FrancophonIA/ELRC3.0 huggingface dataset:
English: - Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information).
Danish: - Patienter, som behandles med Cubicin, kan af og til få ømme, smertende eller svage muskler (se under punkt 4 i denne indlægsseddel for yderligere information).
English: In animal models AUC/MIC and Cmax/MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human adult doses of 4 mg/kg and 6 mg/kg once daily.
Danish: I dyrestudier korrelerer AUC/MIC og Cmax/MIC med virkning og forudsagt bakteriedrab in vivo ved enkeltdoser, der er ækvivalente til humane voksendoser på 4 mg/kg og 6 mg/kg en gang dagligt.
English: The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4).
Danish: De anbefalede doseringer bør anvendes hos ældre patienter, medmindre der foreligger svært nedsat nyrefunktion (se ovenfor og pkt.
English: Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Danish: Samtidig administration af probenecid og daptomycin har ingen effekt på daptomycins farmakokinetik hos mennesker, hvilket tyder på minimal eller ingen tubulær sekretion af daptomycin.
English: Cubicin vials are for single-use only.
Danish: Cubicin hætteglas er kun til engangsbrug.
English: In the paediatric SAB study, the mean duration of IV Cubicin was 12 days, with a range of 1 to 44 days.
Danish: I SAB-studiet med pædiatriske patienter var den gennemsnitlige varighed af intravenøst Cubicin 12 dage med et interval på 1 til 44 dage.
English: Cubicin given as 2-minute intravenous injection (adult patients only) Water should not be used for reconstitution of Cubicin for intravenous injection.
Danish: Cubicin givet som 2 minutters intravenøs injektion (kun voksne patienter) Vand må ikke anvendes til rekonstitution af Cubicin til intravenøs injektion.
English: Clostridium difficile-associated diarrhoea (CDAD) has been reported with Cubicin (see section 4.8).
Danish: Clostridium difficile-associeret diarré (CDAD) er blevet rapporteret under brugen af Cubicin (se pkt.
English: The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper.
Danish: Flip-off låget af polypropylen skal fjernes, så gummiproppens midte kan ses.
English: The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section 4.4).
Danish: Muligheden for fejlagtige resultater kan minimeres ved at tage prøverne til PT- eller INR-analysen nær tidspunktet for laveste daptomycin-plasmakoncentration (se pkt.
English: Among these failures six patients treated with Cubicin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Danish: Blandt disse fejlslagne behandlinger var 6 Cubicinbehandlede patienter og 1 vancomycin-behandlet patient inficeret med Staphylococcus aureus, som udviklede tiltagende MICer på eller efter behandling (se ”Resistensmekanisme” ovenfor).
English: Expel air, large bubbles, and any excess solution in order to obtain the required dose.
Danish: Fjern luft, store luftbobler og eventuel overskydende opløsning for at få den korrekte dosis.
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Danish: Administration af daptomycin som en 2 minutters intravenøs injektion viste også dosis-proportionel farmakokinetik i det godkendte doseringsinterval på 4 til 6 mg/kg.
English: Cubicin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Danish: Cubicin bør kun administreres til sådanne patienter, hvis det forventes, at den kliniske fordel opvejer den potentielle risiko.
English: The dosage regimen for Cubicin in paediatric patients with renal impairment has not been established.
Danish: Doseringsregimet for Cubicin hos pædiatriske patienter med nedsat nyrefunktion er ikke fastlagt.
English: However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in adult patients taking one of these medicinal products at the same time as Cubicin.
Danish: Der opstod dog nogle tilfælde med markante stigninger i CK-værdier og tilfælde med rabdomyolyse hos voksne patienter, som indtog et sådant lægemiddel samtidig med Cubicin.
English: Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Danish: Sikkerhedsmarginer for perifere nervevirkninger i rotter og hunde er henholdsvis 8 til 6 gange større, baseret på sammenligning af Cmax-værdier ved NOEL (No Observed Effect Level) med Cmax opnået ved dosering med 30 minutters infusion af 6 mg/kg en gang dagligt hos patienter med normal nyrefunktion.
English: Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness.
Danish: Du skal med det samme fortælle det til en læge, hvis du får uforklarlige muskelsmerter, -ømhed ellersvaghed.
English: Rates (95% CI)
Danish: (95% KI)
English: - Known or suspected RIE due to Staphylococcus aureus: Cubicin 6 mg/kg is administered once every 24 hours.
Danish: - Kendt eller mistænkt RIE som følge af Staphylococcus aureus: Cubicin 6 mg/kg administreres en gang i døgnet.
English: - cSSTI with concurrent SAB: Cubicin 6 mg/kg is administered once every 24 hours.
Danish: - cSSTI med samtidig SAB: Cubicin 6 mg/kg administreres en gang i døgnet.
English: Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Danish: Nedsat appetit, hyperglykæmi, forstyrrelse i elektrolytbalancen
English: Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Danish: Alle muskelforandringer, inklusive mikroskopiske forandringer, var fuldt reversible inden for 1 til 3 måneder efter seponering af dosis afhængig af studiets varighed.
English: Relative to non-obese subjects daptomycin systemic exposure measured by AUC was about 28% higher in moderately obese subjects (Body Mass Index of 25-40 kg/m2) and 42% higher in extremely obese subjects (Body Mass Index of > 40 kg/m 2).
Danish: I forhold til ikke-adipøse patienter var daptomycins systemiske eksponering målt ved AUC ca. 28% højere hos moderat adipøse patienter (Body Mass Index på 25-40 kg/m2) og 42% højere hos ekstremt adipøse patienter (Body Mass Index på > 40 kg/m 2).
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see also section 4.5).
Danish: Interaktioner mellem lægemiddel og laboratorietest Falsk forlængelse af protrombintid (PT) og forøgelse af international normalised ratio (INR) er blevet observeret, når visse rekombinante tromboplastinreagenser er anvendt til analysen (se også pkt.
English: Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Danish: De mikroskopiske forandringer i skeletmuskulaturen var minimale (ca. 0,05% af myofibre blev påvirket) og var ved højere doser ledsaget af stigninger i CK. Der blev ikke observeret fibrose eller rabdomyolyse.
English: Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).
Danish: Fortæl det straks til en læge eller sundhedspersonalet, hvis du oplever symptomer, der tyder på en allergisk reaktion, såsom hvæsende vejrtrækning, vejrtrækningsbesvær, hævelser i ansigt, hals eller svælg, udslæt og nældefeber eller feber (se punkt 4 i denne indlægsseddel for mere information).
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg)
Danish: (g×timer/ml) Cmax (g/ml) Tilsyneladende t1/2 (timer) CL/vægt (ml/timer/kg)
English: Obesity In obese subjects with Body Mass Index (BMI) > 40 kg/m2 but with creatinine clearance > 70 ml/min, the AUC0-∞ daptomycin was significantly increased (mean 42% higher) compared with non-obese matched controls.
Danish: Adipositas Hos adipøse patienter med BMI (Body Mass Index) > 40 kg/m2 men med kreatininclearance > 70 ml/min, var daptomycins AUC0-∞ signifikant forøget (middelværdi 42% højere) sammenlignet med ikke-adipøse matchede kontroller.
English: Cubicin will usually be given to you by a doctor or a nurse.
Danish: Det er normalt en læge eller en sygeplejerske, der giver dig Cubicin.
English: Children and adolescents (1 to 17 years of age)
Danish: Børn og unge (1 år til 17 år)
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentrationtime curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving 12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Danish: Simulering ved hjælp af en farmakokinetisk populationsmodel viste, at AUCss (areal under kurven for koncentration over tid ved steady state) for daptomycin hos pædiatriske patienter i alderen 1 til <2 år, der fik 12 mg/kg en gang dagligt, kunne sammenlignes med AUCss hos voksne patienter, der fik 6 mg/kg en gang dagligt.
English: What you need to know before you are given Cubicin
Danish: Det skal du vide, før du begynder at få Cubicin
English: Read the package leaflet before use for directions on reconstitution.
Danish: Læs indlægssedlen inden brug for instruktion i rekonstitution.
English: There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Danish: Der er kun begrænset erfaring med samtidig administration af daptomycin og andre lægemidler, som kan udløse myopati (f.eks. HMG-CoA-reduktasehæmmere).
English: No dose adjustment is necessary when administering Cubicin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Danish: Det er ikke nødvendigt med dosisjustering, når Cubicin administreres til patienter, der har let eller moderat nedsat leverfunktion (Child-Pugh klasse B) (se pkt.
English: If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.
Danish: Anvendes opløsningen ikke med det samme, har brugeren ansvar for opbevaringsbetingelser og holdbarhed, som normalt kun er 24 timer ved 2 °C - 8 °C, medmindre rekonstitution/fortynding har fundet sted under anvendelse af kontrolleret og godkendt aseptisk teknik.
English: Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Danish: Daptomycin viste ingen mutagen eller clastogen effekt i en række in vivo og in vitro genotoksicitetstest.
English: Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
Danish: Der er blevet rapporteret om manglende effekt i daptomycin-behandlingen af enterokok-infektioner, der hovedsageligt er ledsaget af bakteriæmi.
English: The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/kg (30-minute intravenous infusion) for patients with normal renal function.
Danish: LOEL-niveauet (lowest observable effect level) for myopati i rotter og hunde fremkom ved eksponeringsværdier på 0,8 til 2,3 gange det humanterapeutiske niveau på 6 mg/kg (intravenøs infusion over 30 minutter) for patienter med normal nyrefunktion.
English: On the basis of reported adverse drug reactions, Cubicin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
Danish: På basis af rapporterede bivirkninger, kan det antages at Cubicin ikke har indflydelse på evnen til at føre bil eller betjene maskiner.
English: Cubicin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Danish: Cubicin er indiceret til behandling af følgende infektioner (se pkt.
English: Uncommon: Supraventricular tachycardia, extrasystole
Danish: Supraventrikulær takykardi, ekstrasystole
English: However, no dose adjustment is considered to be necessary based on obesity alone.
Danish: En dosisjustering baserende udelukkende på adipositas anses dog ikke for at være nødvendig.
English: Not known*: Eosinophilic pneumonia
Danish: Ikke kendt*: Eosinofil pneumoni
English: - Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).
Danish: - Voksne og pædiatriske (i alderen 1 til 17 år) patienter med Staphylococcus aureus bakteriæmi (SAB).
English: Driving and using machines Cubicin has no known effects on the ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Cubicin har ingen kendt indvirkning på evnen til at køre bil eller bruge maskiner.
English: Anaphylaxis/hypersensitivity reactions have been reported with Cubicin.
Danish: Anafylaksi/overfølsomhedsreaktioner ved brug af Cubicin har været rapporteret.
English: The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
Danish: Hætteglasset skal roteres forsigtigt for at sikre komplet gennemfugtning af pulveret og derefter hvile i 10 minutter.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Danish: Det er ikke sandsynligt, at daptomycin vil hæmme eller inducere metabolismen af lægemidler, der metaboliseres af P450-systemet.
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Danish: Nedsat nyrefunktion, inklusive nyresvigt og nyreinsufficiens, øget serum-kreatinin
English: See below for dose adjustments in patients with renal impairment.
Danish: Se nedenfor for dosisjustering hos patienter med nedsat nyrefunktion.
English: Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
Danish: Kliniske studier anvendte infusion af daptomycin til patienter over mindst 30 minutter.
English: The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed 12 hours (24 hours if refrigerated).
Danish: Den samlede opbevaringstid (rekonstitueret opløsning i hætteglas og fortyndet opløsning i infusionsbeholder) ved 25 °C må ikke overstige 12 timer (eller 24 timer ved opbevaring i køleskab).
English: Following administration of a single 4 mg/kg intravenous dose of Cubicin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age).
Danish: Efter administration af en enkelt Cubicindosis på 4 mg/kg intravenøst over 30 minutter var middeltotal-clearance af daptomycin omkring 35% lavere, og middel-AUC0-∞ var omkring 58% højere hos ældre personer (≥ 75 år) sammenlignet med raske unge personer (18 til 30 år).
English: Deep-seated infections
Danish: Dybt-siddende infektioner
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Cubicin susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle laboratorier, som forventes at udføre Cubicin-følsomhedstest, får: - Produktresumé - Information om antibiotisk følsomhedsbestemmelse
English: Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers.
Danish: I disse studier fik 1.221 forsøgspersoner en daglig dosis på 4 mg/kg, heraf var 1.108 patienter og 113 var raske frivillige.
English: Instructions for use and handling
Danish: Instruktion i brug og håndtering
English: It has been demonstrated in clinical studies that Cubicin is not effective in the treatment of pneumonia.
Danish: Kliniske studier har vist, at Cubicin ikke har effekt på pneumoni.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin.
Danish: Meget sjældne alvorlige bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter) Overfølsomhedsreaktion (alvorlig allergisk reaktion, herunder anafylaksi, angioødem, lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS)) er forekommet i nogle tilfælde under behandling med Cubicin.
English: The safety and efficacy of Cubicin in children and adolescents aged below 18 years with right-sided infective endocarditis (RIE) due to Staphylococcus aureus have not been established.
Danish: Cubicins sikkerhed og virkning hos børn og unge under 18 år med højresidig infektiøs endocarditis (RIE) som følge af Staphylococcus aureus er ikke klarlagt.
English: The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see also sections 4.4 and 5.2).
Danish: Behandlingsrespons, nyrefunktion og kreatinkinase- (CK) niveau skal monitoreres tæt hos alle patienter med nedsat nyrefunktion uanset grad (se også pkt.
English: Cubicin given as 2 -minute intravenous injection (adult patients only)
Danish: Cubicin givet som 2 minutters intravenøs injektion (kun til voksne)
English: Cubicin is available in packs containing 1 vial or 5 vials.
Danish: Cubicin fås i pakninger med 1 hætteglas eller 5 hætteglas.
English: The active substance in Cubicin powder for solution for injection or infusion is daptomycin.
Danish: Det aktive stof i Cubicin pulver til injektions- og infusionsvæske, opløsning, er daptomycin.
English: Not known*: Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling, anaphylaxis**, infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
Danish: Ikke kendt*: Overfølsomhed** manifesteret ved isolerede spontane rapporter inklusive, men ikke begrænset til angioødem, lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS), pulmonal eosinofili, vesikobulløst udslæt med involvering af slimhinder og fornemmelsen af hævelse i mund og svælg, anafylaksi**, infusionsreaktioner inklusive følgende symptomer: takykardi, hvæsende vejrtrækning, pyreksi, stivhed, systemiske hedeture, vertigo, synkope og metalsmag
English: Cubicin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin.
Danish: Cubicin bruges til behandling af infektioner i huden eller i vævene under huden hos voksne og hos børn og unge (i alderen 1 år til 17 år).
English: Based on pharmacokinetic data and modelling, the daptomycin AUC during the first day after administration of a 6 mg/kg dose to adult patients on HD or CAPD was 2-fold higher than that observed in adult patients with normal renal function who received the same dose.
Danish: Baseret på farmakokinetiske data og modellering var AUC for daptomycin i løbet af den første dag efter administration af en dosis på 6 mg/kg til voksne patienter, som fik HD eller CAPD, 2 gange højere end observeret hos voksne patienter med normal nyrefunktion, der fik den samme dosis.
English: Vigorous shaking/agitation should be avoided to prevent foaming of the product.
Danish: Det bør undgås at ryste kraftigt, så præparatet ikke skummer.
English: Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.
Danish: Din læge vil tage blodprøver, før du starter behandlingen og jævnligt under behandlingen med Cubicin for at overvåge, om dine muskler tager skade af behandlingen.
English: If this happens, tell your doctor who will decide whether you should continue the treatment.
Danish: Din læge vil beslutte, hvorvidt du skal fortsætte behandlingen.
English: 1 to <2 years (N=30)
Danish: 1 til <2 år (N=30)
English: Paediatric patients below the age of one year should not be given Cubicin due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Danish: Pædiatriske patienter under 1 år bør ikke behandles med Cubicin på grund af den potentielle risiko for virkninger på det muskulære system, det neuromuskulære system og/eller nervesystemerne (det perifere og/eller centrale), der blev observeret hos neonatale hunde (se pkt.
English: No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Danish: Køn Der er ikke observeret forskelle med hensyn til køn i daptomycins farmakokinetik.
English: Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Danish: Mindre hyppigt rapporterede, men alvorligere bivirkninger omfatter overfølsomhedsreaktioner, eosinofil pneumoni (lejlighedsvis i form af organiserende pneumoni), lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS), angioødem og rabdomyolyse.
English: Other medicines and Cubicin Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Methicillin-resistant Staphylococcus aureus (MRSA) Streptococcus pyogenes a
Danish: Methicillin-resistent Staphylococcus aureus (MRSA) Streptococcus pyogenes a
English: An adjustment of Cubicin dose interval is needed for adult patients whose creatinine clearance is < 30 ml/min (see sections 4.2 and 5.2).
Danish: Justering af Cubicins dosisinterval er nødvendig hos voksne patienter, hvis kreatininclearance er < 30 ml/min (se pkt.
English: Tell your doctor or nurse straight away if you experience any of the following symptoms: - Chest pain or tightness, - Rash with blistering, sometimes affecting the mouth and genitals, - Swelling around throat, - Rapid or weak pulse, - Wheezing, - Fever, - Shivering or trembling, - Hot flushes, - Dizziness, - Fainting, - Metallic taste.
Danish: Fortæl det straks til en læge eller sundhedspersonalet, hvis du oplever nogle af følgende symptomer: - Brystsmerter eller brystet snører sig sammen, - Udslæt med blærer, som nogle gange kan være i munden eller omkring kønsdelene, - Hævelse omkring halsen, - Hurtig eller svag puls, - Hiven efter vejret, - Feber,
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and
Danish: I alt blev 81 forsøgspersoner behandlet i studiet, inklusive 55 forsøgspersoner, som fik daptomycin og 26 forsøgspersoner, som fik standardbehandling.