FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not exceed the recommended doses and treatment duration.
Danish: o Oral og intramuskulær formulering: De anbefalede doser og behandlingsvarighed må ikke overskrides.
English: The major glucuro-conjugated metabolite SL18.0740 did not induce gene mutation in bacteria (Ames test); however it induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus test in mouse bone marrow administered orally).
Danish: Den primære glukuronsyrekonjugerede metabolit SL18.0740 inducerede ikke genmutation i bakterier (Ames-test), men det inducerede in vitro kromosomskader (in vitro mikrokernetest på humane lymfocytter) og in vivo kromosomskade (in vivo mikrokernetest i knoglemarven hos mus indgivet oralt).
English: The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH or CREST centromere staining), suggesting aneugenic properties.
Danish: Mikrokernerne skyldtes overvejende kromosomtab (centromerpositive mikrokerner efter FISH- eller CREST-centromer-farvning), hvilket indikerer aneugene egenskaber.
English: The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH centromere staining), suggesting aneugenic properties.
Danish: Mikrokernerne skyldtes overvejende kromosomtab (centromerpositive mikrokerner efter FISHcentromer-farvning), hvilket indikerer aneugene egenskaber.
English: Posology o For the oral form 4 mg and 8 mg: The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day).
Danish: o Oral formulering 4 mg og 8 mg: Den anbefalede og maksimale dosis er 8 mg hver 12. time (dvs. 16 mg per dag).
English: o Both for oral and for IM: Doses exceeding recommended doses or long-term use should be avoided (see section 4.4).
Danish: : Doser, der overstiger de anbefalede doser, og langvarig brug bør undgås (se pkt.
English: Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer [de nuværende godkendte indikationer skal slettes og erstattes af følgende] Adjuverende behandling af smertefulde muskelkontrakturer ved akut spinal patologi hos voksne og unge fra 16 år og opefter.
English: Thiocolchicoside must not be used - in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1 - during the entire pregnancy period - during lactation - in women of childbearing potential not using contraception.
Danish: Thiocolchicosid må ikke anvendes - Til patienter, som er overfølsomme over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: The recommended and maximal dose is 4 mg every 12 hours (i.e. 8 mg per day).
Danish: o Intramuskulær formulering: Den anbefalede og maksimale dosis er 4 mg hver 12. time (dvs. 8 mg per dag).
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Breastfeeding
Danish: Biotransformation
English: o Both for oral and for intramuscular forms:
Danish: o Oral og i.m.
English: unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily per os (see section 5.3).
Danish: Prækliniske studier har vist, at en af thiocolchicosid-metabolitterne (SL59.0955) inducerer aneuploidi (dvs. ulige antal kromosomer i delende celler) ved koncentrationer tæt på eksponeringen hos mennesker observeret ved doser på 8 mg to gange dagligt ved oral indgift (se pkt.
English: Do not take X if: - you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception - you are breast feeding
Danish: Tag ikke X hvis: - du er allergisk over for thiocolchicosid eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The applicant provided an environmental risk assessment for Unisol 10% Oral Solution that followed in general the established guidelines and recommendations.
Danish: Ansøgeren fremlagde en miljørisikovurdering for Unisol 10 % Oral Opløsning, som i store træk fulgte de fastlagte retningslinjer og anbefalinger.
English: Effect studies and calculation of PNEC values
Danish: 2.2 Effektundersøgelser og beregninger af PNEC-værdier
English: Unisol 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product.
Danish: Unisol 10% Oral Opløsning indeholder 100 mg enrofloxacin som aktivt stof pr. 1 ml produkt.
English: The submitted environmental risk assessment report is based on new studies initiated by the applicant and on bibliographical data extracted from peer reviewed journals.
Danish: Den indsendte miljørisikovurderingsrapport er baseret på nye undersøgelser, som ansøgeren har iværksat, og på bibliografiske data fra peer review- bedømte tidsskrifter.
English: The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Unisol 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment.
Danish: Ved fase I-miljørisikovurderingen efter VICH-retningslinjerne fremkommer PECs (Predicted Environmental Contrations) i jord for Unisol 10 % Oral Opløsning til slagtekyllinger (10 mg/kg legemsvægt/dag i 5 dage) over 100 µg/kg, som dermed krævede en fase II-vurdering.
English: During the decentralised procedure concerns were raised that Unisol 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants.
Danish: Under den decentraliserede procedure blev der ytret betænkeligheder med hensyn til, om Unisol 10 % Oral Opløsning kan udgøre en potentielt alvorlig miljørisiko med hensyn til risikoen for blågrønalger og terrestriske planter.
English: A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers.
Danish: En undersøgelse publiceret i peer review-bedømt litteratur (Nowara et al 1997)1, har vist, at enrofloxacin og andre fluoroquinoloner i høj grad adsorberes i jord med et højt indhold af lermineraler af montmorillonit og kaolinit, hvilket grundlæggende sker via elektrostatiske interaktioner mellem ioniserede carboxylerede grupper af fluoroquinoloner og ombyttelige kationer i lerlagene.
English: Application of the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l.
Danish: Ved anvendelse af CVMP's retningslinje for miljøkonsekvensvurdering af veterinærmedicinske lægemidler (Guideline on Environmental Impact Assessment for Veterinary Medicinal Products) i kombination med VICH-retningslinjen GL6 og GL38) fremkommer et estimat for PECoverfladevand på 0,019 µg/l.
English: 2.1.2 Soil adsorption and desorption
Danish: 2.1.2 Jordens adsorption og desorption
English: The Koc was calculated as 110,885 l kg/1(geometric mean).
Danish: Koc blev beregnet til 110.885 l kg/
English: Oral solution 100mg/ml
Danish: Unisol 10 % Oral Opløsning Oral opløsning 100 mg/ml
English: 4 Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW.
Danish: 4 Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW. Fate and Effects of Enrofloxacin in Aquatic Systems under Different Light Conditions.
English: Spain
Danish: Belgien
English: Gran Vía Carlos III, 98 - 7ª 08028 Barcelona Spain
Danish: 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPANIEN
English: Germany Universal Farma, S.L.
Danish: Tyskland Laboratorios Karizoo S.A. Mas Pujades
English: Universal Farma, S.L.
Danish: Laboratorios Karizoo S.A. Mas Pujades
English: Absolute Difference
Danish: Absolut forskel
English: Effects on peri-/postnatal development have not been evaluated.
Danish: Virkninger på peri-/postnatal udvikling er ikke blevet vurderet.
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 2 - 8°C.
Danish: Kemisk og fysisk brugsstabilitet er påvist i 72 timer ved temperaturer på 2-8 ºC.
English: THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
Danish: NEDENSTÅENDE OPLYSNINGER ER TIL LÆGER OG SUNDHEDSPERSONALE:
English: A total of 922 patients participated in two 1 year open label uncontrolled studies, and over the course of these studies, the average patient received 3 treatments.
Danish: I alt 922 patienter deltog i to 1-årige open-label ikke-kontrollerede forsøg, og i løbet af disse forsøg modtog den gennemsnitlige patient 3 behandlinger.
English: The usual dose of NUCEIVA is 20 Units.
Danish: Den sædvanlige dosis NUCEIVA er 20 enheder.
English: Duration of response in the phase 3 study was 139 days, based on a 1 point GLS improvement.
Danish: Responsvarigheden i fase 3-studiet var 139 dage baseret på en GLS-forbedring på 1 point.
English: Most side effects are of mild to moderate severity.
Danish: De fleste bivirkninger er milde til moderate.
English: Uncommon (May affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
English: It works by blocking the nerve impulses to the muscles in which it has been injected.
Danish: Det virker ved at blokere nerveimpulserne til de muskler, hvori det er blevet indsprøjtet.
English: To prevent this, there must be a gap of at least three months between doses.
Danish: For at forebygge dette skal der gå mindst 3 måneder mellem behandlingerne.
English: Local and distant spread of toxin effect
Danish: Lokal og fjern spredning af toksinets virkning
English: Physical manipulation (such as rubbing) of the injection site in the immediate post-administration period should be avoided.
Danish: Fysisk manipulation (såsom gnidning) på injektionsstedet i tidsrummet umiddelbart efter administration skal undgås.
English: Absorption, distribution, biotransformation and elimination (ADME) studies on the active substance have not been performed due to the nature of this product.
Danish: Der er ikke udført studier af absorption, distribution, biotransformation og elimination (ADMEstudier) på det aktive stof på grund af dette produkts beskaffenhed.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, hvilket vil sige, at det stort set er ”natriumfrit”.
English: Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided.
Danish: Injektion i sårbare anatomiske strukturer, såsom nerver og blodkar, skal undgås.
English: Uncommon events occurred in between 2 and 7 subjects.
Danish: Ikke almindelige hændelser forekom hos mellem 2 og 7 forsøgspersoner.
English: Do not drive or use machinery until such effects have cleared.
Danish: Du må ikke køre bil eller betjene maskiner, før disse symptomer er forsvundet.
English: In order to reduce the complication of eyelid ptosis the following steps should be taken:
Danish: For at mindske komplikationer i form af øjenlågs-ptose skal følgende foranstaltninger træffes:
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before you receive this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available.
Danish: Der skal derfor være epinefrin (adrenalin) eller andre forholdsregler mod anafylaksi til rådighed.
English: These instructions for use, handling and disposal should be strictly followed.
Danish: Disse anvisninger vedrørende anvendelse, håndtering og bortskaffelse skal følges nøje.
English: In the event of treatment failure (no visible improvement of glabellar lines at maximum frown) one month after the first course of treatment, the following approaches may be considered:
Danish: Hvis behandlingen mislykkes (ingen synlig forbedring af glabellalinjer ved maksimal panderynken) én måned efter det første behandlingsforløb, kan følgende tages op til overvejelse:
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftning og procedurerelaterede komplikationer
English: Following inactivation, dispose of in accordance with local requirements.
Danish: Bortskaffes efter inaktivering i henhold til lokale krav.
English: The central part of the rubber cap should be cleaned with alcohol.
Danish: Den centrale del af gummiproppen skal rengøres med sprit.
English: Antibody formation may lead to treatment failure.
Danish: Antistofdannelse kan medføre behandlingssvigt.
English: The most commonly reported adverse effects during treatment are headache, occurring in 9.0% of patients, followed by eyelid ptosis, occurring in 1.0% of patients.
Danish: De mest almindeligt indberettede bivirkninger under behandlingen er hovedpine, som forekommer hos 9,0 % af patienterne, efterfulgt af øjenlågs-ptose, som forekommer hos 1,0 % af patienterne.
English: Reconstitution should be performed in accordance with aseptic technique principles.
Danish: Rekonstitution skal udføres i overensstemmelse med principperne for aseptisk teknik.
English: - Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
Danish: - Sørg for at injicere den nøjagtige volumen/dosis, og hold den så vidt muligt på et minimum.
English: Responders for the Primary Efficacy Endpoint
Danish: Respondere for det primære endepunkt for effekt
English: Application related undesirable effects that have been reported following administration of NUCEIVA are uncommon events individually, common when added together.
Danish: Appliceringsrelaterede bivirkninger, der er indberettet efter administration af NUCEIVA, er ikke almindelige hændelser hver for sig, men almindelige, når de lægges sammen.
English: Introduction of an in vitro method as a replacement for the potency assay of the Nuceiva finished product.
Danish: Introduktion af en in vitro-metode som erstatning for styrke-assayet af det færdige Nuceiva-produkt.
English: The anatomy and anatomical land marks of procerus corrugator supercilli muscles and the surrounding vasucular and nervous structures in the glabellar region must be understood prior to administration of NUCEIVA.
Danish: Anatomien og de anatomiske landemærker for musklerne procerus og corrugator supercili og de omgivende kar- og nervestrukturer i glabellaregionen skal være forstået før administration af NUCEIVA.
English: Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only.
Danish: Bemærk: Af de 1659 forsøgspersoner, der er blevet behandlet med NUCEIVA, forekom der kun sjældne bivirkninger hos 1 forsøgsperson.
English: It prevents muscles from contracting, leading to a temporary paralysis.
Danish: Det forhindrer musklerne i at trække sig sammen, hvilket medfører midlertidig lammelse.
English: In general, side effects occur within the first few days after injection and are temporary.
Danish: Bivirkningerne forekommer som regel i løbet af de første par dage efter indsprøjtningen, og de er midlertidige.
English: Pre-existing neuromuscular disorders
Danish: Eksisterende neuromuskulære forstyrrelser
English: The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown.
Danish: Virkningen ved administration af forskellige botulinumneurotoksin-serotyper samtidig eller med flere måneders mellemrum kendes ikke.
English: The psychological impact of glabellar lines was confirmed at study entry and although a beneficial effect could not be demonstrated on psychological wellbeing, significant effects on patient reported outcomes were demonstrated as compared to placebo.
Danish: Glabellalinjernes psykologiske indvirkning blev bekræftet ved indtræden i forsøget, og selvom der ikke kunne påvises nogen gavnlig virkning på det psykologiske velbefindende, sås der en mærkbar virkning på de patientrapporterede kosmetiske resultater sammenlignet med placebo.
English: In the event of an accident when handling the product, whether in the vacuum-dried state or reconstituted, the appropriate measures described below must be initiated immediately.
Danish: Hvis der sker et uheld under håndteringen af produktet, hvad enten det er i vakuumtørret eller rekonstitueret tilstand, skal de forholdsregler, der er beskrevet herunder, straks iværksættes.
English: The potential impact of NUCEIVA on fertility has not been investigated in animals.
Danish: Den potentielle indvirkning af NUCEIVA på fertiliteten er ikke blevet undersøgt hos dyr.
English: Once reconstituted, the solution should be visually inspected prior to use.
Danish: Når opløsningen er rekonstitueret, skal den inspiceres visuelt før brug.
English: Reconstitution should be performed in accordance with good clinical practice, particularly with respect to aseptic technique.
Danish: Rekonstitution skal udføres i overensstemmelse med god klinisk praksis, særlig med hensyn til aseptisk teknik.
English: After injection, there is an initial rapid high-affinity binding of toxin to specific cell surface receptors.
Danish: Efter injektion sker der en initial hurtig binding af toksin med høj affinitet til specifikke receptorer på celleoverfladen.
English: This leaflet was last revised in{month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: There is no relevant use of NUCEIVA in the paediatric population.
Danish: Der findes ingen relevant anvendelse af NUCEIVA hos den pædiatriske population.
English: Signs of overdose may not be apparent immediately post-injection.
Danish: Tegnene på overdosering er ikke nødvendigvis tydelige efter injektionen.
English: NUCEIVA has not been detected in the peripheral blood following intramuscular injection at the recommended dose.
Danish: NUCEIVA er ikke blevet detekteret i det perifere blod efter intramuskulær injektion ved den anbefalede dosis.
English: Do not use NUCEIVA after the expiry date which is stated on the vial and the carton after EXP.
Danish: Brug ikke NUCEIVA efter den udløbsdato, der står på pakningen efter EXP.
English: No specific dose adjustment is required for use in the elderly.
Danish: Ingen specifik dosisjustering er nødvendig hos ældre patienter.
English: GLS=1 at Day 30 at Maximum Contraction
Danish: GLS=1 på dag 30 ved maksimal kontraktion
English: Tell your doctor if you have recently been injected with a medicine containing botulinum toxin (the active substance of NUCEIVA), as this may increase the effect of NUCEIVA excessively.
Danish: Fortæl det til lægen, hvis du for nylig har fået indsprøjtninger med en medicin, der indeholder botulinumtoksin (det aktive stof i NUCEIVA), da det kan give en for stærk virkning af NUCEIVA.
English: Clinical signs are manifest within 2-3 days, with peak effect seen within 4 weeks of injection.
Danish: De kliniske tegn manifesterer sig i løbet af 2-3 dage, og virkningen topper inden for 4 uger efter injektion.
English: NUCEIVA is injected into your muscles (intramuscularly), directly into the affected area above and between the eyebrows.
Danish: NUCEIVA sprøjtes ind i dine muskler (intramuskulært), direkte i det berørte område over og mellem øjenbrynene.
English: • The toxin is very sensitive to heat and certain chemical agents.
Danish: • Toksinet er meget følsomt over for varme og visse kemikalier.
English: 540 patients with moderate to severe glabellar lines seen at maximum frown who felt their glabellar lines had an important psychological impact (on mood, anxiety/or depressive symptoms) have been included in the European/Canadian clinical study.
Danish: 540 patienter med moderate til svære glabellalinjer observeret ved maksimal panderynken, der følte, at deres glabellalinjer havde en vigtig psykologisk indvirkning (på humør-, angst eller depressionssymptomer) har været inkluderet i det europæiske/canadiske kliniske forsøg.
English: CF31 3RT, United Kingdom
Danish: CF31 3RT, Storbritannien
English: Table 1 The NUCEIVA related adverse reactions are classified by System Organ Class and frequency defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Tabel 1 De NUCEIVA-relaterede bivirkninger er klassificeret efter systemorganklasse og deres hyppighed er defineret som følger: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
English: Pack size of one.
Danish: Pakningsstørrelse på ét stk.
English: Further, the effects of NUCEIVA on psychological wellbeing and patient reported outcomes were comparable to BOTOX, the active control used in the pivotal study.
Danish: Ydermere var virkningen af NUCEIVA på det psykologiske velbefindende og de patientrapporterede kosmetiske resultater sammenlignelige med Botox, det aktive kontrolstof i forbindelse med det pivotale studie.
English: EU/1/19/1364/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/1/19/1364/001
English: NUCEIVA (N=245) GLS=0 at Day 30 at Maximum Contraction
Danish: NUCEIVA (N=245) GLS=0 på dag 30 ved maksimal kontraktion
English: Recovery after intramuscular injection takes place normally within 12 weeks of injection as nerve terminals sprout and reconnect with the endplates.
Danish: Normalisering efter intramuskulær injektion finder normalt sted inden for 12 uger, efterhånden som nerveterminalerne vokser ud og forbindes med endepladerne igen.
English: Recommendations in the event of an accident when handling botulinum toxin:
Danish: Anbefalinger i tilfælde af uheld under håndtering af botulinumtoksin:
English: In the absence of adverse reactions during the initial treatment, an additional course of treatment can be performed subject to a minimum interval of 3 months between the initial and repeat treatment.
Danish: Hvis der ikke opstår bivirkninger i løbet af det første behandlingsforløb, kan der udføres endnu et behandlingsforløb, forudsat at der går mindst 3 måneder mellem første og anden behandling.
English: Pharmacotherapeutic group: Muscle relaxants, other muscle relaxants, peripherally acting agents, ATC code: M03AX01.
Danish: Farmakoterapeutisk gruppe: Muskelrelaxantia, andre muskelrelaxantia, perifert virkende, ATC-kode: M03AX01.
English: NUCEIVA has a minor or moderate influence on the ability to drive and use machines.
Danish: NUCEIVA påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Improvement of severity of the lines between the eyebrows generally occurs within a few days of treatment.
Danish: Forbedring af, hvor fremtrædende rynkerne er, finder som regel sted inden for få dage efter behandlingen.
English: Finally, the toxin is released into the cytosol with progressive inhibition of acetylcholine release.
Danish: Endelig frigives toksinet i cytosolet med progressiv hæmning af acetylcholin-frigivelsen til følge.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeat dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af akut toksicitet og toksicitet efter gentagne doser.
English: Overdose of NUCEIVA depends upon dose, site of injection, and underlying tissue properties.
Danish: Overdosering med NUCEIVA afhænger af dosis, injektionssted og det underliggende vævs egenskaber.
English: EXP Read the leaflet for the shelf life of the reconstituted medicine
Danish: EXP Læs indlægssedlen vedrørende holdbarheden af det rekonstituerede lægemiddel