FrancophonIA/ELRC3.0 huggingface dataset:
English: Each powder vial contains 75 mg aztreonam.
Danish: Hvert hætteglas med pulver indeholder 75 mg aztreonam.
English: Cayston 75 mg powder and solvent for nebuliser solution.
Danish: Cayston 75 mg pulver og solvens til opløsning til nebulisator.
English: Each vial contains aztreonam lysine equivalent to 75 mg aztreonam.
Danish: Hvert hætteglas indeholder aztreonamlysin svarende til 75 mg aztreonam.
English: Cayston is indicated for use in paediatric patients aged 6 years and older with repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy based on the above clinical experience.
Danish: Baseret på ovenstående kliniske erfaring er Cayston indiceret til pædiatriske patienter i alderen 6 år og derover i gentagne serier med 28 dages behandling efterfulgt af 28 dage uden behandling med Cayston.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON OUTER CARTON (With a Blue Box - Not for co-packaging with the Altera Nebuliser Handset)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL CAYSTON (med blue box-information - til pakningen uden Altera-nebulisatoren)
English: The emergence of parenteral P. aeruginosa resistance to aztreonam and other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Danish: Fremkomst af parenteral P. aeruginosa-resistens over for aztreonam og over for andre beta-laktamantibiotika kan have mulige konsekvenser for behandlingen af lungeeksacerbationer med systemiske antibiotika.
English: No dose adjustment is necessary in cases of hepatic impairment.
Danish: Dosisjustering er ikke nødvendig ved nedsat leverfunktion.
English: Powder and solvent for nebuliser solution 42 single-use vials
Danish: Pulver og solvens til opløsning til nebulisator 42 hætteglas til engangsbrug 44 1 ml-ampuller med solvens til engangsbrug
English: To re-start the treatment, press and hold the On/Off button for one full second and then restart the treatment.
Danish: Tryk på knappen On/Off i et helt sekund for at genoptage inhalationen.
English: Cayston 75 mg powder for nebuliser solution aztreonam
Danish: Cayston 75 mg pulver til opløsning til nebulisator aztreonam
English: Remove the medicine cap by twisting anticlockwise.
Danish: Fjern medicindækslet ved at dreje imod uret.
English: How to take Cayston
Danish: Sådan skal du bruge Cayston
English: Cayston 75 mg powder and solvent for nebuliser solution aztreonam
Danish: Cayston 75 mg pulver og solvens til opløsning til nebulisator aztreonam
English: Powder and solvent for nebuliser solution 84 single-use vials
Danish: Pulver og solvens til opløsning til nebulisator 84 hætteglas til engangsbrug 88 1 ml-ampuller med solvens til engangsbrug
English: dose was recovered in the urine by 8 hours, and urinary excretion was essentially complete by 12 hours.
Danish: Hos raske personer i studiet blev 60-70% af en enkelt i.m.- eller i.v.-dosis genfundet i urinen efter 8 timer, og efter 12 timer var udskillelsen i urinen praktisk talt afsluttet.
English: Using the Altera Nebuliser to take your Cayston
Danish: Klargøring af Altera-forstøveren til brug af Cayston
English: LIST OF EXCIPIENTS
Danish: Koncentrationer i ekspektorat
English: cough, nasal congestion, wheezing, pharyngolaryngeal pain, dyspnoea
Danish: Meget almindelig: hoste, tilstoppet næse, hvæsende vejrtrækning, faryngolaryngeale smerter,
English: The emergence of parenteral P. aeruginosa resistance to aztreonam or other beta-lactam antibiotics may have potential consequences for the treatment of acute pulmonary exacerbations with systemic antibiotics.
Danish: Hvis der opstår parenteral P. aeruginosa-resistens over for aztreonam eller andre betalaktamantibiotika, kan det muligvis have konsekvenser for behandling af lungeeksacerbationer med systemiske antibiotika.
English: Musculoskeletal and connective tissue disorders: Common:
Danish: Knogler, led, muskler og bindevæv: Almindelig:
English: How to take Cayston using the Altera Nebuliser Handset
Danish: Sådan skal du bruge Cayston med Altera-forstøveren
English: antipseudomonal antibiotics related to respiratory events compared to TNS-treated patients (p = 0.0025).
Danish: Patienter, der blev behandlet med aztreonam, oplevede, at der gik længere tid, før der var behov for i.v.-antibiotika mod pseudomonasrelateret lungeinfektion sammenlignet med TNS-behandlede patienter (p=0,0025).
English: This leaflet was last revised in .
Danish: De foreliggende data er beskrevet i pkt.
English: Haemoptysis
Danish: Hæmoptyse
English: Powder vial and solvent ampoule:
Danish: Hætteglas med pulver og ampul med solvens:
English: What Cayston is and what it is used for What you need to know before you take Cayston How to take Cayston
Danish: Det skal du vide, før du begynder at bruge Cayston Sådan skal du bruge Cayston Bivirkninger
English: Lung function test decreased
Danish: Nedsat nyre- og leverfunktion
English: Respiratory, thoracic and mediastinal disorders: Very common:
Danish: Luftveje, thorax og mediastinum:
English: Fertility, teratology, perinatal and postnatal studies were conducted with aztreonam for i.v.
Danish: Fertilitets-, teratologi-, perinatale og postnatale studier blev udført med aztreonam til i.v.-injektion med rotter ved daglige doser på op til 750 mg/kg uden bivirkninger.
English: Breathe normally (inhale and exhale) through the mouthpiece.
Danish: Træk vejret normalt (træk vejret ind og ud) igennem mundstykket.
English: If you take more Cayston than you should
Danish: Hvis du har brugt for meget Cayston
English: Systemic concentration of aztreonam following inhaled administration of Cayston is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection.
Danish: Den systemiske koncentration af aztreonam efter inhalation af Cayston er cirka 1% af den koncentration, som en standarddosis aztreonam til injektion resulterer i. Derfor og på grund af lav oral absorption er der meget lille sandsynlighed for, at nyfødte, der bliver ammet, udsættes for aztreonam, hvis moderen bliver behandlet med Cayston.
English: whereas MIC90 increased intermittently to 4 times the initial MIC.
Danish: Der blev ikke observeret nogen forøgelse i P. aeruginosa MIC50 (± 2 fortyndingstrin), hvorimod MIC90 intermitterende blev forøget til 4 gange den initiale MIC. I et 24ugers aktivt kontrolleret studie med Cayston-behandling blev der ikke observeret nogen forøgelse i P. aeruginosa MIC50 (± 2 fortyndingstrin), hvorimod MIC90 blev forøget til 4 gange den initiale MIC.
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Danish: Tel: + 31 (0) 20 718 36 98
English: Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: This summary was last updated in 03-2013.
Danish: Dette sammendrag blev sidst ajourført i 03-2013.
English: Pantoprazole-containing medicines have been available in the European Union (EU) since 1994.
Danish: Lægemidler indeholdende pantoprazol har kunnet fås i Den Europæiske Union (EU) siden 1994.
English: Patients should not take the medicine for longer than four weeks without consulting their doctor.
Danish: Patienten bør ikke tage lægemidlet i længere end fire uger uden at konsultere sin læge.
English: The European Commission granted a marketing authorisation valid throughout the EU for Somac Control on 12 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Somac Control den 12. juni 2009.
English: Because pantoprazole has been in use for many years, the applicant presented data from the scientific literature.
Danish: Da pantoprazol har været anvendt i mange år, fremlagde ansøgeren data fra faglitteraturen.
English: The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed.
Danish: Tabletterne bør sluges hele med væske før et måltid og må ikke tygges eller knuses.
English: The full EPAR for Somac Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Somac Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If there is no improvement in symptoms within two weeks of continuous treatment, patients should consult their doctor.
Danish: Hvis der ikke er nogen bedring i symptomerne inden for to ugers kontinuerlig behandling, bør patienten kontakte sin læge.
English: This is a summary of the European public assessment report (EPAR) for Somac Control.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Somac Control.
English: The recommended dose of Somac Control is one tablet once a day until symptoms have stopped.
Danish: Den anbefalede dosis Somac Control er én tablet én gang dagligt, indtil symptomerne forsvinder.
English: It is available as gastroresistant tablets (20 mg).
Danish: Det fås som enterotabletter (20 mg).
English: The main measure of effectiveness was the number of patients with symptoms of heartburn over the first two weeks of treatment.
Danish: Det primære effektmål var antallet af patienter med symptomer på halsbrand i løbet af de første to ugers behandling.
English: The patient may need to take the medicine for two to three days in a row for symptoms to improve.
Danish: Det kan være nødvendigt at tage lægemidlet i to til tre på hinanden følgende dage for at opnå en forbedring af symptomerne.
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Danish: Det må ikke anvendes sammen med atazanavir (et lægemiddel, der anvendes til behandling af humant immundefektvirus (HIV)).
English: Somac Control pantoprazole
Danish: Somac Control pantoprazol
English: The most common side effects with Somac Control (seen in around 1 patient in 100) are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Somac Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Danish: Dette forhindrer det aktive stof i at blive ødelagt af mavesyren.
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 Somac Control.
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 Somac Control.
English: For more information about treatment with Somac Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Somac Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Somac Control.
Danish: Det anvendes til langtidsbehandling og anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene) end Somac Control.
English: The CHMP noted that pantoprazole 20 mg was effective in the short-term treatment of reflux symptoms and that there is a long safety experience with the medicine as a prescription medicine.
Danish: CHMP konkluderede, at pantoprazol 20 mg var effektivt til korttidsbehandling af symptomer på refluks, og at der er lang erfaring med hensyn til sikkerheden ved lægemidlet som receptpligtigt lægemiddel.
English: Somac Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Danish: Somac Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
English: The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began.
Danish: Ansøgeren fremlagde desuden data fra to hovedundersøgelser, som vurderede virkningen af pantoprazol 20 mg hos i alt 563 voksne, som havde symptomer på syrerefluks, herunder mindst ét tilfælde af halsbrand i løbet af de sidste tre dage op til undersøgelsens start.
English: Somac Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Somac.
Danish: Somac Control svarer til et referencelægemiddel ved navn Somac, som allerede er godkendt i Den Europæiske Union (EU).
English: Somac Control is a medicine that contains the active substance pantoprazole.
Danish: Somac Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
English: Somac Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Danish: Somac Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
English: The CHMP therefore decided that Somac Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Somac Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Somac Control.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Danish: Det virker ved at blokere for "protonpumperne", som er proteiner i specialiserede celler i mavesækkens slimhinde, der pumper syren ind i maven.
English: The first study compared pantoprazole with placebo (a dummy treatment) in 219 adults, and the second compared it with ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults.
Danish: Den første undersøgelse sammenlignede pantoprazol med placebo (en uvirksom behandling) hos 219 voksne, og den anden sammenlignede det med ranitidin (et andet lægemiddel, som anvendes til behandling af symptomer på syrerefluks) hos 344 voksne.
English: In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking placebo (48 out of 111) had no heartburn after two weeks.
Danish: I den første undersøgelse havde 74 % af de patienter, der tog pantoprazol (80 ud af 108), og 43 % af de patienter, der tog placebo (48 ud af 111), ingen tilfælde af halsbrand efter to uger.
English: The reference medicine, Somac, is only available with a prescription.
Danish: Referencelægemidlet Somac udleveres kun efter recept.
English: The active substance in Somac Control, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Somac Control, pantoprazol, er en protonpumpehæmmer.
English: In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment.
Danish: I den anden undersøgelse havde 70 % af de patienter, der tog pantoprazol (121 ud af 172), og 59 % af de patienter, der tog ranitidin (102 ud af 172), ingen tilfælde af halsbrand efter to ugers behandling.
English: By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of acid reflux.
Danish: Ved at blokere for disse pumper reducerer pantoprazol syreproduktionen, hvorved symptomerne på syrerefluks mindskes.
English: Acid reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid regurgitation (acid flowing up into the mouth).
Danish: Syrerefluks er en tilstand, hvor mavesyren trænger op i spiserøret, hvilket medfører halsbrand og syreregurgitation (hvor syren trænger op i munden).
English: Other information about Somac Control
Danish: Andre oplysninger om Somac Control:
English: Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux.
Danish: Pantoprazol var mere effektivt end placebo og ranitidin til at forbedre symptomerne på syrerefluks.
English: Pantoprazole was also more effective than placebo at reducing symptoms of acid regurgitation.
Danish: Pantoprazol var også mere effektivt end placebo til at reducere symptomerne på syreregurgitation.
English: ‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
Danish: "Entero" betyder, at kapslens indhold passerer gennem maven og først bliver optaget, når det når ned i tarmene.
English: What is the risk associated with Somac Control?
Danish: Hvilken risiko er der forbundet med Somac Control?
English: Why has Somac Control been approved?
Danish: Hvorfor blev Somac Control godkendt?
English: Somac Control without medical supervision is appropriate.
Danish: CHMP var også af den opfattelse, at adgangen til Somac Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
English: For the full list of all side effects reported with Somac Control, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår af indlægssedlen.
English: What is Somac Control?
Danish: Hvad er Somac Control?
English: How has Somac Control been studied?
Danish: Hvordan blev Somac Control undersøgt?
English: What benefit has Somac Control shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Somac Control?
English: What is Somac Control used for?
Danish: Hvad anvendes Somac Control til?
English: How is Somac Control used?
Danish: Hvordan anvendes Somac Control?
English: How does Somac Control work?
Danish: Hvordan virker Somac Control?
English: What is the outcome of the review?
Danish: Hvad er resultatet af gennemgangen?
English: What is Diotop?
Danish: Hvad er Diotop?
English: EMA completes review following disagreement among EU Member States
Danish: EMA afslutter gennemgang efter uoverensstemmelse blandt medlemsstaterne
English: The two active substances in Diotop have different effects.
Danish: De to aktive stoffer i Diotop virker forskelligt.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Danish: Gennemgangen blev foretaget af EMA's udvalg for lægemidler til mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
English: The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Danish: Gennemgangen af Diotop blev indledt på foranledning af Det Forenede Kongerige, jf. artikel 29, stk. 4, i direktiv 2001/83/EF.
English: On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation.
Danish: Den 15. november 2018 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Diotop efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse.
English: The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.
Danish: Begrundelsen for indbringelsen var Tysklands betænkeligheder ved, at de data, som virksomheden havde fremlagt, ikke var tilstrækkelige til at påvise Diotops sikkerhed og effektivitet.
English: Why was Diotop reviewed?
Danish: Hvorfor blev der foretaget en gennemgang af Diotop?
English: Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State').
Danish: Temmler Pharma GmbH anmodede om, at markedsføringstilladelsen for Diotop, udstedt i Det Forenede Kongerige og Østrig i 2016, blev anerkendt i Tyskland ("den berørte medlemsstat").
English: Both diclofenac and omeprazole have been authorised in the EU for many years.
Danish: Både diclofenac og omeprazol har været godkendt i EU i mange år.
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diotop on 31/01/2019.
Danish: Europa-Kommissionen traf en juridisk bindende afgørelse for hele EU om markedsføringstilladelsen for Diotop den 31/01/2019.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den britiske lægemiddelstyrelse indbragte den 28. september 2018 sagen for EMA med henblik på voldgift.
English: The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Danish: Agenturet konkluderede, at fordelene ved Diotop opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Det Forenede Kongerige, kan anerkendes i andre EU-medlemsstater, hvor virksomheden har ansøgt om en markedsføringstilladelse.
English: The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop.
Danish: Agenturet fandt, at selv om den særlige kombination i Diotop (diclofenac 75 mg/omeprazol 20 mg) aldrig er blevet testet i et offentliggjort studie, er dataene fra studier med højere doser af diclofenac eller andre NSAID'er med omeprazol tilstrækkelige til at understøtte brugen af den specifikke kombination i Diotop.
English: The Agency therefore concluded that the benefits of Diotop outweigh its risks, and therefore the marketing authorisation for Diotop should be granted in Germany.
Danish: Agenturet konkluderede derfor, at fordelene ved Diotop opvejer risiciene, hvorfor der bør udstedes en markedsføringstilladelse for Diotop i Tyskland.
English: Diclofenac is a nonsteroidal antiinflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions.
Danish: Diclofenac er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), der anvendes til lindring af smerter og betændelse i forbindelse med en lang række tilstande.
English: Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately.
Danish: Diotop anvendes hos voksne patienter, som risikerer at udvikle mavesår, og hvis sygdom allerede reguleres med diclofenac og omeprazol, de to aktive stoffer i Diotop, taget hver for sig.
English: The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination.
Danish: Virksomheden fremlagde data fra den offentliggjorte faglitteratur om brugen af flere NSAID'er (herunder diclofenac i en dosis på 50-150 mg dagligt) i kombination med omeprazol.
English: EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU
Danish: EMA anbefaler godkendelse af Diotop (diclofenac/omeprazol i kapselform) i EU
English: EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU EMA/790726/2018
Danish: EMA anbefaler godkendelse af Diotop (diclofenac/omeprazol i kapselform) i EU EMA/98287/2019
English: Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.
Danish: Diotop er et lægemiddel, der anvendes til lindring af symptomer såsom hævelse og smerter forårsaget af ledsygdommene leddegigt, slidgigt eller Bechterews sygdom.