FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: Patienter, som udvikler tegn eller symptomer, der kan tyde på perifer neuropati under behandlingen med Cubicin, bør undersøges, og seponering af daptomycin bør tages i betragtning.
English: How to store Cubicin
Danish: Sådan får du Cubicin
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 i blodbanen (i en blodåre) enten som en infusion, der varer ca. 30 minutter, eller som en injektion, der varer ca. 2 minutter.
English: If an allergic reaction to Cubicin occurs, discontinue use and institute appropriate therapy.
Danish: Hvis en allergisk reaktion over for Cubicin opstår, skal behandlingen med Cubicin seponeres og passende behandling initieres.
English: Cubicin given as an intravenous infusion over 30 or 60 minutes
Danish: Cubicin givet som 30 eller 60 minutters intravenøs infusion
English: Hypertension, hypotension Uncommon: Flushes
Danish: Almindelig: Hypertension, hypotension Ikke almindelig:
English: Microbiological Success rate in Paediatric SAB n/N (%)
Danish: Mikrobiologisk succesrate hos pædiatriske patienter med SAB n/N (%)
English: Therefore caution should be exercised if Cubicin is given to such patients.
Danish: Hvis Cubicin administreres til sådanne patienter, bør der derfor udvises forsigtighed.
English: Cubicin is administered intravenously in 0.9 % sodium chloride (see section 6.6).
Danish: Cubicin administreres intravenøst i 0,9% natriumchlorid (se pkt.
English: 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).
Danish: Kreatinkinase og myopati Der er blevet rapporteret forøget kreatinkinase i plasma (CK; MM-isoenzymer) associeret med muskelsmerter og/eller -svaghed og om tilfælde af myositis, myoglobinæmi og rabdomyolyse under behandlingen med Cubicin (se også pkt.
English: Cubicin 350 mg powder for solution for injection or infusion EU/1/05/328/001
Danish: Cubicin 350 mg pulver til injektions- og infusionsvæske, opløsning EU/1/05/328/001
English: Cubicin 500 mg powder for solution for injection or infusion EU/1/05/328/002
Danish: Cubicin 500 mg pulver til injektions- og infusionsvæske, opløsning EU/1/05/328/002
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 til 17 år, inklusive) med SAB. Daptomycins farmakokinetik hos patienter i dette studie er opsummeret i tabel 3.
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 til 17 år (studie DAP-PEDBAC-11-02) med bakteriæmi forårsaget af Staphylococcus aureus.
English: Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment.
Danish: Din læge vil kontrollere dine lunger og vurdere, om du skal forsætte behandlingen med Cubicin.
English: The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).
Danish: Den rekonstituerede opløsning skal derefter fortyndes med natriumchlorid 9 mg/ml (0,9%) (typisk mængde 50 ml).
English: When used by injection, reconstitute with 0.9% sodium chloride only.
Danish: Ved anvendelse til injektion må der kun rekonstitueres med 0,9% natriumchlorid.
English: After a single 6 mg/kg dose of Cubicin, 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.
Danish: Efter en enkelt 6 mg/kg dosis Cubicin 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 410 mg/kg dosis.
English: In paediatric patients aged 1 to 6 years, Cubicin is given by intravenous infusion over a 60-minute period (see section 6.6).
Danish: Hos pædiatriske patienter i alderen 1 til 6 år indgives Cubicin som intravenøs infusion over 60 minutter (se pkt.
English: Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
Danish: Fjern den rekonstituerede væske (50 mg daptomycin/ml) langsomt fra hætteglasset ved anvendelse af en steril kanyle på 21G eller mindre i diameter.
English: 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.
Danish: Stabilitet af den fortyndede opløsning i infusionsbeholdere er fastsat til 12 timer ved 25 °C eller 24 timer ved opbevaring i køleskab ved 2 °C - 8 °C.
English: Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps
Danish: Myositis, forhøjet myoglobin, muskelsvaghed, muskelsmerter, artralgi, forhøjet serumlaktatdehydrogenase (LDH), muskelkramper Ikke kendt*: Rabdomyolyse
English: Transfer the required reconstituted dose into 50 ml sodium chloride 9 mg/ml (0.9%).
Danish: Overfør den påkrævede rekonstituerede dosis til 50 ml natriumchlorid 9 mg/ml (0,9%).
English: However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Danish: Hos gravide rotter kan daptomycin dog passerer placenta (se pkt.
English: What Cubicin is and what it is used for What you need to know before you are given Cubicin How Cubicin is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at få Cubicin Sådan får du Cubicin
English: Unlike in adults, daptomycin should not be administered by injection over a 2 minute period in paediatric patients.
Danish: Til forskel fra hos voksne må daptomycin ikke administreres som en 2minutters injektion til pædiatriske patienter.
English: Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.
Danish: Rekonstituerede opløsninger af Cubicin har en lysegul til let brun farve.
English: Renal impairment has been reported during treatment with Cubicin.
Danish: Der er blevet rapporteret om nedsat nyrefunktion under behandling med Cubicin.
English: 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 Grampositive pathogens.
Danish: Et fase 4-studie (DAP-PEDS-07-03) blev udført for at vurdere daptomycins sikkerhed, virkning og farmakokinetik hos pædiatriske patienter (1 til 17 år, inklusive) med cSSTI forårsaget af grampositive patogener.
English: Eosinophilic pneumonia has been reported in patients receiving Cubicin (see section 4.8).
Danish: Der er rapporteret om eosinofil pneumoni hos patienter i behandling med Cubicin (se pkt.
English: When administration is by injection reconstitute with 0.9% sodium chloride only.
Danish: Til administration som injektion må der udelukkende rekonstitueres med 0,9% natriumchlorid.
English: After a single 4 mg/kg dose of Cubicin, 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.
Danish: Efter en enkelt 4 mg/kg dosis Cubicin var total-clearance for daptomycin hos børn i alderen 7-11 år med grampositiv infektion højere end den hos unge, hvorimod eliminationshalveringstiden var kortere.
English: 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).
Danish: 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).
English: • 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.
Danish: • CK bør måles hyppigere (f.eks. hver 2.-3. dag i minimun de første to uger af behandlingen) hos patienter, som har øget risiko for at udvikle myopati, f.eks. patienter med alle grader af nedsat nyrefunktion (kreatininclearance < 80 ml/min; se også pkt.
English: Rare side effects (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 patienter) Gulfarvning af hud og øjne,
English: - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Danish: 4.4 og 5.1): - Voksne og pædiatriske (i alderen 1 til 17 år) patienter med komplicerede hud- og bløddelsinfektioner (cSSTI).
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Danish: FOLDEBOKS TIL 1 HÆTTEGLAS FOLDEBOKS TIL 5 HÆTTEGLAS
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension Uncommon: Dyspepsia, glossitis
Danish: Almindelig: Gastrointestinale og abdominale smerter, kvalme, opkastning, obstipation, diarré, flatulens, oppustethed og udspiling
English: 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.
Danish: 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.
English: Cubicin 500 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with blue plastic flip off caps.
Danish: Cubicin 500 mg pulver til injektions- og infusionsvæske, opløsning Engangshætteglas af klart type I glas med 10 ml og med type I gummiprop og forsegling af aluminium med blåt plastik flip-off låg.
English: Invert the vial in order to allow the solution to drain towards the stopper.
Danish: Vend hætteglasset på hovedet for at lade opløsningen løbe mod gummiproppen.
English: Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Danish: Cubicin må kun rekonstitueres med natriumchlorid 9 mg/ml(0,9%).
English: Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
Danish: Tabel 3 Den gennemsnitlige (standardafvigelse) farmakokinetik for daptomycin hos pædiatriske patienter med SAB (1 til 17 år) i studiet DAP-PEDBAC-11-02
English: Cubicin 350 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps.
Danish: Cubicin 350 mg pulver til injektions- og infusionsvæske, opløsning Engangshætteglas af klart type I glas med 10 ml og med type I gummiprop og forsegling af aluminium med gult plastik flip-off låg.
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Danish: Før du fjerner kanylen fra hætteglasset, skal du trække stemplet helt tilbage i sprøjten for at få al opløsningen ud af hætteglasset.
English: However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see also sections 4.8 and 5.2).
Danish: Denne administrationsvej er kun undersøgt i raske frivillige.Ved sammenligning med den samme dosis givet som intravenøs infusion over 30 minutter er der dog ingen klinisk relevant forskel i farmakokinetikken og sikkerhedsprofilen af daptomycin (se også pkt.
English: In paediatric patients aged 7 to 17 years, Cubicin is given by intravenous infusion over a 30-minute period (see section 6.6).
Danish: Hos pædiatriske patienter i alderen 7 til 17 år indgives Cubicin som intravenøs infusion over 30 minutter (se pkt.
English: The efficacy of Cubicin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
Danish: Hos patienter med prostetiske hjerteklapinfektioner eller venstresidigt infektiøs endocarditis som følge af Staphylococcus aureus er effekten af Cubicin ikke blevet vist.
English: a 2-6 years (N=7)
Danish: 2-6 år (N=7)
English: Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C8°C.
Danish: Kemisk og fysisk stabilitet af den fortyndede opløsning i infusionsbeholdere er fastsat til 12 timer ved 25 °C eller 24 timer ved 2 °C - 8 °C.
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove the required solution from the inverted vial.
Danish: Før du fjerner kanylen fra hætteglasset, skal du trække stemplet helt tilbage i injektionssprøjten for at få den påkrævede mængde opløsning ud af hætteglasset.
English: Group G streptococci
Danish: Gruppe G streptokokker
English: Common side effects (may affect up to 1 in 10 people) - Fungal infections such as thrush, - Urinary tract infection, - Decreased number of red blood cells (anaemia), - Dizziness, anxiety, difficulty in sleeping, - Headache, - Fever, weakness (asthenia), - High or low blood pressure, - Constipation, abdominal pain, - Diarrhoea, feeling sick (nausea) or being sick (vomiting), - Flatulence, - Abdominal swelling or bloating, - Skin rash or itching, - Pain, itchiness or redness at the site of infusion, - Pain in arms or legs, - Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) - Svampeinfektioner, som fx trøske (gråhvide belægninger på mundslimhinden), - Urinvejsinfektion, - Nedsat antal røde blodceller (anæmi), - Svimmelhed, angst, søvnbesvær, - Hovedpine, - Feber, svaghed (asteni), - Højt eller lavt blodtryk, - Forstoppelse, mavesmerter, - Diarré, kvalme eller opkastning, - Luft i maven, - Oppustet eller udspilet mave, - Hududslæt eller kløe, - Smerter, kløe eller rødme på infusionsstedet, - Smerter i arme eller ben, - Blodprøver, der viser forhøjede værdier af leverenzymer eller kreatinkinase (CK).
English: Summary of Blinded Evaluator defined clinical outcome at TOC: Clinical Success in Paediatric SAB Daptomycin n/N (%)
Danish: Oversigt over klinisk udfald bedømt af blindet evaluator ved TOC: Klinisk succes hos pædiatriske patienter med SAB
English: After a single 4 mg/kg dose of Cubicin, total clearance normalized by weight and elimination half-life of daptomycin in adolescents (12-17 years of age) with Gram-positive infection were similar to adults.
Danish: Efter en enkelt 4 mg/kg dosis Cubicin var total-clearance normaliseret efter vægt og eliminationshalveringstid for daptomycin hos unge (12-17 år) med grampositiv infektion sammenlignelig med den hos voksne.
English: Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance
Danish: Efter administration af en enkelt intravenøs dosis på 4 mg/kg eller 6 mg/kg daptomycin over 30 minutter til voksne patienter 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 injiceres intravenøst over et tidsrum på 2 minutter.
English: EU/1/05/328/002 1 vial EU/1/05/328/004 5 vials
Danish: EU/1/05/328/002 1 hætteglas EU/1/05/328/004 5 hætteglas
English: Cubicin 350 mg powder for solution for injection or infusion Cubicin 500 mg powder for solution for injection or infusion
Danish: Cubicin 350 mg pulver til injektions- og infusionsvæske, opløsning Cubicin 500 mg pulver til injektions- og infusionsvæske, opløsning
English: Methicillin-resistant Staphylococcus aureus (MRSA)
Danish: Methicillin-resistent Staphylococcus aureus (MRSA)
English: Available in packs containing 1 vial or 5 vials.
Danish: Fås i pakninger med 1 hætteglas eller 5 hætteglas.
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: pseudomembranøs colitis (svær eller vedvarende diarré indeholdende blod og/eller slim og forbundet med mavesmerte eller feber), nemt ved at få blå mærker, blødning fra tandkødet eller næseblod.
English: EU/1/05/328/001 1 vial EU/1/05/328/003 5 vials
Danish: EU/1/05/328/001 1 hætteglas EU/1/05/328/003 5 hætteglas
English: Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C - 8°C).
Danish: 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 opbevaring i køleskab (2 °C - 8 °C).
English: 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).
Danish: Hos pædiatriske patienter under 7 år, der skal have en dosis på 912 mg/kg, skal daptomycin administreres over 60 minutter (se pkt.
English: Slowly remove the appropriate reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle that is 21 gauge or smaller in diameter by inverting the vial in order to allow the solution to drain towards the stopper.
Danish: Fjern den rekonstituerede væske (50 mg daptomycin/ml) langsomt fra hætteglasset med en ny steril kanyle, som er 21G eller mindre i diameter, ved at vende hætteglasset på hovedet for at lade opløsningen løbe mod gummiproppen.
English: For Dilution:
Danish: Til fortynding:
English: Uncommon side effects (may affect up to 1 in 100 people) - Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells), - Decreased appetite, - Tingling or numbness of the hands or feet, taste disturbance, - Trembling, - Changes in heart rhythm, flushes, - Indigestion (dyspepsia), inflammation of the tongue, - Itchy rash of skin, - Muscle pain, cramping, or weakness, inflammation of the muscles (myositis), joint pain, - Kidney problems, - Inflammation and irritation of the vagina, - General pain or weakness, tiredness (fatigue), - Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts, - Itchy eyes.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) - Blodsygdomme (fx forhøjet antal af små blodpartikler, kaldet blodplader, som kan øge tendensen til at blodet klumper sammen eller øgede niveauer af visse typer af hvide blodceller), - Nedsat appetit, - Prikkende eller følelsesløs fornemmelse i hænder eller fødder, smagsforstyrrelser, - Rysten, - Forandringer i hjerterytmen, hedeture, - Dårlig fordøjelse (dyspepsi), betændelse af tungen, - Kløende hududslæt, - Muskelsmerter, muskelkramper eller muskelsvaghed, betændelse i musklerne (myositis),
English: Overall Success a rate in Paediatric cSSTI n/N (%)
Danish: Samlet succesrate a hos pædiatriske patienter med cSSTI n/N (%)
English: Liver function tests abnormal
Danish: Almindelig: Unormale leverfunktionstest
English: Powder for solution for injection or infusion A pale yellow to light brown lyophilised cake or powder.
Danish: Pulver til injektions- og infusionsvæske, opløsning Et lysegult til let brunt frysetørret masse eller pulver.
English: The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDS-07-03) with cSSTI caused by Gram positive pathogens.
Danish: Daptomycins sikkerhed og virkning blev evalueret hos pædiatriske patienter i alderen 1 til 17 år med cSSTI forårsaget af grampositive patogener (studie DAP-PEDS-07-03).
English: • Age group 1 (n=113): 12 to 17 years treated with daptomycin dosed at 5 mg/kg or standard-of care comparator (SOC);
Danish: • Aldersgruppe 1 (n=113): 12 til 17 år blev behandlet med daptomycindoser på 5 mg/kg eller standardbehandling-komparator (SOC).
English: Cubicin 350 mg powder for solution for injection or infusion Each vial contains 350 mg daptomycin.
Danish: Cubicin 350 mg pulver til injektions- og infusionsvæske, opløsning Hvert hætteglas indeholder 350 mg daptomycin.
English: Cubicin 500 mg powder for solution for injection or infusion Each vial contains 500 mg daptomycin.
Danish: Cubicin 500 mg pulver til injektions- og infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg daptomycin.
English: To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.
Danish: Ved fremstilling af Cubicin til intravenøs injektion skal følgende instruktioner følges: Der skal anvendes aseptisk teknik, når lyofiliseret Cubicin rekonstitueres.
English: Infusion site reactions, pyrexia, asthenia
Danish: Almindelig: Reaktioner ved infusionsstedet, pyreksi, asteni Ikke almindelig:
English: Using a new syringe, insert the needle into the inverted vial.
Danish: Brug en ny sprøjte og stik kanylen ind i hætteglasset.
English: VIAL
Danish: Vaginitis
English: Methicillin-susceptible Staphylococcus aureus (MSSA)
Danish: Methicillin-modtagelig Staphylococcus aureus (MSSA)
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Ikke almindelig:
English: Cubicin given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Cubicin 350 mg powder for infusion is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Cubicin givet som 30 eller 60 minutters intravenøs infusion En 50 mg/ml koncentration af Cubicin 350 mg pulver til infusionsvæske, opløsning, opnås ved rekonstitution af det lyofiliserede produkt med 7 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: What Cubicin looks like and contents of the pack Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown cake or powder in a glass vial.
Danish: Cubicin pulver til injektions- og infusionsvæske, opløsning, fås som et lysegult til let brunt masse eller pulver i et hætteglas.
English: • Age group 3 (n=125): 2 to 6 years treated with daptomycin dosed at 9 mg/kg or SOC;
Danish: • Aldersgruppe 3 (n=125): 2 til 6 år blev behandlet med daptomycindoser på 9 mg/kg eller SOC.
English: For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 at 2°C - 8°C).
Danish: 6.6) ved 25 °C ikke overstige 12 timer (eller 48 timer ved 2 °C - 8 °C).