FrancophonIA/ELRC3.0 huggingface dataset:
English: If CDAD is suspected or confirmed, daptomycin may need to be discontinued and appropriate treatment instituted as clinically indicated.
Danish: Hvis CDAD er under mistanke eller allerede er bekræftet, kan det være nødvendigt at seponere behandlingen med Daptomycin Hospira, og iværksætte passende kliniske tiltag.
English: Uncommon: Vaginitis
Danish: Ikke almindelig: Vaginitis
English: - New or worsening fever, cough or difficulty breathing.
Danish: - Pludselig feber eller højere feber, hoste eller vanskeligheder ved at trække vejret.
English: A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: If this happens, tell your doctor who will decide whether you should continue the treatment.
Danish: Din læge vil beslutte, om du skal forsætte behandlingen.
English: Therefore, until more experience is gained, breast-feeding should be discontinued when daptomycin is administered to nursing women.
Danish: Indtil yderligere erfaring er opnået, skal amning ophøre, når Daptomycin Hospira administreres til ammende kvinder.
English: No dose adjustment is necessary when administering daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Danish: Det er ikke nødvendigt med dosisjustering, når daptomycin administreres til patienter, der har let eller moderat nedsat leverfunktion (Child-Pugh klasse B) (se pkt.
English: Single use 10 ml type I clear glass vials with gray rubber closure and aluminium cap.
Danish: Engangshætteglas af klart type I glas med 10 ml og med grå gummiprop og låg af aluminium.
English: Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Daptomycin Hospira.
Danish: Afhængig af hvilken infektioner eller hvilke infektioner du har, vil din læge muligvis også ordinere andre antibakterielle midler, mens du er i behandling med Daptomycin Hospira.
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-behandling af enterokok-infektioner, der hovedsageligt er ledsaget af bakteriæmi.
English: This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly.
Danish: Dette bør tages i betragtning, når behandling med daptomycin initieres, og sådanne patienter bør kontrolleres mere end en gang om ugen, hvis daptomycin administreres.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Daptomycin Hospira are provided with: - Summary of Product Characteristics - Dosage card
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at udskrive/bruge Daptomycin Hospira, får: - Produktresumé - Doseringskort
English: 1 to 6 years (N=19)*
Danish: 1 til 6 år (N=19)*
English: Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with Daptomycin Hospira is initiated.
Danish: Hos patienter, der behandles med Daptomycin Hospira og warfarin, bør den antikoagulerende aktivitet kontrolleres i adskillige dage, efter behandling med Daptomycin Hospira er initieret.
English: Please inform your doctor that you are on treatment with Daptomycin Hospira.
Danish: Fortæl din læge, at du er i behandling med Daptomycin Hospira.
English: Other medicines and Daptomycin Hospira Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Daptomycin Hospira Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
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 0,8-2,3 gange det humanterapeutiske niveau på 6 mg/kg (intravenøs infusion over 30 minutter) for patienter med normal nyrefunktion.
English: See below for dose adjustments in patients with renal impairment.
Danish: Se nedenfor for dosisjustering til patienter med nedsat nyrefunktion.
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Danish: Daptomycins farmakokinetik hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) er ikke evalueret.
English: Excretion of daptomycin into milk of lactating animals has not been studied.
Danish: Udskillelse af daptomycin i modermælk hos diegivende dyr er ikke undersøgt.
English: Caution is warranted when daptomycin is co-administered with tobramycin.
Danish: Forsigtighed er påkrævet, når Daptomycin Hospira administreres i kombination med tobramycin.
English: Clostridium difficile-associated diarrhoea (CDAD) has been reported with daptomycin (see section 4.8).
Danish: Clostridium difficile-associeret diarré Clostridium difficile-associeret diarré (CDAD) er blevet rapporteret under brugen af daptomycin (se pkt.
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, f.eks. hvæsende vejrtrækning, vejrtrækningsbesvær, hævelser i ansigt, hals og svælg, udslæt og nældefeber, eller feber (se afsnit 4 i denne indlægsseddel for mere information).
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Danish: Ikke almindelig: Myositis, forhøjet myoglobin, muskelsvaghed, muskelsmerter, artralgi, forhøjet serumlaktat-dehydrogenase (LDH), muskelkramper
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, hvoraf 1.108 var patienter, og 113 var raske frivillige.
English: Daptomycin Hospira 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: Daptomycin Hospira bruges til behandling af infektioner i huden eller i vævene under huden hos voksne og hos børn og unge (i alderen 1-17 år).
English: To minimise this risk, physicians should be advised that for coagulation levels testing it is recommended to draw blood samples near the time of Daptomycin Hospira trough plasma concentration.
Danish: For at minimire risikoen skal lægerne anbefales at tage blodprøven, som skal bruges til koagulationstest, når Daptomycin Hospira-plasmakoncentrationen er på sit laveste niveau.
English: Indication cSSTI without SAB
Danish: Indikation cSSTI uden SAB
English: Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Danish: Der er blevet rapporteret om tilbagefald af eosinofil pneumoni ved reeksponering.
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
Danish: I forhold til ikke-adipøse patienter er 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 >40 kg/m 2).
English: Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with daptomycin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Danish: Patienter, som udvikler tegn eller symptomer, der kan tyde på perifer neuropati under behandling med Daptomycin Hospira, bør undersøges, og seponering af daptomycin bør overvejes (se pkt.
English: Deep-seated infections
Danish: Dybtsiddende infektioner
English: Hold the vial by the vial neck, tilt the vial and swirl vial contents until the product is completely reconstituted.
Danish: Hold hætteglasset ved hætteglassets krave, vip hætteglasset, og bevæg hætteglasset således, at indholdet hvirvles rundt, indtil produktet er helt rekonstitueret.
English: The polypropylene flip off cap should be removed to expose the central portion of the rubber stopper.
Danish: Flip off-låget af polypropylen skal fjernes, så gummiproppens midte kan ses.
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 sections 4.4 and 5.2).
Danish: Behandlingsrespons, nyrefunktion og kreatinkinase- (CK) niveauer skal monitoreres tæt hos alle patienter med nedsat nyrefunktion uanset grad (se pkt.
English: 2 to 6 years
Danish: 2-6 år
English: No dosage adjustment is necessary when administering daptomycin in patients with moderate hepatic impairment.
Danish: En dosisjustering er ikke nødvendig, når daptomycin administreres til patienter med moderat nedsat leverfunktion.
English: Daptomycin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Danish: Daptomycin Hospira bør kun administreres til sådanne patienter, hvis det forventes, at den kliniske fordel opvejer den potentielle risiko.
English: Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30-minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance (CL) decreased and systemic exposure (AUC) increased as renal function (creatinine clearance) decreased.
Danish: Efter administration af en enkelt intravenøs dosis på 4 mg/kg eller 6 mg/kg daptomycin over 30 minutter til voksne personer med forskellige grader af nedsat nyrefunktion var total-daptomycinclearance nedsat, og den systemiske eksponering (AUC) steg med faldende nyrefunktion (kreatininclearance).
English: The reconstituted solution should then be injected intravenously slowly over 2 minutes.
Danish: Den rekonstituerede opløsning skal herefter injiceres intravenøst og langsomt over 2 minutter.
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 rhabdomyolyse.
English: Comments cSSTI without SAB
Danish: Kommentarer cSSTI uden SAB
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 straks, 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 kontrollerede og validerede aseptiske forhold.
English: On the second day after administration of a 6 mg/kg dose to HD and CAPD adult patients the daptomycin AUC was approximately 1.3-fold higher than that observed after a second 6 mg/kg dose in adult patients with normal renal function.
Danish: På den anden dag efter administration af en dosis på 6 mg/kg til voksne patienter, som fik HD og CAPD, var daptomycins AUC omkring 1,3 gange højere end observeret efter den anden dosis på 6 mg/kg hos voksne patienter med normal nyrefunktion.
English: On the basis of reported adverse drug reactions, daptomycin 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 daptomycin ikke har indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: - Adult and paediatric (1 to 17 years of age) patients withStaphylococcus aureus bacteraemia (SAB).
Danish: - Voksne og pædiatriske (i alderen 1-17 år) patienter med Staphylococcus aureus bakteriæmi (SAB).
English: Following administration of a single 4 mg/kg intravenous dose of daptomycin 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 4 mg/kg intravenøs dosis daptomycin over 30 minutter var middeltotal-clearance af daptomycin ca. 35% lavere, og middel-AUC0-∞ var ca. 58% højere hos ældre personer (≥ 75 år) sammenlignet med raske unge personer (18-30 år).
English: If an allergic reaction to daptomycin occurs, discontinue use and institute appropriate therapy.
Danish: Hvis en allergisk reaktion over for Daptomycin Hospira opstår, skal behandlingen seponeres, og passende behandling initieres.
English: To minimise foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
Danish: UNDGÅ kraftigt omrystning af hætteglasset under eller efter rekonstitution for at minimere skumdannelse.
English: RIE due to Staphylococcus aureus
Danish: RIE som følge af Staphylococcus aureus
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 daptomycin.
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 Daptomycin Hospira.
English: Daptomycin is active against Gram positive bacteria only (see section 5.1).
Danish: Daptomycin er kun aktiv imod grampositive bakterier (se pkt.
English: Paediatric patients below the age of one year should not be given daptomycin 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 daptomycin på grund af den potentielle risiko for virkninger på det muskulære system, det neuromuskulære system og/eller nervesystemerne (enten det perifere og/eller det centrale), der blev observeret hos neonatale hunde (se pkt.
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 simulering 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: If this happens tell your doctor.
Danish: Fortæl det til din læge, hvis dette sker for dig.
English: Release the syringe plunger and allow the syringe plunger to equalise the pressure before removing the syringe from the vial.
Danish: Frigør sprøjtens stempel, og lad sprøjtens stempel udligne trykket, inden sprøjten fjernes fra hætteglasset.
English: Uncommon: Paraesthesia, taste disorder, tremor, eye irritation Not known*: Peripheral neuropathy**
Danish: Ikke almindelig: Paræstesier, smagsforstyrrelser, tremor, øjenirritation Ikke kendt*:
English: Anaphylaxis/hypersensitivity reactions have been reported with daptomycin.
Danish: Anafylaksi/overfølsomhedsreaktioner ved brug af daptomycin har været rapporteret.
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion
Danish: Daptomycin Hospira givet som intravenøs infusion over 30 eller 60 minutter
English: Sodium hydroxide Citric acid
Danish: Natriumhydroxid Citronsyre
English: Daptomycin should not be administered as a 2-minute injection to paediatric patients.
Danish: Daptomycin må ikke administreres som en 2-minutters injektion til pædiatriske patienter.
English: Rare: may affect up to 1 in 1,000 people - Yellowing of the skin and eyes, - Prothrombin time prolonged.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) - Gulfarvning af hud og det hvide i øjnene - Forlænget protrombintid (forlænget størkningstid af blodet).
English: Clinical studies in patients employed infusion of daptomycin over at least 30 minutes.
Danish: Kliniske forsøg anvendte infusion af daptomycin til patienter over mindst 30 minutter.
English: There was no histopathological correlation in the peripheral and central nervous system tissue, or in the skeletal muscle, at any dose level, and the mechanism and clinical relevance for the adverse clinical signs are therefore unknown.
Danish: Der var ingen histopatologisk korrelation i vævet i det perifere og centrale nervesystem eller i skeletmuskulaturen på noget dosisniveau.
English: Summary of sponsor-defined clinical outcome at TOC:
Danish: Oversigt over klinisk udfald bedømt ved sponsordefineret test-of-cure (TOC):
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes.
Danish: Hos pædiatriske patienter under 7 år, der skal have en dosis på 9-12 mg/kg, skal daptomycin administreres over 60 minutter.
English: The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin.
Danish: Det aktive stof i Daptomycin Hospira pulver til injektions-/infusionsvæske, opløsning, er daptomycin.
English: In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes.
Danish: Hos voksne patienter indgives dosis direkte ind i blodbanen (i en blodåre), enten som en infusion, der varer ca. 30 minutter, eller som en injektion, der varer ca. 2 minutter.
English: Renal impairment has been reported during treatment with daptomycin.
Danish: Der er blevet rapporteret om nedsat nyrefunktion under behandling med daptomycin.
English: Daptomycin Hospira given as 2-minute intravenous injection (adult patients only)
Danish: Daptomycin Hospira givet som 2 minutters intravenøs injektion (kun hos voksne patienter)
English: Use in elderly
Danish: Brug til ældre
English: The following have been shown to be compatible when added to Daptomycin Hospira containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Danish: Følgende har vist sig at være forligelige, når de tilsættes infusionsopløsninger, der indeholder Daptomycin Hospira: aztreonam, ceftazidim, ceftriaxon, gentamicin, fluconazol, levofloxacin, dopamin, heparin og lidokain.
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Daptomycin Hospira 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 Daptomycin Hospira-følsomhedstest, får: - Produktresumé - Information om antibiotisk følsomhedsbestemmelse
English: Therefore, it is recommended that: - Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients.
Danish: • Plasma-CK bør måles ved baseline og med regelmæssige mellemrum (mindst en gang om ugen) under hele behandlingen hos alle patienter.
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: 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: Frequency not known: frequency cannot be estimated from the available data Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.
Danish: Hyppighed ikke kendt: (Hyppigheden kan ikke estimeres ud fra forhåndenværende data) Tyktarmsbetændelse (colitis) forårsaget af antibakterielle lægemidler, herunder pseudomembranøs colitis (alvorlig eller vedvarende diarré, der indeholder blod og/eller slim, og er forbundet med mavesmerter eller feber), nemt ved at få blå mærker, blødning fra tandkødet eller næseblod.
English: No clinical data on fertility are available for daptomycin.
Danish: Der foreligger ingen kliniske data på fertilitet for daptomycin.
English: A Phase 4 study (DAP-PEDBAC-11-02) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with SAB. Daptomycin pharmacokinetics inpatients in this study are summarized in Table 3.
Danish: Et fase 4-studie (DAP-PEDBAC-11-02) blev udført for at vurdere daptomycins sikkerhed, virkning og farmakokinetik hos pædiatriske patienter (1-17 år, inklusive) med SAB. Daptomycins farmakokinetik hos patienter i dette studie er opsummeret i tabel 3.
English: Renal impairment Daptomycin is eliminated primarily by the kidney.
Danish: Nedsat nyrefunktion Daptomycin elimineres primært via nyrerne.
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDBAC-11-02) with bacteraemia caused by Staphylococcus aureus.
Danish: Daptomycins sikkerhed og virkning blev evalueret hos pædiatriske patienter i alderen 1-17 år (studie DAP-PEDBAC-11-02) med bakteriæmi forårsaget af Staphylococcus aureus.
English: Daptomycin is excreted primarily by the kidneys.
Danish: Daptomycin udskilles primært via nyrerne.
English: Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry (perform the same for the sodium chloride solution vial, if applicable).
Danish: Tør toppen af gummiproppen af med en spritserviet eller et andet desinfketionsmiddel og lad den tørre (foretag det samme med hætteglasset med natriumchloridopløsning, hvis relevant).
English: Caution is advised when administering daptomycin to patients who already have some degree of renal impairment (creatinine clearance <80 ml/min) before commencing therapy with Daptomycin Hospira.
Danish: Der bør udvises forsigtighed, når daptomycin administreres til patienter, som allerede har en vis grad af nedsat nyrefunktion (kreatininclearance <80 ml/min.