FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no established dose recommendations for patients receiving peritoneal dialysis.
Danish: Dosisanbefalinger er ikke fastlagt for patienter, som får peritoneal dialyse.
English: Common headache
Danish: Almindelig hovedpine
English: Where the data results in a variation, an application for a variation will be submitted to the RMS.
Danish: Hvis dataene resulterer i en ændring, skal der indgives en ansøgning om en ændring til referencemedlemsstaten.
English: However, if it is almost time for your next injection, skip the missed injection.
Danish: Hvis det næsten er tid til din næste dosis, skal du dog springe den glemte dosis over.
English: The safety of Meronem in CF derived from trials, national and international named patient/compassionate use data and comparative studies between meropenem and tobramycin or ceftazidim was also discussed.
Danish: Sikkerheden ved Meronem til CF udledt af undersøgelser, nationale og internationale navngivne patientdata/data med særlig udleveringstilladelse og sammenlignende undersøgelser mellem meropenem og tobramycin eller ceftazidim blev også drøftet.
English: Limited safety data are available to support the 2 g intravenous bolus or the corresponding paediatric 40 mg/kg bolus
Danish: Begrænsede sikkerhedsdata er til rådighed til at understøtte den 2 g intravenøse bolus eller den tilsvarende pædiatriske 40 mg/kg bolus
English: The clinical and bacteriological effectiveness of meropenem as monotherapy was similar to the combination treatment of clindamycin plus gentamicin.
Danish: Den kliniske og bakteriologiske effekt af meropenem som monoterapi lignede kombinationsbehandlingen med clindamycin plus gentamicin.
English: This extrapolation is considered valid because the pathophysiology of meningitis and its bacterial aetiology are essentially the same in adults and children, with knowledge of the dose relationship between adults and children (40 mg/kg in children is equivalent to a 2 g unit dose in adults).
Danish: Ekstrapoleringen betragtes som gyldig, fordi patofysiologien i meningitis og dets bakterielle ætiologi er stort set de samme hos voksne og børn, med viden om dosisforholdet mellem voksne og børn (40 mg/kg til børn svarer til en 2 g enkeltdosis til voksne).
English: Gram-negative anaerobes Bacteroides caccae Bacteroides fragilis group Prevotella bivia Prevotella disiens
Danish: Gramnegative anaerober Bacteroides caccae Bacteroides fragilis gruppen Prevotella bivia Prevotella disiens
English: If you are using Meronem at home, dispose of any needles and infusion lines that you have used in an appropriate way.
Danish: Hvis du bruger Meronem derhjemme så kasser nåle og infusionsslanger, som du har brugt, på en sikker måde.
English: Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2.
Danish: Relativ overdosering kan forekomme hos patienter med nedsat nyrefunktion, hvis dosis ikke justeres som beskrevet under pkt.
English: The medicinal product is supplied in pack sizes of 1 or 10 vials.
Danish: Dette lægemiddel leveres i pakningsstørrelser på 1 eller 10 hætteglas.
English: There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Danish: Der er ikke nogen target-baseret krydsresistens mellem meropenem og grupperne quinoloner, aminoglykosider, makrolider og tetracykliner.
English: Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60 %T>MIC for P. aeruginosa in 95 % of pre-term and 91 % of full term neonates.
Danish: Monte Carlo simulering baseret på en populationsfarmakokinetisk model, har vist, at man ved et dosisregime på 20 mg/kg hver 8. time opnåede 60% T>MIC for P. aeruginosa hos 95% af for tidligt fødte og hos 91% af fuldbårne nyfødte.
English: Staphylococcus aureus (methicillin-susceptible) £
Danish: Staphylococcus aureus (methicillinfølsomme)£
English: • Shortness of breath, wheezing or trouble breathing.
Danish: • Åndenød, hvæsen eller problemer med at trække vejret.
English: Non-species related breakpoints5
Danish: Ikke-artsrelaterede grænseværdier5
English: Resistant (R) (mg/l)
Danish: Følsomhed (S) (mg/l) Resistens (R) (mg/l)
English: The following table of pathogens listed is derived from clinical experience and therapeutic guidelines.
Danish: Nedenstående tabel med opstilling af patogener stammer fra klinisk erfaring og terapeutiske retningslinjer.
English: Draw up the recommended amount of sterile ‘Water for Injections' into the syringe.
Danish: Træk den anbefalede mængde sterilt ”vand til injektionsvæsker” op i sprøjten.
English: The CHMP agreed to add the following statement in section 4.2 of the SPC:
Danish: CHMP vedtog at føje følgende udtalelse til afsnit 4.2 i produktresuméet:
English: Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved.
Danish: Træk nålen ud af hætteglasset og ryst hætteglasset godt i cirka 5 sekunder, eller indtil alt pulveret er opløst.
English: The CHMP agreed that intentional overdosing of Meronem is unlikely, although unintentional overdosing could occur, particularly in patients with renal impairment.
Danish: CHMP vedtog, at tilsigtet overdosering med Meronem er usandsynlig, selv om utilsigtet overdosering kan finde sted, især til patienter med nedsat nyrefunktion.
English: Gram-negative aerobes Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
Danish: Gramnegative aerober Citrobacter freudii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens
English: It is preferable to avoid the use of meropenem during pregnancy.
Danish: Man skal helst undgå at tage meropenem under graviditeten.
English: Take special care with Meronem Check with your doctor before using Meronem:
Danish: Vær ekstra forsigtig med at tage Meronem Tal med din læge, inden du tager Meronem:
English: Meronem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):
Danish: Meronem er indiceret til behandling af følgende infektioner hos voksne og børn over 3 måneder (se pkt.
English: • The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child.
Danish: Dosis til børn i alderen 3 måneder til 12 år bliver bestemt ud fra alder og kropsvægt.
English: Connect a new sterile needle to a new sterile syringe, without touching the ends.
Danish: Saml en ny, steril nål med en ny, steril sprøjte uden at røre ved enderne.
English: In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor.
Danish: In vitro udviser meropenem en nedsat følsomhed over for hydrolyse ved hjælp af humant dehydropeptidase-I (DHP-I), sammenlignet med imipenem, og der er ikke behov for samtidig administration af en DHP-I hæmmer.
English: Regarding the dosage schedule for adults with impaired renal function, the MAH stated that dose adjustments of the upper limit from 1 g to 2 g had not been studied but are widely used in clinical practice.
Danish: Med hensyn til doseringsplanen for voksne med nedsat nyrefunktion meddelte indehaveren af markedsføringstilladelsen, at dosisjusteringer til den øvre grænse fra 1 g til 2 g ikke var blevet undersøgt, men anvendes i vid udstrækning i klinisk praksis.
English: Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg.
Danish: Der blev set påvirkning i akutte toksicitetsstudier i gnavere ved doser over 1.000 mg/kg.
English: Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
Danish: Krampeanfald er sjældent blevet rapporteret under behandlingen med carbapenemer, herunder meropenem (se afsnit 4.8).
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Danish: Afsnit 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: Based on the Quality data submitted, the CHMP agreed that this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: På grundlag af de indsendte kvalitetsdata vedtog CHMP, at dette præparat ikke må blandes med andre præparater med undtagelse af dem, som er nævnt i afsnit 6.6.
English: 4 Meropenem breakpoints in Neisseria meningitidis relates to meningitis only.
Danish: 4 Meropenems grænseværdi for Neisseria meningitidis relaterer alene til meningit.
English: Dose in elderly patients
Danish: Dosis til ældre patienter
English: The MAH also searched the patient safety database for cases with a medical history of CF. A total of 484 events were identified in 273 cases, which were summarised and discussed by the MAH.
Danish: Indehaveren af markedsføringstilladelsen gennemsøgte også patientsikkerhedsdatabasen efter tilfælde med en sygejournal med CF. I alt 484 hændelser blev identificeret i 273 tilfælde, som blev opsummeret og drøftet af indehaveren af markedsføringstilladelsen.
English: The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours.
Danish: Meropenems farmakokinetik hos nyfødte, der kræver antiinfektiøs behandling, har vist, at clearance er større hos nyfødte med højere kronologisk eller gestationel alder; den totale gennemsnitlige halveringstid var 2,9 timer.
English: Hypersensitivity to any other carbapenem antibacterial agent.
Danish: Overfølsomhed over for ethvert andet carbapenem antibakterielt middel.
English: Haemophilus influenzae1 and Moraxella catarrhalis Neisseria meningitidis2,4
Danish: Haemophilus influenzae1 og Moraxella catarrhalis ≤ 2 Neisseria meningitidis2, 4
English: Streptococcus groups A, B, C, G Streptococcus pneumoniae1 Other streptococci Enterococcus
Danish: Streptococcus gruppe A, B, C, G Streptococcus pneumoniae1 Andre streptokokker Enterococcus
English: Not known antibiotic-associated colitis (see section 4.4)
Danish: Ikke kendt antibiotika-associeret colitis (se pkt.
English: Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis Streptococcus agalactiae (Group B)
Danish: Staphylococcus arter (methicillinfølsomme) inklusive Staphylococcus epidermidis Streptococcus agalactiae (gruppe B)
English: The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs.
Danish: Den normale dosis er mellem 10 mg og 40 mg Meronem pr. kg, barnet vejer.
English: Not known agranulocytosis, haemolytic anaemia
Danish: Ikke kendt agranulocytose, hæmolytisk anæmi
English: You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
Danish: Du skal ikke tage antibiotika, der er udskrevet til andre personer, heller ikke selvom de har haft en infektion, der er magen til din.
English: European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below.
Danish: Kliniske grænseværdier for MIC prøver i henhold til European Committee for Antimicrobial Susceptibility Testing (EUCAST) er opstillet nedenfor.
English: Acinetobacter
Danish: Acetinobacter
English: The CHMP considered that meropenem has a relatively low acute toxicity, even though effects on the kidney were seen in mice at 2200 mg/kg, dogs at 2000 mg/kg and monkeys at 500mg/kg.
Danish: CHMP vurderede, at meropenem har en forholdsvis lav akut toksicitet, selv om effekter på nyrerne blev set hos mus ved 2200 mg/kg, hunde ved 2000 mg/kg og aber ved 500 mg/kg.
English: Nevertheless, despite the inadequate clinical data provided the critical interest of this drug should not be disregarded, especially in resistant Gram negative strains producing extended spectrum betalactamase.
Danish: Ikke desto mindre trods de utilstrækkelige kliniske data bør man ikke se bort fra den afgørende interesse i dette lægemiddel, især til resistente gramnegative stammer, der producerer bredspektret beta-lactamase.
English: There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg.
Danish: Der var ikke tegn på mutagent potentiale i en konventionel serie af tests og heller ingen tegn på reproduktionstoksicitet inklusive teratogent potentiale i undersøgelser med rotter ved doser op til 750 mg/kg og med aber ved doser op til 360 mg/kg.
English: AstraZeneca AB 151 85 Södertälje Sweden
Danish: AstraZeneca AB S-15185 Södertälje Sverige
English: • if you have health problems, such as liver or kidney problems.
Danish: • Hvis du har heldbredsproblemer såsom lever- og nyreproblemer.
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint (in italics) they should be reported as resistant.
Danish: Indtil der er evidens med hensyn til klinisk respons for bekræftede isolater med MIC-værdier over den nuværende resistensgrænseværdi, skal de rapporteres som resistente.
English: Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem.
Danish: Patienter med leversygdom: Hos patienter med leverlidelser i anamnesen skal leverfunktionen monitoreres under behandling med meropenem.
English: Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Danish: Meropenem udøver sin baktericide aktivitet ved at hæmme cellevægssyntesen i grampositive og gramnegative bakterier via binding til penicillinbindende proteiner (PBP'er).
English: Common transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased.
Danish: Almindelig forhøjede transaminaser, forhøjet alkalisk fosfatase i blodet, forhøjet laktatdehydrogenase i blodet.
English: Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
Danish: Læs vejledningen i indlægssedlen og bed din læge eller apoteket om at forklare det, hvis der er noget du ikke forstår.
English: There are limited data to support the application of these dose adjustments for a unit dose of 2 g.
Danish: Der er kun begrænsede data, som understøtter brug af disse dosisjusteringer for en dosisenhed på 2 g.
English: Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem.
Danish: Probenecid konkurrerer med meropenem om aktiv tubulær sekretion og hæmmer derved den renale ekskretion, hvorved eliminationshalveringstiden og plasmakoncentrationen af meropenem forøges.
English: Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius) Streptococcus pneumoniae
Danish: Streptococcus milleri gruppe (S. anginosus, S. constellatus og S. intermedius) Streptococcus pneumoniae
English: The safety profile is based primarily on monotherapy clinical trials and the numbers of post marketing reports of adverse events of patients receiving bi-therapy are small, therefore it would not be possible to extrapolate from these.
Danish: Sikkerhedsprofilen er primært baseret på kliniske monoterapiundersøgelser, og der er kun et lille antal af rapporter efter markedsføringen om uønskede hændelser hos patienter, der fik biterapi; derfor ville det ikke være muligt at ekstrapolere fra disse.
English: Always use Meronem exactly as your doctor has told you.
Danish: Anvend altid Meronem nøjagtigt efter lægens anvisning.
English: Remove the Meronem bottle (vial) from the packaging.
Danish: Tag flasken (hætteglasset) med Meronem ud af æsken.
English: Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days.
Danish: Der har været rapporteret om nedsat serumvalproatniveauer ved samtidig administration med carbapenemlægemidler, hvilket resulterede i, at valproatniveauet faldt 60-100% i løbet af cirka to dage.
English: Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours).
Danish: Sammenligning har vist overensstemmende farmakokinetik mellem doser og halveringstider hos voksne og børn bortset fra de yngste patienter (<6 måneder: t1/2 = 1,6 timer).
English: A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses.
Danish: Et klinisk forsøg med patienter med alkoholisk cirrose har vist, at leversygdom ikke har nogen indvirkning på farmakokinetikken af meropenem efter gentagne doser.
English: AstraZeneca UK Ltd. Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
Danish: AstraZeneca UK Ltd. Alderley Park Macclesfield Cheshire SK10 4TF Storbritannien
English: The CHMP agreed the following harmonised indication:
Danish: CHMP vedtog følgende harmoniserede indikation:
English: • If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem
Danish: • Hvis du er overfølsom (allergisk) over for andre antibiotika såsom penicilliner, cefalosporiner eller carbapenemer, fordi du så også kan være overfølsom over for meropenem.
English: The CHMP considered the MAH arguments to be satisfactory, and agreed that the specific mention of cystic fibrosis in the indication section should be placed just under lower respiratory tract infections:
Danish: CHMP vurderede, at argumenterne fra indehaveren af markedsføringstilladelsen var tilfredsstillende, og vedtog, at den særlige omtale af cystisk fibrose i indikationspunktet bør placeres lige under nedre luftvejsinfektioner:
English: Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes.
Danish: Alternativt kan doser op til 1 g gives som intravenøs bolusinjektion i løbet af cirka 5 minutter.
English: The CHMP considered that the clinical documentation submitted by the MAH did not greatly contribute to the assessment as the studies include a mix of wide cutaneous infections without a robust documentation on severe cellulitis, not completely relevant considering the interest of penems.
Danish: CHMP vurderede, at den kliniske dokumentation, som blev indsendt af indehaveren af markedsføringstilladelsen, ikke i nævneværdig grad bidrog til vurderingen, da undersøgelserne omfatter en blanding af brede kutane infektioner uden nogen pålidelig dokumentation for svær cellulitis, som ikke er helt relevant i betragtning af interessen i penemer.
English: The CHMP proposed to retain the information on convulsions and hepatic reactions as such statement warrants the attention of prescribers on the need for careful use of meropenem, taking into account both adverse events.
Danish: CHMP foreslog at fastholde informationen om kramper og leverreaktioner, da et sådant udsagn garanterer, at behandlerne bliver opmærksomme på behovet for forsigtig brug af meropenem i betragtning af begge uønskede hændelser.
English: Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function.
Danish: Farmakokinetiske studier med patienter har ikke vist nogle signifikante farmakokinetiske forskelle i forhold til raske personer med tilsvarende nyrefunktion.
English: For the AZ studies, complicated UTI was associated with structural and/or functional abnormalities such as prostatic hypertrophy, hydronephrosis, neurogenic bladder, vesicoureteric reflux, stricture, calculus, tumour, upper UTI or prolapse, indwelling urinary catheter, or concomitant urologic diagnostic or surgical procedure.
Danish: Til AZ-undersøgelserne blev komplicerede urinvejsinfektioner forbundet med strukturelle og/eller funktionelle anormaliteter såsom prostatisk hypertrofi, hydronefrose, neurogenisk blære, vesico-uretal refluks, forsnævring, nyresten, tumor, øvre urinvejsinfektion eller prolaps, fast indlagt urinkateter eller samtidig urologisk diagnostisk eller kirurgisk procedure.
English: In individuals with normal renal function, rapid renal elimination will occur.
Danish: Til individer med normal nyrefunktion sker der en hurtig elimination via nyrerne.
English: If you forget to use Meronem
Danish: Hvis du har glemt at tage Meronem
English: The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2-5 years), 5.3 ml/min/kg (623 months) and 4.3 ml/min/kg (2-5 months).
Danish: De gennemsnitlige værdier for meropenemclearance var 5,8 ml/min/kg (6-12 år), 6,2 ml/min/kg (2-5 år), 5,3 ml/min/kg (6-23 måneder) og 4,3 ml/min/kg (2-5 måneder).
English: Do not use Meronem
Danish: Tag ikke Meronem
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler, end dem, der er nævnt under pkt.
English: If you have a severe allergic reaction, stop having Meronem and see a doctor straight away.
Danish: Hvid du får en alvorlig allergisk reaktion, skal du stoppe med at tage Meronem og straks søge læge.
English: Clinical guidance recommends penems in cUTI without distinction of drugs regarding efficacy and safety.
Danish: Klinisk vejledning anbefaler penemer til komplicerede urinvejsinfektioner uden forskel mellem lægemidler vedrørende effekt og sikkerhed.
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Danish: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Postal 22876 Wedel Tyskland
English: If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
Danish: Hvis du har noget antibiotikum tilovers, når du har taget din behandling efter din læges anvisning, skal du aflevere resterne på apoteket, som vil destruere det på behørig vis.
English: 1, Place Renault 92844 RUEIL-MALMAISON Cédex
Danish: AstraZeneca 1, Place Renault 92844 RUEILMALMAISON Cédex Frankrig
English: Section 6.2 - Incompatibilities
Danish: Afsnit 6.2 - Uforligeligheder
English: Common inflammation, pain
Danish: Almindelig inflammation, smerte
English: Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.
Danish: Meropenem, som skal bruges til intravenøs bolusinjektion, skal fortyndes med sterilt vand til injektion.
English: If your doctor decides to stop your treatment, dispose of any unused Meronem in an appropriate way.
Danish: Hvis din læger beslutter, at du skal stoppe behandlingen, så aflever ubrugt Meronem på apoteket.
English: Remove any air in the syringe by gently pushing the plunger until all the air has gone.
Danish: Fjern alt luft fra sprøjten ved forsigtigt at trykke på stemplet, indtil alt luft er forsvundet.
English: Data from these studies showed that meropenem was effective in the treatment of bacterial meningitis, and similar in effectiveness to cefotaxime/ceftriaxone.
Danish: Data fra disse undersøgelser viste, at meropenem var effektiv i behandlingen af bakteriel meningitis og havde en lignende effekt som cefotaxim/ceftriaxone.
English: Section 4.7 - Effects on ability to drive and use machines
Danish: Afsnit 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner