FrancophonIA/ELRC3.0 huggingface dataset:
English: Instructions for subcutaneous insertion of Sixmo
Danish: Anvisninger i subkutan indsættelse af Sixmo
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant
Danish: LÆGEMIDLETS NAVN Sixmo 74,2 mg implantat
English: Figure 14
Danish: Figur 14
English: • adhesive bandage
Danish: • selvklæbende bandage
English: • reduced kidney function
Danish: • nedsat nyrefunktion
English: NOTE: Be sure to inject the local anaesthetic deep to the centre of the implants; this will effectively lift the implants toward the skin, facilitating removal of the implants.
Danish: BEMÆRK: Der sørges for, at lokalanæstetika injiceres dybt i midten af implantaterne.
English: LIST OF EXCIPIENTS Excipient: Ethylene vinyl acetate copolymer
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestof: Ethylenvinylacetat-copolymer
English: Retreatment with Sixmo implants
Danish: Genbehandling med Sixmo-implantater
English: • dizziness, drowsiness
Danish: • svimmelhed, døsighed
English: • adhesive bandages
Danish: • selvklæbende bandager
English: • dry mouth, wind, indigestion, bloody stool
Danish: • mundtørhed, luftafgang, fordøjelsesbesvær, blodig afføring
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert implantat indeholder buprenorphinhydrochlorid, svarende til 74,2 mg buprenorphin.
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of Sixmo implants.
Danish: Sublingualt buprenorphin bør seponeres 12 til 24 timer før den subkutane indsættelse af Sixmoimplantater.
English: • have had an increased formation of scare tissue
Danish: • har haft en øget ardannelse
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants.
Danish: Sublingualt buprenorphin bør seponeres 12 til 24 timer, før Sixmo-implantaterne indsættes.
English: • abnormal function of the bile duct
Danish: • unormal funktion af galdevejene
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Sachet
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Brev
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine)
Danish: LÆGEMIDLETS NAVN Sixmo 74,2 mg implantat (buprenorphin)
English: • fainting
Danish: • amning
English: • muscle spasms, limb discomfort
Danish: • muskelspasmer, utilpashed i lemmer
English: Frequency Adverse reactions Infections and infestations common viral infection, bronchitis**, infection**, influenza**, pharyngitis**, rhinitis** uncommon cellulitis, skin infection, peritonsillar abscess, rash pustular, urinary tract infection, vulvovaginal mycotic infection, implant site infection*, implant site abscess*
Danish: Infektioner og parasitære sygdomme almindelig virusinfektion, bronkitis**, infektion**, influenza**, faryngitis**, rhinitis** ikke almindelig cellulitis, hudinfektion, peritonsillær byld, pustuløst udslæt, urinvejsinfektion, vulvovaginal mykotisk infektion, infektion på implantatstedet*, byld på implantatstedet* Blod og lymfesystem ikke almindelig lymfadenopati, neutropeni Metabolisme og ernæring almindelig nedsat appetit ikke almindelig unormal vægtøgning, dehydrering, øget appetit
English: • mosquito forceps
Danish: • moskito-tang
English: Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Danish: Hvert implantat indeholder buprenorphinhydrochlorid svarende til 74,2 mg buprenorphin.
English: IMPORTANT INFORMATION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Danish: VIGTIGE OPLYSNINGER Hvert implantat indeholder buprenorphinhydrochlorid svarende til 74,2 mg buprenorphin.
English: CI of mean
Danish: CI af gennemsnit
English: • sterile ruler
Danish: • steril lineal
English: • breathing depression, yawning
Danish: • undertrykkelse af vejrtrækningen, gaben
English: What Sixmo is and what it is used for What you need to know before you use Sixmo How to use Sixmo
Danish: Det skal du vide, før du begynder at bruge Sixmo Sådan skal du bruge Sixmo Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant buprenorphine
Danish: LÆGEMIDLETS NAVN Sixmo 74,2 mg implantat buprenorphin
English: • cough, breathlessness
Danish: • hoste, åndenød
English: Musculoskeletal and connective disorders common bone pain**, myalgia** uncommon muscle spasms, limb discomfort, musculoskeletal pain, neck pain, pain in extremity, temporomandibular joint syndrome, arthralgia*** Renal and urinary disorders uncommon urinary hesitation, micturition urgency, pollakisuria
Danish: Knogler, led, muskler og bindevæv almindelig knoglesmerter**, myalgi** ikke almindelig muskelspasmer, utilpashed i lemmer, muskuloskeletale smerter, nakkesmerter, smerter i ekstremiteter, temporomandibulært ledsyndrom, artralgi***
English: Using the surgical marker, mark the location of the implants and the location of the incision.
Danish: Placeringen af implantaterne og indsnitstedet markeres med den kirurgiske tusch.
English: • pregnancy
Danish: • graviditet
English: • changes in blood levels increased enzyme levels: aspartate aminotransferase, gamma-glutamyltransferase, blood lactate dehydrogenase, lipase, amylase decreased enzyme levels: alkaline phosphatase increased bicarbonate level increased bilirubin level - a yellow breakdown substance of the blood pigment increased glucose level decreased cholesterol level decreased haematocrit - the percentage of blood cells on the blood volume decreased haemoglobin - the red blood cell pigment, increased mean cell haemoglobin increase in certain white blood cell count: monocyte, neutrophils decreased cell count: platelets, red blood cells, lymphocytes
Danish: - nedsat hæmaglobin - pigmentet i de røde blodlegemer, forhøjet gennemsnitligt hæmaglobin i cellerne forhøjet antal af visse hvide blodlegemer: monocytter, neutrofiler nedsat antal blodplader, røde blodlegemer, lymfocytter
English: Rare but serious complications, including nerve damage and migration resulting in embolism and death, may result from improper insertion of drug implants in the upper arm. Additional complications may include local migration, protrusion, expulsion and implant breakage after insertion or during removal.
Danish: Yderligere komplikationer kan omfatte lokal migration, fremspringning, udstødning og knækning af implantatet efter indsættelse eller når det fjernes.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert implantat indeholder buprenorphinhydrochlorid svarende til 74,2 mg buprenorphin.
English: • liquid adhesive
Danish: • flydende klæbemiddel
English: Respiratory, thoracic and mediastinal disorders common cough**, dyspnoea** uncommon respiratory depression, yawning Gastrointestinal disorders common constipation, nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal disorder**, tooth disorder** uncommon dry mouth, dyspepsia, flatulence, haematochezia
Danish: Mave-tarm-kanalen almindelig forstoppelse, kvalme, opkastning, diarré, abdominalsmerter, mave-tarmsygdom**, tandsygdom** ikke almindelig mundtørhed, dyspepsi, flatulens, hæmatokezi Hud og subkutane væv almindelig hyperhidrose ikke almindelig koldsved, tør hud, udslæt, hudlæsion, ekkymose*
English: • alcohol pad
Danish: • spritserviet
English: Medicinal product subject to special and restricted medical prescription.
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept.
English: • hot flush, bruising, dilation of blood vessels
Danish: • hedetur, blå mærker, udvidede blodkar
English: General disorders and administration site conditions common fatigue, chills, asthenia, pain, implant site haematoma*, implant site pain*, implant site pruritus*, implant site haemorrhage*, implant site erythema*, implant site scar*, chest pain**, malaise***, drug withdrawal syndrome*** uncommon oedema peripheral, discomfort, face oedema, feeling cold, pyrexia, swelling, implant site oedema*, implant site reaction*, device expulsion*, impaired healing*, implant site
Danish: Almene symptomer og reaktioner på administrationsstedet almindelig træthed, kulderystelser, asteni, smerter, hæmatom på implantatstedet*, smerter på implantatstedet*, pruritus på implantatstedet*, blødning på implantatstedet*, erytem på implantatstedet*, ar på implantatstedet*, brystsmerter**, utilpashed***, lægemiddelabstinenssyndrom***
English: • increased sweating, feeling unwell
Danish: • øget svedtendens, utilpashed
English: Blood and lymphatic system disorders uncommon lymphadenopathy, neutropenia
Danish: lactatdehydrogenase i blodet, lipase, amylase
English: • underactive thyroid
Danish: • underaktiv skjoldbruskkirtel
English: • sterile fenestrated drape
Danish: • sterile klæder med hul
English: What is the withdrawal period?
Danish: Hvor lang er tilbageholdelsestiden?
English: This will help to protect them against the disease.
Danish: Dette vil bidrage til at beskytte mod sygdommen.
English: This summary was last updated on 03/09/2012.
Danish: Dette sammendrag blev sidst ajourført den 3. september 2012.
English: Every year, the European Medicines Agency reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur supplerende oplysninger i henhold til en aftalt tidsplan vedrørende kvaliteten, sikkerheden og effektiviteten af vaccinen.
English: The vaccine is given to animals as an injection under the skin.
Danish: Vaccinen gives til dyret som en injektion under huden.
English: After vaccination, there can be a small swelling at the injection site lasting up to two weeks.
Danish: Efter vaccination kan der være en mindre hævelse på injektionsstedet, som varer i op til to uger.
English: Both sheep and cattle will need a second injection three to four weeks later.
Danish: Både får og kvæg skal have en yderligere injektion tre til fire uger senere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BTVPUR AlSap 8 on 17 March 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BTVPUR AlSap 8 den 17. marts 2009.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: The duration of protection was also investigated in studies using sheep and cattle and was found to be 12 months for both species.
Danish: Varigheden af beskyttelsen blev også undersøgt i undersøgelser med får og kvæg og viste sig at være på 12 måneder for begge arter.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Danish: Vaccinen indeholder desuden "adjuvanser" (aluminiumhydroxid og saponin), der forstærker immunresponset.
English: Animals may show a temporary increase in body temperature, usually of no more than 1°C, in the 24 hours after vaccination.
Danish: Dyrene kan også udvise forbigående temperaturforhøjelse, der normalt ikke overstiger et gennemsnit på 1 ºC, og som kan forekomme inden for 24 timer efter vaccination.
English: The first injection is given at one month of age in animals that have never been exposed to the disease, and at two-and-a-half months if the animal's mother is already immune to the disease.
Danish: Den første injektion gives, når dyret er en måned gammelt, hvis det aldrig har været udsat for sygdommen, og når det er to en halv måned gammelt, hvis dyrets mor allerede er immun over for sygdommen.
English: The studies also demonstrated that the vaccine can be used in pregnant sheep and cows.
Danish: Undersøgelserne viste også, at vaccinen kan anvendes på drægtige får og køer.
English: In the future, if the animals are exposed to the bluetongue virus their immune systems will be able to produce antibodies more quickly.
Danish: Hvis dyrene udsættes for bluetonguevirus, vil deres immunsystem fremover kunne producere antistoffer hurtigere.
English: The CVMP considered that the benefits of BTVPUR AlSap 8 are greater than the risks and recommended that it be given a marketing authorisation.
Danish: CVMP besluttede, at fordelene ved BTVPUR AlSap 8 er større end risiciene og anbefalede udstedelse af en markedsføringstilladelse.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved, at de "lærer" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdommen.
English: BTVPUR AlSap 8 was initially authorised under ‘exceptional circumstances'.
Danish: BTVPUR AlSap 8 blev oprindelig godkendt under "særlige omstændigheder".
English: This means that it was not possible to obtain complete information about BTVPUR AlSap 8 at the time of the initial authorisation.
Danish: Det betyder, at det ikke var muligt at indhente fyldestgørende oplysninger om BTVPUR AlSap 8 på tidspunktet for den oprindelige godkendelse.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Lægemidler til Dyr (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine was initially intended for use in an emergency situation.
Danish: Resultaterne af en række sikkerhedsundersøgelser i laboratorium gennemført med vacciner med en tilsvarende sammensætning, men med forskellige bluetongueserotyper, blev også fremlagt, så sikkerhedskonklusionerne kunne ekstrapoleres, da vaccinen oprindelig var beregnet til brug i en nødsituation.
English: When it is given to sheep and cattle, the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når vaccinen indgives til får og kvæg, registrerer dyrenes immunsystem virussene som "fremmede" og reagerer ved at danne antistoffer imod dem.
English: No withdrawal period for meat and milk with BTVPUR AlSap 8 is necessary (zero days withdrawal period).
Danish: Der gælder ingen tilbageholdelsestid for kød og mælk i forbindelse med BTVPUR AlSap 8 (tilbageholdelsestiden er nul dage).
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 8 to convert to normal.
Danish: I 2012 besluttede CVMP, at de indsendte oplysninger var tilstrækkelige til, at godkendelsen for BTVPUR AlSap 8 kunne ændres til en normal godkendelse.
English: Another laboratory study looked at the use of the vaccine in sheep aged three to four months.
Danish: I en anden laboratorieundersøgelse blev brugen af vaccinen på får i alderen tre til fire måneder undersøgt.
English: The effects of maternally derived antibodies were investigated and the vaccine was shown to be effective in animals from 2.5 months of age.
Danish: Virkningen af antistoffer erhvervet fra moderen blev undersøgt, og vaccinen viste sig at være effektiv hos dyr fra en alder af to en halv måned.
English: BTVPUR AlSap 8 contains bluetongue virus of one type (‘serotype 8').
Danish: BTVPUR AlSap 8 indeholder bluetonguevirus af én type ("serotype 8").
English: The safety of the vaccine was studied in a number of laboratory safety studies carried out with BTVPUR AlSap in sheep and cattle using a high dose of the vaccine in animals of the minimum age.
Danish: Vaccinens sikkerhed blev undersøgt i en række sikkerhedsundersøgelser i laboratorium gennemført med BTVPUR AlSap 8 på får og kvæg, hvor dyr i minimumsalderen fik en høj dosis af vaccinen.
English: The studies showed that the vaccine is safe for sheep and cattle and that it prevents viraemia and reduces the signs of the disease in animals from one month of age that are infected with bluetongue virus serotype 8.
Danish: Undersøgelserne viste, at vaccinen er sikker for får og kvæg, og at den forebygger viræmi og nedbringer symptomerne på sygdommen hos dyr fra enmånedsalderen, som inficeres med bluetonguevirus serotype 8.
English: Inactivated vaccine against bluetongue disease virus, serotype 8
Danish: Inaktiveret vaccine mod bluetonguevirus serotype 8
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease caused by bluetongue virus serotype 8.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) og lindre symptomer forårsaget af bluetonguevirus serotype 8.
English: BTVPUR AlSap 8 is a vaccine.
Danish: BTVPUR AlSap 8 er en vaccine.
English: BTVPUR AlSap 8 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: BTVPUR AlSap 8 anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetonguevirus, som overføres gennem mitter.
English: The efficacy of the vaccine in cattle was studied in a laboratory study using the vaccine in cattle from one month of age.
Danish: Vaccinens effektivitet hos kvæg blev undersøgt i en laboratorieundersøgelse, hvor vaccinen blev brugt på kvæg i alderen 1 måned og opefter.
English: It contains inactivated (killed) bluetongue serotype 8 virus.
Danish: Det indeholder inaktiveret (dræbt) bluetonguevirus serotype 8.
English: BTVPUR AlSap 8 contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: BTVPUR AlSap 8 indeholder bluetonguevirus, som er blevet inaktiveret, så det ikke kan fremkalde sygdom.
English: Other information about BTVPUR AlSap 8:
Danish: Andre oplysninger om BTVPUR AlSap 8:
English: BTVPUR AlSap 8 is a vaccinethat is available as a suspension for injection.
Danish: BTVPUR AlSap 8 er en vaccine, der leveres som en injektionsvæske, suspension.
English: What is the risk associated with BTVPUR AlSap 8?
Danish: Hvilken risiko er der forbundet med BTVPUR AlSap 8?
English: Why has BTVPUR AlSap 8 been approved?
Danish: Hvorfor blev BTVPUR AlSap 8 godkendt?
English: What is BTVPUR AlSap 8?
Danish: Hvad er BTVPUR AlSap 8?
English: How has BTVPUR AlSap 8 been studied?
Danish: Hvordan blev BTVPUR AlSap 8 undersøgt?
English: What is BTVPUR AlSap 8 used for?
Danish: Hvad anvendes BTVPUR AlSap 8 til?
English: What benefit has BTVPUR AlSap 8 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved BTVPUR AlSap 8?
English: How does BTVPUR AlSap 8 work?
Danish: Hvordan virker BTVPUR AlSap 8?
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Leflunomide ratiopharm with a physician educational pack containing the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen (MAH) vil forsyne alle læger, som forventes at ordinere/anvende Leflunomide ratiopharm, med en undervisningspakke for læger indeholdende følgende:
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Danish: Læger og patienter skal gøres opmærksomme på, at der findes en ad hoc-informationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Danish: Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure i situationer med forhøjet ALAT.
English: These measures will help to protect the environment.
Danish: Disse forholdsregler hjælper med til at beskytte miljøet.
English: (this may also occur on the arms, face or body)*
Danish: (dette kan også forekomme på armene, ansigtet eller kroppen)*
English: However, the distribution of OS was not significantly different between the 2 groups.
Danish: Dog var fordelingen af SO ikke signifikant forskellig i de to grupper.
English: Each carton contains:
Danish: Hver karton indeholder:
English: Tumour size ≤2 cm >2 cm
Danish: Tumour størrelse ≤2 cm >2 cm
English: Median duration of follow-up was 77 months.
Danish: Den mediane varighed af follow-up perioden var 77 måneder.
English: Very rare: one case of alopecia non-reversible at the end of the study.
Danish: Meget sjælden: et enkelt tilfælde af ikke-reversibel alopeci ved slutningen af studiet.
English: An appropriate aseptic technique should be used for all steps.
Danish: Der skal anvendes en passende aseptisk teknik til alle trin.
English: • fever*: tell your doctor or nurse immediately
Danish: • feber*: fortæl det straks til din læge eller sygeplejerske
English: An interim analysis was performed with a median follow up of 55 months.
Danish: En interim-analyse blev udført med et median-opfølgning ved 55 måneder.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 6 (dated January 2010) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: MAH skal sikre, at pharmacovigilancesystemet, som beskrevet i version 6 (Januar 2010) præsenteret i modul 1.8.1 i ansøgningen om markedsføringstilladelsen, er på plads og i funktion, inden og imens præparatet er på markedet.
English: • change or absence of menstrual period*
Danish: • ændring i eller fravær af menstruation*
English: An effective method of contraception should be used during treatment.
Danish: Der bør anvendes en effektiv metode til prævention under behandlingen.
English: Shake well for complete solubilisation of powder (the powder will be dissolved in less than 90 seconds).
Danish: Ryst grundigt, så pulveret opløses fuldstændigt (pulveret vil blive opløst på under 90 sekunder).
English: • allergic reactions (see above)
Danish: • allergiske reaktioner (se ovenstående)
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket, hvordan du bortskaffer medicin der ikke længere er nødvendig.
English: However, given that it can cause dizziness, tiredness and fainting, you should not drive or use machines if you experience any of these side effects.
Danish: Da det imidlertid kan forårsage svimmelhed, træthed og besvimelse, bør du ikke køre bil eller betjene maskiner, hvis du får én af disse bivirkninger.
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale
English: total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Danish: 1006 patienter med KPS ≥ 60 blev randomiseret i følgende behandlingsgrupper:
English: If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Danish: Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m2 bør behandlingen stoppes.
English: • OTHER CONDITIONS
Danish: ANDRE BETINGELSER
English: Ask your doctor for advice before being given any medicine.
Danish: Spørg din læge til råds, før du begynder at få medicin.
English: The reconstituted solution should be used immediately after preparation.
Danish: Den rekonstituerede opløsning bør bruges straks efter tilberedning.
English: Risk Management plan
Danish: Risikostyringsprogram
English: Elderly patients treated with TCF should be closely monitored.
Danish: Ældre patienter, som behandles med TCF, bør monitoreres nøje.
English: • infections, including pneumonia and blood poisoning
Danish: • infektioner, herunder lungebetændelse og blodforgiftning