FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop taking Amoxil and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at tage Amoxil og gå til lægen med det samme, hvis du bemærker nogen af nedenstående alvorlige bivirkninger - du kan have behov for omgående behandling.
English: Dry powder: 3 years
Danish: Tørt pulver: 3 år.
English: This belongs to a group of medicines called ‘penicillins'.
Danish: Denne tilhører en gruppe af lægemidler, der kaldes penicilliner.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresume og denne etikettering og indlægsseddel er resultatet af den referral-procedure, som denne afgørelse fra Kommissionen vedrører.
English: Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Danish: Amoxicillin kan anvendes under graviditet, hvis de potentielle fordele opvejer de potentielle risici forbundet med behandlingen.
English: 9The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility.
Danish: 9Grænseværdierne er baseret på epidemiologiske skæringsværdier (ECOFF'er), som skelner vildtypeisolater fra isolater med nedsat følsomhed.
English: This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.
Danish: Dette gælder især, når behandling til patienter med urinvejsinfektioner og alvorlige infektioner i øre, næse eller hals overvejes.
English: Make sure you drink plenty of fluids to reduce the chance of these symptoms
Danish: Sørg for at drikke rigeligt med væske for at nedsætte risikoen for disse symptomer.
English: Indication+
Danish: Indikation+
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ}.
English: The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.
Danish: Tiden over den mindste hæmmende koncentration (T > MIC) anses for at være den vigtigste bestemmende faktor for effekten af amoxicillin.
English: Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.
Danish: Farmakoterapeutisk klassifikation: penicilliner med udvidet spektrum, ATC-kode: J01CA04.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Probenecid
English: From a microbiological point of view, the product should be used immediately.
Danish: Parenterale formuleringer Ud fra et mikrobiologisk synspunkt skal præparatet anvendes med det samme.
English: Amoxil may be administered either by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or via a drip tube or by infusion over 20 to 30 minutes.
Danish: Amoxil kan administreres enten ved langsom intravenøs injektion over en periode på 3-4 minutter direkte i en vene, via drop eller ved infusion over 20-30 minutter.
English: Mucocutaneous candidiasis
Danish: Mukokutan candidiasis.
English: • hyperactivity
Danish: • hyperaktivitet.
English: The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults.
Danish: Amoxicillins eliminationshalveringstid er af samme størrelsesorden hos børn i alderen ca. 3 måneder til 2 år og ældre børn og voksne.
English: Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.
Danish: Amoxicillin udskilles delvist i urinen som inaktiv penicillinsyre i mængder, der svarer til op til 10-25 % af den oprindelige dosis.
English: For intramuscular use after reconstitution.
Danish: Til intramuskulær anvendelse efter rekonstitution.
English: About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg.
Danish: Ca. 18 % af det samlede amoxicillin i plasma er bundet til protein, og det tilsyneladende fordelingsvolumen er ca. 0,3-0,4 l/kg.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: • the blood may take longer to clot than it normally would.
Danish: • blodet størkner langsommere end normalt.
English: Reproductive studies in animals have shown no effects on fertility.
Danish: Reproduktionsstudier hos dyr har ikke vist nogen virkning på fertiliteten.
English: A moderate rise in AST and/or ALT.
Danish: Moderat forhøjet ASAT og/eller ALAT.
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: Hos meget små børn (herunder præmature nyfødte) bør administration højst ske 2 gange daglig i den første leveuge, da eliminationsvejen via nyrerne endnu ikke er tilstrækkeligt udviklet.
English: Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.
Danish: Hæmning af peptidoglykan-syntesen fører til svækkelse af cellevæggen, hvilket normalt efterfølges af cellelyse og celledød.
English: 1Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins.
Danish: 1Vildtype-enterobacteriaceae kategoriseres som følsomme for aminopenicilliner.
English: Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Danish: God mundhygiejne kan være med til at forebygge misfarvning af tænderne, da misfarvningen normalt kan fjernes ved tandbørstning.
English: Therapy can be started parenterally according to the dosing recommendations of the intravenous formulation and continued with an oral preparation.
Danish: Behandling kan startes parenteralt med de doser, der er anbefalet til den intravenøse formulering, og fortsættes med et oralt præparat.
English: • Amoxil will be given as an injection or an infusion into a vein (intravenously) or muscle
Danish: • Amoxil vil blive givet som en injektion eller en infusion i en blodåre (intravenøst) eller i en muskel
English: Acute cystitis may be treated with 3 g twice daily for one day
Danish: Akut cystitis kan behandles med 3 g 2 gange daglig i én dag
English: Absorption of Amoxil is unimpaired by food.
Danish: Absorptionen af Amoxil hæmmes ikke af mad.
English: Post-marketing Data Very rare
Danish: Data efter markedsføring Meget sjælden
English: Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.
Danish: På grund af de høje koncentrationer af amoxicillin i urinen er falsk positive resultater almindelige ved brug af kemiske metoder.
English: Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations.
Danish: Begrænsede data fra anvendelse af amoxicillin hos gravide kvinder indikerer ikke en øget risiko for medfødte misdannelser.
English: • Make sure you drink plenty of fluids while having Amoxil.
Danish: • Sørg for at drikke rigeligt med væske, mens du er i behandling med Amoxil.
English: (see section 4.4).
Danish: (angivet i punkt 6).
English: Carcinogenicity studies have not been conducted with amoxicillin.
Danish: Der er ikke udført karcinogenicitetsstudier med amoxicillin.
English: Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.
Danish: Gastrointestinale symptomer behandles symptomatisk, med opmærksomhed rettet mod væske/elektrolytbalancen.
English: Treatment of endocarditis
Danish: Behandling af endocarditis
English: The dose of Amoxil that is selected to treat an individual infection should take into account:
Danish: Når der vælges en dosis Amoxil til behandling af en individuel infektion, skal der tages højde for følgende:
English: Do not take Amoxil if any of the above apply.
Danish: Tag ikke Amoxil, hvis noget af ovenstående gælder for dig.
English: Premature Neonates < 4kg Indication*
Danish: Præmaturenyfødte < 4 kg Indikation*
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: Der bør ved behov søges råd hos eksperter, når den lokale prævalens af resistens er således, at præparatets anvendelighed kan betvivles ved i hvert fald visse infektioner.
English: They are mainly associated with people having treatment over a long period, males and the elderly.
Danish: De ses primært hos personer, der har fået behandling over en lang periode, hos mænd/drenge og hos ældre.
English: • Amoxil contains lactose.
Danish: • Amoxil indeholder lactose.
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 ældre patienter med større sandsynlighed har nedsat nyrefunktion, bør der udvises forsigtighed ved valg af dosis, og det kan være hensigtsmæssigt at monitorere nyrefunktionen.
English: • The age, weight and renal function of the patient; as shown below
Danish: • Patientens alder, vægt og nyrefunktion - som vist nedenfor.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: De officielle retningslinjer for hensigtsmæssig brug af antibakterielle midler skal tages i betragtning.
English: Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly.
Danish: Relevant monitorering skal foretages, hvis der samtidigt ordineres antikoagulantia.
English: Beta-lactamase positive isolates should be reported resistant.
Danish: Betalaktamase-positive isolater bør rapporteres som resistente.
English: Probenecid decreases the renal tubular secretion of amoxicillin.
Danish: Probenecid nedsætter den renale tubulære sekretion af amoxicillin.
English: Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria.
Danish: Impermeabilitet eller effluksmekanismer kan forårsage eller bidrage til bakteriers resistens, særligt hos gramnegative bakterier.
English: Magnesium stearate (E572)
Danish: Magnesiumstearat (E 572)
English: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
Danish: • De forventede patogener og deres formodede følsomhed for antibakterielle midler (se pkt.
English: Enterococcus spp.3 Streptococcus groups A, B, C and G Note 4
Danish: Enterococcus spp.3 Streptokokker gruppe A, B, C og G Note4
English: You should not give antibiotics that were prescribed for you to other people.
Danish: Du må ikke give antibiotika, der oprindeligt blev ordineret til dig, til andre.
English: • the tongue may change to yellow, brown or black and it may have a hairy appearance
Danish: • ændret udseende af tungen; den kan blive gul, brun eller sort, og den kan få belægninger.
English: Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin (see section 5.1).
Danish: Amoxicillin er ikke egnet til behandling af visse typer infektion, medmindre patogenet allerede er påvist, og det vides, at patogenet er følsomt, eller der er en meget høj sandsynlighed for, at patogenet kan behandles med amoxicillin (se pkt.
English: All doses are worked out depending on the child's body weight in kilograms.
Danish: Alle doser er udregnet efter barnets vægt i kilo.
English: Amoxil can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive.
Danish: Amoxil kan give bivirkninger, og symptomerne (såsom allergiske reaktioner, svimmelhed og kramper) kan gøre dig uegnet til at køre.
English: Urinary recovery (%, 0 to 6 h )
Danish: Udskilt via urinen (%, 0-6 t)
English: Liquid suspension
Danish: Flydende suspension
English: Parenteral formulations
Danish: Parenterale formuleringer
English: These may be associated with fever, headaches and body aches
Danish: Disse kan være forbundet med feber, hovedpine og smerter i kroppen.
English: • Once you finish treatment, if you still feel unwell you should go back to see the doctor.
Danish: • Hvis du stadig ikke har det godt, når behandlingen er slut, skal du gå til lægen igen.
English: Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
Danish: Hvis antibiotika anvendes med omhyggelighed, kan det være med til at nedsætte risikoen for, at bakterier bliver resistente over for dem.
English: Do not inject more than 1 g of amoxicillin at one time in adults.
Danish: Der må ikke injiceres mere end 1 g amoxicillin ad gangen til voksne.
English: There are no data on the effects of amoxicillin on fertility in humans.
Danish: Der foreligger ingen data om amoxicillins virkning på fertiliteten hos mennesker.
English: Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
Danish: Hvis du følger nedenstående råd, kan du hjælpe med at forebygge fremkomsten af resistente bakterier, der kan medføre, at antibiotikummet ikke virker.
English: Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.
Danish: Samtidig brug af probenecid kan resultere i højere og længerevarende niveauer af amoxicillin 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 anvisningerne på etiketten, og hvis du ikke forstår dem, så få lægen eller apotekspersonalet til at forklare dem. 2.
English: Any residual antibiotic solution should be discarded.
Danish: Eventuelt resterende antibiotisk opløsning bør kasseres.
English: This can include a skin rash or swelling of the face or throat.
Danish: Dette kunne være et hududslæt eller hævelse af ansigtet eller halsen.
English: Do not inject more than 60 mg/kg at one time in children.
Danish: Der må ikke injiceres mere end 60 mg/kg ad gangen til børn.
English: The expiry date and storage instructions stated on the label are for the doctor, pharmacist or nurse's information.
Danish: Udløbsdatoen og opbevaringsinstruktionerne på etiketten er information til lægen, apotekspersonalet og sundhedspersonalet.
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 halvsyntetisk penicillin (betalaktam-antibiotikum), der hæmmer et eller flere enzymer (som ofte kaldes penicillinbindende proteiner, PBP'er) i biosyntesen af bakterielt peptidoglykan, der er en vigtig strukturel komponent i bakteriernes cellevæg.
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: This should be considered if you are on a sodium controlled diet.
Danish: Der skal tages højde for dette, hvis du er på en diæt med kontrolleret natriumindhold.
English: For oral formulations only Black hairy tongue
Danish: Gælder kun for orale formuleringer Sort belægning på tungen.
English: Parenteral:
Danish: Parenteralt:
English: Susceptibility inferred from the MIC of ampicillin.
Danish: Følsomheden er udledt ud fra MIC af ampicillin.
English: • Asymptomatic bacteriuria in pregnancy
Danish: • Asymptomatisk bakteriuri under graviditet
English: Aspartame (E951)
Danish: Aspartam (E 951)
English: Resistant >
Danish: Resistent >
English: Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of 0.5 to 1 hour.
Danish: Rekonstituerede opløsninger af amoxicillin kan injiceres i dropslangesystemet over en periode på 0,5-1 time.
English: *Uncommon
Danish: *Ikke almindelig
English: Kidney problems If you have kidney problems the dose might be lower than the usual dose.
Danish: Nyreproblemer Hvis du har nyreproblemer, kan den dosis, du får, være lavere end den sædvanlige dosis.
English: In the range 250 to 3000 mg the bioavailability is linear in proportion to dose (measured as Cmax and AUC).
Danish: I intervallet 250-3.000 mg er der en lineær sammenhæng mellem biotilgængelighed og dosis (målt som Cmax og AUC).
English: Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy.
Danish: Der er indberettet alvorlige og ved enkelte lejligheder dødelige overfølsomhedsreaktioner (anafylaktoide reaktioner) hos patienter i behandling med penicillin.
English: • an excessive breakdown of red blood cells causing a type of anaemia.
Danish: • overdreven nedbrydning af de røde blodlegemer, hvilket kan give en form for anæmi (blodmangel).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 250 mg capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 250 mg kapsler
English: No dose adjustment is considered necessary.
Danish: Det anses ikke for nødvendigt at justere dosis.
English: Amoxil is for oral use.
Danish: Oralt: Amoxil er til oral anvendelse.
English: It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi.
Danish: Reaktionen kommer direkte som følge af amoxicillins baktericide virkning på den bakterie, der forårsager Lyme-sygdom, spirokæten Borrelia burgdorferi.
English: Dose+
Danish: Dosis+
English: Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6).
Danish: Amoxicillin kan som de fleste penicilliner påvises i mælk (se pkt.
English: Magnesium Stearate
Danish: Magnesiumstearat
English: If you forget to take Amoxil
Danish: Hvis du har glemt at tage Amoxil
English: However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin.
Danish: I litteraturen er der dog beskrevet tilfælde af forhøjet international normaliseret ratio (INR) hos patienter i vedligeholdelsesbehandling med acenocoumarol eller warfarin, som har fået ordineret amoxicillin.
English: • Urine tests ( glucose) or blood tests for liver function
Danish: • urinprøver (glucose) eller blodprøver for at få undersøgt leverfunktionen
English: Amoxil Powder for Solution for Injection or Infusion is usually used for urgent treatment of severe infection or if patients cannot take Amoxil by mouth.
Danish: Amoxil pulver til injektions-/infusionsvæske, opløsning anvendes normalt til akut behandling af alvorlig infektion, eller hvis patienter ikke er i stand til at tage Amoxil gennem munden.
English: Should antibiotic-associated colitis occur, amoxicillin should immediately be discontinued, a physician consulted and an appropriate therapy initiated.
Danish: Skulle der opstå antibiotikum-relateret colitis, skal amoxicillin omgående seponeres, en læge konsulteres, og en hensigtsmæssig behandling indledes.
English: Amoxicillin does not adequately distribute into the cerebrospinal fluid.
Danish: Amoxicillin fordeles ikke til cerebrospinalvæsken i tilstrækkelig grad.
English: • Space the doses evenly during the day, at least 4 hours apart.
Danish: • Fordel doserne ligeligt over dagen og med mindst 4 timer mellem hver dosis.
English: Water for injections is the normal diluent.
Danish: Vand til injektionsvæsker er den normale solvens.
English: The main mechanisms of resistance to amoxicillin are:
Danish: De primære mekanismer bag amoxicillinresistens er:
English: Amoxicillin 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: Amoxicillin bør undgås, hvis der er mistanke om mononukleose, da forekomst af morbilliformt udslæt efter anvendelse af amoxicillin er blevet forbundet med denne tilstand.
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 må ikke tage antibiotika, der er blevet ordineret til andre, selvom de havde en infektion, der var magen til din.
English: Amoxicillin is excreted into breast milk in small quantities with the possible risk of sensitisation.
Danish: Amoxicillin udskilles i små mængder i human mælk med en mulig risiko for sensibilisering.
English: • Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.
Danish: • Ændring af PBP'er, som reducerer amoxicillins affinitet til angrebspunktet.
English: Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of large doses.
Danish: Det er set, at amoxicillin udfældes i blærekatetre, primært efter intravenøs administration af store doser.
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 en rest antibiotikum tilovers, efter at du har fuldendt behandlingsforløbet som foreskrevet af lægen, skal du aflevere resten på apoteket, så det kan blive bortskaffet på den rigtige måde.
English: Some infections require longer periods of treatment (see section 4.4 regarding prolonged therapy).
Danish: Nogle infektioner kræver længere behandlingsperioder (se pkt.
English: • serious liver side effects may occur.
Danish: • alvorlige bivirkninger relateret til leveren.
English: Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.
Danish: Tetracykliner og andre bakteriostatiske lægemidler kan påvirke amoxicillins baktericide virkning.
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 hyppigste årsager til dette er, at de bakterier, der forårsager infektionen, er modstandsdygtige (resistente) over for det antibiotikum, der tages.
English: *Consideration should be given to the official treatment guidelines for each indication.
Danish: *De officielle retningslinjer for behandling af de enkelte indikationer skal tages i betragtning.
English: Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction.
Danish: Orale antikoagulantia og penicilliner er blevet anvendt hyppigt klinisk uden indberetning af interaktioner.
English: Amoxicillin fully dissociates in aqueous solution at physiological pH.
Danish: Amoxicillin dissocieres fuldstændigt i vandig opløsning ved fysiologisk pH.
English: Check cap seal is intact before use.
Danish: Kontroller, at hættens forsegling er intakt før brug.
English: Late stage (systemic involvement): 2 g every 8 hours
Danish: Sent stadium (systemisk involvering): 2 g hver 8. time
English: Amoxicillin is less stable in infusions containing carbohydrate.
Danish: Amoxicillin er mindre stabilt i infusionsvæsker, der indeholder kulhydrat.
English: Commonly Susceptible Species
Danish: Arter, der normalt er følsomme
English: Blood and lymphatic system disorders Very rare
Danish: Blod og lymfesystem Meget sjælden
English: • inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever
Danish: • betændelse i tyktarmen (colon) med diarré (sommetider med blod), smerter og feber.
English: Latvia - Amoxil 500 mg kapsulas Lithuania - Amoxil
Danish: Letland - Amoxil 500 mg kapsulas Litauen - Amoxil