FrancophonIA/ELRC3.0 huggingface dataset:
English: tubocurarine-type muscle relaxants that weaken the muscles.
Danish: muskelafslappende midler såsom tubocurarin, som svækker muskulaturen.
English: Native Botulinum toxin is a high molecular weight complex, which, in addition to the neurotoxin (150 kD) contains other non-toxic proteins, like haemagglutinins and nonhaemagglutinins.
Danish: Nativt botulinumtoksin er et kompleks med høj molekylvægt, som ud over neurotoksinet (150 kD) indeholder andre non-toksiske proteiner som hæmagglutininer og non-hæmagglutininer.
English: In cases of non-response, alternative therapies should be considered.
Danish: I tilfælde af manglende respons bør andre behandlingsformer overvejes.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest revideret den
English: Like many other proteins of its size, Botulinum neurotoxin type A has been shown to undergo retrograde axonal transport after intramuscular injection.
Danish: I lighed med mange andre proteiner på samme størrelse er det påvist, at botulinum type Aneurotoksin gennemgår retrograd aksonal transport efter intramuskulær injektion.
English: • Phase III Blepharospasm Study
Danish: • Fase III-undersøgelsen vedrørende blefarospasme
English: What Xeomin is and what it is used for Before you use Xeomin How to use Xeomin Possible side effects How to store Xeomin Further information
Danish: Xeomins virkning og hvad De skal bruge det til Det skal De vide, før De begynder at bruge Xeomin Sådan skal De bruge Xeomin Bivirkninger
English: The following additional information is based on publications on conventional preparations containing the Botulinum toxin type A complex.
Danish: Følgende supplerende oplysninger er baseret på publikationer om konventionelle præparater, der indeholder botulinum type A-toksinkomplekset.
English: • different techniques of preparation of the product by your doctor
Danish: • lægen anvender forskellige metoder til klargøring af medicinen
English: Symptoms of overdose are not apparent immediately after the injection and may be general weakness, drooping eyelid, double vision, swallowing and speech difficulties, and pneumonia.
Danish: Symptomerne på overdosering er ikke åbenbare umiddelbart efter injektionen, men kan være generel svækkelse, hængende øjenlåg, dobbeltsyn, synke- og talebesvær og lungebetændelse.
English: - The paralytic efficacy of Xeomin and Botox was analysed by electromyography (EMG) in vivo in male monkeys after a single intramuscular injection of 16 LDU/kg in the left gluteus medius muscle.
Danish: - Den paralytiske virkning af Xeomin og Botox blev analyseret ved elektromyografi (EMG) in vivo i hanaber efter en enkelt intramuskulær injektion af 16 LDU/kg i venstre m. glutaeus medius.
English: Taken altogether, the data from the non-clinical and clinical development program, which has been designed with support of Scientific Advice, provided sufficient evidence that a 1:1 dose ratio between Xeomin and Botox with respect to efficacy and safety can be concluded and the adoption of the dosage which has been established for Botox is adequately justified.
Danish: Det ikke-kliniske og kliniske udviklingsprogram er tilrettelagt efter videnskabelig rådgivning fra EMEA og giver som helhed tilfredsstillende dokumentation for, at dosisforholdet mellem Xeomin og Botox er 1:1 hvad angår virkning og sikkerhed, og at det er tilstrækkelig velbegrundet at anvende samme dosering som den, der gælder for Botox.
English: • Two Phase I studies MRZ/BTC-9901 and MRZ/BTC-0113, of which the latter was performed after completion of the Phase III studies
Danish: • De to fase I-undersøgelser MRZ/BTC-9901 og MRZ/BTC-0113, hvoraf sidstnævnte blev udført,
English: Free circulating Botulinum neurotoxin type A molecules which have not bound to presynaptic cholinergic nerve terminal receptors will be phagocytosed or pinocytosed and degraded like any other free circulating protein.
Danish: Frit cirkulerende botulinum type A-neurotoksinmolekyler, der ikke er bundet til præsynaptiske kolinerge nerveterminalreceptorer, vil blive optaget ved fagocytose eller pinocytose og nedbrudt som ethvert andet frit cirkulerende protein.
English: For Botox, 57 out of 232 patients (24.6%) reported a total of 90 adverse events.
Danish: For Botox rapporterede 57 ud af 232 patienter (24,6 %) om i alt 90 bivirkninger.
English: Large doses may cause paralysis in muscles distant to the injection site.
Danish: Store doser kan medføre lammelse i muskler, der ligger fjernt fra injektionsstedet.
English: For intramuscular use
Danish: Intramuskulær anvendelse.
English: Pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Danish: Pakningsstørrelser: 1 (enkeltstykpakning), 2, 3 eller 6 hætteglas (flerstykpakninger).
English: The occurrence of dysphagia is attributable to the spread of the pharmacological effect of Xeomin as the result of the neurotoxin spread into the oesophageal musculature.
Danish: Forekomsten af dysfagi kan henføres til spredningen af Xeomins farmakologiske virkning som følge af neurotoksinets spredning ind i den øsofageale muskulatur.
English: An injection volume of approximately 0.05 to 0.1 ml is recommended.
Danish: Det anbefalede injektionsvolumen er ca. 0,05 til 0,1 ml.
English: An almost identical percentage of patients in both treatment groups reported AEs (26.6% in the Xeomin group and 26.0% in the Botox group).
Danish: Procentdelen af patienter med bivirkninger var næsten ens i de to behandlingsgrupper (26,6 % i Xeomin-gruppen og 26,0 % i Botox-gruppen).
English: In this trial, 40 out of 148 patients (27.0%) treated with Xeomin reported a total of 57 adverse events.
Danish: 40 ud af 148 (27,0 %) af de Xeomin-behandlede patienter i undersøgelsen rapporterede om i alt 57 bivirkninger.
English: Measures in cases of overdose:
Danish: Tiltag i tilfælde af overdosering:
English: The exposed portion of the rubber stopper of the vial is cleaned with alcohol (70%) prior to insertion of the needle.
Danish: Den blottede del af hætteglassets gummiprop renses med alkohol (70%), før nålen stikkes ind. Solvensen skal sprøjtes forsigtigt ind i hætteglasset.
English: The optimum dosage and number of injection sites in the treated muscle should be determined by the physician individually for each patient.
Danish: Den optimale dosering og antallet af injektionssteder i den behandlede muskel fastsættes af lægen til den enkelte patient.
English: From a quality point of view, Xeomin is highly purified and differs from the drug substance in Botox® and Dysport® in that it is free of complexing proteins (haemagglutinins).
Danish: Kvalitetsmæssigt er Xeomin højtrenset, og lægemiddelstoffet adskiller sig fra Botox® og Dysport® ved at være fri for kompleksdannende proteiner (hæmagglutininer).
English: There are rare reports on side effects related to the cardiovascular system, such as irregular heartbeat (arrhythmia) and heart attack, some of them with fatal outcome.
Danish: Der foreligger sjældne rapporter om bivirkninger forbundet med hjerte-karsystemet såsom uregelmæssig hjerterytme (arytmi) og hjerteanfald - nogle af dem med dødelig udgang.
English: There have been rare reports of undesirable effects related to cardiovascular system, such as arrhythmia and myocardial infarction, some with fatal outcomes.
Danish: Der har været sjældne rapporter om bivirkninger relateret til det kardiovaskulære system såsom arytmi og myokardieinfarkt - nogle med dødelig udgang.
English: The only severe case of dysphagia occurred in the Botox group.
Danish: Det eneste tilfælde af svær dysfagi forekom i Botox-gruppen.
English: In this trial, 65 out of 231 patients (28.1%) treated with Xeomin reported a total of 110 adverse events.
Danish: 65 ud af 231 (28,1 %) af de Xeomin-behandlede patienter i undersøgelsen rapporterede om i alt 110 bivirkninger.
English: Data of changes in TWSTRS-Severity score in patients with hemidiaphragm assay (HAD) positive group between control visit (3 weeks after one injection) and final visit (12 weeks after one injection) were submitted.
Danish: Hos patienter, der var positive ved hemidiafragmaassayet, blev der redegjort for ændringen i TWSTRS-smertescore fra kontrolbesøget (3 uger efter én injektion) til det afsluttende besøg (12 uger efter én injektion).
English: Of the Botox patients 4 individuals with a negative result at baseline had a positive result (<5 mU/mL in 3 patients, >5 mU/mL in 1 patient) at the final visit.
Danish: Af Botox-patienterne var de fire negative ved baseline, men var positive ved det afsluttende besøg (< 5 millienheder/ml hos 3 patienter, og > 5 millienheder/ml hos én patient).
English: The findings made in repeat-dose toxicity studies conducted with Xeomin were mainly related to its pharmacodynamic action.
Danish: I undersøgelser af Xeomins toksicitet efter gentagne doser var fundene især relateret til stoffets farmakodynamiske virkning.
English: Avoiding medial injections into the lower lid may reduce this adverse reaction.
Danish: Ved at undgå mediale injektioner i det nedre øjenlåg kan bivirkningen reduceres.
English: Due to the nature of your disease being treated, the ability to drive and to operate machines can be reduced.
Danish: På grund af den type sygdom, De får behandlet, kan Deres evne til at føre bil og betjene maskiner være nedsat.
English: Of the Xeomin patients with a negative mouse hemidiaphragm assay (HDA) result at baseline, indicating that no neutralising antibodies are present, 2 individuals had a positive result (<5 mU/mL) at the final visit.
Danish: Af de Xeomin-patienter, som havde negativt muse-hemidiafragma-assay ved baseline som tegn på fravær af neutraliserende antistoffer, reagerede de to positivt (< 5 millienheder/ml) ved det afsluttende besøg.
English: In the management of spasmodic torticollis, Xeomin is usually injected into the sternocleidomastoid, levator scapulae, scalenus, splenius capitis, and/or the trapezius muscle(s).
Danish: Ved behandling af spasmodisk torticollis injiceres Xeomin sædvanligvis i musculus sternocleidomastoideus, musculus levator scapulae, musculus scalenus, musculus splenius capitis og/eller musculus trapezius.
English: In clinical trials with Botulinum toxin type A complex it was reported that dysphagia occurs less frequently with total doses below 200 U per treatment session.
Danish: I kliniske forsøg med botulinum type A-neurotoksinkompleks rapporteredes det, at dysfagi forekommer mindre hyppigt med totaldoser under 200 E pr. behandlingsforløb.
English: Previously akinetic or sedentary patients should be reminded to gradually resume activities following the injection of Xeomin.
Danish: Patienter, der tidligere har været ubevægelige eller inaktive, skal mindes om, at genoptræning skal ske gradvist efter injektion af Xeomin.
English: If you develop swallowing difficulties, speech or breathing disorders, please contact medical emergency services or ask your relatives to do so (see section 4).
Danish: Kontakt lægevagten eller skadestuen, hvis De får synke- tale eller vejrtrækningsbesvær, eller bed Deres pårørende om at gøre det (se afsnit 4).
English: Ecchymosis easily occurs in the soft tissues of the eyelid.
Danish: Ekkymose opstår let i øjenlågets bløde væv.
English: • the posology of Xeomin
Danish: • doseringen af Xeomin
English: - In LPT12444, in week 36, three weeks after the final injection, the ELISA test (indicating the presence of antibodies against Botulinum neurotoxin type A) revealed that seven of the 20 rabbits treated with Botox showed a positive response and four of these rabbits displayed BoNT/A neutralising activity in the hemidiaphragm assay (HDA indicating if antibodies are neutralising or non-neutralising).
Danish: - I uge 36 af LPT12444, tre uger efter den sidste injektion, var 7 ud af 20 Botox-behandlede kaniner positive i ELISA-testen for antistoffer mod botulinumneurotoxin type A. Heraf udviste 4 kaniner neutraliserende aktivitet mod botulinumneurotoxin type A i hemidiafragma-assayet (der viser, om antistofferne er neutraliserende eller ikke-neutraliserende).
English: Injury, poisoning and procedural complications Uncommon: inflicted injury
Danish: Traumer, forgiftninger og behandlingskomplikationer Ikke almindelig:
English: The following side effect probabilities and allocated frequencies are used for the categorisation of side effects:
Danish: Bivirkninger inddeles efter sandsynlighed og hyppighed med følgende betegnelser:
English: Hypersensitivity to the active substance Botulinum neurotoxin type A or to any of the excipients.
Danish: Overfølsomhed over for det aktive stof botulinum type A-neurotoksin eller over for et eller flere af hjælpestofferne.
English: Theoretically, the effect of Botulinum neurotoxin may be potentiated by aminoglycoside antibiotics or other medicinal products that interfere with neuromuscular transmission e.g. tubocurarine-type muscle relaxants.
Danish: Teoretisk set kan virkningen af Botulinum neurotoksin blive forstærket af aminoglykosidantibiotika eller andre lægemidler, der interfererer med neuromuskulær transmission, fx muskelafslappende midler af tubocurarintypen.
English: An injection volume of approximately 0.1 to 0.5 ml is recommended.
Danish: Det anbefalede injektionsvolumen er ca. 0,1 til 0,5 ml.
English: In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 63 patients received the 2nd injection, 27 patients received the 3rd, and 6 patients received the 4th injection, respectively.
Danish: I undersøgelsen af cervikal dystoni (MRZ 0408) hvor Xeomin anvendes i doser på indtil 240 E, har 63 patienter fået den anden injektion, 27 patienter den tredje og 6 patienter den fjerde injektion.
English: Symptoms of overdose are not immediately apparent post-injection and may include general weakness, ptosis, diplopia, swallowing and speech difficulties or paralysis of the respiratory muscles resulting in an aspiration pneumonia.
Danish: Symptomerne på overdosering opstår ikke umiddelbart efter injektionen, men kan omfatte generel svækkelse, ptose, diplopi, synke- og talebesvær eller lammelse af åndedrætsmusklerne, der fører til aspirationspneumoni.
English: (Jankovic et al, 20031, 20062, Barnes et al, 20053) to support the hypothesis that the amount of antibodies is correlated to the amount of clostridial protein load and thus, that there might be a lower risk for patients treated with Xeomin to develop secondary non-response.
Danish: Publicerede kliniske undersøgelser (Jankovic et al, 20031, 20062, Barnes et al, 20053) støtter antagelsen om en sammenhæng mellem blodets antistofindhold og indholdet af Clostridium-proteiner, hvilket muligvis er ensbetydende med mindre risiko for sekundært behandlingssvigt ved brug af Xeomin.
English: The most common AEs (i.e. with an incidence of ≥1%) were dysphagia, ptosis, back and skeletal pain and muscle weakness, the majority of them assessed as mild or moderate.
Danish: De hyppigste bivirkninger (dvs. med en forekomst ≥ 1 %) var dysfagi, ptose, ryg- og knoglesmerter samt muskelsvaghed.
English: A case of peripheral neuropathy has been reported in a male after receiving four sets of injections of a conventional preparation containing the Botulinum toxin type A complex (for neck and back spasm, and severe pain) over an 11 week period.
Danish: Et tilfælde af perifer neuropati er rapporteret hos en mand, efter at han havde fået fire serier injektioner af et konventionelt præparat med botulinum type A-toksinkompleks (for hals- og rygspasme og kraftige smerter) over en 11-ugers periode.
English: However, in clinical trials the related adverse events were numerically more frequent in the Xeomin group compared to the Botox group.
Danish: I de kliniske undersøgelser var de behandlingsrelaterede bivirkninger imidlertid numerisk hyppigere i Xeomin-gruppen end i Botox-gruppen.
English: • In the blepharospasmus study (MRZ 0433) one patient has entered the second injection cycle.
Danish: • I blefarospasmeundersøgelsen (MRZ 0433) har én patient påbegyndt det andet injektionsforløb.
English: What Xeomin looks like and contents of the pack
Danish: Xeomins udseende og pakningstørrelse
English: Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site.
Danish: Øgede doseringer af botulinum type A-neurotoksin kan resultere i udtalt neuromuskulær paralyse fjernt fra injektionsstedet.
English: For instructions on reconstitution / dilution of the vials, see section 6.6.
Danish: Vedrørende vejledning i rekonstitution/fortynding af hætteglassene, se pkt.
English: In the blepharospasmus study (MRZ 0433) 6 patients received the 2nd injection.
Danish: I blefarospasmeundersøgelsen (MRZ 0433) har seks patienter modtaget den anden injektion.
English: • if you suffer from generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
Danish: • hvis De lider af sygdomme som forstyrrer muskelaktivitet (f.eks. myasthenia gravis, Lambert
English: LIST OF EXCIPIENTS Human albumin, sucrose
Danish: LISTE OVER HJÆLPESTOFFER Humant albumin, saccharose
English: The applicant has committed to perform a post-marketing surveillance study, in which immunogenicity of Xeomin will be further investigated after repeated administration (up to 6 injection sessions) .
Danish: Ansøgeren har forpligtet sig til at udføre en post-marketing overvågningsundersøgelse, hvor immunogeniciteten af Xeomin vil blive nærmere undersøgt efter gentagen administration (indtil 6 injektionsforløb).
English: In addition, the HDA titer increased from <5 mU/mL to >5 mU/mL in 2 patients in each treatment group.
Danish: Hos to patienter i hver behandlingsgruppe steg HDA-titeren desuden fra < 5 millienheder/ml til > 5-millienheder/ml.
English: The median first onset of effect is observed within seven days after injection.
Danish: Den mediane første virkning indtræffer i løbet af syv dage efter injektion.
English: Botulinum neurotoxin type A blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.
Danish: Botulinum type A-neurotoksin blokerer kolinerg transmission ved den neuromuskulære forbindelse ved at hæmme frigivelsen af acetylcholin.
English: • Phase III Cervical Dystonia Study (MRZ 0013)
Danish: • Fase III-undersøgelse vedrørende cervikal dystoni (MRZ 0013)
English: This reconstituted solution may be stored for up to 24 hours at 2 to 8 °C.
Danish: Den fortyndede opløsning kan opbevares i op til 24 timer ved 2ºC til 8ºC.
English: Of the 908 participants, 239 thereof experienced adverse events (AEs).
Danish: Af disse 908 patienter fik de 239 bivirkninger.
English: Any used vials, syringes, and spillage etc. should be sterilised under high pressure and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Danish: Alle ubrugte hætteglas, injektionssprøjter og spild m.v. skal steriliseres under højt tryk, og rester af Xeomin skal inaktiveres med fortyndet saltvandsopløsning (0,1 N NaOH).
English: Xeomin has a protein content of only 0,6 ng/100U as it only consists of the 150 kDa neurotoxin, free from complexing proteins.
Danish: Xeomin har et proteinindhold på kun 0,6 ng/100 E, der udelukkende består af neurotoksinet på 150 kDa uden kompleksdannende proteiner.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Xeomin til andre.
English: It remains unclear whether these deaths were induced by conventional preparations containing the Botulinum toxin type A complex or caused by pre-existing cardiovascular disease.
Danish: Det forbliver uklart, om disse dødsfald blev induceret af konventionelle præparater med botulinum type A-toksinkompleks eller skyldtes eksisterende kardiovaskulære lidelser.
English: • To perform a post-marketing study to confirm the safety and efficacy of Xeomin after repeated injections (up to 6 injection sessions).
Danish: • Gennemførelse af en post-marketing undersøgelse til undersøgelse af sikkerheden og virkningen af Xeomin ved gentagen administration (indtil 6 injektionsforløb).
English: Your doctor should not use Xeomin if the vial reconstituted according to the instructions has a cloudy appearance or contains e.g. floccular or particulate matter.
Danish: Lægen bør ikke anvende Xeomin, hvis indholdet efter fortynding i henhold til vejledningen er uklart eller indeholder fnug eller partikler.
English: Erythema multiforme, urticaria, psoriasis-like rash, pruritus, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Danish: Erythema multiforme, urticaria, psoriasis-lignende udslæt, pruritus og allergiske reaktioner er beskrevet ved brug af konventionelle præparater med botulinum type A-toksinkompleks, men den kausale sammenhæng er fortsat uklar.
English: Manufacturer
Danish: Fremstilleren
English: The most frequent at least possibly related AE was dysphagia (5.2% for Xeomin vs. 3.4% for Botox in the pooled sample and 10% for Xeomin vs. 8.2% in the cervical dystonia Phase III study, respectively).
Danish: Den hyppigste bivirkning, der i det mindste muligvis var behandlingsrelateret, var dysfagi (henholdsvis 5,2 % for Xeomin mod 3,4 % for Botox i den poolede stikprøve, og 10 % for Xeomin mod 8,2 % i den cervikale fase III-dystoniundersøgelse).
English: Botox has a protein content of 5 ng/100U, i.e. the 150 kDa neurotoxin and non-effective complexing proteins, and quickly dissociates into the neurotoxin and the complexing proteins after administration.
Danish: Botox har et proteinindhold på 5 ng/100 E som et kompleks af neurotoksinet på 150 kDa og inaktive kompleksdannende proteiner, der efter administration hurtigt dissocierer til neurotoksin og kompleksdannende proteiner.
English: The median first onset of effect is observed within four days after injection.
Danish: Den mediane første virkning indtræffer i løbet af fire dage efter injektion.
English: Any used vials, syringes, and spillage etc. should be autoclaved and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Danish: Alle ubrugte hætteglas, injektionssprøjter og spild m.v. skal autoklaveres, og rester af Xeomin skal inaktiveres med fortyndet natriumhydroxidopløsning (0,1 N NaOH).
English: It is not known whether the active substance of Xeomin is excreted into the breast milk.
Danish: Det vides ikke, om det aktive stof i Xeomin udskilles i modermælk, og Xeomin bør ikke anvendes til ammende kvinder.
English: Therefore, no valid conclusions can be drawn from the resulting data with respect to immunogenicity of Xeomin compared to Botox.
Danish: Der kan derfor ikke sluttes noget heraf om immunogeniciteten af Xeomin i forhold til Botox.
English: - Efficacy issues
Danish: - Spørgsmål vedrørende virkning
English: Rare reports of severe allergic (anaphylactic) reactions after injection of a conventional preparation containing the Botulinum toxin type A complex have been received.
Danish: Der foreligger sjældne rapporter om alvorlig allergiske (anafylaktiske) reaktioner efter injektion af et almindeligt præparat med botulinum type A-toksinkompleks.
English: The applicant has committed to perform a post-marketing study, in which immunogenicity of Xeomin is further investigated after repeated administration (up to 6 injection sessions).
Danish: Ansøgeren har forpligtet sig til at udføre en post-marketing undersøgelse, hvor immunogeniciteten af Xeomin vil blive nærmere undersøgt ved gentagen administration (indtil 6 injektionsforløb).
English: WHAT XEOMIN IS AND WHAT IT IS USED FOR Xeomin is a medicine that relaxes the muscles.
Danish: XEOMINS VIRKNING OG HVAD DE SKAL BRUGE DET TIL Xeomin er en medicin til afslapning af skeletmusklerne (perifert muskelrelaksantium).
English: After reconstitution: the product may be stored for a maximum of 24 hours at 2°C to 8°C.
Danish: Efter rekonstitution må lægemidlet højst opbevares i 24 timer ved 2°C to 8°C.
English: Additionally, the following undesirable effects and accordingly their frequencies are known for the comparative compound containing conventional Botulinum toxin type A complex used in clinical trials with Xeomin.
Danish: Derudover kendes følgende bivirkninger og dermed deres hyppighed for det sammenlignelige stof, der indeholder konventionelt botulinum type-A-toksinkompleks, og som er anvendt i kliniske afprøvninger med Xeomin.