natgillin/translations-raw huggingface dataset:
Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low potential to alter the disposition of other medicinal products (see section 5.2).
Na podlagi in vitro podatkov o presnavljajočih encimih in prenašalcih, ima delafloksacin majhen potencial za spremembo učinka drugih zdravil (glejte poglavje 5.2).
Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Zdravilo Quofenix je indicirano za zdravljenje akutnih bakterijskih okuţ b koţ e in koţ nih struktur (ABSSSI - acute bacterial skin and skin structure infections) pri odraslih, kadar uporaba drugih protibakterijskih zdravil, ki se običajno priporočajo za začetno zdravljenje teh okuţ b, ni primerna (glejte poglavji 4.4 in 5.1).
However, delafloxacin should not be co-administered with any solution containing multivalent cations, e.g. magnesium, through the same intravenous line (see section 4.2 and
Vendar pa se delafloksacina skozi isto intravensko linijo ne sme dajati skupaj z nobeno raztopino, ki vsebuje večvalentne katione, npr. magnezij (glejte poglavji 4.2 in 6.2).
There are no or limited amount of data from the use of delafloxacin in pregnant women.
O uporabi delafloksacina pri nosečnicah podatkov ni ali so omejeni.
Quofenix is an antibiotic that contains the active substance delafloxacin.
Zdravilo Quofenix je antibiotik, ki vsebuje učinkovino delafloksacin.
Therefore, delafloxacin should be used with caution in these patients.
Zato je pri teh bolnikih delafloksacin treba uporabljati previdno.
Delafloxacin is excreted both unchanged and as glucuronide metabolites in urine.
Delafloksacin se izloča v nespremenjeni obliki in kot presnovki glukuronida v urinu.
Quofenix must not be co-infused with other medications.
Zdravila Quofenix ne smete infundirati sočasno z drugimi zdravili.
• Muscle weakness in the extremities
• mišična šibkost v okončinah
It is available in perforated unit dose blister pack which contains blisters of 10x1 tablets into pack size of 10,20,30,50, 60 or 100 tablets per carton.
Na voljo so v perforiranih deljivih pretisnih omotih s posameznimi odmerki, ki vsebujejo pretisne omote po 10x1 tableto in so pakirani v škatle z 10, 20, 30, 50, 60 ali 100 tabletami.
The use of delafloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Izogibati se je potrebno uporabi delafloksacina pri bolnikih, ki so imeli v preteklosti resne neţ elene učinke pri uporabi zdravil, ki vsebujejo kinolon ali fluorokinolon (glejte poglavje 4.8).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve:
• Inflammation of joints, pain in hands or feet, back pain, muscle spasm
• vnetje sklepov, bolečine v dlaneh in stopalih, bolečina v hrbtu, mišični krči
Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated disease is suspected.
Zdravila, ki zavirajo peristaltiko, so kontraindicirana, če obstaja sum na bolezen, povezano s Clostridioides difficile.
If women of a sexually mature age are treated, effective contraception must be used during treatment (see section 4.6).
Če se zdravijo spolno zrele ţ enske, je treba med zdravljenjem uporabiti učinkovito kontracepcijo (glejte poglavje 4.6).
In rats foetal effects occurred at a level of exposure exceeding about 2fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of exposure well below that observed in humans.
Pri podganah so se pojavili učinki na plod pri izpostavljenosti, ki je bila pribliţ no 2krat višja kot pri ljudeh, ob upoštevanju AUC, medtem ko so pri kuncih, za katere je znano, da so zelo občutljivi na toksičnost protibakterijskih zdravil, učinke na plod opazili pri ravneh izpostavljenosti precej pod izpostavljenostjo, ki je primerna za človeka.
These adverse reactions may occur following the first dose.
Ti neţ eleni učinki se lahko pojavijo po prvem odmerku.
This medicine contains 39 mg of sodium (main component of cooking salt) in each tablet.
To zdravilo vsebuje 39 mg natrija (glavne sestavine kuhinjske soli) na tableto.
• Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii,
• Skupina Streptococcus mitis (vključno s Streptococcus cristatus, Streptococcus gordonii,
The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 patients exposed to delafloxacin, intravenous or oral formulation, were diarrhoea and nausea (6.91% and 7.83%, respectively) which were mild to moderate in intensity.
Najpogostejši neţ eleni učinki, o katerih so poročali v študijah faze 2 in 3 ABSSSI, ki so vključevale 868 bolnikov, ki so bili izpostavljeni delafloksacinu, bodisi v intravenski ali peroralni obliki, sta bili driska in navzea (6,91 % oziroma 7,83 %), ki sta bili blagi do zmerno intenzivni.
Peak exposure (Cmax) was not statistically significantly different between renal impaired and healthy subjects.
Najvišja izpostavljenost (Cmax) ni bila statistično pomembno različna za bolnike z ledvično okvaro in za zdrave osebe.
Quofenix is a beige to mottled beige, oblong biconvex tablets, with RX3341 debossed on one side.
Quofenix tablete so beţ do pikčasto beţ barve, podolgovate bikonveksne tablete z vtisnjeno oznako RX3341 na eni strani.
Quofenix has moderate influence on the ability to drive and use machines.
Zdravilo Quofenix ima zmeren vpliv na sposobnost voţ nje in upravljanja strojev.
No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min).
Pri bolnikih z blagimi do zmernimi motnjami v delovanju ledvic, prilagoditev odmerka ni potrebna (CrCl ≥ 30 ml/min).
This medicinal product contains sulfobutylbetadex sodium.
To zdravilo vsebuje natrijev sulfobutilbetaciklodekstrin.
The glucuronidation of delafloxacin is mediated mainly by UGT1A1,UGT1A3 and UGT2B15.
Glukuronidacijo delafloksacina posredujejo večinoma UGT1A1, UGT1A3 in UGT2B15.
20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.
20-ml prozorne viale iz stekla tipa I so zaprte z gumijastim zamaškom tipa I velikosti 20 mm in 20 mm pokrovčki (flip-off).
Delafloxacin may be administered with or without food as total systemic exposure (AUC∞) is unchanged between fasted and fed (high-fat, high-calorie) conditions.
Delafloksacin se lahko vzame s hrano ali brez nje, saj ostane skupna sistemska izpostavljenost (AUC∞) nespremenjena ne glede na to ali se ga vzame pred ali po obroku (bogat z maščobami, visoko kalorični).
Hypoglycaemia (see section 4.4) Hyperglycaemia (see section 4.4) Decreased appetite
Hipoglikemija (glejte poglavje 4.4) Hiperglikemija (glejte poglavje 4.4) Zmanjšan apetit
Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism representing <1% of an administered dose.
Glukuronidacija delafloksacina je glavna presnovna pot, oksidativna presnova, ki predstavlja < 1 % apliciranega odmerka.
• You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
• so vam postavili diagnozo povečanja ali „izbokline“ velike krvne ţile (aortna anevrizma ali periferna anevrizma velike ţ ile);
Before initiating therapy with Quofenix, careful inquiry should be made about previous hypersensitivity reactions to other quinolone or fluoroquinolone antibacterial medicinal products.
Pred uporabo zdravila Quofenix je pomembno, da se natančno pozanimate o predhodnih preobčutljivostnih reakcijah na druga kinolonska in fluorokinolonska protibakterijska zdravila.
Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis)
Streptococcus oralis, Streptococcus mitis in Streptococcus sanguinis)
Abnormal dreams
• neobičajne sanje
• Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
• Skupina Streptococcus anginosus (vključno s Streptococcus anginosus, Streptococcus intermedius in Streptococcus constellatus)
For the full list of excipients, see section 6.1.
Za celoten seznam pomoţ nih snovi glejte poglavje 6.1.
Delafloxacin tablets can be taken with or without food.
Tablete delafloksacina se lahko zauţ ije skupaj s hrano ali brez nje.
However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.
Vendar pa Quofenixa skozi isto intravensko linijo ne smemo aplicirati skupaj z nobeno raztopino, ki vsebuje snovi, kot sta kalcij in magnezij.
Other types of skin infections have not been studied.
Drugih vrst koţ nih okuţ b niso preučevali.
This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
The radioactivity recovered from faeces is unchanged delafloxacin.
Radioaktivnost, pridobljena v blatu, je nespremenjen delafloksacin.
Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP.
Prav tako v klinično pomembnih koncentracijah, delafloksacin ne zavira prenašalcev MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K in BSEP.
Intravenous use after reconstitution and dilution.
Za intravensko uporabo po rekonstituciji in redčenju.
Each vial contains 175 mg of sodium.
Ena viala vsebuje 175 mg natrija.
Effect of other medicinal products on delafloxacin
Učinek drugih zdravil na delafloksacin
The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Najvišji dnevni intravenski odmerek v kliničnih študijah je bil 1200 mg; bolniki, ki so prejeli ta odmerek med študijo niso imeli nobenih neţ elenih učinkov ali klinično pomembnih sprememb izvidov laboratorijskih preiskav.
• Flushing (e.g. redness of the face or neck)
• vročinski oblivi (npr. rdečica obraza in vratu)
Importantly, gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with histopathological changes of gastrointestinal and annexed tissues (pancreas, liver).
Pomembno je, da gastrointestinalni učinki in rahlo povišani jetrni encimi pri psih niso bili povezani s histopatološkimi spremembami prebavil in povezanih tkiv (trebušne slinavke, jeter).
• Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased,
• spremembe krvnih testov zaradi sprememb v delovanju ledvic ali jeter (povišane vrednosti alkalne fosfataze, zmanjšane vrednosti albumina)
The vial contains light yellow to tan cake powder.
Viala vsebuje prah svetlo rumen do beţ barve.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
This medicinal product contains 175 mg sodium per vial, equivalent to 8.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 175 mg natrija na vialo, kar je enako 8,8 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
In repeat dose toxicity studies in rats and dogs, gastrointestinal effects were the main findings: these included dilated cecum (oral only), abnormal stool, and decreased food intake and / or body weight in rats, and emesis, salivation and abnormal stool / diarrhoea in dogs.
V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah in psih so bile glavne ugotovitve gastrointestinalni učinki: ti so vključevali razširjen cekum (samo po peroralnem odmerjanju), nenormalno blato in zmanjšan vnos hrane in/ali zniţ anje telesne mase pri podganah ter bruhanje, slinjenje in nenormalno blato/driska pri psih.
Clostridioides difficile-associated disease has been reported in users of nearly all systemic antibacterial medicinal products, with severity ranging from mild diarrhoea to fatal colitis.
O bolezni, povezani s Clostridioides difficile so poročali pri skoraj vseh uporabnikih sistemskih protibakterijskih zdravil, resnost pa sega od blage diareje do smrtno nevarnega kolitisa.
The highest daily oral dose administered in clinical studies was 1600 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Najvišji dnevni peroralni odmerek v kliničnih študijah je bil 1600 mg; bolniki, ki so prejeli ta odmerek, med študijo niso imeli nobenih neţ elenih učinkov ali klinično pomembnih sprememb izvidov laboratorijskih preiskav.
Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity is excreted in the urine as unchanged delafloxacin and glucuronide metabolites and 48% is excreted unchanged in the faeces.
C, se 50 % radioaktivnosti izloči z urinom v nespremenjeni obliki in kot presnovek glukuronida ter 48 % nespremenjenega z blatom.
Patients with known hypersensitivity to delafloxacin or other fluoroquinolones must not take Quofenix (see section 4.3).
Bolniki z znano preobčutljivostjo na delafloksacin ali druge fluorokinolone ne smejo jemati zdravila Quofenix (glejte poglavje 4.3).
The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion.
Priporočen odmerek je 300 mg delafloksacina v obliki 60-minutne intravenske infuzije na 12 ur.
• Muscle inflammation/pain
• vnetje mišic/bolečina
These may be signs of an infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels from moving.
To so lahko znaki okuţ be črevesja in se ne smejo zdraviti z zdravili proti driski, ki zaustavijo črevesno peristaltiko.
Cases of hypoglycaemic coma have been reported.
Opisani so primeri hipoglikemične kome.
If an anaphylactic reaction to Quofenix occurs, the medicinal product should be discontinued immediately and appropriate therapy should be instituted.
Če pri uporabi zdravila Quofenix pride do anafilaktične reakcije, je treba zdravljenje z zdravilom nemudoma prekiniti in uvesti ustrezno zdravljenje.
As delafloxacin is excreted in milk, severe toxicity was observed in newborn rats during lactation when mothers were treated during pregnancy and lactation with delafloxacin at a dose producing a systemic exposure about 5-fold higher than observed in humans.
Ker se delafloksacin izloča v mleko, so pri novorojenih podganah v času laktacije opazili hudo toksičnost pri samicah, ki so bile med brejostjo in laktacijo zdravljene z delafloksacinom v odmerku, ki je povzročil sistemsko izpostavljenost, pribliţ no 5-krat višjo kot pri ljudeh.
This medicinal product contains 39 mg sodium per tablet, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 39 mg natrija na tableto, kar je enako 2 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
Chelation active substance: antacids, sucralfate, metal cations, multivitamins There are no data concerning an interaction of intravenous delafloxacin with multivitamins, didanosine, or metal cations.
Kelacijske učinkovine: antacidi, sukralfat, kovinski kationi, multivitamini Podatkov o interakciji intravenskega delafloksacina z multivitamini, didanozinom ali kovinskimi kationi, ni.
• Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
• oteklina, rdečina ali bolečina okoli mesta dajanja injekcije v veno (reakcija na mestu infundiranja)
Read the package leaflet before use.
POSTOPEK UPORABE Pred uporabo preberite priloţ eno navodilo!
Effect of delafloxacin on other medicinal products
Učinek delafloksacina na druga zdravila
Oral administration of delafloxacin with antacids containing aluminium or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the paediatric powder for oral solution, may substantially interfere with the absorption of delafloxacin, resulting in systemic concentrations considerably lower than desired.
Peroralno dajanje delafloksacina z antacidi, ki vsebujejo aluminij ali magnezij, s sukralfatom, s kovinskimi kationi, kot je ţ elezo, ali z multivitamini, ki vsebujejo ţ elezo ali cink, ali s oblikami, ki vsebujejo dvovalentne in trivalentne katione, kot so didanozinijeve puferske tablete za peroralno suspenzijo ali pediatrični prašek za peroralno raztopino, lahko pomembno moti absorpcijo delafloksacina, kar ima za posledico sistemske koncentracije, znatno niţ je od ţ elenih.
Following intravenous use of 300 mg delafloxacin every 12 hours, steady state concentrations are achieved after approximately 3-5 days with about 10% accumulation after multiple administrations.
Po intravenski uporabi 300 mg delafloksacina vsakih 12 ur je stanje dinamičnega ravnovesja doseţ eno po pribliţ no 3-5 dneh, s pribliţ no 10 % kopičenjem po večkratnem apliciranju.
Delafloxacin does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5.
Delafloksacin ne inducira encima CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 ali CYP3A4/5.
Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with other quinolones.
Bolniki z druţ insko anamnezo ali dokazanim pomanjkanjem glukoze-6-fosfat dehidrogenaze so nagnjeni k hemolitičnim reakcijam med zdravljenjem z drugimi kinoloni.
Delafloxacin should be used when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.
Delafloksacin je treba uporabiti, kadar koristi zdravljenja presegajo tveganja pri bolnikih z znanimi ali motnjami CNS ali sumom nanje (npr. huda cerebralna arterioskleroza, epilepsija) ali ob prisotnosti drugih dejavnikov tveganja, ki lahko povzročijo napade ali zniţ ajo prag napadov.
Peak concentrations for the mild and moderate renal impairment patients were similar to that of healthy subjects, whereas peak concentrations were 2.1-fold, 5.9-fold and 6.4-fold higher for patients with severe renal impairment and ESRD on haemodialysis with and without haemodialysis after dosing, respectively.
Najvišje koncentracije pri blagih in zmernih ledvičnih okvarah so bile podobne kot pri zdravih kontrolnih osebah, medtem ko so bile najvišje koncentracije 2,1-krat, 5,9-krat in 6,4-krat višje pri bolnikih s hudo okvaro ledvic in s končno ledvično odpovedjo na hemodializi, s hemodializo po aplikaciji in brez nje.
In the absence of human data and findings in non-clinical studies at human therapeutic exposures, delafloxacin is contraindicated during pregnancy and in women of childbearing potential not using contraception (see sections 4.3 and 4.4).
Ker podatkov in ugotovitev v predkliničnih študij pri izpostavljenosti odmerkov, ki ustrezajo terapevtskim odmerkom pri ljudeh, ni, je delafloksacin kontraindiciran med nosečnostjo in pri ţ enskah v rodni dobi, ki ne uporabljajo kontracepcije (glejte poglavji 4.3 in 4.4).
Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.
Črevesna okuţ ba (okuţ ba z bakterijo Clostridioides difficile) je občasni neţ eleni učinek in se lahko pojavi pri največ 1 od 100 bolnikov.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neporabljeno zdravilo ali odpadni material je potrebno odstraniti v skladu z lokalnimi predpisi.
Unchanged parent drug is the predominant component in plasma.
Prevladujoča oblika v plazmi je nespremenjeno matično zdravilo.
• Low haemoglobin level (anaemia)
• nizek hemaglobin (anemija)
Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.
Fluorokinoloni lahko povzročijo tudi reakcije CNS kot so ţ ivčnost, vznemirjenost, nespečnost, tesnoba, nočne more, paranoja, omotica, zmedenost, tresenje, halucinacije, depresija in samomorilne misli ali dejanja.
Psychiatric disorders*
Psihiatrične motnje*
Women of childbearing potential have to use effective contraception during treatment with delafloxacin.
Ţenske v rodni dobi morajo med zdravljenjem z delafloksacinom uporabljati učinkovito kontracepcijo.
Tendonitis (see section 4.4) Musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness Muscle spasm
Tendonitis (glejte poglavje 4.4) Mišično-skeletne bolečine (npr. bolečina v okončinah, v hrbtu, v vratu), mišična šibkost Mišični krči
For storage conditions after dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila po redčenju glejte poglavje 6.3.
Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length, with RX3341 debossed on one side.
Podolgovate bikonveksne tablete od beţ do lisaste beţ barve, pribliţ no 10 mm širine x 21 mm dolţ ine, ki imajo na eni strani vtisnjeno oznako RX3341.
• Burning sensation in the mouth
• pekoč občutek v ustih
Previous history of tendon disorders related to fluoroquinolone administration.
Pretekle bolezni tetiv, povezane z uporabo fluorokinolonov.
• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
• Redko se lahko pojavijo bolečina in otekanje sklepov ter vnetje ali pretrganje tetiv.
Peripheral neuropathy (including paraesthesia and hypoaesthesia) (see section 4.4)
Periferna nevropatija (vključno s parestezijo in hipestezijo) (glejte poglavje 4.4)
Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Fluorokinoloni blokirajo ţ ivčno-mišične povezave in pri bolnikih z miastenijo gravis lahko poslabšajo šibkost mišic.
The half-life of IV delafloxacin is approximately 10 hours.
Razpolovni čas intravensko danega delafloksacina je pribliţ no 10 ur.
In patients with moderate to severe renal impairment, accumulation of cyclodextrins occurs.
Pri bolnikih z zmerno do hudo okvaro ledvic se lahko pojavi kopičenje ciklodekstrinov.
Quofenix contains sodium
Zdravilo Quofenix vsebuje natrij
In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose producing maternal toxicity.
V študijah razvoja zarodkov in plodov pri podganah in kuncih, delafloksacin ni imel teratogenih učinkov, vendar je bilo pri apliciranju odmerkov, toksičnih za samico, opaziti zakasnitev rasti in osifikacije fetusa.
The 450-mg tablet and 300-mg IV formulations are bioequivalent with regard to total exposure (AUC).
450-mg tableta in 300-mg intravenska oblika sta bioekvivalentni glede na skupno izpostavljenost (AUC).
The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC).
300-mg intravenska oblika in 450-mg tableta sta bioekvivalentni glede na skupno izpostavljenost (AUC).
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite katere koli neţ elene učinke, ki niso navedeni v tem navodilu.
Medical device complication
Zapleti z medicinskim pripomočkom
Each vial contains 2480 mg of sulfobutylbetadex sodium.
Ena viala vsebuje 2480 mg natrijevega sulfobutilbetaciklodekstrina.
Dermatitis allergic Urticaria
Alergijski dermatitis Urtikarija