FrancophonIA/ELRC3.0 huggingface dataset:
English: Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony France
Danish: Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony Frankrig
English: Levviax is indicated for the treatment of the following infections:
Danish: Levviax er indiceret til behandling af følgende:
English: Pharmaco-therapeutic group (ATC Code):
Danish: Farmakoterapeutisk klassifikation (ATC kode):
English: LEVVIAX International Nonproprietary Name (INN): Telithromycin Abstract
Danish: LEVVIAX Internationalt fællesnavn (INN): Telithromycin Sammendrag
English: Adverse events assessed as possibly related to study treatment were reported for 35.8% of the telithromycin patients, versus 28.3% of the comparators.
Danish: Der blev indberettet bivirkninger, som muligvis kan tilskrives undersøgelsens behandling, for 35,8 % af de patienter, der var behandlet med telithromycin i forhold til 28,3 % af de patienter, der var behandlet med sammenligningsstoffer.
English: The initial approval was based on studies, which showed that the potential benefits with telithromycin particularly relate to its use in the treatment of infections caused by penicillin and/or erythromycin resistant S. pneumoniae.
Danish: Den oprindelige godkendelse var baseret på resultaterne af undersøgelser, der viste, at de potentielle fordele ved telithromycin især optræder ved anvendelse heraf til behandling af infektioner forårsaget af penicilin og/eller erythromycin-resistent S. pneumoniae.
English: The most common side effects are, as for macrolides, mainly reported from the digestive and nervous systems, with diarrhoea, nausea, headache and dizziness.
Danish: Som for macrolider er de hyppigste bivirkninger hovedsagelig observeret i forbindelse med fordøjelsessystemet og nervesystemet bl.a. diarré, opkastninger, hovedpine og svimmelhed.
English: The CHMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit risk ratio for Levviax is favourable in the approved indication
Danish: CHMP var på grundlag af de forelagte oplysninger om kvalitet, sikkerhed og virkning af den opfattelse, at der forelå et tilfredsstillende risk/benefit-forhold til den godkendte indikation.
English: EMEA/H/C/0355 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
English: However, clinical experience is still rather limited in the treatment of these infections, and therefore telithromycin should be used with caution until further experience of emergence of resistance has been gained, especially in areas with a high prevalence of resistant pneumococci.
Danish: Der foreligger dog kun begrænsede kliniske erfaringer med behandling af disse infektioner, og telithromycin bør derfor anvendes med forsigtighed, indtil der foreligger erfaringer med forekomst af resistens, især inden for områder med høj forekomst af resistent pneumokok.
English: Currently approved therapeutic indication(s):
Danish: Nuværende, gyldige indikation(er):
English: The active substance of Levviax is telithromycin, an antibacterial medicinal product which is a novel semi-synthetic antibacterial agent belonging to a new family of antibiotics, the ketolides, closely related to the well-known macrolide antibiotics.
Danish: Det aktive stof i Levviax er telithromycin, et nyt semisyntetisk antibakterielt middel (JO1), der tilhører en ny gruppe af semisyntetiske antibiotika, ketoliderne, som er nært beslægtet med det velkendte makrolidantibiotika.
English: Telithromycin interacts with the translation at the 23S ribosomal RNA level and some data also indicate that assembly of the 30S subunit may be impaired.
Danish: Telithromycin indgår i en gensidig påvirkning af oversættelsen på det 23S ribosomale RNA-niveau, og af data fremgår det også, at dannelsen af 30S
English: Clinical trials, in general, support similar efficacy of telithromycin and comparators in the indications investigated (CAP not clinically serious enough to warrant parenteral therapy but efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years, AECB, sinusitis, and pharyngotonsillitis caused by S. pyogenes).
Danish: Kliniske undersøgelser understøtter generelt, at telithromycin har samme virkning som sammenligningsstofferne i de undersøgte indikationer (samfundserhvervet pneumoni (CAP) er ikke klinisk alvorlig nok til at begrunde parental behandling, virkning er dog påvist hos et begrænset antal patienter med risikofaktorer såsom pneumokok bakteriæmi eller over 65 års alderen, med akutte eksacerbationer af kronisk bronkitis (AECB), sinusitis og pharyngotonsillitis forårsaget af S. pyogenes).
English: When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Når Levviax ordineres skal generelle retningslinjer vedrørende rationel brug af antibiotika følges.
English: The frequency and severity of increased hepatic enzyme activity and liver disease appear similar to clarithromycin but justify close post-marketing surveillance, as does the potential prolongation of the QT-interval
Danish: Hyppighed og sværhedsgrad af forhøjet leverenzymaktivitet og leversygdommme synes at svare til clarithromycin, men dette og den potentielle forlængelse af QT-intervallet begrunder dog en nøje kontrolundersøgelse efter markedsføringen.
English: For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules.
Danish: Se venligst de relevante moduler for nærmere oplysninger om anvendelsen af dette lægemiddel, den videnskabelige information eller oplysninger vedrørende procedurerne.
English: The pharmacological action of telithromycin involves inhibition of bacterial protein synthesis and is similar to that of macrolides, but
Danish: Telithromycins farmakologiske virkningsmekanisme medfører hæmning af den bakterielle proteinsynstese og svarer til makrolidernes virkningsmekanisme, men der
English: Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate
Danish: beta streptococci som alternativ når beta laktam antibiotika ikke er egnet.
English: Orphan medicinal product designation date:
Danish: Dato for udpegelse som lægemiddel til sjældne sygdomme:
English: In patients of 18 years and older: - Community-acquired pneumonia, mild or moderate, - Acute exacerbation of chronic bronchitis, - Acute sinusitis, - Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate.
Danish: Patienter på 12 år og opefter: - Tonsilitis/pharyngitis, forårsaget af gruppe A beta streptococci, som alternativ når betalaktam antibiotika ikke er egnet.
English: Authorised presentations:
Danish: Autoriserede pakningsstørrelser:
English: London, 15 November 2007 Doc.
Danish: London, den 15. november 2007 Dok.
English: This could have had an impact on the types of treatment chosen by doctors if they had relied on the test's results.
Danish: Det kunne have fået indflydelse på, hvilken form for behandling lægerne ville have valgt, hvis de havde stolet på testens resultater.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GASTROMOTAL
Danish: SPØRGSMÅL OG SVAR I FORBINDELSE MED TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGTILLADELSE for GASTROMOTAL
English: Gastromotal is a diagnostic test.
Danish: Gastromotal er en diagnostisk test.
English: This means that it contains 13C, a non-radioactive, rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Danish: Det betyder, at det indeholder 13C, en ikke-radioaktiv, sjælden form for kulatom, i stedet for kulstof-12 (12C), den mest almindeligt forekommende form i naturen.
English: This labelled carbon dioxide can be detected in breath samples taken every 15 to 30 minutes in the four hours after the test meal.
Danish: Den mærkede kuldioxid kan påvises i prøver af udåndingsluft, som tages hvert 15. til 30. minut i fire timer efter testmåltidet.
English: The application was at day 200 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 200, da virksomheden trak sin ansøgning tilbage.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: The CHMP was assessing the responses given by the company to a list of questions.
Danish: CHMP var i færd med at vurdere de svar, virksomheden havde givet på en række spørgsmål.
English: International non-proprietary name (INN): 1-13C-caprylic acid
Danish: Internationalt fællesnavn (INN): 1-13C-caprylsyre
English: In the main studies, the level of agreement between Gastromotal and the standard test was too low to be acceptable, resulting in a considerable risk of false positive and false negative results.
Danish: I hovedundersøgelserne var overensstemmelsen mellem Gastromotal og standardtesten for lille til at være acceptabel, hvilket resulterede i en betydelig risiko for falsk positive og falsk negative resultater.
English: The effects of Gastromotal were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Gastromotal er først blevet undersøgt i forsøgsmodeller, inden det blev undersøgt hos mennesker.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen..
English: What is Gastromotal?
Danish: Hvad er Gastromotal?
English: When a patient takes a dose of Gastromotal mixed into a test meal, it enters the stomach with the food.
Danish: Når en patient tager en dosis Gastromotal blandet med et testmåltid, kommer det ned i maven sammen med maden.
English: In both studies, the main measure of effectiveness was how long it took for half of the stomach's solid contents to be emptied.
Danish: I begge undersøgelser var hovedeffektmålet, hvor længe det varede, før halvdelen af mavens faste indhold var udtømt.
English: On 5 November 2007, INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solidphase gastric half emptying time in gastric motility disorders.
Danish: Den 5. november 2007 meddelte INFAL, Institut für biomedizinische Analytik & NMR-Imaging GmbH, officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at man ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Gastromotal til in vivo-diagnose af fast-fase gastrisk halv tømningstid ved gastriske motilitetsforstyrrelser.
English: The rate of stomach emptying can then be determined by looking at the speed at which labelled carbon dioxide is released in the breath.
Danish: Den hastighed, maven tømmes med, kan derefter fastlægges ved at bedømme, hvor hurtigt den mærkede kuldioxid frigives i udåndingen.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har afgivet sine svar på spørgsmålene, gennemgår CHMP disse og stiller eventuelt yderligere spørgsmål på dag 180, inden det
English: What was Gastromotal expected to be used for?
Danish: Hvad forventedes Gastromotal anvendt til?
English: It was to be available as a syringe containing a liquid for drinking, containing the active substance 1-13C-caprylic acid (90 mg).
Danish: Det skulle have kunnet fås som en injektionssprøjte med en væske til at drikke, som indeholdt det aktive stof 1-13C-caprylsyre (90 mg).
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 Gastromotal could not have been approved for the diagnosis of delayed stomach emptying.
Danish: På baggrund af gennemgangen af dataene og virksomhedens svar på CHMP's liste med spørgsmål på tidspunktet for tilbagetrækning af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Gastromotal ikke kunne være blevet godkendt til diagnosticering af forsinket tømning af maven.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Gastromotal had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP således af den opfattelse, at fordelen ved Gastromotal ikke var blevet tilstrækkeligt påvist, og at eventuelle fordele ikke opvejede de påviste risici.
English: Gastromotal was expected to be used to diagnose delayed stomach emptying in patients with stomach problems.
Danish: Man havde forventet, at Gastromotal skulle anvendes til diagnosticering af forsinket tømning af maven hos patienter med maveproblemer.
English: The active substance in Gastromotal, 1-13C-caprylic acid, is a natural chemical called caprylic acid that has been labelled with carbon-13 (13C).
Danish: Det aktive stof i Gastromotal, 1-13C-caprylsyre, er et naturligt kemikalium, caprylsyre, som er mærket med kulstof-13 (13C).
English: As the food in the stomach is gradually emptied into the gut, it takes the Gastromotal with it, where it is absorbed into the blood and then broken down, releasing carbon dioxide gas labelled with 13C into the breath.
Danish: Når maden i maven gradvist tømmes ud i tarmen, følger Gastromotal med og absorberes i blodet, hvor det nedbrydes og afgiver kuldioxidgas mærket med 13C i ånden.
English: The effectiveness of Gastromotal has been compared with that of a standard test called 99Tc-scintigraphy (a type of scan using radioactive tracers) in two main studies involving a total of 310
Danish: Effekten af Gastromotal er blevet sammenlignet med en standardtest, 99Tc-scintigrafi (en type scanning, som benytter radioaktive sporstoffer) i to hovedundersøgelser med i alt 310 voksne deltagere, som omfattede raske frivillige og patienter med maveproblemer.
English: The CHMP was concerned that the reliability and usefulness of Gastromotal in diagnosing delayed stomach empting had not been shown.
Danish: CHMP var betænkelig ved, at Gastromotals pålidelighed og nytte ved diagnosticering af forsinket tømning af maven ikke var blevet påvist.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Gastromotal?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Gastromotal eller i programmer for anvendelse med særlig udleveringstilladelse?
English: How is Gastromotal expected to work?
Danish: Hvordan forventedes Gastromotal at virke?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Gastromotal.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Gastromotal eller i programmer for anvendelse af Gastromotal med særlig udleveringstilladelse.
English: Powder for suspension for parenteral use (IM)
Danish: Pulver til suspension til parenteral anvendelse (IM)
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Danish: Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesveje og indehavere af markedsføringstilladelse i medlemsstaterne
English: Quinta da Fonte Edifício Vasco da Gama, 19 P.O.
Danish: Quinta da Fonte Edifício Vasco da Gama, 19 P.O. BOX 214
English: Pelham House South County Business Park Leopardstown
Danish: South County Business Park Leopardstown
English: Merck Sharp & Dohme, UAB, Kęstučio 59/27, LT-08124 Vilnius
Danish: Merck Sharp & Dohme, UAB, Kęstučio 59/27, LT-08124 Vilnius Lithuania
English: Euro Platz 2 1120 Wien Austria
Danish: 1120 Wien
English: Merck Sharp & Dohme OÜ Peterburi St 46, 11415 Tallinn
Danish: Merck Sharp & Dohme OÜ Peterburi St 46, 11415 Tallinn Estonia
English: Primaxin DR.PD.INJ (500+500)mg/Vial (IV)
Danish: Primaxin DR.PD.INJ (500+500)mg/Vial (IV) 500 mg
English: 18th Km Athens-Lamia National Road 14671 Nea Erythrea Greece
Danish: 14671 Nea Erythrea Greece
English: Merck Sharp & Dohme Ireland (Human Health) Limited
Danish: Merck Sharp & Dohme Ireland (Human Health) Limited Pelham House
English: Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 1180 Bruxelles Belgium
Danish: Chaussée de Waterloo 1135 1180 Bruxelles Belgium
English: Dry Powder for injection
Danish: Tørt pulver til injektion Intravenøs anvendelse
English: Box 581, 2003 PC Haarlem
Danish: P.O. Box 581, 2003 PC Haarlem The Netherlands
English: Primaxin IV 500mg Injection 500mg
Danish: Primaxin IV 500mg Injection
English: PrimaxinIV 500mg Injection 500mg
Danish: PrimaxinIV 500mg Injection
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem
Danish: Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem
English: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Danish: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
English: Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands
Danish: Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands
English: 250 mg/250 mg Powder for infusion
Danish: 250 mg/250 mg Pulver til infusionsvæske Intravenøs anvendelse
English: Merck Sharp & Dohme Bulgaria EOOD Nikola Vaptzarov Blvd., Expo
Danish: 55, Nikola Vaptzarov Blvd., Expo 2000
English: Powder for solution for infusion Intravenous infusion
Danish: Pulver til koncentrat til infusionsvæske, opløsning Intravenøs anvendelse
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, The Netherlands
Danish: Waarderweg 39, 2031 BN Haarlem, The Netherlands
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem
Danish: Waarderweg 39, 2031 BN Haarlem
English: 500 mg/500 mg Powder for infusion
Danish: 500 mg/500 mg Pulver til infusionsvæske Intravenøs anvendelse
English: 500mg/500mg Powder for Solution for Infusion
Danish: 500 mg powder for solution for infusion
English: TIENAM 500 mg/500 mg, poudre pour perfusion 500 mg/500 mg Powder for infusion
Danish: 500mg/500mg Powder for Solution for Infusion 500 mg/500 mg
English: 500 mg + 500 mg Powder for solution for injection Intravenous use
Danish: 500 mg + 500 mg Pulver til injektionssvæske, opløsning
English: Merck Sharp & Dohme Limited
Danish: Merck Sharp & Dohme B.V.
English: Keytruda received a marketing authorisation valid throughout the EU on 17 July 2015.
Danish: Keytruda fik en markedsføringstilladelse med gyldighed i hele EU den 17. juli 2015.
English: Further information on Keytruda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/keytruda.
Danish: Yderligere oplysninger om Keytruda findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/keytruda.
English: The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Danish: Lægemidlet fås kun på recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i kræftbehandling.
English: As for all medicines, data on the use of Keytruda are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Keytruda løbende overvåget.
English: Other information about Keytruda
Danish: Andre oplysninger om Keytruda
English: When it is given with other cancer medicines, the dose is always 200 mg every three weeks.
Danish: Når det gives sammen med andre kræftlægemidler, er dosis altid 200 mg hver tredje uge.
English: It can be used on its own or in combination with other cancer medicines for NSCLC and HNSCC.
Danish: Den kan anvendes alene eller i kombination med andre kræftlægemidler til NSCLC og HNSCC.
English: What measures are being taken to ensure the safe and effective use of Keytruda?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Keytruda?
English: When Keytruda is given alone the dose is either 200 mg every three weeks or 400 mg every six weeks.
Danish: Når Keytruda gives alene, er dosis enten 200 mg hver tredje uge eller 400 mg hver sjette uge.
English: The company that markets Keytruda will provide patients with an information pack and alert card to inform them about the risks of potential immune-related side effects and give instructions on when to contact their doctor if they experience symptoms.
Danish: Den virksomhed, der markedsfører Keytruda, vil forsyne patienterne med en informationspakke og et advarselskort for at oplyse dem om risikoen for potentielle immunrelaterede bivirkninger og give instrukser om, hvornår de skal kontakte deres læge, hvis de oplever symptomer.
English: The doctor may delay doses if certain side effects occur or stop treatment altogether if side effects are severe.
Danish: Lægen kan udsætte behandlingerne, hvis der opstår visse bivirkninger, eller helt standse behandlingen, hvis bivirkningerne er svære.
English: The side effects with this medicine are manageable and are similar to those of various other cancer treatments.
Danish: Bivirkningerne ved dette lægemiddel er håndterbare og svarer til bivirkningerne ved forskellige andre kræftbehandlinger.
English: In addition, the company will provide the final results of studies with Keytruda to confirm the longterm benefits of the medicine.
Danish: Virksomheden vil derudover forelægge de endelige resultater af studierne med Keytruda for at bekræfte lægemidlets fordele på lang sigt.
English: The European Medicines Agency decided that Keytruda's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Keytruda opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In some patients, tumours have to produce a high level of PD-L1 for the medicine to be effective.
Danish: Hos nogle patienter skal tumorerne danne et højt niveau af PD-L1, for at lægemidlet er effektivt.
English: What is Keytruda and what is it used for?
Danish: Hvad er Keytruda, og hvad anvendes det til?
English: Keytruda can delay worsening of melanoma and improve survival.
Danish: Keytruda kan forsinke forværringen af melanomer og forbedre overlevelsen.
English: Why is Keytruda authorised in the EU?
Danish: Hvorfor er Keytruda godkendt i EU?
English: Side effects reported with Keytruda are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Keytruda vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target') called PD-1.
Danish: Det aktive stof i Keytruda, pembrolizumab, er et monoklonalt antistof, dvs. et protein, der er designet til at genkende og blokere en receptor (et mål), der kaldes PD-1.
English: An overview of Keytruda and why it is authorised in the EU
Danish: En oversigt over Keytruda, og hvorfor det er godkendt i EU
English: Keytruda is a cancer medicine used to treat:
Danish: Keytruda er et kræftlægemiddel, der anvendes til at behandle:
English: The side effects of Keytruda are mostly related to the activity of the immune system, which may cause inflammation of body organs and tissues and can be serious, although most side effects resolve with appropriate treatment or on stopping Keytruda.
Danish: Bivirkningerne ved Keytruda er primært relateret til immunsystemets aktivitet, hvilket kan medføre betændelse i kropsorganer og -væv, og de kan være alvorlige, selvom de fleste bivirkninger forsvinder med passende behandling eller ved ophør med Keytruda.