FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.
Danish: De patienter, som fik Afinitor, levede i gennemsnit 4,9 måneder, uden at sygdommen blev værre, sammenlignet med 1,9 måneder for de patienter, der fik placebo.
English: How does Afinitor work?
Danish: Hvordan virker Afinitor?
English: A study in 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin compared Afinitor with placebo.
Danish: Afinitor blev sammenlignet med placebo i et studie med 410 patienter med fremskredne veldifferentierede eller moderat differentierede neuroendokrine tumorer med oprindelse i bugspytkirtlen.
English: Patients who took Afinitor lived for an average of 11.0 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
Danish: De patienter, som fik Afinitor, levede i gennemsnit 11,0 måneder, uden at sygdommen blev værre, sammenlignet med 4,6 måneder for de patienter, der fik placebo.
English: Patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo (a dummy treatment).
Danish: De patienter, der fik Afinitor, levede i gennemsnit 7,8 måneder, uden at sygdommen blev værre, sammenholdt med 3,2 måneder for de patienter, der fik placebo.
English: EU/1/16/1116/001 Epclusa
Danish: EU/1/16/1116/001
English: Invented name Strength
Danish: (Særnavn) Navn Styrke
English: 400 mg / 100 mg Film-coated tablet
Danish: 400 mg/100 mg Filmovertrukket tablet Oral anvendelse beholder (HDPE) 28 tabletter
English: This is more likely if:
Danish: Dette er mere sandsynligt, hvis:
English: Treatment should not exceed 4 months.
Danish: Behandlingen må ikke overstige 4 måneder.
English: Italy, Portugal : Targosid
Danish: Italien, Portugal : Targosid
English: a No current data were available when the tables were published.
Danish: a Ingen aktuelle data var tilgængelige, da tabellerne blev offentliggjort.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Luxemburg, Malta, Netherlands, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Targocid
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig, Belgien, Bulgarien, Tjekkiet, Danmark, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Luxemburg, Malta, Holland, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Storbritannien: Targocid
English: After the fourth day of treatment:
Danish: Efter den fjerde behandlingsdag:
English: No specific interaction studies have been performed.
Danish: Der er ikke udført specifikke interaktionsstudier.
English: Targocid is an antibiotic.
Danish: Targocid er et antibiotikum.
English: The duration of treatment should be decided based on the clinical response.
Danish: Behandlingsvarigheden skal besluttes på basis af det kliniske respons.
English: Only clear and yellowish solutions should be used.
Danish: Kun klare og gullige opløsninger må anvendes.
English: The highest values of Vss are observed in the recent studies where the sampling period was superior to 8 days.
Danish: De højeste værdier af Vss er observeret i de seneste studier, hvor prøvetagningsperioden var længere end 8 dage.
English: • your treatment will last for a long time
Danish: • du skal behandles i længere tid
English: c IE indicates that there is insufficient evidence that the species in question is a good target for therapy with the drug.
Danish: c IE indikerer, at der ikke er tilstrækkelige beviser for, at den pågældende art er et godt mål for terapi med lægemidlet.
English: For infective endocarditis a minimum of 21 days is usually considered appropriate.
Danish: Ved infektiøs endocarditis anses et minimum på 21 dage for passende.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal lægemidlet anvendes straks.
English: Superinfection (overgrowth of non-susceptible organisms)
Danish: Superinfektion (overvækst af ikkefølsomme organismer)
English: • hearing loss, ringing in the ears or a feeling that you, or things around you are moving
Danish: • høretab, ringen for ørerne eller en følelse af, at du selv eller ting omkring dig bevæger sig
English: This is because Targocid can affect the way some other medicines work.
Danish: Dette skyldes, at Targocid kan påvirke måden, hvorpå andre lægemidler virker.
English: Mechanism of resistance Resistance to teicoplanin can be based on the following mechanisms:
Danish: Resistensmekanisme Resistens over for teicoplanin kan baseres på følgende mekanismer:
English: It works by killing the bacteria that cause infections in your body.
Danish: Det virker ved at dræbe bakterier, der forårsager infektioner i kroppen.
English: Therefore, teicoplanin should not be used during pregnancy unless clearly necessary.
Danish: Derfor bør teicoplanin ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Paediatric population The dose recommendations are the same in adults and children above 12 years of age.
Danish: Pædiatrisk population Dosisanbefalingerne er de samme hos voksne og hos børn over 12 år.
English: Treatment of teicoplanin overdose should be symptomatic.
Danish: Behandling af teicoplanin-overdosis skal være symptomatisk.
English: It is unlikely that your doctor or nurse will give you too much medicine.
Danish: Det er usandsynligt, at lægen eller sygeplejersken giver dig for meget medicin.
English: System organ class
Danish: Organsystem klasse
English: • you are allergic to an antibiotic called ‘vancomycin'
Danish: • du er allergisk over for et antibiotikum kaldet "vancomycin"
English: The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 3.1, February 11, 2013 are displayed in the following table:
Danish: MIC-grænseværdier i henhold til den Europæiske Komité For Resistensbestemmelse (EUCAST), version 3.1, 11. februar 2013 er vist i nedenstående tabel:
English: Cases of accidental administration of excessive doses to paediatric patients have been reported.
Danish: Tilfælde af utilsigtet administration af store doser til pædiatriske patienter er rapporteret.
English: Practical information for healthcare professionals on preparation and handling of Targocid.
Danish: Praktiske oplysninger til sundhedspersonale om klargøring og håndtering af Targocid.
English: The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the teicoplanin concentrations.
Danish: Bindingen til humane serumproteiner spænder fra 87,6 til 90,8 % uden nogen variation i funktionen for teicoplanin-koncentrationerne.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter Kommissionens afgørelse skal de relevante nationale myndigheder ajourføre produktoplysningerne i overensstemmelse hermed.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer vedrørende hensigtsmæssig brug af antibakterielle midler.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Danish: Seponering eller langsommere infusion kan muligvis bremse disse reaktioner.
English: • Paediatric population
Danish: • Pædiatrisk population
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette sker, må du ikke køre bil eller betjene værktøj eller maskiner.
English: As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of nonsusceptible organisms.
Danish: Som med andre antibiotika kan brugen af teicoplanin, især hvis den er langvarig, resultere i overvækst af ikke-følsomme organismer.
English: The ability to drive or use machines may be affected.
Danish: Evnen til at køre eller betjene maskiner kan blive påvirket.
English: • Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium.
Danish: • Ændret struktur af target: denne form for resistens er især opstået hos Enterococcus faecium.
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af resistens kan variere geografisk og over tid for udvalgte arter, og lokal information om resistens er ønskelig, især ved behandling af alvorlige infektioner.
English: • It can also be given as a infusion through a drip into a vein.
Danish: • Det kan også gives som en infusion gennem et drop i en vene.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Danish: Identifikation og antimikrobielle følsomhedstest af sådanne isolater skal gentages, og hvis resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
English: Patients experiencing these undesirable effects should not drive or use machines.
Danish: Patienter, der oplever disse bivirkninger, bør ikke køre bil eller betjene maskiner.
English: Information about storage and the time to use Targocid, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Targocid'.
Danish: Oplysninger om opbevaring og tid til at bruge Targocid, efter det er blevet opløst og er klart til brug, er beskrevet i "Praktiske oplysninger for sundhedspersonale om klargøring og håndtering af Targocid ”.
English: Primary packaging:
Danish: Primær emballage:
English: In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention:
Danish: I tabellen nedenfor er alle bivirkninger, som forekommer hyppigere end ved placebo og hos mere end én patient, opført efter følgende konvention:
English: Two metabolites are formed probably by hydroxylation and represents 2 to 3% of the administered dose.
Danish: Der findes to metabolitter, sandsynligvis dannet ved hydroxylering, og de repræsenterer 2 til 3 % af den indgivne dosis.
English: If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment:
Danish: Hvis du har problemer med nyrerne, skal din dosis som regel nedsættes efter den fjerde behandlingsdag:
English: Periodic haematological examinations are recommended during treatment, including complete cell blood count.
Danish: Periodisk hæmatologiske kontrol anbefales under behandlingen, herunder komplet blodtælling.
English: • Aminoglycosides as they must not be mixed together with Targocid in the same injection.
Danish: • Aminoglykosider, da de ikke må blandes med Targocid i samme injektion.
English: The volume of distribution at steady-state (Vss) varies from 0.7 to 1.4 mL/kg.
Danish: Fordelingsvolumen ved steady state (Vss) varierer fra 0,7 til 1,4 ml/kg.
English: • getting more infections than usual - these could be signs of a decrease in your blood cell count
Danish: • hyppigere infektioner end sædvanligt - det kan være tegn på et nedsat antal blodlegemer
English: Teicoplanin did not show any potential to cause antigenicity (in mice, guinea-pigs or rabbits), genotoxicity or local irritancy.
Danish: Teicoplanin viste intet potentiale for antigenicitet (hos mus, marsvin eller kaniner), genotoksicitet eller for lokal irritation.
English: Your doctor or nurse will have instructions about when to give you Targocid.
Danish: Lægen eller sygeplejersken har en vejledning om, hvornår de skal give dig Targocid.
English: During treatment you may have tests to check your kidneys and/or your hearing.
Danish: Under behandlingen kan du få taget prøver for at kontrollere dine nyrer og/eller din hørelse.
English: In people who are given Targocid for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this.
Danish: Hos personer, der får Targocid i længere tid, kan bakterier, der ikke påvirkes af det aktive stof teicoplanin, vokse mere end normalt - din læge vil tjekke for dette.
English: Under this regimen blood creatinine values should be monitored in addition to the recommended periodic haematological examination.
Danish: Under dette regime skal blodkreatinin monitoreres udover den anbefalede periodiske hæmatologiske kontrol.
English: Microorganism
Danish: Mikroorganismer
English: They will decide whether or not you are given this medicine while you are pregnant.
Danish: De vil beslutte, om du kan få dette lægemiddel, mens du er gravid.
English: The final solution is isotonic with plasma and has a pH of 7.2-7.8.
Danish: Den endelige opløsning er isotonisk med plasma og har en pH-værdi på 7,2-7,8.
English: Do not use Targocid if: • you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Targocid hvis: • du er allergisk over for teicoplanin eller et af de øvrige indholdsstoffer (anført i punkt 6).
English: If the solution does become foamy, then it should be left to stand for about 15 minutes.
Danish: Hvis opløsningen skummer, skal den stå urørt i ca. 15 minutter.
English: Sodium hydroxide (for pH adjustment)
Danish: Natriumhydroxid (til justering af pH)
English: • peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD), • bacteraemia that occurs in association with any of the indications listed above.
Danish: • peritonitis forbundet med kontinuerlig ambulant peritonealdialyse (CAPD), • bakteriæmi, der forekommer i forbindelse med enhver af ovenstående indikationer.
English: The responsible enzymes are a newly synthesised D-lactate dehydrogenase or ligase.
Danish: De ansvarlige enzymer er en nyligt syntetiseret D-laktatdehydrogenase eller -ligase.
English: Following repeated parenteral administration to the rat and dog, effects on the kidney were observed and were shown to be dose-dependent and reversible.
Danish: Efter gentagen parenteral administration til rotter og hunde blev der observeret virkninger på nyrerne, som viste sig at være dosisafhængige og reversible.
English: The medicine will normally be given to you by a doctor or nurse.
Danish: Du vil normalt få lægemidlet af en læge eller sygeplejerske.
English: A higher total clearance (15.8 mL/h/kg for neonates, 14.8 mL/h/kg for a mean age 8 years) and a shorter elimination half-life (40 hours neonates; 58 hours for 8 years) are observed compared to adult patients.
Danish: En højere total clearance (15,8 ml/t/kg for nyfødte, 14,8 ml/t/kg for en gennemsnitsalder på 8 år) og en kortere eliminationshalveringstid (40 timer for nyfødte, 58 timer for 8-årige) er iagttaget i forhold til voksne patienter.
English: In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously (95 mg/kg).
Danish: I ét tilfælde forekom agitation hos en 29 dage gammel nyfødt, som havde fået 400 mg intravenøst (95 mg/kg).
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Danish: Indtil der er evidens for klinisk respons for bekræftede isolater med MIC over det aktuelle resistens-breakpoint, skal de rapporteres som resistente.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkninger opstillet efter faldende alvorlighed.
English: Shelf life of powder as packaged for sale: 3 years
Danish: Holdbarhed for pulver i salgspakning: 3 år
English: Preparation of the diluted solution before infusion:
Danish: Klargøring af den fortyndede opløsning før infusion:
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 of types of infections is questionable.
Danish: Om nødvendigt bør der søges ekspertrådgivning, når den lokale forekomst af resistens er således, at lægemidlets nyttevirkning er tvivlsom i det mindste for nogle typer infektion.
English: a Glycopeptide MICs are method dependent and should be determined by broth microdilution (reference ISO 20776).
Danish: a Glykopeptid-MICer er metodeafhængige og skal bestemmes ved mikrobouillonfortynding (henvisning ISO 20776).
English: Elimination half-life of teicoplanin varies from 100 to 170 hours in the most recent studies where blood sampling duration is about 8 to 35 days.
Danish: Eliminationsshalveringstiden for teicoplanin varierer fra 100 til 170 timer i de seneste studier, hvor blodprøvetagningperioden er omkring 8 til 35 dage.
English: Teicoplanin can cause dizziness and headache.
Danish: Teicoplanin kan forårsage svimmelhed og hovedpine.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der opstår superinfektion under behandlingen, skal der træffes passende foranstaltninger.
English: The resistance breakpoint for S. aureus has been reduced to 2 mg/mL to avoid reporting of GISA isolates intermediate as serious infections with GISA isolates are not treatable with increased doses of vancomycin or teicoplanin.
Danish: Resistensbreakpoint for S. aureus er blevet reduceret til 2 mg/ml for at undgå indberetning af intermediære GISA-isolater, da alvorlige infektioner med GISA-isolater ikke kan behandles med øgede doser af vancomycin eller teicoplanin.
English: On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.
Danish: På dette grundlag forventes det, at teicoplanin i de fleste tilfælde vil blive brugt til at behandle alvorlige infektioner hos patienter, hvor antibakterielle standardpræparater anses for at være uegnede.
English: You may have regular tests to check if your blood, kidneys and/or liver are working properly (see ‘Other medicines and Targocid').
Danish: Du kan få taget prøver regelmæssigt for at kontrollere, om dit blod, nyrer og/eller lever fungerer korrekt (se ” Brug af anden medicin sammen med Targocid").
English: The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function.
Danish: Dosis og behandlingsvarighed skal justeres i overensstemmelse med den underliggende infektionstype og -sværhedsgrad, og patientens kliniske respons samt patientfaktorer som alder og nyrefunktion.
English: The rational use of teicoplanin 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 teicoplanin skal tage hensyn til det bakterielle spektrum, sikkerhedsprofilen og egnetheden af antibakteriel standardterapi ved behandling af den enkelte patient.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: There are a limited amount of data from the use of teicoplanin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af teicoplanin til gravide kvinder.
English: The primary literature, standard volumes and treatment recommendations assume sensitivity b Collective term for a heterogeneous group of streptococcus species.
Danish: Den primære litteratur, diverse standarder for følsomhed og behandlingsanbefalinger antager følsomhed b Samlet betegnelse for en heterogen gruppe af streptokok-arter.
English: b Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported.
Danish: b Isolater med MIC-værdier over grænseværdien for følsomhed er meget sjældne eller endnu ikke rapporteret.
English: Powder as packaged for sale: This medicinal product does not require any special storage condition.
Danish: Pulver i salgspakning: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
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 teicoplanin.
Danish: Det er ikke egnet til brug i monoterapi ved behandling af visse typer infektioner, medmindre patogenet allerede er identificeret og kendt for at være følsomt, eller der er en klar mistanke om, at de(t) mest sandsynlige patogen(er) ville være egnet til behandling med teicoplanin.
English: However, there is no evidence of synergistic toxicity in combinations with teicoplanin.
Danish: Der er dog ingen tegn på synergistisk toksicitet ved kombination med teicoplanin.
English: Severe bullous reactions
Danish: Alvorlige bulløse reaktioner
English: Solvent: water for injections.
Danish: Solvens: vand til injektionsvæsker.
English: S. aureus with vancomycin MIC values of 2 mg/mL are on the border of the wild type MIC distribution and there may be an impaired clinical response.
Danish: S. aureus med vancomycin-MIC-værdier på 2 mg/ml er på grænsen af MIC-fordelingen for vildtypen, og der kan være nedsat klinisk respons.
English: If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.
Danish: Hvis der opstår en allergisk reaktion over for teicoplanin, skal behandlingen straks seponeres og passende nødforanstaltninger iværksættes.
English: The total and renal clearances of teicoplanin depends on the creatinine clearance.
Danish: Den totale og renale clearance af teicoplanin afhænger af kreatininclearance.
English: Cross-resistance between teicoplanin and the glycoprotein vancomycin may occur.
Danish: Der kan forekomme krydsresistens mellem teicoplanin og glykoproteinet vancomycin.
English: Not known (frequency cannot be estimated from the available data) • problems where the injection was given - such as reddening of the skin, pain or swelling
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data) • problemer på injektionsstedet - såsom hudrødme, smerter eller hævelse
English: Not known (cannot be estimated from available data)
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er tænkt læger og sundhedspersonale:
English: The modification is based on exchange of the terminal D-alanine-D-alanine function of the aminoacid chain in a murein precursor with D-Ala-D-lactate, thus reducing the affinity to vancomycin.
Danish: Modifikationen er baseret på udveksling af aminosyrekædens terminale D-alanin-D-alanin-funktion med D-Ala-D-laktat i et mureinforstadium, hvorved affiniteten til vancomycin reduceres.
English: • you are taking or may take other medicines that may affect your nervous system, kidneys or hearing.
Danish: • du tager eller måske skal have andre lægemidler, der kan påvirke dit nervesystem, nyrer eller hørelse.
English: When administered by oral route at 250 or 500 mg single dose to healthy subjects, teicoplanin is not detected in serum or urine but only recovered in feces (about 45% of the administered dose) as unchanged medicinal product.
Danish: Når teicoplanin administreres oralt som 250 eller 500 mg enkeltdosis til raske forsøgspersoner, kan det ikke detekteres i serum eller urin, men genfindes kun i fæces (omkring 45 % af den indgivne dosis) som uændret lægemiddel.
English: Volume withdrawable from the
Danish: Volumen, der kan udtrækkes fra