FrancophonIA/ELRC3.0 huggingface dataset:
English: Injections near the levator palpebrae superioris should be avoided to reduce the occurrence of ptosis.
Danish: For at reducere forekomsten af ptose må injektionerne helst ikke gives nær musculus levator palpebrae superioris.
English: (Invented) Name
Danish: Særnavn Styrke
English: Foreign substances in your lungs may lead to an inflammation or infection (pneumonia).Your doctor will give you special medical treatment if needed (e.g. in the form of artificial nutrition).
Danish: Lægen kan give Dem medicinsk specialbehandling efter behov (f.eks. kunstig ernæring).
English: HDA tests are performed at baseline and repeatedly during the course of the study and the results which are, amongst others, available for 107 patients after the 2nd injection cycle and for 73 patients four weeks after 3rd injection did not show any neutralising antibodies.
Danish: Resultater heraf foreligger for 107 patienter efter det andet injektionsforløb og for 73 patienter fire uger efter det tredje injektionsforløb.
English: [See Annex I - To be completed nationally]
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [To be completed nationally]
English: Spasmodic torticollis The following adverse reactions were reported with Xeomin:
Danish: Spasmodisk torticollis Følgende bivirkninger ved Xeomin blev rapporteret:
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Xeomin til Dem personligt.
English: • eyelid spasm (blepharospasm)
Danish: • kramper i øjenlåget (blefarospame)
English: An anaphylactic reaction may occur rarely after injection of Botulinum neurotoxin type A (see section 4.8).
Danish: I sjældne tilfælde kan der opstå en anafylaktisk reaktion efter injektion af botulinum type Aneurotoksin (se pkt.
English: HOW TO STORE XEOMIN
Danish: SÅDAN OPBEVARER DE XEOMIN
English: Respiratory, thoracic and mediastinal disorders Uncommon: dysphonia
Danish: Luftveje, thorax og mediastinum Ikke almindelig:
English: disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration
Danish: Lidelse i synsnerven, der sædvanligvis forbindes med øget tryk i øjet
English: By reason of these facts it is implausible, that injection of Xeomin would lead to more frequent secondary therapeutic failures than Botox.
Danish: Dette forhold gør det usandsynligt, at sekundært behandlingssvigt oftere skulle forekomme efter injektion af Xeomin end efter injektion af Botox.
English: Barnes MP, Best D, Kidd L, Roberts B, Stark S, Weeks P, et al.
Danish: Barnes MP, Best D, Kidd L, Roberts B, Stark S, Weeks P, et al. The use of Botulinum toxin type-B in the treatment of patients who have become unresponsive to Botulinum toxin type-A -- initial experiences.
English: HOW TO USE XEOMIN
Danish: SÅDAN SKAL DE BRUGE XEOMIN
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning
English: Swallowing difficulties can last for up to two to three weeks after injection, for one patient a duration of up to five months is known.
Danish: Synkebesvær kan vare i op til 2-3 uger efter en injektion, men der er kendskab til en enkelt patient, hvor det varede op til 5 måneder.
English: swallowing difficulties (dysphagia), muscle weakness, back pain
Danish: Synkebesvær (dysfagi), muskelsvækkelse, rygsmerter
English: OTHER SPECIAL WARNING(S); IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: • If you have further questions, please ask your doctor or pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25°C.
English: Uncommon: facial paralysis, facial muscle weakness, inflammation of the cornea (keratitis), everted margin of the lid (ectropion), double vision (diplopia), inverted margin of the lid (entropion), visual disturbance, blurred vision, dizziness, inflammatory skin reaction (dermatitis), tiredness
Danish: Ikke almindelige: Ansigtslammelse, svækkelse af ansigtsmusklen, betændelse i øjets hornhinde (keratitis), udkrængning af øjenlåget (ektropion), dobbeltsyn (diplopi), indadkrængning af øjenlåget (entropion), synsforstyrrelser, uskarpt syn, svimmelhed, betændelsesreaktion i huden (dermatitis), træthed
English: nausea, oral dryness Skin and subcutaneous tissue disorders Common:
Danish: Hud og subkutane væv Almindelig:
English: However, as one of the two positive results four weeks after 1st injection and before 2nd injection was found in a patient pretreated with
Danish: Men da det ene af de to positive resultater fire uger efter første injektion og før anden injektion optrådte hos en patient, der forinden var blevet behandlet med Botox, og da undersøgelsen stadig er blindet, kan der ikke heraf drages konklusioner om immunogeniciteten af Xeomin.
English: The difference of the total number of adverse events related or not related between Xeomin and Botox was not statistically significant.
Danish: Der var ikke statistisk signifikant forskel mellem Xeomin og Botox med hensyn til det samlede antal behandlingsrelaterede eller ikke behandlingsrelaterede bivirkninger.
English: Blepharospasm The following adverse reactions were reported with Xeomin:
Danish: Blefarospasme Følgende bivirkninger ved Xeomin blev rapporteret:
English: • twisted neck (spasmodic torticollis)
Danish: • ufrivillig halsdrejning (spastisk torticollis)
English: Dysphagia can last for up to two to three weeks after injection, but a duration of up to five months has been reported in one case.
Danish: Dysfagi kan vare i op til 2-3 uger efter injektion, men i et enkelt tilfælde rapporteredes op til 5 måneders varighed.
English: Eyelid spasm (blepharospasm) The following side effects were reported with Xeomin:
Danish: Kramper i øjenlåget (blefarospasme) Følgende bivirkninger ved Xeomin blev rapporteret:
English: 1 vial contains 100 LD50 units Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
Danish: 1 hætteglas indeholder 100 LD50-enheder Clostridium botulinum type A-neurotoksin (150kD) uden kompleksdannende proteiner.
English: Skin and subcutaneous tissue disorders Uncommon: skin rash
Danish: Hud og subkutane væv Ikke almindelig:
English: ADMINISTRATION
Danish: Enhed
English: Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Danish: Xeomin 100 LD50 enheder pulver til injektionsvæske, opløsning Clostridium botulinum type A-neurotoksin (150kD), uden kompleksdannende proteiner
English: Eyelid spasm (blepharospasm)
Danish: Kramper i øjenlåget (blefarospasme)
English: Xeomin is presented as a powder for solution for injection.
Danish: Xeomin er et pulver til injektionsvæske, opløsning.
English: In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital.
Danish: Kontakt omgående lægevagten eller skadestuen, eller bed Deres pårørende om at gøre det, så De kan blive indlagt, hvis De mærker symptomer på overdosering.
English: Uncommon: muscle weakness, pins and needles (paraesthesia), headache, inflammation of the conjunctiva (conjunctivitis), dry mouth, skin rash, inflicted injury
Danish: Ikke almindelige: Muskelsvækkelse, myrekryb (paræstesi), hovedpine, betændelse i øjets bindehinder (conjunctivitis), mundtørhed, hududslæt, påført skade
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Merz Pharmaceuticals GmbH
English: rhinitis, upper respiratory tract infection Uncommon: dyspnoea, voice alteration
Danish: Rhinitis, øvre luftvejsinfektion
English: 95 % CI of differences between related adverse effect proportions (Xeomin versus Botox)
Danish: 95 % SI for forskellen i andelen af behandlingsrelaterede bivirkninger
English: Unopened vial: Do not store above 25°C For storage conditions of the reconstituted medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
English: NAME OF THE MEDICINAL PRODUCT Xeomin 100 LD50 units powder for solution for injection [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN Xeomin 100 LD50 enheder pulver til injektionsvæske, opløsning.
English: Swallowing difficulties may persist for two to three weeks after injection, but has been reported in one case to last five months.
Danish: Synkebesvær kan vare i 2-3 uger efter injektion, men et enkelt tilfælde havde varet i 5 måneder.
English: One case with severe dysphagia was reported in the Botox group.
Danish: I Botox-gruppen var der ét tilfælde af svær dysfagi.
English: Twisted neck (spasmodic torticollis)
Danish: Ufrivillig halsdrejning (spastisk torticollis)
English: Twisted neck (spasmodic torticollis) The following side effects were reported with Xeomin:
Danish: (vinkelblokglaukom), sårdannelse på øjets hornhinde (cornea-ulceration) Ufrivillig halsdrejning (spastisk torticollis) Følgende bivirkninger ved Xeomin blev rapporteret:
English: Dysphagia may persist for two to three weeks after injection, but has been reported in one case to last five months.
Danish: Dysfagi kan vare i 2-3 uger efter injektion, men et tilfælde rapporteredes at have varet 5 måneder.
English: skin sores
Danish: Øjensmerter
English: BEFORE YOU USE XEOMIN
Danish: Hvis De har brugt for meget Xeomin
English: NAME OF THE MEDICINAL PRODUCT Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Xeomin 100 LD50 enheder pulver til injektionsvæske, opløsning Clostridium botulinum type A-neurotoksin (150kD), uden kompleksdannende proteiner
English: Antibodies may reduce the therapeutic effectiveness of the product.
Danish: Når De har fået botulinum type A-toksin, kan organismen danne antistoffer, Antistofferne kan nedsætte lægemidlets terapeutiske effekt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 100 LD50 enheder Clostridium botulinum type A-neurotoksin (150kD), uden kompleksdannende proteiner
English: ptosis, dry eyes Uncommon: conjunctivitis
Danish: Ptose, tørre øjne
English: • In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 31 patients entered the second injection cycle.
Danish: • I undersøgelsen vedrørende cervikal dystoni (MRZ 0408) anvendes Xeomin i doser på indtil
English: Reconstituted solution: Store in a refrigerator (2 - 8°C) Your doctor will reconstitute the medicine with physiological saline before use.
Danish: Fortyndet opløsning: Opbevares i køleskab (2 ºC - 8 ºC).
English: Pharmaceutical Form
Danish: LÆGEMIDLETS NAVN
English: Nervous system disorders Uncommon: headache, tremor
Danish: Hovedpine, tremor
English: General disorders and administration site conditions Uncommon: asthenia, injection site inflammation, injection site tenderness
Danish: Asteni, inflammation ved injektionsstedet, ømhed ved injektionsstedet
English: superficial punctate keratitis, lagophthalmos, eye irritation, photophobia, lacrimation Uncommon: keratitis, ectropion, diplopia, entropion, visual disturbance, blurred vision Rare:
Danish: Keratitis, ektropion, diplopi, entropion, synsforstyrrelser, uskarpt syn
English: Musculoskeletal and connective tissue disorders Uncommon: muscle weakness
Danish: Knogler, led, muskler og bindevæv Ikke almindelig:
English: isolated cases
Danish: Påført skade
English: angle closure glaucoma, corneal ulceration Skin and subcutaneous tissue disorders Uncommon: dermatitis Musculoskeletal and connective tissue disorders Uncommon: facial muscle weakness General disorders and administration site conditions Uncommon: tiredness
Danish: Svækkelse af ansigtsmuskler Almene symptomer og reaktioner på administrationssted Ikke almindelig:
English: This summary was last updated in January 2015.
Danish: Dette sammendrag blev sidst ajourført i januar 2015
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stronghold on 25 November 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stronghold den 25. november 1999.
English: This does not affect the safety or effectiveness of the medicine.
Danish: Dette berører ikke lægemidlets sikkerhed eller virkning.
English: Other information about Stronghold:
Danish: Andre oplysninger om Stronghold:
English: Stronghold must not be used in animals under six weeks of age.
Danish: Stronghold må ikke anvendes til dyr, som er under seks uger gamle.
English: It must also not be used in cats that are suffering from another disease or that are weakened and underweight for their size and age.
Danish: Det må desuden ikke anvendes til katte, der lider af andre sygdomme, eller som er svækkede og undervægtige i forhold til deres størrelse og alder.
English: On the day of treatment, children must not handle treated animals and the animals should not sleep with their owners, especially children.
Danish: På selve behandlingsdagen må de behandlede dyr ikke komme i nærheden af børn eller sove sammen med deres ejere, navnlig børn.
English: People with sensitive skin or known allergy to products of this type should handle Stronghold with caution.
Danish: Personer med følsom hud eller med kendt overfølsomhed over for lægemidler af denne type bør udvise forsigtighed ved håndtering af Stronghold.
English: Stronghold treatment was found to be effective after a single administration or repeated treatments at monthly intervals, depending on the type of infestation it was being used to treat or prevent.
Danish: Stronghold blev fundet at være effektiv efter en enkelt behandling eller efter gentagne behandlinger med en måneds mellemrum, afhængigt af typen af angreb, det blev anvendt til at behandle eller forebygge.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Danish: Selamectin aktiverer særlige proteiner ved navn »kloridkanaler« på overfladen af parasittens nerve- og muskelceller, hvilket gør det muligt for ladede kloridpartikler at trænge ind i nervecellerne og afbryde deres normale elektriske aktivitet.
English: Treated animals must not be touched until the application area is dry.
Danish: Undgå at berøre de behandlede dyr, indtil påføringsstedet er tørt.
English: Stronghold is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Danish: Stronghold er meget brandfarligt og skal holdes på afstand af varme, gnister, åben ild eller andre antændelseskilder.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Stronghold exceed the risks for the approved indications and recommended that Stronghold be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Stronghold opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Stronghold.
English: This small volume of liquid is absorbed through the skin and has an effect throughout the animal's body.
Danish: Denne lille væskemængde optages gennem huden og virker i hele dyrets krop.
English: It is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg).The concentration and the strength to use depends on the weight and species of the animal being treated.
Danish: Det fås som spot-on-opløsning i to forskellige koncentrationer (6 % og 12 %) og i tuber i forskellige styrker (15, 30, 45, 60, 120, 240 og 360 mg).
English: Stronghold is an antiparasitic medicine that contains the active substance selamectin.
Danish: Stronghold er et antiparasitært lægemiddel, der indeholder det aktive stof selamectin.
English: The contents of the tube are squeezed onto the skin after parting the fur between the shoulder blades.
Danish: Tubens indhold trykkes ud på huden, efter at pelsen er delt mellem skulderbladene.
English: What is the risk associated with Stronghold?
Danish: Hvilken risiko er der forbundet med Stronghold?
English: In the treatment of sarcoptic mange in dogs, two treatments given 30 days apart were required to completely eliminate the mites in dogs.
Danish: Til behandling af skab forårsaget af Sarcoptes hos hunde var det nødvendigt med to behandlinger med 30 dages mellemrum for helt at fjerne miderne.
English: Shampooing or soaking the animal two hours or more after treatment did not affect the medicine's effectiveness.
Danish: Vask med shampoo og gennemblødning af dyrets pels mindst to timer efter behandlingen nedsatte ikke behandlingens effektivitet.
English: If Stronghold comes into contact with the eyes, they should be flushed immediately with water and medical attention sought.
Danish: Hvis Stronghold kommer i kontakt med øjnene, skal du straks skylle dem med rent vand og søge lægehjælp.
English: The effectiveness was then confirmed in field studies in cats and dogs by looking at the number of live parasites at various times after treatment.
Danish: Virkningen blev derefter bekræftet i feltundersøgelser hos katte og hunde, hvor antallet af levende parasitter blev undersøgt på forskellige tidspunkter efter behandlingen.
English: Why has Stronghold been approved?
Danish: Hvorfor blev Stronghold godkendt?
English: The user must not smoke, eat or drink while handling Stronghold.
Danish: Undgå rygning og indtagelse af mad og drikke under håndtering af Stronghold.
English: How has Stronghold been studied?
Danish: Hvordan blev Stronghold undersøgt?
English: The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Danish: Den anvendte styrke og antallet af behandlinger afhænger af det behandlede dyrs vægt og art samt af parasittypen.
English: Stronghold causes temporary alopecia (hair loss) at the application site in less than 1 in 1,000 cats.
Danish: Stronghold medfører forbigående hårtab på påføringsstedet hos færre end 1 ud af 1 000 katte.
English: In field studies, it reduced the flea comb counts by up to 98% in cats and 99% in dogs 90 days after treatment, as well as preventing flea eggs from hatching, and killing and preventing the development of flea larvae.
Danish: I feltundersøgelser mindskede Stronghold antallet af lopper (talt ved kæmning) med op til 98 % hos katte og 99 % hos hunde 90 dage efter behandlingen, forhindrede udklækning af loppeæg, dræbte loppernes larver og forhindrede udvikling af larver.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom to treat biting lice in cats and dogs,
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom til behandling af hunde med voksne rundorm i tarmsystemet til behandling af hunde og katte med pelslus til behandling af hunde med skab forårsaget af Sarcoptes.
English: Field studies also showed that Stronghold was 100% effective in preventing heartworm disease in dogs and cats.
Danish: Det blev i feltundersøgelser desuden påvist, at Stronghold var 100 % effektivt til forebyggelse af hjerteorm hos hunde og katte.
English: Used applicators should be disposed of immediately and not left within sight or reach of children.
Danish: Brugte applikatorer bortskaffes straks og opbevares utilgængeligt for børn.
English: Stronghold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Danish: Stronghold indeholder selamectin, der er et lægemiddel mod parasitter og tilhører gruppen »avermectiner«.
English: What is Stronghold used for?
Danish: Hvad anvendes Stronghold til?
English: What is Stronghold?
Danish: Hvad er Stronghold?
English: Stronghold may produce clumping of the hair at the application site or the appearance of a small quantity of a white powder in less than 1 in 1,000 cats.
Danish: Stronghold kan hos færre end 1 ud af 1 000 katte give sammenklumpning af pelsen på påføringsstedet eller fremtræde som en smule hvidt pulver.
English: What benefit has Stronghold shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Stronghold?
English: Stronghold is used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Danish: Stronghold anvendes til behandling og forebyggelse af angreb af parasitter, der lever på huden eller i pelsen hos katte og hunde, såsom lopper og mider, samt til behandling af orm, der lever inde i dyrets krop.
English: The effectiveness of Stronghold against the specified parasites was investigated in laboratory studies in cats and dogs.
Danish: Strongholds virkning mod de angivne parasitter var genstand for en laboratorieundersøgelse hos katte og hunde.
English: The package leaflet contains detailed information on dosage and duration of treatment.
Danish: Nærmere oplysninger om dosis og behandlingsvarighed fremgår af indlægssedlen.
English: Stronghold was also effective in the treatment of adult intestinal hookworms in cats, adult intestinal roundworms in cats and dogs, and biting lice in dogs and cats.
Danish: Stronghold var desuden effektivt til behandling af katte med voksne hageorm i tarmsystemet, voksne katte og hunde med rundorm i tarmsystemet og hunde og katte med pelslus.
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs,
Danish: Det kan desuden anvendes som led i behandlingen for loppeallergi (hudbetændelse) til forebyggelse af hjerteorm hos katte og hunde til behandling af katte og hunde med øremider til behandling af katte med voksne rundorm og voksne hageorm i tarmsystemet
English: It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Danish: Det dræber voksne lopper og deres larver og æg på dyret og i afkommet af drægtige eller diegivende katte og hunde.
English: How does Stronghold work?
Danish: Hvordan virker Stronghold?
English: There is no alternative available for this purpose in the EU at present.
Danish: Der findes i øjeblikket intet alternativ hertil i EU.
English: A Phase I and a Phase II environmental risk assessment were conducted.
Danish: Der blev udført en fase I- og en fase II-miljørisikovurdering.
English: Consequently, the benefit-risk balance is considered positive.
Danish: Derfor betragtes benefit/risk-forholdet som værende positivt.
English: This value is used for the calculation of the initial PECsurfacewater value.
Danish: Denne værdi bruges til beregning af den første PECoverfladevands-værdi.
English: The CVMP noted that measures are already in place to reduce runoff based on European and national legislation.
Danish: CVMP bemærkede, at der allerede er foranstaltninger på plads til at reducere afstrømning baseret på europæisk og national lovgivning.
English: Hungary Ceva-Phylaxia Zrt.
Danish: Ceva-Phylaxia Zrt.
English: Thus, the PECsoil, and hence PECsurfacewater, could be conservatively reduced by 85% and not only by 69%.
Danish: Derfor kunne PECjord og dermed PECoverfladevand konservativt reduceres med 85 % og ikke kun med 69 %.