FrancophonIA/ELRC3.0 huggingface dataset:
English: - Moxifloxacin solution for infusion is for intravenous administration only.
Danish: Moxifloxacin infusionsvæske er kun beregnet til intravenøs indgift.
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Danish: Udslæt Urticaria Tør hud hudreaktioner som StevensJohnsons syndrom eller toksisk epidermal nekrolyse (potentielt livstruende, se pkt.
English: In conclusion, the CHMP accepts that moxifloxacin may be indicated for the treatment of CAP, however the data it must be remembered that safety and benefitrisk were the main concerns triggering the referral and therefore, the conclusion that moxifloxacin has acceptable efficacy must be placed into context.
Danish: Uanset dataene skal man dog huske, at sikkerheden og risk/benefit-forholdet var de største betænkeligheder, der gav anledning til sagens indbringelse, og derfor skal den konklusion, at moxifloxacin har en acceptabel virkning, placeres i den rette sammenhæng.
English: Take special care with Avalox
Danish: Vær ekstra forsigtig med at tage Avelox
English: Dyspnea (including asthmatic conditions)
Danish: vejrtrækningsproblemer inklusive astmatiske tilstande
English: - The efficacy of Avalox in the treatment of severe burns, infections of deep tissue, major purulent ulcers (abscesses) and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Danish: - Effekten af Avelox kendes ikke ved alvorlige forbrændinger, infektioner dybt nede i vævet, meget materiefyldte sår (bylder) og ved fodinfektioner med knoglemarvsbetændelse hos sukkersygepatienter .
English: - There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose, with symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.
Danish: Der er en sjælden risiko for, at De vil få en alvorlig, pludselig allergisk reaktion (en anafylaktisk reaktion/shock) selv ved den første dosis.
English: The frequency of possible side effects listed below is defined using the following convention: Very common: affects more than 1 user in 10
Danish: Hyppigheden af de mulige bivirkningerne nedenfor er opgjort i henhold til følgende hyppighedstabel:
English: Belgium Bayer SA-NV Avenue Louise 143
Danish: Bayer SA-NV Avenue Louise 143 Louizalaan B-1050 Brussel Belgien
English: - the benefit-risk relationship for use of moxifloxacin to treat these infections was considered to be favourable only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections,
Danish: Moxifloxacin bør udelukkende anvendes, når det anses som uhensigtsmæssigt at anvende de antibakterielle midler, der almindeligvis anbefales til indledende behandling af disse infektioner.
English: Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
Danish: Avelox skal derfor anvendes med forsigtighed til patienter med CNS-lidelser, der kan disponere til kramper eller nedsætte krampetærsklen.
English: Unspecific abnormal heart rhythms, irregular heart beat (Torsade de Pointes),
Danish: uspecifik unormal hjerterytme, uregelmæssig hjerteslag (torsades de pointes), hjertestop (se afsnittet 2.
English: Increased gamma-glutamyl-transferase
Danish: Øget gammaglutamyltransferase
English: In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
Danish: I disse tilfælde bør moxifloxacin seponeres, og passende behandling iværksættes (f.eks. - Tilfælde af fulminant hepatitis, som potentielt kan føre til leversvigt (herunder dødsfald), er set ved brug af moxifloxacin (se pkt.
English: Bayer Hellas S.A.
Danish: Bayer Hellas S.A. Sorou 18-20
English: Germany Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen Germany
Danish: Tyskland Bayer Vital GmbH Kaiser Wilhelm Allee 51368 Leverkusen Tyskland
English: affects 1 to 10 users in 10,000
Danish: forekommer mellem 1 og 10 ud af 10.000 behandlede
English: Avalox is a clear, yellow solution for infusion.
Danish: Avelox-infusionsvæske, opløsning, er en klar, gullig opløsning til infusion.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides Avalox, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: Difficulty in swallowing, inflammation of the mouth, severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl.
Danish: besvær med at synke, betændelse i munden, alvorlig diaré med blod og/eller slim (antibiotikaassocieret tyktarmsbetændelse inklusive pseudomembranøs colitis), hvor der i meget sjældne tilfælde kan opstå livstruende komplikationer
English: affects 1 to 10 users in 100
Danish: forekommer hos mellem1 og 10 ud af 100 behandlede
English: The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:
Danish: behandlede patienter med eller uden efterfølgende oral behandling:
English: What Avalox is and what it is used for Before you use Avalox How to use Avalox Possible side effects How to store Avalox Further information
Danish: Det skal De vide, før De begynder at tage Avelox Sådan skal De tage Avelox Bivirkninger
English: - Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Danish: - Hvis De er ældre og har nyreproblemer, skal De sørge for at indtage tilstrækkelig væske, da væskemangel kan øge risikoen for nyresvigt.
English: Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14
Danish: ATC-kode: J01MA14
English: - Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Danish: - Overfølsomhed over for moxifloxacin, andre quinoloner eller over for et eller flere af hjælpestofferne - Graviditet og amning (se pkt.
English: Avalox and associated names (see Annex I) 400mg/250ml solution for infusion
Danish: Avelox og tilhørende navne (se bilag I) 400 mg/250 ml infusionsvæske, opløsning
English: Unspecified arrhythmias Torsade de Pointes (see section 4.4) Cardiac arrest (see section 4.4)
Danish: Uspecifikke arytmier Torsade de pointes (se pkt.
English: gait disturbances, esp. due to dizziness or vertigo)
Danish: gangforstyrrelser, især pga. svimmelhed eller Krampeanfald inkl.
English: Avalox should not be co-infused with other drugs.
Danish: Avelox-infusionsvæske, opløsning, må ikke infunderes sammen med andre lægemidler.
English: - If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure - Avalox may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids.
Danish: - Avelox kan lejlighedsvis give smerter eller betændelse i Deres sener, især hvis De er ældre eller hvis De for tiden er i behandling med kortikosteroider.
English: Uncommon: Feeling unwell (predominantly weakness or tiredness), aches and pains such as back,
Danish: følelse af ubehag (overvejende svaghed og træthed), ømhed og smerte i ryg, bryst, bækken, arme og ben, svedtendens
English: increase in BUN and creatinine), renal failure (see section 4.4)
Danish: stigning i blod-ureanitrogen og creatinin, nyresvigt (se pkt.
English: Your doctor will decide on the duration of your treatment with Avalox.
Danish: Lægen vil afgøre behandlingensvarigheden med Avelox-infusionsvæske.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane
English: Uncommon: Itching, rash, skin hives, dry skin Very rare:
Danish: kløe, udslæt, kløende hududslæt, tør hud
English: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Danish: Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Tyskland
English: HOW TO USE AVALOX
Danish: SÅDAN SKAL DE TAGE AVELOX
English: Uncommon: Anxiety, restlessness/agitation Rare:
Danish: angst, rastløshed/uro
English: Denmark Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen Germany
Danish: Danmark Bayer HealthCare AG Kaiser Wilhelm Allee 51368 Leverkusen
English: stopping of heart beat (see section 2.
Danish: Hjertestop (se pkt.
English: Colourless glass bottles (type 2) with a chlorobutyl rubber stopper as closure.
Danish: Farveløse glasflasker (type 2) med chlorbutylgummiprop.250 ml flasken fås i pakker med 1 og 5 flasker.
English: Ventricular tachyarrhythmias, hypotension, oedema, antibiotic associated colitis (incl.
Danish: Ventrikulære takyarytmier, hypotension, ødemer, antibiotikarelateret colitis (inklusive pseudomembranøs colitis, i meget sjældne tilfælde forbundet med livstruende komplikationer, se pkt.
English: Cardiac and vascular disorders
Danish: led- og muskelsmerter
English: Pain or inflammation at injection site Uncommon: Inflammation of a vein
Danish: smerter og infektion på injektionsstedet
English: Prothrombin level increased / INR decreased
Danish: Forhøjet protrombinniv eau/
English: Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Danish: Lægemidler, som hæmmer peristaltikken, er kontraindiceret hos patienter, Ældre patienter med nyresygdom bør anvende moxifloxacin med forsigtighed, hvis de ikke der udvikler svær diaré.
English: the CHMP has recommended the amendment of the Summary of Product Characteristics and the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Avalox and associated names (see Annex I).
Danish: - Risk/benefit-forholdet for brugen af moxifloxacin til behandling af disse infektioner blev udelukkende betragtet som gunstigt, når det anses for uhensigtsmæssigt at anvende de antibakterielle midler, der almindeligvis anbefales til indledende behandling af disse infektioner anbefaler CHMP ændring af produktresuméet og udstedelse af markedsføringstilladelser for Avalox og tilhørende navne (se bilag I).
English: If you receive more Avalox than you should If you are concerned that you may have been received too much Avalox, contact your doctor immediately.
Danish: Hvis De har taget for meget Avelox Kontakt straks lægen, hvis De de tror, De har fået for meget Avelox.
English: Avelox 400 mg/250 ml oplossing voor infusie
Danish: 400mg/250ml oplossing voor infusie
English: BEFORE YOU USE AVALOX
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE AVELOX
English: Uncommon: Dehydration Rare:
Danish: Generelle bivirkninger Ikke almindelige:
English: Fulminant inflammation of the liver potentially leading to life-threatening liver failure (incl.
Danish: Hurtigt udviklende leverbetændelse, som måske kan føre til livstruende leversvigt (herunder tilfælde af dødsfald)
English: EMA/39462/2012 EMEA/V/C/002473
Danish: EMA/39462/2012 EMEA/H/C/002473
English: This will help to protect them against the disease.
Danish: Dette vil hjælpe med at beskytte dem mod sygdommen.
English: Local reactions at the injection site are common and normally resolve within 4 weeks.
Danish: Lokale reaktioner på injektionsstedet er almindelige og forsvinder normalt i løbet af 4 uger.
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Danish: Lokale reaktioner kan forstærkes en smule efter den anden dosis, og disse kan vare op til 15 dage.
English: Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination.
Danish: Der kan forekomme en forbigående stigning i kvægets kropstemperatur på højst 2,7 0C inden for 48 timer efter vaccinationen.
English: Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection.
Danish: I en anden laboratorieundersøgelse hos kvæg blev der fokuseret på, hvor længe vaccinen var i stand til at beskytte mod bluetongue-infektionen.
English: Zulvac 1+8 Bovis was initially authorised under ‘exceptional circumstances'.
Danish: Zulvac 1+8 Bovis blev oprindeligt godkendt under "særlige omstændigheder".
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zulvac 1+8 Bovis on 08/03/2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zulvac 1+8 Bovis den 8. marts 2012.
English: The withdrawal period for Zulvac 1 + 8 Bovis for meat and milk is zero days.
Danish: Tilbageholdelsestiden for Zulvac 1 + 8 Bovis for kød og mælk er nul dage.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Zulvac 1+8 Bovis.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om Zulvac 1+8 Bovis.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in cattle from three months of age.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) hos kalve, når de er tre måneder gamle.
English: Zulvac 1+8 Bovis was studied in calves in four main studies carried out in a laboratory.
Danish: Zulvac 1+8 Bovis blev undersøgt hos kalve i fire hovedundersøgelser udført i et laboratorium.
English: The studies looked at the strength of vaccine required to protect against bluetongue infection, and at the safety of the vaccine.
Danish: Undersøgelserne fokuserede på den nødvendige vaccinestyrke til at beskytte mod bluetongue-infektion samt på vaccinens sikkerhed.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status.
Danish: I 2013 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne ændre godkendelsen af Zulvac 1+8 Bovis til en normal godkendelse.
English: A field study was also conducted investigating the safety of the vaccine in dairy cows, including pregnant and lactating cows.
Danish: Der blev også gennemført en feltundersøgelse, hvor der blev set på vaccinens sikkerhed hos malkekøer, herunder drægtige og lakterende køer.
English: The studies showed that the vaccine is safe and that it prevents viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age.
Danish: Undersøgelserne viste, at vaccinen er sikker, og at den forebygger viræmi forårsaget af bluetonguevirus, serotype 1 og 8, hos kvæg fra tremåneders alderen.
English: The CVMP concluded that the benefits of Zulvac 1+8 Bovis exceed the risks for prevention of viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age and recommended that Zulvac 1+8 Bovis be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Zulvac 1+8 Bovis er større end risiciene ved forebyggelse af viræmi forårsaget af bluetongue-virus, serotype 1 og 8 hos kalve, når de er tre måneder gamle, og anbefalede udstedelse af markedsføringstilladelse for Zulvac 1+8 Bovis.
English: immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når kvæget vaccineres, opfatter immunsystemet viraene som "fremmede" og producerer antistoffer mod dem.
English: Zulvac 1+8 Bovis is a vaccine.
Danish: Zulvac 1+8 Bovis er en vaccine.
English: Zulvac 1+8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: Zulvac 1+8 Bovis indeholder bluetongue-vira, som er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: Zulvac 1+8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: Zulvac 1 + 8 Bovis anvendes til kvæg som beskyttelse mod sygdommen bluetongue, en infektion forårsaget af bluetongue-virus, der overføres gennem mitter.
English: Zulvac 1+8 Bovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Danish: Zulvac 1+8 Bovis er en vaccine, der indeholder inaktiveret (dræbt) bluetongue-virus, serotype 1 og 8, som aktivt stof.
English: The field study showed that the vaccine can be used safely in pregnant and lactating cows.
Danish: Feltundersøgelsen viste, at vaccinen er sikker, og at den kan anvendes hos drægtige og lakterende køer.
English: Other information about Zulvac 1+8 Bovis:
Danish: Andre oplysninger om Zulvac 1+8 Bovis:
English: What is the risk associated with Zulvac 1+8 Bovis?
Danish: Hvilken risiko er der forbundet med Zulvac 1+8 Bovis?
English: Why has Zulvac 1+8 Bovis been approved?
Danish: Hvorfor blev Zulvac 1+8 Bovis godkendt?
English: The virus exists in several forms (serotypes) throughout the world; the types used in Zulvac 1+8 Bovis are serotypes 1 and 8.
Danish: De typer, der anvendes i Zulvac 1 + 8 Bovis er serotype 1 og 8.
English: What is Zulvac 1+8 Bovis?
Danish: Hvad er Zulvac 1+8 Bovis?
English: How has Zulvac 1+8 Bovis been studied?
Danish: Hvordan blev Zulvac 1+8 Bovis undersøgt?
English: What is Zulvac 1+8 Bovis used for?
Danish: Hvad anvendes Zulvac 1+8 Bovis til?
English: How does Zulvac 1+8 Bovis work?
Danish: Hvordan virker Zulvac 1+8 Bovis?
English: What benefit has Zulvac 1+8 Bovis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zulvac 1+8 Bovis?
English: Further doses are given at the end of weeks 8 and 12.
Danish: Der gives yderligere doser i slutningen af uge 8 og 12.
English: Doses are calculated using the patient's weight.
Danish: Doserne beregnes ved hjælp af patientens vægt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nulojix on 17 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nulojix den 17. juni 2011.
English: Belatacept has been designed to attach to two of these molecules called CD80 and CD86.
Danish: Belatacept er udviklet til at binde sig til to af disse molekyler, der kaldes CD80 og CD86.
English: The studies also looked at the number of organ rejections that occurred within one year of the transplant.
Danish: I undersøgelserne så man også på antallet af organafstødninger, der fandt sted inden for et år efter transplantationen.
English: T cells must be ‘activated' before they work.
Danish: T-celler skal "aktiveres", før de virker.
English: The full EPAR for Nulojix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Nulojix findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance belatacept.
Danish: Det indeholder det aktive stof belatacept.
English: This is a summary of the European public assessment report (EPAR) for Nulojix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nulojix.
English: In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28.
Danish: I den indledende fase gives det som en dosis på 10 mg pr. kg. legemsvægt på dag 1 (den dag, hvor transplantationen finder sted, eller dagen før) og igen på dag 5, 14 og 28.
English: The main measures of effectiveness were the proportion of patients who survived with their transplanted kidneys intact and how well their kidneys functioned.
Danish: De primære effektmål var andelen af patienter, der overlevede med en intakt transplanteret nyre, og hvor godt deres nyrer fungerede.
English: This happens when certain molecules attach to receptors on the surface of the T cells.
Danish: Dette sker, når visse molekyler binder sig til receptorer på Tcellernes overflade.
English: After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.
Danish: Efter den indledende fase, som varer tre måneder, gives der en vedligeholdelsesdosis af Nulojix på 5 mg/kg hver fjerde uge fra slutningen af uge 16.
English: The most common serious side effects of Nulojix seen in more than 2% of patients are: urinary tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal cell carcinoma (a cancer), anaemia (low red blood cell counts), dehydration.
Danish: De mest almindelige bivirkninger med Nulojix, som optræder hos flere end 2 % af patienterne, er urinvejsinfektioner (infektion i de strukturer, der leder urinen), cytomegalovirusinfektion, pyreksi (feber), forhøjet blodkreatinin (markør for nyreproblemer), pyelonefritis (nyreinfektion), diarré, gastroenteritis (diarré og opkastning), dårlig funktion af den transplanterede nyre, leukopeni (lavt antal hvide blodlegemer), pneumoni (infektion i lungerne), basalcellekarcinom (en kræfttype), anæmi (lavt antal røde blodlegemer) og dehydrering.
English: A risk management plan has been developed to ensure that Nulojix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Nulojix anvendes så risikofrit som muligt.
English: For more information about treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nulojix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Nulojix, belatacept, is an immunosuppressive medicine.
Danish: Det aktive stof i Nulojix, belatacept, er immunsuppressivt lægemiddel.
English: Some patients were given intensive Nulojix treatment which involved a longer initial phase of six months.
Danish: Nogle patienter fik en intensiv Nulojix-behandling, som omfattede en længere indledende fase på seks måneder.
English: Other information about Nulojix
Danish: Andre oplysninger om Nulojix
English: This stops them activating the T cells, helping to prevent organ rejection.
Danish: Dette forhindrer dem i at aktivere T-cellerne, hvilket er med til at hindre organafstødning.
English: Nulojix is given as an infusion into a vein over 30 minutes.
Danish: Nulojix gives som en infusion i en vene i løbet af 30 minutter.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nulojix.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Nulojix skal anvendes.
English: What measures are being taken to ensure the safe and effective use of Nulojix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nulojix?
English: Although the studies showed more acute rejections after one year of treatment with Nulojix compared with cyclosporine A, this did not lead to reduced patient and organ survival after three years.
Danish: Selv om undersøgelserne viste flere akutte afstødninger efter ét års behandling med Nulojix end med cyclosporin A, førte dette ikke til reduceret patient- og organoverlevelse efter tre år.
English: Intensive Nulojix treatment with a longer initial phase of six months produced similar results to treatment with a three-month initial phase.
Danish: Intensiv Nulojix-behandling med en længere indledende fase på seks måneder gav samme resultater som behandling med en indledende fase på tre måneder.