natgillin/translations-raw huggingface dataset:
No dose adjustment is necessary when administering daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro jeter (Child-Pugh B) prilagajanje odmerka daptomicina ni potrebno (glejte poglavje 5.2).
Anaphylaxis/hypersensitivity reactions have been reported with daptomycin.
Pri uporabi daptomicina so poročali o anafilaktičnih/preobčutljivostnih reakcijah.
Drug/laboratory test interactions
Vpliv zdravila na rezultate laboratorijskih preiskav
There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes.
Kliničnih izkušenj pri bolnikih, ki bi prejemali daptomicin v obliki injekcije v trajanju 2 minut, ni.
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.
Razredčena raztopina v infuzijskih vrečkah je kemijsko in fizikalno stabilna 12 ur pri 25 °C ali 24 ur pri 2 °C - 8 °C.
Clostridium difficile-associated diarrhoea
diareja, ki jo povzroča bakterija Clostridium difficile**
If this happens tell your doctor.
Če se vam pojavijo taki simptomi, obvestite svojega zdravnika.
False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see section
Pri uporabi določenih rekombinantnih tromboplastinskih reagentov za določanje protrombinskega časa so opažali lažno podaljšanje protrombinskega časa (PČ) in zvišanje vrednosti mednarodno umerjenega razmerja (INR - International Normalised Ratio) (glejte poglavje 4.5).
In all populations the clinical success rates were comparable in the daptomycin versus the SOC treatment arm.
V vseh populacijah so bili deleži kliničnega uspeha med skupino z daptomicinom in skupino s standardno oskrbo primerljivi.
Comparator n/N (%)
Primerjalno zdravilo n/N (%)
AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Navedeni sta posamezni vrednosti, ker so le od dveh bolnikov v tej starostni skupini pridobili farmakokinetične vzorce, ki so omogočali farmakokinetično analizo; AUC, navidezni t1/2 in očistek na telesno maso so lahko določili le pri enem od teh dveh bolnikov.
Renal impairment has been reported during treatment with daptomycin.
Med zdravljenjem z daptomicinom so poročali o okvari ledvic.
500 mg presentation:
Pakiranje po 500 mg:
Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Preglednica 2 Povprečje (standardni odklon) farmakokinetike daptomicina pri pediatričnih bolnikih (starih od 1 do 17 let) z zapletenimi okužbami kože in mehkih tkiv v študiji DAP-PEDS-07-03 Razpon starosti
Comparable exposure (AUC and Cmax) was demonstrated in healthy adult subjects following administration of daptomycin as a 30-minute intravenous infusion or as a 2-minute intravenous injection.
Pri zdravih odraslih preskušancih so po uporabi daptomicina v obliki 30-minutne intravenske infuzije ali 2-minutne intravenske injekcije opazili primerljivo izpostavljenost zdravilu (AUC in Cmax).
Skin and subcutaneous tissue disorders
Zapletene okužbe kože in mehkih tkiv (cSSTI) brez SAB
Table 3 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric SAB Patients (1 to 17 Years of Age) in Study DAP-PEDBAC-11-02
Preglednica 3 Povprečje (standardni odklon) farmakokinetike daptomicina pri pediatričnih bolnikih (starih od 1 do 17 let) z bakteriemijo z bakterijo Staphylococcus aureus v študiji DAP-PEDBAC-11-02 Razpon starosti
Fungal infections, urinary tract infection, candida infection, anaemia, anxiety, insomnia, dizziness, headache, hypertension, hypotension, gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Neželeni učinki, o katerih so najpogosteje poročali (s pogostnostjo "pogosti" (≥ 1/100 do < 1/10)), so: glivične okužbe, okužbe sečil, okužba s kandido, anemija, tesnoba, nespečnost, omotica, glavobol, hipertenzija, hipotenzija, bolečine v prebavilih in trebuhu, navzea, bruhanje, zaprtje, diareja, flatulenca, napihnjenost trebuha, nenormalni izvidi preiskav delovanja jeter (zvišane vrednosti alaninaminotransferaze (ALT), aspartat-aminotransferaze (AST) ali alkalne fosfataze (ALP)), izpuščaj, pruritis, bolečine v okončinah, zvišane vrednosti kreatin-fosfokinaze (CPK) v serumu, reakcije na mestu infundiranja, zvišana telesna temperatura, astenija.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Glede na primerjavo vrednosti Cmax pri odmerku brez opaznega učinka (NOEL - No Observed Effect Level) in vrednosti Cmax pri odmerjanju 6 mg/kg enkrat dnevno s 30-minutno intravensko infuzijo pri bolnikih z normalnim delovanjem ledvic je varno območje za učinke na periferne živce pri podganah in psih 8-kratna oziroma 6-kratna vrednost.
Common: 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).
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov - glivične okužbe, kot je kandidoza - okužba sečil - zmanjšano število rdečih krvnih celic (anemija) - omotica, tesnoba, težave s spanjem - glavobol - zvišana telesna temperatura, oslabelost (astenija) - visok ali nizek krvni tlak - zaprtje, bolečine v trebuhu - driska, slabost s siljenjem na bruhanje (navzea) ali bruhanje - nabiranje plinov v želodcu ali črevesju - otekanje ali napihnjenost trebuha - kožni izpuščaj ali srbenje kože - bolečina, srbenje ali rdečina na mestu infundiranja - bolečine v rokah ali nogah - izvidi krvnih preiskav, ki kažejo zvišane vrednosti jetrnih encimov ali kreatin-fosfokinaze (CPK)
5 mg/kg 30 minutes
5 mg/kg 30 minut
Daptomycin Hospira 350 mg powder for solution for injection/infusion Daptomycin Hospira 500 mg powder for solution for injection/infusion
Daptomicin Hospira 350 mg prašek za raztopino za injiciranje/infundiranje Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje
AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) Pharmacokinetic parameter values estimated using a model-based approach with sparsely collected pharmacokinetic samples from individual patients in the study.
(ml/h/kg) Vrednosti farmakokinetičnih parametrov, ocenjene na podlagi modela z redkim farmakokinetičnim vzorčenjem pri posameznih bolnikih v študiji.
Microbiological Success rate in Paedatric SAB n/N (%)
Mikrobiološki delež uspeha pri pediatričnih bolnikih z bakteriemijo z bakterijo Staphylococcus aureus n/N (%)
Daptomycin Hospira 350 mg powder for solution for injection/infusion Each vial contains 350 mg daptomycin.
Daptomicin Hospira 350 mg prašek za raztopino za injiciranje/infundiranje Ena viala vsebuje 350 mg daptomicina.
Caution is warranted when daptomycin is co-administered with tobramycin.
Pri sočasni uporabi daptomicin s tobramicinom je potrebna previdnost.
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).
Po 30-minutnem dajanju daptomicina v enkratnem intravenskem odmerku 4 mg/kg je bila pri starejših osebah (starih ≥ 75 let) povprečna vrednost celotnega očistka daptomicina nižja za približno 35 %,
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.
Varnost in učinkovitost daptomicina so ocenjevali pri pediatričnih bolnikih, ki so bili stari od 1 do 17 let in so imeli zapleteno okužbo kože in mehkih tkiv s katerim od grampozitivnih patogenov (študija DAP-PEDS-07-03).
12 mg/kg 60 minutes
12 mg/kg 60 minut
Daptomycin Hospira should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Zdravilo Daptomicin Hospira lahko rekonstituirate samo z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida.
Daptomycin should not be administered as a 2-minute injection to paediatric patients.
Pediatričnim bolnikom se daptomicina ne sme dajati v obliki 2-minutne injekcije.
7 mg/kg 30 minutes
7 mg/kg 30 minut
Daptomycin Hospira 500 mg powder for solution for injection/infusion Each vial contains 500 mg daptomycin.
Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje Ena viala vsebuje 500 mg daptomicina.
• Age group 1 (n=113): 12 to 17 years treated with daptomycin dosed at 5 mg/kg or standard-of-care comparator (SOC);
• starostna skupina 1 (n = 113): bolniki v starosti od 12 do 17 let so prejemali daptomicin v odmerkih 5 mg/kg ali primerjalno zdravilo za standardno oskrbo;
UNIQUE IDENTIFIER -HUMAN READABLE DATA
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
10 mg/kg 60 minutes
10 mg/kg 60 minut
• Age group 3 (n=125): 2 to 6 years treated with daptomycin dosed at 9 mg/kg or SOC;
• starostna skupina 3 (n = 125): bolniki v starosti od 2 do 6 let so prejemali daptomicin v odmerkih 9 mg/kg ali primerjalno zdravilo za standardno oskrbo;
9 mg/kg 60 minutes
9 mg/kg 60 minut
• Age group 4 (n=45): 1 to < 2 years treated with daptomycin dosed at 10 mg/kg or SOC.
• starostna skupina 4 (n = 45): bolniki v starosti od 1 do manj kot 2 leti so prejemali daptomicin v odmerkih 10 mg/kg ali primerjalno zdravilo za standardno oskrbo.
9 mg/kg 30 minutes
9 mg/kg 30 minut
• Age group 2 (n=28): 7 to 11 years treated with daptomycin dosed at 9 mg/kg or SOC;
• 2. starostna skupina (n = 28): stari od 7 do 11 let, zdravljeni z daptomicinom v odmerku 9 mg/kg ali primerjalnim zdravilom za standardno oskrbo;
One vial of powder contains 350 mg daptomycin.
Ena viala praška vsebuje 350 mg daptomicina.
No dosage adjustment is necessary when administering daptomycin in patients with moderate hepatic impairment.
Pri dajanju daptomicina bolnikom z zmerno okvaro jeter prilagajanje odmerka ni potrebno.
5 mg/kg once every 24 hours infused over 30 minutes
5 mg/kg vsakih 24 ur v infuziji, ki traja 30 minut
It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice (see sections 4.4 and 5.1).
Odločitev naj temelji na presoji strokovnjaka (glejte poglavji 4.4 in 5.1).
Slowly remove the reconstituted liquid (50mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or smaller in diameter.
S sterilno iglo premera 21 G ali manj počasi izvlecite rekonstituirano tekočino (50 mg daptomicina/ml) iz viale.
Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the product plug in the vial.
S sterilno iglo za prenos premera 21 G ali manj ali z brezigelnim pripomočkom v injekcijsko brizgo povlecite 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje in jo nato skozi sredino gumijastega zamaška, neposredno prek zamaška zdravila, POČASI injicirajte v vialo.
Methicillin-susceptible Staphylococcus aureus (MSSA) Methicillin-resistant Staphylococcus aureus (MRSA)
Na meticilin odporen sev Staphylococcus aureus (MRSA)
• Age group 1 (n=21): 12 to 17 years treated with daptomycin dosed at 7 mg/kg or SOC comparator;
• 1. starostna skupina (n = 21): stari od 12 do 17 let, zdravljeni z daptomicinom v odmerku 7 mg/kg ali primerjalnim zdravilom za standardno oskrbo;
Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the product plug in the vial.
S sterilno iglo za prenos premera 21 G ali manj ali z brezigelnim pripomočkom v injekcijsko brizgo povlecite 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje in jo nato skozi sredino gumijastega zamaška, neposredno prek zamaška zdravila, POČASI injicirajte v vialo.
Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Zdravilo Daptomicin Hospira za dajanje v obliki 30- ali 60-minutne intravenske infuzije Koncentracijo 50 mg/ml daptomicina za infundiranje dobimo z rekonstitucijo liofiliziranega zdravila s 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Zdravilo Daptomicin Hospira za dajanje v obliki 30- ali 60-minutne intravenske infuzije Koncentracijo 50 mg/ml daptomicina za infundiranje dobimo z rekonstitucijo liofiliziranega zdravila z 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
• Age group 3 (n=32): 1 to 6 years treated with daptomycin dosed at 12 mg/kg or SOC;
• 3. starostna skupina (n = 32): stari od 1 do 6 let, zdravljeni z daptomicinom v odmerku 12 mg/kg ali primerjalnim zdravilom za standardno oskrbo.
12 mg/kg once every 24 hours infused over 60 minutes
12 mg/kg vsakih 24 ur v infuziji, ki traja 60 minut
10 mg/kg once every 24 hours infused over 60 minutes
10 mg/kg vsakih 24 ur v infuziji, ki traja 60 minut
Summary of Blinded Evaluator defined clinical outcome at TOC:
Povzetek kliničnih izidov po definiciji naročnika glede na TOC: Klinični uspeh pri pediatričnih zapletenih okužbah kože in mehkih tkiv
cSSTI associated with SAB
RIE ali cSSTI s sočasno SAB
One vial of powder contains 500mg daptomycin.
Ena viala praška vsebuje 500 mg daptomicina.
9 mg/kg once every 24 hours infused over 30 minutes
9 mg/kg vsakih 24 ur v infuziji, ki traja 30 minut
7 mg/kg once every 24 hours infused over 30 minutes
7 mg/kg vsakih 24 ur v infuziji, ki traja 30 minut
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.
Pediatrični bolniki z zapletenimi okužbami kože in mehkih tkiv Za oceno varnosti, učinkovitosti in farmakokinetike daptomicina pri pediatričnih bolnikih (od 1 do vključno 17 let starosti) z zapletenimi okužbami kože in mehkih tkiv zaradi grampozitivnih patogenov so izvedli študijo 4. faze (DAP-PEDS-07-03).
9 mg/kg once every 24 hours infused over 60 minutes
9 mg/kg vsakih 24 ur v infuziji, ki traja 60 minut
Daptomycin Hospira 500 mg powder for solution for injection/infusion
Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje
Reproductive system and breast disorders
Infekcijske in parazitske boleznipogosti:
Daptomycin Hospira 500 mg powder for solution for injection/infusion daptomycin
Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje daptomicin
Each vial contains 500 mg daptomycin.
Ena viala vsebuje 500 mg daptomicina.
Daptomycin Hospira 350 mg powder for solution for injection/infusion
Daptomicin Hospira 350 mg prašek za raztopino za injiciranje/infundiranje
• Age group 2 (n=113): 7 to 11 years treated with daptomycin dosed at 7 mg/kg or SOC;
• starostna skupina 2 (n = 113): bolniki v starosti od 7 do 11 let so prejemali daptomicin v odmerkih 7 mg/kg ali primerjalno zdravilo za standardno oskrbo;
Daptomycin Hospira 350 mg powder for solution for injection/infusion daptomycin
Daptomicin Hospira 350 mg prašek za raztopino za injiciranje/infundiranje daptomicin
- 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.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - bolezni krvi (npr. zvečano število majhnih krvnih ploščic, ki jih imenujemo trombociti in ki lahko povečajo nagnjenost k strjevanju krvi, zvišane ravni nekaterih vrst belih krvnih celic) - pomanjkanje apetita - mravljinčenje ali odrevenelost dlani ali stopal, motnje okušanja - tresenje - spremembe srčnega ritma, vročinski oblivi - prebavne motnje (dispepsija), vnetje jezika - srbeč kožni izpuščaj - bolečine ali krči v mišicah ali mišična oslabelost, vnetje mišic (miozitis), bolečine v sklepih - težave z ledvicami - vnetje in draženje nožnice - splošne bolečine ali oslabelost, utrujenost - izvidi krvnih preiskav, ki kažejo zvišane vrednosti glukoze v krvi, kreatinina v serumu, mioglobina ali laktat-dehidrogenaze (LDH), podaljšan čas strjevanja krvi ali neravnovesje soli - srbeče oči
Each vial contains 350 mg daptomycin.
Ena viala vsebuje 350 mg daptomicina.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora neznana pogostnost *:
- Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.
Če se vam pojavijo taki simptomi, obvestite svojega zdravnika, ki bo odločil, ali lahko nadaljujete zdravljenje ali ne. -driska, posebno če opazite tudi kri ali sluz ali če driska postane huda ali trdovratna.
In the paediatric SAB study, the mean duration of IV Daptomycin Hospira was 12 days, with a range of 1 to 44 days.
V pediatrični SAB študiji je bilo srednje trajanje zdravljenja z daptomicinom i.v.
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.
Pediatrični bolniki z bakteriemijo z bakterijo Staphylococcus aureus Za oceno varnosti, učinkovitosti in farmakokinetike daptomicina pri pediatričnih bolnikih (od 1 do vključno 17 let starosti) z bakteriemijo z bakterijo Staphylococcus aureus so izvedli študijo 4. faze
Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Ko vlečete raztopino v injekcijsko brizgo, naj bo konica injekcijske igle v še vedno obrnjeni viali nameščena čisto na dnu raztopine v viali.
Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
glivične okužbe, okužbe sečil, okužba s kandido občasni:
Overall Success a rate in Paedatric cSSTI n/N (%)
Celotni delež uspeha a pri pediatričnih zapletenih okužbah kože in mehkih tkiv n/N (%)
A 50 mg/ml concentration of Daptomycin Hospira for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Koncentracijo 50 mg/ml zdravila Daptomicin Hospira za injiciranje dobimo z rekonstitucijo liofiliziranega zdravila s 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
A 50 mg/ml concentration of Daptomycin Hospira for infusion can be achieved by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Koncentracijo 50 mg/ml zdravila Daptomicin Hospira za infundiranje lahko dobimo z rekonstitucijo liofiliziranega zdravila s 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
Therefore caution should be exercised if Daptomycin Hospira is given to such patients.
Pri bolnikih s hudo okvaro jeter (Child-Pugh C) ni na voljo nobenih podatkov, zato je potrebna previdnost, če zdravilo daptomicin dajemo takšnim bolnikom.
A 50 mg/ml concentration of Daptomycin Hospira for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Koncentracijo 50 mg/ml zdravila Daptomicin Hospira za injiciranje dobimo z rekonstitucijo liofiliziranega zdravila z 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
Paediatric patients with SAB
Zapletene okužbe kože in mehkih tkiv (cSSTI) s SAB
A 50 mg/ml concentration of Daptomycin Hospira for infusion can be achieved by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Koncentracijo 50 mg/ml zdravila Daptomicin Hospira za infundiranje lahko dobimo z rekonstitucijo liofiliziranega zdravila z 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje.
One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
En mililiter po rekonstituciji s 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida vsebuje 50 mg daptomicina.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
En mililiter po rekonstituciji z 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida vsebuje 50 mg daptomicina.
You should not be given Daptomycin Hospira
Shranjevanje zdravila Daptomicin Hospira
Comparator
Odmerjanje
- Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Daptomicin je indiciran za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1): - pri odraslih in pediatričnih bolnikih (starih od 1 do 17 let) z zapletenimi okužbami kože in mehkih tkiv (cSSTI - Complicated Skin and Soft Tissue Infections).
Daptomycin Hospira 500 mg powder for solution for injection/infusion Powder for solution for injection/infusion.
Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje daptomicin i.v.
STATEMENT OF ACTIVE SUBSTANCE(S)
podaljšanje protrombinskega časa (PČ)
Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključki, podlaga za spremembo pogojev dovoljenj za promet z zdravilom ter podrobna obrazložitev znanstvenih razlogov za odstopanja od
EU Number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/99/122/001 Thyrogen
Vsebina (koncentracija)
3 hours before taking the other.
3 ure, preden vzamete drugo.
They are packed in bottles.
Pakirane so v stekleničkah.
After taking one of them, wait at least 2 to
Po zaužitju enega od teh zdravil počakajte vsaj 2 do
Date of first authorisation: 22 September 1998 Date of latest renewal: 03 September 2008
Datum prve odobritve: 22. september 1998 Datum zadnjega podaljšanja: 03. september 2008