FrancophonIA/ELRC3.0 huggingface dataset:
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: Small amounts of this medicine may pass into the breast milk and it may affect the baby.
Danish: Små mængder af medicinen kan gå over i modermælken, og det kan påvirke barnet.
English: The CHMP adopted a harmonised text for this section.
Danish: CHMP vedtog en harmoniseret tekst for dette afsnit.
English: Revisions were also made to the table of antibacterial spectrum.
Danish: Der blev også gennemført revisioner af tabellen vedrørende antibakterielt spektrum.
English: Considering this, Section 4.4 was revised with amendments to the paragraphs on hypersensitivity and the gastro-intestinal system.
Danish: I betragtning af dette blev afsnit 4.4 revideret med ændringer af afsnittene om overfølsomhed og det gastrointestinale system.
English: Damage to red blood cells (not known) The signs include:
Danish: Ødelæggelse af røde blodceller (hyppighed ikke kendt) Tegnene er:
English: Uncommon oral and vaginal candidiasis
Danish: Ikke almindelig oral og vaginal candidiasis
English: Sections of the SPC pertaining to the quality aspects of the dossier, in particular sections 6.3 and 6.4 were also harmonised.
Danish: Afsnittene i produktresuméet, der vedrører kvalitetsaspekterne i dossieret, især afsnit 6.3 og 6.4, blev også harmoniseret.
English: MIC summary data was also included.
Danish: De sammenfattede MIC-data blev også inkluderet.
English: Lower doses to treat such infections have to be avoided because of the risk of sub-optimal concentrations.
Danish: Lavere doser til behandling af sådanne infektioner skal undgås på grund af risikoen for suboptimale koncentrationer.
English: A further 28% is recovered as the microbiologically inactive metabolite.
Danish: Yderligere 28% genfindes som den mikrobielt inaktive metabolit.
English: They are for use for species not mentioned in the table and footnotes.
Danish: De skal bruges til arter, som ikke er angivet i tabellen eller fodnoterne.
English: The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified.
Danish: Sikkerhed og virkning af meropenem er ikke fastlagt hos børn under 3 måneder, og det optimale dosisregime er ikke identificeret.
English: Meropenem is generally well tolerated by the central nervous system.
Danish: Meropenem tolereres generelt godt af centralnervesystemet.
English: • Increased numbers of platelets in your blood (shown in a blood test).
Danish: • Øget antal blodplader i dit blod (ses ved en blodprøve).
English: However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
Danish: Proteinbindingen er dog så lav, at der ikke forventes interaktioner med andre lægemidler på baggrund af denne mekanisme.
English: The information presented reflects that currently approved for Dainippon Sumitomo Pharma and for ACS Dobfar SpA, and includes additional information and the changes that have taken place up to date.
Danish: De fremlagte oplysninger afspejler det, der på nuværende tidspunkt er godkendt for Dainippon Sumitomo Pharma og for ACS Dobfar SpA og omfatter yderligere oplysninger og de forandringer, der til dato har fundet sted.
English: Consequently the CLSI paragraph was deleted and only EUCAST information was specified for this harmonised EU SPC.
Danish: Som følge deraf blev CLSI-afsnittet slettet, og kun EUCASTinformation blev specificeret til dette harmoniserede EU-produktresumé.
English: The intravenous formulation was well tolerated in animal studies.
Danish: Den intravenøse formulering var veltolereret i dyreforsøgene.
English: Check the vial and the expiry date.
Danish: Tjek hætteglasset og udløbsdatoen.
English: Faecal elimination represents only approximately 2% of the dose.
Danish: Fækal elimination udgør kun omkring 2% af dosis.
English: Nausea and changes in tests of liver function are among the commonest risks and these findings were reversible on discontinuation.
Danish: Kvalme og ændringer i test af leverfunktionen er blandt de mest almindelige risici, og disse resultater var reversible ved seponering.
English: Meronem should not be used because it may decrease the effect of sodium valproate.
Danish: Meronem bør ikke anvendes, da det kan nedsætte virkningen af natriumvalproat.
English: The conditions of the Marketing Authorisation are listed in Annex IV.
Danish: Betingelserne for markedsføringstilladelsen fremgår af bilag IV.
English: • However, some patients, parents and carers are trained to give Meronem at home.
Danish: • Dog er der nogle patienter, forældre eller hjælpere, der er oplært i at give Meronem i hjemmet.
English: Dose to be administered every 8 hours
Danish: Dosis som skal administreres hver 8. time
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Danish: Identifikation og antimikrobielle følsomhedstests af sådanne isolater skal gentages, og hvis resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
English: When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness.
Danish: Når din læge udskriver en antibiotikabehandling, er det kun beregnet til at behandle din aktuelle sygdom.
English: Studies 3591IL/0065 and 3591IL/0022 included only paediatric patients but studies 3591IL/0020 and 3591IL/0021 included both paediatric and adult patients.
Danish: Undersøgelse 3591IL/0065 og 3591IL/0022 omfattede kun pædiatriske patienter, men undersøgelse 3591IL/0020 og 3591IL/0021 omfattede både pædiatriske og voksne patienter.
English: • The injection may take about 5 minutes or between 15 and 30 minutes.
Danish: • Det kan tage 5 minutter eller mellem 15 og 30 minutter af få injektionen.
English: After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion.
Danish: Efter hurtig administration (5 minutter eller mindre) er farmakokinetikken bieksponentiel, men dette var meget mindre evident efter 30 minutters infusion.
English: There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals.
Danish: Der var ingen tegn på øget følsomhed over for meropenem hos unge dyr sammenlignet med voksne dyr.
English: A positive direct or indirect Coombs test may develop during treatment with meropenem.
Danish: En positiv direkte eller indirekte Coombs test kan forekomme under behandling med meropenem.
English: This may also help to reduce resistance through reducing horizontal transmission of inadequately treated infections due to antibiotic-resistant pathogens.
Danish: Dette kan også hjælpe med at reducere resistensen ved at reducere horisontal overførsel af utilstrækkeligt behandlede infektioner på grund af antibiotika-resistente patogener.
English: Warning - You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.
Danish: Advarsel - Du må kun give denne medicin til dig selv eller andre i hjemmet, efter du er oplært af en læge eller sygeplejerske.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MERONEM AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF MERONEM OG TILSVARENDE NAVNE (SE BILAG I)
English: Furthermore, meropenem has not been formally evaluated in a clinical trial for VAP.
Danish: Desuden er meropenem ikke blevet formelt vurderet i en klinisk undersøgelse med VAP.
English: The CHMP agreed that there should be an “immediate use” of reconstituted solutions, especially since very rapid degradation of Glucose 5% occurs.
Danish: CHMP vedtog, at der bør være en ”øjeblikkelig anvendelse” af rekonstituerede opløsninger, især da nedbrydningen af glukose 5 % sker meget hurtigt.
English: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid
Danish: C/ Serrano Galvache 56 Edificio Roble 28033 Madrid Spanien
English: Do not use Meronem after the expiry date which is stated on the container.
Danish: Brug ikke Meronem efter den udløbsdato, der står på pakningen.
English: Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite.
Danish: Cirka 60% af dosis udskilles i urinen i løbet af 12 timer som meropenem og yderligere 12% som metabolit.
English: • Your doctor or nurse will normally give Meronem to you.
Danish: • Normalt vil en læge eller sygeplejerske give dig Meronem.
English: All of these studies (1 pivotal and 6 supportive) have been previously submitted in the original MAA.
Danish: Alle disse undersøgelser (1 hovedundersøgelse og 6 understøttende) er tidligere blevet indsendt i den originale ansøgning om markedsføringstilladelse.
English: Important information about some of the ingredients of Meronem Meronem contains sodium.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Meronem Meronem indeholder natrium.
English: Other possible side effects of unknown frequency
Danish: Bivirkninger med ukendt hyppighed
English: • Changes in your blood.
Danish: • Forandringer i dit blod.
English: Like all medicines, Meronem can cause side effects, although not everybody gets them.
Danish: Meronem kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The CHMP agreed with the updated harmonised wording proposed for the sections Pregnancy and Lactation in section 4.6, that was in line with the ‘Guideline on risk assessment of medicinal products on human reproduction and lactation (EMEA/CHMP/203927/2005, July 2008)'
Danish: CHMP vedtog den opdaterede harmoniserede ordlyd, som blev foreslået til emnerne graviditet og amning i afsnit 4.6, der var på linje med ‘Guideline on risk assessment of medicinal products on human reproduction and lactation (EMEA/CHMP/203927/2005, July 2008)‘ (Vejledning i risikovurdering af medicinalprodukter på human reproduktion og amning (EMEA/CHMP/203927/2005, juli 2008))
English: • Swelling of the face, lips, tongue or other parts of the body.
Danish: • Hævelse af ansigt, læber, tunge eller andre dele af kroppen.
English: Therefore, the CHMP considered it more appropriate to group these sub-indications under general terms and therefore agreed the following indication:
Danish: Derfor vurderede CHMP, at det var mere passende at gruppere disse underindikationer under generelle termer og vedtog derfor følgende indikation:
English: • Sore veins where Meronem is injected.
Danish: • Ømme vener, der hvor Meronem bliver sprøjtet ind.
English: -- = Susceptibility testing not recommended as the species is a poor target for therapy with the medicinal product.
Danish: -- = Følsomhedstest anbefales ikke, da arten er et dårligt mål for behandling med dette lægemiddel.
English: The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied.
Danish: Meronems potentielle påvirkning af andre lægemidlers proteinbinding eller metabolisme er ikke undersøgt.
English: The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration.
Danish: Den gennemsnitlige plasmaproteinbinding for meropenem var cirka 2% og var uafhængig af koncentrationen.
English: Streptococcus pyogenes (Group A)
Danish: Streptococcus pyogenes (gruppe A)
English: Therefore, section 6.3 of the SPC states that reconstituted solutions are to be used within 1 hour (this covers the preparation of the reconstituted solution and the duration of intravenous injection or infusion of the reconstituted solution).
Danish: Derfor står der i afsnit 6.3 i produktresuméet, at rekonstituerede opløsninger skal anvendes inden for 1 time (dette omfatter forberedelsen af den rekonstituerede opløsning og varigheden af en intravenøs injektion eller infusion af den rekonstituerede opløsning).
English: These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin'.
Danish: Disse omfatter et nedsat antal blodplader (som kan gøre, at du lettere får blå mærker), øget antal af nogle hvide blodceller, nedsat antal af andre hvide blodceller og et øget indhold af et stof, som kaldes bilirubin.
English: • Infections that you can catch during or after the delivery
Danish: • Infektioner, som du kan få under eller efter fødslen
English: There are no or limited amount of data from the use of meropenem in pregnant women.
Danish: Der er ingen eller kun en begrænset mængde data for anvendelse af meropenem til gravide.
English: 5 Non-species related breakpoints have been determined mainly from PK/PD data and are independent of the MIC distributions of specific species.
Danish: 5 Ikke-artsrelaterede grænseværdier er hovedsageligt blevet fastlagt udfra PK/PD-data og er uafhængige af MIC-fordelingerne for specifikke arter.
English: This means that they can survive and even multiply despite the antibiotic.
Danish: Dette betyder, at bakterierne kan overleve og endda formere sig på trods af antibiotika.
English: Cheshire SK10 2NA United Kingdom
Danish: Cheshire SK10 2NA Storbritannien
English: You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells.
Danish: Du kan udvikle en positiv Coombs test, som viser, at du har antistoffer, der kan ødelægge røde blodceller.
English: 2 Strains with MIC values above the S/I breakpoint are rare or not yet reported.
Danish: 2 Stammer med MIC-værdier over S/I-grænseværdien er sjældne eller endnu ikke rapporteret.
English: Meropenem is mentioned as a recommended drug in therapeutic guidelines and the indication “Intra-abdominal infections” is approved in all 29 European countries.
Danish: Meropenem er nævnt i terapeutiske vejledninger som et anbefalet lægemiddel, og indikationen “Intraabdominale infektioner” er godkendt i alle 29 europæiske lande.
English: • Other changes in your blood.
Danish: • Andre forandringer i dit blod.
English: Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union.
Danish: Lokaliserede klynger af infektioner forårsaget af carbapenemresistente bakterier har været rapporteret inden for den europæiske union.
English: AstraZeneca AS Hoffsveien 70 B/Postboks 200 Vinderen 0319 OSLO Norway
Danish: AstraZeneca AS Hoffsveien 70 B/Postboks 200 Vinderen 0319 OSLO Norge
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen for erhvervet resistens kan variere afhængig af geografi og over tid for udvalgte arter, og lokal information om resistens er ønskværdig, specielt ved behandling af alvorlige infektioner.
English: There is no experience in children with renal impairment.
Danish: Der er ingen erfaring med børn med nedsat nyrefunktion.
English: Finally, the “Species for which acquired resistance may be a problem” and the “Inherently resistant organisms” were revised.
Danish: Endelig blev “Arter, hvor erhvervet resistens kan være et problem” og “Medfødt resistente organismer” revideret.
English: If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.
Danish: Hvis du ved en fejl har taget mere end din foreskrevne dosis, skal du kontakte din læge eller det nærmeste hospital med det samme.
English: If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Danish: Såfremt der opstår alvorlige allergiske reaktioner, skal behandlingen afbrydes, og passende forholdsregler tages.
English: To date, 7 AstraZeneca (AZ) sponsored studies have been conducted in UTIs.
Danish: Til dato er der blevet gennemført 7 AstraZeneca (AZ) sponsorerede undersøgelser med urinvejsinfektioner.
English: The CHMP therefore unanimously considered that there is no place for CLSI as soon as EUCAST breakpoints are available.
Danish: CHMP vurderede derfor enstemmigt, at der ikke er plads til CLSI, så snart EUCAST-breakpoints er til rådighed.
English: It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent.
Danish: Det anbefales, at INR monitoreres hyppigt under og kort tid efter samtidig administration af antibiotika og et oralt antikoagulans.
English: Therefore, improvement in lung function is the key benefit to be derived from treatment with meropenem.
Danish: Derfor er forbedring i lungefunktionen den nøglefordel, der skal udledes af behandlingen med meropenem.
English: Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Seponering af meropenembehandlingen og administration af specifik behandling for Clostridum difficile bør overvejes.
English: The CHMP noted that EU countries themselves do not consider that CLSI breakpoints are required in addition to the EUCAST breakpoints.
Danish: CHMP bemærkede, at EU-landene ikke selv vurderer, at CLSI-breakpoints er påkrævede foruden EUCAST-breakpoints.
English: Children from 3 months to 11 years of age and up to 50 kg body weight The recommended dose regimens are shown in the table below:
Danish: Børn fra 3 måneder til 11 år og med en kropsvægt op til 50 kg Det anbefalede dosisregime vises i tabellen nedenfor:
English: It works by killing bacteria, which can cause serious infections.
Danish: Det virker ved at dræbe bakterier, som kan give alvorlige infektioner.
English: AstraZeneca A/S Roskildevej 22 2620 Albertslund Denmark
Danish: AstraZeneca A/S Roskildevej 22 2620 Albertslund Danmark
English: • The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is.
Danish: • Dosis afhænger af, hvilken type infektion du har, hvor infektionen er i kroppen, og hvor alvorlig den er. Din læge vil beslutte, hvilken dosis du skal have.
English: • The medicine must be mixed with another liquid (the diluent).
Danish: • Denne medicin skal blandes med en anden væske (opløsningsmidlet).
English: Data from this study showed that meropenem was highly effective in the treatment of bacterial gynaecological infections.
Danish: Data fra denne undersøgelse viste, at meropenem var yderst effektiv i behandlingen af bakterielle gynækologiske infektioner.
English: The MAH has undertaken to submit further data within the specified time frame specified in their letter of undertaking dated 23 July 2009.
Danish: Indehaveren af markedsføringstilladelsen har påtaget sig at indsende yderligere data inden for den fastlagte tidsramme, som er angivet i deres tilsagnsbrev af 23. juli 2009.
English: Additional modifications mentioning the effects on the CNS in rodents were also added to section 5.3 of the SPC.
Danish: Yderligere ændringer, som omhandlede virkningerne på CNS hos gnavere, blev også føjet til afsnit 5.3 i produktresuméet.
English: Meronem belongs to a group of medicines called carbapenem antibiotics.
Danish: Meronem tilhører en gruppe af stoffer, der hedder carbapenem-antibiotika.
English: This may be associated with a high fever and joint pains.
Danish: Dette kan være ledsaget af høj feber og ledsmerter.
English: Advice/medical education
Danish: Vejledning/medicinsk oplysning
English: The active substance meropenem trihydrate is manufactured by two manufacturers.
Danish: Det aktive stof meropenemtrihydrat fremstilles af to producenter.
English: However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s).
Danish: Dog kan bakterier udvise resistens over for mere end en klasse antibiotika, når mekanismen omfatter impermeabilitet og/eller en efflukspump(er).
English: In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs.
Danish: I studier på op til 6 måneder med gentagen dosering til hunde sås kun en mindre påvirkning inklusive et fald i røde blodcelleparametre.
English: Children who weigh over 50 kg will be given an adult dose.
Danish: Børn, der vejer over 50 kg, skal have voksendosis.
English: It was noted that this indication was claimed for adults and children, but no paediatric posology recommendation were proposed by the MAH, however, this is accepted given the claimed gynaecological infections.
Danish: Det blev bemærket, at denne indikation var påstået for voksne og børn, men ingen pædiatrisk doseringsanbefaling blev foreslået af indehaveren af markedsføringstilladelsen, men dette er accepteret i betragtning af de hævdede gynækologiske infektioner.
English: You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
Danish: Du skal ikke tage et antibiotikum medmindre det er blevet udskrevet specifikt til dig, og du skal kun bruge det til at behandle den infektion, det er udskrevet til.
English: EUCAST clinical MIC breakpoints for meropenem (2009-06-05, v 3.1) Organism
Danish: EUCAST kliniske MIC grænseværdier for meropenem (2009-06-05, v 3.1) Organisme
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Danish: Arter for hvilke erhvervet resistens kan være et problem Grampositive anaerober
English: Based on the Quality data submitted, the CHMP concluded that the product should not be stored above 30°C and that the reconstituted solution should not be frozen.
Danish: På grundlag af de indsendte kvalitetsdata konkluderede CHMP, at produktet ikke bør opbevares ved over 30 °C, og at den rekonstituerede opløsning ikke bør nedfryses.
English: The CHMP agreed that valproic acid should be avoided during treatment with Meronem.
Danish: CHMP vedtog, at valproinsyre bør undgås under behandling med Meronem.
English: Meropenem is detectable at very low concentrations in animal breast milk.
Danish: Meropenem kan påvises i meget lave koncentrationer i modermælk hos dyr.
English: A dose is usually given every 8 hours.
Danish: Der gives normalt en dosis hver 8. time.
English: It was added to aid in the dissolution of the bulk drug by increasing the pH of the solution above the pKa value of the carboxyl group of meropenem.
Danish: Det blev tilføjet, at det hjælper til opløsningen af lægemiddelmassen ved at øge pH i opløsningen over pKa-værdien i carboxyl-gruppen af meropenem.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from meropenem therapy taking into account the benefit of therapy for the woman.
Danish: Der må træffes et valg om enten at ophøre med amning eller at ophøre med/undlade meropenembehandling under hensyntagen til kvindens gavn af behandlingen.
English: AstraZeneca Kft. H-2045 Törökbálint Park u. 3.
Danish: AstraZeneca Kft. - Hungary H-2045 Törökbálint Park u. 3.
English: Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 -75 %) of the dose is excreted unchanged within 12 hours.
Danish: Meropenem udskilles hovedsageligt uomdannet via nyrerne; omkring 70% (50-75%) af den indgivne dosis udskilles uomdannet inden for 12 timer.
English: Treatment of febrile neutropenic patients
Danish: Behandling af febrile neutropeniske patienter
English: The CHMP noted that the safety profile of meropenem is well-known and that hypersensitivity including serious reactions is considered typical for the carbapenem class.
Danish: CHMP bemærkede, at sikkerhedsprofilen for meropenem er velkendt, og at overfølsomhed, herunder alvorlige reaktioner, vurderes som typiske for carbapenem-gruppen.