FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Danish: Hæmning af bakteriens peptidoglycansyntese medfører en svækkelse af cellevæggen, som normalt efterfølges af cellelyse og bakteriedød.
English: These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects (see section 4.8).
Danish: Disse er næsten altid sket hos patienter med alvorlig bagvedliggende sygdom eller ved samtidig indtagelse af anden medicin, der er kendt for at påvirke leveren (se pkt.
English: • feeling sick (nausea), especially when taking high doses → if affected take Augmentin before food
Danish: • Kvalme, især ved høje doser  Hvis de får kvalme, skal De tage Augmentin før et måltid
English: • thrush (candida - a yeast infection of the vagina, mouth or skin folds)
Danish: • Svamp (candida - en svampeinfektion i skede, mund eller hudfolder)
English: The other active component (clavulanic acid) stops this from happening.
Danish: Det andet aktive stof (clavulansyre) forhindrer dette.
English: This can include a skin rash or swelling of the face or neck
Danish: Det kan være hududslæt eller hævelse af ansigt eller hals.
English: Bullous exfoliative-dermatitis
Danish: Bulløs eksfoliativ dermatitis
English: Very rare (<1/10,000)
Danish: Meget sjælden (<1/10000)
English: See ‘Conditions you need to look out for' in Section 4.
Danish: Se ”Tilstande, De skal være særlig opmærksom på ”i afsnit 4.
English: Treatment with Augmentin may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for the individual patient.
Danish: Behandling må gerne påbegyndes parenteral ved brug af en intravenøs opløsning og herefter afsluttes med en passende oral præsentation som anses for at være passende for den enkelte patient.
English: • crystals in urine
Danish: • Krystaludfældning i urinen
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: De skal ikke tage antibiotikum, der er udskrevet til andre, selvom de har haft en infektion, som minder om Deres.
English: Spain - Augmentine, Clavumox
Danish: Spanien - Augmentine, Clavumox
English: If it is considered that a higher daily dose of amoxicillin is required, this must not be achieved by increasing the Augmentin dose.
Danish: Hvis en højere dosis amoxicillin er påkrævet, opnås dette ved at øge Augmentin dosis.
English: In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates.
Danish: I en enkelt undersøgelse omfattende kvinder med for tidlig perforering af fosterhinden er profylaktisk behandling med amoxicillin-clavulansyre blevet forbundet med øget risiko for nekrotiserende enterocolitis hos neonatale.
English: Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/h in healthy subjects.
Danish: Amoxicillin/clavulansyre har en gennemsnitlig halveringstid på ca. en time og en gennemsnitlig nedbrydningshastighed på ca. 25 l/time hos raske personer.
English: The side effects below may happen with this medicine.
Danish: Følgende bivirkninger kan forekomme med dette lægemiddel.
English: The contents of the single-dose sachet are to be dispersed in half a glass of water before ingestion.
Danish: Indholdet af enkeltdosis breve skal opløses i et halvt glas vand før indtagelse
English: Augmentin is for intravenous use.
Danish: Augmentin er til intravenøs brug.
English: Augmentin is not recommended for children aged less than 3 months.
Danish: Augmentin er ikke anbefalet til børn under 3 måneder.
English: Netherlands - Augmentin Spain - Augmentine
Danish: Nederlandene - Augmentin Spanien - Augmentine
English: AUC (0-24h)
Danish: AUC(0-24t)
English: The s effects below may happen with this medicine.
Danish: Nedenstående bivirkninger kan opstå ved denne medicin.
English: The dose of Augmentin that is selected to treat an individual infection should take into account:
Danish: Ved dosering af Augmentin til behandling af en speciel infektion bør der tages højde for følgende:
English: Children aged 3 months and over:
Danish: Børn på 3 måneder eller derover
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
Danish: 6.2 Uforligeligheder [Udfyldes nationalt] 6.3 Opbevaringstid [Udfyldes nationalt] 6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
English: Probenecid decreases the renal tubular secretion of amoxicillin.
Danish: Probenecid nedsætter den renale tubulære udskillelse af amoxicillin.
English: Abdominal pain
Danish: Abdominal smerte
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ}
English: Cyprus -Noprilam
Danish: Cypern - Noprilam
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: De officielle retningslinjer vedrørende korrekt brug af antibiotika bør følges.
English: In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.
Danish: Hvis en infektion viser sig at skyldes en amoxicillinfølsom mikroorganisme(er), bør man overveje at skifte fra behandling med amoxicillin/clavulansyre til amoxicillinbehandling i overenstemmelse med de officielle retningslinjer.
English: The following terminologies have been used in order to classify the occurrence of undesirable effects.
Danish: De følgende frekvenser bruges til at angive forekomsten af bivirkninger.
English: Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
Danish: Vær opmærksom på følgende råd, som kan hjælpe med at forebygge udvikling af modstandsdygtige bakterier, der stopper virkningen af antibiotikummet.
English: Immune system disorders10 Angioneurotic oedema
Danish: Immunsystemet10 Angioneurotisk ødem
English: Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Danish: Behandling med Amoxicillin/clavulansyre bør undgås ved mistanke om infektiøs mononukleose, da et morbiliformt udslæt er blevet forbundet med denne tilstand efter brug af amoxicillin.
English: However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).
Danish: Bivirkninger (fx allergiske reaktioner, svimmelhed, kramper), som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner kan dog forekomme (se pkt.
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 dette er, at bakterien, som er skyld i infektionen, er modstandsdygtig over for det antibiotikum, der tages.
English: Antibiotics are used to treat infections caused by bacteria.
Danish: Antibiotika bruges til behandling af infektioner forårsaget af bakterier.
English: If you still feel unwell you should go back to see the doctor.
Danish: Hvis De stadig føler Dem utilpas, skal De kontakte Deres læge igen.
English: The pharmacokinetic results that have been obtained for amoxicillin and clavulanic acid following the administration of Augmentin (2 x 1000 mg/62.5 mg single dose) to healthy adults at the start of a meal are presented below:
Danish: De nedenfornævnte farmakokinetiske resultater er opnået for amoxicillin og clavulansyre efter administration af Augmentin (2 x 1000 mg/62,5 mg enekelt dosis) til raske voksne i begyndelsen af et måltid:
English: Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.
Danish: Behandling må gerne påbegyndes parenteral i henhold til SPC'et for IV-formuleringen og herefter forsætte med oral formuleringer.
English: Sweden - Spektramox
Danish: Sverige - Spektramox
English: Carcinogenicity studies have not been conducted with amoxicillin/clavulanic acid or its components.
Danish: Der er ikke udført cacinogenetiske studier med amoxicillin/clavulansyre eller dets hjælpestoffer.
English: Two tablets twice daily for seven to ten days;
Danish: 2 tabletter 2 gange daglig i 7 til 10 dage
English: AMX - amoxicillin, CA - clavulanic acid
Danish: AMX - amoxicillin, CA - clavulansyre
English: The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing renal function.
Danish: Den totale clearance af amoxicillin/clavulansyre fra serum er proportionel med den nedsatte nyrefunktion.
English: For very severe infections, the dose may be increased up to 2000 mg/200 mg every 8 hours.
Danish: Ved alvorlige infektioner, kan doseringen hæves til 2000 mg/200 mg hver 8. time
English: Augmentin 2000 mg/200 mg should only be used in patients with creatinine clearance less than 30 ml/min for surgical prophylaxis when it should be used in one infusion.
Danish: Augmentin 2000 mg/200 mg bør kun bruges til patienter med et kreatinin-clearance på under 30 ml/min i forbindelse med profylakse ved operation og må kun gives som en infusion.
English: The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8).
Danish: Hvis der i begyndelsen af behandlingen opstår et febrilt generaliseret erytem i forbindelse med pustula kan det være symptomer på akut generaliseret eksantematøs pustulose (AGEP) (se pkt.
English: These include allergic reactions, convulsions (fits) and inflammation of the large intestine.
Danish: Disse inkluderer allergiske reaktioner, kramper og betændelse i tyktarmen.
English: Blood and urine tests
Danish: Blod- og urinprøver
English: • Allergic reactions (see above)
Danish: • Allergiske reaktioner (se ovenstående)
English: Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods.
Danish: Derfor bør positive testresultater hos patienter i behandling med amoxicillin/clavulansyre fortolkes med forsigtighed og bekræftes med andre diagnostiske metoder.
English: • diarrhoea
Danish: • Diarre
English: The recommended dose of Augmentin suspension is 90/6.4 mg/kg/day in two divided doses.
Danish: Den anbefalede dosis af Augmentin suspension er 90 mg/6,4 mg/kg/dag fordelt på 2 doser.
English: Acute generalised exanthemous pustulosis (AGEP)10
Danish: Akut generaliseret eksantematøs pustulose (AGEP)10
English: Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH.
Danish: Amoxicillin og clavulansyre er fuldt dissocierede i vandig opløsning ved fysiologisk pH.
English: There are no clinical data on Augmentin in children under 3 months of age.
Danish: Der findes ingen kliniske data for Augmentin til børn under 3 måneder.
English: Augmentin tablets have a scored breakline to allow the tablet to be broken into two halves for ease of swallowing.
Danish: Augmentin tabletter er forsynet med en delekærv, som tillader at dele tabletten i 2 dele for at hjælpe med at synke.
English: • severe ear, nose and throat infections
Danish: • Alvorlig øre, næse og hals infektioner
English: Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.
Danish: Gastrointestinale symptomer og forstyrrelser i væske- og elektrolytbalancen kan forekomme.
English: Augmentin is not indicated in children aged < 16 years.
Danish: Augmentin er ikke indiceret til børn under 16 år.
English: Augmentin may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Augmentin is not suitable for intramuscular administration.
Danish: Augmentin kan enten administreres som en langsom intravenøs injektion over 3-4 minutter direkte i venen eller via drop eller ved infusion over 30-40 min. Augmentin er ikke egnet til intramuskulær administration.
English: Final volume of reconstituted oral suspension (ml)
Danish: Færdige volumen af den opløste orale suspension (ml)
English: Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.
Danish: Administreres i starten af et måltid for at nedsætte risikoen for gastrointestinal intolerance og for at optimere absorptionen af amoxicillin/clavulansyre.
English: • inflammation of the liver (hepatitis)
Danish: • Betændelse i leveren (hepatitis)
English: It contains two different medicines called amoxicillin and clavulanic acid.
Danish: Det indeholder 2 forskellige lægemiddelstoffer som hedder amoxicillin og clavulansyre.
English: Sometimes an infection caused by bacteria does not respond to a course of an antibiotic.
Danish: Nogle gange reagerer en bakteriel infektion ikke på en behandling med antibiotika.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: • Animal bites
Danish: • Dyrebid
English: AMX - amoxicillin, CA - clavulanic acid * Median (range)
Danish: AMX - amoxicillin, CA - clavulansyre * Median (interval)
English: Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and vomiting, and discoloured tongue.
Danish: Studier af dosistoksicitet hos hunde ved gentagne doser af amoxicillin/clavulansyre viser gastrisk irritation og opkastninger samt misfarvet tunge.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Alt efter behov bør en specialist konsulteres, hvis den lokale forekomst af resistens er således, at præparatets anvendelighed er problematiske ved mindst nogle typer infektion.
English: The presence of clavulanic acid in Augmentin may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
Danish: Tilstedeværelsen af clavulansyre i Augmentin kan forårsage en uspecifik binding af IgG og albumin i røde cellemembraner, hvilket kan resultere i en falsk positiv Coombs test.
English: Without delay the reconstituted solution should be added to 50 ml of infusion fluid using a minibag or in-line burette.
Danish: Den rekonstituerede opløsning bør uden forsinkelse tilsættes 50 ml infusionsvæske ved hjælp af en lille pose eller en in-line burette.
English: Immune system disorders11 Angioneurotic oedema
Danish: Immunsystemet11 Angioneurotisk ødem
English: • 40 mg/5 mg/kg/day to 80 mg/10 mg/kg/day (not exceeding 3000 mg/375 mg per day) given in three divided doses, depending on the severity of infection.
Danish: • 40 mg/5 mg/kg/dag op til 80 mg/10 mg/kg/dag (må ikke overstige 3000 mg/375 mg pr. dag) fordelt på 3 doser, afhængig af infektionens sværhedsgrad.
English: The presence of Clavulanic acid in Augmentin may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.
Danish: Tilstedeværelsen af clavulansyre i Augmentin kan forårsage en uspecifik binding af IgG og albumin i røde cellemembraner, hvilket kan resulterer i en falsk positiv Coombs test.
English: Following oral administration of amoxicillin/clavulanic acid to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of either amoxicillin or clavulanic acid.
Danish: Oral indgift af amoxicillin/clavulansyre hos raske mænd og kvinder viser, at der ikke er signifikant forskel på de farmakokinetiske egenskaber for hverken amoxicillin eller clavulansyre hos de to køn..
English: • higher dose - (particularly for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 875 mg/125 mg three times a day.
Danish: • høj dosering (til infektioner såsom otitis media, sinusitis, nedre luftvejsinfektioner og urinvejsinfektioner): 875 mg/125 mg tre gange daglig Børn < 40 kg
English: Without delay the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.
Danish: Den rekonstituerede opløsning bør uden forsinkelse tilsættes 100 ml infusionsvæske ved hjælp af en lille pose eller en in-line burette.
English: Serum sickness-like syndrome
Danish: Serumsygdomlignende syndrom
English: In some cases, your doctor may investigate the type of bacteria that is causing your infection.
Danish: I nogle tilfælde vil Deres læge undersøge nærmere, hvilken type bakterie, der er årsag til Deres infektion.
English: • Severe dental abscess with spreading cellulitis.
Danish: • Svær dental absces med spredende cellulitis
English: Species for which acquired resistance may be a problem Aerobic Gram-negative micro-organisms Klebsiella pneumoniae
Danish: Andre arter for hvilke resistens kan være et problem Aerobe gramnegative mikroorganismer Klebsiella pneumoniae
English: Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see section 4.2).
Danish: Amoxicillin/clavulansyre bør anvendes med forsigtighed til patienter med tegn på nedsat leverfunktion (se pkt.
English: Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations.
Danish: Data for anvendelse af amoxicillin/clavulansyre hos et begrænset antal gravide kvinder indikerer ingen forhøjet risiko for medfødte misdannelser.
English: 15 mg/3.75 mg/kg per day once daily.
Danish: 15 mg/3,75 mg/kg pr. dag 1 gang daglig.
English: • low number of red blood cells (haemolytic anaemia)
Danish: • Nedsat antal røde blodlegemer (hæmolytisk anæmi)
English: Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall.
Danish: Amoxicillin er et semisyntetisk penicillin (betalaktam antibiotikum), der hæmmer et eller flere af de enzymer (ofte betegnet som penicillinbindende proteiner - PBP) i den biosyntetiske stofskiftevej for peptidoglycan, som er en strukturel bestanddel af bakteriens cellevæg.
English: Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive).
Danish: Amoxicillin tilhører gruppen af lægemidler kaldet penicilliner, som nogen gange kan stoppe med at virke (bliver inaktive).
English: • Do not take Augmentin for more than 2 weeks.
Danish: • De må ikke tage Augmentin i mere end 14 dage.
English: Take the medicine carton to show the doctor.
Danish: Medbring medicin kartonen til lægen.
English: Acute generalised exanthemous pustulosis (AGEP)9
Danish: Akut generaliseret eksantematøs pustulose (AGEP)9
English: • standard dose: (for all indications) 875 mg/125 mg two times a day;
Danish: • Standard dosering: (for alle indikationer) 875 mg/125 mg to gange daglig
English: Other micro-organisms Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetti Mycoplasma pneumoniae
Danish: Andre mikroorganismer Chlamydophila pneumaniae Chlamydophila psittaci Coxiella burnetti Mycoplasma pneumoniae
English: For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination.
Danish: fortidlig fødte) i den første leveege må doseringsintervallet ikke overstige 2 gange daglig pga. umodenhed af den renale udskillelsesvej.
English: • genital organ infections in women.
Danish: • Infektioner i kønsorganer hos kvinder
English: • black tongue which looks hairy
Danish: • Sort tunge, der ser ud som om, den er behåret
English: Recommended dose:
Danish: Den anbefalede dosis:
English: Mean (SD) Pharmacokinetic parameters are given below for Augmentin administered at 45 mg/3.2 mg/kg every 12 h to paediatric patients.
Danish: De farmokokinetiske gennemsnitsparametre ( SD) er vist nedenfor for Augmentin 45 mg/3,2 mg/kg administreret hver 12. time til paediatriske patienter.
English: Higher dose
Danish: Høj dosering
English: Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal.
Danish: Absorptionen af amoxicillin/clavulansyre er størst ved indgift i starten af et måltid.
English: About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein.
Danish: Ca. 25% af den totale plasma clavulansyre og 18% af den total plasma amoxicillin er proteinbundet.
English: Marketing Authorisatio
Danish: INDEHAVER Af MARKEDSFØRINGSTILLADELSEN
English: • diarrhoea (in children).
Danish: • Diarre (hos børn)
English: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Danish: Gastrointestinale symptomer skal behandles symptomatisk med opmærksomhed rettet mod elektrolytbalancen.
English: Add volume of water (as indicated below) invert and shake well.
Danish: Tilsæt vandmængde (som er indikeret nedenfor).
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: De skal ikke tage antibiotikum medmindre det er udskrevet personligt til Dem, og De skal kun tage det til behandling af den infektion, for hvilket det er udskrevet.
English: This yields approximately 20.9 ml of solution for single-dose use.
Danish: Dette giver en 20,9 ml opløsning til en enkeltdosis brug.
English: • convulsions (in people taking high doses of Augmentin or who have kidney problems)
Danish: • Kramper (hos patienter, der får høje doser Augmentin, eller hos patienter med nyreproblemer)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY}
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: • standard dose (for all indications): 1000 mg/125 mg three times a day;
Danish: • Standard dosering: (for alle indikationer) 1000 mg/125 mg 3 gange daglig
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Enterococcus faecium $
Danish: Andre arter for hvilke resistens kan være et problem Aerobe grampositive mikroorganismer Enterococcus faecium $
English: During administration of high doses of amoxicillin it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.
Danish: Ved administration af høje doser amoxicillin anbefales det at opretholde tilstrækkelig væskeindtag og urinudskillelse for at nedsætte risikoen for udkrystallisering af amoxicillin.
English: Clavulanic acid is extensively metabolized in man and eliminated in urine and faeces and as carbon dioxide in expired air.
Danish: Clavulansyre metaboliseres ekstensivt hos mennesker og elimineres i urin og fæces og som kuldioxid med udåndingsluften.
English: The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).
Danish: Anvendelse af alternative formuleringer af Augmentin (fx formuleringer som indeholder større dosis af amoxicillin og/eller ændret forhold mellem amoxicillin og clavulansyre) bør overvejes om nødvendigt (se afsnit 4.4 og 5.1)