FrancophonIA/ELRC3.0 huggingface dataset:
English: • marginally varying effectiveness of the active substance of Xeomin
Danish: • små udsving i effekten af det aktive stof i Xeomin
English: The possible reasons for an increase or decrease are:
Danish: Der kan være forskellige årsager til en større eller mindre virkning:
English: - clinical verification of the neurotoxin effect on the injected muscle: e.g. an electromyographic investigation in a specialised facility - analysis of the reason for non-response, e.g. poor isolation of the muscles intended to be injected, too low dose, poor injection technique, fixed contracture, too weak antagonist, possible development of antibodies - review of Botulinum neurotoxin type A treatment as an adequate therapy - if no adverse reactions have occurred during the initial treatment, an additional course of treatment can be performed under the following conditions: 1) dose adjustment with regard to analysis of the most recent failure to respond, 2) EMG-guidance, 3) the recommended minimum interval between the initial and repeat treatment is not exceeded
Danish: klinisk verifikation af neurotoksinets virkning på den injicerede muskel: fx en elektromyografisk undersøgelse på en specialafdeling analyse af årsagen til manglende respons, fx dårlig isolation af de muskler, der skal injiceres, for lav dosis, dårlig injektionsteknik, fikseret kontraktur, for svag antagonist, eventuel udvikling af antistoffer revurdering af behandlingen med botulinum type A-neurotoksin som en adækvat behandling hvis der ikke er forekommet bivirkninger under den initiale behandling, kan der udføres yderligere et behandlingsforløb under følgende betingelser: 1) dosisjustering under hensyntagen til analyse af det seneste manglende respons, 2) EMG-vejledning, 3) det anbefalede mindste interval mellem initial og gentaget behandling må ikke overskrides
English: Your doctor may reduce the starting dose of relaxant, or use an intermediate-action substance rather than substances with longer lasting effects.
Danish: Lægen kan nedsætte startdosis af det muskelafslappende middel eller give et stof med mellemlang varighed i stedet for stoffer med langtidsvirkning.
English: A suitable sterile needle (e.g. 25-30 gauge/0.30-0.50 mm) is used for injections into superficial muscles, and an e.g. 22 gauge/0.70 mm needle may be used for injections into deeper musculature.
Danish: En egnet steril kanyle (fx 25-30 gauge/0,30-0,50 mm) anvendes til injektioner i overfladiske muskler og fx en 22 gauge/0,70 mm kanyle til injektioner i dybere muskulatur.
English: Tell your doctor immediately or go to the casualty department at your nearest hospital if you suffer from any of these symptoms.
Danish: Kontakt omgående lægen eller tag på nærmeste skadestue, hvis De får et af disse symptomer.
English: In cases of nonresponse, alternative therapies should be taken into consideration.”
Danish: I tilfælde af manglende respons bør andre behandlingsformer overvejes."
English: • the scope of the referral was the potential risk to public health concerning the need for data in repeated administration and data on immunogenicity for Xeomin
Danish: • indbringelsen vedrørte den potentielle offentlige sundhedsrisiko som følge af manglende oplysninger om gentagen administration og om immunogeniciteten af Xeomin
English: In both treatment groups, 4 patients with a positive HDA result at baseline had a negative result at the final visit.
Danish: I begge behandlingsgrupper var der fire patienter, hvis HDA-test var positiv ved baseline, men negativ ved det afsluttende besøg.
English: • The other ingredients are: human albumin, sucrose
Danish: • Øvrige indholdsstoffer: Humant albumin, saccharose.
English: One LD50 unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Danish: En LD50-enhed svarer til den mediane letale dosis (LD50), når det rekonstituerede lægemiddel injiceres intraperitonealt hos mus under nærmere fastlagte betingelser.
English: Xeomin may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin and in the use of the necessary equipment, e.g. EMG (electromyography).
Danish: Xeomin må kun anvendes af læger med specialviden og dokumenteret erfaring i administration af botulinumtoksin samt i brug af det nødvendige udstyr, fx EMG (elektromyografi).
English: These data were divided into 3 subgroups: patients with HDA negative, patients with positive antibodies < 5 mU/mL and patients with positive antibodies > 5 mU/mL.
Danish: Disse patienter blev inddelt i tre undergrupper: patienter, der var HDA-negative, patienter, der var positive med antistoftiter < 5 millienheder/ml, og patienter, der var positive med antistoftiter > 5 millienheder/ml.
English: Blepharospasm
Danish: Blefarospasme
English: Overall, safety data from 908 participants have been included in these trials, 466 subjects were treated with Xeomin and 442 subjects were treated with Botox.
Danish: Tilsammen indeholder undersøgelserne data fra 908 patienter, hvoraf 466 er blevet behandlet med Xeomin og 442 med Botox.
English: In the management of spasmodic torticollis, Xeomin dosing must be tailored to the individual patient, based on the patient's head and neck position, location of possible pain, muscle hypertrophy, patient's body weight, and response to the injection.
Danish: Ved behandlingen af spasmodisk torticollis skal doseringen af Xeomin tilpasses den enkelte patient ud fra patientens hoved- og nakkestilling, placering af eventuelle smerter, muskelhypertrofi, legemsvægt og respons på injektionen.
English: The management of spasmodic torticollis may cause dysphagia with varying degrees of severity with the potential for aspiration which may require medical intervention.
Danish: Behandlingen af spasmodisk torticollis kan medføre dysfagi af forskellig sværhedsgrad, som potentielt kan udvikle sig til aspiration med behov for medicinsk intervention.
English: In cases of repeated injections with Xeomin, the therapeutic effect of the product may vary.
Danish: Hvis De skal have gentagne injektioner med Xeomin, kan virkningen af lægemidlet variere.
English: After reconstitution, the Xeomin solution is injected using a suitable sterile needle (e.g. 27-30 gauge/0.30-0.40 mm).
Danish: Efter rekonstitution injiceres Xeomin-opløsningen ved hjælp af en egnet, steril kanyle (fx 2730 gauge/0,30-0,40 mm).
English: Do not use Xeomin
Danish: Brug ikke Xeomin
English: However, the administration of Xeomin at dose levels exhibiting clear maternal toxicity at weekly to biweekly intervals increased the number of abortions in a prenatal toxicity study in rabbits.
Danish: Administration af Xeomin i dosisniveauer, der udviser klar maternel toksicitet, med en eller to ugers interval øgede antallet af aborter i en prænatal toksicitetsundersøgelse hos kaniner.
English: In order to prevent ectropion, injections into the lower lid area should be avoided, and vigorous treatment of any epithelial defect is necessary.
Danish: For at forebygge ektropion bør injektioner ikke gives i området ved det nedre øjenlåg, og omhyggelig behandling af enhver epiteldefekt er nødvendig.
English: Xeomin may only be used by health care professionals experienced in the application of Botulinum toxin.
Danish: Xeomin må kun gives af sundhedspersonale med erfaring i anvendelse af botulinumtoksin.
English: This can occur more often if you suffer from disorders of your facial nerves.
Danish: Dette sker hyppigere i forbindelse med en lidelse i ansigtsnerverne.
English: Blocking antibodies were detected in 4 of 42 (9.5%) patients treated only with original Botox and in none of the patients treated with only the current Botox, despite a higher mean dose of current Botox per visit than original Botox.
Danish: Blokerende antistoffer blev konstateret hos 4 (9,5 %) af 42 patienter, der kun var blevet behandlet med det oprindelige Botox, men ikke hos nogen af de patienter, der kun var blevet behandlet med det nuværende Botox, skønt den anvendte gennemsnitsdosis pr. gang af det nuværende Botox var højere end af det oprindelige Botox.
English: Reproductive toxicity studies with Xeomin, performed in rabbits, did not show adverse effects on male or female fertility nor direct effects on embryo-foetal development.
Danish: Undersøgelser af Xeomins reproduktionstoksicitet udført hos kaniner viste ingen uønskede virkninger på fertiliteten hos han- eller hundyr eller direkte virkninger for embryoets/fosterets udvikling.
English: In addition, two adverse events have been assessed as related to study medication, versus none in the Botox group.
Danish: Desuden er to bivirkninger blevet vurderet til at have sammenhæng med forsøgsmedicinen, men ingen i Botox-gruppen.
English: The mechanism of action by which Botulinum neurotoxin type A exerts its effects on cholinergic nerve terminals can be described by a three-step sequential process which includes the following steps:
Danish: Virkningsmekanismen, hvorved botulinum type A-neurotoksin udøver sin virkning på kolinerge nerveterminaler, kan beskrives ved en tretrins sekventiel proces, der omfatter følgende trin:
English: It is possible that these undesirable effects may also occur with Xeomin.
Danish: Disse bivirkninger kan muligvis også forekomme med Xeomin.
English: Reconstituted Xeomin is intended for intramuscular injection.
Danish: Rekonstitueret Xeomin er beregnet til intramuskulær injektion.
English: Patients with related adverse effects
Danish: Patienter med behandlingsrelaterede bivirkninger
English: Dysphagia appears to be dose-dependent.
Danish: Dysfagi synes at være dosisafhængigt.
English: Botox and Xeomin are different drug substances in terms of clostridial protein content, although both contain the same 150 kDa neurotoxin, which is the actual active substance.
Danish: Lægemiddelstofferne i Botox og Xeomin er forskellige med hensyn til indhold af Clostridiumproteiner, skønt begge indeholder det samme neurotoksin på 150 kDa, som er det egentlige aktive stof.
English: No genotoxicity, carcinogenicity and pre- and postnatal development studies have been conducted with Xeomin.
Danish: Der er ikke udført undersøgelser af Xeomin for genotoksicitet, karcinogenicitet og præ- og postnatal udvikling.
English: Xeomin should not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or particulate matter.
Danish: Xeomin må ikke anvendes, hvis den rekonstituerede opløsning (tilberedt som angivet ovenfor) er uklar eller indeholder fnug eller partikler.
English: Based on the results, it could be concluded that pharmacological effect of Xeomin and Botox are almost comparable in animals.
Danish: Af resultaterne kan det konkluderes, at Xeomin og Botox har stort set samme farmakologiske virkning i dyr.
English: Due to the latency of onset, some of the therapeutic and/or adverse effects of Xeomin may also interfere with the ability to drive and operate machinery.
Danish: Grundet latenstiden for deres opståen kan nogle af de terapeutiske virkninger og/eller bivirkninger ved Xeomin også interferere med evnen til at føre bil eller betjene maskiner.
English: Following injection of conventional Botulinum toxin type A complex, EMG showed increased jitter in some distant muscles which was not associated with muscle weakness or other types of electrophysiological abnormalities.
Danish: Efter injektion af konventionelt botulinum type A-toksinkompleks viste EMG øget sitren i nogle fjerne muskler, som ikke var forbundet med muskelsvaghed eller andre typer elektrofysiologiske anormaliteter.
English: A titration of the dose should be performed.
Danish: Dosis skal titreres.
English: Vial (type 1 glass) with rubber stopper (bromobutyl rubber) and tamper-proof seal (aluminium) in pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Danish: Hætteglas (type 1-glas) med gummiprop (brombutylgummi) og børnesikret forsegling (aluminium) i pakningsstørrelser med 1 (enkeltdosispakning), 2, 3 eller 6 hætteglas (flerstykspakninger).
English: Reduced blinking following Xeomin injection into the orbicularis muscle can lead to corneal exposure, persistent epithelial defects and corneal ulceration, especially in patients with cranial nerve disorders (facial nerve).
Danish: Reduceret blinken efter injektion af Xeomin i musculus orbicularis kan føre til eksposition af cornea, vedvarende epiteldefekter og cornea-ulceration, især hos patienter med lidelser i kranienerver (ansigtsnerven).
English: Solvent added (sodium chloride 9 mg/ml (0.9%) solution for injection)
Danish: Tilsat solvens (natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning)
English: Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
Danish: Generaliserede forstyrrelser i muskelaktivitet (fx myasthenia gravis, Lambert-Eaton syndrom).
English: Xeomin has minor or moderate influence on the ability to drive and use machines.
Danish: Xeomin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Patients with smaller neck muscle mass, or patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk.
Danish: Patienter med mindre halsmuskelmasse eller patienter med behov for bilaterale injektioner i musculus sternocleidomastoideus har større risiko for dysfagi.
English: Swallowing difficulties appear to be dose-dependent.
Danish: Synkebesvær synes at være dosisafhængigt.
English: The most frequently reported adverse event was dysphagia (Xeomin 10.8%; Botox 8.2%; p=0.29).
Danish: De hyppigst indberettede bivirkninger var dysfagi (Xeomin 10,8 %; Botox 8,2 %; p = 0,29).
English: Medical intervention may be necessary (e.g. in the form of a gastric feeding tube) (see also section 4.8).
Danish: Det kan kræve medicinske indgreb (fx i form af en ernæringssonde) (se også pkt.
English: The heavy chain of the Botulinum neurotoxin type A binds with an exceptionally high selectivity and affinity to receptors only found on cholinergic terminals.
Danish: Botulinum type A-neurotoksins tunge kæde bindes med en exceptionel selektivitet og affinitet til receptorer, der kun findes på kolinerge terminaler.
English: In contrast, one animal treated with Xeomin was tested positively in the ELISA test, but no neutralising activity was detected in the HDA.
Danish: Ét af de Xeomin-behandlede dyr reagerede derimod positivt i ELISA-testen, men udviste ikke neutraliserende aktivitet i hemidiafragma-assayet.
English: The clinical effects of Botulinum neurotoxin type A can increase or decrease by repeated injections.
Danish: Den kliniske virkning af botulinum type A-neurotoksin kan øges eller reduceres ved gentagne injektioner.
English: A similar dose-efficacy response relationship has been demonstrated for Xeomin and Botox after one injection in spasmodic torticollis Phase III study.
Danish: En tilsvarende dosis-responssammenhæng er påvist for Xeomin og Botox efter én injektion i fase IIIundersøgelsen vedrørende torticollis spastica.
English: Measures in cases of overdose
Danish: Tiltag i tilfælde af overdosering
English: The informational value of the Phase III studies concerning immunogenicity is limited, as the patients were pretreated with Botox, and Xeomin was administered only once.
Danish: Fase III-undersøgelserne fortæller ikke så meget om immunogeniciteten, da patienterne forud var blevet behandlet med Botox, og da Xeomin kun blev givet én gang.
English: Because of the anticholinergic effect of Botulinum neurotoxin type A, Xeomin should be used with caution in patients at risk of developing an angle closure glaucoma.
Danish: På grund af den anticholinerge virkning af botulinum type A-neurotoksin bør Xeomin anvendes med forsigtighed hos patienter med risiko for at udvikle vinkelblokglaukom.
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C.
Danish: Rekonstitueret opløsning: Kemisk og fysisk holdbarhed efter rekonstitution er påvist i 24 timer ved 2ºC til 8ºC.
English: • are at risk of developing a disease called angle closure glaucoma.
Danish: • har risiko for at få en sygdom, der hedder vinkelblokglaukom.
English: It has not been investigated whether secondary non-response due to the development of antibodies is less frequent under Xeomin therapy than under treatment with conventional preparations containing the Botulinum toxin type A complex.
Danish: Det er ikke undersøgt, om sekundært manglende respons grundet udviklingen af antistoffer er mindre hyppig under Xeomin-behandling end under behandling med konventionelle præparater, der indeholder botulinum type A-toksinkomplekset.
English: Due to the nature of the diseases being treated, the ability to drive and to operate machines can be reduced.
Danish: Grundet arten af de sygdomme, der behandles, kan evnen til at føre bil og betjene maskiner være nedsat.
English: All of the SAEs were assessed as unrelated to treatment.
Danish: Alle alvorlige bivirkninger blev bedømt som ikke-behandlingsrelaterede.
English: After the injection you may develop mild to severe swallowing difficulties.
Danish: Efter injektionen kan De få let til svært synkebesvær.
English: The smaller the injection volume the less pressure sensation and less spread of Botulinum neurotoxin type A in the injected muscle occurs.
Danish: Jo mindre injektionsvolumen, desto mindre bliver trykfornemmelsen og udbredelsen af botulinum type A-neurotoksin i den injicerede muskel.
English: Do not use Xeomin after the expiry date which is stated on the carton and vial label after “EXP”.
Danish: Brug ikke Xeomin efter den udløbsdato, der står på pakningen.
English: If signs of intoxication appear, hospitalisation with general supportive measures is necessary.
Danish: Hvis der fremkommer tegn på forgiftning, skal patienten indlægges og have generel understøttende behandling.
English: Too frequent dosing of Botulinum toxin may result in antibody formation which may lead to resistance to treatment (see section 4.2).
Danish: For hyppig administration af botulinumtoksin kan føre til dannelse af antistoffer og dermed til resistens mod behandlingen (se pkt.
English: This exposure may lead to a damaging of the surface and an inflammation (corneal ulceration).
Danish: Derved kan der opstå skader på overfladen og betændelse (cornea-ulceration).
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: Til trods herfor kan muligheden for overførsel af infektionskilder ikke fuldstændigt udelukkes ved administration af lægemidler fremstillet ud fra humant blod eller plasma.
English: - The influence of Xeomin and Botox on motility (static and active movements) was assessed within an acute intravenous toxicity study in mice up to 68 LDU/kg.
Danish: - Virkningen af Xeomin og Botox på bevægeligheden (passiv og aktiv bevægelse) blev vurderet i en akut intravenøs toksicitetsundersøgelse i mus med indtil 68 LDU/kg.
English: Symptoms of overdose:
Danish: Symptomer på overdosering:
English: dizziness, numbness, drowsiness
Danish: Svimmelhed, følelsesløshed, sløvhed
English: Receptor-bound Botulinum neurotoxin type A is endocytosed into the nerve terminal prior to reaching its target (SNAP 25) and will eventually be degraded intracellularly.
Danish: Receptorbundet botulinum type A-neurotoksin optages i nerveterminalen ved endocytose, før det når sit mål (SNAP-25), og nedbrydes til sidst intracellulært.
English: Clinical pack.
Danish: Hospitalspakning.
English: Up to now the FIA (Fluorescence Immuno Assay) screening test revealed no trend of a development of antibodies after Xeomin injection.
Danish: Indtil nu er der ved screening med FIA (fluorescensimmunoassay) ikke fundet antistofdannelse efter injektion af Xeomin.
English: In non-clinical studies, the pharmacological effect (i.e. degree of the paralytic activity, effect on motility, effect on paralysis over time, duration) of Xeomin was compared to Botox: - The paralytic activity of Xeomin and Botox was assessed in the mouse regional paralysis test, after 3 repeated intramuscular injections at 6 and 13 week intervals up to a dose of 0.64 Lethal Dose Unit (LDU)/animal for Xeomin and Botox (approx. 32 LDU/kg).
Danish: I de ikke-kliniske undersøgelser blev Xeomin og Botox sammenlignet med hensyn til farmakologisk virkning (graden af paralytisk aktivitet, virkningen på bevægeligheden, det tidsmæssige forløb af virkningen på paralysen samt varigheden): - Den paralytiske aktivitet af Xeomin og Botox blev vurderet ved regional paralysetest hos mus efter 3 gentagne intramuskulære injektioner med 6 og 13 ugers mellemrum af en dosis på indtil 0,64 letaldosisenheder (LDU) til hvert dyr af Xeomin og Botox (ca. 32 LDU/kg).
English: Nervous system disorders Common:
Danish: Nervesystemet Almindelige:
English: The most frequently reported adverse event was ptosis (Xeomin 6.1%; Botox 4.6%).
Danish: Den hyppigst indberettede bivirkning var ptose (Xeomin 6,1%; Botox 4,6%).
English: Lastly, the proposed SPC for Xeomin does not claim a potentially lower risk of development of antibodies with the product: “It has not been investigated whether secondary non-response due to the development of antibodies is less frequent under Xeomin therapy than under treatment with conventional preparations containing the Botulinum neurotoxin type A complex.
Danish: Endelig påberåbes der ikke potentielt lavere risiko for antistofdannelse i det foreslåede produktresumé for Xeomin: "Det er ikke undersøgt, om sekundært manglende respons grundet udviklingen af antistoffer er mindre hyppig under Xeomin-behandling end under behandling med konventionelle præparater, der indeholder botulinum type A-toksinkomplekset.
English: Multiple injection sites permit Xeomin more uniform coverage of the innervated areas of the dystonic muscle and are especially useful in larger muscles.
Danish: Ved at anvende flere injektionssteder opnås en mere ensartet udbredelse af Xeomin i de innerverede områder af den dystoniske muskel, hvilket især er en fordel i større muskler.
English: The rate of serious adverse events (SAEs) in all studies was 2.1% with Xeomin and 2.7% with Botox.
Danish: Hyppigheden af alvorlige bivirkninger i alle undersøgelserne var 2,1 % for Xeomin og 2,7 % for Botox.
English: They may be restricted to the area around the injection site (e.g. local pain, tenderness at the injection site, and injection site haemorrhage).
Danish: De kan være begrænset til området omkring injektionsstedet (f.eks. lokale smerter, ømhed eller blødning på injektionsstedet).
English: PHARMACEUTICAL FORM Powder for solution for injection White powder
Danish: LÆGEMIDDELFORM Pulver til injektionsvæske, opløsning Hvidt pulver
English: In Phase II dose finding trial, the efficacy in patients with rotational cervical dystonia at three doses (10, 20 and 30 U) of Xeomin was compared to the optimal dose of Botox (30 U).
Danish: I fase II-dosisfastsættelsesundersøgelsen hos patienter med rotationel cervikal dystoni blev virkningen af tre forskellige doser (10, 20 og 30 E) Xeomin sammenlignet med Botox i optimal dosis (30 E).
English: For Botox, 45 out of 152 patients (29.6%) reported a total of 62 adverse events.
Danish: For Botox rapporterede 45 ud af 152 patients (29,6 %) om i alt 62 bivirkninger.
English: The clinical development program was composed by 5 studies provided in the following table:
Danish: Det kliniske udviklingsprogram bestod af 5 undersøgelser som angivet i følgende tabel: Tabel 1: Oversigt over kliniske undersøgelser
English: The study failed with respect to the determination of the optimal therapeutic dose of Xeomin in the treatment of spasmodic torticollis, as no statistically significant treatment differences (overall or pair-wise) were observed, but similar effectiveness of Xeomin and Botox in EMG measurements could be demonstrated.
Danish: I undersøgelsen lykkedes det ikke at fastlægge den optimale terapeutiske dosis af Xeomin ved torticollis spastica, da der ikke var statistisk signifikante forskelle mellem behandlingerne (totalt eller parvis), men det blev påvist, at Xeomin og Botox svarer til hinanden med hensyn til virkning, bestemt ved EMG.