FrancophonIA/ELRC3.0 huggingface dataset:
English: Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avaglim.
Danish: Kvinder, som er infertile på grund af polycystisk ovariesyndrom, skal være opmærksomme på, at ægløsningen kan blive genetableret under behandling med Avaglim.
English: In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute
Danish: I betragtning af risikoen for udvikling af hjerteinsufficiens bør behandling med rosiglitazon ikke initieres hos patienter med akut hjertetilfælde, og det bør seponeres i den akutte fase (se afsnit 4.3).
English: The frequency of glimepiride adverse reactions identified from clinical trial and post
Danish: Frekvensen af glimepirid bivirkninger identificeret fra kliniske undersøgelser og postmarketingdata.
English: No new safety findings were observed.
Danish: Undersøgelsen viste ingen nye bivirkninger.
English: Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Danish: Data fra kliniske undersøgelser og post-marketing-data Tabel 3 viser de bivirkninger, der er baseret på erfaringer med glimepirid og andre sulfonylurinstoffer.
English: The following statements reflect the information available on the individual active substances (rosiglitazone and glimepiride).
Danish: Følgende angivelser henviser til de to enkelte aktive delkomponenter (rosiglitazon og glimepirid).
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone or glimepiride between males and females.
Danish: Køn: I den farmakokinetiske analyse med poolet population sås ingen klar forskel i rosiglitazons
English: You may need to have the dose adjusted or change the other
Danish: Din dosis skal måske ændres eller der bør ske en ændring i den medicin, du allerede anvender.
English: In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
Danish: I forlængelse af bivirkningsdata, der blev fundet i kliniske undersøgelser, er de data, der blev fundet efter markedsføring af rosiglitazon vist i tabellen nedenfor.
English: The following statements refer to AVAGLIM or the two individual active substances (rosiglitazone
Danish: Følgende angivelser henviser enten til AVAGLIM eller til de to enkelte aktive delkomponenter
English: In the fed state, the rate and extent of absorption of the rosiglitazone-glimepiride 4 mg/4 mg combination were equivalent to concomitant administration of 4 mg rosiglitazone and 4 mg glimepiride.
Danish: Under fødeindtagelse var hyppighed og omfang af absorptionen af kombinationen af rosiglitazonglimepirid 4 mg/4 mg ækvivalent med samtidig administration af 4 mg rosiglitazon og 4 mg glimepirid.
English: The maximum recommended daily dose is 8 mg rosiglitazone/4 mg glimepiride (given as one AVAGLIM tablet 8 mg/4 mg, once daily).
Danish: Maksimal anbefalet daglig dosis er 8 mg rosiglitazon/4 mg glimepirid (givet som en AVAGLIM 8 mg/4 mg tablet).
English: Each tablet contains either: 4 mg or 8 mg rosiglitazone and 4 mg glimepiride.
Danish: En tablet indeholder enten: 4 mg eller 8 mg rosiglitazon og 4 mg glimepirid.
English: Take special care with Avaglim Avaglim is not recommended for people aged under 18, as the safety and effectiveness are not known.
Danish: Avaglim bør ikke anvendes af personer under 18 år, da sikkerheden og virkningen er ukendt hos denne patientgruppe.
English: The frequency of adverse reactions identified from clinical trial data with rosiglitazone
Danish: Frekvensen af bivirkninger identificeret under kliniske undersøgelser med rosiglitazon
English: The usual starting dose is one combined tablet (4 mg rosiglitazone and 4 mg glimepiride), taken once
Danish: Den sædvanlige startdosis er en tablet (4 mg rosiglitazon og 4 mg glimepirid) en gang dagligt.
English: Clinical trial data and post-marketing data
Danish: Post-marketing-data
English: AVAGLIM is not indicated for combination use with metformin and therefore should not be used in
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Der er ikke indikation for samtidig brug af AVAGLIM og metformin, og derfor bør AVAGLIM ikke
English: Blood and the lymphatic system disorders
Danish: Blod og lymfesystem Agranulocytose
English: quinolone antibiotics, probenecid, miconazol, pentoxifylline (high dose parenteral), tritoqualine, fluconazole.
Danish: MAO-hæmmere quinoloner probenecid miconazol pentoxifyllin (høje parenterale doser) tritoqualin
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Avaglim til dig personligt.
English: Your doctor should regularly test your
Danish: Tjek din vægt jævnligt.
English: Hospitalisation should be considered as appropriate.
Danish: Normalt anbefales derfor indlæggelse på hospital.
English: A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Danish: Undersøgelsen viste, at alle patienter med kreatininklearance < 22 ml/min havde tilstrækkelig kontrol over deres glukoseniveauer med et behandlingsregime på 1 mg dagligt (se afsnit 4.2 og 4.4)
English: The minimum effective oral dose is approximately 0.6 mg.
Danish: Den mindste, effektive perorale dosis er hos raske forsøgspersoner ca. 0,6 mg. Glimepirids virkning er dosisafhængig og reproducerbar.
English: Therefore, AVAGLIM should not be used during lactation.
Danish: AVAGLIM skal derfor ikke anvendes af
English: If jaundice is observed, drug
Danish: Hvis icterus observeres, bør behandlingen afbrydes.
English: The majority of the fractures were reported in the upper limbs and distal lower limbs (see
Danish: Hovedparten af frakturerne var i overekstremiteterne og de distale
English: In clinical trials, the glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Danish: Den stiger til næsten maksimal reduktion i fastende plasmaglucose (FPG), hvilket er påviseligt efter ca. 8 ugers behandling.
English: The maximum dose is one combined tablet of 8 mg rosiglitazone and 4 mg glimepiride, taken once a day.
Danish: Den maksimale dosis er en tablet (8 mg rosiglitazon og 4 mg glimepirid) en gang dagligt.
English: In addition, rosiglitazone preserved ß-cell function as shown by increased pancreatic islet mass and insulin content and prevented the development of overt hyperglycaemia in animal models of type 2 diabetes.
Danish: Rosiglitazon forhindrede dertil udviklingen af udtalt hyperglykæmi i dyremodeller af type 2-diabetes.
English: NAME OF THE MEDICINAL PRODUCT AVAGLIM 4 mg/4 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN AVAGLIM 4 mg/4 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT AVAGLIM 8 mg/4 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN AVAGLIM 8 mg/4 mg filmovertrukne tabletter
English: Î Check with your doctor, as Avaglim may not be suitable for you.
Danish: Det er ikke sikkert, at Avaglim er den rigtige behandling til dig.
English: The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM
Danish: Startdosis er 4 mg rosiglitazon plus 4 mg glimiprid dagligt (givet som en AVAGLIM tablet 4 mg/4 mg).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon og 4 mg glimepirid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon og 4 mg glimepirid.
English: Rosiglitazone should be discontinued if any deterioration in
Danish: Rosiglitazon skal seponeres ved enhver klinisk forringelse i den kardiale status.
English: - contains lactose (approximately 104 mg) For a full list of excipients, see section 6.1.
Danish: Indeholder lactose (hver tablet indeholder ca. 104 mg).
English: If glimepiride is taken simultaneously with certain other medicines, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Danish: Samtidig administration af glimepirid og andre lægemidler kan føre til, at glimepirids hypoglykæmiske virkning forstærkes eller nedsættes på en måde, som ikke er ønsket.
English: - contains lactose (approximately 235 mg) For a full list of excipients, see section 6.1.
Danish: Indeholder lactose (hver tablet indeholder ca. 235 mg).
English: A switch to insulin should be considered in stress situations (e.g. trauma, surgery, infections).
Danish: • stressede situationer (såsom traume, operation eller infektioner)
English: In their entirety, the available data on the risk of cardiac ischaemia are
Danish: Alt i alt kan der ikke drages nogen konklusion ud fra de foreliggende oplysninger om risikoen for myokardieiskæmi.
English: Elderly: In the pooled population pharmacokinetic analysis, age was not found to influence the pharmacokinetics of rosiglitazone or glimepiride to any significant extent.
Danish: Ældre: I den farmakokinetiske analyse med poolet population havde alder ingen signifikant
English: Administration with other medicinal products
Danish: • samtidig brug af andre lægemidler til behandling af diabetes
English: Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Danish: Hver tablet indeholder rosiglitazonmaleat svarende til 4 mg rosiglitazon og 4 mg glimepirid
English: Î Tell your doctor or pharmacist if any of the side effects listed gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre eller du får
English: Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
Danish: Hver tablet indeholder rosiglitazonmaleat svarende til 8 mg rosiglitazon og 4 mg glimepirid
English: Î Tell a doctor or pharmacist if you think that Avaglim is not working as it should, particularly if you are taking any other medicines.
Danish: Fortæl det til din læge eller på apoteket, hvis du mener, at du ikke får effekt af Avaglim.
English: The potential
Danish: Bivirkning
English: The dose of your
Danish: Symptomerne på
English: General disorders and administration site conditions oedema
Danish: Almene symptomer og reaktioner på administrationsstedet Ødem
English: 4.2 Posology and method of administration
Danish: 6.5 Emballagetype og pakningsstørrelser
English: Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Danish: Der bør derfor udvises forsigtighed, når patienter med G6PD-mangel behandles med glimepirid, og behandling med et stof fra en anden
English: Rare hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5 Rare Skin and subcutaneous tissue disorders (see Immune system disorders)
Danish: Immunsystemet (se Sygdomme i hud og subkutane væv) Anafylaktisk reaktion
English: This will help to protect the environment.
Danish: Dette vil kræve anden behandling.
English: The clinical significance of the glucose-lowering effect of M1 is unclear.
Danish: I kliniske undersøgelser indtræder den glucosesænkende effekt langsomt.
English: If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Danish: Kontakt lægen eller apoteket, hvis du kommer til at tage for mange tabletter.
English: Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Danish: Glimepirids hypoglykæmiske virkning nedsættes med en deraf følgende ringere metabolisk kontrol, hvis glimepirid administreres samtidigt med lægemidler, som indeholder følgende aktive stoffer:
English: Rare congestive heart failure/pulmonary oedema
Danish: Knogler, led, muskler og bindevæv Frakturer4
English: Avaglim 8 mg/4 mg tablets are red, rounded triangular-shaped, and marked "gsk" on one side and
Danish: Avaglim 8 mg/4 mg er røde, afrundede trekantede tabletter.
English: 05 October 2012
Danish: Den 5. oktober 2012
English: The full European Public Assessment Report for Erbitux can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Erbitux findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Erbitux is an anticancer medicine which has been authorised in the European Union (EU) since 29 June 2004.
Danish: Erbitux er et kræftmiddel, der har været godkendt i Den Europæiske Union (EU) siden den 29. juni 2004.
English: When it attaches to EGFR, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Danish: Når det bindes til EGFR, kan kræftcellerne ikke længere modtage de signaler, der får dem til at vokse, udvikles og spredes.
English: In the study, patients were given cisplatin and vinorelbine (two chemotherapy medicines) with or without Erbitux.
Danish: I undersøgelsen fik patienterne cisplatin og vinorelbin (to kemoterapi-midler) med eller uden Erbitux.
English: The applicant presented a re-analysis of the data from one main study involving 1,125 patients with advanced or metastatic non-small cell lung cancer with EGFR.
Danish: Ansøgeren fremlagde en fornyet analyse af data fra én hovedundersøgelse med deltagelse af 1 125 patienter med fremskreden eller metastatisk ikke-småcellet lungekræft med EGFR.
English: What is happening with Erbitux for the treatment of other diseases?
Danish: Hvad vil der ske med brugen af Erbitux til behandling af andre sygdomme?
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækningen af ansøgningen, kan ses under fanen “All documents”.
English: It was to be used in combination with platinum-based chemotherapy in patients who had not been treated before.
Danish: Det skulle anvendes sammen med platinbaseret kemoterapi til tidligere ubehandlede patienter.
English: There are no consequences on the use of Erbitux in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Erbitux til de godkendte indikationer.
English: In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Danish: Til lokalt fremskreden kræft (hvor svulsten er vokset, men ikke har bredt sig), gives Erbitux sammen med strålebehandling.
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far are not sufficient to address CHMP's concerns and that more data will be needed.
Danish: I sit officielle brev angav virksomheden, at den havde besluttet at trække ansøgningen tilbage på baggrund af CHMP's holdning, dvs. at de hidtil forelagte data ikke var tilstrækkelige til at imødekomme udvalgets betænkeligheder, og at det ville være nødvendigt med yderligere data.
English: In non-small cell lung cancer, Erbitux was expected to work in the same way as it does in its existing indications.
Danish: Ved ikke-småcellet lungekræft forventedes Erbitux at virke på samme måde som ved de eksisterende anvendelser.
English: Erbitux was also expected to be used to treat advanced or metastatic non-small cell lung cancer, when the tumour cells have high levels of EGFR on their surface.
Danish: Erbitux forventedes desuden anvendt til behandling af fremskreden eller metastatisk ikke-småcellet lungekræft, hvor kræftcellerne har et højt niveau af EGFR på overfladen.
English: Erbitux is also used to treat squamous cell cancers of the head and neck.
Danish: Erbitux anvendes desuden til behandling af pladecellekræft i hoved og hals.
English: The study had been previously used to support an application for the use of Erbitux in non-small cell lung cancers, but this application had been refused.
Danish: Undersøgelsen var tidligere blevet fremlagt som støtte for en ansøgning om anvendelse af Erbitux til ikke-småcellet lungekræft, men denne anvendelse var ikke blevet godkendt.
English: The active substance in Erbitux, cetuximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to EGFR, which can be found on the surface of some tumour cells.
Danish: Det aktive stof i Erbitux, cetuximab, er et monoklonalt antistof, en type protein, der er fremstillet således, at det genkender og bindes til EGFR, der findes på overfladen af visse kræftceller.
English: Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain a ‘wildtype' (non-mutated) gene called ‘KRAS'.
Danish: Erbitux anvendes til patienter, hvis kræftceller bærer overfladeproteinet epidermal vækstfaktor (EGFR) og indeholder et “vildtype”-gen (et ikke-muteret gen), der kaldes “KRAS”.
English: It is used to treat adults with colorectal cancer (a cancer of the large intestine) when the cancer is metastatic (has spread to other parts of the body).
Danish: Det anvendes til behandling af kolorektal cancer (tyktarmskræft), som er metastatisk (dvs. har bredt sig til andre dele af kroppen).
English: In cancer that is recurrent (has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination.
Danish: Hvis kræften er vendt tilbage efter forudgående behandling eller er metastatisk, anvendes Erbitux i kombination med platinbaseret kræftmedicin.
English: In colorectal cancer it can be used in combination with chemotherapy (medicines to treat cancer) or on its own.
Danish: Ved tyktarmskræft kan det enten anvendes sammen med kemoterapi (en gruppe lægemidler mod kræft) eller som eneste behandling.
English: The Committee was concerned that, although the re-analysis of the data indicated that there might be a beneficial effect on survival for patients whose tumour cells had high levels of EGFR, there were some concerns, particularly over the way that patients had been categorised into high or low EGFR level groups in the retrospective analysis, as well as the fact that the effect seen in patients with high EGFR levels in the main study had not been confirmed in another study.
Danish: Selv om den fornyede analyse af dataene viste, at der muligvis var en gunstig virkning på overlevelsen af patienter med kræftceller med højt niveau af EGFR, var der i udvalget betænkelighed ved den måde, patienterne var blevet kategoriseret på i grupper med henholdsvis højt og lavt EGFR-niveau ved den retrospektive (tilbageskuende) analyse.
English: The company informed the CHMP that there were no ongoing clinical trials with Erbitux in non-small cell lung cancer at the time of the withdrawal.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med Erbitux til ikke-småcellet lungekræft.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Erbitux eller i programmer for anvendelse af Erbitux med særlig udleveringstilladelse?
English: The company presented an analysis of the study data, comparing the survival of patients whose tumour cells had high levels of EGFR on their surface, with the survival of patients whose tumours had low levels of EGFR.
Danish: Virksomheden fremlagde en analyse af undersøgelsesdataene, der sammenlignede overlevelsen hos patienter med henholdsvis højt og lavt niveau af EGFR på overfladen af kræftcellerne.
English: On 17 September 2012, Merck KGaA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Erbitux, to extend its use in the treatment of non-small cell lung cancer.
Danish: (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af markedsføringstilladelsen for Erbitux med henblik på tilføjelse af anvendelse til behandling af ikke-småcellet lungekræft.
English: Therefore, at the time of the withdrawal, the CHMP concluded that the medicine could not have been approved based on the data presented by the company and that further studies were required to confirm the benefit of Erbitux in patients whose tumour cells have high EGFR levels.
Danish: CHMP konkluderede derfor på tilbagetrækningstidspunktet, at lægemidlet ikke kunne godkendes på grundlag af de oplysninger, virksomheden havde fremlagt.
English: Based on the review of the data and the company's response to the questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Erbitux could not have been approved for the treatment of non-small cell lung cancer.
Danish: Efter gennemgang af de foreliggende oplysninger og virksomhedens besvarelse af CHMP's spørgsmål havde udvalget på tilbagetrækningstidspunktet visse betænkeligheder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Multaq on 26 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Multaq den 26. november 2009.
English: Multaq dronedarone
Danish: Multaq dronedaron
English: The full EPAR for Multaq can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Multaq findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Multaq.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Multaq.
English: Multaq contains the active substance dronedarone.
Danish: Multaq indeholder det aktive stof dronedaron.
English: Multaq should only be prescribed after alternative treatment options have been considered.
Danish: Multaq bør først ordineres, efter at der er overvejet alternative behandlingsmuligheder.
English: This followed a review of data that became available since its authorisation including data from the PALLAS study.1
Danish: Dette skete efter en gennemgang af data, som blev tilgængelige efter lægemidlets godkendelse, herunder data fra PALLASundersøgelsen.1
English: However, more patients taking amiodarone had to stop treatment because of side effects.
Danish: Flere af de patienter, som fik amiodaron, måtte imidlertid stoppe med behandlingen på grund af bivirkninger.
English: It must also not be used in patients with some other heart problems, such as some problems with the electrical activity, very slow heart beats or heart failure.
Danish: Det må desuden ikke anvendes til patienter med visse andre hjerteproblemer såsom problemer med elektrisk aktivitet , meget langsom hjerterytme, eller hjerteinsufficiens.
English: Multaq must not be used in patients who have severe problems with their liver or kidneys.
Danish: Multaq må ikke anvendes til patienter, som har svære problemer med deres lever eller nyrer.
English: Other information about Multaq
Danish: Andre oplysninger om Multaq: