FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMEA/MB/305975/2009] The Board adopted the draft EMEA transparency policy for release for public consultation.
Danish: [EMEA/MB/305975/2009] Bestyrelsen vedtog udkastet til gennemsigtighedspolitik for EMEA med henblik på frigivelse til offentlig høring.
English: The Management Board thanked the Board topic coordinators (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) for their contribution.
Danish: Bestyrelsen takkede emnekoordinatorerne (Aginus Kalis, Jean Marimbert, Marcus Müllner, Gro Wesenberg) for deres bidrag.
English: Revision refers to amendements made in item 16.
Danish: Referat af det 62.
English: The Board thanked the EMEA and Management Board topic coordinators (Jean Marimbert and Lisette Tiddens-Engwirda) for their contributions.
Danish: Bestyrelsen takkede EMEA og bestyrelsens emnekoordinatorer (Jean Marimbert og Lisette TiddensEngwirda) for deres bidrag.
English: Lenka Balážová
Danish: Den Tjekkiske Republik Lenka Balážová
English: Documents for information [EMEA/MB/287743/2009] Update report on EMEA implementation of EU telematics strategy.
Danish: [EMEA/MB/287743/2009] Ajourført rapport om EMEA's gennemførelse af EU's telematikstrategi [EMEA/MB/282675/2009, EMEA/MB/317275/2009] Rapporter om gennemførelsen af EudraVigilance for humanmedicinske og veterinærmedicinske lægemidler.
English: Minutes of the sixty-third meeting of the Management Board
Danish: møde i bestyrelsen
English: EMEA/FDA liaison exchange
Danish: Udveksling af personale mellem EMEA og FDA
English: − Reflection paper on the way forward
Danish: Debatoplæg om den fremtidige udvikling
English: Tienam was approved in the EU in 1985 and is currently authorised in 28 European countries (Norway, Iceland and all EU countries with the exception of Denmark).
Danish: Tienam blev godkendt i EU i 1985 og er i øjeblikket tilladt i 28 europæiske lande (Norge, Island og alle EU-landene med undtagelse af Danmark).
English: Unjustified and nonsubstantiated prophylactic use is not acceptable.
Danish: Uberettiget eller ikke-underbygget profylaktisk anvendelse er ikke acceptabel.
English: Doses ≥ 4 gm/day
Danish: Doser ≥ 4 gm/dag
English: Overall summary of the scientific evaluation of Tienam and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Tienam og relaterede navne (se bilag I)
English: The maximum total daily dose should not exceed 4000 mg/day.
Danish: Den samlede daglige maksimumsdosis bør ikke overskride 4000 mg/dag.
English: 500 mg every 6 hours OR 1000 mg every 8 hours OR every 6 hours
Danish: 500 mg hver 6. time ELLER 1000 mg hver 8. time ELLER hver 6. time
English: In sections 6.3 and 6.6, a warning was added to state that diluted solutions should be used immediately and that the interval between beginning of reconstitution and the end of intravenous infusion should not exceed two hours.
Danish: I punkt 6.3 og 6.6 blev der tilføjet en advarsel om, at opløsninger skal anvendes straks, og at tiden mellem påbegyndelsen af rekonstitutionen og afslutningen af den intravenøse infusion ikke bør overstige to timer.
English: SECTION 6 - PHARMACEUTICAL PARTICULARS
Danish: Punkt 6 - Farmaceutiske oplysninger
English: Moreover, the use of imipenem in the management of any type of endocarditis has not been mentioned in the EU endocarditis Guideline, 2004.
Danish: Desuden er brugen af imipenem i behandlingen af enhver form for endocarditis ikke nævnt i EU's retningslinje om endocarditis, 2004.
English: “Tienam may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.”
Danish: "Tienam kan anvendes til behandling af neutropeniske patienter med feber, der formodes at skyldes en bakterieinfektion."
English: For patients with normal renal function (creatinine clearance of >70 ml/min/1.73 m2), the recommended dose regimens are:
Danish: For patienter med normal nyrefunktion (kreatininclearance på > 70 ml/min/1,73 m2) er det anbefalede dosisregimen:
English: In addition, the recommended solutions were specified as being 0.9% sodium chloride solution and water for injection, while the use of 5% glucose was restricted to exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons.
Danish: Derudover blev de anbefalede opløsninger angivet som værende 0,9 % natriumkloridopløsning og vand til injektion, men anvendelsen af 5 % glukose blev begrænset til særlige omstændigheder, hvor 0,9 % natriumklorid ikke kan anvendes af kliniske årsager.
English: Tienam is approved as an intravenous (IV) formulation: Powder for solution for infusion, 250 mg/250mg and 500 mg/500 mg.
Danish: Tienam er godkendt som en intravenøs (IV) formulering: Pulver til infusionsvæske, opløsning 250 mg/250mg og 500 mg/500 mg.
English: In addition, potential failure of Tienam therapy might lead to surgical interventions or amputations which should be considered as serious adverse outcomes.
Danish: Desuden vil en potentiel fejlslagen behandling med Tienam føre til kirurgiske indgreb eller amputationer, som bør betragtes som alvorlige bivirkninger.
English: “Adults and adolescents
Danish: "Unge og voksne
English: 4.1.12 Non-indication in the treatment of meningitis.
Danish: 4.1.12 Ingen indikation for behandling af meningitis
English: These infections are mostly caused by Gram-positive bacteria, S. aureus being the most important.
Danish: Disse infektioner forårsages for det meste af grampositive bakterier, hvoraf S. Aureus er den vigtigste.
English: In addition, the term “genitourinary tract infections” was considered outdated.
Danish: Desuden blev betegnelsen "urogenitale infektioner" anset for at være forældet.
English: The CHMP did not consider this to be an indication and removed this information from section 4.1.
Danish: CHMP fandt ikke, at dette var en indikation og fjernede denne information i punkt 4.1.
English: Sections 4.3 - Contraindications, 4.5 - Interaction with other medicinal products and other forms of interaction, 4.6 - Fertility, Pregnancy and Lactation, 4.7 - Effects on ability to drive and use machines, 4.8 - Undesirable effects, 4.9 - Overdose, 5.1 - Pharmacodynamic properties, 5.2 - Pharmacokinetic properties and 5.3 - Preclinical safety data
Danish: Punkt 4.3 - Kontraindikationer, 4.5 - Interaktion med andre lægemidler og andre former for interaktion, 4.6 - Fertilitet, graviditet og amning, 4.7 - Virkning på evnen til at føre motorkøretøj eller betjene maskiner, 4.8 - Bivirkninger, 4.9 - Overdosering, 5.1Farmakodynamiske egenskaber, 5.2 - Farmakokinetiske egenskaber og 5.3 - Prækliniske sikkerhedsdata
English: During the course of the procedure, a Drafting Group meeting was convened by the CHMP.
Danish: I løbet af denne indbringelsesprocedure indkaldte CHMP til et møde i en udarbejdelsesgruppe.
English: However, the CHMP acknowledged that high clinical cure rates were reported in a large number of patients with bacteraemia associated with the approved indications.
Danish: CHMP anerkendte imidlertid, at der var indberettet høje kliniske helbredelsesrater hos et stort antal patienter med bakteriæmi i forbindelse med de godkendte indikationer.
English: The CHMP also deleted the low doses of 250 mg every 6 hours as mild infections should not be treated with imipenem/cilastatin.
Danish: CHMP slettede også de lave doser på 250 mg hver 6. time, da milde infektioner ikke bør behandles med imipenem/cilastatin.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Tienam and associated names (see Annex I).
Danish: • produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse, anbefalede CHMP ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Tienam og relaterede navne (se bilag I).
English: A referral under Article 30 of Directive 2001/83, as amended, was started in May 2009 for Tienam and associated names.
Danish: I maj 2009 blev der foretaget en indbrindelse for Tienam og relaterede navne i henhold til artikel 30 i direktiv 2001/83/EF.
English: In particular, four divergent indications (i.e., gynaecological infections, septicaemia, bone and joint infections, and endocarditis) and the use in paediatric patients less than 3 years of age were discussed.
Danish: Navnlig fire divergerende indikationer (dvs. gynækologiske infektioner, septikæmi, knogle- og ledinfektioner og endocarditis) og brugen hos børn under 3 år blev drøftet.
English: With regards to safety, the CHMP considered that the available documentation supports a similar safety profile of imipenem/cilastatin in children compared to adults.
Danish: Med hensyn til sikkerheden fandt CHMP, at den tilgængelige dokumentation støtter en tilsvarende sikkerhedsprofil for imipenem/cilastatin hos børn sammenlignet med voksne.
English: The CHMP assessed the available data regarding use in children, in particular taking into account 2 large efficacy/safety paediatric studies (Paediatric Study 1 and Paediatric Study 2/3) and the available peer-review medical literature.
Danish: CHMP vurderede de foreliggende data om brug til børn, navnlig under hensyntagen til to store virknings- og sikkerhedsundersøgelser med børn og unge (Paediatric Study 1 og Paediatric Study 2/3) og den tilgængelige medicinske peer-review litteratur.
English: The CHMP adopted a harmonised wording for these sections.
Danish: CHMP vedtog således en harmoniseret tekst til disse punkter.
English: The CHMP adopted a harmonised wording for section 4.4 and in particular, the following statement concerning the limited susceptibility of specific pathogens and the concomitant use of an appropriate anti-MRSA agent or of an aminoglycoside was included:
Danish: CHMP vedtog en harmoniseret formulering af punkt 4.4, og navnlig følgende erklæring om bestemte patogeners begrænsede modtagelighed og den samtidige anvendelse af et passende middel mod MRSA eller af en aminoglykosid blev medtaget:
English: There were no useful comparator-controlled clinical trials conducted and published in the peer-review literature from 2000 through 2010 in this indication and the epidemiological studies were of questionable quality and not sufficiently informative, in particular with regards to the used imipenem/cilastatin dosage.
Danish: Der var ikke gennemført eller offentliggjort nogen nyttige sammenligningskontrollerede kliniske undersøgelser i peer-review litteratur fra 2000 til 2010 om denne indikation, og de epidemiologiske undersøgelser var af tvivlsom kvalitet og ikke tilstrækkeligt informative, navnlig med hensyn til den anvendte dosis af imipenem/cilastatin.
English: The overall clinical efficacy of imipenem/cilastatin was high and evaluable patients and the used dosage was effective and safe.
Danish: Den generelle kliniske virkning af imipenem/cilastatin var høj og evaluerbar, og den anvendte dosering var effektiv og sikker.
English: The CHMP also discussed the possibility of limiting the indication to “Osteomyelitis” however there were not enough data to support this indication.
Danish: CHMP drøftede også muligheden for at begrænse indikationen til "Osteomyelitis", men der forelå ikke tilstrækkelige data til støtte for denne indikation.
English: Based on information from the submitted studies, the CHMP considered that no dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment.
Danish: På grundlag af information fra de fremsendte undersøgelser fandt CHMP ikke, at en dosisjustering for ældre er påkrævet, undtagen i tilfælde af moderat til svært nedsat nyrefunktion.
English: “intra- and post-partum infections
Danish: "intra- og post-partum-infektioner"
English: Adults and adolescents.
Danish: Unge og voksne
English: Although most studies were outdated and/or of poor quality, the CHMP was of the opinion that a restricted indication would be justified and in conclusion, adopted the following harmonised indication:
Danish: Selv om de fleste undersøgelser var forældede og/eller af dårlig kvalitet, var CHMP af den opfattelse, at en begrænset indikation ville være berettiget og vedtog derfor følgende harmoniserede indikation:
English: Paediatric population <1 year of age Clinical data are insufficient to recommend dosing for children less than 1 year of age.”
Danish: Børn < 1 år De kliniske data er ikke tilstrækkelige til, at behandling af børn under 1 år kan anbefales."
English: “The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in lifethreatening conditions before embarking on any empiric treatment.
Danish: "Imipenem/cilastatins antibakterielle spektrum bør tages i betragtning, navnlig i livstruende situationer, før der indledes en empirisk behandling.
English: The CHMP considered that the frequency of seizures in the paediatric population < 1 year was unacceptably high and that this risk was confirmed by spontaneous adverse event reports.
Danish: CHMP fandt, at hyppigheden af anfald hos børn < 1 år var uacceptabelt høj, og at denne risiko blev bekræftet af spontane indberetninger af bivirkninger.
English: Concomitant use of an appropriate anti-MRSA agent may be indicated when MRSA infections are suspected or proven to be involved in the approved indications.
Danish: Samtidig brug af et passende middel mod MRSA kan være indiceret, når MRSA-infektioner formodentlig eller beviseligt er involveret i de godkendte indikationer.
English: Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications (see section 4.1).”
Danish: Samtidig brug af et aminoglykosid kan være indiceret, når Pseudomonas aeruginosa-infektioner antageligt eller beviseligt er involveret i de godkendte indikationer (jf. punkt 4.1).
English: Tienam is a broad spectrum antibacterial agent that belongs to the group of carbapenems and consists of a fixed combination (1:1 ratio) of imipenem (a carbapenem antibiotic which is a derivative of thienamycin) and cilastatin (an inhibitor of dehydropeptidase I, a renal enzyme which metabolizes and inactivates imipenem).
Danish: Tienam er et bredspektret antibakterielt middel tilhørende gruppen af carbapenemer og består af en fast kombination (i forholdet 1:1) af imipenem (et carbapenemantibiotikum, som er et derivat af thienamycin) og cilastatin (en dehydropeptidase Ihæmmer, et renalt enzym, som metaboliserer og inaktiverer imipenem).
English: The CHMP requested the MAH to carry out a relevant safety analysis across dose levels to confirm that the reason for not recommending the higher dose of 1 g q6h in several indications was not driven by safety aspects.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at gennemføre en relevant sikkerhedsanalyse af alle dosisniveauer for at bekræfte, at den manglende anbefaling af doser over 1 g hver 6. time i flere indikationer ikke var begrundet i sikkerhedsaspekter.
English: Imipenem has activity against a wide variety of bacteria, including Grampositive aerobic cocci, Gram-positive aerobic bacilli, Gram-negative aerobic bacteria, and anaerobes.
Danish: Imipenem er aktivt mod en lang række bakterier, herunder grampositive, aerobe kokker, grampositive, aerobe baciller, gramnegative, aerobe bakterier og anaerobe bakterier.
English: Paediatric patients above 1 year of age
Danish: Børn over 1 år
English: The MAH provided a categorised summary of the enrolled patients, according to age groups to provide a basis for a discussion on the need for limiting the use of imipenem/cilastatin to children above 1 year of age for safety reasons.
Danish: Indehaveren af markedsføringstilladelsen fremlagde et kategoriseret sammendrag af de deltagende patienter i henhold til aldersgruppe som grundlag for drøftelse af behovet for at begrænse brugen af imipenem/cilastatin til børn over 1 år af sikkerhedshensyn.
English: The CHMP therefore considered that the benefit-risk for imipenem/cilastatin in children under 1 year of age is negative and inserted a statement that the clinical data are insufficient to recommend dosing for children under the age of 1 year.
Danish: CHMP fandt derfor, at benefit/risk-forholdet for imipenem/cilastatin til børn under 1 år er negativt, og medtog en erklæring om, at de kliniske data er utilstrækkelige til, at anvendelse til børn under 1 år kan anbefales.
English: The CHMP noted the proposed indication “mixed infections” but was of the opinion that this wording is not in line with the current antimicrobial guidelines and recent European regulatory decisions, which require a site of infection to be specified.
Danish: CHMP noterede sig den foreslåede indikation "blandede infektioner", men var af den opfattelse, at denne formulering ikke er i overensstemmelse med de aktuelle antimikrobielle retningslinjer og nyere europæiske lovgivningsbeslutninger, som kræver, at infektionsstedet angives.
English: In conclusion, the CHMP adopted the following harmonised indication:
Danish: CHMP vedtog således følgende harmoniserede indikation:
English: “severe pneumonia including hospital and ventilator-associated pneumonia”
Danish: "svær pneumoni, herunder hospitalserhvervet og respiratorerhvervet pneumoni".
English: The CHMP also noted the additional information in the form of abstracts or brief publications and considered that an indication for complicated intra-abdominal infections was supported.
Danish: CHMP noterede sig også den supplerende information i form af sammendrag eller korte publikationer og fandt, at en indikation for komplicerede intraabdominale infektioner var underbygget.
English: The CHMP observed that no new safety issues or increased ADRs were observed with the use of imipenem/cilastatin doses of ≥ 4 gm/day as compared to doses of <4 gm/day, based on the review of clinical trial data in the original WMA, PMS data and the literature.
Danish: CHMP bemærkede, at ingen nye sikkerhedsspørgsmål eller øgede bivirkninger blev observeret ved brug af imipenem/cilastatindoser på ≥ 4 gm/dag sammenlignet med doser på < 4 gm/dag baseret på en gennemgang af kliniske undersøgelsesdata i de oprindelige WMA, data om sikkerhed efter markedsføring og litteraturen.
English: In conclusion, the CHMP adopted a harmonised wording for section 4.2, including the following dose recommendations:
Danish: CHMP vedtog således en harmoniseret tekst til punkt 4.2 med følgende dosisanbefalinger:
English: For paediatric patients ≥1 year of age, the recommended dose is 15 or 25 mg/kg/dose administered every 6 hours.
Danish: Børn ≥1 år For børn ≥1 år er den anbefalede dosis 15 eller 25 mg/kg/dosis hver 6. time.
English: The CHMP noted the proposed indication “gynaecological infections” but commented that the discussion of the available documentation focused primarily on intra- and post-partum infections.
Danish: CHMP noterede sig den foreslåede indikation "gynækologiske infektioner", men bemærkede, at drøftelsen af den tilgængelige dokumentation hovedsageligt fokuserede på intra- og post-partuminfektioner.
English: The MAH provided a cumulative review of adverse event reports received for imipenem/cilastatin in paediatric patients between 3 months to 3 years of age, which identified a total of 163 events in 82 reports.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en kumulativ gennemgang af indberetninger af bivirkninger for imipenem/cilastatin hos børn mellem 3 måneder og 3 år, hvor der blev påvist i alt 163 tilfælde af bivirkninger i 82 indberetninger.
English: 4.1.4 Septicaemia
Danish: 4.1.4 Septikæmi
English: 4.1.10 Management of bacterial infections in patients with febrile neutropenia
Danish: 4.1.10 Behandling af bakterieinfektioner hos neutropeniske patienter med feber
English: The CHMP considered that imipenem/cilastatin is a broad spectrum antibiotic which should be used in the treatment of severe/life-threatening infections accompanying with microbial resistance and/or when microbial resistance is demonstrated.
Danish: CHMP fandt, at imipenem/cilastatin er et bredspektret antibiotikum, som skal anvendes til behandling af alvorlige/livstruende infektioner ledsaget af mikrobiel resistens, og/eller når mikrobiel resistens er påvist.
English: The CHMP also assessed the limited data from literature sources and concluded that the claimed broad indication in the treatment of bone and joint infections could not be supported.
Danish: CHMP vurderede også de begrænsede data fra litteraturkilder og konkluderede, at den påståede brede indikation i behandlingen af knogle- og ledinfektioner ikke kunne understøttes.
English: The CHMP noted the MAH proposal for this section and made a number of revisions.
Danish: CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen til dette punkt og foretog en række ændringer.
English: Imipenem/cilastatin is not considered to be the best anti-staphylococcal agent, as other agents like semi-synthetic penicillins are generally considered to be more effective.
Danish: Imipenem/cilastatin anses ikke for at være det bedste middel mod stafylokokinfektioner, da andre midler som f.eks. halvsyntetiske penicilliner generelt anses for at være mere effektive.
English: The CHMP noted the proposed indication “endocarditis” but considered that the claimed indication in the treatment of endocarditis was insufficiently substantiated.
Danish: CHMP noterede sig den foreslåede indikation "endocarditis", men fandt, at den foreslåede indikation for behandling af endocarditis var utilstrækkeligt dokumenteret.
English: The MAH acknowledged that the spectrum of imipenem/cilatstatin does not cover Chlamydia trachomatis, and that there is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with this agent.
Danish: Indehaveren af markedsføringstilladelsen erkendte, at spektret for imipenem/cilastatin ikke omfatter Chlamydia trachomatis, og at der er utilstrækkelig dokumentation for, at Neisseria gonorrhoeae er et godt mål for behandling med dette lægemiddel.
English: The issue of seizures in paediatric patients with systemic malignancies during therapy with imipenem/cilastatin was also discussed and the CHMP was reassured by the absence of evidence in support of an increased risk of seizures in this population.
Danish: Spørgsmålet om anfald hos børn og unge med systemiske maligniteter under behandling med imipenem/cilastatin blev også drøftet, og CHMP hæftede sig ved manglen på dokumentation til støtte for en øget risiko for anfald i denne gruppe.
English: In conclusion, the CHMP was of the opinion that this indication was inadequately substantiated, and therefore deleted the indication.
Danish: CHMP mente således, at denne indikation var utilstrækkeligt underbygget, og slettede derfor indikationen.
English: Although data supporting this indication is limited, the CHMP considered the following harmonised indication to be acceptable:
Danish: Selv om dataene til støtte for denne indikation er begrænset, fandt CHMP, at følgende harmoniserede indikation var acceptabel: