FrancophonIA/ELRC3.0 huggingface dataset:
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Danish: 6.1. hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV).
English: What Glustin is and what it is used for What you need to know before you take Glustin How to take Glustin
Danish: Det skal De vide, før De begynder at tage Glustin Sådan skal De tage Glustin Bivirkninger
English: If you take more Glustin than you should
Danish: Hvis De har taget for meget Glustin
English: Glustin 15 mg tablets pioglitazone
Danish: LÆGEMIDLETS NAVN Glustin 15 mg tabletter pioglitazon
English: Glustin 30 mg
Danish: INFORMATION I BRAILLESKRIFT Glustin 30 mg
English: Investigations weight increased6
Danish: Unde rs øge ls e r øget vægt6
English: Glustin 45 mg
Danish: INFORMATION I BRAILLESKRIFT Glustin 45 mg
English: Renal impairment
Danish: Svimmelhed almindelig
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: Indberetning af formodede bivirkninger
English: Package leaflet: Information for the patient Glustin 15 mg tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Glustin 15 mg tabletter
English: Eye disorders visual disturbance2
Danish: Øjne synsforstyrrelser2 almindelig almindelig ikke almindelig
English: Glustin with food and drink
Danish: Brug af Glustin sammen med mad og drikke De kan tage Deres tabletter i forbindelse med et måltid, men det er ikke nødvendigt.
English: nausea or vomiting).
Danish: − blærecancer i anamnesen
English: 14 January 2013
Danish: Den 14. januar 2013
English: The European Commission issued a decision on 14 January 2013.
Danish: Europa-Kommissionen traf en afgørelse den 14. januar 2013.
English: It controls many body functions, mainly to do with growth and energy.
Danish: Det regulerer mange af kroppens funktioner, hovedsagelig dem, der vedrører vækst og energi.
English: It was to be available as oral drops (100 microgram/ml).
Danish: Det var hensigten, at det skulle leveres som orale dråber (100 µg/ml).
English: EMA/659681/2012 Rev1.
Danish: EMA/659681/2012
English: This could potentially lead to medication errors and pose a risk to public health.
Danish: Dette kunne potentielt medføre fejlmedicinering og kunne være en risiko for den offentlige sundhed.
English: Since the solution is highly concentrated and the active substance highly potent, there was an unacceptable risk of serious medication errors.
Danish: Da opløsningen er stærkt koncentreret og det aktive indholdsstof er meget kraftigt virkende, var der en uacceptabel risiko for alvorlige medicineringsfejl.
English: However, the Member States were not able to reach an agreement and the Dutch agency referred the matter to the CHMP for arbitration on 26 January 2012.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den nederlandske lægemiddelstyrelse indbragte den 26. januar 2012 sagen for CHMP til voldgift.
English: On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Levothyroxine Alapis.
Danish: Den 18. oktober 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union vedrørende godkendelsen af lægemidlet Levothyroxine Alapis.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that there was a risk that the dropper used for delivery might deliver variable doses, and that large numbers of drops might be hard to count.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget afgjorde CHMP, at der var risiko for, at den anvendte dråbetæller kunne afgive varierende doser, og at det kunne være vanskeligt at tælle så stort et antal dråber.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and the marketing authorisation cannot be granted in the Netherlands or in the following EU Member States: Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Levothyroxine Alapis ikke opvejer risiciene, og at der ikke kan udstedes markedsføringstilladelse i Nederlandene eller i følgende EU-medlemsstater: Belgien, Bulgarien, Cypern, Det Forenede Kongerige, Grækenland, Malta, Portugal, Rumænien og Tyskland.
English: Therefore the CHMP concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Levothyroxine Alapis ikke opvejer risiciene, og at der ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater.
English: In addition, there remained concern over the safety of the long-term use of the ingredients ethanol and propylene glycol in children, and some groups of adults such as those with alcoholism.
Danish: Desuden var der fortsat betænkelighed vedrørende sikkerheden af den langvarige anvendelse af indholdsstofferne ethanol og propylenglycol hos børn og hos visse grupper af voksne såsom alkoholikere.
English: In addition there were concerns over the safety of the combined long-term use of the ingredients ethanol and propylene glycol at the proposed concentrations, particularly in children.
Danish: Derudover var der betænkelighed ved sikkerheden af kombineret langvarig brug af indholdsstofferne ethanol og propylenglycol i de ansøgte koncentrationer, navnlig til børn.
English: EMEA/H/A-29/1328
Danish: EMA/659681/2012 rev. 1 EMEA/H/A-29/1328
English: • a condition known as Hashimoto's thyroiditis, in which the immune system (the body's natural defences) attacks the thyroid causing it to swell and preventing it from working properly;
Danish: • sygdommen Hashimotos thyroiditis, hvor immunsystemet (kroppens naturlige forsvar) angriber skjoldbruskkirtlen, så den hæver og ikke fungerer rigtigt
English: • thyroid cancer.
Danish: • skjoldbuskkirtelkræft.
English: Thyroxine is normally produced in the body by the thyroid gland in the neck.
Danish: Thyroxin produceres normalt i kroppen af skjoldbruskkirtlen i halsen.
English: Alapis S.A. submitted an application for Levothyroxine Alapis to the Dutch medicines regulatory agency for a decentralised procedure.
Danish: Alapis S.A. ansøgte om godkendelse af Levothyroxine Alapis hos den nederlandske lægemiddelstyrelse ved en decentral procedure.
English: What is Levothyroxine Alapis?
Danish: Hvad er Levothyroxine Alapis?
English: Why was Levothyroxine Alapis reviewed?
Danish: Hvorfor blev Levothyroxine Alapis vurderet igen?
English: The active substance in Levothyroxine Alapis, levothyroxine sodium, is a synthetic form of the hormone thyroxine.
Danish: Det aktive stof i Levothyroxine Alapis, levothyroxinnatrium, er en syntetisk form af hormonet thyroxin.
English: • conditions in which the thyroid gland is underactive (hypothyroidism, including diffuse non-toxic goitre) and so does not make enough thyroxine for the body's needs;
Danish: • sygdomme, hvor skjoldbruskkirtlen ikke er tilstrækkelig aktiv (hypotyroidisme, herunder diffus ikke-toksisk struma) og derfor ikke producerer tilstrækkeligt med thyroxin
English: Levothyroxine Alapis was intended to be used to treat:
Danish: Det var hensigten, at Levothyroxine Alapis skulle anvendes til behandling af:
English: Levothryoxine Alapis is a medicine that contains the active substance levothyroxine sodium.
Danish: Levothyroxine Alapis er et lægemiddel, der indeholder det aktive stof levothyroxinnatrium.
English: Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom).
Danish: Ved sådanne procedurer vurderer én medlemsstat ("referencemedlemsstaten", her Nederlandene) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", her Belgien, Bulgarien, Cypern, Det Forenede Kongerige, Grækenland, Malta, Portugal, Rumænien og Tyskland).
English: The grounds for the referral were concerns raised by the UK related to the dropper insert as a proposed administration device, due to the large number of drops that may be required and concerns about its accuracy in delivering the required dose.
Danish: Betænkelighederne vedrørte det store antal dråber, der kunne være nødvendigt, og dråbetællerens nøjagtighed ved afgivelse af den nødvendige dosis.
English: 30 mg Capsule, hard Oral use bottle (HDPE)
Danish: Oral anvendelse Flaske (HDPE) 56 kapsler
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Indre emballage Pakningsstørrelse
English: This summary was last updated in 07-2012.
Danish: Dette sammendrag blev sidst ajourført i 07-2012.
English: ‘Complicated' means that the infection is difficult to treat;
Danish: ”Kompliceret” betyder, at infektionen er svær at behandle.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Doribax on 25 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Doribax den 25. juli 2008.
English: The standard dose of Doribax is 500 mg every eight hours.
Danish: Standarddosis af Doribax er 500 mg hver ottende time.
English: The full EPAR for Doribax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Doribax findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used to treat the following infections in adults:
Danish: Det anvendes hos voksne til behandling af følgende infektioner:
English: This is a summary of the European public assessment report (EPAR) for Doribax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Doribax.
English: It works by attaching to certain types of protein on the surface of the bacteria cells.
Danish: Det virker ved at angribe visse proteintyper på overfladen af bakteriecellerne.
English: Each infusion lasts for one hour, although some patients with nosocomial pneumonia may need infusions lasting four hours.
Danish: Hver infusion varer en time, selv om nogle patienter med nosokomiel pneumoni kan have brug for infusioner, som varer fire timer.
English: The CHMP decided that Doribax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Doribax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effect with Doribax (seen in more than 1 patient in 10) is headache.
Danish: Den hyppigste bivirkning ved Doribax (som ses hos mere end 1 ud af 10 patienter) er hovedpine.
English: Other information about Doribax
Danish: Andre oplysninger om Doribax
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Doribax.
English: Because the medicine is removed from the body by the kidneys, the dose should be reduced in patients who have moderately or severely reduced kidney function.
Danish: Da medicinen udskilles fra kroppen via nyrerne, bør dosen nedsættes hos patienter, som har moderate eller svære problemer med nyrerne.
English: For more information about treatment with Doribax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Doribax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Doribax is an antibiotic.
Danish: Doribax er et antibiotikum.
English: It must not be used in patients who are severely allergic to other ‘beta-lactam' antibiotics, such as penicillins or cephalosporins.
Danish: Det må ikke anvendes til patienter, som har svær allergi over for andre "beta-lactam"-antibiotika som penicillin eller cefalosporin.
English: • complicated infections of the urinary tract (the structures that carry urine).
Danish: • Komplicerede infektioner i urinvejene (de strukturer, som leder urinen).
English: Before using Doribax, doctors should consider official guidance on the use of antibiotics.
Danish: Før Doribax anvendes, bør lægen læse eventuelle officielle retningslinjer for korrekt brug af antibiotika.
English: Treatment usually continues for between five and 14 days, depending on the type and severity of the infection and the patient's response (10 to 14 days are usually needed in nosocomial pneumonia).
Danish: Behandlingen varer som regel mellem fem og 14 dage afhængig af infektionens type og sværhedsgrad, og hvordan patienten reagerer på behandlingen.
English: Doribax was as effective as the other antibiotics in treating the infections:
Danish: Doribax var lige så effektivt til behandling af infektioner som de andre antibiotika:
English: The active substance in Doribax, doripenem, is an antibiotic that belongs to the group ‘carbapenems'.
Danish: Det aktive stof i Doribax, doripenem, er et antibiotikum, som tilhører gruppen af ‘carbapenemer'.
English: Doribax must not be used in people who are hypersensitive (allergic) to doripenem or to other carbapenems.
Danish: Doribax bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for doripenem eller andre carbapenemer.
English: • complicated infections in the abdomen.
Danish: • Komplicerede infektioner i maven.
English: It is available as a powder to be made up into a solution for infusion (drip into a vein).
Danish: Det fås som et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Doribax is a medicine containing the active substance doripenem.
Danish: Doribaxer et lægemiddel, der indeholder det aktive stof doripenem.
English: Why has Doribax been approved?
Danish: Hvorfor blev Doribax godkendt?
English: What is the risk associated with Doribax?
Danish: Hvilken risiko er der forbundet med Doribax?
English: For the full list of all side effects reported with Doribax, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Doribax fremgår af indlægssedlen.
English: • two studies compared Doribax with meropenem in a total of 962 patients with complicated
Danish: • To undersøgelser sammenlignede Doribax med meropenem hos i alt 962 patienter med
English: When treating nosocomial pneumonia, a dose of 1 g every eight hours infused over four hours may be considered for patients who have augmented renal clearance (where the kidneys clear the medicine from the body too quickly) or whose infection is caused by certain types of bacteria.
Danish: Ved behandling af nosokomiel pneumoni kan det til patienter, som har forhøjet nyreclearance (hvis nyrerne udskiller medicinen for hurtigt fra kroppen), eller hvis infektion er forårsaget af visse typer af bakterier, overvejes at anvende en dosis på 1 g hver ottende time.
English: • in complicated urinary tract infections, 82% of the patients receiving Doribax were cured (230 out of 280), compared with 83% of the patients receiving levofloxacin (221 out of 265).
Danish: • Ved komplicerede urinvejsinfektioner blev 82 % af de patienter, som fik Doribax, helbredt (230 ud af 280) sammenlignet med 83 % af de patienter, som fik levofloxacin (221 ud af 265)
English: • nosocomial pneumonia (an infection of the lungs).
Danish: • Nosokomiel pneumoni (en infektion i lungerne) "Nosokomiel" betyder, at man har fået infektionen på et hospital.
English: • looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/tazobactam or imipenem (174 out of 241);
Danish: • Ifølge de samlede resultater af de to undersøgelser med nosokomiel pneumoni, blev 75 % af de patienter, som fik Doribax, helbredt (195 ud af 260) sammenlignet med 72 % af de patienter, som tog piperacillin/tazobactam eller imipenem (174 ud af 241).
English: ‘Nosocomial' means that the infection was caught in hospital, including pneumonia caused by the use of a ventilator (a machine that helps a
Danish: Dette inkluderer lungebetændelse, som skyldes brug af en ventilator (en maskine,
English: How does Doribax work?
Danish: Hvordan virker Doribax?
English: • looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309);
Danish: • Ifølge de samlede resultater af de to undersøgelser med komplicerede infektioner i maven, blev 85 % af de patienter, som fik Doribax, helbredt (275 ud af 325) sammenlignet med 84 % af de
English: This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
Danish: Det forhindrer bakterierne i at opbygge deres cellevægge, hvilket dræber bakterierne Der findes en liste over de bakterier, som Doribax virker mod, i produktresuméet (der også er en del af denne EPAR).
English: What benefit has Doribax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Doribax?
English: • one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract
Danish: • En undersøgelse sammenlignede Doribax med levofloxacin hos 753 patienter med komplicerede I alle undersøgelserne var det primære mål for virkningen antallet af patienter, hos hvem infektionen forsvandt.
English: Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/tazobactam or imipenem in a total of 979 patients
Danish: Doribax blev undersøgt i fem hovedundersøgelser, som sammenlignede Doribax med andre antibiotika.
English: 26 July 2013
Danish: Den 26. juli 2013
English: It has been authorised in the European Union since 4 April 2008.
Danish: Effentora har været godkendt i Den Europæiske Union siden den 4. april 2008.
English: The full European Public Assessment Report for Effentora 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 Effentora findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is a well-known substance, which has been used to control pain for many years.
Danish: Det er et velkendt stof, som i mange år har været anvendt til at kontrollere smerter.
English: Each patient ranked their pain intensity on a scale of 0 to 10.
Danish: Hver patient vurderede styrken af smerterne på en skala fra 0 til 10.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Effentora og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Danish: Behandlingsvarigheden blev bestemt som den tid, hver patient behøvede til at kontrollere 9 episoder med gennembrudssmerter inden for en 21-dages periode.
English: The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
Danish: Virkningerne af Effentora blev sammenlignet med virkningerne af placebo (en virkningsløs behandling) hos 79 patienter med neuropatiske smerter (smerter pga. nervebeskadigelse) i én undersøgelse og hos 77 patienter med lænderygsmerter i en anden undersøgelse.
English: In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
Danish: I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, efter at CHMP havde tilkendegivet, at de forelagte oplysninger ikke var tilstrækkelige til at imødekomme udvalgets betænkeligheder.
English: There are no consequences on the use of Effentora in its authorised indication.
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Effentora til den godkendte indikation.
English: What was Effentora expected to be used for?
Danish: Hvad forventedes Effentora anvendt til?
English: Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Danish: Effentora leveres som “bukkaltabletter” (tabletter, der opløses i munden).
English: The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Danish: Ansøgeren fremlagde data fra 3 hovedundersøgelser hos voksne, som havde gennembrudssmerter og i forvejen brugte opioider.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Effentora.
English: In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
Danish: I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på styrken af smerterne i de første 60 minutter efter indtagelse af tabletter.
English: The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
Danish: Den tredje undersøgelse, der varede i 12 uger, vedrørte virkningerne af Effentora hos 148 patienter med længerevarende smerter af anden årsag end kræft.
English: How was Effentora expected to work?
Danish: Hvordan forventedes Effentora at virke?
English: The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Danish: Udvalget fandt det også betænkeligt, at patienterne i undersøgelserne havde et højt niveau af baggrundssmerter og ikke nødvendigvis var repræsentative for den påtænkte behandlingsgruppe, dvs. patienter, som har gennembrudssmerter, men hvis baggrundssmerter i øvrigt er velkontrollerede ved regelmæssig behandling med opioider.
English: What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
Danish: Hvad vil der ske med brugen af Effentora til behandling af “gennembrudssmerter” hos voksne med kræft?
English: Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Danish: Når fentanyl er optaget, virker det på receptorer i hjernen og rygmarven og kontrollerer derved smerterne.
English: It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Danish: Det anvendes i forvejen til behandling af “gennembrudssmerter” hos voksne, som anvender opioide smertestillende midler til kontrol af længerevarende kræftbetingede smerter.