natgillin/translations-raw huggingface dataset:
Der var ingen histopatologisk korrelation i vævet i det perifere og centrale nervesystem eller i skeletmuskulaturen på noget dosisniveau.
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.
Oversigt over klinisk udfald bedømt ved sponsordefineret test-of-cure (TOC):
Summary of sponsor-defined clinical outcome at TOC:
Hos pædiatriske patienter under 7 år, der skal have en dosis på 9-12 mg/kg, skal daptomycin administreres over 60 minutter.
In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes.
Det aktive stof i Daptomycin Hospira pulver til injektions-/infusionsvæske, opløsning, er daptomycin.
The active substance in Daptomycin Hospira powder for solution for injection/infusion is daptomycin.
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.
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.
Der er blevet rapporteret om nedsat nyrefunktion under behandling med daptomycin.
Renal impairment has been reported during treatment with daptomycin.
Daptomycin Hospira givet som 2 minutters intravenøs injektion (kun hos voksne patienter)
Daptomycin Hospira given as 2-minute intravenous injection (adult patients only)
Brug til ældre
Use in elderly
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.
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.
Indehaveren af markedsføringstilladelsen skal sikre, at alle laboratorier, som forventes at udføre Daptomycin Hospira-følsomhedstest, får: - Produktresumé - Information om antibiotisk følsomhedsbestemmelse
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
• Plasma-CK bør måles ved baseline og med regelmæssige mellemrum (mindst en gang om ugen) under hele behandlingen hos alle patienter.
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.
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
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
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.
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.
Der foreligger ingen kliniske data på fertilitet for daptomycin.
No clinical data on fertility are available for daptomycin.
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.
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.
Nedsat nyrefunktion Daptomycin elimineres primært via nyrerne.
Renal impairment Daptomycin is eliminated primarily by the kidney.
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.
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.
Daptomycin udskilles primært via nyrerne.
Daptomycin is excreted primarily by the kidneys.
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).
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).
Der bør udvises forsigtighed, når daptomycin administreres til patienter, som allerede har en vis grad af nedsat nyrefunktion (kreatininclearance <80 ml/min.
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.
Kliniske studier har vist, at daptomycin ikke har effekt på pneumoni.
It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
Stabilitet af den fortyndede opløsning i infusionspose er fastsat til 12 timer ved 25°C eller 24 timer ved opbevaring i køleskab ved 2°C-8°C.
Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration at 2°C-8°C.
Efter en enkelt 6 mg/kg dosis daptomycin var clearance og eliminationshalveringstid for daptomycin hos børn i alderen 13-24 måneder sammenlignelig med dem hos børn i alderen 2-6 år, som fik en enkelt 4-10 mg/kg dosis.
After a single 6 mg/kg dose of daptomycin, the clearance and elimination half-life of daptomycin in children 13-24 months of age were similar to children 2-6 years of age who received a single 4-10 mg/kg dose.
Kreatinkinase (CK)-niveauet skal monitoreres ved baseline og med regelmæssige mellemrum (mindst en gang om ugen) under behandlingen (se pkt.
Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Træk langsomt den rekonstituerede væske (50 mg daptomycin/ml) op af hætteglasset med en steril kanyle, der har en diameter på 21G eller mindre.
Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
Svampeinfektion, urinvejsinfektion, candidainfektion Ikke almindelig: Fungæmi Ikke kendt*:
Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
Der blev observeret påvirkning af perifere nerver ved doser, der var større end dem, der blev associeret med påvirkning af skeletmuskulatur, hos voksne rotter og hunde.
Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
- cSSTI med samtidigSAB: daptomycin 6 mg/kg administreres en gang i døgnet.
- cSSTI with concurrent SAB: daptomycin 6 mg/kg is administered once every 24 hours.
- At antibiotisk følsomhedsbestemmelse for daptomycin kræver calcium i testmediet, og testmetoder med passende Ca-koncentration i mediet anbefales.
- That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
Daptomycin Hospira må kun rekonstitueres med natriumchlorid 9 mg/ml (0,9%).
Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Da der er begrænset klinisk erfaring (se tabel og fodnoter nedenfor) bør daptomycin kun anvendes til voksne patienter med nedsat nyrefunktion af enhver grad (kreatininclearance <80 ml/min.
Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl <80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Daptomycins sikkerhed og virkning hos børn og unge under 18 år med højresidig infektiøs endocarditis (RIE) som følge af Staphylococcus aureus er ikke klarlagt.
The safety and efficacy of daptomycin in children and adolescents aged below 18 years with RIE due to Staphylococcus aureus have not been established.
Doseringsregimet for daptomycin hos pædiatriske patienter med nedsat nyrefunktion er ikke fastlagt.
The dosage regimen for daptomycin in paediatric patients with renal impairment has not been established.
Daptomycin Hospira har ingen kendt indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
Driving and using machines Daptomycin Hospira has no known effects on the ability to drive or use machines.
Kreatinkinase og myopati Der er blevet rapporteret forøget kreatinkinase i plasma (CK, MM isoenzym) forbundet med muskelsmerter og/eller -svækkelse og om tilfælde af myositis, myoglobinæmi og rabdomyolyse under behandlingen med daptomycin (se også pkt.
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 daptomycin (see also sections 4.5, 4.8 and 5.3).
Gastrointestinale og abdominale smerter, kvalme,opkastning, obstipation, diarré, flatulens oppustethed og udspiling Ikke almindelig: Dyspepsi, glossitis
Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension
Daptomycin Hospira administreres intravenøst i 0,9% natriumchlorid (se pkt.
Daptomycin Hospira is administered intravenously in 0.9 % sodium chloride (see section 6.6).
De anbefalede doseringsregimer for pædiatriske patienter baseret på alder og indikation er vist nedenfor.
Paediatric patients (1 to 17 years of age) The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Hos voksne kan daptomycin administreres intravenøst som infusion over 30 minutter eller som injektion over 2 minutter.
In adults, daptomycin may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
Metabolisme og ernæring Ikke almindelig: Nedsat appetit, hyperglykæmi, forstyrrelser i elektrolytbalancen
Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance
Det skal du vide, før du begynder at få Daptomycin Hospira
What you need to know before you are given Daptomycin Hospira
Du må ikke få Daptomycin Hospira: - hvis du er allergisk over for daptomycin eller et af de øvrige indholdsstoffer (angivet i afsnit
If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Methicillin-følsom Staphylococcus aureus (MSSA) Methicillin-resistent Staphylococcus aureus (MRSA) Streptococcus pyogenes
Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA) Streptococcus pyogenes a
4.4 og 5.1): - Voksne og pædiatriske (i alderen 1-17 år) patienter med komplicerede hud- og bløddelsinfektioner (cSSTI).
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
7-11 år (N=19)
7-11 years (N=19)
350 mg tilberedning:
350 mg presentation:
6 mg/kg en gang dagligt
6 mg/kg once daily
Hos voksne kan Daptomycin Hospira administreres intravenøst som infusion over 30 minutter eller som injektion over 2 minutter.
In adults, daptomycin Hospira may be administered intravenously as an infusion over 30 minutes or as an injection over 2 minutes.
500 mg tilberedning:
500 mg presentation:
Til forskel fra hos voksne må daptomycin ikke administreres som en 2minutters injektion til pædiatriske patienter.
Unlike in adults, daptomycin should not be administered by injection over a 2-minute period in paediatric patients.
12-17 år (N=13)
12-17 years (N=13)
Rekonstituerede opløsninger af Daptomycin Hospira har en gul til lys brun farve.
Reconstituted solutions of Daptomycin Hospira range in colour from yellow to light brown.
Akut generaliseret eksantematøs pustulose
Not known*: Acute generalised exanthematous pustulosis
Resultater fra disse studier viste, at begge metoder til administration af daptomycin, 2-minutters intravenøs injektion og 30 minutters intravenøs infusion, havde sammenlignelig sikkerheds- og tolerabilitetsprofil.
Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion,
Mikrobiologisk succesrate hos pædiatriske patienter med SAB n/N (%)
Microbiological Success rate in Paedatric SAB n/N (%)
Ved fremstilling af Daptomycin Hospira til intravenøs injektion skal følgende instruktioner følges: Der skal anvendes aseptisk teknik, når lyofiliseret Daptomycin Hospira rekonstitueres.
To prepare Daptomycin Hospira for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Der foreligger ikke kliniske data om daptomycin under graviditet.
No clinical data on pregnancies are available for daptomycin.
Din læge vil tage blodprøver, før du start behandlingen og jævnligt under behandlingen med Daptomycin Hospira for at kontrollere, om dine muskler tager skade af behandlingen.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Daptomycin Hospira.
4.2), inklusive patienter i hæmodialyse eller CAPD, og patienter, som bruger andre lægemidler, der vides at være forbundet med myopati (f.eks. HMG-CoA reduktasehæmmere, fibrater og ciclosporin).
For example, patients with any degree of renal impairment (creatinine clearance <80 ml/min; see also section 4.2), including those on haemodialysis or CAPD, and patients taking other medicinal products known to be associated with myopathy (e.g. HMG-CoA reductase inhibitors, fibrates and ciclosporin).
Efter en enkelt 4 mg/kg dosis daptomycin var total-clearance for daptomycin hos børn i alderen 7-11 år med grampositiv infektion højere end den hos unge, hvorimod eliminationshalveringstiden var kortere.
After a single 4 mg/kg dose of daptomycin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Ved fremstilling af Daptomycin Hospira til intravenøs infusion skal følgende instruktioner følges: Der skal anvendes aseptisk teknik, når lyofiliseret Daptomycin Hospira rekonstitueres.
To prepare Daptomycin Hospira for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Daptomycin Hospira.
Et fase 4-studie (DAP-PEDS-07-03) blev udført for at vurdere daptomycins sikkerhed, virkning og farmakokinetik hos pædiatriske patienter (1-17 år, inklusive) med cSSTI forårsaget af grampositive patogener.
A Phase 4 study (DAP-PEDS-07-03) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with cSSTI caused by Gram-positive pathogens.
Hos patienter med prostetiske hjerteklapinfektion eller venstresidigt infektiøs endocarditis som følge af Staphylococcus aureus er effekten af daptomycin ikke blevet vist.
The efficacy of daptomycin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
4 mg/kg en gang dagligt
4 mg/kg once daily
Før brug blandes det med et opløsningsmiddel, så der dannes en væske.
It is mixed with a solvent to form a liquid before it is administered.
Daptomycin Hospira (se afsnit 3 i denne indlægsseddel).
Your doctor may need to change the dose of Daptomycin Hospira (see section 3 of this leaflet).
Kemisk og fysisk stabilitet af den fortyndede opløsning i infusionspose er fastsat til 12 timer ved 25°C eller 24 timer ved 2°C-8°C.
Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
Efter rekonstitution: Der er påvist kemisk og fysisk stabilitet under brug af den rekonstituerede opløsning i hætteglasset i 12 timer ved 25°C og i op til 48 timer ved 2°C-8°C.
After reconstitution: Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
Hos pædiatriske patienter i alderen 1-6 år indgives Daptomycin Hospira som intravenøs infusion over 60 minutter (se pkt.
In paediatric patients aged 1 to 6 years, Daptomycin Hospira is given by intravenous infusion over a 60-minute period (see section 6.6).
Justering af dosisinterval af Daptomycin Hospira er nødvendig hos voksne patienter, hvis kreatininclearance er <30 ml/min.
An adjustment of daptomycin dose interval is needed for adult patients whose creatinine clearance is <30 ml/min (see sections 4.2 and 5.2).
En sjælden, men muligvis alvorlig lungesygdom, der hedder eosinofil pneumoni, er blevet indberettet fra patienter i behandling med Daptomycin Hospira, for det meste efter mere end 2 ugers behandling.
Serious side effects with frequency not known (frequency cannot be estimated from the available data) A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given daptomycin, mostly after more than 2 weeks of treatment.
Erstat kanylen med en ny kanyle til den intravenøse injektion.
Replace needle with a new needle for the intravenous injection.
Der er rapporteret om eosinofil pneumoni hos patienter i behandling med daptomycin (se pkt.
Eosinophilic pneumonia has been reported in patients receiving daptomycin (see section 4.8).
Tabel 2 Den gennemsnitlige (standardafvigelse) farmakokinetik for daptomycin hos pædiatriske patienter med cSSTI (1 til 17 år) i studiet DAP-PEDS-07-03
Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Tabel 3 Den gennemsnitlige (standardafvigelse) farmakokinetik for daptomycin hos pædiatriske patienter med SAB (1-17 år) i studiet DAP-PEDBAC-11-02
Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
• CK bør måles hyppigere (f.eks. hver 2.-3. dag i minimum de første to uger af behandlingen) hos patienter, som harøget risiko for at udvikle myopati, f.eks. patienter med alle grader af nedsat nyrefunktion (kreatininclearance <80 ml/min; se også pkt.
- CPK should be measured more frequently (e.g. every 2-3 days at least during the first two weeks of treatment) in patients who are at higher risk of developing myopathy.
Erstat kanylen med en ny kanyle til den intravenøse infusion.
Replace needle with a new needle for the intravenous infusion.
Sådan får du Daptomycin Hospira
How to store Daptomycin Hospira
Din læge vil kontrollere dine lunder og vurdere, om du skal fortsætte behandlingen med Daptomycin Hospira.
Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin Hospira treatment.
Daptomycin Hospira pulver til injektions-/infusionsvæske, opløsning, leveres som en lysegul til lysebrun lyofiliseret masse eller pulver i et hætteglas.
What Daptomycin Hospira looks like and contents of the pack Daptomycin Hospira powder for solution for injection/infusion is supplied as a light yellow to light brown lyophilised cake or powder in a glass vial.
Pulver til injektions-/infusionsvæske, opløsning 1 hætteglas
Powder for solution for injection/infusion 1 vial
Daptomycin Hospira er indiceret til behandling af følgende infektioner (se pkt.
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Hvis Daptomycin Hospira administreres til sådanne patienter, bør der derfor udvises forsigtighed.
Therefore caution should be exercised if Daptomycin Hospira is given to such patients.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 1 HÆTTEGLAS
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Hætteglas med Daptomycin Hospira er kun til engangsbrug.
Daptomycin Hospira vials are for single-use only.
Fortæl det straks til en læge eller sundhedspersonalet, hvis du oplever nogle af følgende symptomer: - Brystsmerter eller brystet snører sig sammen - Udslæt med blæredannelse, som nogle gange kan være i munden og omkring kønsdelene - Hævelse omkring halsen - Hurtig eller svag puls - Hvæsende vejrtrækning - Feber - Kulderystelser eller skælven
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.
Hos pædiatriske patienter under 7 år, der skal have en dosis på 9-12 mg/kg, skal daptomycin administreres over 60 minutter (se pkt.
In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes (see sections 4.2 and 5.2).
Den rekonstituerede og fortyndede opløsning skal gives som intravenøs infusion over 30 eller 60 minutter.
The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.
Efter en enkelt 4 mg/kg dosis daptomycin var total-clearance normaliseret efter vægt og eliminationshalveringstid for daptomycin hos unge (12-17 år) med grampositiv infektion sammenlignelig med den hos voksne.
After a single 4 mg/kg dose of daptomycin, total clearance normalised by weight and elimination half-life of daptomycin in adolescents (12-17 years of age) with Gram-positive infection were similar to adults.
En lysegul til lysebrun, frysetørret masse eller pulver.
A light yellow to light brown lyophilised cake or powder.