FrancophonIA/ELRC3.0 huggingface dataset:
English: Careful observation of the patient is essential.
Danish: Omhyggelig observation af patienten er afgørende.
English: This preparation is for oral use only and is not systemically absorbed.
Danish: Dette præparat er kun til oral anvendelse og absorberes ikke systemisk.
English: Linerarity/non-linearity
Danish: Linearitet/non-linearitet
English: Species for which acquired resistance may be a problem
Danish: Arter, for hvilke erhvervet resistens kan være et problem
English: Monitoring of vestibular and auditory function in the elderly should be carried out during and after treatment.
Danish: Overvågning af vestibulær og auditiv funktion hos ældre bør udføres under og efter behandlingen.
English: Stopping the infusion usually results in a prompt cessation of these reactions.
Danish: Hvis infusionen standses, resulterer det normalt i et hurtigt ophør af disse reaktioner.
English: The safety profile is generally consistent among children and adult patients.
Danish: Sikkerhedsprofilen er generelt den samme for børn og voksne patienter.
English: [to be completed nationally]
Danish: [Skal udfyldes nationalt]
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Danish: Disse ændringer i de relevante punkter af produktinformationen er resultatet af referralproceduren.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af medlemsstatens relevante myndighed i samarbejde med referencemedlemsstaten, hvor det er passende, i overensstemmelse med procedurerne, som er beskrevet i kapitel 4 titel III i direktiv 2001/83/EU.
English: In addition, appropriate information should be given under Method of administration and in section 6.6.]
Danish: Desuden bør der gives passende information under Administration og i punkt 6.6.]
English: Suggested treatment duration is shown in table below.
Danish: Foreslået behandlingsvarighed er vist i tabellen nedenfor.
English: Streptococcus groups A, B, C and G
Danish: Streptococcus grupper A, B, C og G
English: If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Danish: Hvis din læge har ordineret antibiotika, har du brug for dem mod netop din nuværende sygdom.
English: Despite antibiotics, some bacteria may survive or grow.
Danish: På trods af antibiotika kan nogle bakterier overleve eller vokse.
English: This phenomenon is called resistance: some antibiotic treatments become ineffective.
Danish: Dette fænomen kaldes resistens: visse antibiotiske behandlinger bliver virkningsløse.
English: Misuse of antibiotics increases resistance.
Danish: Misbrug af antibiotika øger resistensen.
English: IV dose
Danish: IV dosis
English: Biliary excretion is insignificant (less than 5% of a dose).
Danish: Galdesekretion er ubetydelig (mindre end 5% af en dosis).
English: The capsule should not be open and should be taken with plenty of water.
Danish: Kapslen må ikke åbnes og bør indtages med rigeligt vand.
English: Advice/medical education
Danish: Rådgivning/medicinsk uddannelse
English: Vancomycin concentration generally increases proportionally with increasing dose.
Danish: Vancomycinkoncentrationen forøges almindeligvis proportionalt med stigende dosis.
English: 2 - Strictly follow the prescription.
Danish: 2 - altid følger ordinationen nøje.
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below.
Danish: Bemærk: Den eksisterende indlægsseddel skal ændres (indsættelse, udskiftning eller sletning af teksten efter behov) for at afspejle nedenstående ordlyd.
English: You will be given Vancomycin by medical staff while you are in hospital.
Danish: Du får Vancomycin af sundhedspersonalet, mens du er på sygehuset.
English: Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.
Danish: Lægen beslutter, hvor meget medicin du skal have hver dag, og hvor længe behandlingen skal vare.
English: Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
Danish: Erfaring med andre antibiotika tyder på at døvhed kan være progressiv trods ophør af behandling.
English: Adults and children
Danish: Voksne og børn
English: For information about the preparation of the solution, please see section 6.6.
Danish: For information om fremstilling af opløsningen, se punkt 6.6.
English: Acute bacterial meningitis (For parenteral formulations authorised for Acute bacterial meningitis)
Danish: Akut bakteriel meningitis (For parenterale formuleringer godkendt til akut bakteriel meningitis)
English: Secondary development of resistance during therapy is rare.
Danish: Sekundær udvikling af resistens under behandling er sjælden.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Renal function must be taken into consideration for subsequent doses and interval of administration.
Danish: Nyrefunktionen skal tages i betragtning ved efterfølgende doser og administrationsinterval.
English: Gram positive anaerobes
Danish: Gram positive anaerober
English: However, the safety of increased vancomycin dosing has not been properly assessed and higher doses than 60 mg/kg/day cannot be generally recommended.
Danish: Sikkerheden ved øget vancomycindosering er dog ikke blevet behørigt vurderet, og højere doser end 60 mg/kg/dag kan ikke anbefales generelt.
English: Potential for Systemic Absorption
Danish: Potentiale for systemisk absorption
English: 3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
Danish: 3 - ikke genbruger antibiotika uden recept, selv om du vil behandle en lignende sygdom.
English: As a consequence, prudent use of oral vancomycin is advised.
Danish: Som en konsekvens heraf anbefales forsigtig anvendelse af oral vancomycin.
English: Contents of the pack and other information Other sources of information
Danish: Pakningsstørrelser og yderligere oplysninger Andre informationskilder
English: Lower maintenance doses may be required due to the age-related reduction in renal function.
Danish: Lavere vedligeholdelsesdoser kan være påkrævet på grund af aldersrelateret nyrefunktionsnedsættelse.
English: 10 to 21 days
Danish: 10 til 21 dage
English: Summary of the Safety profile
Danish: Resumé af Sikkerhedsprofilen
English: The emergence of resistance towards vancomycin differs from one hospital to another and a local microbiological laboratory should therefore be contacted for relevant local information.
Danish: Fremkomsten af resistens over for vancomycin varierer fra et sygehus til et andet, og derfor bør et lokalt mikrobiologisk laboratorium kontaktes for relevant lokal information.
English: 5 - After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly.
Danish: 5 - efter endt behandling afleverer alle ubrugte lægemidler på apoteket for at sikre, at de bortskaffes korrekt.
English: The length of treatment depends on the infection you have and may last a number of weeks.
Danish: Varigheden af behandlingen afhænger af, hvilken infektion du har, og kan vare i flere uger.
English: Characteristics in specific groups
Danish: Egenskaber hos specifikke grupper
English: Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body.
Danish: Intravenøs infusion betyder, at lægemidlet strømmer fra en infusionsflaske eller -pose gennem en slange til et af blodkarrene og ind i kroppen.
English: In any case, the duration of treatment should be tailored to the type and severity of infection and the individual clinical response.
Danish: Under alle omstændigheder bør behandlingens varighed tilpasses type og sværhedsgrad af infektion og individuel klinisk respons.
English: The initial dose should be based on total body weight.
Danish: Den indledende dosis bør baseres på total kropsvægt.
English: Swallow the capsules whole with water.
Danish: Kapslerne skal sluges hele med vand.
English: The reactions abate when administration is stopped, generally between 20 minutes and 2 hours.
Danish: Reaktionerne formindskes når administrationen stoppes, generelt efter 20 minutter til 2 timer.
English: System organ class Frequency
Danish: Systemorganklasse Hyppighed
English: The elderly are particularly susceptible to auditory damage.
Danish: Ældre er særligt disponerede for høreskader.
English: They are ineffective against viral infections.
Danish: De er virkningsløse mod virusinfektioner.
English: Therefore adverse events following intake of capsules are unlikely.
Danish: Derfor er bivirkninger efter indtagelse af kapsler usandsynlige.
English: There is no cross-resistance between vancomycin and other classes of antibiotics.
Danish: Der er ingen krydsresistens mellem vancomycin og andre klasser af antibiotika.
English: Use in children
Danish: Anvendelse til børn
English: Subsequently, optimal dose should be calculated in line with dosing recommendations provided in section 4.2.
Danish: Efterfølgende skal optimal dosis beregnes i overensstemmelse med doseringsanbefalingerne i punkt 4.2.
English: Transient or permanent loss of hearing
Danish: Forbigående eller permanent høretab
English: Concurrent or sequential use of other ototoxic substances should be avoided.
Danish: Samtidig eller sekventiel anvendelse af andre ototoksiske stoffer bør undgås.
English: The maximum daily dose should not exceed 2 g.
Danish: Den maksimale daglige dosis bør ikke overstige 2 g.
English: You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate: - dosage - schedules - duration of treatment
Danish: Du kan endda hjælpe bakterierne til at blive resistente, hvilket kan forsinke din helbredelse eller nedsætte antibiotikummets effektivitet, hvis du ikke overholder den korrekte: - dosering - tidsplan - behandlingsvarighed.
English: Model-based methods may be useful in the prediction of individual dose requirements to reach an adequate AUC.
Danish: Modelbaserede metoder kan være nyttige til bestemmelse af individuelle doser for at opnå en tilstrækkelig AUC.
English: Subsequent dose adjustments should be based on serum concentrations to achieve targeted therapeutic concentrations.
Danish: Efterfølgende dosisjusteringer bør baseres på serumkoncentrationer for at opnå målrettede terapeutiske koncentrationer.
English: Below 12 years, age-appropriate formulation should be used.
Danish: Hos patienter under 12 år skal en formulering, der er egnet til alderen, anvendes.
English: Anti-diarrhoeic medicinal products must not be given.
Danish: Der må ikke gives lægemidler mod diarré.
English: In patients with severe renal failure, it is preferable to prolong the interval of administration rather than administer lower daily doses.
Danish: Hos patienter med svær nyreinsufficiens foretrækkes det at forlænge administrationsintervallet frem for at administrere lavere daglige doser.
English: Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Danish: Alvorlige og lejlighedsvis dødelige overfølsomhedsreaktioner er mulige (se punkt 4.3 og 4.8).
English: The risk of toxicity is increased by high blood concentrations or prolonged therapy.
Danish: Risikoen for toksicitet øges med høje blodkoncentrationer eller langvarig behandling.
English: Half-life varies between 3.5 and 10 h and is longer than in adults, reflecting the usual lower values for clearance in the neonate.
Danish: Halveringstid varierer mellem 3,5 og 10 timer og er længere end hos voksne, hvilket afspejler de sædvanlige, lavere værdier for clearance hos den nyfødte.
English: The model-based approach can be used both in calculating the personalized starting dose and for dose adjustments based on TDM results (see section 5.1).
Danish: Den modelbaserede fremgangsmåde kan anvendes både i beregningen af den personlige startdosis og for dosisjusteringer baseret på TDM resultater (se punkt 5.1).
English: 4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
Danish: 4 - ikke giver dit antibiotikum til en anden; måske passer det ikke til vedkommendes sygdom.
English: This dose can be increased to 500 mg every 6 hours for 10 days in case of severe or complicated disease.
Danish: Denne dosis kan øges til 500 mg hver 6. time i 10 dage i tilfælde af alvorlig eller kompliceret sygdom.
English: Treatment of Clostridium difficile infection (CDI):
Danish: Behandling af Clostridium difficile-infektion (CDI):
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der bør tages hensyn til officiel vejledning om passende anvendelse af antibakterielle midler.
English: Antibiotics are used to cure bacterial infections.
Danish: Antibiotika anvendes til at helbrede bakterielle infektioner.
English: Where appropriate, vancomycin should be administered in combination with other antibacterial agents.
Danish: Hvor det er relevant, skal vancomycin administreres i kombination med andre antibakterielle midler.
English: It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with vancomycin.
Danish: Det er ikke egnet til anvendelse som enkeltstående middel til behandling af visse typer af infektioner, medmindre patogenet allerede er dokumenteret og vides at være følsomt, eller der er en særlig mistanke om, at de(t) mest sandsynlige patogen(er) vil være egnet til behandling med vancomycin.
English: Spectrum of antibacterial activity
Danish: Spektrum af antibakteriel aktivitet
English: Position changes should be delayed until the infusion is completed to allow for postural adjustment (see section 4.5).
Danish: Positionsskift bør udsættes, indtil infusionen er afsluttet, for at muliggøre postural justering (se punkt 4.5).
English: The rational use of vancomycin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient.
Danish: Rationel anvendelse af vancomycin bør tage hensyn til spektret af aktivitet, sikkerhedsprofilen og egnetheden af standard antibakteriel terapi til behandling af den enkelte patient.
English: Stevens-Johnson syndrome (SJS) has been reported with the use of vancomycin (see section 4.8).
Danish: Stevens-Johnson syndrom (SJS) er blevet rapporteret ved anvendelse af vancomycin (se punkt 4.8).
English: Synergism
Danish: Synergi
English: Vomiting, Diarrhoea
Danish: Opkastning, diarré
English: Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms.
Danish: Langvarig anvendelse af vancomycin kan resultere i overvækst af ikke-følsomme organismer.
English: In the first 24 hours, approximately 80 % of an administered dose of vancomycin is excreted in the urine through glomerular filtration.
Danish: I de første 24 timer udskilles ca. 80% af en administreret dosis af vancomycin i urinen gennem glomerulær filtration.
English: This age group may need blood tests for controlling vancomycin levels in blood.
Danish: For denne aldersgruppe skal der muligvis tages blodprøver til kontrol af vancomycinniveauet i blodet.
English: The blood concentrations of vancomycin should therefore be monitored carefully in these children.
Danish: Blodkoncentrationerne af vancomycin bør derfor kontrolleres nøje hos disse børn.
English: When using for the treatment of infections related to peritoneal dialysis, your doctor will decide exactly how much vancomycin you need.
Danish: Ved anvendelse til behandling af infektioner relateret til peritonealdialyse vil din læge beslutte, præcis hvor meget vancomycin du har brug for.
English: Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle.
Danish: Lægen eller sundhedspersonalet vil altid give vancomycin i blodet og ikke i en muskel.
English: During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.
Danish: Under behandlingen kan du få taget blodprøver, blive bedt om at give urinprøver og skal muligvis have foretaget en høretest for at fastslå mulige bivirkninger.
English: Deafness may be preceded by tinnitus.
Danish: Døvhed kan forudgås af tinnitus.
English: Infective endocarditis
Danish: Infektiv endokarditis
English: Alternative aetiologies should always be sought and Clostridium difficile enterocolitis be proven.
Danish: Alternative ætiologier bør altid søges, og Clostridium difficile enterocolitis bevises.
English: Orientative dosing recommendations for the paediatric population are shown in table below that follow the same principles as in adult patients.
Danish: Vejledende doseringsanbefalinger til den pædiatriske population er vist i nedenstående tabel, der følger de samme principper som hos voksne patienter.
English: This may be reduced by administering vancomycin by infusion over at least 60 minutes, before anaesthetic induction.
Danish: Dette kan reduceres ved at indgive vancomycin ved infusion over mindst 60 minutter før anvendelse af anæstesi.
English: Vancomycin is not usually absorbed into the blood after oral administration.
Danish: Vancomycin absorberes normalt ikke i blodet efter oral administration.
English: To reduce the risk of ototoxicity, blood levels should be determined periodically and periodic testing of auditory function is recommended.
Danish: For at reducere risikoen for ototoksicitet bør blodniveauerne måles periodisk, og der anbefales periodisk test af auditiv funktion.
English: In case of hypersensitivity reactions, treatment with vancomycin must be discontinued immediately and the adequate emergency measures must be initiated.
Danish: I tilfælde af overfølsomhedsreaktioner, skal behandlingen med vancomycin straks afbrydes, og passende nødforanstaltninger skal initieres.
English: 7 to 14 days
Danish: 7 til 14 dage
English: Vancomycin powder is made into a <solution for infusion> <or> <oral solution>.
Danish: Vancomycin pulver opløses til en <infusionsopløsning> <eller en> <oral opløsning>.
English: Specimens for bacterial cultures should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to vancomycin.
Danish: Der bør indhentes prøver til bakteriekulturer med henblik på at isolere og identificere de sygdomsfremkaldende organismer og bestemme deres følsomhed over for vancomycin.
English: In patients with mild or moderate renal failure, the starting dose must not be reduced.
Danish: Hos patienter med let eller moderat nyresvigt må startdosis ikke reduceres.
English: For establishing the dosing regimen for neonates, the advice of a physician experienced in the management of neonates should be sought.
Danish: For at etablere doseringsregime for nyfødte bør der søges rådgivning fra en læge med erfaring i behandling af nyfødte.
English: The elimination half-life of vancomycin is 4 to 6 hours in patients with normal renal function and 2.2-3 hours in children.
Danish: Halveringstiden af vancomycin er 4 til 6 timer hos patienter med normal nyrefunktion og 2,2-3 timer hos børn.
English: Vertigo, tinnitus, dizziness
Danish: Vertigo, tinnitus, svimmelhed
English: The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.
Danish: Ældre, gravide og patienter med nyrelidelser, herunder patienter i dialyse, kan have brug for en anden dosis.
English: [The below wording should be introduced in this section for all vancomycin containing products] Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: [Nedenstående formulering skal introduceres i dette afsnit for alle vancomycinholdige produkter] Der bør tages hensyn til officiel vejledning vedrørende passende anvendelse af antibakterielle midler.
English: On basis of in vitro, animal and limited human data, an AUC/MIC ratio of 400 has been established as a PK/PD target to achieve clinical effectiveness with vancomycin.
Danish: På basis af in vitro-data, data fra dyreforsøg og begrænsede menneskelige data er et AUC/MIC-forhold på 400 blevet etableret som PK/PD mål for at opnå klinisk effektivitet med vancomycin.
English: Depending on the clinical situation, consideration could be given to withhold the next dose while awaiting the results of vancomycin levels.
Danish: Afhængigt af den kliniske situation kan man overveje at tilbageholde den næste dosis, mens man afventer resultaterne af vancomycinniveauerne.
English: In the critically ill patient with renal insufficiency, the initial loading dose (25 to 30 mg/kg) should not be reduced.
Danish: Ved kritisk syge patienter med nyreinsufficiens bør den initiale ladningsdosis (25 til 30 mg/kg) ikke reduceres.
English: The current intravenous dosing recommendations for the paediatric population, in particular for children below 12 years of age, may lead to sub-therapeutic vancomycin levels in a substantial number of children.
Danish: De nuværende intravenøse doseringsanbefalinger til den pædiatriske population, især for børn under 12 år, kan føre til subterapeutiske vancomycinniveauer hos et betydeligt antal børn.
English: After intraperitoneal administration of 30 mg/kg serum levels of approximately 10 mg/l are reached.
Danish: Efter intraperitoneal administration af 30 mg/kg opnås serumniveauer på ca. 10 mg/l.
English: [The below should be introduced in section 4.2 for all vancomycin products powder for concentrate]
Danish: [Det følgende skal indføres i punkt 4.2 for alle vancomycinprodukter pulver til koncentrat]
English: Monitoring of vancomycin serum concentrations
Danish: Overvågning af serumkoncentrationerne af vancomycin
English: Gram-negative bacteria are resistant.
Danish: Gramnegative bakterier er resistente.
English: In contrast, high concentrations of vancomycin are found in the faeces (>3100 mg/kg with doses of 2 g/day).
Danish: I modsætning hertil er høje koncentrationer af vancomycin fundet i fæces (> 3100 mg/kg ved doser på 2 g/dag).
English: The frequency of therapeutic drug monitoring (TDM) needs to be individualized based on the clinical situation and response to treatment, ranging from daily sampling that may be required in some hemodynamically unstable patients to at least once weekly in stable patients showing a treatment response.
Danish: Hyppigheden af terapeutisk lægemiddelovervågning (TDM) skal individualiseres ud fra den kliniske situation og respons på behandling, fra daglig prøveudtagning, som kan være nødvendig hos nogle hæmodynamisk ustabile patienter til mindst en gang om ugen hos stabile patienter, der viser behandlingsrespons.
English: Intravenous vancomycin should be infused slowly.
Danish: Intravenøs vancomycin bør infunderes langsomt.
English: Dose adjustments in adult patients could be based on glomerular filtration rate estimated (eGFR) by the following formula:
Danish: Dosisjusteringer hos voksne patienter kan baseres på estimeret glomerulær filtreringshastighed (eGFR) efter følgende formel:
English: Necrosis may occur after intramuscular injection.
Danish: Nekrose kan forekomme efter intramuskulær injektion.
English: Vancomycin works by eliminating certain bacteria that cause infections.
Danish: Vancomycin virker ved at udrydde visse bakterier, der forårsager infektioner.