FrancophonIA/ELRC3.0 huggingface dataset:
English: • intra- and post-partum infections (infections during and after childbirth);
Danish: • Intra- og postpartum infektioner (infektioner under og efter fødsel)
English: It contains the active substance meropenem.
Danish: Det indeholder det aktive stof meropenem.
English: 23 July 2009
Danish: den 23. juli 2009
English: The CHMP agreed on a harmonised list of contra-indications.
Danish: CHMP vedtog en harmoniseret liste med kontraindikationer.
English: The company that markets Meronem is AstraZeneca.
Danish: Virksomheden, der markedsfører Meronem er AstraZeneca.
English: The CHMP agreed on the following diseases for which the medicine may be used:
Danish: CHMP blev også enige om, at lægemidlet kunne anvende til følgende sygdomme:
English: The new wording mentions that medicines containing valproic acid should be avoided when taking Meronem.
Danish: Af den nye ordlyd fremgår det, at lægemidler, der indeholder valproesyre, bør undgås, når man tager Meronem.
English: London, 23 July 2009 Doc.
Danish: London, den 19.oktober 2009 Dok.
English: The active substance in Meronem, meropenem, is an antibiotic that belongs to the group ‘carbapenems'.
Danish: Det aktive stof i Meronem, meropenem, er et antibiotikum, som tilhører gruppen af ‘carbapenemer'.
English: Because the recommended dose for both adults and children differed among Member States, the CHMP recommended harmonised dosage schedules:
Danish: Da den anbefalede dosis til voksne og børn varierede i medlemsstaterne, anbefalede CHMP at harmonisere doseringsplanerne:
English: The Committee also harmonised the SPC section on interactions with other medicines.
Danish: Udvalget harmoniserede også produktresuméets afsnit om interaktion med andre lægemidler.
English: On 1 October 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Meronem and associated names in the EU.
Danish: Den 1. oktober 2008, indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Meronem og tilknyttede navne i EU.
English: This has led to divergences across member states in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Danish: Dette har ført til forskelle mellem medlemsstaterne med hensyn til den måde, hvorpå lægemidlet anvendes, hvilket fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Meronem og tilknyttede navne meropenem pulver til injektions-og infusionsvæske, opløsning 500 mg og 1 g
English: Meronem may also be used in patients with neutropenic fever (fever associated with low levels of neutrophils, a type of white blood cell) that is suspected to be caused by bacterial infection.
Danish: Meronem kan også anvendes hos patienter med feber i forbindelse med et meget lavt antal neutrofiler, en form for hvide blodceller, som formodes at være forårsaget af en bakterieinfektion.
English: The European Medicines Agency has completed a review of Meronem and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en undersøgelse af Meronem og tilknyttede navne.
English: The CHMP harmonised the SPC section on special warnings and retained warnings about convulsions and hepatic reactions.
Danish: CHMP harmoniserede produktresumeéts afsnit om Særlige advarsler og forsigtighedsregler og fastholdt advarsler om kramper og leverreaktioner.
English: Meronem is a powder that is made up into a solution for injection or infusion.
Danish: Meronem er et koncentrat, der benyttes til at fremstille en opløsning til injektion eller infusion.
English: The Committee recommended that Meronem should not be used in patients who are hypersensitive to any carbapenem medicine or in patients who have severe hypersensitivity to any type of beta-lactam anti-bacterial medicines such as penicillins or cephalosporins.
Danish: Udvalget anbefalede, at Meronem ikke matte anvendes til patienter, som er overfølsomme over for carbapener, eller til patienter, som er overfølsomme over for enhver form for antibakterielle lægemidler i gruppen beta-lactam såsom penicillin eller cephalosporin.
English: • broncho-pulmonary infections in patients with cystic fibrosis;
Danish: • bronkopulmonale infektioner i forbindelse med cystisk fibrose
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Meronem and associated names in the European Union (EU).
Danish: Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysninger for Meronem og tilknyttede navne i Den Europæiske Union (EU).
English: At the start of the referral, some Member States did not include hypersensitivity (allergy) to carbapenems, penicillins or other beta-lactam antibiotics as contra-indications (situations where the medicine must not be used) and some Member States included hypersensitivity to excipients (other ingredients in the medicine).
Danish: Da indbringelsen fandt sted havde visse medlemsstater ikke medtaget overfølsomhed (allergi) over for carbapenemer, penicillin eller andre beta-lactam-antibiotika som kontraindikationer (tilfælde hvor lægemidlet ikke må anvendes), og visse medlemsstater havde medtaget overfølsomhed over for hjælpestoffer (andre indholdsstoffer i lægemidlet).
English: • for broncho-pulmonary infections in cystic fibrosis and acute bacterial meningitis, the CHMP recommended a dose of 2 g every eight hours in adults and children weighing over 50 kg, and 40 mg/kg every eight hours in children aged from three months to 11 years and those weighing less than 50 kg.
Danish: • ved bronkopulmonære infektioner ved cystisk fibrose og akut bakteriel meningitis anbefaler CHMP en dosis på 2 g hver ottende time hos voksne og børn , der vejer over 50 kg, og 40 mg/kg hver ottende time hos børn i alderen tre måneder til 11 år og personer, der vejer under 50 kg.
English: Meronem is used to treat various bacterial infections including infections of the lungs, urinary tract (structures that carry urine), the abdomen, skin, the female reproductive system and brain.
Danish: Meronem anvendes til behandling af forskellige bakterieinfektioner, herunder infektioner i lunger, urinveje, maven, huden, kvindens forplantningsorganer og hjernen.
English: • for pneumonia, complicated urinary tract infections, complicated intra-abdominal infections, intraand post-partum infections and complicated skin and soft tissue infections, the recommended dose in adults and children weighing more than 50 kg should 500 mg or 1 g every eight hours, while children aged from three months to 11 years and those weighing less than 50 kg should be given 10 or 20 mg/kg every eight hours.
Danish: • ved pneumoni, komplicerede urinvejsinfektioner, komplicerede intraabdominale infektioner,intraog post-partum-infektioner og komplicerede infektioner i hud og blødt væv er den anbefalede dosis til voksne og børn , der vejer over 50 kg, 500 mg eller 1 g hver ottende time, mens den anbefalede dosis til børn i alderen tre måneder til 11 år og personer, der vejer under 50 kg, er 10 eller 20 mg/kg hver ottende time.
English: At the start of the referral, some of the indications such as skin and skin tissue infections and urinary tract infections or infections of the female reproductive system were not approved in all Member States.
Danish: Da indbringelsen fandt sted var nogle af indikationerne såsom hud- og vævsinfektioner og urinvejsinfektioner eller infektioner i kvindens forplantningsorganer ikke godkendt i alle
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På baggrund af alle de fremlagte oplysninger og den faglige drøftelse i udvalget var CHMP af den opfattelse af, at produktresuméer, etikettering og indlægssedler skulle harmoniseres i hele EU.
English: 4.3 Contra-indications
Danish: Kontraindikationer
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: Sag indbragt med den begrundelse, at der er truffet afvigende afgørelser af medlemsstaterne, i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer.
English: • complicated urinary tract infections;
Danish: • komplicerede urinvejsinfektioner
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 Det fås også i EU under handelsnavnene under Optinem og Merrem.
English: The Committee noted that for most indications Meronem should be used for children above three months of age, but that doctors should retain the option of treating younger children.
Danish: • akut bakteriel meningitis (infektion af membranerne omkring hjernen og rygmarven) Udvalget bemærkede, at Meronem for de fleste indikationer skulle anvendes til børn over tre måneder, men at læger skulle have mulighed for at behandle yngre børn.
English: • complicated skin and soft tissue infections;
Danish: • komplicerde hud- og bløddelsinfektioner:
English: Meronem has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - humanmedicinske lægemidler (CMD(h)) har fastslået, at der er behov for at harmonisere oplysningerne vedrørende Meronem.
English: Co-rapporteur(s):
Danish: Dato for udtalelsen:
English: Company responses provided on: 26 January 2009 Opinion date:
Danish: Virksomhedens svar afgivet:
English: • complicated infections in the abdomen;
Danish: • komplicerede maveinfektioner
English: • pneumonia (infection of the lungs);
Danish: • lungebetændelse
English: A European Commission decision on this opinion will be issued in due course.
Danish: Europa-Kommissionen traf en afgørelse den 15. oktober 2009.
English: This summary was last updated in 07-2009.
Danish: Dette sammendrag blev sidst ajourført i 07-2009.
English: The standard dose of Clopidogrel Acino Pharma GmbH is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel Acino Pharma GmbH er én 75 mg -tablet én gang dagligt med eller uden et måltid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Acino Pharma GmbH to Acino Pharma GmbH on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Acino Pharma GmbH til Acino Pharma GmbH den 21. september 2009.
English: This means that Clopidogrel Acino Pharma GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Acino Pharma GmbH er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: clopidogrel EPAR summary for the public
Danish: clopidogrel EPAR - sammendrag for offentligheden
English: Clopidogrel Acino Pharma GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Acino Pharma GmbH anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Acino Pharma GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Acino Pharma GmbH i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: GmbH can be started between a few days and 35 days after the attack;
Danish: Acino Pharma GmbH kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Clopidogrel Acino Pharma GmbH can be given to the following groups of patients:
Danish: Clopidogrel Acino Pharma GmbH kan gives til følgende patientgrupper:
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Acino Pharma GmbH er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Danish: • patienter med perifer ateriesygdom (problemer med blodgennemstrømningen i arterierne).
English: Because Clopidogrel Acino Pharma GmbH is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Acino Pharma GmbH er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Clopidogrel Acino Pharma GmbH is a ‘generic medicine'.
Danish: Clopidogrel Acino Pharma GmbH er et ‘generisk lægemiddel'.
English: Other information about Clopidogrel Acino Pharma GmbH:
Danish: Andre oplysninger om Clopidogrel Acino Pharma GmbH:
English: Clopidogrel Acino Pharma GmbH is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Acino Pharma GmbH er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: The full EPAR for Clopidogrel Acino Pharma GmbH can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Acino Pharma GmbH findes her.
English: The Committee recommended that Clopidogrel Acino Pharma GmbH be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Acino Pharma GmbH.
English: What are the benefit and risk of Clopidogrel Acino Pharma GmbH?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Acino Pharma GmbH?
English: The active substance in Clopidogrel Acino Pharma GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Acino Pharma GmbH, clopidogrel, er en trombocytfunktionshæmmer.
English: Clopidogrel Acino Pharma GmbH can be started between seven days and six
Danish: Behandlingen med Clopidogrel Acion Pharma GmbH kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter,
English: Why has Clopidogrel Acino Pharma GmbH been approved?
Danish: Hvorfor blev Clopidogrel Acino Pharma GmbH godkendt?
English: How has Clopidogrel Acino Pharma GmbH been studied?
Danish: Hvordan blev Clopidogrel Acino Pharma GmbH undersøgt?
English: What is Clopidogrel Acino Pharma GmbH?
Danish: Hvad er Clopidogrel Acino Pharma GmbH?
English: What is Clopidogrel Acino Pharma GmbH used for?
Danish: Hvad anvendes Clopidogrel Acino Pharma GmbH til?
English: How is Clopidogrel Acino Pharma GmbH used?
Danish: Hvordan anvendes Clopidogrel Acino Pharma GmbH?
English: How does Clopidogrel Acino Pharma GmbH work?
Danish: Hvordan virker Clopidogrel Acino Pharma GmbH?
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Danish: • udvalget behandlede indbringelsen i henhold til artikel 13, stk. 2, i forordning nr. 1234/2008,
English: Overall summary of the scientific evaluation of Oxynal and Targin and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Oxynal og Targin og relaterede navne (se bilag I)
English: However, the protocol did not stipulate dose tapering and in the majority of these subjects no tapering had been performed.
Danish: Protokollen foreskrev imidlertid ikke dosisnedtrapning, og hos størstedelen af disse personer havde nedtrapning ikke fundet sted.
English: On the basis of the questions raised by the Netherlands the points to be considered by the CHMP were:
Danish: På grundlag af de spørgsmål, der var rejst af Nederlandene, blev CHMP anmodet om at tage stilling til følgende punkter:
English: 97% of patients completing the double-blind controlled study entered the extension phase.
Danish: 97 % af de patienter, der gennemførte den dobbeltblindede, kontrollerede undersøgelse, indgik i forlængelsesfasen.
English: Further 10 patients out of 176 reported signs of physical dependence as a result of a specific follow-up visit 4 weeks after the end of the extension phase.
Danish: Andre 10 patienter ud af 176 angav tegn på fysisk afhængighed ved et specifikt opfølgningsbesøg 4 uger efter afslutningen af forlængelsesfasen.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelsen
English: As the reference and concerned member states were not able to reach an agreement in respect of the variation, on 2 May 2014, Germany triggered a referral under Article 13(2) of Regulation EC No
Danish: Da referencemedlemsstaten og de berørte medlemsstater ikke kunne nå til enighed om ændringsansøgningen, foretog Tyskland den 2. maj 2014 en indbringelse i medfør af artikel 13, stk. 2, i forordning (EF) nr. 1234/2008.
English: The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
Danish: 2 Walters AS et al. The MU Opiate Receptor Knock-out Mouse Shows Increased Sensitivity to Pain, Increased Motor Activity During the Sleep Period and Decreased Serum Iron Parallel to Human Restless Legs Syndrome.
English: In addition, clear instructions have been proposed for section 4.2 of the SmPC to re-evaluate the benefits and risks in individual RLS patients regularly every 3 months and to consider a discharge regimen by gradual tapering before treatment is continued beyond 1 year.
Danish: Desuden er der foreslået klare anvisninger til punkt 4.2 i produktresuméet om regelmæssigt at genvurdere fordele og risici for den enkelte RLS-patient hver 3. måned og tage stilling til et udskrivningsregime med gradvis nedtrapning, før behandlingen fortsættes ud over 1 år.
English: There is a lack of confirmatory evidence regarding the maintenance of efficacy and the long-term safety, which has not been provided by the open-label extension study phase, due to its methodological limitations.
Danish: Der savnes bekræftende evidens for opretholdelse af virkning og langsigtet sikkerhed, idet dette ikke kan udledes af undersøgelsens åbne forlængelsesfase på grund af dennes metodemæssige begrænsninger.
English: Therefore, further justification that the different criteria for approval on the basis of one pivotal trial should be provided by the applicant.
Danish: Ansøgeren bør derfor nærmere godtgøre, at de forskellige kriterier for godkendelse er opfyldt på grundlag af én hovedundersøgelse.
English: The results at the end of the extension phase at week 52 showed a further slight improvement of the IRLS sum score compared to the results towards the end of 12-week double-blind phase.
Danish: Resultaterne ved slutningen af forlængelsesfasen i uge 52 viste en yderligere let forbedring i samlet IRLS-score i forhold til resultaterne ved slutningen af den 12-ugers dobbeltblinde fase.
English: Grounds for the variation to the terms of the marketing authorisation with amendments to the relevant sections of the summary of product characteristics
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen med ændringer af de relevante afsnit af produktresuméet
English: Oxynal 10mg/5mg, 20mg/10mg prolonged-release tablets and Targin 5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg prolonged-release tablets and associated names (OXN PR) are fixed combination products of oxycodone hydrochloride and naloxone hydrochloride.
Danish: Oxynal, depottabletter, 10 mg/5 mg, 20 mg/10 mg, og Targin, depottabletter, 5 mg/2,5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg, og relaterede navne (OXN PR) er faste kombinationsprodukter af oxycodonhydrochlorid og naloxonhydrochlorid.
English: The available clinical data of only one single, short term, pivotal trial are considered insufficient considering the risks.
Danish: De foreliggende kliniske data, der består af en enkelt kortvarig hovedundersøgelse, anses for utilstrækkelige i betragtning af risiciene.
English: A detailed review of safety data from both the double-blind phase and extension phase (OXN3502/S) was conducted.
Danish: Der blev foretaget en detaljeret gennemgang af sikkerhedsdata fra både den dobbeltblinde fase og forlængelsesfasen (OXN3502/S).
English: Overall, the CHMP considered that benefits of Oxynal and Targin and associated names in the sought indication outweigh the risks, taking into account the additional risk minimisations measures which had already been agreed at CMD(h) and the changes recommended to the product information.
Danish: Overordnet fandt CHMP, at fordelene ved Oxynal og Targin og relaterede navne til den ansøgte indikation overstiger risiciene i betragtning af de supplerende risikominimeringsforanstaltninger, der allerede var godkendt i CMD(h), og de anbefalede ændringer af produktinformationen.
English: The results of the pivotal phase III clinical study are considered robust and consistent with respect to primary and secondary efficacy parameters (addressing severity and impact of the disease and quality of life) as well as with respect to responder rates and various subgroup analyses.
Danish: Resultaterne af fase III-hovedundersøgelsen anses for pålidelige og konsistente, hvad angår de primære og sekundære virkningsparametre (som vedrører sygdommens sværhed og følgevirkninger samt livskvalitet), og hvad angår responderrater og diverse undergruppeanalyser.
English: The maintenance of treatment effect was investigated in the open extension phase of the pivotal study.
Danish: Opretholdelsen af virkning blev undersøgt i den åbne forlængelsesfase af hovedundersøgelsen.
English: The treatment effect during the extension phase was independent from treatment during the pivotal study.
Danish: Behandlingsvirkningen i forlængelsesfasen var uafhængig af behandlingen i hovedundersøgelsen.
English: These findings are in line with the results of the post-marketing surveillance with OXN PR in the treatment of pain where addiction and related abuse are carefully monitored.
Danish: Disse resultater svarer til resultaterne af overvågningen efter markedsføring med OXN PR til smertebehandling, hvor afhængighed og det tilknyttede misbrug overvåges nøje.
English: The CHMP noted that there is evidence from the literature that the endogenous opioid system is involved in the pathogenesis of RLS on a spinal and supraspinal level and therefore there is a plausible rationale to justify the use of opioids for treatment of RLS 1,2.
Danish: CHMP bemærkede, at der i litteraturen er evidens for, at det endogene opioidsystem er inddraget i patogenesen af RLS på spinalt og supraspinalt niveau, hvorfor der er et plausibelt rationale for anvendelse af opioider til behandling af RLS 1,2.
English: The CHMP acknowledged the methodological limitations of the open label study however the CHMP considered that reasonable justifications for maintenance of effect up to 52 weeks of treatment were provided by the MAH.
Danish: CHMP vedgik de metodemæssige begrænsninger af den åbne undersøgelse, men fandt det rimeligt godtgjort, at virkningen blev opretholdt ved op til 52 ugers behandling.