FrancophonIA/ELRC3.0 huggingface dataset:
English: It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days.
Danish: Det er meget vigtigt, at De tager antibiotikummet i den rigtige dosis, på det rette tidspunkt og i det rette antal dage.
English: These events have been very rarely reported in children.
Danish: Disse bivirkninger er meget sjældent rapporteret hos børn.
English: Some infections (e.g. osteomyelitis) require longer periods of treatment.
Danish: Nogle infektioner (f.eks. osteomyelitis) kræver en længere behandlingsperiode.
English: Children < 16 years
Danish: Børn < 16 år
English: Anti-peristaltic medicinal products are contra-indicated in this situation.
Danish: Peristaltiskhæmmende lægemidler er kontraindikeret i denne situation
English: Ask your doctor or pharmacist for advice when giving Augmentin tablets to children weighing less than 40 kg.
Danish: Spørg Ders læge eller på apoteket om råd, når De skal give Augmentin tabletter til børn, der vejer mindre end 40 kg
English: Don't drive or operate machinery unless you are feeling well.
Danish: Lad være med at køre eller betjene maskiner medmindre De føler Dem godt tilpas.
English: Mechanisms of resistance
Danish: Mekanismer for resistens
English: • Augmentin will be given as an injection into a vein or by intravenous infusion.
Danish: • Augmentin gives som en injektion i en vene, eller ved intravenøs infusion.
English: Dose adjustments are based on the maximum recommended level of amoxicillin.
Danish: Dosisjusteringer er baseret på det maksimalt anbefalede niveau for amoxicillin.
English: Augmentin should be administered within 20 min of reconstitution.
Danish: Augmentin bør administreres indenfor 20 min. efter rekonstituering.
English: Antibiotic-associated colitis4
Danish: Antibiotikaassocieret colitis4
English: Anaerobic micro-organisms Bacteroides fragilis Fusobacterium nucleatum Prevotella spp.
Danish: Anaerobe mikroorganismer Bacteroides fragilis Fusobacterium nucleatum Prevotella spp.
English: • You will not normally be given Augmentin for longer than 2 weeks without the doctor reviewing your treatment.
Danish: • De vil normalt ikke få Augmentin i mere end 14 dage, uden at deres læge igen vurderes Deres tilstand.
English: Concomitant use of probenecid is not recommended.
Danish: Samtidig brug med probenecid kan ikke anbefales.
English: 3 Nausea is more often associated with higher oral doses.
Danish: 3 Kvalme ses oftest ved høje orale doseringer.
English: Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported.
Danish: Krydsreaktioner med non-Aspergillus polysakkarider og polyfuranoser med Bio-Rad Laboratories Platelia Aspergillus EIA test er rapporteret.
English: • Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D.
Danish: • Inaktivering af de bakterielle betalaktamaser, som ikke selv inaktiveres af clavulansyre inklusive klasse B, C og D
English: Overgrowth of non-susceptible organisms
Danish: Overvækst af ikke-følsomme organismer
English: Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Danish: God mundhygiejne kan hjælpe med til at forebygge misfarvning af tænder, da den normalt kan fjernes ved tandbørstning.
English: • Space the doses evenly during the day, at least 4 hours apart.
Danish: • Fordel doserne ligeligt over dagen med mindst 4 timer mellem hver dosis.
English: Both components are rapidly and well absorbed by the oral route of administration.
Danish: Begge absorberes hurtigt og fuldstændigt efter oral indgift.
English: Organism
Danish: Organismer
English: Reversible hyperactivity
Danish: Reversibel hyperaktivitet
English: The T>MIC obtained with Augmentin can not be achieved with the same dose formulated as an immediate release tablet.
Danish: T>MIC opnået med Augmentin kan ikke opnås med den samme dosis-formulering med en omgående udløsning tablet.
English: 2 Strains with decreased susceptibility have been reported in some countries in the EU with a frequency higher than 10%.
Danish: 4.2 og 4.4) 2 Stammer med nedsat følsomhed er rapporteret i nogle lande i EU med en frekvens højere end 10%
English: Do not use Augmentin after the expiry date which is stated on the carton.
Danish: Brug ikke Augmentin efter den udløbsdato, der står på pakningen.
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 antibiotikummet.
English: IVEN ne. A qualified person, like a doctor or a nurse, will give you is medicine.
Danish: Kun en kvalificeret person, som en læge eller en sygeplejerske, må give Dem dette lægemiddel.
English: Black hairy tongue
Danish: Sort behåret tunge
English: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
Danish: • Forventede patogener og deres formodede følsomhed over for antibakterielle midler (se afsnit
English: This is in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
Danish: Dette er for at undgå administration af unødvendige høje døgndoser af clavulansyre.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Bemærk: Versionen af dette SPC, mærkning og indlægssedel er gældende efter Commissionen afgørelse.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg indikerer ikke direkte eller indirekte skadelige virkninger på drægtighed, embryonets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Your doctor may repeat the dose if your surgery takes longer than 1 hour.
Danish: Det kan være nødvendigt at gentage dosis hvis Derse operationer tager mere end 1 time.
English: Like all medicines, Augmentin can cause side effects, although not everybody gets them.
Danish: Augmentin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Danish: Hos visse arter kan forekomsten af resistens variere geografisk og over tid, og det tilrådes at indhente information om resistens lokalt, især ved behandling af alvorlige infektioner.
English: Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Danish: Længerevarende brug kan til tider resultere i overvækst af ikke-følsomme bakterier.
English: There is no experience with Augmentin suspension in adults and children  40 kg, and therefore no dose recommendation can be given.
Danish: Der er ingen erfaring med Augmentis hos voksne og unge ≥ 40 kg. Der kan derfor ikke gives dosis anbefalinger.
English: In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased.
Danish: I alle befolkningsgrupper viser symptomer og tegn sig typisk under behandlingen eller kort tid efter, men i enkelte tilfælde kan der gå op til flere uger efter at behandlingen er afsluttet.
English: From animal studies there is no evidence for significant tissue retention of drug-derived material for either component.
Danish: Dyrestudier viser ingen tegn på signifikant vævsretention af nedbrydningsprodukter for nogen af stofferne.
English: • Head and neck
Danish: • Hoved og hals
English: Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy.
Danish: Alvorlige, til tider fatale, overfølsomhedsreaktioner (anafylaktoide reaktioner), er rapporteret hos patienter i penicillinbehandling.
English: When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness.
Danish: Når Deres læge udskriver en antibiotikakur, er den kun beregnet til at, behandle Deres aktuelle sygdom.
English: The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.
Danish: Den tid, hvor serumkoncentrationen er over MIC (minimum inhibition concentration) (T>MIC), anses for at være den mest afgørende faktor for virkningen af amoxicillin.
English: Bacteria can become resistant to antibiotics for many reasons.
Danish: Bakterier kan blive modstandsdygtige over for antibiotika af mange grunde.
English: Various studies have found the urinary excretion to be 50-85% for amoxicillin and between 27-60% for clavulanic acid over a 24 hour period.
Danish: Forskellige studier har vist en urinudskillelse af amoxicillin på 50-85 % og mellem 27-60 % af clavulansyre over en 24-timers periode.
English: • hyperactivity
Danish: • Hyperaktivitet
English: How Augmentin will be given to you
Danish: Hvordan bliver Augmentin givet til Dem
English: Following oral administration, amoxicillin and clavulanic acid are approximately 70% bioavailable.
Danish: Efter oral administration har amoxicillin og clavulansyre en biotilgængelighed på ca. 70 %.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics.
Danish: Det er derfor vigtigt at tage denne diagnose i betragtning hos patienter, der får diaré under eller efter antibiotikabehandling.
English: • Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Danish: • Ændring af PBP, som reducerer det antibakterielle stofs affinitet til angrebspunktet
English: Legionella pneumophila Morganella morganii Providencia spp.
Danish: Legionella pneumophila Morganella moganii Providencia spp.
English: Reversible agranulocytosis
Danish: Reversibel agranulocytose
English: In the case of clavulanic acid, the largest amount of drug is excreted during the first 2 hours after administration.
Danish: For clavulansyres vedkommende udskilles den største mængde i løbet af de første 2 timer efter indgift.
English: Allergic reactions:
Danish: Allergiske reaktioner
English: Reconstituted solutions are normally colourless or a pale straw colour.
Danish: Brugsfærdige rekonstituerede opløsninger vil normalt være farveløse eller svage hørgule.
English: Blood and lymphatic system disorders Reversible leucopenia (including neutropenia)
Danish: Blod og lymfesystem Reversibel leukopeni (inklusive neutropeni)
English: Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Danish: Amoxicillin kan nedbrydes af betalaktamaser, der er produceret af resistente bakterier, og aktivitetsspektret for amoxicillin alene omfatter derfor ikke de organismer, som producerer disse enzymer.
English: $ Natural intermediate susceptibility in the absence of acquired mechanism of resistance.
Danish: $ Naturlig intermediær følsomhed på grund af manglende resistensmekanisme.
English: • Make sure you drink plenty of fluids while having Augmentin.
Danish: • Husk at drikke rigeligt med væske under behandling med Augmentin.
English: Children weighing less than 40 kg Children aged 6 years or less should preferably be treated with Augmentin oral suspension or sachets.
Danish: Børn, der vejer mindre end 40 kg Børn under 6 år bør blive behandlet med Augmention oral suspension eller breve.
English: Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant).
Danish: Begge aktive stoffer passerer over i modermælken (clavulansyres virkning på det ammede barn kendes ikke).
English: The two main mechanisms of resistance to amoxicillin/clavulanic acid are:
Danish: De to væsentligste resistensmekanismer for amoxicillin/clavulansyre er:
English: There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection.
Danish: Der har været rapporteret positive test resultater ved brug af Bio-Rad Laboratories Platelia Aspergillus EIA test hos patienter i behandling med amoxicillin/clavulansyre, som efterfølgende blev fundet at være uden Aspergillus-infektion.
English: The recommended dose of Augmentin is two tablets twice a day.
Danish: Den anbefalede dosis af Augmentin er 2 tabletter 2 gange daglig.
English: Shake the bottle before each dose (see section 6.6).
Danish: Flasken skal rystes hver gang før brug (se afsnit 6.6).
English: Store in the original package in order to protect from moisture
Danish: Opbevares i original beholder for at beskytte mod fugt.
English: Hepatic events may be severe and, in extremely rare circumstances, deaths have been reported.
Danish: Bivirkninger fra leveren kan være alvorlige og i meget sjældne tilfælde har der været rapporteret dødsfald.
English: Germany - Augmentan IV
Danish: Tyskland - Augmentan IV
English: If some bacteria survive they can cause the infection to come back.
Danish: Hvis der er nogle bakterier der overlever, kan infektionen vende tilbage.
English: Mycoplasma pneumoniae $ Natural intermediate susceptibility in the absence of acquired mechanism of resistance.
Danish: Mycoplasma pneumoniae $ Naturlig intermediær følsomhed på grund af manglende resistensmekanisme.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: The usual doses are:
Danish: Den sædvanlige dosis er:
English: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Danish: Da det er overvejende sandsynligt, at ældre mennesker har nedsat nyrefunktion, bør dette tages i betragtning ved valg af dosis, ligesom det kan være nyttigt at monitorere patientens nyrefunktion.
English: Dispersible tablets should be stirred into a little water before taking.
Danish: Opløselige tabletter bør opløses i lidt vand, før de gives.
English: The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax) in each case is approximately one hour.
Danish: De to stoffers plasmaprofiler er ens, og tiden før maksimal plasmakoncentration (Tmax) for begge er ca. 1 time.
English: Morganella morganii Providencia spp.
Danish: Morganella moganii Providencia spp.
English: Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.
Danish: Impermeabilitet af bakteriens væg eller effluxpumpemekanismer kan forårsage eller medvirke til resistens, især hos gramnegative bakterier.
English: Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.
Danish: Lokale retningslinier bør følges for en passenden doseringsfrekvens af amoxicillin/clavulansyre.
English: Use should be avoided during pregnancy, unless considered essential by the physician.
Danish: Augmentin bør undgås under graviditet medmindre lægen vurderer, at behandling er nødvendig.
English: Children may be treated with Augmentin tablets, suspensions or paediatric sachets.
Danish: Børn kan behandles med Augmentin tabletter, suspensioner eller breve til børn.
English: Treatment of intoxication
Danish: Behandling ved forgiftning
English: Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.
Danish: Amoxicillin/clavulansyre bør kun anvendes under amning efter en forudgående benefit/risk-vurdering af læge.
English: Volume of water to be added at reconstitution (ml)
Danish: Vandmængde der skal tilsættes ved fortynding (ml)
English: It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin.
Danish: Det inaktiverer nogle betalaktamaser og forhindrer derved inaktivering af amoxicillin.
English: Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
Danish: Profylaktisk mod infektioner i forbindelse med store operationer hos voksne som f.eks i nedenfornævnte områder:
English: epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
Danish: sinuitis i forbindelse med alvorlige systemiske tegn og symptomer)
English: Children < 40 kg (aged  3 months)
Danish: Børn < 40 kg (og ≥ 3 måneder)
English: For susceptibility testing purposes, the concentration of Clavulanic acid is fixed at 2 mg/l.
Danish: Til brug for følsomhedstest er koncentrationen af clavulansyre sat til 2 mg/l.
English: MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Danish: MIC-grænseværdierne for amoxicillin/clavulansyre er dem som er angivet i ” The European Committee on Antimicrobial Susceptibility Testing (EUCAST)”.
English: Adults and adolescents  16 years
Danish: Voksne og unge ≥ 16 år
English: Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are similar to those produced by the oral administration of equivalent doses of amoxicillin or clavulanic acid alone.
Danish: De serumkoncentrationer af amoxicillin og clavulansyre, der opnås med amoxicillin/clavulansyre, svarer til dem, der opnås ved oral administration af ækvivalente doser med amoxicillin og clavulansyre alene.
English: Preparation of solutions for intravenous infusion
Danish: Tilberedning af opløsninger til intravenøs brug
English: Medicinal product administered
Danish: Administreret lægemiddel
English: Children under 16 years Augmentin tablets are not recommended.
Danish: Børn under 16 år Augmentin tabletter er normalt ikke anbefalet
English: Do not take Augmentin if any of the above apply to you.
Danish: De må ikke tage Augmentin, hvis et af ovenstående punkter gælder for Dem.
English: • Your doctor will advise you how much Augme
Danish: • Deres læge vil fortælle hvor meget Augmentin De skal give til Deres barn
English: Children < 40 kg
Danish: Børn < 40 kg
English: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Danish: Penicilliner kan nedsætte udskillelsen af methotrexat, og derved potentielt øge toksiciteten.
English: Moraxella catarrhalis Neisseria gonorrhoeae§ Pasteurella multocida
Danish: Neisseria gnonorrhoeae § Pasteurella multocida
English: • Do not take Augmentin for more than 10 days.
Danish: • De må ikke tage Augmentin i mere end 10 dage.
English: The apparent volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for clavulanic acid.
Danish: Det tilsyneladende fordelingsvolumen er ca. 0,3-0,4 l/kg for amoxicillin og ca. 0,2 l/kg for clavulansyre.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer
English: This includes medicines that can be bought without a prescription and herbal medicines.
Danish: Dette gælder også for medicin, som ikke er købt på recept eller naturmedicin.
English: This reaction requires Augmentin discontinuation and contra-indicates any subsequent administration of amoxicillin.
Danish: Denne reaktion kræver, at Augmentin seponeres og kontraindicerer enhver samtidig administration af amoxicillin.
English: Prolongation of bleeding time and prothrombin time1
Danish: Forlænget blødningstid og protrombin-tid1
English: A transient pink colouration may or may not develop during reconstitution.
Danish: En gennemsigtig lyserød farve kan opstå i forbindelse med rekonstituering.
English: Active substance(s) administered
Danish: Aktive stof(fer) administreret
English: Non-species related breakpoints1
Danish: Non-specifik relaterede grænseværdier1
English: The reduction in drug clearance is more pronounced for amoxicillin than for clavulanic acid, as a higher proportion of amoxicillin is excreted via the renal route.
Danish: Nedsættelse af clearance er mere udtalt for amoxicillin end for clavulansyre, fordi en større mængde amoxicillin udskilles via nyrerne.
English: You should not give antibiotics that were prescribed for you to other people.
Danish: De skal ikke give antibiotikum, der er udskrevet til Dem, til andre mennesker.
English: Clavulanic acid alone does not exert a clinically useful antibacterial effect.
Danish: Clavulansyre alene har ingen klinisk relevant antibakteriel effekt.
English: Following intravenous administration, both amoxicillin and clavulanic acid have been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus.
Danish: Efter intravenøs indgift er både amoxicillin og clavulansyre målt i galdeblære, abdominalvæv, hud, fedt, muskelvæv, synovial- og periotenealvæske, galde og pus.
English: Treatment should not be extended beyond 14 days without review.
Danish: Behandlingsvarigheden bør sædvanligvis ikke overskride 14 dage uden ny vurdering.
English: Denmark - Spektraforte
Danish: Danmark - Spektraforte
English: The dose can differ depending on the type of operation you are having.
Danish: Doseringen kan variere alt afhængig af operationens type.
English: Germany - Augmentan
Danish: Tyskland - Augmentan
English: Advice/medical education
Danish: Råd/lægelig anvisning
English: Spain - Augmentine Intravenoso
Danish: Spanien - Augmentine Intravenoso
English: This medicine should be used with caution in patients with phenylketonuria.
Danish: Dette lægemiddel bør anvendes med forsigtighed til patienter med fenylketonuri.
English: Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Danish: Tydelige kliniske indikationer på infektion i forbindelse med operation, skal behandles efterfølgende med intravenøs eller oral tablet behandling.
English: Very common side effects These may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger De forekommer hos flere end 1 ud af 10 patienter
English: Amoxicillin does not adequately distribute into the cerebrospinal fluid.
Danish: Amoxicillin fordels ikke i tilstrækkelig grad i cerebrospinalvæsken.
English: They have no effect against infections caused by viruses.
Danish: De har ingen effekt på infektioner forårsaget af virus.
English: Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid.
Danish: Forlænget protombintid er i sjældne tilfælde rapporteret hos patienter i behandling med amoxicillin/clavulansyre.
English: Very common (1/10)
Danish: Meget almindelig (1/10)
English: Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Danish: Samtidig brug af allopurinol under behandling med amoxicillin kan øge sandsynligheden for allergiske hudreaktioner.
English: • Acute bacterial sinusitis (adequately diagnosed)
Danish: • Akut bakteriel sinusitis (adækvat diagnosticeret)
English: Renal and urinary disorders Interstitial nephritis
Danish: Nyrer og urinveje Interstitiel nephritis
English: • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections,
Danish: • Alvorlige infektioner i øre, næse og hals (f.eks. mastoiditis, infektioner i bughinden, epiglottitis,
English: • The age, weight and renal function of the patient as shown below.
Danish: • Patientens alder, vægt og nyrefunktion i henhold til nedennævnte
English: Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
Danish: Samtidig brug af probenecid kan føre til forhøjede og længerevarende serumkoncentrationer af amoxicillin, men ikke af clavulansyre.
English: • diarrhoea (in adults).
Danish: • Diarre (hos voksne)
English: Amoxicillin/clavulanic acid
Danish: Amoxicillin/clavulansyre