FrancophonIA/ELRC3.0 huggingface dataset:
English: Glivec is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Danish: Glivec anvendes til behandling af voksne med DFSP, som ikke kan fjernes kirurgisk, og til voksne, som ikke egner sig til et kirurgisk indgreb, når der er tilbagefald af kræften efter behandling, eller når den har spredt sig til andre dele af kroppen.
English: One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size.
Danish: En undersøgelse omfattede 147 patienter, hvis GIST ikke kunne fjernes kirurgisk, eller hvis GIST havde spredt sig til andre dele af kroppen, og så nærmere på, om tumorernes størrelse var reduceret.
English: • gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs.
Danish: • gastrointestinale stromale tumorer (GIST), en form for kræft (sarkom) i mave og tarm, som opstår ved en ukontrolleret vækst af celler i disse organers støttevæv.
English: Glivec is used to treat adults with GIST that cannot be removed with surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal;
Danish: Glivec anvendes til behandling af voksne med GIST, som ikke kan fjernes kirurgisk, eller som har spredt sig til andre dele af kroppen, og til voksne, hvor der er risiko for et tilbagefald af GIST efter operativ fjernelse
English: What is Glivec used for?
Danish: Hvad anvendes Glivec til?
English: What benefit has Glivec shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Glivec?
English: How has Glivec been studied?
Danish: Hvordan blev Glivec undersøgt?
English: How is Glivec used?
Danish: Hvordan anvendes Glivec?
English: Glivec was also better than standard chemotherapy in patients with Ph+ ALL.
Danish: Også hos patienter med Ph +ALL var Glivec bedre end standardkemoterapi.
English: How does Glivec work?
Danish: Hvordan virker Glivec?
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Danish: • fremskredent hypereosinofilt syndrom (HES) eller kronisk eosinofil leukæmi (CEL), som er sygdomme, hvor eosinofiler (en anden form for hvide blodlegemer) begynder at vokse ukontrolleret Glivec anvendes til behandling af voksne med HES eller CEL, hos hvem der forekommer en særlig omarrangering af de to gener FIP1L1 og PDGFRα
English: In both studies, the majority of patients were adults.
Danish: I begge undersøgelser var hovedparten af patienterne voksne.
English: It must not be used in pregnant or breastfeeding women.
Danish: Det må ikke anvendes hos gravide eller ammende kvinder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Quinsair on 26 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Quinsair den 26. marts 2015.
English: Treatment cycles may be repeated for as long as the patient benefits.
Danish: Disse behandlingsforløb kan gentages, så længe patienten har fordel af det.
English: Systemic formulations of levofloxacin (such as tablets and solutions for infusion) have been authorised in the EU since the 1990s.
Danish: Systemiske formuleringer af levofloxacin (såsom tabletter og infusionsvæsker) har været godkendt i EU siden 1990'erne.
English: This is a summary of the European public assessment report (EPAR) for Quinsair.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Quinsair.
English: The full EPAR and risk management plan summary for Quinsair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Quinsair findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Danish: Efter 28 dages behandling holder patienten pause med behandlingen i 28 dage og begynder derefter på et nyt 28-dages behandlingsforløb.
English: Other information about Quinsair
Danish: Andre oplysninger om Quinsair
English: A risk management plan has been developed to ensure that Quinsair is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Quinsair anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Quinsair's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Quinsair opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because levofloxacin has a potential risk on cartilage, the use of the product was not considered justified in adolescents.
Danish: Da levofloxacin udgør en mulig risiko for bruskvævet, anses der ikke for berettiget at anvende det hos unge.
English: Levofloxacin is a well-known antibiotic.
Danish: Levofloxacin er et velkendt antibiotikum.
English: In addition, the company that markets Quinsair will carry out a study to investigate the long-term safety of Quinsair when used in clinical practice in the European Union.
Danish: Desuden skal den virksomhed, der markedsfører Quinsair, udføre en undersøgelse af den langsigtede sikkerhed af Quinsair ved praktisk klinisk anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Quinsair?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Quinsair?
English: It works by blocking enzymes that P. aeruginosa bacteria use to make copies of their DNA during cell multiplication.
Danish: Det virker ved at blokere enzymer, som bakterien P. aeruginosa anvender til at kopiere sit DNA, når den formerer sig.
English: The most common side effects with Quinsair are cough (seen in 54% of patients), dysgeusia (taste disturbances, 30%) and tiredness/weakness (25%).
Danish: De hyppigste bivirkninger ved Quinsair er hoste (der optræder hos 54 % af patienterne), smagsforstyrrelser (dysgeusi), der optræder hos 30 %, og træthed/svaghed (25 %).
English: Before using Quinsair, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Før Quinsair anvendes, bør lægen tage hensyn til de officielle retningslinjer for forsvarlig brug af antibiotika.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Quinsair, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Quinsair, herunder passende forholdsregler, som patienter og sundhedspersonaleskal følge.
English: Why is Quinsair approved?
Danish: Hvorfor blev Quinsair godkendt?
English: What are the risks associated with Quinsair?
Danish: Hvilke risici er der forbundet med Quinsair?
English: The second study showed that Quinsair was at least as good as tobramycin at improving FEV1 following 1 to 3 treatment cycles.
Danish: Den anden undersøgelse viste, at Quinsair var mindst lige så godt som tobramycin til at forbedre FEV1 efter 1 til 3 behandlingsforløb.
English: It is not intended to provide practical advice on how to use Quinsair.
Danish: Det er ikke en praktisk vejledning i, hvordan Quinsair bør anvendes.
English: Quinsair contains the active substance levofloxacin.
Danish: Quinsair indeholder det aktive stof levofloxacin.
English: What is Quinsair and what is it used for?
Danish: Hvad er Quinsair, og hvad anvendes det til?
English: Regarding safety, Quinsair was well tolerated with side effects similar to those of levofloxacin given systemically (throughout the body).
Danish: Vedrørende sikkerheden var Quinsair veltolereret, og bivirkningerne svarede til bivirkningerne ved at indgive levofloxacin i hele kroppen (systemisk).
English: For more information about treatment with Quinsair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Quinsair, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP considered that the modest improvement in FEV1 seen with Quinsair meant that it could help to meet the need for additional inhaled antibiotics to treat long-term P. aeruginosa infections in cystic fibrosis.
Danish: CHMP fandt, at den beskedne forbedring i FEV1 med Quinsair betød, at det kunne medvirke til at opfylde behovet for supplerende antibiotika til inhalation til behandling af langvarig infektion med P. aeruginosa ved cystisk fibrose.
English: Quinsair has been investigated in two main studies in patients who had cystic fibrosis with P. aeruginosa lung infection.
Danish: Quinsair er blevet undersøgt i to hovedundersøgelser hos patienter, der havde cystisk fibrose og lungeinfektion med P. aeruginosa.
English: Following 28 days of treatment, the patients taking Quinsair had an improvement in FEV1 of 1.73%, while for patients taking placebo the improvement in FEV1 was of around 0.43%.
Danish: De patienter, der fik Quinsair, havde forbedret deres FEV1 med 1,73 % efter 28-dages behandling, sammenholdt med en forbedring i FEV1 på ca. 0,43 % hos dem, der fik placebo.
English: The active substance in Quinsair, levofloxacin, belongs to the group of antibiotics known as ‘fluoroquinolones'.
Danish: Det aktive stof i Quinsair, levofloxacin, tilhører en gruppe af antibiotika kaldet fluorquinoloner.
English: However, the study failed to show that Quinsair is more effective than placebo at increasing the time it took before the patients had an exacerbation (flare-up) of their disease.
Danish: Undersøgelsen kunne imidlertid ikke vise, at Quinsair var mere effektivt end placebo til at forlænge tiden til der indtrådte en forværring i sygdommen.
English: Quinsair is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in adults who have cystic fibrosis.
Danish: Quinsair er et antibiotikum til behandling af langvarig lungeinfektion, som skyldes bakterien Pseudomonas aeruginosa hos voksne med cystisk fibrose.
English: For the full list of all side effects reported with Quinsair, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Quinsair fremgår af indlægssedlen.
English: By doing this, it stops the bacteria that are causing the infection from growing and multiplying.
Danish: Derved standser det væksten og formeringen af de bakterier, der bevirker infektionen.
English: For practical information about using Quinsair, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Quinsair, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Quinsair is inhaled using a device called Zirela nebuliser system, which converts the solution in the ampoule into a fine mist.
Danish: Quinsair inhaleres med Zirela-nebulisatorsystemet, der omdanner opløsningen i ampullerne til en fin tåge.
English: In the first study, Quinsair was shown to be better than placebo at improving the patients' forced expiratory volume in one second (FEV1), adjusted for the patient's age, height and sex. FEV1 is the most air a person can breathe out in one second.
Danish: Den første undersøgelse viste, at Quinsair var bedre end placebo til at forbedre patienternes forcerede udåndingsluftmængde i 1 sekund (FEV1), når man korrigerede for patientens alder, højde og køn.
English: What benefits of Quinsair have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Quinsair?
English: How is Quinsair used?
Danish: Hvordan anvendes Quinsair?
English: Quinsair must not be used in patients with epilepsy and those with a history of tendon disorders related to the use of fluoroquinolone antibiotics.
Danish: Quinsair må ikke anvendes hos patienter, der har epilepsi eller tidligere har fået senelidelser ved brug af antibiotika af fluorquinolontypen.
English: The first study, which involved 330 patients, compared Quinsair with placebo (a dummy treatment), while the second, involving 282 patients, compared it with another inhaled antibiotic (tobramycin).
Danish: I den anden undersøgelse, hvor der deltog 282 patienter, blev det sammenlignet med et andet antibiotikum til inhalation (tobramycin).
English: How does Quinsair work?
Danish: Hvordan virker Quinsair?
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily, causing infections.
Danish: Cystisk fibrose er en arvelig sygdom, der giver ophobning af tyk slim i lungerne.
English: Quinsair is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Danish: Quinsair fås som inhalationsvæske til nebulisator i enkeltdosisbeholdere (ampuller).
English: Ref.: EMEA/CHMP/730064/2009
Danish: ref.: EMA/730064/2009 EMEA/H/C/997
English: The company that applied for authorisation is BioMimetic Therapeutics Ltd.
Danish: Virksomheden, som ansøgte om tilladelse, er BioMimetic Therapeutics Ltd.
English: The main measure of effectiveness was the change in ‘clinical attachment level' (CAL) after 24 weeks.
Danish: Behandlingens virkning blev hovedsagelig bedømt ved ændringen i ‘klinisk fæstningsniveau' (CAL) efter 24 uger.
English: Gemesis is a kit for implant.
Danish: Gemesis er et sæt til implantat.
English: The effects of Gemesis were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Gemesis blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: What is Gemesis?
Danish: Hvad er Gemesis
English: Questions and answers on the recommendation for the refusal of the marketing authorisation for Gemesis
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Gemesis becaplermin
English: What was Gemesis expected to be used for?
Danish: Hvad forventedes Gemesis anvendt til?
English: In one main study involving 180 adults with advanced periodontal disease, Gemesis was compared with the matrix alone.
Danish: I en hovedundersøgelse med deltagelse af 180 voksne med fremskreden periodontal sygdom blev Gemesis sammenlignet med matricen alene.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Gemesis, intended for bone and periodontal (around the teeth) regeneration in adults.
Danish: Den 23. juli 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Gemesis til knogleregeneration og periodontal regeneration (vævet omkring tænderne) hos voksne.
English: The CHMP was also concerned about the level of product-related impurities present.
Danish: CHMP havde også betænkeligheder med hensyn til niveauet af produktrelaterede urenheder.
English: The active substance in Gemesis, becaplermin, is a recombinant human platelet-derived growth factor (PDGF).
Danish: Det aktive stof i Gemesis, becaplermin, er en rekombinant human trombocytderiveret vækstfaktor (PDGF).
English: Growth factors are proteins that stimulate cells to multiply.
Danish: Vækstfaktorer er proteiner, der stimulerer celler til at dele sig.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Gemesis did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Gemesis ikke opvejede risiciene.
English: The CHMP was of the opinion that the main study failed to show that Gemesis was effective in treating periodontal defects.
Danish: Det var CHMP's opfattelse, at det i hovedundersøgelsen ikke lykkedes at påvise, at Gemesis var effektivt til behandling af periodontale defekter.
English: Becaplermin is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human platelet-derived growth factor.
Danish: Becaplermin produceres via en metode, der er kendt som ”rekombinant DNA-teknologi”: det produceres af gærceller, der har fået indsat et gen (DNA) og derved sættes i stand til at producere human trombocytderiveret vækstfaktor.
English: The CHMP noted that the company did not at this time have sufficient information on how strongly becaplermin binds to PDGF receptors and did not sufficiently demonstrate that Gemesis used in clinical studies was comparable to the product intended to be placed on the market.
Danish: CHMP bemærkede, at virksomheden på dette tidspunkt ikke havde tilstrækkelige oplysninger om, hvor stærkt becaplermin binder sig til PDGFreceptorer, og ikke i tilstrækkelig grad dokumenterede, at Gemesis ved anvendelse i kliniske undersøgelser var sammenligneligt med det lægemiddel, som skulle markedsføres.
English: How was Gemesis expected to work?
Danish: Hvordan forventedes Gemesis at virke?
English: The kit consists of a prefilled syringe containing the active substance becaplermin and a cup containing granules of β-tricalcium phosphate to be used as a matrix.
Danish: Sættet består af en fyldt injektionssprøjte indeholdende det aktive stof becaplermin og et bæger indeholdende granulat af β-tricalciumfosat, der skal anvendes som matrice.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Gemesis?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Gemesis eller i programmer for anvendelse af Gemesis med særlig udleveringstilladelse?
English: CAL is a measure of the loss of support to the teeth from surrounding tissue.
Danish: CAL er et mål for tabet af støttevæv omkring tænderne.
English: Becaplermin was expected to work in the same way as human platelet-derived growth factor, stimulating cell growth in the bone and gums around the teeth and helping tissue to heal.
Danish: Becaplermin forventedes at virke på samme måde som human trombocytderiveret vækstfaktor og derigennem stimulere cellevæksten i knogler og tandkød og fremme ophelingen af vævet.
English: Gemesis was expected to be used to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums.
Danish: Gemesis forventedes anvendt til at regenerere væv hos voksne med defekter omkring tænderne, herunder defekter i det omgivende knoglevæv eller i form at tilbagetrukket tandkød.
English: Gemesis was to be prepared by mixing the solution containing becaplermin with the matrix, which was then to be placed into the defect around the teeth to promote healing.
Danish: Gemesis skulle have været fremstillet ved at blande opløsningen indeholdende becaplermin med matricen, som herefter skulle have været implanteret i defekten omkring tænderne for at fremme helingen.
English: Hence, the CHMP recommended that Gemesis be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Gemesis.
English: Platelet-derived growth factors act on cells that are involved in wound repair.
Danish: Trombocytderiverede vækstfaktorer virker på celler, der medvirker til sårheling.
English: The company informed the CHMP that there are no patients in clinical trials or compassionate use programmes using Gemesis.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Gemesis.
English: This leaflet was last approved on {date}
Danish: Denne pjece er sidst godkendt den {dato}
English: After first opening, the product should be used immediately.
Danish: Efter første åbning, skal produktet anvendes øjeblikkeligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/093/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/98/093/002
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 11-01-1999
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 11-01-1999
English: He will take the appropriate countermeasures.
Danish: Han vil så tage de nødvendige forholdsregler.
English: Very common ( >1/10); common (>1/100, <1/10); uncommon (>1/1,000, < 1/100); rare (>1/10,000, < 1/1,000); very rare (<1/10,000), including isolated reports.
Danish: Meget almindelig (>1/10); almindelig (>1/100, <1/10); usædvanlig (>1/1.000, <1/100); sjælden (>1/10.000, <1/1.000); meget sjælden (<1/10.000), herunder enkeltstående tilfælde.
English: Other possible but less frequent undesirable effects are:
Danish: Andre mulige, men mindre hyppigt forekomne bivirkninger er:
English: Do not pass it on to anyone else.
Danish: Den må ikke gives videre til andre.
English: This medicine has been prescribed for you personally and you should not pass it on to others.
Danish: Dette lægemiddel er ordineret til Dem personligt, og De bør ikke give det videre til andre.
English: These are not allergic reactions but are due to a pharmacological effect, and are usually observed 10 to 20 minutes after administration.
Danish: Disse er ikke allergiske reaktioner, men skyldes en farmakologisk effekt og kan sædvanligvis observeres 10-20 minutter efter administration.
English: Driving and using machines:
Danish: Kørsel og anvendelsen af maskineri:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: I fraværet af uforligelighedsundersøgelser må dette lægemiddel ikke blandes med andre lægemidler.
English: The treatment should be maintained until patients are fully mobilized.
Danish: Behandlingen bør fortsætte, indtil patienten er fuldt mobiliseret.
English: Should symptoms of overdose appear, treatment should be symptomatic.
Danish: Hvis der forekommer symptomer på overdosering, bør behandlingen være symptomatisk.
English: Plasma protein binding is 30 to 40%.
Danish: Plasma-proteinbindingen er 30-40%.
English: Please ask him to explain the reasons for any changes in your treatment schedule.
Danish: Bed ham om at forklare grunden til ændringen i behandlingsplanen.
English: if you have hypocalcaemia.
Danish: hvis du har hypocalcæmi.
English: Frequency categories:
Danish: Hyppighedskategorier:
English: It is not known whether this medicine is safe to use during pregnancy.
Danish: Det vides ikke, om det er sikkert at anvende denne medicin under graviditet.
English: It is contained in a glass ampoule.
Danish: Den leveres i en glasampul.
English: The same applies to patients with altered hepatic function.
Danish: Dette gælder også patienter med ændret leverfunktion.
English: Salmon calcitonin is rapidly absorbed and eliminated.
Danish: Laksecalcitonin absorberes og elimineres hurtigt.
English: Nausea/vomiting are less frequent when the injection is done in the evening and after meals.
Danish: Kvalme/opkastning er mindre hyppigt, hvis injektionen foretages om aftenen og efter måltider.
English: Do not use Forcaltonin if you notice the solution is not completely clear and colourless.
Danish: Anvend ikke Forcaltonin, hvis det bemærkes, at opløsningen ikke er helt klar og farveløs.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ubrugte produkter eller affaldsmaterialer skal bortskaffes i henhold til lokale krav.
English: WHAT FORCALTONIN IS AND WHAT IT IS USED FOR
Danish: HVAD FORCALTONIN ER OG HVAD DET ANVENDES TIL