FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with underlying neurological disorders including swallowing difficulties are at increased risk of these side effects.
Danish: Patienter med tilgrundliggende neurologiske lidelser inklusive synkebesvær har en øget risiko for at få disse bivirkninger.
English: In the management of blepharospasm, total dosing should not exceed 100 U every 12 weeks.
Danish: Til behandling af blefarospasme må den totale administrerede dosis ikke overstige 100 E hver 12. uge.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of cardiovascular safety pharmacology.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af kardiovaskulær sikkerhedsfarmakologi.
English: o Evaluation of the spread reactions, specifically as part of future studies.
Danish: o Særlig vurdering af spredningsreaktioner som led i fremtidige kliniske forskningsundersøgelser.
English: • in targeted muscles which display pronounced weakness or atrophy.
Danish: • i målmuskler, der udviser udtalt svaghed eller atrofi.
English: In each of the ongoing studies, data are still blinded, but no secondary therapy failures due to antibody development have been reported up to now.
Danish: I de igangværende undersøgelser er data stadig blindet, men indtil nu er der ikke kommet meldinger om sekundært behandlingssvigt som følge af antistofdannelse.
English: Xeomin has been developed with the aim of reducing the risk of formation of neutralising antibodies, which may lead to secondary therapy failure.
Danish: Xeomin er udviklet med henblik på at mindske risikoen for dannelse af neutraliserende antistoffer, der kan føre til sekundært behandlingssvigt.
English: (MRZ/BTC-0013) and blepharospasm (MRZ/BTC-0003) respectively)
Danish: (MRZ/BTC-0013) og blefarospasme (MRZ/BTC-0003)
English: A continuous systemic exposure of the dams during the (unknown) sensitive phase of the organogenesis as a pre-requisite for the induction of teratogenic effects cannot necessarily be assumed.
Danish: Det kan dog ikke nødvendigvis antages, at kontinuerlig systemisk eksponering af moderdyrene i den (ukendte) følsomme fase af organogenesen er forudsætningen for induktion af teratogene virkninger.
English: • Safety data
Danish: • Sikkerhedsdata
English: Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.
Danish: Opløsning, der er opbevaret i over 24 timer samt ikke anvendt opløsning skal kasseres.
English: METHODS AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intramuskulær anvendelse.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 LD50 units
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 LD50 enheder
English: After reconstitution, Xeomin should be used for only one injection session and for only one patient.
Danish: Efter rekonstitution må Xeomin kun anvendes til et enkelt injektionsforløb og kun til én patient.
English: • if you suffer from a disease called amyotrophic lateral sclerosis.
Danish: • hvis De har en sygdom, der hedder amyotrofisk lateralsklerose.
English: • if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin (see section 6 “Further information”)
Danish: • hvis De er allergisk (overfølsom) over for over for botulinum type A-toksin eller et af de øvrige indholdsstoffer i Xeomin (se under 6 "Yderligere oplysninger").
English: Limiting the dose injected into the sternocleidomastoid muscle to less than 100 U may decrease the occurrence of dysphagia.
Danish: Begrænsning af den dosis, der injiceres i musculus sternocleidomastoideus til mindre end 100 E kan muligvis nedsætte forekomsten af dysfagi.
English: Theoretically, the effect of Xeomin may be reduced by: • certain anti-malaria / anti-rheumatic medicines (4-Aminochinolines).
Danish: I teorien kan virkningen af Xeomin blive forstærket af: • visse malariamidler / gigtmidler (4-aminoquinoliner).
English: These may lead to breathing in foreign materials, which may require medical intervention.
Danish: Det kan føre til indånding af fremmedlegemer, hvilket kan kræve medicinsk behandling.
English: In the non-clinical study, Xeomin was not more or less immunogenic than Botox even at dose levels clearly exceeding the recommended human dose.
Danish: I den ikke-kliniske undersøgelse var Xeomin hverken mere eller mindre immunogent end Botox, selv i doser klart over den anbefalede maksimale dosis til mennesker.
English: The nerve terminals of the neuromuscular junction no longer respond to nerve impulses, and secretion of the neurotransmitter is prevented (chemical denervation).
Danish: Nerveterminalerne ved den neuromuskulære forbindelse responderer ikke længere på nerveimpulser, og sekretion af neurotransmitteren forhindres (kemisk denervering).
English: • if you receive substances that prevent the blood from clotting (anticoagulant therapy)
Danish: • hvis De får medicin, der hindrer blodet i at størkne (antikoagulantia)
English: • in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction
Danish: • hos patienter, der lider af amyotrofisk lateralsklerose eller andre sygdomme, der resulterer i perifer neuromuskulær dysfunktion
English: Pharmacotherapeutic group: Muscle relaxant, peripherally acting agent, ATC code: M03AX01
Danish: Farmakoterapeutisk klassifikation: Andre muskelrelaksantia, perifert virkende, ATC-kode: M03AX01
English: After internalisation of the neurotoxin the light chain cleaves very specifically a target protein (SNAP 25) that is essential for the release of acetylcholine.
Danish: Efter internalisering af neurotoksinet spalter den lette kæde meget specifikt målproteinet (SNAP 25), som er essentielt for frigivelse af acetylcholin.
English: At present there are three ongoing clinical studies with Xeomin (all of which have a placebocontrolled single injection main period and subsequent extension periods, in which only Xeomin is administered).
Danish: Der kører i øjeblikket tre kliniske undersøgelser med Xeomin (alle med en placebo-kontrolleret hovedperiode med én enkelt injektion og efterfølgende forlængelsesperioder, hvor der kun gives Xeomin).
English: The study proposed is an open, single arm study in which 74 patients with cervical dystonia (naïve and pre-treated) are planned.
Danish: Den påtænkte undersøgelse er en åben undersøgelse med én forsøgsarm, hvor der er planlagt deltagelse af 74 patienter med cervikal dystoni (naive og tidligere behandlede).
English: Three patients discontinued the studies prematurely due to adverse events considered as unrelated to study drug.
Danish: Tre patienter udgik af undersøgelserne før tid på grund af bivirkninger, der blev anset for ikkemedicinrelaterede.
English: Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate-acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.
Danish: Perifere muskelrelaksantia bør anvendes med forsigtighed, om nødvendigt med reduktion af initialdosis af det muskelafslappende middel eller ved brug af et intermediært virkende stof såsom vecuronium eller atracurium frem for stoffer med længerevarende virkning.
English: Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Danish: Patienter, der behandles med terapeutiske doser, kan opleve voldsom muskelsvaghed.
English: It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage.
Danish: Det er god praksis at udføre rekonstitution af hætteglas og tilberedning af injektionssprøjter over plastforede papirhåndklæder for at opsamle spild.
English: Prior to administering Xeomin the physician must make himself familiar with the patient's anatomy and any alterations to the anatomy due to prior surgical procedures.
Danish: Før administration af Xeomin skal lægen gøre sig bekendt med patientens anatomi og eventuelle ændringer af anatomien grundet tidligere kirurgiske indgreb.
English: Usually, side effects are observed within the first week after treatment and are temporary in nature.
Danish: Sædvanligvis indtræffer bivirkninger i løbet af den første uge efter behandlingen, og de er normalt midlertidige.
English: This study showed the non-inferiority of Xeomin (70-300 U) compared to Botox (70-300 U).
Danish: Undersøgelsen viste, at Xeomin (70-300 E) ikke er underlegent i forhold til Botox (70-300 E).
English: The period between each treatment session should be at least 10 weeks.
Danish: Der bør gå mindst 10 uger mellem to behandlingsforløb.
English: For hospital use only
Danish: Kun til hospitalsbrug.
English: The immunological reactions on Xeomin were specifically investigated in the Phase III study MRZ0013 in patients with cervical dystonia.
Danish: De immunologiske reaktioner mod Xeomin blev specifikt undersøgt i fase III-undersøgelsen MRZ-0013 hos patienter med cervikal dystoni.
English: Post-marketing experience revealed no different or new safety signals for Xeomin compared to other Botulinum toxin containing medicinal products.
Danish: Erfaringerne efter markedsføring viste ikke anderledes eller nye sikkerhedssignaler for Xeomin end for andre lægemidler indeholdende botulinumtoksin.
English: o Specifically include toxin spread events in their sentinel list of events for active monitoring.
Danish: o Specifik inkludering af hændelser med toksinspredning i listen over hændelser, der aktivt overvåges.
English: • in patients receiving anticoagulant therapy
Danish: • hos patienter, der behandles med antikoagulantia
English: There are no adequate data from the use of Botulinum neurotoxin type A in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af botulinum type A-neurotoksin hos gravide kvinder.
English: Therefore, Xeomin should not be used during pregnancy unless clearly necessary and unless the potential benefit justifies the risk.
Danish: Xeomin bør derfor ikke anvendes under graviditet, med mindre det er klart nødvendigt, og kun såfremt risikoen retfærdiggøres af den potentielle fordel.
English: The sternocleidomastoid should not be injected bilaterally as there is an increased risk of adverse reactions (in particular dysphagia) when bilateral injections or doses in excess of 100 U are administered into this muscle.
Danish: Musculus sternocleidomastoideus bør ikke injiceres bilateralt, da der er en øget risiko for bivirkninger (især dysfagi), når bilaterale injektioner eller doser over 100 E indgives i denne muskel.
English: The fact that the Phase III studies were performed in patients pretreated with Botox is adequately addressed in the SPC, which now states that ‘there is limited experience in treatment-naïve patients'.
Danish: Det forhold, at fase III-undersøgelserne blev udført hos patienter, der forinden var blevet behandlet med Botox, er passende omhandlet i produktresuméet, der nu har ordlyden "erfaringerne med behandlingsnaive patienter er begrænsede".
English: What Xeomin contains
Danish: Xeomin indeholder
English: Patients with a history of dysphagia and aspiration should be treated with extreme caution.
Danish: Patienter med dysfagi og aspiration i anamnesen bør behandles med ekstrem forsigtighed.
English: The applicant has submitted the total number of adverse events with no distinction between adverse events related or not related.
Danish: Ansøgeren har oplyst det totale antal bivirkninger uden at skelne mellem, om de er behandlingsrelaterede eller ikke behandlingsrelaterede.
English: Extra caution is required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Danish: Der bør udvises ekstra forsigtighed, når injektionen gives tæt på følsomme strukturer såsom halspulsåren og lungespidser.
English: A decrease or increase in the Xeomin dose is possible by administering a smaller or larger injection volume.
Danish: Doseringen af Xeomin kan reduceres eller øges ved at administrere et større eller mindre injektionsvolumen.
English: The recommended dilutions are indicated in the following table:
Danish: Den anbefalede fortynding fremgår af tabellen nedenfor:
English: This disease can cause the inner eye pressure to rise and may lead to a damaging of your optic nerve.
Danish: Denne sygdom kan øget det indre tryk i øjet og derved beskadige synsnerven.
English: Eur J Neurol 2005; 12(12): 947-955.
Danish: Eur J Cancer 2005; 12: 947-955.
English: are available, showing one positive test result at baseline and before 3rd injection and two positive results four weeks after 1st injection and before 2nd injection.
Danish: I mellemtiden er resultaterne blevet til rådighed og viser ét positivt testresultat ved baseline og før tredje injektion, samt to positive resultater fire uger efter første injektion og før anden injektion.
English: In practice, the maximum total dose is usually not more than 200 U. Doses of up to 300 U may be given.
Danish: I praksis er den maksimale totale dosis sædvanligvis ikke mere end 200 E. Der kan gives doser på op til 300 E. Der bør højst gives 50 E på hvert injektionssted.
English: The initial recommended dose is 1.25-2.5 U (0.05-0.1 ml volume) at each site.
Danish: Den anbefalede initialdosis er 1,25-2,5 E (volumen 0,05-0,1 ml) i hvert sted.
English: The nonclinical data clearly demonstrated that one unit of Xeomin is equipotent to one unit of Botox and a clear dose-response was shown in two species.
Danish: De ikke-kliniske data viste klart, at én enhed Xeomin er ækvipotent med én enhed Botox, og der blev påvist klar dosis-responssammenhæng hos to dyrearter.
English: a) binding to the cholinergic nerve terminals b) entry or internalisation into the nerve terminal and c) inhibition of acetylcholine release by intracellular poisoning within the nerve terminal.
Danish: a) Binding til de kolinerge nerveterminaler b) Indtrængen eller internalisering i nerveterminalen, samt c) Hæmning af acetylcholinfrigivelse ved intracellulær forgiftning inde i nerveterminalen.
English: It should be noted that some adverse events have only been reported in patients who received Xeomin, such as dysphagia (reported in one patient in each of the Xeomin groups versus no patients in the Botox group).
Danish: Det skal bemærkes, at visse bivirkninger kun er rapporteret for patienter, der har fået Xeomin; dette gælder således dysfagi (rapporteret for én patient i hver Xeomin-gruppe, men ikke for nogen af patienterne i Botox-gruppen).
English: Spasmodic torticollis
Danish: Spasmodisk torticollis
English: The applicant submitted three non-clinical, two Phase I, one Phase II and one Phase III studies to demonstrate that a safe posology has been established for Xeomin.
Danish: Ansøgeren forelagde tre ikke-kliniske undersøgelser samt to fase I-, én fase II- og én fase IIIundersøgelse som dokumentation for, at der er fastlagt en sikker dosering for Xeomin.
English: • Overall Comparison of Adverse Events in Phase I - III Studies A total of five clinical trials (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013, MRZ-0003) have been completed to provide data on the safety and efficacy of Xeomin.
Danish: • Overordnet sammenligning af bivirkninger i fase I-III-undersøgelser Der er i alt udført fem kliniske undersøgelser (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013 og MRZ-0003) af sikkerheden og virkningen af Xeomin.
English: Patients should be informed that injections of Xeomin for the management of spasmodic torticollis may cause mild to severe dysphagia with the risk of aspiration and dyspnoea.
Danish: Patienterne bør oplyses om, at injektioner med Xeomin til behandling af spasmodisk torticollis kan medføre let til svær dysfagi med risiko for aspiration og dyspnø.
English: Your doctor can limit these by immediately applying gentle pressure at the injection site.
Danish: Lægen kan begrænse deres omfang ved omgående at trykke let på injektionsstedet.
English: The optimum number of injection sites is dependent upon the size of the muscle to be chemically denervated.
Danish: Det optimale antal injektionssteder afhænger af størrelsen på den muskel, der skal kemisk denerveres.
English: Unopened vial: Do not store above 25°C
Danish: Uåbnet hætteglas: Må ikke opbevares over 25°C.
English: The applicant presented efficacy data of Phase III study in spasmodic torticollis.
Danish: Ansøgeren forelagde virkningsdata fra fase III-undersøgelsen vedrørende torticollis spastica.
English: If you have been inactive for a long period of time, any activity should be started gradually after the Xeomin injection.
Danish: Hvis De har været inaktiv i længere tid, skal De gå gradvist i gang efter injektion af Xeomin.
English: Retrograde transsynaptic passage of active Botulinum neurotoxin type A into the central nervous system however has not been found.
Danish: Retrograd transsynaptisk passage af aktivt botulinum type A-neurotoksin ind i centralnervesystemet er imidlertid ikke påvist.
English: The primary efficacy variable was the decrease from baseline of the most relevant (i.e. highest amplitude) surface electromyography (EMG) level in the dystonic sternocleidomastoid muscle during maximal voluntary activation 14 days post-injection.
Danish: Den primære virkningsvariabel var reduktionen i forhold til baseline af det mest relevante signal (dvs. signalet med størst amplitude) ved overfladisk elektromyografi (EMG) fra den dystoniske m. sternocleidomastoideus ved maksimal voluntær aktivering 14 dage efter injektion.
English: • if an infection is present at the injection site.
Danish: • hvis De har en infektion ved injektionsstedet
English: Both Phase I studies showed equal doses of Xeomin to be as effective as Botox in the EMG measurements; it was clearly demonstrated that the paralytic effects of Xeomin and Botox increased with ascending doses and a comparable trend was seen in a Phase II study.
Danish: Begge fase I-undersøgelser viste, at Xeomin ved samme dosis var lige så effektivt som Botox i EMGmålingerne; det blev klart demonstreret, at den paralytiske virkning af Xeomin og Botox stiger med stigende dosis, og en tilsvarende tendens blev iagttaget i en fase II-undersøgelse.
English: During treatment, small punctuated bleedings may occur in the soft tissues of the eyelid.
Danish: Under behandlingen kan der opstå små punktformige blødninger i øjelågets bløddele.
English: This may lead to problems with breathing and you may have a higher risk of inhaling foreign substances or fluids.
Danish: Dette kan føre til vejrtrækningsbesvær, og De kan være mere tilbøjelig til at indånde fremmedlegemer eller væske.
English: Thus, up to now no case of secondary therapy failure can be derived from the ongoing studies, in which Xeomin (or placebo) has been used repetitively in a total of 213 patients, even though Xeomin doses are partially very high (which is usually a risk factor of antibody formation).
Danish: I de igangværende undersøgelser har der således indtil nu ikke været tilfælde af sekundært behandlingssvigt efter gentagne administrationer af Xeomin (eller placebo) til i alt 213 patienter, skønt Xeomin til dels er blevet anvendt i meget høje doser (hvad der sædvanligvis er en risikofaktor for antistofdannelse).
English: This is of benefit in reducing effects on nearby muscles when small muscle groups are being injected.
Danish: Dette er en fordel, da det reducerer påvirkningen af nærliggende muskler ved injektion i små muskelgrupper.
English: • One Phase II study (MRZ/BTC-9801)
Danish: • Én fase II-undersøgelse (MRZ/BTC-9801)
English: 2 Jankovic J, Hunter C, Dolimbek BZ, Dolimbek GS, Adler CH, Brashear A, et al. Clinicoimmunologic aspects of botulinum toxin type B
Danish: Jankovic J, Hunter C, Dolimbek BZ, Dolimbek GS, Adler CH, Brashear A, et al. Clinicoimmunologic aspects of botulinum toxin type B treatment of cervical dystonia.
English: Phone: +49-69/15 03-1
Danish: Tlf.: +49-69/15 03-1
English: Classic kinetic and distribution studies cannot be conducted with Botulinum neurotoxin type A because the active substance is applied in such small quantities (picograms per injection), and because it binds so rapidly and irreversibly to cholinergic nerve terminals.
Danish: Klassiske undersøgelser af kinetik og fordeling kan ikke gennemføres med botulinum type Aneurotoksin, fordi det aktive stof administreres i så små mængder (pikogram pr. injektion), og fordi det bindes så hurtigt og irreversibelt til kolinerge nerveterminaler.
English: Most of the adverse events were of mild or moderate severity in both groups.
Danish: De fleste bivirkninger var lette til moderate i begge grupper.
English: All adverse events were of mild or moderate severity except one case of treatment-related ptosis in the Xeomin and one case of unrelated myocardial infarction in the Botox group.
Danish: Alle bivirkninger var af let til moderat grad bortset fra ét tilfælde af behandlingsrelateret ptose i Xeomingruppen og ét tilfælde af ikke-behandlingsrelateret myokardieinfarkt i Botox-gruppen.
English: Therefore the concomitant use of Xeomin with aminoglycosides or spectinomycin requires special care.
Danish: Derfor kræver samtidig anvendelse af Xeomin og aminoglykosider eller spectinomycin særlig omhu.
English: Please inform your doctor prior to any treatment, if you:
Danish: Fortæl det til lægen før behandlingen, hvis De:
English: The possible reasons are different techniques of reconstitution, the chosen injection intervals, the injected muscles and marginally varying toxin activity resulting from the biological testing procedure employed or secondary non-response.
Danish: Det kan muligvis skyldes forskellige rekonstitutionsmetoder, de valgte intervaller mellem injektioner, de injicerede muskler og marginale forskelle mellem toksinets virkning, der skyldes den anvendte biologiske testprocedure eller sekundært manglende respons.
English: In the Phase III study MRZ-0003 in patients with blepharospasm, no patient in both treatment groups had a HDA antibody titer higher than 1 mU/l at baseline or at final visit.
Danish: I fase III-undersøgelsen MRZ-0003 hos patienter med blefarospasme havde ingen af patienterne i nogen af de to behandlingsgrupper en antistoftiter over 1 millienhed/ml, målt ved HDA, ved baseline eller ved det afsluttende besøg.
English: Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.
Danish: Patienter eller deres omsorgspersoner bør rådgives om, at de omgående skal søge lægehjælp, hvis der opstår synke-, tale eller vejrtrækningsbesvær.
English: Adrenaline and other medical aids for treating anaphylaxis should be available.
Danish: Adrenalin og andre antianafylaksimidler skal være til rådighed.
English: Considering the data from the non-clinical studies, the early Phase I study and its conclusions, and the Phase II study - although limited conclusions could be drawn from it, the dosage of Xeomin in both Phase III studies was based on the established dose of Botox.
Danish: Når der tages hensyn til data fra de ikke-kliniske undersøgelser, den tidlige fase I-undersøgelse og dens konklusioner samt fase II-undersøgelsen - som dog kun tillod at drage begrænsede slutningervar Xeomin-dosis i de to fase III-undersøgelser baseret på den fastlagte dosis af Botox.
English: After you receive a Xeomin injection into your eye muscle your blinking rate may be reduced.
Danish: Efter at De har fået en injektion Xeomin i øjenmusklen, kan blinkehastigheden blive nedsat.
English: • Non-clinical data
Danish: • Ikke-kliniske data
English: If you are pregnant, Xeomin should not be used, unless your doctor could decide whether there is a clear necessity and whether the potential benefit justifies the risk.
Danish: Hvis De er gravid, må De ikke anvende Xeomin, med mindre Deres læge vurderer, at det er klart nødvendigt, og at den mulige fordel opvejer risikoen.
English: Specifically this information should include advice to seek immediate medical help in the event of swallowing, speech or respiratory difficulties arise.
Danish: Denne information bør specielt indeholde en anvisning om straks at søge lægehjælp ved synke-, tale- eller vejrtrækningsproblemer.