FrancophonIA/ELRC3.0 huggingface dataset:
English: Daclizumab beta did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Danish: Daclizumab beta påvirkede ikke reproduktionsevnen hos cynomolgus-hunner eller -hanner (AUC hos hunner og hanner op til henholdsvis 85 og 100 gange højere end eksponeringen ved den kliniske dosis).
English: The active substance in Zinbryta is daclizumab beta.
Danish: Det aktive stof i Zinbryta er daclizumab beta.
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Danish: I overensstemmelse med resultater fra individuelle studier indikerede en tværgående farmakokinetisk analyse af studiepopulationen, at eksponeringen for daclizumab beta er mere end proportional med dosis i dosisintervallet 50 mg til 100 mg subkutant, og proportional med dosis i dosisintervallet 100 mg til 300 mg subkutant.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Danish: Hovedeffekterne af denne modulering af IL-2-signaleringen, der potentielt er relateret til daclizumab betas terapeutiske virkninger ved MS, inkluderer selektiv antagonisering af aktiverede T-celleresponser og ekspansion af immunregulerende CD56bright naturlige dræberceller (NK-celler), som er vist selektivt at reducere aktiverede T-celler.
English: As an IgG1 monoclonal antibody, daclizumab beta is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Danish: Som et IgG1 monoklonalt antistof forventes daclizumab beta at blive kataboliseret til peptider og aminosyrer på samme måde som endogent IgG.
English: • The contraindication in all patients with pre-existing hepatic disease or hepatic impairment;
Danish: • Kontraindikationen for alle patienter med forudeksisterende leversygdom eller nedsat
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā
Danish: Latvija UAB "JOHNSON & JOHNSON" filiāle Latvijā
English: These findings (dry, red raised patchy areas of the skin, as compared to controls, that correlated microscopically with acanthosis/hyperkeratosis and subacute to chronic inflammation) were characterised predominantly as mild to moderate, with one case assessed as severe.
Danish: Disse fund (tørre, rødplettede, hævede områder i huden, der mikroskopisk svarede til acanthose/hyperkeratose og subakut til kronisk inflammation) blev hovedsageligt karakteriseret som lette til moderate, med et tilfælde vurderet som svært.
English: Following subcutaneous administration of daclizumab beta 150 mg every 4 weeks, steady-state serum daclizumab beta concentrations were achieved by the 4th dose and daclizumab beta accumulated to a level approximately 2.5-fold compared to a single dose.
Danish: Efter subkutan administration af daclizumab beta 150 mg hver 4. uge blev der opnået steady state koncentrationer af daclizumab beta i serum ved den 4. dosis, og daclizumab beta akkumulerede til et niveau på cirka 2,5-fold sammenlignet med en enkelt dosis.
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab beta is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen er fordelingsvolumenet af daclizumab beta ved steady state 6,34 l hos en patient, der vejer 68 kg (omtrenlige median for de evaluerede patienter).
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab beta was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Danish: I to studier af 9 måneders varighed udført hos cynomolgusaber blev daclizumab beta administreret subkutant to gange om ugen i doser på 10-200 mg/kg.
English: No studies were conducted to evaluate daclizumab beta pharmacokinetics in patients with renal or hepatic impairment.
Danish: Der blev ikke udført studier til evaluering af daclizumab betas farmakokinetik hos patienter med nedsat nyre- eller leverfunktion.
English: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab beta is 0.212 L/day with a terminal half-life value of approximately 21 days.
Danish: Baseret på den tværgående farmakokinetiske analyse af studiepopulationen er daclizumab betas clearance 0,212 l/dag med en terminal halveringstid på cirka 21 dage.
English: The absolute bioavailability of daclizumab beta 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Danish: Den absolutte biotilgængelighed af daclizumab beta 150 mg administreret subkutant var cirka 90% baseret på en tværgående, farmakokinetisk analyse af subkutan og intravenøs dosering hos studiepopulationen.
English: • Educate the patient on the importance of: o Adhering to the monthly liver function tests (or more frequently, as clinically indicated during treatment); o Recognising the symptoms and signs of possible hepatic injury so that they are aware of situations in which they should contact a physician in a timely manner;
Danish: • Uddanne patienten i vigtigheden af at: o Overholde de månedlige leverfunktionsprøver (eller hyppigere efter klinisk indikation o Genkende symptomer og tegn på mulig leverskade, så de er opmærksomme på situationer, hvor de bør kontakte lægen snarest,
English: The causal relationship between daclizumab beta and colitis is possible.
Danish: Et kausalt forhold mellem daclizumab beta og colitis er muligt.
English: Do not use Zinbryta - if you have previously had a serious allergic reaction to any form of daclizumab, or any of the other ingredients of this medicine listed in section 6.
Danish: Brug ikke Zinbryta - Hvis du er allergisk over for enhver form af daclizumab eller et af de øvrige indholdsstoffer i
English: Preclinical safety studies were conducted in cynomolgus monkeys due to species specificity of daclizumab beta binding only to human or primate CD25.
Danish: De prækliniske sikkerhedsstudier blev udført på cynomolgusaber grundet artsspecificitet for daclizumab beta, der kun binder til CD25 hos mennesker og primater.
English: Within the studied regimens of daclizumab beta 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab beta exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Danish: Inden for de undersøgte behandlingsregimer med daclizumab beta 150 mg og 300 mg administreret subkutant hver 4. uge hos MS-patienter var der ikke en tydelig sammenhæng mellem daclizumab betaeksponeringen og de kliniske effektendepunkter (ARR, T2-læsioner og Gd-forstærkede læsioner) eller relevante sikkerhedsendepunkter (alvorlig infektionstilstand, moderat eller svær kutan bivirkning eller ASAT/ALAT > 5 gange ULN).
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form;
Danish: • Før behandlingen initieres eller genoptages, bekræftelse af: o En diskussion mellem lægen og patienten om risikoen for alvorlig og potentielt dødelig leverskade, og uforudsigeligheden af sådanne reaktioner, og om muligheden for, at skifte til en anden behandling i tilfælde af ALAT- eller ASAT
English: Let your injection site dry on its own before injecting your dose.
Danish: Lad injektionsstedet tørre af sig selv, inden dosis injiceres.
English: *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular)
Danish: *Observeret med en ≥ 2% højere frekvens end for placebo †Observeret med en ≥ 2% højere frekvens end for interferon beta-1a (intramuskulært)
English: Section 4.8 of the SmPC has been reviewed to add the adverse reaction sarcoidosis with a frequency uncommon and the adverse reaction colitis with a frequency common.
Danish: 4.8 i produktresuméet er blevet gennemgået, og bivirkningen sarkoidose er blevet tilføjet med hyppigheden ikke almindelig, og bivirkningen colitis med hyppigheden almindelig.
English: Carcinogenicity studies with daclizumab beta have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med daclizumab beta.
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to all forms of daclizumab or to any of the excipients in Zinbryta (see section
Danish: Zinbryta er kontraindiceret til patienter med alvorlig overfølsomhed (f.eks. anafylaksi eller anafylaktoide reaktioner) over for alle former af daclizumab eller over for et eller flere af hjælpestofferne i Zinbryta (se pkt.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room Do not freeze or expose to high temperatures.
Danish: • Om nødvendigt kan Zinbryta opbevares uden afkøling i den lukkede originale yderpakning ved Sæt ikke den fyldte Zinbryta injektionssprøjte tilbage i køleskab, efter den har opnået Må ikke nedfryses eller udsættes for høje temperaturer.
English: • Before you use the Zinbryta pre-filled syringe for the first time, your doctor or nurse should show you or your carer how to prepare and inject the Zinbryta pre-filled syringe.
Danish: • Før du bruger den fyldte injektionssprøjte med Zinbryta første gang, skal lægen eller sygeplejersken vise dig, hvordan du klargør og injicerer den fyldte injektionssprøjte med
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab beta in milk (for details see section 5.3).
Danish: Tilgængelige toksikologiske data fra diegivende cynomolgusaber har vist, at daclizumab beta udskilles i mælk (se pkt.
English: Do not touch or blow on this area again
Danish: Du må ikke røre ved eller puste på dette
English: The causal relationship between daclizumab beta and sarcoidosis is considered possible.
Danish: Et kausalt forhold mellem daclizumab beta og sarkoidose anses for muligt.
English: Daclizumab beta clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Danish: Daclizumab betas clearance hos patienter, der udviklede neutraliserende antistoffer, var i gennemsnit 19% højere (se pkt.
English: The active substance is daclizumab beta.
Danish: Aktivt stof: daclizumab beta.
English: In patients with neutralising antibodies, daclizumab beta clearance was increased on average by 19% (see section 5.2).
Danish: Hos patienter med neutraliserende antistoffer steg daclizumab beta-clearance med gennemsnitligt 19% (se pkt.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to
Danish: • Den anbefalede opbevaring er kontrolleret afkøling mellem 2 °C og 8 °C i den lukkede, originale yderpakning for at beskytte mod lys.
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab beta) antibodies at week 4 and approximately every 3 months thereafter.
Danish: 5.1) blev patienterne testet for antistoffer mod daclizumab beta ved uge 4 og cirka hver 3. måned derefter.
English: • Prescriber name, signature and date.
Danish: • Patientoplysninger, underskrift og dato, • Navn, underskrift og dato for den ordinerende læge.
English: Daclizumab beta is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Danish: Daclizumab beta forventes ikke at blive metaboliseret vha. leverenzymer såsom CYP-isoenzymer (se pkt.
English: There is also a plausible mechanism of action for the development of sarcoidosis due to the immunomodulatory effects of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Danish: Der er også en plausibel virkningsmekanisme for udvikling af sarkoidose på grund af den immunmodulerende virkning af daclizumab beta og daclizumab betas involvering i udviklingen af andre immunmedierede hændelser.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: There is a plausible mechanism of action for the development of this colitis due to immunomodulatory properties of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Danish: Der er en plausibel virkningsmekanisme for udvikling af denne colitis på grund af de immunmodulerende egenskaber ved daclizumab beta og daclizumab betas involvering i udviklingen af andre immunmedierede hændelser.
English: Do not inject directly into your belly
Danish: Injicér ikke direkte i navlen.
English: Green Stripes Visible
Danish: Grønt flueben synlig
English: • The importance of detecting signs and symptoms which might indicate hepatic injury, and if any of these occur, to promptly contact their physician;
Danish: • Vigtigheden af at opdage tegn og symptomer, der kan indikere leverskade, og hvis de opstår,
English: Elimination As an IgG1 monoclonal antibody, daclizumab beta is not expected to undergo renal elimination.
Danish: Elimination Som et IgG1monoklonalt antistof forventes daclizumab beta ikke at blive elimeret via nyrerne.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C
Danish: • Om nødvendigt kan Zinbryta opbevares uden afkøling i den lukkede originale æske ved op til 30 °C i op til 30 dage.
English: • Check that the Zinbryta medicine is colourless or slightly yellow (See Figure syringe if the liquid is cloudy, or has
Danish: • Kontroller, at Zinbryta-lægemidlet er farveløst eller let gulligt (se figur E).
English: If you experience any of the following, contact your doctor immediately:
Danish: Hvis dette sker, skal du kontakte din læge,
English: • If you do forget a dose, and it is within 2 weeks of your missed dose, inject as soon as you can.
Danish: • Hvis du glemmer en dosis, og det er inden for 2 uger fra din glemte dosis, skal du give dig selv en injektion, så snart du kan. Fortsæt derefter som normalt og hold dig til din sædvanlige injektionsdag.
English: - at least monthly blood tests during treatment, as close as possible before each dose of Zinbryta, and more often if your doctor decides this is necessary - tests for up to 6 months after stopping treatment.
Danish: - mindst månedlige blodprøver under behandlingen, så tæt på hver dosis af Zinbryta som muligt, og hyppigere, hvis lægen beslutter, at det er nødvendigt.
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an
Danish: • Hvis der er blod på injektionsstedet, skal du tørre det af med gazeservietten og sætte en selvklæbende bandage eller et plaster på.
English: The exact metabolic pathway for daclizumab beta has not been characterised.
Danish: Daclizumab betas nøjagtige metabolisme er ikke blevet karakteriseret.
English: After your injection
Danish: Efter injektion
English: Step 8: Disposing of the used Zinbryta Pre-filled Syringe
Danish: Trin 8: Bortskaffelse af den brugte Zinbryta injektionssprøjte
English: Inflammation of the bowel (colitis): (Common - may affect up to 1 in 10 people)
Danish: Tarminflammation (colitis): (Almindelig - kan påvirke op til 1 ud af 10 personer)
English: Quickly insert the needle straight into the skin fold until the needle is fully
Danish: Stik hurtigt kanylen lige i hudfolden, indtil kanylen er trængt helt ind under huden (se figur I).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab beta
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zinbryta 150 mg injektionsvæske, opløsning daclizumab beta s.c.
English: • The liquid is cloudy or contains floating
Danish: • injektionsvæsken er uklar eller indeholder partikler
English: Daclizumab beta has not been studied in patients with renal impairment.
Danish: Daclizumab beta er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: • Check with your doctor, pharmacist or nurse about the right way to throw away the used syringe.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvordan du bortskaffer den brugte pen på korrekt vis.
English: Daclizumab beta is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Danish: Daclizumab beta forventes ikke at blive elimineret via nyrerne eller blive metaboliseret vha. leverenzymer (se pkt.
English: • However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your
Danish: • Hvis der er gået mere end 2 uger fra din glemte dosis, skal du springe den glemte dosis over og tage den næste dosis på den sædvanlige dag.
English: Do not take the Zinbryta pre-filled syringe out of the injection site until you have pushed the plunger all the way down.
Danish: injektionssprøjte ud af injektionsstedet, før du har trykket stemplet helt i bund.
English: • You should hold the pen over your
Danish: • Hold pennen i en vinkel på 90o over
English: • Check the expiry date on the Zinbryta pre
Danish: • Kontroller udløbsdatoen på den fyldte
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt injektionssprøjte indeholder 150 mg daclizumab beta i 1 ml injektionsvæske, opløsning.
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL Each pre-filled pen contains 150 mg of daclizumab beta in 1 mL
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldte injektionssprøjte indeholder 150 mg daclizumab beta i 1 ml Hver fyldte pen indeholder 150 mg daclizumab beta i 1 ml
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Danish: Zinbryta 150 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Zinbryta 150 mg injektionsvæske, opløsning, i fyldt pen daclizumab beta
English: Solution for injection
Danish: Klargøring til injektion
English: Do not share Zinbryta pre-filled syringe.
Danish: Del ikke den fyldte Zinbryta injektionssprøjte med andre.
English: • Zinbryta pre-filled syringe is for injecting the medicine under the skin only (subcutaneous).
Danish: • Den fyldte injektionssprøjte med Zinbryta er kun beregnet til injektion af lægemidlet under
English: Gauze Pad Adhesive Bandage
Danish: Hætte bandage
English: Hold the Zinbryta pre-filled syringe at a 45°-90° angle to the injection site (see Figure I).
Danish: Trin 6: Injicér lægemidlet Hold den fyldte Zinbryta injektionssprøjte i injektionsstedet (se figur I).
English: Injection Status
Danish: Grønne striber injektionsstatus
English: Each pre-filled pen contains 150 mg of daclizumab beta in 1 mL solution for injection.
Danish: Hver fyldte pen indeholder 150 mg daclizumab beta i 1ml injektionsvæske, opløsning.
English: (Uncommon - may affect up to 1 in 100 people) • Severe inflammation of the liver which might be life-threatening or result in death
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter) • Immunsygdom, der kan påvirke lungerne, huden og lymfeknuderne (sarkoidose)
English: Step 9: Care for your injection site
Danish: Trin 5: Klem forsigtigt om injektionsstedet
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Danish: Hver fyldte injektionssprøjte indeholder 150 mg daclizumab beta i 1 ml injektionsvæske, opløsning.
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection.
Danish: Hver fyldt pen indeholder en fyldt injektionssprøjte med 150 mg daclizumab beta i 1 ml injektionsvæske, opløsning.
English: Bandage
Danish: Fingerkrave
English: Pull the needle straight out.
Danish: Slip hudfolden, når kanylen er stukket ind.
English: Choose an injection site in your thigh, abdomen, or the back of your upper arm (See
Danish: Vælg et injektionssted på låret, maven eller
English: You may be tested for TB before starting Zinbryta
Danish: Måske vil din læge teste dig for TB, inden du begynder behandling med Zimbryta, og overvåge dig under behandlingen.
English: Pad
Danish: Lår
English: PC:
Danish: Pkt.
English: You should then contact your doctor, nurse or pharmacist.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The procedure started on 2 June 2006.
Danish: Proceduren blev indledt den 2. juni 2006.
English: London, 29 May 2007 Doc.Ref.
Danish: London, den 29. maj 2007 Ref.dok.
English: A Decision was issued by the European Commission on 29 May 2007.
Danish: Europa-Kommissionen vedtog en beslutning den 29. maj 2007.
English: The Marketing Authorisation Holder provided supplementary information on 21 September 2006 and 12 January 2007.
Danish: Indehaveren af markedsføringstilladelsen forelagde yderligere oplysninger den 21. september 2006 og den 12. januar 2007.
English: EMEA/144030/2007
Danish: EMEA/CHMP/275055/2007
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Xefo and associated names International Non-Proprietary Name (INN): lornoxicam
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Xefo og tilknyttede navne Internationalt fællesnavn (INN): lornoxicam
English: Xefo and associated names, 4mg and 8mg film-coated tablets, 8mg rapid film coated tablet, and 8mg powder and solvent for solution for injection, is a non-steroidal anti-inflammatory drug (NSAID), used for short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.
Danish: Xefo og tilknyttede navne, filmovertrukne tabletter, 4 mg og 8 mg, filmovertrukne tabletter med hurtig udløsning, 8 mg, og pulver og solvens til injektionsvæske, opløsning, 8 mg, er et non-steroidt antiinflammatorisk lægemiddel (NSAID), der anvendes til korttidsbehandling af akutte lette til moderate smerter, smertelindring og mindskelse af betændelse ved osteoartritis samt smertelindring og mindskelse af betændelse ved reumatoid artritis.
English: On 16 May 2006 Nycomed Denmark Aps presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Package Leaflets and Labelling of the medicinal product Xefo and associated names.
Danish: Den 16. maj 2006 indbragte Nycomed Danmark ApS en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF med henblik på en harmonisering af de nationale produktresuméer, indlægssedler og etiketteringer for lægemidlet Xefo og tilknyttede navne.