FrancophonIA/ELRC3.0 huggingface dataset:
English: In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
Danish: Ligesom det gælder for botulismetoksin type A, kan der i fjerne muskler optræde elektrofysiologisk tremor, som ikke er forbundet med klinisk svaghed eller andre elektrofysiologiske abnormiteter.
English: Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.
Danish: Det absorberede toksin anbringes i en autoklaveringspose, forsegles og behandles som medicinsk, biologisk, miljøfarligt affald i henhold til lokale retningslinjer.
English: Do not freeze keep the vial in the outer carton in order to protect from light within its shelf-life, NeuroBloc may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25oC.
Danish: Må ikke nedfryses opbevar beholderen i den ydre karton for at beskytte mod lys inden for produktets opbevaringstid kan NeuroBloc tages ud af køleskabet i en enkelt periode på op til 3 måneder ved en temperatur på under 25 °C.
English: Aspiration pneumonia caused by food particles or vomit entering into the lungs, and respiratory disease, have been reported after treatment with botulinum toxins (Type A and Type B).
Danish: Aspirationspneumoni forårsaget af madrester eller opkast, der kommer ned i lungerne, samt respiratorisk sygdom er blevet rapporteret efter behandling med botulismetoksiner (type A og type B).
English: Nervous system disorders dry mouth, headache torticollis (worsening from baseline), taste perversion
Danish: Nervesystemet mundtørhed, hovedpine torticollis (forværring fra baseline), dysgeusi
English: In rabbits, the NOAEL was 0.1 U/kg/day for maternal effects and 0.3 U/kg/day for foetal effects.
Danish: Hos kaniner var NOAEL 0,1 E/kg/dag for påvirkning af moderdyret og 0,3 E/kg/dag for påvirkning af fosteret.
English: NeuroBloc must only be administered by intramuscular injection.
Danish: NeuroBloc må kun indgives ved intramuskulær injektion.
English: If he/she is unavailable seek emergency assistance.
Danish: Hvis han/hun ikke er til rådighed, skal De tage på skadestuen, De kan have behov for akut medicinsk behandling.
English: Talk to your doctor or pharmacist before using NeuroBloc: if you have a bleeding problem such as haemophilia if you have lung problems if you have difficulty swallowing.
Danish: Kontakt lægen eller apotekspersonalet, før De bruger NeuroBloc hvis De lider af en blødersygdom såsom hæmofili hvis De har lungeproblemer hvis De har svært ved at synke.
English: NeuroBloc is indicated for the treatment of cervical dystonia (torticollis) in adults.
Danish: NeuroBloc er indiceret til behandling af cervikal dystoni (torticollis) hos voksne.
English: Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse reaction cases reported during the post-marketing experience (including the following adverse reactions: dry mouth, dysphagia and blurred vision).
Danish: Efter lokal intramuskulær injektion af NeuroBloc blev der i 12 % af de tilfælde af bivirkninger, der blev indberettet efter markedsføringen, observeret alvorlige bivirkninger, der kunne skyldes systemiske virkninger af botulismetoksin type B (inklusive følgende bivirkninger: tørhed i munden, dysfagi og sløret syn).
English: The potency of Neurobloc is 5000 U/ml.
Danish: Styrken af NeuroBloc er 5.000 E/ml.
English: The extent and time course of seroconversion were similar in patients with prior toxin A exposure and those who were toxin A naïve, and between toxin A resistant and toxin A responsive patients.
Danish: Graden og tidsforløbet af serokonversion var sammenlignelig hos patienter med tidligere eksponering for toksin A og toksin A-naive patienter og mellem toksin A-resistente og toksin Aresponderende patienter.
English: However, the clinical relevance of the presence of antibodies as determined by the mouse neutralisation/ mouse protection assay is uncertain.
Danish: Den kliniske relevans af tilstedeværelsen af antistoffer, bestemt ud fra neutraliserings-/beskyttelsesassays med mus, er dog usikker.
English: Assessments
Danish: Vurderinger
English: Lack of interchangeability between botulinum toxin products The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
Danish: Der kan ikke skiftes mellem forskellige botulismetoksinpræparater Den initiale dosis på 10.000 E (eller 5000 E) er kun relevant for NeuroBloc (botulismetoksin type B).
English: The effect of administering different botulinum neurotoxin serotypes concurrently is unknown.
Danish: Virkningen ved samtidig indgivelse af forskellige botulismeneurotoksin-serotyper er ukendt.
English: General disorders and administration site conditions injection site pain neck pain influenza like illness
Danish: Almene symptomer og reaktioner på administrationsstedet smerter på injektionsstedet nakkesmerter influenzalignende sygdom
English: Pregnancy, breast-feeding and fertility you will not normally be given NeuroBloc if you are pregnant or breast-feeding.
Danish: De vil normalt ikke få NeuroBloc, hvis De er gravid eller ammer.
English: Contents of the pack and other information What NeuroBloc contains
Danish: Pakningsstørrelser og yderligere oplysninger NeuroBloc indeholder:
English: United Kingdom
Danish: Storbritannien og
English: Co-administration of NeuroBloc and aminoglycosides or agents interfering with neuromuscular transmission (e.g. curare-like compounds) should be considered with caution.
Danish: Samtidig indgivelse af NeuroBloc og aminoglykosider eller midler, som påvirker neuromuskulær transmission (f.eks. curarelignende stoffer), bør ske efter nøje overvejelse.
English: The active substance is Botulinum Toxin Type B. One millilitre (ml) contains 5000 U.
Danish: Aktivt stof: botulismetoksin type B. Én milliliter (ml) indeholder 5000 E.
English: If there are any visible signs of deterioration, the medicine should not be used, but discarded any unused solution should be discarded due to the special nature of NeuroBloc, the doctor will ensure that all used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements
Danish: Hvis der er synlige tegn på nedbrydning, må medicinen ikke bruges, men skal bortskaffes eventuelt ubrugt opløsning bør bortskaffes på grund af NeuroBlocs særlige karakter skal lægen sørge for, at brugte hætteglas, nåle og kanyler behandles som biologisk farligt affald og bortskaffes i henhold til lokale retningslinjer
English: Physician Global
Danish: Læge - Global
English: Such dilutions with sodium chloride should be done in a syringe, pulling out the desired amount of NeuroBloc into the syringe first, and then adding sodium chloride to the syringe.
Danish: Sådanne fortyndinger med natriumchlorid skal udføres i en kanyle, hvor den ønskede mængde NeuroBloc først trækkes ind i kanylen, hvorefter natriumchlorid tilsættes til kanylen.
English: The solution is clear and colourless to pale yellow.
Danish: Opløsningen er klar og farveløs til lysegul.
English: Within its shelf-life, the product may be removed from the refrigerator for one single period of up to 3 months at a temperature not above 25°C without being refrigerated again.
Danish: Inden for produktets opbevaringstid kan produktet tages ud af køleskabet i en enkelt periode på op til 3 måneder ved en temperatur på under 25 °C uden igen at blive sat på køl.
English: NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Danish: NeuroBloc bør kun indgives af en læge med kendskab til og erfaring i behandling af cervikal dystoni og i anvendelse af botulismetoksiner.
English: Within its shelf-life, the product may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25°C, without being refrigerated again.
Danish: Inden for produktets opbevaringstid kan produktet tages ud af køleskabet, i en enkelt periode på op til 3 måneder ved en temperatur på under 25 °C, uden igen at blive sat på køl.
English: Dysphagia has been reported following injection to sites other than the cervical musculature.
Danish: Der er indberettet dysfagi efter injektion andre steder end i halsmuskulaturen.
English: Use immediately if diluted (see section 4.2 and section 6.6).
Danish: Anvendes omgående hvis fortyndet (se pkt.
English: In the development studies, the No Observed Adverse Effect Dose Level (NOAEL) in rats was 1000 U/kg/day for maternal effects and 3000 U/kg/day for foetal effects.
Danish: I udviklingsstudier var det dosisniveau, hvor der ikke blev observeret negative virkninger (NOAEL, No Observed Adverse Effect Dose Level) på rotter 1000 E/kg/dag for påvirkning af moderdyret og 3000 E/kg/dag for påvirkning af fosteret.
English: Neuromuscular effects related to spread of toxin, distant from the site of administration have been reported (see section 4.8).
Danish: Der er indberettet neuromuskulære virkninger relateret til spredning af toksin fjernt fra indgivelsesstedet (se pkt.
English: Respiratory thoracic and mediastinal disorders dysphonia
Danish: Luftveje, thorax og mediastinum dysfoni
English: Adverse reactions related to spread of toxin distant from the site of administration have been reported: exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases (see section 4.4).
Danish: Der er blevet rapporteret bivirkninger med relation til spredning af toksin på andre steder end administrationsstedet: overdreven muskelsvaghed, dysfagi, dyspnø, aspirationspneumoni med dødelig udgang i nogle tilfælde (se pkt.
English: if you are allergic to Botulinum Toxin Type B or any of the other ingredients of NeuroBloc (listed in section 6) if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis (Lou Gehrig's disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain) if you have been experiencing shortness of breath or difficulty swallowing
Danish: hvis De har andre problemer med Deres nerver eller muskler, såsom amyotrofisk lateralsklerose (Lou Gehrigs sygdom), perifer neuropati, myasthenia gravis eller Lambert-Eatons syndrom (muskelsvaghed eller følelsesløshed eller smerter).
English: Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Danish: Der er indberettet bivirkninger relateret til spredning af toksin fjernt fra indgivelsesstedet (forøget muskelsvaghed, dysfagi, dyspnø, aspirationspneumoni - i nogle tilfælde med fatalt udfald) (se pkt.
English: How to use NeuroBloc
Danish: Sådan skal De bruge NeuroBloc
English: NeuroBloc will be given to you by a doctor with specialist experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Danish: De vil kun få NeuroBloc af en læge med speciallægeerfaring i behandling af cervikal dystoni og i anvendelse af botulismetoksiner.
English: Other medicines and NeuroBloc
Danish: Brug af anden medicin sammen med NeuroBloc
English: To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and the solution used immediately.
Danish: For at gøre det muligt at dele den totale dosis i flere indsprøjtninger, kan NeuroBloc fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, og opløsningen skal straks anvendes.
English: NeuroBloc is recommended for intramuscular administration only.
Danish: NeuroBloc anbefales kun til intramuskulær injektion.
English: Individuals with known neuromuscular diseases (e.g. amyotrophic lateral sclerosis or peripheral neuropathy) or known neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome) must not be given NeuroBloc.
Danish: Der må ikke gives NeuroBloc til personer med kendte neuromuskulære sygdomme (f.eks. amyotrofisk lateralsklerose eller perifer neuropati) eller kendte neuromuskulære transmissionssygdomme (f.eks. myasthenia gravis eller Eaton-Lambert's syndrom).
English: Gastrointestinal disorders dysphagia dyspepsia
Danish: Mave-tarm-kanalen dysfagi dyspepsi
English: Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Biohazardous Waste in accordance with local requirements.
Danish: Al ubrugt opløsning, alle hætteglas med NeuroBloc, hvor udløbsdatoen er overskredet og udstyr anvendt til at administrere lægemidlet, skal forsigtigt bortskaffes som biologisk farligt affald i henhold til lokale retningslinjer.
English: How NeuroBloc is given
Danish: Sådan gives NeuroBloc
English: This may occur when higher doses of up to 15,000 units are given if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately.
Danish: Hvis De har vejrtrækningsbesvær eller De er bekymret over nogle symptomer, som De udvikler på et andet sted end hvor indsprøjtningen blev givet, skal De omgående tale med Deres læge.
English: The other ingredients are disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid (for pH adjustment) and water for injections.
Danish: Øvrige indholdsstoffer: dinatriumsuccinat, natriumchlorid, human serumalbuminopløsning, saltsyre (til pH-justering) og vand til injektionsvæsker.
English: To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Danish: For at gøre det muligt at dele den totale dosis i flere indsprøjtninger, kan NeuroBloc fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning (se pkt.
English: NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones are causing the problem your doctor may inject part of the dose into different places in your muscles
Danish: NeuroBloc vil blive indsprøjtet i Deres nakke- eller skuldermuskler, afhængigt af hvilke muskler der forårsager problemet.
English: Disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid and water for injections.
Danish: Dinatriumsuccinat, natriumchlorid, human serumalbuminopløsning, saltsyre og vand til injektionsvæsker.
English: Eye disorders blurred vision
Danish: Øjne sløret syn
English: NeuroBloc 5000 U/ml solution for injection.
Danish: NeuroBloc 5000 E/ml injektionsvæske, opløsning.
English: This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother's breast milk if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Danish: Dette skyldes, at det er ukendt, hvordan NeuroBloc påvirker patienter, som er gravide, og at det er ukendt, om NeuroBloc udskilles i den ammende mors mælk.
English: Each ml contains 5000 U Botulinum Toxin Type B.
Danish: Hver ml indeholder 5000 E botulismetoksin type B.
English: Extracellular binding of the toxin to specific acceptors on motor nerve terminals Internalisation and release of the toxin into the cytosol of the nerve terminals Inhibition of acetylcholine release from nerve terminals at the neuromuscular junction
Danish: Internalisering og frigørelse af toksinet i nerveendernes cytosol.
English: NeuroBloc 5000 U/ml Solution for injection Botulinum Toxin Type B
Danish: NeuroBloc 5000 E/ml injektionsvæske, opløsning Botulismetoksin type B
English: Keep this leaflet.
Danish: Gem indlægssedlen.
English: Tabulated list of adverse reactions
Danish: Skematisk liste over bivirkninger
English: As with many biological/biotechnology proteins used as therapeutic agents, repeated administration of NeuroBloc may be associated with development of antibodies to Botulinum Toxin Type B in some patients.
Danish: Som for mange biologiske/bioteknologiske proteiner, der anvendes som terapeutiske stoffer, kan gentagen indgivelse af NeuroBloc, hos nogle patienter, være forbundet med dannelse af antistoffer mod botulismetoksin type B. Immunogenicitetsdata fra tre langvarige kliniske undersøgelser indikerer, at ca. en tredjedel af patienterne udvikler antistoffer, bestemt ved neutraliserings-/beskyttelsesassays med mus, afhængigt af eksponeringens varighed (se pkt.
English: Human serum albumin Hydrochloric acid (for pH adjustment) Water for injections
Danish: Dinatriumsuccinat Natriumchlorid Humant serumalbumin Saltsyre (til pH-justering) Vand til injektionsvæsker.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 0.5 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER TIL HÆTTEGLAS 0,5 ml hætteglas
English: What NeuroBloc is and what it is used for What you need to know before you use NeuroBloc How to use NeuroBloc
Danish: Det skal De vide, før De begynder at bruge NeuroBloc Sådan skal De bruge NeuroBloc Bivirkninger
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1.0 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE 1,0 ml hætteglas
English: One vial of 0.5 ml contains 2500 U of Botulinum Toxin Type B. One vial of 1 ml contains 5000 U of Botulinum Toxin Type B. One vial of 2 ml contains 10,000 U of Botulinum Toxin Type B.
Danish: Et hætteglas med 0,5 ml indeholder 2500 E botulismetoksin type B. Et hætteglas med 1 ml indeholder 5000 E botulismetoksin type B. Et hætteglas med 2 ml indeholder 10.000 E botulismetoksin type B.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 0.5 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE 0,5 ml hætteglas
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 1.0 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER TIL HÆTTEGLAS 1,0 ml hætteglas
English: NeuroBloc 5000 U/ml solution for injection IM
Danish: NeuroBloc 5000 E/ml injektionsvæske, opløsning i.m.
English: Having more injections of NeuroBloc the effects of NeuroBloc will usually last about 12 to 16 weeks your doctor will decide if you need another injection and how much to give you
Danish: Hvis De allerede har fået injektioner med NeuroBloc tidligere, vil lægen tage det med i betragtningerne, hvor godt det virkede de andre gange.
English: Marketing Authorisation holder
Danish: Indehaveren af markedsføringstilladelsen:
English: If you are not sure talk to your doctor or pharmacist.
Danish: Tal med lægen eller på apoteket, hvis De er i tvivl.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 2.0 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTER TIL HÆTTEGLAS 2,0 ml hætteglas
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2.0 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE 2,0 ml hætteglas
English: If you have further questions, please ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: Each ml contains 5000 U Botulinum Toxin Type B. One vial of 0.5 ml contains 2500 U of Botulinum Toxin Type B.
Danish: Hver ml indeholder 5000 E botulismetoksin type B Et hætteglas med 0,5 ml indeholder 2500 E botulismetoksin type B
English: NeuroBloc is provided in vials for single use only.
Danish: NeuroBloc leveres som engangshætteglas.
English: Each ml contains 5000 U Botulinum Toxin Type B. One vial of 1 ml contains 5000 U of Botulinum Toxin Type B.
Danish: Hver ml indeholder 5000 E botulismetoksin type B Et hætteglas med 1 ml indeholder 5000 E botulismetoksin type B
English: Solution for injection 1 vial
Danish: Injektionsvæske, opløsning 1 hætteglas
English: Each ml contains 5000 U of Botulinum Toxin Type B. One vial of 2 ml contains 10,000 U of Botulinum Toxin Type B.
Danish: Hver ml indeholder 5000 E botulismetoksin type B. Et hætteglas med 2 ml indeholder 10.000 E botulismetoksin type B.
English: Musculoskeletal connective tissue and bone disorders myasthenia
Danish: Knogler, led, muskler og bindevæv myasteni
English: Change from Baseline -2.0 P-Value*
Danish: Middel ved basislinie Middel ved uge 4 Ændring fra basislinie P-Værdi*
English: The application was withdrawn after ‘day 181'.
Danish: Ansøgningen blev trukket tilbage efter dag '181'.
English: ‘Metastatic' means the cancer has spread to other parts of the body.
Danish: "Metastatisk" betyder, at canceren har bredt sig til andre dele af kroppen.
English: • metastatic breast cancer in patients at risk of heart problems.
Danish: • Metastatisk brystcancer hos patienter med risiko for hjerteproblemer.
English: This reduces the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Danish: Dette reducerer hastigheden, hvormed det aktive stof nedbrydes, og giver det mulighed for at cirkulere i blodet i længere tid.
English: The company also presented the results of animal studies showing the distribution of the two medicines in different body tissues such as the heart, skin, kidney and spleen, since this could not be studied in humans.
Danish: Virksomheden fremlagde også resultaterne af dyreforsøg, der viste fordelingen af de to lægemidler i forskelligt kropsvæv, såsom hjerte, nyrer og milt, eftersom dette ikke kunne undersøges hos mennesker.
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Danish: Det virker ved at påvirke cellernes dna, idet det forhindrer dem i at fremstille flere kopier af dna og fremstille proteiner.
English: This means that cancer cells cannot divide and eventually die.
Danish: Det betyder, at kræftcellerne ikke kan dele sig, og de dør efterhånden.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækning af ansøgningen, kan ses under "All documents".
English: The active substance has an effect in the body when it is released (freed) from the liposome.
Danish: Det aktive stof virker i kroppen, når det frigives (befries) fra liposomet.
English: It contains the active substance doxorubicin (2 mg/ml).
Danish: Det indeholder det aktive stof doxorubicin (2 mg/ml).
English: It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Danish: Det reducerer også dets virkninger på væv og celler, som ikke er cancervæv og -celler, og gør visse bivirkninger mindre sandsynlige.
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Danish: • Multipelt myelom (kræft i knoglemarvens celler) hos patienter med progredierende sygdom, som har modtaget mindst én anden behandling tidligere, og som allerede har gennemgået eller er uegnet til knoglemarvstransplantation.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindeligt havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Because Doxorubicin SUN was assessed as a hybrid generic medicine, the company presented the results of studies carried out to investigate whether it is similar to the reference medicine.
Danish: Eftersom Doxorubicin SUN blev vurderet som et hybridt generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser, som blev udført for at undersøge, hvorvidt det svarede til referencelægemidlet.