FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Dose is based on CrCL.
Danish: Dosen er baseret på CrCL.
English: Mix gently to reconstitute and check to see that the contents have dissolved completely.
Danish: Bland forsigtigt for at rekonstituere, og kontroller, at indholdet er fuldstændigt opløst.
English: Your doctor may increase your dose to 600 mg every 8 hours for some infections.
Danish: Lægen kan øge din dosis til 600 mg hver 8. time ved nogle infektioner.
English: ≥ 15 to ≤ 30
Danish: ≥ 15 til ≤ 30
English: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Danish: Pulveret skal rekonstitueres med vand til injektion, og det deraf resulterende koncentrat skal derefter straks fortyndes før brug.
English: Zinforo will be given to you by a doctor or nurse.
Danish: Zinforo gives til dig af en læge eller sundhedspersonalet.
English: Therefore, these findings were not considered to be adverse.
Danish: Derfor blev disse fund ikke anset som værende bivirkninger.
English: Zinforo should not be mixed with or physically added to solutions containing other drugs.
Danish: Zinforo bør ikke blandes med eller fysisk tilsættes opløsninger indeholdende andre lægemidler.
English: Limitations of the clinical data
Danish: Begrænsninger for de kliniske data
English: If the level of your red blood cells fall your doctor may check to see if these antibodies have caused this.
Danish: Hvis niveauet af dine røde blodlegemer falder, kan din læge kontrollere, om det skyldes disse antistoffer.
English: Paediatric population As with adults, the interaction potential is expected to be low in paediatrics.
Danish: Pædiatrisk population Som hos voksne forventes interaktionspotentialet at være lavt hos børn.
English: Clostridium difficile-associated disease (CDAD) and severe hypersensitivity reactions may also occur.
Danish: Clostridium difficile-associeret sygdom (CDAD) og alvorlige overfølsomhedsreaktioner kan også forekomme.
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8 °C.
Danish: Den kemiske og fysiske holdbarhed efter ibrugtagning er vist at være op til 24 timer ved 2-8°C.
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening;
Danish: Disse kan være tegn på en alvorlig allergisk reaktion (anafylaksi) og kan være livstruende.
English: • Changes in tests which measure how well your blood clots.
Danish: • Ændringer i testresultater, som skal vise, hvor let dit blod størkner.
English: This may impair your ability to drive or operate machinery.
Danish: Dette kan forringe din evne til at køre bil eller betjene maskiner.
English: The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Danish: Det samlede tidsinterval fra påbegyndt rekonstitution og til færdiggørelsen af den intravenøse infusionsvæske bør ikke overstige 30 minutter.
English: After dilution:
Danish: Efter fortynding:
English: > 30 to ≤ 50
Danish: > 30 til ≤ 50
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Anvendes det ikke med det samme, er opbevaringstid og -forhold inden anvendelse brugerens ansvar og vil normalt ikke være mere end 24 timer ved 2-8ºC, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Infusion related reactions (such as phlebitis) can be managed by prolonging the infusion duration.
Danish: Infusionsrelaterede reaktioner (såsom flebitis) kan håndteres ved at forlænge infusionsvarigheden.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Danish: • Streptococcus anginosus gruppe (inklusive S. anginosus, S. intermedius og S. constellatus)
English: There was a 33% increase in AUC0-∞ in the elderly that was mainly attributable to age-related changes in renal function.
Danish: Der var en stigning på 33 % i AUC0-∞ hos de ældre forsøgspersoner, som hovedsageligt blev tilskrevet aldersbetingede forandringer i nyrefunktionen.
English: • Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Danish: • Pludselig hævelse af læber, ansigt, hals eller tunge; et alvorligt udslæt; og synke- eller åndedrætsbesvær.
English: • Bleeding or bruising more than usual.
Danish: • Blødning eller blå mærker mere end normalt.
English: The usual recommended dose for adults is 600 mg every 12 hours.
Danish: Den normale anbefalede dosis til voksne er 600 mg hver 12. time.
English: Clostridium difficile-associated diarrhoea
Danish: Clostridium difficile-relateret diarré
English: There is limited experience in treating patients with diabetic foot infections.
Danish: Der er kun begrænset erfaring med behandling af patienter med diabetiske fodinfektioner.
English: Overall, the adverse events reported in these studies were consistent with the known safety profile for Zinforo.
Danish: Generelt var de indberettede bivirkninger i disse studier i overensstemmelse med den kendte sikkerhedsprofil for Zinforo.
English: Therefore, Zinforo should be used with caution in this patient population.
Danish: Zinforo skal derfor anvendes med forsigtighed til denne patientgruppe.
English: Staphylococcus aureus Streptococcus pneumoniae Streptococcus Groups A, B, C, G
Danish: Staphylococcus aureus Streptococcus pneumoniae Streptococcus gruppe A, B, C, G
English: • Redness, pain or swelling where the injection was given.
Danish: • Rødme, smerte eller hævelse, hvor injektionen blev givet.
English: Once removed from refrigeration to room temperature, the diluted product must be used within 6 hours.
Danish: Efter udtagning af køleskab til stuetemperatur skal det fortyndede produkt anvendes inden for 6 timer.
English: • The other ingredient is arginine.
Danish: • Øvrige indholdsstoffer: arginin.
English: From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme, med mindre rekonstitution og fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: You may experience fever, flu-like symptoms, sore throat, or any other infection which may be serious.
Danish: Du kan få feber, influenzalignende symptomer, ondt i halsen eller en anden infektion, der kan være alvorlig.
English: If a severe allergic reaction occurs during treament with Zinforo, the medicinal product should be discontinued and appropriate measures taken.
Danish: Hvis der opstår en alvorlig allergisk reaktion under behandling med Zinforo, skal lægemidlet seponeres, og der skal træffes passende forholdsregler.
English: The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Danish: De mest almindelige bivirkninger hos ≥ 3 % af de ca. 3.242 patienter, der blev behandlet med Zinforo i kliniske studier, var diarré, hovedpine, kvalme og kløe, og de var generelt milde eller moderate i sværhedsgrad.
English: However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common (18.5%).
Danish: Dog var hyppigheden af udslæt i en undergruppe af asiatiske patienter, der er blevet behandlet med Zinforo hver 8. time, meget almindelig (18,5 %).
English: For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable.
Danish: Hos patienter med supranormal renal clearance, som får standarddosen, kan en infusionstid på 60 minutter være mere hensigtsmæssig.
English: The compatibility of Zinforo with other medicines has not been established.
Danish: Zinforos kompatibilitet med andre lægemidler er endnu ikke blevet fastslået.
English: The following side effects may happen with this medicine:
Danish: Denne medicin kan have følgende bivirkninger:
English: In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Danish: I kliniske studier blev der ikke observeret tegn på hæmolyse hos patienter, som udviklede en positiv DAT ved behandlingen.
English: How Zinforo works Zinforo works by killing certain bacteria, which can cause serious infections.
Danish: Sådan virker Zinforo Zinforo virker ved at dræbe bestemte bakterier, som kan forårsage alvorlige infektioner.
English: The safety assessment in paediatric patients is based on the safety data from 2 trials in which 227 patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo.
Danish: Sikkerhedsvurderingen for pædiatriske patienter er baseret på sikkerhedsdata fra 2 studier, hvor 227 patienter i alderen fra 2 måneder til 17 år med cSSTI eller CAP fik Zinforo.
English: Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a given dose was recovered in the dialysate.
Danish: Ceftarolin kan fjernes ved hæmodialyse; efter en dialyseperiode på 4 timer blev ca. 74 % af en given dosis genfundet i dialysatet.
English: In addition, the safety assessment in neonates is based on the safety data from 2 trials in which 34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo.
Danish: Derudover er sikkerhedsvurderingen for nyfødte baseret på sikkerhedsdata fra 2 studier, hvor 34 patienter (i alderen fra fødsel til under 60 dage) fik Zinforo; 23 af disse patienter fik kun en enkelt dosis Zinforo.
English: The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions.
Danish: Farven på Zinforo infusionsvæsker spænder fra klar, lys til mørk gul, afhængigt af koncentration og opbevaringsforhold.
English: • infections of the skin and the tissues below the skin
Danish: • infektioner i huden og vævet under huden
English: • If you have had severe diarrhoea whilst taking antibiotics in the past
Danish: • hvis du tidligere har haft alvorlig diarré, mens du tog antibiotika.
English: Table 5 Frequency of adverse reactions by system organ class from clinical trials and post marketing experience
Danish: Tabel 5 Hyppighed af bivirkninger efter systemorganklasse fra kliniske forsøg og efter markedsføring
English: • Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zinforo.
Danish: • Diarré, der bliver kraftig eller ikke går væk, eller afføring, der indeholder blod eller slim under eller efter behandling med Zinforo.
English: Anaemia, leucopenia, neutropenia, thrombocytopenia, prothrombin time (PT) prolonged, activated partial thromboplastin time (aPTT) prolonged, international normalized ratio (INR) increased
Danish: Anæmi, leukopeni, neutropeni, trombocytopeni, forlænget prothrombintid (PT), forlænget aktiveret delvis tromboplastintid (aPTT), øget internationalt normaliseret ratio (INR)
English: If you have kidney problems your doctor may lower your dose because Zinforo is removed from your body by the kidneys.
Danish: Hvis du har problemer med nyrerne vil lægen muligvis reducere din dosis, fordi din krop udskiller Zinforo via nyrerne.
English: This test looks for certain antibodies which may act against your red blood cells.
Danish: Denne test kan påvise visse antistoffer, som kan ødelægge dine røde blodlegemer.
English: Relative overdosing could occur in patients with moderate renal impairment.
Danish: Relativ overdosering kan forekomme hos patienter med moderat nedsat nyrefunktion.
English: If ceftaroline is commenced before susceptibility test results are available then local information on the risk of encountering organisms that express these enzymes should be taken into consideration.
Danish: Hvis ceftarolin påbegyndes, inden der foreligger følsomhedstestresultater, bør den lokale information om risikoen ved at blive udsat for mikroorganismer, som udtrykker disse enzymer, indgå i overvejelserne.
English: • More enzymes produced by your liver (as shown in blood tests)
Danish: • Øget enzymproduktion i leveren (påvist i blodprøver)
English: Parenteral drug products should be inspected visually for particulate matter prior to administration.
Danish: Parenterale lægemidler bør efterses visuelt for partikler før indgivelse.
English: CrCL should be closely monitored and the dose adjusted according to changing renal function.
Danish: CrCL bør monitoreres tæt, og dosis justeres, hvis nyrefunktionen ændrer sig.
English: The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints for susceptibility testing are presented below.
Danish: Grænseværdierne ved følsomhedsbestemmelse i henhold til European Committee on Antimicrobial Susceptibility Testing (EUCAST) er anført nedenfor.
English: Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room temperature.
Danish: Studier har vist, at Zinforo infusionsvæsker er stabile i op til 6 timer ved stuetemperatur.
English: * Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.
Danish: * Beregnet under anvendelse af Schwartz-formlen (ml/min/1,73 m2) for pædiatriske patienter.
English: Therefore, interactions of ceftaroline with medicinal products that are substrates or inhibitors (e.g. probenecid) of these transporters would not be expected.
Danish: Derfor vil interaktioner mellem ceftarolin og lægemidler, som er substrater for eller hæmmere (f.eks. probenecid) af disse transportstoffer ikke forventes.
English: The cysts involved a small portion of the kidney and ocurred in the absence of significant changes in either renal function or urinary parameters.
Danish: Cysterne omfattede en lille del af nyren og forekom uden signifikante ændringer i hverken nyrefunktion eller urinparametre.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Organisms that express these enzymes and which are therefore resistant to ceftaroline occur at very variable rates between countries and between healthcare facilities within countries.
Danish: Mikroorganismer, der producerer disse enzymer, og som derfor er resistente over for ceftarolin, forekommer med meget varierende hyppighed i forskellige lande og i forskellige sundhedsinstitutioner inden for de enkelte lande.
English: Infer susceptibility from susceptibility to benzylpenicillin.
Danish: Udledt følsomhed fra følsomhed over for benzyl-penicillin
English: Total volume
Danish: Samlet mængde
English: A 250 mL, 100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Danish: Der kan anvendes en 250 ml-, 100 ml- eller 50 ml-infusionspose til at klargøre infusionen, alt efter patientens volumenbehov.
English: As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with Zinforo's antibacterial profile.
Danish: For en sikkerheds skyld bør Zinforo undgås under graviditet, medmindre kvindens kliniske tilstand kræver behandling med et antibiotikum med Zinforos antibakterielle profil.
English: Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse reactions as observed in the patients receiving recommended dosages.
Danish: En begrænset mængde data fra patienter, som fik højere doser af Zinforo end anbefalet, viser tilsvarende bivirkninger, som blev observeret hos patienter, der fik de anbefalede doser.
English: After reconstitution: The reconstituted vial should be diluted immediately.
Danish: Efter rekonstitution: Det rekonstituerede hætteglas skal fortyndes med det samme.
English: Clinical efficacy against specific pathogens
Danish: Klinisk effekt mod specifikke patogener
English: It belongs to a group of medicines called ‘cephalosporin antibiotics.'
Danish: Det tilhører en gruppe af lægemidler kaldet "cefalosporin-antibiotika".
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI02
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, andre cefalosporiner og penemer, ATC-kode: J01DI02
English: Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure.
Danish: Samlet set blev der ikke observeret skadelige virkninger på fertilitet eller den postnatale udvikling hos rotter ved eksponeringer på op til 5 gange den observerede kliniske eksponering.
English: Patients experiencing anaemia during or after treatment with Zinforo should be investigated for this possibility.
Danish: Patienter, der udvikler anæmi under eller efterbehandlingen med Zinforo, bør derfor undersøges for denne risiko.
English: It is given as a drip into a vein lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose.
Danish: Den gives gennem et drop i en blodåre over 5 til 60 minutter, hvis du får den sædvanlige dosis, eller 120 minutter, hvis du får en højere dosis.
English: You may get another infection caused by another bacteria during or following treatment with Zinforo.
Danish: Du har risiko for at få en anden infektion forårsaget af en anden bakterie under eller efter behandlingen med Zinforo.
English: ACS Dobfar S.p.A. Nucleo Industriale S. Atto 64100 Teramo Italy
Danish: Nucleo Industriale S. Atto 64100 Teramo Italien
English: As with other beta-lactam antimicrobial agents, the percent time above the minimum inhibitory concentration (MIC) of the infecting organism over the dosing interval (%T > MIC) has been shown to be the parameter that best correlates with the efficacy of ceftaroline.
Danish: Som med andre antimikrobielle beta-laktamer er den procentvise tid over den mindste hæmmende koncentration (MIC) for den inficerende organisme over doseringsintervallet (%T > MIC) vist at være den parameter, som korrelerer bedst med virkningen af ceftarolin.
English: Biochemical studies have shown that ceftaroline has high affinity for PBP2a of methicillin-resistant Staphylococcus aureus (MRSA) and PBP2x of penicillin non-susceptible Streptococcus pneumoniae (PNSP).
Danish: Biokemiske studier har vist, at ceftarolin har en høj affinitet til PBP2a fra methicillin-resistente Staphylococcus aureus (MRSA) og PBP2x fra ikke-penicillinfølsomme Streptococcus pneumoniae (PNSP).
English: However, when ceftaroline was administered throughout pregnancy and lactation, there was no effect on pup weight or growth.
Danish: Når ceftarolin blev administreret under graviditet og dieperioden, forekom der dog ingen virkninger på afkommets vægt eller vækst.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zinforo therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Zinforo seponeres/undgås, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.5 hours.
Danish: Den gennemsnitlige terminale eliminationshalveringstid af ceftarolin hos raske voksne er cirka 2,5 timer.
English: Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.
Danish: Dosisanbefalingerne til nyfødte, spædbørn og børn og unge er baseret på farmakokinetiske (PK)-modeller.
English: • Pain and irritation of the veins
Danish: • Smerte og irritation i blodårerne
English: 60/every 8 hours
Danish: 60/hver 8. time
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zinforo.
Danish: Hvis noget af ovenstående gælder for dig (eller du ikke er sikker), så tal med din læge eller sundhedspersonalet, før du bruger Zinforo.
English: Furthermore, in vivo micronucleus assays in rat and mouse were negative.
Danish: Desuden var in vivo-mikronukleustest på rotter og mus negative.
English: • an infection of the lungs called ‘pneumonia'
Danish: • en infektion i lungerne kaldet "lungebetændelse"
English: Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and OAT3) in vitro.
Danish: Ceftarolin er hverken et substrat for eller en hæmmer af transportstofferne for optagelse i nyrerne (OCT2, OAT1 og OAT3) in vitro.
English: Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations.
Danish: Dyreforsøg udført på rotter og kaniner viser ingen skadelige virkninger med hensyn til reproduktionstoksicitet ved doser svarende til terapeutiske koncentrationer.
English: You may develop an abnormal lab test (called Coombs test) that looks for certain antibodies which may act against your red blood cells.
Danish: Du kan få et unormalt resultat for en laboratorietest (kaldet Coombs test), der kan påvise visse antistoffer, som kan ødelægge dine røde blodlegemer.
English: Zinforo may cause side effects such as dizziness.
Danish: Zinforo kan give bivirkninger såsom svimmelhed.
English: • A decrease in the total number of white blood cells, ora certain type of white blood cells in your blood (leucopenia and neutropenia).
Danish: • En nedsættelse af det samlede antal hvide blodlegemer eller af visse typer af hvide blodlegemer i dit blod (leukopeni og neutropeni).
English: In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents (e.g. amikacin, azithromycin, aztreonam, daptomycin, levofloxacin, linezolid, meropenem, tigecycline, and vancomycin).
Danish: In vitro-studier har ikke påvist nogen antagonisme mellem ceftarolin i kombination med andre almindeligt anvendte antibakterielle midler (f.eks. amikacin, azithromycin, aztreonam, daptomycin, levofloxacin, linezolid, meropenem, tigecyklin og vancomycin).
English: There are no or limited amount of data from the use of ceftaroline fosamil in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om anvendelse af ceftarolinfosamil til gravide kvinder.
English: Ceftaroline is primarily eliminated by the kidneys.
Danish: Ceftarolin elimineres hovedsageligt via nyrerne.
English: Aseptic technique must be followed in preparing the infusion solution.
Danish: Aseptisk teknik skal følges ved fremstillingen af infusionsvæsken.
English: Amount to be withdrawn
Danish: Mængde, der skal tappes
English: It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk.
Danish: Det vides ikke, om ceftarolinfosamil eller ceftarolin udskilles i human mælk.