natgillin/translations-raw huggingface dataset:
De mest almindelige bivirkninger ved Cubicin (som ses hos flere end 1 ud af 10 patienter) er vampeinfektioner (skimmelsvamp og gær), hovedpine, kvalme, opkastninger, diarré forårsaget af svampe (hovedpine, kvalme eller opkastning, diarre, udslæt, reaktioner på infusionsstedet, unormale leverprøver og forhøjede blodkoncentrationer af et enzym kaldet CPK (som er en markør for muskelskader.
The most common side effects with Cubicin (seen in more than 1 patient in 10) are infections caused by fungi (moulds and yeasts), headache, nausea (feeling sick), vomiting, diarrhoea, rash, infusion site reactions, abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage).
Den fuldstændige liste over alle indberettede bivirkninger ved Cubicin fremgår af indlægssedlen.
For the full list of all side effects reported with Cubicin, see the Package Leaflet.
Cubicin må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for daptomycin eller det andet indholdsstof (natriumhydroxid).
Cubicin should not be used in people who may be hypersensitive (allergic) to daptomycin or the other ingredient (sodium hydroxide).
Cubicin skal udvises forsigtighed, hvis det gives til patienter med nyreproblemer, og dosis skal muligvis reduceres.
Caution is needed when it is given to patients with kidney problems and the dose may need to be reduced.
Alle patienter skal regelmæssigt have målt deres CPK- niveau, især hvis de har kendte risikofaktorer for muskelskader.
All patients must have their CPK levels measured at regular intervals, particularly if they have any known risk factors for muscle damage.
Den fuldstændige liste over forholdsregler fremgår af indlægssedlen.
For the full list of precautions, see the Package Leaflet.
Hvorfor blev CUBICIN godkendt?
Why has Cubicin been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Cubicin er større end risiciene ved behandling af voksne med komplicerede infektioner i hud eller blødt væv og højresidig infektiøs endocarditis og med bakteriæmia forårsaget af Staphylococcus aureus i tilknytning til en af disse infektioner Udvalget anbefalede udstedelse af markedsføringstilladelse for Cubicin.
The Committee recommended that Cubicin be given marketing authorisation.
Hvilke foranstaltninger skal der træffes for at sikre risikofri anvendelse af Cubicin?
Which measures are being taken to ensure the safe use of Cubicin?
Firmaet, som fremstiller Cubicin skal foretage yderligere undersøgelser af Cubicin for at se nærmere på, om det har en effekt på musklen, og for at undersøge lægemidlets sikkerhed og effekt hos patienter med nyresygdom og hos ældre.
The company that makes Cubicin will carry out further studies with Cubicin to investigate whether it has an effect on the muscle, and to look at its safety and effectiveness in patients with kidney disease and in the elderly.
Andre oplysninger om CUBICIN:
Other information about Cubicin:
Europa- Kommissionen udstedte en markedsføringstilladelse for Cubicin med gyldighed i hele Den Europæiske Union den 23. januar 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 23 January 2006.
Indehaveren af markedsføringstilladelsen er Novartis Europharm Limited.
The marketing authorisation holder is Novartis Europharm Limited.
Den fuldstændige EPAR for Cubicin findes her.
The full EPAR for Cubicin can be found here.
Dette sammendrag blev sidst ajourført i 08- 2007
This summary was last updated in 08-2007.
EU- nummer
Content
Hætteglas
Intravenous use
1 hætteglas
10 ml (50 mg/ ml)** 1 vial
* En koncentration på 50 mg/ ml opnås ved rekonstitution med 7 ml natriumklorid (0, 9%) injektionsvæske eller vand til injektion. ** En koncentration på 50 mg/ ml opnås ved rekonstitution med 10 ml natriumklorid (0, 9%) injektionsvæske eller vand til injektion.
* following reconstitution: with 7 ml of 0.9% sodium chloride or water for injection ** following reconstitution: with 10 ml of 0.9% sodium chloride or water for injection
Cubicin 350 mg pulver til koncentrat til infusionsvæske, opløsning
Cubicin 350 mg powder for concentrate for solution for infusion
1 ml indeholder 50 mg daptomycin efter rekonstitution med 7 ml natriumkloridopløsning 9 mg/ ml (0, 9%) eller med vand til injektion.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ ml (0.9%) solution or water for injections.
Et lysegult til let brunt lyofilisat.
A pale yellow to light brown lyophilised powder.
4. 4 og 5. 1).
Cubicin is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1).
- Komplicerede hud - og bløddelsinfektioner (cSSTI).
- Complicated skin and soft-tissue infections (cSSTI).
- Højresidigt smitsom endocarditis (RIE) som følge af Staphylococcus aureus.
- Right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
Beslutningen om
It is recommended that
at anvende daptomycin bør tage højde for organismens antibakterielle følsomhed og bør være baseret på ekspert- rådgivning.
the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.
4. 4 og 5. 1.
See sections 4.4 and 5.1.
- Staphylococcus aureus bakteriæmi (SAB), hvis det er associeret med RIE eller med cSSTI.
- Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.
5. 1).
Daptomycin is active against Gram positive bacteria only (see section 5.1).
I blandede infektioner, hvor der er mistanke om både Gram- negative og/ eller visse typer anaerobe bakterier, bør Cubicin administreres sammen med et eller flere hensigtsmæssige antibakterielle lægemidler.
In mixed infections where Gram negative and/ or certain types of anaerobic bacteria are suspected, Cubicin should be co- administered with appropriate antibacterial agent(s).
- cSSTI uden samtidig Staphylococcus aureus bakteriæmi:
- cSSTI without concurrent Staphylococcus aureus bacteraemia:
Den anbefalede dosis er 4 mg/ kg
The recommended dose is
5. 1).
4 mg/ kg administered once every 24 hours for 7-14 days or until the infection is resolved (see section 5.1).
- cSSTI med samtidig Staphylococcus aureus bakteriæmi:
- cSSTI with concurrent Staphylococcus aureus bacteraemia:
Den anbefalede dosis er 6 mg/ kg
The recommended dose is 6 mg/ kg
administreret én gang i døgnet.
administered once every 24 hours.
Se nedenfor for dosisjusteringer hos patienter med nyreinsufficiens.
See below for dose adjustments in patients with renal insufficiency.
- Kendt eller mistænkt højresidigt smitsom endocarditis som følge af Staphylococcus aureus:
- Known or suspected right-sided infective endocarditis due to Staphylococcus aureus:
anbefalede dosis er 6 mg/ kg administreret én gang i døgnet.
recommended dose is 6 mg/ kg administered once every 24 hours.
Nyreinsufficiens Daptomycin elimineres primært via nyrerne.
Renal insufficiency Daptomycin is eliminated primarily by the kidney.
2 Da der er begrænset klinisk erfaring (se tabel og fodnoter nedenfor), bør Cubicin kun anvendes til patienter med nyreinsufficiens af enhver grad (kreatininclearance < 80 ml/ min), når den forventede kliniske fordel opvejer den potentielle risiko.
2 Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal insufficiency (Cr Cl < 80 ml/ min) when it is considered that the expected clinical benefit outweighs the potential risk.
4. 4 og 5. 2).
The response to treatment and renal function should be closely monitored in all patients with some degree of renal insufficiency (see also sections 4.4 and 5.2).
Dosisjusteringer hos patienter med nyreinsufficiens afhængig af indikation og kreatininclearance
Dose adjustments in patients with renal insufficiency by indication and creatinine clearance
Indikation (1) cSSTI uden S. aureus
Indication for use (1) cSSTI without S.
Kreatininclearance( 1)
Creatinine clearance (1)
Dosisanbefaling (1)
Dose recommendation (1)
bakteriæmi
aureus bacteraemia
4 mg/ kg én gang daglig
4 mg/ kg once daily
5. 1
See section 5.1
4 mg/ kg hver 48 timer
mg/ kg every 48 hours
RIE eller cSSTI
RIE or cSSTI
associeret med S. aureus bakteriæmi
associated with S. aureus bacteraemia
6 mg/ kg én gang daglig
6 mg/ kg once daily
4. 4 og 5. 2).
(1) The safety and efficacy of the dose interval adjustment has not been clinically evaluated and the recommendation is based on pharmacokinetic modelling data (see sections 4.4 and 5.2).
(2) Den samme dosisjustering, der er baseret udelukkende på modellering, anbefales hos patienter, der får hæmodialyse eller kontinuerlig ambulant peritonaldialyse (CAPD).
(2) The same dose adjustments, which are also based solely on modelling are recommended for patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
5. 2).
Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
(3) Der er utilstrækkelig data til at støtte dosisanbefalinger for patienter med RIE eller cSSTI associeret med Staphylococcus aureus bakteriæmi, der har en kreatininclearance < 50 ml/ min.
(3) There are insufficient data to support a dose recommendation for patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia who have a creatinine clearance < 50 ml/ min.
Der er ingen data tilgængelig til at understøtte effekten af 4 mg/ kg daglig hos patienter med RIE eller cSSTI associeret med Staphylococcus aureus bakteriæmi, der har en kreatininclearance mellem 30- 49 ml/ min eller til at understøtte brugen af 4 mg/ kg hver 48 timer i sådanne patienter, der har kreatininclearance < 30 ml/ min.
There are no data available to support the efficacy of 4 mg/ kg daily in patients with RIE or cSSTI associated with Staphylococcus aureus bacteraemia whose creatinine clearance is between 30-49 ml/ min or to support the use of 4 mg/ kg every 48 hours in such patients whose creatinine clearance is < 30 ml/ min.
5. 2).
Hepatic insufficiency No dose adjustment is necessary when administering Cubicin to patients with mild or moderate hepatic insufficiency (Child-Pugh Class B) (see section 5.2).
Der foreligger ingen data for patienter med svær leverinsufficiens (Child- Pugh klasse C).
No data are available in patients with severe hepatic insufficiency (Child-Pugh Class C).
Ældre patienter De anbefalede doseringer bør anvendes hos ældre patienter, med mindre der foreligger svær nyreinsufficiens (se ovenfor og pkt.
Elderly patients The recommended doses should be used in elderly patients except those with severe renal insufficiency (see above and section 4.4).
Der foreligger dog kun begrænset data om sikkerhed og effekt af daptomycin hos patienter over 65 år, og der bør derfor udvises forsigtighed, hvis Cubicin administreres til sådanne patienter.
However, there are limited data on the safety and efficacy of daptomycin in patients aged > 65 years and caution should be exercised if Cubicin is given to such patients.
Børn og unge (under 18 år) Cubicin bør ikke anvendes til børn og unge (under 18 år) p. g. a. utilstrækkelig dokumentation for sikkerhed og virkning.
Children and adolescents (< 18 years old) Due to the lack of data on safety and efficacy Cubicin is not recommended for use in children and adolescents (< 18 years of age).
5. 2.
See also section 5.2.
6. 6) over et tidsrum på 30 minutter.
Method of administration Cubicin is given by intravenous infusion (see section 6.6) and administered over a 30 minute period.
4. 3 Kontraindikationer
3 4.3 Contraindications
Overfølsomhed over for det aktive stof eller over for hjælpestoffet.
Hypersensitivity to the active substance or excipient.
3 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
Hvis et infektionsfokus udover CSSTI eller RIE identificeres efter initieringen af Cubicin- behandling, bør det overvejes om der skal startes alternativ antibakteriel behandling, som har vist effekt i behandlingen af den specifikke tilstedeværende type infektion( er).
If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Kliniske undersøgelser har vist, at Cubicin ikke har effekt i behandlingen af pneumoni.
It has been demonstrated in clinical studies that Cubicin is not effective in the treatment of pneumonia.
5. 1).
Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 patients (see “ Information from clinical trials” in section 5.1).
Hos patienter med prostetiske hjerteklapper eller venstresidigt smitsom endocarditis som følge af Staphylococcus aureus er effekten af Cubicin ikke blevet vist.
The efficacy of Cubicin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Patienter med dybt- siddende infektioner bør få foretaget ethvert nødvendigt kirurgisk indgreb (f. eks. oprensning, fjernelse af proteser, kirurgisk udskiftning af hjerteklappen) uden forsinkelse.
Patients with deep-seated infections should receive any required surgical interventions (e. g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Desuden er der ikke blevet fastlagt nogen dosisregimer for daptomycin, som vil være passende til behandlingen af enterokok- infektioner med eller uden bakteriæmi.
In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Der er blevet rapporteret om manglende effekt i daptomycin- behandlingen af entekok- infektioner, der hovedsageligt er ledsaget af bakteriæmi.
Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
5. 1).
In some instances treatment failure has been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin (see section 5.1).
4. 5, 4. 8 og 5. 3).
Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/ or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with Cubicin (see also sections 4.5, 4.8 and 5.3).
I kliniske undersøgelser forekom markante stigninger i plasma- CPK til > 5 x den øvre grænse for normalværdi (Upper Limit of Normal, ULN) uden muskelsymptomer hyppigere hos patienter, der blev behandlet med Cubicin, (1, 9%) end hos dem, der blev behandlet med sammenligningspræparater (0, 5%).
In clinical studies, marked increases in plasma CPK to > 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated patients (1.9%) than in those that received comparators (0.5%).
Følgende anbefales derfor: • Plasma- CPK bør måles ved baseline og i regelmæssige intervaller (mindst én gang om ugen) under hele behandlingen hos alle patienter. • Det kan ikke udelukkes, at patienter, hvis CPK- værdi overstiger 5 gange den øvre grænse for normalværdi ved baseline, kan have større risiko for yderligere stigninger under behandlingen med daptomycin.
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. • It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
Dette bør tages i betragtning, når behandling med daptomycin initieres, og sådanne patienter bør overvåges mere end én gang om ugen, hvis daptomycin administreres. • CPK bør måles mere end én gang om ugen hos patienter, som har større risiko for at udvikle myopati.
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. • CPK should be measured more frequently than once weekly in patients who are at higher risk of developing myopathy.
4. 2), og for patienter, som indtager andre lægemidler, der er kendt for at blive associeret med myopati (f. eks.
These patients include those with severe renal insufficiency (creatinine clearance < 30 ml/ min; see also section 4.2) and patients taking other medications known to be associated with myopathy (e. g.
HMG- CoA reduktase hæmmere, fibrater og ciclosporin). • Cubicin bør ikke administreres til patienter, som tager andre lægemidler associeret med myopati, medmindre fordelen for patienten anses for at opveje risikoen. • Patienterne bør undersøges regelmæssigt under behandlingen for alle tegn og symptomer, der kan tyde på myopati. • Alle patienter, der udvikler uforklarlige muskelsmerter, - ømhed, - svaghed eller - kramper bør have overvåget CPK- værdierne hver anden dag.
HMG-CoA reductase inhibitors, fibrates and ciclosporin). • Cubicin should not be administered to patients who are taking other medications associated with myopathy unless it is considered that the benefit to the patient outweighs the risk. • Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy. • Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Cubicin bør seponeres, hvis der foreligger uforklarlige muskelsymptomer, og CPK- værdien bliver større end 5 gange den øvre grænse for normalværdi.
Cubicin should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
4. 8 og 5. 3).
4 Peripheral Neuropathy Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with Cubicin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
Nyreinsufficiens Der er blevet rapporteret om nyreinsufficiens under behandling med Cubicin.
Renal Insufficiency Renal insufficiency has been reported during treatment with Cubicin.
Svær nyreinsufficiens kan i sig selv prædisponere for øgede daptomycinniveauer, som kan øge risikoen for, at der udvikles myopati (se ovenfor).
Severe renal insufficiency may in itself also pre-dispose to elevations in daptomycin levels which may increase the risk of development of myopathy (see above).
4. 2 og 5. 2).
Dose adjustment is needed for patients with cSSTI without bacteraemia whose creatinine clearance is < 30 ml/ min (see sections 4.2 and 5.2).
4. 2 er baseret på farmakokinetisk modellering og er endnu ikke evalueret klinisk.
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on pharmacokinetic modelling and have not been clinically evaluated.
Derudover er der ingen data, der understøtter anvendelsen af 6 mg/ kg daptomycin én gang daglig til patienter med RIE eller med cSSTI associeret med bakteriæmi, hvis kreatininclearance er < 50 ml/ min.
In addition there are no data to support the use of 6 mg/ kg daptomycin once daily in patients with RIE or with cSSTI associated with bacteraemia whose creatinine clearance is < 50 ml/ min.
Der bør udvises forsigtighed, når Cubicin administreres til patienter, som allerede har en vis grad af nyreinsufficiens (kreatininclearance < 80 ml/ min), før behandlingen med Cubicin indledes.
Caution is advised when administering Cubicin to patients who already have some degree of renal insufficiency (creatinine clearance < 80 ml/ min) before commencing therapy with Cubicin.
5. 2).
Regular monitoring of renal function is advised (see also section 5.2).
4. 5).
In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient’ s pre-existing renal function (see also section 4.5).
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.
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.
5. 2).
However, there is currently no evidence that a dose reduction is required (see section 5.2).
Brug af antibiotika kan forårsage overvækst af ikke- følsomme mikroorganismer.
The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms.
Hvis der opstår en superinfektion under behandlingen, bør der træffes hensigtsmæssige foranstaltninger.
If superinfection occurs during therapy, appropriate measures should be taken.
Alvorligheden kan være fra mild til livstruende.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening.
Det er derfor vigtigt at tage denne diagnose i betragtning, hvis en patient fremstår med diarré under eller kort tid efter behandlingen.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or shortly following treatment.
Daptomycin undergår kun en lille til slet ingen cytokrom P450 (CYP450) medieret metabolisme.
Daptomycin undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
I in vitro- undersøgelser blev det fastslået, at daptomycin hverken hæmmer eller fremkalder klinisk signifikant aktivitet i humane CYP- isoformer (lA2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4).
In vitro studies have determined that daptomycin does not inhibit or induce the activities of clinically significant human CYP isoforms (1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4).
CYP450 - relaterede lægemiddelinteraktioner forventes derfor ikke.
Therefore, no CYP450-related drug interactions are to be expected.
Der er kun begrænset erfaring med samtidig administration af daptomycin og andre lægemidler, som kan udløse myopati.
There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy.
Der opstod dog nogle tilfælde med markante stigninger i CPK- værdier og tilfælde med rhabdomyolyse hos patienter, som indtog et sådant lægemiddel samtidig med Cubicin.
However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in patients taking one of these medications at the same time as Cubicin.
Det anbefales, at andre lægemidler, der associeres med myopati, seponeres midlertidigt under behandlingen med Cubicin, hvis det er muligt, medmindre fordelen ved samtidig administration opvejer risikoen.
It is recommended that other medications associated with myopathy should if possible be temporarily discontinued during treatment with Cubicin unless the benefits of concomitant administration outweigh the risk.
Hvis samtidig administration ikke kan undgås, bør CPK- værdier måles regelmæssigt mere end én gang om ugen, og patienterne bør overvåges tæt for ethvert tegn eller symptom, som kan tyde på myopati.
If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy.
4. 4, 4. 8 og 5. 3.
See sections 4.4, 4.8 and 5.3.
5 Daptomycin elimineres primært ved renal filtration, og derfor kan plasmaniveauer være forhøjede ved samtidig administration af lægemidler, som reducerer renal filtration (f. eks.
5 Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co- administration with medicinal products that reduce renal filtration (e. g.
NSAID' er og COX- 2 hæmmere).
NSAIDs and COX-2 inhibitors).