FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment.
Danish: Det er derfor vigtigt at tage denne diagnose i betragtning hos de patienter, som får diarré
English: Women of childbearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal anvende sikker antikonception under behandlingen.
English: As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with telavancin (see section 4.8).
Danish: Ligesom ved brug af andre glycopeptider er der rapporteret om ototoksicitet (døvhed og tinnitus) hos patienter, der behandles med telavancin (se pkt.
English: Caution should be exercised when prescribing telavancin to patients with a prior history of hypersensitivity reaction to vancomycin.
Danish: Der skal udvises forsigtighed, når telavancin ordineres til patienter med tidligere overfølsomhedsreaktioner over for vancomycin.
English: Telavancin dose (mg) = 10 mg/kg (or 7.5 mg/kg) x patient body weight (in kg) Volume of reconstituted concentrate (ml) = Telavancin dose (mg)/15 (mg/ml)
Danish: Telavancindosis (mg) = 10 mg/kg (eller 7,5 mg/kg) x patientens vægt (i kg) Volumen af rekonstitueret koncentrat (ml) = telavancindosis (mg)/15 (mg/ml)
English: The nosocomial pneumonia (NP) studies excluded known or suspected pulmonary disease like granulomatous diseases, lung cancer, or other malignancy metastatic to the lungs; cystic fibrosis or active tuberculosis; Legionella pneumophila pneumonia; meningitis, endocarditis, or osteomyelitis; refractory shock defined as supine systolic blood pressure <90 mm Hg for >2 hours with evidence of hypoperfusion or requirement for high-dose sympathomimetic agents.
Danish: Nokosomiel pneumoni (NP)-studierne ekskluderede kendt eller mistænkt lungesygdom som granulomatøse sygdomme, lungecancer eller andre maligne sygdomme med metastaser til lungerne, cystisk fibrose eller aktiv tuberkulose, Legionella pneumophila pneumoni, meningitis, endokarditis eller osteomyelitis, refraktært shock defineret som systolisk blodtryk i liggende stilling <90 mm HG i >2 timer med evidens for hypoperfusion eller behov for højdosis sympatomimetiske stoffer.
English: No clinically significant differences in pharmacokinetics of telavancin were observed between healthy elderly and healthy young subjects.
Danish: Der er ikke observeret nogen klinisk signifikante forskelle i farmakokinetikken af telavancin hos raske ældre og raske unge forsøgspersoner.
English: For doses of 150 to 800 mg, the appropriate volume of reconstituted concentrate must be further diluted in 100 to 250 ml prior to infusion.
Danish: Til doser på 150 mg til 800 mg skal et passende volumen af det rekonstituerede koncentrat fortyndes yderligere i 100 til 250 ml før infusion.
English: These measures will help to protect the environment.
Danish: Disse reaktioner kan være livstruende.
English: If renal function markedly decreases during treatment, the benefit of continuing telavancin should be assessed.
Danish: Hvis nyrefunktionen falder drastisk under behandlingen, skal fordelene ved at fortsætte
English: The pharmacokinetics of telavancin have not been evaluated in severe hepatic impairment (Child-Pugh class C).
Danish: Telavancins farmakokinetik er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child Pugh klasse C).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 September 2011
Danish: Dato for første markedsføringstilladelse: 2. september 2011 Dato for seneste fornyelse: 26. maj 2016
English: The effect of renal impairment on the pharmacokinetics of telavancin has been evaluated in 2 clinical pharmacology studies in healthy subjects with normal renal function and subjects with mild to severe renal impairment.
Danish: Effekten af nedsat nyrefunktion på telavancins farmakokinetik er blevet evalueret i to kliniske farmakologistudier i raske forsøgspersoner med normal nyrefunktion og forsøgspersoner med mild til svær nedsat nyrefunktion.
English: No adjustment of dosage is required for patients with mild to moderate degrees of hepatic impairment (see section 4.2).
Danish: Der kræves ingen justering af dosis hos patienter med mild til moderat nedsat leverfunktion (se pkt.
English: VIBATIV is used to treat adult patients with infections of the lungs that have developed in the hospital, including patients on artificial ventilation, when these infections are known or suspected to be caused by bacteria called methicillin-resistant Staphylococcus aureus (MRSA).
Danish: VIBATIV bruges til behandling af voksne patienter med lungeinfektioner, der er udviklet på hospitalet, inklusiv patienter tilkoblet respirator, hvis det er påvist eller formodes, at disse infektioner skyldes bakterier kaldt meticillin-resistente Staphylococcus aureus (MRSA).
English: Obese patients (defined as those with BMI > 30 kg/m2) should receive telavancin at the reduced dose of 7.5 mg/kg once every 24 hours (see section 5.2).
Danish: Svært overvægtige patienter (defineret som patienter med BMI >30 kg/m²) bør have en reduceret telavancindosis på 7,5 mg/kg én gang i døgnet (se pkt.
English: Do not take any diarrhoea medicine without first checking with your doctor.
Danish: Du må ikke tage medicin mod diaré uden først at have talt med din læge om det. hvis du lider af mere end én infektion.
English: Ex vivo platelet aggregation Chromogenic factor Xa assay Functional (chromogenic) factor X assay Bleeding time
Danish: Fuldblod (Lee-White) koagulationstid Ex vivo blodpladeaggregation Kromogen faktor Xa test Funktionel (kromogen) faktor X test Blødningstid
English: Coagulation tests unaffected by telavancin
Danish: Koagulationstests upåvirket af telavancin
English: If you get any side effects, talk your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: At a dose of 10 mg/kg, mean Vss averaged between 133 (SD 24) ml/kg after multiple dosing, corresponding to a value of approximately 10 l for a 75 kg person.
Danish: Ved en dosis på 10 mg/kg svarer middel Vss på omkring 133 (SD 24) ml/kg efter gentagen dosering til en værdi på ca. 10 l for en person på 75 kg.
English: It is unknown whether telavancin is excreted in human breast milk.
Danish: Det er ukendt, om telavancin udskilles i human mælk.
English: VIBATIV will be given to you by a doctor or a nurse.
Danish: Det er normalt en læge eller en sygeplejerske, der giver dig VIBATIV.
English: The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be
Danish: Medlemsstaterne skal være enige med MAH om kommunikationsplanen for DHCP-brevet.
English: Information to be collected shall include data on renal impairment, fatal outcomes (assessed for causality), cardiac disorders, liver and hepatobiliary disorders, tinnitus and hearing loss, adherence to the SmPC and off label use.
Danish: Information som skal registreres inkluderer data vedrørende nedsat nyrefunktion, dødsfald (med vurdering af årsagssammenhæng), hjertesygdom, lever- og galdevejssygdomme, tinnitus og tab af hørelse, ved brug i henhold til præparatomtalen og ved brug udenfor indikationsområdet.
English: A retrospective, chart review, post authorisation safety study (PASS) shall be conducted with the objective to further characterise the adverse drug reaction profile of telavancin when used in the clinical setting.
Danish: Et retrospektivt studie med skematisk gennemgang af sikkerheden efter markedsføring (post authorisation safety study, PASS) skal gennemføres for yderligere, at beskrive bivirkningsprofilen for telavancin ved klinisk brug.
English: Shelf life of diluted product: Chemical and physical in use stability of the reconstituted solution and the diluted solution in the infusion bag has been demonstrated for 24 hours under refrigeration (2-8°C).
Danish: Opbevaringstid for det fortyndede produkt: Kemisk og fysisk stabilitet under brug af både den rekonstituerede opløsning og den fortyndede opløsning i infusionspose er vist at være 24 timer i køleskab (2ºC-8ºC).
English: Do not use VIBATIV after the expiry date that is stated on the label and carton after EXP: The expiry date refers to the last day of that month.
Danish: Brug ikke VIBATIV efter den udløbsdato, der står på pakningen.
English: Renal function (serum creatinine and urinary output for oliguria/anuria) should be monitored daily for at least the first 3 to 5 days of therapy and every 48 to 72 hours thereafter in all patients receiving telavancin.
Danish: Hos alle patienter, der får telavancin, bør nyrefunktionen (serumkreatinin og urinmængde for oliguri/anuri) overvåges dagligt minimum de første 3-5 dage af behandlingen og derefter hver 48.-72. time.
English: Mixing is continued until the content of the vial is completely dissolved and is free of particulate
Danish: Blanding forsætter indtil indholdet i hætteglasset er fuldstændig opløst og opløsningen ved visuel
English: Shelf life of reconstituted concentrate: The reconstituted concentrate should be diluted immediately
Danish: Opbevaringstid for rekonstitueret koncentrat: Det rekonstituerede koncentrat skal fortyndes straks
English: Telavancin is a low clearance active substance with a mean (SD) CL of 13.1 (2.0) ml/hr/kg in subjects with normal renal function, corresponding to a total CL of approximately 1 l/hr in a 75 kg subject.
Danish: Telavancin er et lav-clearance aktivt stof med en middel (SD) CL på 13,1 (2,0) ml/time/kg hos forsøgspersoner med normal nyrefunktion svarende til en total CL på ca. 1 l/time hos en person på 75 kg.
English: Caution is warranted when using telavancin to treat patients taking medicinal products known to prolong the QT interval.
Danish: Forsigtighed er berettiget, når der udskrives telavancin til patienter, der tager lægemidler, som er kendt for at forlænge QT-intervallet.
English: A dose adjustment should be made in obese patients with BMI > 30 kg/m2 (see section 4.2).
Danish: Dosis skal justeres hos svært overvægtige patienter med BMI >30 kg/m² (se pkt.
English: Each vial contains 250 mg or 750 mg telavancin (as hydrochloride).
Danish: Hvert hætteglas indeholder 250 mg eller 750 mg telavancin (som hydrochlorid).
English: Initial dose and dosage adjustments during treatment should be made based on calculated or measured creatinine clearance according to the dosing regimen in section 4.2.
Danish: Startdosis og dosisjusteringer under behandlingen bør foretages på basis af den beregnede eller målte kreatininclearance i henhold til doseringsregimet i pkt.
English: For instructions on reconstitution and dilution, see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding se pkt.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke blandes med andre præparater end dem, som er nævnt i pkt.
English: In the liver, treatment for 13 weeks or longer resulted in reversible degeneration/necrosis of hepatocytes accompanied by elevations in serum AST and ALT in rats and dogs.
Danish: I leveren observeredes reversibel degenerering/nekrose af hepatocytter efter en behandlingsperiode på 13 uger eller længere, hvilket var forbundet med øget serum-AST og -ALT hos rotter og hunde.
English: Rapid intravenous infusions of antimicrobial agents of the class of glycopeptides have been associated with red man syndrome-like reactions, including flushing of the upper body, urticaria, pruritus or rash (see section 4.8).
Danish: Hurtige intravenøse infusioner med antimikrobielle stoffer af glycopeptidklassen er blevet associeret med ”red man syndrome”-lignende reaktioner, herunder rødme af overkroppen, urticaria, kløe eller hududslæt (se pkt.
English: In the absence of compatibility studies, this medicine must not be mixed with other medicines.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør denne medicin ikke
English: Despite in vitro susceptibility, there are insufficient clinical data to assess the potential for efficacy of telavancin in infections due to hGISA/GISA.
Danish: På trods af in-vitro følsomhed er der ikke tilstrækkelige kliniske data til at vurdere virkningspotentialet af telavancin ved infektioner, som er forårsaget af hGISA/GISA (heterogen glycopeptid-intermediat S. aureus/glycopeptid-intermediat S. aureus).
English: Reconstitution time is not more than 5 minutes for the vial containing 250 mg and not more than 10 minutes for the vial containing 750 mg.
Danish: Rekonstitutionstiden er normalt ikke mere end 5 minutter for hætteglasset med 250 mg, og ikke mere end 10 minutter for hætteglasset indeholdende 750 mg.
English: Therefore, the use of telavancin in patients with pre-existing acute renal failure and in patients with severe renal impairment is contraindicated (see
Danish: Derfor er brugen af telavancin kontraindiceret hos patienter med eksisterende akut nyresvigt og hos patienter med svært nedsat nyrefunktion (se pkt.
English: VIBATIV powder for concentrate for solution for infusion is provided as a 30 ml or 50 ml clear glass vial with rubber stopper, with an aluminium closure with plastic flip-off caps.
Danish: VIBATIV pulver til koncentrat til infusionsvæske, opløsning, leveres som et 30 ml eller 50 ml klart hætteglas med gummiprop og med en aluminiumsforsegling med plastik flip-off låg.
English: Shelf life of diluted product: Chemical and physical in use stability of the reconstituted solution and the diluted solution in the infusion bag has been demonstrated for 24 hours under refrigeration
Danish: Opbevaringstid for fortyndet produkt: Kemisk og fysisk stabilitet under brug af både den rekonstituerede opløsning og den fortyndede opløsning i infusionspose er vist at være 24 timer i
English: Therefore, no dose adjustment is needed in elderly patients except in those with creatinine clearance of 30-50 ml/min (see sections 4.2 and 4.3).
Danish: Derfor er en dosisjusering ikke nødvendig hos ældre patienter undtagen hos dem, der har en kreatininclearance på 30-50 ml/min (se pkt.
English: After reconstitution, each ml contains 15 mg of telavancin.
Danish: Efter rekonstitution indeholder hver ml 15 mg telavancin.
English: Powder for concentrate for solution for infusion A white to pale pink, whole or fragmented cake
Danish: En hvid til svag lyserød hel eller fragmenteret klump.
English: If you are given more VIBATIV than you should receive, the chance of experiencing the following side effects increases: disturbed taste, nausea (feeling sick), vomiting, reactions at the site of the infusion, headache, rash, skin flushing of the upper body.
Danish: Hvis du har fået mere VIBATIV, infusionsvæske, end du burde Hvis du får mere VIBATIV end du burde få, så er der en øget risiko for, at du oplever følgende bivirkninger: Smagsforstyrrelser, kvalme, opkastning, reaktioner på infusionsstedet, hovedpine, udslæt, rødmen af huden på overkroppen.
English: Patients with severe renal impairment, i.e. creatinine clearance (CrCl) <30 ml/min, including patients undergoing haemodialysis (see section 4.4).
Danish: Patienter med svært nedsat nyrefunktion, dvs. kreatininclearance (CrCL) <30ml/min, herunder patienter, som er i hæmodialyse (se pkt.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, anført i pkt.
English: Caution should be used when prescribing VIBATIV to patients receiving concomitant nephrotoxic medicines, those with pre existing renal disease or with co-morbidity known to predispose to kidney dysfunction (e.g. diabetes mellitus, congestive heart failure, hypertension).
Danish: Andre faktorer der kan forhøje risikoen for nefrotoksicitet Der skal udvises forsigtighed, når VIBATIV ordineres til patienter, som samtidig får anden nefrotoksisk medicin, patienter med eksisterende nyresygdom eller med co-morbiditet, kendt for at præ-disponere for nyredysfunktion (fx diabetes mellitus, kongestiv hjerteinsufficiens, hypertension).
English: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT
Danish: Central Park, Western Avenue Bridgend Industrial Estate
English: It is not known if telavancin passes into breast milk in humans.
Danish: Det vides ikke om telavancin udskilles i modermælken hos mennesker.
English: Reconstitution time is not more than 5 minutes for the vial containing 250 mg.
Danish: Rekonstitutionstiden er ikke mere end 5 minutter for hætteglasset med 250 mg.
English: 1 vial of 30 ml with 250 mg telavancin 1 vial of 50 ml with 750 mg telavancin
Danish: 1 hætteglas på 30 ml med 250 mg telavancin 1 hætteglas på 50 ml med 750 mg telavancin
English: The use in patients with acute renal failure or creatinine clearance (CrCl) <30 ml/min including patients undergoing haemodialysis is contraindicated (see section 4.3).
Danish: Anvendelse til patienter med akut nyresvigt eller kreatininclearance (CrCL) <30 ml/min, herunder patienter som er i hæmodialyse, er kontraindiceret (se pkt.
English: Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy.
Danish: Der er rapporteret krydsreaktivitet, inklusive anafylaksi, hos patienter med vancomycinallergi i anamnesen.
English: Therefore, caution should be exercised if telavancin is given to subjects with severe hepatic impairment.
Danish: Der bør derfor udvises forsigtighed, hvis telavancin anvendes til personer med svær nedsat leverfunktion.
English: The most commonly reported related adverse reactions (occurring in >1% of patients) were: fungal infection, insomnia, dysgeusia, headache, dizziness, nausea, constipation, diarrhoea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, pruritus, rash, renal failure acute, blood creatinine increased, urine abnormality (foamy urine), fatigue and chills.
Danish: De mest almindeligt rapporterede relaterede bivirkninger (forekommer hos >1 % af patienterne) var: svampeinfektion, søvnløshed, smagsforstyrrelser, hovedpine, svimmelhed, kvalme, forstoppelse, diarré, opkastning, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, kløe, hududslæt, akut nyreinsufficiens, forhøjet blodkreatinin, unormal urin (skummende urin), træthed og kuldegysninger.
English: Reconstitution time is not more than 10 minutes for the vial containing 750 mg.
Danish: Rekonstitutionstiden er ikke mere end 10 minutter for hætteglasset med 750 mg.
English: Therefore, no dose adjustment is necessary when administering telavancin to subjects with mild or moderate degrees of hepatic impairment.
Danish: Det er derfor ikke nødvendigt med dosisjustering, når telavancin anvendes til personer med let til moderat nedsat leverfunktion.
English: Your doctor will tell you if this is the case and may decide to monitor you more closely during treatment.
Danish: Hvis dette er tilfældet vil din læge fortælle det til dig og muligvis følge dig tæt under behandlingen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION VIBATIV 250 mg powder for concentrate for solution for infusion Each vial contains 250 mg telavancin (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING VIBATIV 250 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 250 mg telavancin (som hydrochlorid).
English: If an allergic reaction to telavancin occurs, discontinue treatment and institute appropriate therapy.
Danish: Hvis en allergisk reaktion over for telavancin forekommer, skal lægemidlet seponeres og passende behandling iværksættes.
English: Recommendations for dose adjustment can be found in section 4.2.
Danish: Anbefalinger vedrørende dosisjustering findes under pkt.
English: The following formula can be used to calculate the volume of reconstituted VIBATIV concentrate
Danish: Følgende formel kan anvendes til at beregne volumen af det rekonstituerede VIBATIV koncentrat, som er nødvendig for at tilberede en dosis:
English: Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion og anden håndtering
English: Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function (see sections 4.3 and 5.2).
Danish: Ældre patienter bør have en telavancindosis, der er justeret efter deres legemsvægt og nyrefunktion (se pkt.
English: Reconstituted concentrate must be further diluted prior to administration.
Danish: Tilberedning af færdig fortyndet opløsning til infusion Det rekonstituerede koncentrat skal fortyndes yderligere før administration.
English: The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Danish: Før brug skal pulveret rekonstitueres, og det opnåede koncentrat skal straks derefter fortyndes
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende
English: 6.6 Special precautions for disposal and other handling The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use.
Danish: Regler for destruktion og anden håndtering Før brug skal pulveret rekonstitueres og det opnåede koncentrat skal straks derefter fortyndes
English: Telavancin demonstrated efficacy against MSSA and MRSA in two randomised controlled studies in patients with nosocomial pneumonia, including ventilator-associated pneumonia, involving 751 patients who received telavancin.
Danish: Telavancin demonstrerede virkning mod methicillinfølsomme Staphylococcus aureus (MSSA) og MRSA i to randomiserede, kontrollerede studier hos patienter med nosokomiel pneumoni, herunder respiratorassocieret pneumoni.
English: An increase in the number of stillborn pups was observed in these pre- and post-natal studies (see section 4.3).
Danish: I disse præ- og postnatale studier sås et øget antal
English: Sodium hydroxide (for pH adjustment) (E524) Hydrochloric acid (for pH adjustment) (E507)
Danish: Natriumhydroxid (til pH justering) (E524)
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including telavancin (see section 4.8), and may range in severity from mild to life-threatening.
Danish: Antibiotikaassocieret colitis og pseudomembranøs colitis er blevet rapporteret med næsten alle antibakterielle lægemidler, inklusive telavancin (se pkt.
English: The mean (SD) maximum telavancin concentration (Cmax) amounts to 108 (26) µg/ml at steady state at a once daily dose of 10 mg/kg infused over a period of 1 h (tmax) and then falls to a trough value of 8.55 (2.84) µg/ml (C24h ).
Danish: Den gennemsnitlige maksimale (SD) telavancinkoncentration (Cmax) er 108 (26) µg/ml ved steady-state ved administration af en daglig dosis på 10 mg/kg indgivet over 1 time (tmax).
English: VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant
Danish: VIBATIV er indiceret til behandling af voksne med nosokomiel pneumoni (NP), herunder respiratorassocieret pneumoni, når infektionen vides eller formodes at være forårsaget af methicillinresistente Staphylococcus aureus (MRSA).
English: In healthy volunteers who received a dose of 15 mg/kg, a higher incidence of adverse reactions to telavancin was seen: dysgeusia, nausea, vomiting, injection site erythema, headache, macular rash, and red man syndrome.
Danish: Hos raske forsøgspersoner, som fik en dosis på 15 mg/kg, blev der set en højere incidens af bivirkninger forbundet med telavancin: smagsforstyrrelser, kvalme, opkastning, rødmen på injektionsstedet, hovedpine, makuløst hududslæt og ”red man syndrome”.