FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that it would be artificial to put emphasis on some sub-gynaecological infections as the level of demonstration was limited overall for gynaecological infections and especially when scrutinizing specific sub-indications such as episiotomy, endometritis.
Danish: CHMP vurderede, at det ville være kunstigt at lægge vægt på nogle sub-gynækologiske infektioner, da påvisningsniveauet var begrænset generelt for gynækologiske infektioner og især ved nærmere undersøgelse af underindikationer som episiotomi, endometritis.
English: The solution should be shaken before use.
Danish: Opløsningen skal rystes før brug.
English: This is because Meronem can affect the way some medicines work and some medicines can have an effect on Meronem.
Danish: Det skyldes, at Meronem kan påvirke virkningen af andre lægemidler, og at andre lægemidler kan påvirke virkningen af Meronem.
English: The CHMP noted that the proposed indication in complicated IAIs is in accordance with the clinical documentation and the clinical experience gained in this field.
Danish: CHMP vurderede, at den foreslåede indikation til komplicerede IAI'er er i overensstemmelse med den kliniske dokumentation og den kliniske erfaring, der er indhentet på området.
English: The CHMP considered that although the level of demonstration was more limited in adults than in children, meropenem is an adequate option for also treating adult cases of acute meningitis.
Danish: CHMP vurderede, at selv om påvisningsniveauet var mere begrænset for voksne end for børn, er meropenem en tilstrækkelig valgmulighed til også at behandle voksne tilfælde af akut meningitis.
English: The CHMP noted that the scope of this SPC harmonisation procedure covers two strengths (500 mg and 1g) of the unique IV pharmaceutical form.
Danish: CHMP bemærkede, at omfanget af denne harmonisering af produktresuméet omfatter to styrker (500 mg og 1g) af den unikke intravenøse lægemiddelform.
English: The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
Danish: Meropenems eneste metabolit havde samme toksicitetsprofil i dyreforsøg.
English: Bedfordshire LU1 3LU United Kingdom
Danish: Bedfordshire LU1 3LU Storbritannien
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer ikke direkte eller indirekte skadelige virkninger på reproduktionstoksicitet (se pkt.
English: A white to light yellow powder.
Danish: Et hvidt til lysegult pulver.
English: From a conceptual perspective, combinations of antibacterials from different classes may cover unsuspected pathogens, improve coverage for antibiotic-resistant pathogens like P. aeruginosa, prevent or reduce antibiotic resistance and achieve better clinical and bacteriological outcomes.
Danish: Fra et konceptperspektiv kan kombinationer af antibakterielle midler fra forskellige grupper dække uforudsete patogener, forbedre dækningen for antibiotika-resistente patogener som P. aeruginosa, forhindre eller reducere antibiotikaresistens og opnå bedre kliniske og bakteriologiske resultater.
English: A number of areas of disharmony in the product information for meropenem have been evaluated by the CHMP and the revised Product Information (PI) was adopted.
Danish: CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for meropenem, og en revideret produktinformation (PI) blev vedtaget.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: Pharmacokinetic studies in healthy elderly subjects (65-80 years) have shown a reduction in plasma clearance, which correlated with age-associated reduction in creatinine clearance, and a smaller reduction in non-renal clearance.
Danish: Farmakokinetiske forsøg hos raske ældre personer (65-80 år) har vist en reduktion i plasmaclearance, som stemmer overens med den aldersassocierede reduktion i kreatininclearance samt en mindre reduktion i ikke-renal clearance.
English: The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion.
Danish: Den registrerede renale clearance og effekten af probenecid viser, at meropenem både undergår filtration og tubulær sekretion.
English: Improvement in lung function following an acute pulmonary exacerbation in CF is important to the quality of life and survival of the patient since lung function is the best predictor of mortality.
Danish: Forbedring i lungefunktionen efter en akut pulmonær forværring ved CF er af betydning for patientens livskvalitet og overlevelse, da lungefunktionen er den bedste forudsigelse for dødelighed.
English: Most specialists would recommend using combinations of antibiotics to treat patients with CF, including combinations administered intravenously, orally, or by inhalation.
Danish: De fleste specialister ville anbefale at bruge kombinationer af antibiotika til at behandle patienter med CF, herunder kombinationer, der indgives intravenøst, peroralt eller ved inhalation.
English: Based on the Quality data submitted, the CHMP agreed that anhydrous sodium carbonate is the only inactive ingredient in the product.
Danish: På grundlag af de indsendte kvalitetsdata vedtog CHMP, at vandfri natriumkarbonat er den eneste inaktive ingrediens i produktet.
English: Safety and Efficacy issues
Danish: − Aspekter vedrørende sikkerhed og effekt
English: Although other drugs do have activity against P. aeruginosa, specialists prefer to have a choice of agents to overcome issues of temporary reductions in susceptibility (i.e. antibiotic cycling), allergy or other intolerances.
Danish: Selv om andre lægemidler faktisk har aktivitet mod P. aeruginosa, foretrækker specialisterne at have et udvalg af lægemidler til at afhjælpe problemer med midlertidige reduktioner i følsomhed (dvs. antibiotiske cyklusser), allergi eller andre intolerancer.
English: Not known toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme.
Danish: Ikke kendt toksisk epidermal nekrolyse, StevensJohnsons syndrom, erythema multiforme.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages højde for de officielle retningslinjer for korrekt anvendelse af antibakterielle midler.
English: No data is available, but it is not expected that Meronem will affect the ability to drive or use machines.
Danish: Der er ingen data til rådighed, men det forventes ikke, at Meronem vil påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Meronem contains sodium.
Danish: Meronem indeholder natrium.
English: The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment.
Danish: AUC for den mikrobiologisk inaktive åben-ringedemetabolit var også betydeligt forøget hos patienter med nedsat nyrefunktion.
English: 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25/1 mg/L.
Danish: 1 Grænseværdier for meropenem for Streptococcus pneumoniae og Haemophilus influenzae ved meningit er 0,25/1 mg/l.
English: Based on the discussed data, the MAH concluded that the safety profile reported in the population of patients with CF is similar to that reported overall and that meropenem is well tolerated.
Danish: På grundlag af de drøftede data konkluderede indehaveren af markedsføringstilladelsen, at den sikkerhedsprofil, der er rapporteret for patientpopulationen med CF, ligner den, der er rapporteret generelt, og at meropenem er veltolereret.
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Meronem and associated names (see Annex I).
Danish: har CHMP anbefalet ændringen af markedsføringstilladelsen(-tilladelserne), hvortil produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Meronem og tilsvarende navne (se bilag I).
English: Quality issues
Danish: − Kvalitetsaspekter
English: Recent susceptibility data for European isolates from various surveillance programmes and in light of clinical data, AstraZeneca propose that P. aeruginosa and Burkholderia cepacia will be listed under species that may be resistant to meropenem.
Danish: I lyset af nyeste følsomhedsdata for europæiske isolater fra forskellige overvågningsprogrammer og de kliniske data foreslår AstraZeneca, at P. aeruginosa og Burkholderia cepacia bliver listet under arter, der kan være resistente over for meropenem.
English: However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2).
Danish: Begrænsede farmakokinetiske data antyder dog, at 20 mg/kg hver 8. time vil være passende (se pkt.
English: The CHMP considered that co-administration of probenecid and meropenem is not expected to have clinical consequences, in view of the limited increase.
Danish: CHMP vurderede, at samtidig indgift af probenecid og meropenem ikke forventes at have kliniske konsekvenser i betragtning af den begrænsede stigning.
English: A population model developed from data in 79 patients with intra-abdominal infection or pneumonia, showed a dependence of the central volume on weight and the clearance on creatinine clearance and age.
Danish: En populationsmodel udviklet af data fra 79 patienter med intraabdominal infektion eller pneumoni, har vist, at det centrale volumen afhænger af vægt, kreatinin-clearance og alder.
English: The MAH submitted a harmonisation of Module 3.
Danish: Indehaveren af markedsføringstilladelsen indsendte en harmonisering af modul 3.
English: The MAH commits to carrying out a number of quality-related steps pertaining to the Drug Substance and the Drug Product and to submit the data listed in the Letter of Undertaking within the specified timeframe.
Danish: Indehaverne af markedsføringstilladelsen forpligter sig til at tage en række kvalitetsrelaterede skridt vedrørende lægemiddelstoffet og lægemiddelproduktet og fremlægge de data, der er anført i tilsagnsbrevet inden for den fastsatte tidsramme.
English: • Probenecid (used to treat gout).
Danish: • Probenecid (bruges til behandling af gigt).
English: The tables below provide general recommendations for dosing.
Danish: Tabellerne nedenfor foreskriver generelle doseringsanbefalinger.
English: Antibiotics are used to treat infections caused by bacteria.
Danish: Antibiotika bruges til at behandle infektioner, der skyldes bakterier.
English: Therefore, the CHMP agreed that the two ADRs “blood creatinine increased” and “blood urea increased” should be included in the harmonised SPC for Meronem as ‘uncommon ADRs'.
Danish: Derfor vedtog CHMP, at de to bivirkninger “øget blodkreatinin” og “øget urinstof i blodet” bør inkluderes i det harmoniserede produktresumé for Meronem som ‘ikke almindelige bivirkninger'.
English: No specific medicinal product interaction studies other than probenecid were conducted.
Danish: Der er ikke udført specifikke forsøg med lægemiddelinteraktioner ud over forsøg med probenecid.
English: The following wording was therefore agreed by the CHMP:
Danish: Følgende ordlyd blev derfor vedtaget af CHMP:
English: Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
Danish: Omhyggeligt brug af antibiotika kan hjælpe med til at nedsætte risikoen for, at bakterier bliver resistente over for dem.
English: The CHMP agreed to the additional modifications in this section of the SPC, mentioning the effects on the kidney in mice, dogs and monkeys.
Danish: CHMP vedtog de yderligere ændringer i dette afsnit af produktresuméet og nævnte virkningerne på nyrerne hos mus, hunde og aber.
English: Your doctor will tell you how to give Meronem.
Danish: Din læge vil fortælle dig, hvordan du skal have Meronem.
English: Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems.
Danish: Bakteriel resistens over for meropenem kan stamme fra: (1) Nedsat permeabilitet af den ydre membran på gramnegative bakterier (på grund af nedsat produktion af poriner), (2) nedsat affinitet til target PBP'er, (3) forøget ekspression af efflukspumpekomponenter og (4) produktion af betalaktamaser, som kan hydrolysere carbapenemer.
English: Dainippon Sumitomo Pharma Co. Ltd. (Oita, Japan), was the originator and ACS Dobfar SpA (Milano / Italy) is an alternative manufacturer of both the intermediate HECA, and the pure sterile meropenem trihydrate.
Danish: Dainippon Sumitomo Pharma Co. Ltd. (Oita, Japan) var den oprindelige producent, og ACS Dobfar SpA (Milano / Italien) er en alternativ producent af både mellemproduktet HECA, og det rene, sterile stof meropenemtrihydrat.
English: The MAH's recommendation for administration over 15 to 30 minutes is based on dosage recommendations used in the efficacy studies conducted to support the registration of meropenem.
Danish: Anbefalingerne fra indehaveren af markedsføringstilladelsen om indgivelse i løbet af 15 til 30 minutter er baseret på doseringsanbefalinger, som bruges i de effektivitetsundersøgelser, der gennemføres for at understøtte registreringen af meropenem.
English: Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter-individual variability.
Danish: Meropenemkoncentrationer i cerebrospinalvæsken hos børn med meningit er cirka 20% af det samtidige plasmaniveau, selvom der er signifikant interindividuel variabilitet.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8).
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, som får diarré under eller efter administration af meropenem (se pkt.
English: Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
Danish: Ved at være opmærksom på de følgende råd kan du hjælpe med til at forebygge, at der opstår resistente bakterier, som kan forhindre, at antibiotikummet virker.
English: You should not give antibiotics that were prescribed for you to other people.
Danish: Du må ikke give antibiotika, som er udskrevet til dig, til andre.
English: • Meronem will be given to you as an injection or infusion into a large vein.
Danish: • Du vil få Meronem som en injektion eller infusion ind i en stor blodåre.
English: Finally, with regards to the potential interaction with anticoagulants, the CHMP maintains its position that oral anticoagulants effects may be augmented when used concomitantly with antibiotics
Danish: Endelig med henblik på den potentielle interaktion med antikoagulantia fastholder CHMP den holdning, at virkningerne af perorale antikoagulantia kan forhøjes, når midlet anvendes sammen med antibiotika.
English: The CHMP considered that there was no compulsory need for a specific statement on combination strategies in the SPC since the clinical practice is guided by official guidance, as referred to in section 4.1 of the SPC:
Danish: CHMP vurderede, at der ikke var noget tvingende behov for en specifik erklæring om kombinationsstrategier i produktresuméet, da den kliniske praksis vejledes af officiel vejledning, som henvist til i afsnit 4.1 i produktresuméet:
English: • Sodium valproate (used to treat epilepsy).
Danish: • Natriumvalproat (bruges til behandling af epilepsi).
English: • Changes in blood tests, including tests that show how well your liver is working.
Danish: • Ændringer i blodprøveresultater, inklusive prøver som viser, hvordan din lever fungerer.
English: One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken.
Danish: En af de mest almindelige årsager til det er, at bakterien, som er skyld i infektionen, er resistent over for det antibiotikum, der tages.
English: It is unknown whether meropenem is excreted in human milk.
Danish: Det vides ikke, om meropenem udskilles i human modermælk.
English: For intravenous infusion meropenem vials may be directly constituted with 0.9 % sodium chloride or 5% glucose solutions for infusion.
Danish: Til intravenøs infusion kan meropenem fortyndes direkte med 0,9% natriumchlorid eller 5% glucoseopløsning til infusion.
English: Regarding the posology in elderly, the CHMP considered that being above 65 years of age does not per se constitute a problem for the drug administration, unless the clinical status and renal function of the patient are significantly altered.
Danish: Vedrørende doseringen til ældre mennesker vurderede CHMP, at en alder over 65 år i sig selv ikke udgør et problem for indgivelse af lægemidlet, medmindre patientens kliniske status og nyrefunktion er betydeligt ændret.
English: The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below.
Danish: Dosis til voksne og unge skal justeres, når kreatinin-clearance er mindre end 51 ml/min, som vist nedenfor.
English: If you notice any of the above, see a doctor straight away.
Danish: Hvis du får nogle af ovennævnte symptomer, skal du straks søge læge.
English: Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH02
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, carbapenemer, ATC-kode: J 01 DH 02
English: In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval.
Danish: I prækliniske modeller viste meropenem aktivitet, når plasmakoncentrationerne oversteg MIC for den inficerende organisme i cirka 40% af doseringsintervallet.
English: Based on the Quality data submitted, the CHMP revised the text in this section and stated that the medicinal product is supplied in pack sizes of 1 or 10 vials and that not all pack sizes may be marketed.
Danish: På grundlag af de indsendte kvalitetsdata reviderede CHMP teksten i dette afsnit og angav, at præparatet leveres i pakkestørrelser på 1 eller 10 hætteglas, og at ikke alle pakkestørrelser må markedsføres.
English: In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %).
Danish: I en gennemgang af 4.872 patienter med 5.026 meropenembehandlinger var de mest almindeligt rapporterede bivirkninger diarré (2,3%), udslæt (1,4%), kvalme/opkastning (1,4%) og inflammation på injektionsstedet (1,1%).
English: The adequacy of meropenem to treat acute bacterial meningitis in adults is based upon the evaluation in adults referred to above, plus an extrapolation of efficacy from the much larger group of children with meningitis also evaluated.
Danish: Meropenems tilstrækkelighed til at behandle akut bakteriel meningitis hos voksne er baseret på den vurdering af voksne, der henvises til ovenfor, foruden en ekstrapolering af effekten fra den meget større gruppe børn med meningitis, som også blev vurderet.
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Danish: Du skal specielt være opmærksom på at fortælle lægen eller sundhedspersonalet, hvis du tager nogle af følgende lægemidler:
English: Renal impairment results in higher plasma AUC and longer half-life for meropenem.
Danish: Nedsat nyrefunktion resulterer i højere plasma-AUC og en længere halveringstid for meropenem.
English: Although it is acknowledged that not all patients with community-acquired pneumonia (CAP) require treatment with a carbapenem the MAH argued that restriction of the indication to severe cases only is not required since severity is already implied by the route of administration of the product and other aspects of labelling.
Danish: Selv om det er anerkendt, at ikke alle patienter med samfundserhvervet pneumoni (CAP: Communityacquired pneumonia) behøver behandling med en carbapenem, fremførte indehaveren af markedsførings-tilladelsen, at begrænsning af indikationen til svære tilfælde alene ikke er påkrævet, da sværhedsgraden allerede er underforstået gennem produktets indgivelsesvej og andre aspekter i etiketteringen.
English: Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Danish: Peptostreptococcus arter (inklusive P. micros, P. anaerobius, P. magnus)
English: Animal studies indicate that meropenem is well tolerated by the kidney.
Danish: Dyreforsøg indikerer, at meropenem tolereres godt af nyrerne.
English: In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: I tabellen nedenfor er alle bivirkninger anført efter organklasse og hyppighed: Meget almindelige (≥1/10); almindelige (≥ 1/100 til <1/10); ikke almindelige (≥ 1/1.000 til <1/100); sjældne (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000) og ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: • Infection affecting the lungs (pneumonia)
Danish: • Infektion, der påvirker lungerne (pneumoni)
English: Data from this and a further study, of 122 patients (of whom 70 received meropenem in combination with tobramycin), conducted since the first registration show that meropenem is effective in the treatment of LRTI in patients with CF, and similar in effectiveness to ceftazidime alone or in combination with tobramycin.
Danish: Data fra dette og en yderligere undersøgelse med 122 patients (hvoraf 70 fik meropenem kombineret med tobramycin), som blev gennemført siden den første registrering, viser, at meropenem er effektiv i behandlingen af LRTI til patienter med CF, og at effekten ligner effekten af ceftazidim alene eller kombineret med tobramycin.
English: Consequently the CHMP agreed that the wording of the therapeutic indication was appropriate as follows:
Danish: CHMP vedtog derfor, at ordlyden i den terapeutiske indikation var passende som følger:
English: Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects.
Danish: Samtidig administration af antibiotika og warfarin kan forstærke den antikoagulerende effekt.
English: Wash your hands and dry them very well.
Danish: Sådan blandes medicinen Vask dine hænder og tør dem godt.
English: The CHMP noted the MAH proposal for this section, and considered it acceptable.
Danish: CHMP noterede forslaget fra indehaveren af markedsføringstilladelsen til dette afsnit, og vurderede, at det var acceptabelt.
English: Meronem and associated names (see Annex I) 500 mg
Danish: Meronem og tilsvarende navne (se bilag I) 500 mg
English: The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %).
Danish: De mest almindeligt rapporterede meropenembivirkninger relateret til laboratorieværdier var trombocytose (1,6%) og forhøjede leverenzymer (1,5-4,3%).
English: Adverse reactions listed in the table with a frequency of “not known” were not observed in the 2,367 patients who were included in pre-authorisation clinical studies with intravenous and intramuscular meropenem but have been reported during the post-marketing period.
Danish: Bivirkninger, der fremgår af tabellen med frekvensen ”ikke kendt”, blev ikke observeret hos de 2.367 patienter, som var inkluderet i de kliniske forsøg med intravenøs og intramuskulær meropenem før markedsføring, men er blevet rapporteret i perioden efter markedsføring.
English: • Changes in blood tests, including tests that show how well your kidney is working.
Danish: • Forandringer i blodprøveresultater, inklusive undersøgelser, som viser, hvor godt dine nyrer virker.