FrancophonIA/ELRC3.0 huggingface dataset:
English: In the overall SJIA programme, transient decreases in absolute neutrophil count (ANC) to less than 1 x 109/l were reported in 12 patients (6.0%).
Danish: I det samlede SJIA-program blev forbigående fald i absolut neutrofiltal (ANC) til <1 x 10
English: Never re-use the leftover solution.
Danish: Genbrug aldrig rester af injektionsvæsken.
English: Clean the rubber stopper of the vial with an alcohol swab.
Danish: Rens hætteglassets gummiprop med en spritserviet.
English: Vulvovaginal candidiasis Nervous system disorders Common
Danish: Proteinuri Leukopeni Almindelig Neutropeni Ikke almindelig Nedsat trombocyttal
English: Posology
Danish: Leukopeni
English: - Keep this medicine out of the sight and reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: The other ingredients are: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate
Danish: - Øvrige indholdsstoffer: saccharose, histidin, histidinhydrochloridmonohydrat, polysorbat 80.
English: - Take off the cap from the withdrawal needle.
Danish: - Tag hætten af udtrækningskanylen.
English: Insert the transfer needle through the centre of the stopper of the vial of Ilaris powder, taking care not to touch the needle or the stopper.
Danish: Indfør overførselskanylen gennem midten af proppen i hætteglasset med Ilaris-pulver.
English: Ear infection
Danish: Selve indsprøjtningen
English: How to use Ilaris
Danish: Sådan skal du tage Ilaris
English: If you use more Ilaris than you should
Danish: Hvis du har taget for meget Ilaris
English: Common
Danish: Meget almindelig
English: However, all other concerns remain.
Danish: Alle de øvrige betænkeligheder tilbagestår imidlertid.
English: The applicant requested a reexamination of the opinion.
Danish: Ansøgeren anmodede om fornyet overvejelse af udtalelsen.
English: London, 20 March 2007 Doc.
Danish: London, den 20. marts 2007 Ref.dok.
English: International non-proprietary name (INN): efungumab
Danish: Internationalt fællesnavn (INN): efungumab
English: Ref. EMEA/129723/2007
Danish: EMEA/129723/2007
English: The company that applied for authorisation is NeuTec Pharma plc.
Danish: Det firma, der har indgivet ansøgningen, er NeuTec Pharma plc.
English: Invasive candidiasis is a life-threatening disease.
Danish: Invasiv candidiasis er en livstruende sygdom.
English: The main study of the medicine's effects involved 139 adults with invasive candidiasis.
Danish: Hovedundersøgelsen af lægemidlets virkning omfattede 139 voksne patienter med invasiv candidiasis.
English: The effects of Mycograb were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Mycograb blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It also had concerns about the safety of Mycograb.
Danish: I udvalget var der desuden betænkelighed ved sikkerheden af Mycograb.
English: What is Mycograb?
Danish: Hvad er Mycograb?
English: This weakens the cell wall, making the fungal cells fragile and unable to grow.
Danish: Derved svækkes cellevæggen, så svampecellerne bliver skrøbelige og ude af stand til at vokse.
English: Too few patients have received Mycograb for its safety to be sufficiently assessed.
Danish: Der var for få patienter, der havde fået Mycograb, til at sikkerheden kunne bedømmes tilstrækkeligt.
English: This protein is involved in the formation and the repair of the cell wall and is essential for the survival of the fungal cells.
Danish: Proteinet medvirker ved dannelse og reparation af cellevæggen og er nødvendigt for svampecellernes overlevelse.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYCOGRAB
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for MYCOGRAB
English: At this point in time, the committee was of the opinion that the benefits of Mycograb in the treatment of invasive candidiasis did not outweigh its risks.
Danish: På dette tidspunkt var det udvalgets opfattelse, at fordelene ved Mycograb til behandling af invasiv candidiasis ikke opvejer risiciene.
English: The powder needs to be dissolved in sterile water before being injected into a vein.
Danish: Pulveret opløses i sterilt vand, før det indsprøjtes i en vene.
English: It has been designed to attach to a specific protein on the surface of the fungal cells, called Heat Shock Protein 90 (hsp90).
Danish: Det er udformet, så det bindes til et bestemt protein på svampecellernes overflade, "Heat Shock Protein 90" (hsp90).
English: By attaching to hsp90, efungumab blocks the protein's normal activities.
Danish: Ved at bindes til hsp90 blokerer efungumab dette proteins normale funktioner.
English: What was Mycograb expected to be used for?
Danish: Hvad forventedes Mycograb anvendt til?
English: In invasive candidiasis, the fungal infection spreads to the internal organs such as the liver, spleen and kidneys via the bloodstream.
Danish: Ved invasiv candidiasis har svampeinfektionen gennem blodet bredt sig til indre organer som f.eks. lever, milt og nyrer.
English: Mycograb is a white powder that contains the active substance efungumab.
Danish: Mycograb er et hvidt pulver, der indeholder det aktive stof efungumab.
English: Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Danish: Da invasive svampeinfektioner er sjældne, blev Mycograb udpeget som "lægemiddel til sjældne sygdomme" den 5. december 2001.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgningen om markedsføringstilladelse?
English: On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Danish: Den 16. november 2006 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori det anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Mycograb, pulver til injektionsvæske, opløsning, 2 mg/ml, til behandling af invasiv candidiasis hos voksne i kombination med amphotericin B eller en lipidformulering af amphotericin B.
English: The effectiveness was measured by looking at the percentage of patients responding to treatment, based on improvement of their symptoms (including fever) and elimination of the fungus from samples, as measured on day 10 (5 days after the end of Mycograb or placebo treatment).
Danish: Virkningen blev bedømt på, hvor stor en procentdel af patienterne, der reagerede på behandlingen, baseret på bedring i symptomerne (herunder feber) og elimination af svampen fra prøverne, målt på dag 10 (dvs. 5 dage efter ophør af behandlingen med Mycograb eller placebo).
English: After having considered the grounds for this request, the CHMP reexamined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 20. marts 2007 afslaget på ansøgningen om markedsføringstilladelse.
English: In March 2007, following the re-examination, the CHMP removed their concern regarding the cytokine release syndrome and hypertension, as these would be manageable in clinical practice.
Danish: Efter fornyet overvejelse i marts 2007 ophævede CHMP sine forbehold vedrørende cytokinfrigivelsessyndrom og blodtryksforhøjelse, da disse kan håndteres ved behandlingen.
English: How is Mycograb expected to work?
Danish: Hvordan forventes Mycograb at virke?
English: This disease is caused by infection with a common fungus (yeast) called Candida.
Danish: Denne sygdom forårsages af en almindelig gærsvamp, der kaldes Candida.
English: Mycograb was to be used together with amphotericin B (another antifungal medicine) to treat adult patients with invasive candidiasis.
Danish: Mycograb forventedes anvendt sammen med amphotericin B (et andet svampemiddel) til behandling af invasiv candidiasis hos voksne patienter.
English: The company informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Mycograb.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Mycograb.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mycograb?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Mycograb eller i programmer for anvendelse med særlig udleveringstilladelse?
English: This means that it is made by a bacterium that has received a gene (DNA), which makes it able to produce the substance.
Danish: Efungumab fremstilles ved "rekombinant DNA-teknik": Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
English: Hence, the CHMP recommended that Mycograb be refused marketing authorisation.
Danish: CHMP anbefalede derfor afslag på ansøgningen om markedsføringstilladelse for Mycograb.
English: The study compared the effects of Mycograb to those of a placebo (a dummy treatment), when they were given with amphotericin B for 5 days.
Danish: I undersøgelsen blev virkningen af Mycograb sammenlignet med placebo (uvirksom behandling) ved indgivelse sammen med amphotericin B i 5 dage.
English: The active substance in Mycograb, efungumab, is an antifungal agent.
Danish: Det aktive stof i Mycograb, efungumab, er et svampemiddel.
English: The medicine is associated with ‘cytokine release syndrome', a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Danish: Der er sammenhæng mellem brug af Mycograb og forekomst af "cytokinfrigivelsessyndrom", en tilstand med kvalme, opkastning, smerter og for højt blodtryk.
English: In November 2006, the CHMP was concerned about some aspects of the quality of the medicine (such as the way the molecules of efungumab may fold or aggregate in the solution for injection and the level of some substances that could stimulate an immune response in patients).
Danish: Betænkelighederne vedrørte således den måde, hvorpå molekyler af efungumab kan folde sig eller bindes til hinanden i injektionsvæsken, og indholdet af visse stoffer, der kan tænkes at fremprovokere en immunreaktion hos patienterne.
English: The results did not support the second method.
Danish: Resultaterne understøttede ikke den anden metode.
English: Date of first authorisation: 8 June 2004 Date of latest renewal: 30 April 2009
Danish: Dato for første tilladelse: 8. juni 2004 Dato for seneste fornyelse: 30. april 2009
English: See section 6.6 for more detailed instructions.
Danish: 6.6 for mere detaljerede instruktioner.
English: • Risk management plan(RMP)
Danish: • Risikostyringsplan (RMP)
English: The active components are made from human blood.
Danish: De aktive komponenter fremstilles fra humant blod.
English: Therefore the studies were performed as open-label studies.
Danish: Studierne blev derfor udført som åbne studier.
English: • Periodic safety update reports(PSURs)
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: In addition, an updated RMP should be submitted
Danish: Desuden skal en opdateret RMP fremsendes:
English: Immunogenicity:
Danish: Immunogenicitet:
English: If the dates for submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Strong (pulsating) bleeding should be stopped surgically.
Danish: Stærk (pulserende) blødning bør stoppes kirurgisk.
English: In case of shock, the current medical standards for shock treatment should be observed.
Danish: I tilfælde af shock skal gældende medicinsk standard for shockbehandling iværksættes.
English: No evidence of local intolerability has been observed in animal studies.
Danish: Der sås ingen tegn på lokal intolerance i dyrestudierne.
English: Open the inner sterile package and remove the matrix.
Danish: Åbn den sterile inderpakning og tag matrixen ud.
English: In this study two application techniques for TachoSil were evaluated: application of TachoSil over the dura and application of TachoSil on both sides of the dura.
Danish: I dette studie blev to teknikker til at applicere TachoSil på undersøgt: applikation af TachoSil over dura og applikation af TachoSil på begge sider af dura.
English: TachoSil is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
Danish: TachoSil bør ikke anvendes til børn under 18 år, da data for sikkerhed og virkning er utilstrækkelige.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Danish: Dette lægemiddel kan som alle andre lægemidler give bivirkninger, men ikke alle får bivirkninger.
English: POLYETHYLENE TEREPHTHALATE BLISTER
Danish: POLYETHYLEN TEREPHTHALAT BLISTER
English: This is followed by the fibrinogen-thrombin reaction which initiates the last phase of physiological blood coagulation.
Danish: Herefter sker en fibrinogen-thrombin reaktion, som initierer den sidste fase af den fysiologiske blodkoagulation.
English: Remove the light pressure carefully after 3-5 minutes.
Danish: Fjern forsigtigt trykket efter 3-5 minutter.
English: If these symptoms occur, the administration has to be discontinued immediately.
Danish: Hvis disse symptomer opstår skal anvendelsen straks afbrydes.
English: Single dose toxicity studies in different species of animals have shown no signs of acute toxic effects.
Danish: Toksikologiske enkeltdosisstudier udført på forskellige dyrearter har ikke vist tegn på akut toksisk effekt.
English: Anaphylactic shock, Hypersensitivity
Danish: Anafylaktisk shock, overfølsomhed
English: In the integrated analyses, 997 patients were treated with TachoSil and 984 patients were treated with comparator treatment.
Danish: I de integrerede analyser blev 997 patienter behandlet med TachoSil og 984 patienter blev behandlet med komparator.
English: Do not resterilise.
Danish: Kan ikke resteriliseres.
English: If a trocar is used for getting access to the wound, the inside of the trocar should be dry.
Danish: Hvis en trokar anvendes til at få adgang til såret, bør indersiden af trokaren være tør.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberettebivirkninger direktetil Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: It is not known whether recent radiation therapy affects the efficacy of TachoSil when used for dura mater sealing.
Danish: Det vides ikke, om nylig strålebehandling påvirker virkningen af TachoSil ved anvendelse til forsegling af dura mater.
English: 9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Data from the eight controlled clinical trials conducted by the MAH has been pooled into an integrated dataset.
Danish: Data fra de otte kontrollerede kliniske studier, foretaget af markedsføringsindehaveren, er blevet samlet i et integreret datasæt.
English: Intestinal obstruction (in abdominal surgeries)
Danish: Tarmobstruktion (ved abdominalkirurgi)
English: Such substances should be removed to the greatest possible extent before applying the sealant.
Danish: Disse bør derfor fjernes bedst muligt, før matrixen appliceres.
English: The safety data of TachoSil generally reflect the type of post-operative complications related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Danish: TachoSils sikkerhedsdata afspejler generelt typen af post-operative komplikationer forbundet med de operative forhold, hvor undersøgelserne er foretaget, samt patienternes tilgrundliggende sygdom.
English: In this study, superiority over current practise practice (which included suture, duraplasty and fibrin and polymer sealants or combinations of these) could not be documented.
Danish: I dette studie kunne superioritet i forhold til den normale praksis (som inkluderede sutur, duraplastik samt fibrin- og polymervævsklæbere eller kombinationer af disse) ikke dokumenteres.
English: The active side of TachoSil should be applied so that it extends 1-2 cm beyond the margins of the wound.
Danish: Den aktive side af TachoSil skal appliceres, så den dækker 1-2 cm uden for sårkanten.
English: Pre-rolled TachoSil can be used for both open surgery and in minimally invasive surgery, and it can pass through a 10 mm or larger port or trocar.
Danish: Den prærullede TachoSil kan anvendes både ved åben kirurgi og ved minimal invasiv kirurgi, og den kan passere gennem en 10 mm eller større port eller trokar.
English: But please note that the matrix should cover 1-2 cm beyond the margins of the wound.
Danish: BEMÆRK at matrixen skal dække 1-2 cm uden for sårkanten.
English: One patient developed antibodies to human fibrinogen.
Danish: Én patient dannede antistoffer mod humant fibrinogen.
English: TachoSil is made of protein-containing components.
Danish: TachoSil fremstilles af proteinholdige komponenter.
English: TachoSil was found to be well tolerated and safe for use as an adjunct to dura mater closure in neurosurgery.
Danish: TachoSil blev fundet at være veltolereret og sikkert at bruge som tillæg til lukning af dura mater i neurokirurgi.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også alle ukendte eller nyopdagede vira og andre typer infektioner.
English: The frequency of all of the events listed below has been categorised as not known (cannot be estimated from the available data).
Danish: Hyppigheden af alle de nedenfor anførte bivirkninger er kategoriseret som Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Place the yellow, active side of TachoSil against the wound.
Danish: Anbringden gule, aktive side af TachoSil mod såret.
English: There is very limited clinical data available regarding re-exposure to TachoSil.
Danish: Der er meget begrænsede kliniske data fra gentagen eksponering for TachoSil.
English: Pharmacotherapeutic group: Local haemostatics, ATC code: B02BC30
Danish: Farmakoterapeutisk gruppe: Hæmostatika til lokalbrug, ATC-kode: B02BC30.
English: Do not use TachoSil - if you are allergic (hypersensitive) to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke TachoSil - hvis du er allergisk (overfølsom) over for human fibrinogen, human thrombin eller et eller flere af de øvrige indholdsstoffer i TachoSil (angivet i pkt.
English: In animal studies, TachoSil biodegrades after administration to a wound surface with few remnants left after 13 weeks.
Danish: I dyrestudier nedbrydes TachoSil biologisk efter administration på en såroverflade med få tilbageværende rester efter 13 uger.
English: The quantity of TachoSil to be applied should always be oriented towards the underlying clinical need for the patient.
Danish: Antallet af TachoSil, der skal appliceres, bør altid være i overensstemmelse med det grundlæggende kliniske behov hos den pågældende patient.
English: The safety of TachoSil for use in human pregnancy or breastfeeding has not been established in controlled clinical trials.
Danish: Sikkerheden ved brug af TachoSil under graviditet eller i ammeperioden er ikke undersøgt i kontrollerede kliniske studier.
English: Read all of this leaflet carefully.
Danish: Læs denne indlægsseddel grundigt.
English: TachoSil is for local use only and should not be applied inside a blood vessel.
Danish: TachoSil er kun til lokal brug og bør ikke anvendes i blodkar.
English: If more than one matrix is needed, they should overlap.
Danish: Hvis det er nødvendigt at anvende mere end én matrix, skal samlingen overlappe.
English: However, the 95% confidence intervals for the odds ratio results indicated that TachoSil had similar efficacy to current practice.
Danish: 95% konfidensintervallerne for oddsratio-resultaterne indikerede dog, at TachoSil havde samme virkning som den normale praksis.
English: Use a moistened glove or a moist pad to keep TachoSil in place.
Danish: Brug en fugtet handske eller et fugtet gazekompres til at holde TachoSil på plads.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også for ukendte eller nyopdagede vira samt andre patogener.
English: Therefore, intravascular pharmacokinetic studies were not performed in man.
Danish: Som en konsekvens af dette er der ikke udført intravaskulære farmakokinetiske studier hos mennesker.
English: • only to use undamaged packages which have not been opened (post-sterilisation is not possible).
Danish: • udelukkende at anvende uåbnede/ubeskadigedepakninger - resterilisation er ikke mulig.
English: Two subjects have been re-exposed in a clinical trial and have not reported any immune-mediated adverse events; however, their antibody status to collagen or fibrinogen is unknown.
Danish: To forsøgspersoner er blevet reeksponeret i et klinisk studie, og der blev ikke indberettet nogen immunmedierede bivirkninger, men deres status for antistoffer mod kollagen eller fibrinogen kendes dog ikke.
English: In neurosurgery, TachoSil should be applied on top of the primary dura closure.
Danish: Ved neurokirurgi skal TachoSil appliceres oven på den primære dura-lukning.
English: As with any protein-containing product, allergic type hypersensitivity reactions are possible.
Danish: Som ved ethvert andet proteinholdigt præparat kan allergiske overfølsomhedsreaktioner forekomme.
English: Due to practical reasons (comparison to standard surgical and standard haemostatic treatment), blinding was not possible in the TachoSil trials.
Danish: Af praktiske grunde (sammenligning med standard operativ- og standard hæmostasebehandling), var det ikke muligt at blinde TachoSil-studierne.
English: From the experience in humans there have been isolated cases where remnants were observed as coincidental findings with no signs of functional impairment.
Danish: Hos mennesker har der været enkelte tilfælde, hvor rester blev observeret som tilfældige fund uden tegn på svækkelse af virkningen.
English: It is possible that you could suffer an allergic reaction after TachoSil has been applied.
Danish: Det er sandsynligt, at du kan få en allergisk reaktion efter brug af TachoSil.
English: These allergic reactions may occur especially if TachoSil is used repeatedly or if you are allergic to any of the ingredients in TachoSil.
Danish: Disse allergiske reaktioner kan især forekomme hvis TachoSil anvendes ved gentagne operationereller hvis du er allergisk over for et eller flere af indholdsstofferne i TachoSil.