FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - bolezni krvi (na primer zvečano število majhnih krvnih ploščic, ki jih imenujemo trombociti in lahko povečajo nagnjenje krvi k strjevanju, zvišane koncentracije nekaterih vrst belih krvnih celic), - zmanjšan apetit, - mravljinčenje ali odrevenelost dlani ali stopal, motnje okušanja, - tresenje, - spremembe srčnega ritma, navali rdečice, - prebavne težave (dispepsija), vnetje jezika, - srbeč kožni izpuščaj, - bolečine ali krči v mišicah ali šibkost mišic, vnetje mišic (miozitis), bolečine v sklepih, - težave z ledvicami, - vnetje in draženje v nožnici, - bolečine po celem telesu ali šibkost, utrujenost (izčrpanost), - izvidi preiskav krvi, ki kažejo zvišane vrednosti glukoze v krvi, kreatinina v serumu,
English: 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.
Slovenian: Če se pojavi kateri koli od spodaj navedenih simptomov, takoj povejte zdravniku ali medicinski sestri: - bolečina ali stiskanje v prsih, - izpuščaj z mehurčki, ki lahko prizadene usta in spolovila, - otekanje okrog grla in žrela, - hiter ali slaboten pulz, - piskajoče dihanje, - zvišana telesna temperatura, - tresenje ali drgetanje, - navali vročine, - omotičnost,
English: If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2C - 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Ta čas naj ne bi bil daljši od 24 ur pri 2 °C - 8 °C, razen če je bila rekonstitucija/razredčitev izvedena v nadzorovanih in validiranih aseptičnih pogojih.
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).
Slovenian: Kemijska in fizikalna stabilnost rekonstituirane raztopine v viali v času uporabe zdravila je bila dokazana za 12 ur pri 25 °C in do 48 ur, če je bila raztopina shranjena v hladilniku (2 °C - 8 °C).
English: No dose adjustment is necessary when administering Cubicin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (Child Pugh B) prilagajanje odmerka zdravila Cubicin ni potrebno (glejte poglavje 5.2).
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).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - glivične okužbe kot je ustni oprh ali gobice, - okužba sečil, - znižano število rdečih krvnih celic (anemija), - omotičnost, 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, - vetrovi, - napihnjenost ali napenjanje v trebuhu, - kožni izpuščaj ali srbenje, - bolečina, srbenje ali rdečina na mestu infundiranja, - bolečine v rokah ali nogah, - izvidi preiskav krvi, ki kažejo zvišane vrednosti jetrnih testov ali kreatin-fosfokinaze (CPK).
English: No preservative or bacteriostatic agent is present in this product.
Slovenian: Zdravilo ne vsebuje niti konzervansov niti bakteriostatičnih sredstev.
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.
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje 10-ml viale za enkratno uporabo iz prozornega stekla tipa I z gumijastimi zamaški tipa I in aluminijskimi zaporami z modrimi snemnimi zaporkami.
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.
Slovenian: Po enkratnem odmerku 4 mg/kg zdravila Cubicin sta bila celotni očistek, normaliziran glede na telesno maso, in eliminacijski razpolovni čas daptomicina pri mladostnikih (starih od 12 do 17 let) z grampozitivnimi okužbami podobna kot pri odraslih.
English: Powder for solution for injection or infusion A pale yellow to light brown lyophilised cake or powder.
Slovenian: prašek za raztopino za injiciranje ali infundiranje liofilizirana pogača ali prašek bledo rumene do svetlo rjave barve
English: The lyophilised product takes approximately 15 minutes to dissolve.
Slovenian: Liofilizirano zdravilo se raztopi v približno 15 minutah.
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.
Slovenian: Preden injekcijsko iglo izvlečete iz viale, potegnite bat povsem do konca cevi injekcijske brizge, tako da lahko iz obrnjene viale odstranite potrebno količino raztopine.
English: The specific cell surface component directly targeted has not been identified.
Slovenian: Niso pa ugotovili, na katero specifično strukturo celične površine daptomicin neposredno deluje.
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.
Slovenian: Pri bolnikih z okužbo umetne zaklopke ali z levostranskim infekcijskim endokarditisom zaradi bakterije Staphylococcus aureus učinkovitosti zdravila Cubicin niso dokazali.
English: Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Slovenian: Zdravilo Cubicin se sme rekonstituirati samo z raztopino natrijevega klorida 9 mg/ml (0,9 %).
English: Not known*: Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling, anaphylaxis**, infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste
Slovenian: preobčutljivost**, opisana v posameznih spontanih poročilih, ki med drugim vključujejo angioedem, z zdravilom povezani izpuščaj z eozinofilijo in sistemskimi simptomi (sindrom DRESS), pljučna eozinofilija, vezikulobulozni izpuščaj s prizadetostjo sluznic in občutek otekanja v ustih in požiralniku, anafilaksija**, infuzijske reakcije, ki vključujejo naslednje simptome: tahikardijo, piskanje pri dihanju, zvišano telesno temperaturo, okorelost, pordevanje po celem telesu, vrtoglavico, sinkopo in kovinski okus v ustih
English: However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in adult patients taking one of these medicinal products at the same time as Cubicin.
Slovenian: Vendar pa je pri odraslih bolnikih, ki so jemali ta zdravila sočasno z zdravilom Cubicin, v nekaj primerih prišlo do izrazitega porasta ravni CPK in do nekaj primerov rabdomiolize.
English: Use in elderly
Slovenian: Uporaba pri starejših
English: Although small changes in the pharmacokinetics of daptomycin and tobramycin were observed during coadministration by intravenous infusion over a 30-minute period using a Cubicin dose of 2 mg/kg, the changes were not statistically significant.
Slovenian: Pri sočasnem odmerjanju tobramicina z zdravilom Cubicin s 30-minutno intravensko infuzijo v odmerku 2 mg/kg so opažali manjše spremembe farmakokinetičnih lastnosti obeh zdravil, vendar spremembe niso bile statistično značilne.
English: Anaphylaxis/hypersensitivity reactions have been reported with Cubicin.
Slovenian: Pri uporabi zdravila Cubicin so poročali o anafilaktičnih/preobčutljivostnih reakcijah.
English: Drug/laboratory test interactions
Slovenian: Vpliv zdravila na rezultate laboratorijskih testov
English: Staphylococcus haemolyticus
Slovenian: Staphylococcus haemolyticus koagulaza negativni stafilokoki
English: • Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients.
Slovenian: • Vrednost CPK v plazmi je treba pri vseh bolnikih izmeriti pred začetkom zdravljenja kot izhodiščno vrednost in nato meritve izvajati med zdravljenjem v rednih intervalih (vsaj enkrat tedensko).
English: Expel air, large bubbles, and any excess solution in order to obtain the required dose.
Slovenian: Iztisnite zrak, velike mehurčke in morebitno odvečno količino raztopine, tako da pripravite predpisan odmerek.
English: Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/or following administration for prolonged periods.
Slovenian: Posebno pri zdravljenju bolnikov s hudimi okužbami, ki jih je težko zdraviti, in/ali po dolgotrajnejšem zdravljenju so poročali o sevih z zmanjšano občutljivostjo za daptomicin.
English: Using a new syringe, insert the needle into the inverted vial.
Slovenian: Vzemite novo injekcijsko brizgo in injekcijsko iglo vstavite v obrnjeno vialo.
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.
Slovenian: Zdravilo Cubicin prašek za raztopino za injiciranje ali infundiranje je na voljo v obliki pogače ali praška bledo rumene do svetlo rjave barve v stekleni viali.
English: - Known or suspected RIE due to Staphylococcus aureus: Cubicin 6 mg/kg is administered once every 24 hours.
Slovenian: - Dokazan desnostranski infekcijski endokarditis zaradi SAB ali sum nanj: Zdravilo Cubicin je treba dajati v odmerku 6 mg/kg vsakih 24 ur.
English: Cubicin 350 mg powder for solution for injection or infusion Each vial contains 350 mg daptomycin.
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje Ena viala vsebuje 350 mg daptomicina.
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension Uncommon: Dyspepsia, glossitis
Slovenian: bolečine v prebavilih in trebuhu, navzea, bruhanje, obstipacija, diareja, vetrovi, napihnjenost in napenjanje v trebuhu občasni:
English: Cubicin 500 mg powder for solution for injection or infusion Each vial contains 500 mg daptomycin.
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje Ena viala vsebuje 500 mg daptomicina.
English: EXP Read the leaflet for the shelf life of the reconstituted product
Slovenian: EXP Za rok uporabnosti rekonstituiranega zdravila glejte navodilo za uporabo.
English: 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.
Slovenian: Glivne okužbe, okužbe sečil, okužba s kandido, anemija, tesnoba, nespečnost, omotičnost, glavobol, hipertenzija, hipotenzija, bolečine v prebavilih in trebuhu, navzea, bruhanje, obstipacija, diareja, vetrovi, napihnjenost in napenjanje v trebuhu, patološke vrednosti testov jetrne funkcije (zvišane vrednosti alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST) ali alkalne fosfataze (ALP)), izpuščaj, srbenje, bolečine v okončinah, zvišana vrednost kreatin-fosfokinaze v serumu (CPK), reakcije na mestu infundiranja, zvišana telesna temperatura, astenija.
English: - New or worsening fever, cough or difficulty breathing.
Slovenian: - če pride do zvišane telesne temperature, kašlja ali oteženega dihanja oziroma poslabšanja navedenih simptomov.
English: When used by injection, reconstitute with 0.9% sodium chloride only.
Slovenian: Za vnos z injiciranjem pripravite zdravilo samo z 0,9 % raztopino natrijevega klorida.
English: Table 2 Mean (Standard Deviation) of Daptomycin Pharmacokinetics in Paediatric cSSTI Patients (1 to 17 Years of Age) in Study DAP-PEDS-07-03
Slovenian: 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 DAPPEDS-07-03 Razpon starosti
English: Methicillin-resistant Staphylococcus aureus (MRSA)
Slovenian: Na meticilin odporen sev Staphylococcus aureus (MRSA)
English: Microbiological Success rate in Paediatric SAB n/N (%)
Slovenian: Mikrobiološki delež uspeha pri pediatričnih bolnikih z bakteriemijo z bakterijo Staphylococcus aureus n/N (%)
English: Using a syringe, insert the needle into the inverted vial.
Slovenian: Vzemite injekcijsko brizgo in injekcijsko iglo vstavite v obrnjeno vialo.
English: Caution is warranted when Cubicin is co-administered with tobramycin.
Slovenian: Pri sočasni uporabi zdravila Cubicin s tobramicinom je potrebna previdnost.
English: - Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).
Slovenian: Glejte poglavji 4.4 in 5.1; - pri odraslih in pediatričnih bolnikih (starih od 1 do 17 let) z bakteriemijo z bakterijo Staphylococcus aureus (SAB).
English: - cSSTI with concurrent SAB: Cubicin 6 mg/kg is administered once every 24 hours.
Slovenian: - Zapletene okužbe kože in mehkih tkiv s sočasno SAB: Zdravilo Cubicin je treba dajati v odmerku 6 mg/kg vsakih 24 ur.
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
Slovenian: Pri dajanju enkratnih 30-minutnih intravenskih odmerkov daptomicina 4 mg/kg ali 6 mg/kg odraslim osebam z različnimi stopnjami okvare ledvic se je s slabšanjem ledvične funkcije (zmanjševanjem očistka kreatinina) njihov celotni očistek daptomicina (CL) zmanjševal, sistemska izpostavljenost (AUC) pa povečevala.
English: - That Cubicin can interfere with coagulation tests (PT/INR) and this might lead to false results.
Slovenian: Pri bolnikih s povečanim tveganjem za nastanek miopatij je treba vrednosti kreatin-fosfokinaze meriti bolj pogosto, - zdravilo Cubicin lahko moti koagulacijske teste za določanje protrombinskega časa/mednarodnega normaliziranega razmerja (PT/INR), zato lahko pride do napačnih rezultatov.
English: Vigorous shaking/agitation should be avoided to prevent foaming of the product.
Slovenian: Izogibajte se močnemu stresanju, da se zdravilo ne začne peniti.
English: Summary of Blinded Evaluator defined clinical outcome at TOC: Clinical Success in Paediatric SAB Daptomycin n/N (%)
Slovenian: Povzetek kliničnih izidov ocenjenih s slepim načinom ocenjevanja pri testu ozdravitve: Klinični uspeh pri pediatričnih bolnikih z bakteriemijo z bakterijo Staphylococcus aureus
English: The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Slovenian: Aztreonam ni bistveno vplival na farmakokinetične lastnosti daptomicina.
English: • Age group 1 (n=113): 12 to 17 years treated with daptomycin dosed at 5 mg/kg or standard-of care comparator (SOC);
Slovenian: • 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;
English: - Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.
Slovenian: Če pride do navedenega, obvestite zdravnika, ki bo odločil, ali morate nadaljevati zdravljenje ali ne. - driska, še posebej, če opazite zraven še kri ali sluz ali če driska postane huda ali trdovratna.
English: Cubicin 500 mg powder for solution for injection or infusion daptomycin
Slovenian: Cubicin 500 mg prašek za raztopino za injiciranje ali infundiranje daptomicin
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.
Slovenian: Zdravilo Cubicin za vnos s 30- oziroma 60-minutno intravensko infuzijo Koncentracijo 50 mg/ml zdravila Cubicin 350 mg prašek za vnos z infuzijo je mogoče pripraviti z rekonstitucijo liofiliziranega zdravila s 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Cubicin 350 mg powder for solution for injection or infusion daptomycin
Slovenian: Cubicin 350 mg prašek za raztopino za injiciranje ali infundiranje daptomicin
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.
Slovenian: Z novo sterilno iglo premera 21 G ali manj počasi povlecite ustrezno rekonstituirano tekočino (50 mg daptomicina/ml) iz viale tako, da vialo obrnete in raztopina lahko steče proti zamašku.
English: To prepare Cubicin for intravenous injection, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.
Slovenian: Pri pripravljanju zdravila Cubicin za intravensko injiciranje upoštevajte naslednja navodila: Za rekonstitucijo liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: One vial of powder contains 350 mg daptomycin.
Slovenian: Ena viala s praškom vsebuje 350 mg daptomicina.
English: Posology
Slovenian: vaginitis
English: Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
Slovenian: trombocitemija, eozinofilija, zvišanje vrednosti mednarodnega normaliziranega razmerja (INR), levkocitoza redki: neznana pogostnost*:
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.
Slovenian: S sterilno iglo premera 21 G ali manj počasi povlecite rekonstituirano tekočino (50 mg daptomicina/ml) iz viale.
English: One vial of powder contains 500 mg daptomycin.
Slovenian: Ena viala s praškom vsebuje 500 mg daptomicina.
English: 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 into the vial pointing the needle towards the wall of the vial.
Slovenian: S sterilno iglo za prenos premera 21 G ali manj ali z brezigelnim pripomočkom v injekcijsko brizgo povlecite 7 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje in jo nato skozi sredino gumijastega zamaška počasi vbrizgajte v vialo, pri tem naj bo igla usmerjena proti steni viale.
English: Methicillin-susceptible Staphylococcus aureus (MSSA)
Slovenian: Na meticilin občutljiv sev Staphylococcus aureus (MSSA)
English: 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 into the vial pointing the needle towards the wall of the vial.
Slovenian: S sterilno iglo za prenos premera 21 G ali manj ali z brezigelnim pripomočkom v injekcijsko brizgo povlecite 10 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje in jo nato skozi sredino gumijastega zamaška počasi vbrizgajte v vialo, pri tem naj bo igla usmerjena proti steni viale.
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic studies and modelling results (see sections 4.4 and 5.2).
Slovenian: (1) Varnost in učinkovitost prilagajanja intervalov med odmerki nista bili ovrednoteni v kontroliranih kliničnih preskušanjih in priporočila temeljijo na farmakokinetičnih študijah in rezultatih modeliranja (glejte poglavji 4.4 in 5.2).
English: For Dilution:
Slovenian: Za redčenje:
English: To prepare Cubicin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute or dilute lyophilised Cubicin.
Slovenian: Pri pripravljanju zdravila Cubicin za intravensko infundiranje upoštevajte naslednja navodila: Za rekonstitucijo ali redčenje liofiliziranega zdravila Cubicin je treba med celotnim postopkom uporabljati aseptično tehniko.
English: • Age group 1 (n=21): 12 to 17 years treated with daptomycin dosed at 7 mg/kg or SOC
Slovenian: • 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;
English: Cardiac disorders
Slovenian: Desnostranski infekcijski endokarditis
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.
Slovenian: 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).
English: - That daptomycin susceptibility testing needs Ca in the testing medium and testing methods with mediums providing consistent Ca concentrations are recommended.
Slovenian: Priporočena je uporaba testnih metod, ki zagotavljajo stalno koncentracijo kalcija v testnem mediju.
English: 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.
Slovenian: Pokazalo se je, da je po odmerjanju daptomicina s 30-minutno intravensko infuzijo ali z 2-minutno intravensko injekcijo izpostavljenost zdravilu (AUC in Cmax) pri zdravih odraslih preiskovancih medsebojno primerljiva.
English: Obesity
Slovenian: Dojenje
English: Overall Success a rate in Paediatric cSSTI n/N (%)
Slovenian: Celotni delež uspeha a pri pediatričnih zapletenih okužbah kože in mehkih tkiv n/N (%)