansvar, og de er normalt ikke længere end 24 timer ved 2 °C - 8 °C, medmindre opløsningen har fundet sted under kontrollerede og validerede aseptiske omstændigheder.
English: MVASI is not approved for use in patients under the age of 18 years.
Danish: MVASI er ikke godkendt til anvendelse hos patienter under 18 år.
English: Key efficacy results for the superiority analysis (ITT population, trial NO16966)
Danish: Nøgletal for effektresultater af superioritets-analysen (ITT Population, studie NO16966)
English: Efficacy results for study ML18147 (ITT population)
Danish: Effektresultater for studie ML18147 (ITT population)
English: Final overall survival analysis performed when 46.9% of the patients had died.
Danish: Den endelige analyse for samlet overlevelse blev udført, da 46,9 % af patienterne var døde.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og på hætteglasset, efter forkortelsen ”EXP”.
English: The adverse reactions listed in this section fall into the following frequency categories: 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); not known (cannot be estimated from the available data).
Danish: Bivirkninger, som er opsummeret i dette afsnit, er delt ind i følgende frekvenskategorier: 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), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: • post-authorisation safety studies,
Danish: • sikkerhedsstudier efter markedsføringstilladelse,
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: • A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with MVASI treatment.
Danish: • En sjælden neurologisk bivirkning kaldet posteriort reversibelt encefalopati- syndrom (PRES) har været knyttet til MVASI-behandling.
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting MVASI treatment.
Danish: Hvis du har forhøjet blodtryk, som ikke er velbehandlet med blodtrykssænkende medicin, skal du kontakte din læge, fordi det er vigtigt at sikre, at dit blodtryk er under kontrol, før du starter i behandling med MVASI.
English: Systemic effects following intravitreal use
Danish: Systemiske bivirkninger efter intravitreal anvendelse
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
Danish: De 649 randomiserede patienter (641 behandlede) havde Karnofsky performancestatus (KPS) på ≥ 70 %, ingen CNS-metastaser og tilstrækkelig organfunktion.
English: Therefore fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with bevacizumab.
Danish: Fertilitetsbevarende strategier bør derfor drøftes med kvinder i den fertile alder før igangsættelse af behandling med bevacizumab.
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly diagnosed high-grade glioma.
Danish: Der er utilstrækkelig information til at fastslå sikkerhed og effekt af bevacizumab hos børn med nylig diagnosticeret høj-grads-gliom.
English: MVASI is not formulated for intravitreal use.
Danish: MVASI er ikke formuleret til intravitreal anvendelse.
English: *** The final analysis of overall survival was performed when 266 deaths, which account for 73.7% of enrolled patients, were observed.
Danish: *** Den endelige analyse af samlet overlevelse er udført efter registrering af 266 dødsfald, hvilket udgør 73,7 %
English: These clinically significant reactions have therefore been included in table 2 within the column entitled “Frequency not known”.
Danish: Disse klinisk signifikante bivirkninger er derfor inkluderet i Tabel 2 under kolonnen ”Hyppighed ikke kendt”
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Danish: • negativ påvirkning af kvinders evne til at få børn (for yderligere anbefalinger se nedenfor efter bivirkningslisten),
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Danish: a Termerne repræsenterer grupperede bivirkninger, der beskriver et medicinsk koncept frem for en enkelttilstand eller MedDRA (Medical Dictionary for Regulatory Activities) foretrukne term.
English: Caution should be exercised when bevacizumab and intravenous bisphosphonates are administered simultaneously or sequentially.
Danish: Der bør udvises forsigtighed, når bevacizumab og intravenøse bisfosfonater administreres samtidigt eller sekventielt.
English: • if you undergo surgery.
Danish: • hvis du skal opereres.
English: • if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Danish: • hvis du får svært forhøjet blodtryk, der kræver behandling med blodtryksmedicin,
English: The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA-125 levels, or symptomatic deterioration per protocol.
Danish: Det primære endepunkt var PFS, baseret på investigators vurdering af sygdomsprogression baseret på radiologiske scanninger eller CA-125-niveauer, eller symptomatisk forværring per protokol.
English: CI, confidence interval; HR, Hazard ratio from unstratified Cox regression analysis; NR, not reached.
Danish: HR, Hazard ratio fra ikke-stratificeret Cox regression analyse; NR, ikke opnået.
English: • The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Danish: • Risikoen for at udvikle blodpropper i arterierne (en type blodkar) kan øges, hvis du er over 65 år, hvis du har sukkersyge, eller hvis du tidligere har haft blodpropper i arterierne.
English: The dose of MVASI needed depends on your body weight and the kind of cancer to be treated.
Danish: Dosis af MVASI afhænger af din legemsvægt og af den type kræft, der skal behandles.