FrancophonIA/ELRC3.0 huggingface dataset:
English: Other common side effects (seen in up to 1 patient in 10) are development of another form of cancer in patients with advanced cancer, hypophosphataemia (low levels of phosphate in the blood), excessive sweating, tooth loss and osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
Danish: Andre almindelige bivirkninger (som forekommer hos op til 1 ud af 10 patienter) er udvikling af en anden type kræft hos patienter med fremskreden kræft, for lavt fosfatindhold af i blodet (hypofosfatæmi), stærk svedtendens, tab af tænder og beskadigelse af knoglerne (osteonekrose) i kæben, som kan medføre smerter, mundsår og løse tænder.
English: For the full list of side effects and restrictions with Xgeva, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Xgeva fremgår af indlægssedlen.
English: To prevent bone complications in cancer that has spread to the bone, 120 mg is given once every 4 weeks as a single injection under the skin in the thigh, abdomen (belly) or upper arm.
Danish: For at undgå knoglekomplikationer ved kræft, der har bredt sig til knoglen, gives der en enkelt injektion under huden (120 mg) én gang hver fjerde uge i låret, maven eller overarmen.
English: These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Danish: Disse komplikationer omfatter knoglebrud, sammentrykning af rygmarven forårsaget af beskadigelse af den omgivende knogle, og knogleproblemer, der kræver strålebehandling eller operation.
English: In these studies, Xgeva reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid.
Danish: I disse studier nedbragte Xgeva risikoen for at udvikle en første knoglerelateret hændelse med 18 % i forhold til zoledronsyre.
English: How is Xgeva used?
Danish: Hvordan anvendes Xgeva?
English: In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
Danish: I dette studie nedbragte Xgeva risikoen for at udvikle en første knoglerelateret hændelse med 16 % i forhold til zoledronsyre.
English: Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone.
Danish: Xgeva er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der har bredt sig til knoglerne.
English: The European Medicines Agency decided that Xgeva's benefits are greater than its risks for patients with cancers that has spread to the bone, and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Xgeva opvejer risiciene hos patienter med kræft, der har bredt sig til knoglerne, og at det kan godkendes til anvendelse i EU.
English: What benefits of Xgeva have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xgeva?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xgeva have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xgeva.
English: The application was withdrawn at ‘day 180'.
Danish: Ansøgningen blev trukket tilbage ved 'dag 180'.
English: The company presented results of one main study involving 463 patients undergoing different types of
Danish: Virksomheden fremlagde resultaterne af én hovedundersøgelse med 463 patienter, der gennemgik forskellige typer operationer.
English: It contains the active substance thrombin alfa.
Danish: Det indeholder det aktive stof thrombin alfa.
English: According to EU requirements, Recothrom should have been compared with a standard treatment that did not contain thrombin.
Danish: Ifølge EU-kravene burde Recothrom have været sammenlignet med en standardbehandling, som ikke indeholdt thrombin.
English: The effects of Recothrom were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Recothrom blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden havde indleveret, og formuleret en liste med spørgsmål.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene, var der fortsat visse uafklarede spørgsmål.
English: Finally, there were concerns about the medicine that Recothrom was compared with (the comparator) in the main study.
Danish: Endelig var der betænkeligheder i forbindelse med det lægemiddel, som Recothrom blev sammenlignet med (sammenligningsstoffet) i hovedundersøgelsen.
English: Thrombin converts another protein called fibrinogen into smaller units called fibrin.
Danish: Thrombin omdanner et andet protein, der kaldes fibrinogen, til mindre enheder kaldet fibrin.
English: In addition, not enough evidence was presented to show that Recothrom used with a gelatin sponge was more effective than a sponge alone.
Danish: Desuden blev der ikke fremlagt tilstrækkelig dokumentation til at vise, at Recothrom brugt med en gelatinesvamp var mere effektiv end en svamp alene.
English: The active substance in Recothrom, thrombin alfa, is a copy of thrombin, a protein that is found naturally in the blood.
Danish: Det aktive stof i Recothrom, thrombin alfa, er en kopi af thrombin, et protein, der findes naturligt i blodet.
English: What is Recothrom?
Danish: Hvad er Recothrom?
English: What documentation did the company present to support its application to the Agency?
Danish: Hvilken dokumentation fremlagde virksomheden for at underbygge sin ansøgning til lægemiddelagenturet?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Recothrom could not have been approved for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Danish: På baggrund af gennemgangen af dataene og virksomhedens svar på CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Recothrom ikke kunne være blevet godkendt til at standse blødninger under kirurgiske indgreb, hvor kirurgiske metoder er utilstrækkelige.
English: The CHMP was concerned that the company provided evidence from specialised surgeries, whereas Recothrom was intended for more general use.
Danish: CHMP var betænkelig ved, at virksomheden fremlagde dokumentation fra specialiserede operationer, hvor Recothrom var beregnet til en mere almindelig brug.
English: The fibrin particles then stick together, forming clots which help to stop the bleeding.
Danish: Fibrinpartiklerne klæber derefter sammen og danner propper, der bevirker, at blødningen standser.
English: What was Recothrom expected to be used for?
Danish: Hvad forventedes Recothrom at blive anvendt til?
English: The study compared Recothrom with another medicine containing thrombin and the main measure of effectiveness was the number of patients whose bleeding stopped within 10 minutes.
Danish: lægemiddel, der indeholder thrombin, og det primære effektmål var antallet af patienter, hvis blødninger standsede inden for 10 minutter.
English: How was Recothrom expected to work?
Danish: Hvordan forventedes Recothrom at virke?
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Recothrom?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Recothrom eller i programmer for anvendelse af Recothrom med særlig udleveringstilladelse?
English: Recothrom was expected to be applied to the surgical wounds either using a gelatin sponge soaked with the solution, or by spraying the solution directly into the surgical wound.
Danish: Recothrom forventedes at blive anvendt på kirurgiske sår, enten ved at bruge en gelatinesvamp, der er gennemvædet med opløsningen, eller ved at sprøjte opløsningen direkte ind i det kirurgiske sår.
English: The company informed the CHMP that at this time there are no ongoing clinical trials or compassionate use programmes with Recothrom in Europe.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt ikke er nogen igangværende kliniske undersøgelser med Recothrom eller programmer for anvendelse af Recothrom med særlig udleveringstilladelse i Europa.
English: Thrombin also helps to make specialised cells in the blood called platelets to stick together, forming clots which also reduce the bleeding.
Danish: Thrombin bevirker også, at bestemte celler i blodet, der kaldes blodplader, klæber sammen og danner propper, som også hæmmer blødningen.
English: The Committee also noted that because the sponge and spray worked differently and should have been studied separately, there was not enough to determine the effects of the spray.
Danish: Udvalget bemærkede ligeledes, at der ikke var nok materiale til at afgøre sprayens virkninger, fordi svampen og sprayen virkede forskelligt og burde have været undersøgt separat.
English: Recothrom was expected to be used to stop bleeding during an operation when standard surgical techniques are insufficient.
Danish: Recothrom forventedes at blive anvendt til at standse blødninger under en operation, hvor gængse kirurgiske metoder er utilstrækkelige.
English: On 11 December 2009, Bayer Schering Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Recothrom, for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Danish: Den 11. december 2009 meddelte Bayer Schering Pharma AG officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Recothrom tilbage.
English: Recothrom is a powder and solvent for solution to be applied to a surgical wound.
Danish: Recothrom er et pulver og en solvens til opløsning, der er beregnet til anvendelse på et kirurgisk sår.
English: EMA/828729/2009
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Recothrom (thrombin alfa) EMA/828729/2009
English: After reconstitution: 4 weeks.
Danish: Efter rekonstitution: 4 uger.
English: • PSUR should be submitted every 6 months for a year.
Danish: • Der skal hver 6. måned i et år fremlægges PSUR.
English: • If you are more than 3 months pregnant.
Danish: • hvis De er mere end 3 måneder henne i graviditeten.
English: • The follow-up measures as set out in the CHMP Assessment Report
Danish: • Opfølgningsforanstaltningerne som foreskrevet i CHMP's vurderingsrapport
English: frequency can not be estimated from the available data
Danish: Frekvensen kan ikke estimeres ud fra forhåndenværende data.
English: Austria, Belgium/Luxembourg, Bulgaria, Cyprus, Germany, Denmark, Estonia, Greece, Finland, France, Hungary, Ireland, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom, Iceland, Norway
Danish: Belgien/Luxembourg, Bulgarien, Cypern, Danmark, Estland, Finland, Frankrig, Grækenland, Holland, Irland, Italien, Letland, Litauen, Malta, Polen, Portugal, Rumænien, Slovenien, Spanien, Storbritannien, Sverige, Tyskland, Ungarn, Østrig, Island, Norge,
English: The mean length of follow-up was 4.8 years.
Danish: Den gennemsnitlige opfølgningstid var 4,8 år.
English: After that year the safety data will be evaluated and it will be decided whether a longer PSUR period is permitted.
Danish: Efter dette år evalueres sikkerhedsoplysningerne, og der træffes beslutning om, hvorvidt der skal åbnes mulighed for en længere PSUR-periode.
English: Stabilisation of the cardiovascular system should be given priority.
Danish: Stabilisering af kredsløbet bør prioriteres.
English: Losartan may be administered with or without food.
Danish: Losartan kan administreres med eller uden mad.
English: The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State for evaluation:
Danish: Ansøgeren forpligter sig til at fremlægge følgende oplysninger for den nationale kompetente myndighed i referencemedlemsstaten til vurdering:
English: The solvent contains sorbitol.
Danish: Solvensen indeholder sorbitol.
English: Sector 1, Bucureşti, România
Danish: Sector 1, Bucureşti, Rumænien
English: Losartan has been evaluated in clinical studies as follows:
Danish: Losartan er vurderet i kliniske undersøgelser som følger:
English: 11415 Tallinn, Estonia
Danish: 11415 Tallinn, Estland
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Danish: De nationale kompetente myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: H-1123 Budapest, Hungary
Danish: H-1123 Budapest, Ungarn
English: Long-term effects of losartan on growth, puberty and general development have not been studied.
Danish: Losartans langtidsvirkning på vækst, pubertet og generel udvikling er ikke undersøgt.
English: Side effects in children are similar to those seen in adults.
Danish: Bivirkninger hos børn svarer til dem, der er set hos voksne.
English: It may harm them even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har.
English: Safety data should be presented in the PSUR separated by age group and used formulation (e.g. tablets or oral suspension).
Danish: Sikkerhedsoplysningerne skal fremlægges i PSUR opdelt efter aldersgruppe og anvendt formulering (f.eks. tabletter eller oral suspension).
English: 28027 MADRID, Spain
Danish: 28027 MADRID, Spanien
English: The following components are packed in a kit:
Danish: Følgende komponenter er pakket i én pakning:
English: • if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
Danish: • hvis De er overfølsom (allergisk) over for losartan eller et af de øvrige indholdsstoffer,
English: Exposure in infants/ toddlers was comparatively high.
Danish: Eksponering hos spædbørn/små børn var forholdsvis høj.
English: Infants whose mothers have taken losartan should be closely observed for hypotension.
Danish: Spædbørn, hvis mødre har taget losartan, bør observeres omhyggeligt for hypotension.
English: Sorbitol/Fructose intolerance
Danish: Sorbitol/fructoseintolerance
English: An increased mortality was observed in ELITE II in the small subgroup (22 % of all HF patients) taking beta-blockers at baseline.
Danish: Der sås en stigning i mortalitet i ELITE II i den lille undergruppe (22 % af alle HF-patienter), der tog beta-blokkere ved baseline.
English: The systemic bioavailability of losartan tablets is approximately 33 %.
Danish: Den systemiske biotilgængelighed af losartantabletter er ca. 33 %.
English: Measures are depending on the time of medicinal product intake and kind and severity of symptoms.
Danish: Forholdsreglerne afhænger af tidspunktet for indtagelse af medicinen samt symptomernes type og sværhedsgrad.
English: 1407 Sofia, Bulgaria
Danish: 1407 Sofia, Bulgarien
English: • if you are breast-feeding (see also "Pregnancy and breast-feeding").
Danish: • hvis De ammer (se også "Graviditet og amning").
English: VARIPHARM ARZNEIMITTEL GmbH
Danish: Tyskland VARIPHARM ARZNEIMITTEL GmbH
English: Like all medicines, COZAAR can cause side effects, although not everybody gets them.
Danish: Cozaar kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Shake the suspension prior to each use and return promptly to the refrigerator.
Danish: Ryst suspensionen før hver brug og sæt den omgående tilbage i køleskabet.
English: Use in children and adolescents COZAAR has been studied in children.
Danish: Brug til børn og unge Cozaar er undersøgt hos børn.
English: Other warnings and precautions:
Danish: Andre advarsler og forholdsregler
English: 00-867 Warsaw, Poland
Danish: 00-867 Warsaw, Polen
English: You should not take losartan in the first 12 weeks of pregnancy, and you must not take it at all after the 13th week as its use during pregnancy may possibly be harmful to the baby.
Danish: De bør ikke tage Cozaar i de første 12 uger af graviditeten, og De må overhovedet ikke tage det efter 13. uge, da brug under graviditet kan skade fostret.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter med sjælden arvelig fructoseintolerance bør ikke tage denne medicin.
English: Renal function should be regularly monitored during treatment with losartan as it may deteriorate.
Danish: Nyrefunktionen skal monitoreres regelmæssigt under behandling med losartan, da den kan forværres.
English: 75114 Paris Cedex 08, France
Danish: 75114 Paris Cedex 08, Frankrig
English: The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, to < 1/10); uncommon (≥ 1/1,000, to < 1/100); rare (≥ /10,000, to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvensen af de nedenfor nævnte bivirkninger er defineret i henhold til følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is important to continue taking COZAAR for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
Danish: Det er vigtigt at fortsætte med at tage Cozaar, så længe lægen foreskriver det, det vil sikre en jævn kontrol af Deres blodtryk.
English: This also applies to children 6 to 16 years of age.
Danish: Dette gælder også for børn i alderen 6-16 år.
English: COZAAR powder and solvent for oral suspension is packaged in a kit containing:
Danish: Cozaar pulver og solvens til oral suspension er pakket i en pakning, der indeholder følgende:
English: Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Danish: Doser over 1,4 mg/kg (eller mere end 100 mg) dagligt er ikke blevet undersøgt hos pædiatriske patienter.
English: The doctor may increase the dose if blood pressure is not controlled.
Danish: Lægen kan øge dosis, hvis blodtrykket ikke er under kontrol.
English: Do not use COZAAR after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke Cozaar efter den udløbsdato, der står på pakningen.
English: The patients should have a left ventricular ejection fraction ≤ 40 % and should be stabilised under the treatment of the chronic heart failure.
Danish: Patienterne bør have en ejektionsfraktion på ≤40 % i venstre ventrikel og bør stabiliseres under behandlingen for kronisk hjerteinsufficiens.
English: The side effects of medicines are classified as follows:
Danish: Medicinens bivirkninger inddeles på følgende måde:
English: If you experience the following, stop taking losartan and tell your doctor immediately or go to the casualty department of your nearest hospital:
Danish: Hvis De oplever følgende, skal De stoppe med at tage losartan og straks fortælle lægen om det eller tage på skadestuen på det nærmeste hospital:
English: Shake the closed bottle of losartan oral suspension well before use.
Danish: Ryst den lukkede flaske med losartan oral suspension omhyggeligt før anvendelse.
English: Losartan is not recommended:- for use in children below 6 years old due to insufficient data on safety and/or efficacy in these patient groups.
Danish: Losartan bør ikke anvendes til børn under 6 år, p.g.a. manglende dokumentation for sikkerhed og/eller effekt hos disse patientgrupper.
English: Your doctor will decide on the appropriate dose of COZAAR, depending on your condition and whether you are taking other medicines.
Danish: Lægen bestemmer, hvilken dosis af Cozaar der er hensigtsmæssig for Dem, afhængigt af Deres tilstand, og om De tager anden medicin.
English: Losartan should not be initiated during pregnancy.
Danish: Behandling med losartan bør ikke opstartes under graviditet.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of medicinal products.
Danish: Selvom der ikke findes kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin II receptorhæmmere (AIIRAer), kan de samme risici være forbundet med denne lægemiddelklasse.
English: Take particular care if you are taking the following medicines while under treatment with COZAAR:
Danish: Vær særlig forsigtig, hvis De får den medicin, der nævnes nedenfor, mens De er i behandling med Cozaar:
English: These conditions should be corrected prior to administration of losartan, or a lower starting dose should be used (see section 4.2).
Danish: Disse tilstande bør korrigeres før administration af losartan, eller der bør anvendes lavere startdosis (se pkt.
English: Discard the excess solvent not used in the preparation of the suspension.
Danish: Kasser den overskydende solvens, der ikke anvendes til tilberedningen af suspensionen.
English: Always shake <COZAAR>oral suspension well before use!
Danish: Ryst altid Cozaar oral suspension omhyggeligt før brug!
English: Other antihypertensive agents may increase the hypotensive action of losartan.
Danish: Andre antihypertensiva kan øge losartans hypotensive virkning.
English: The solvent is a cloudy, colorless liquid.
Danish: Solvensen er en uklar, farveløs væske.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S), ROUTE(S) OF ADMINISTRATION OF THE MEDICINAL PRODUCT(S), MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Therefore, the use of losartan is not recommended.
Danish: Derfor kan anvendelse af losartantabletter ikke anbefales.
English: Very rare cases have also been reported with angiotensin II receptor antagonists.
Danish: Der er også rapporteret om meget sjældne tilfælde med antiotensin-II-receptorantagonister.
English: The observation of the ELITE Study, that, compared with captopril, Losartan reduced the mortality risk, was not confirmed in the subsequent ELITE II Study, which is described in the following.
Danish: Observationen i ELITE I-undersøgelsen, at losartan reducerede risikoen for dødsfald sammenlignet med captopril, blev ikke bekræftet i den efterfølgende ELITE II-undersøgelse, som beskrives nedenfor.
English: However, when driving vehicles or operating machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.
Danish: Når man kører bil eller betjener maskiner, skal man dog tænke på, at svimmelhed eller døsighed lejlighedsvis kan forekomme i forbindelse med antihypertensiv behandling, i særdeleshed ved initiering af behandlingen, eller når dosis øges.
English: Shake the bottle well before use.
Danish: Ryst flasken omhyggeligt før brug.