FrancophonIA/ELRC3.0 huggingface dataset:
English: • Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
Slovenian: • Skupina Streptococcus anginosus (vključno s Streptococcus anginosus, Streptococcus intermedius in Streptococcus constellatus)
English: For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomoţ nih snovi glejte poglavje 6.1.
English: Delafloxacin tablets can be taken with or without food.
Slovenian: Tablete delafloksacina se lahko zauţ ije skupaj s hrano ali brez nje.
English: However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.
Slovenian: Vendar pa Quofenixa skozi isto intravensko linijo ne smemo aplicirati skupaj z nobeno raztopino, ki vsebuje snovi, kot sta kalcij in magnezij.
English: Other types of skin infections have not been studied.
Slovenian: Drugih vrst koţ nih okuţ b niso preučevali.
English: This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: The radioactivity recovered from faeces is unchanged delafloxacin.
Slovenian: Radioaktivnost, pridobljena v blatu, je nespremenjen delafloksacin.
English: Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP.
Slovenian: Prav tako v klinično pomembnih koncentracijah, delafloksacin ne zavira prenašalcev MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K in BSEP.
English: Intravenous use after reconstitution and dilution.
Slovenian: Za intravensko uporabo po rekonstituciji in redčenju.
English: Each vial contains 175 mg of sodium.
Slovenian: Ena viala vsebuje 175 mg natrija.
English: Effect of other medicinal products on delafloxacin
Slovenian: Učinek drugih zdravil na delafloksacin
English: 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.
Slovenian: 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.
English: • Flushing (e.g. redness of the face or neck)
Slovenian: • vročinski oblivi (npr. rdečica obraza in vratu)
English: Importantly, gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with histopathological changes of gastrointestinal and annexed tissues (pancreas, liver).
Slovenian: 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).
English: • Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased,
Slovenian: • spremembe krvnih testov zaradi sprememb v delovanju ledvic ali jeter (povišane vrednosti alkalne fosfataze, zmanjšane vrednosti albumina)
English: The vial contains light yellow to tan cake powder.
Slovenian: Viala vsebuje prah svetlo rumen do beţ barve.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: C, se 50 % radioaktivnosti izloči z urinom v nespremenjeni obliki in kot presnovek glukuronida ter 48 % nespremenjenega z blatom.
English: Patients with known hypersensitivity to delafloxacin or other fluoroquinolones must not take Quofenix (see section 4.3).
Slovenian: Bolniki z znano preobčutljivostjo na delafloksacin ali druge fluorokinolone ne smejo jemati zdravila Quofenix (glejte poglavje 4.3).
English: The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion.
Slovenian: Priporočen odmerek je 300 mg delafloksacina v obliki 60-minutne intravenske infuzije na 12 ur.
English: • Muscle inflammation/pain
Slovenian: • vnetje mišic/bolečina
English: These may be signs of an infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels from moving.
Slovenian: To so lahko znaki okuţ be črevesja in se ne smejo zdraviti z zdravili proti driski, ki zaustavijo črevesno peristaltiko.
English: Cases of hypoglycaemic coma have been reported.
Slovenian: Opisani so primeri hipoglikemične kome.
English: If an anaphylactic reaction to Quofenix occurs, the medicinal product should be discontinued immediately and appropriate therapy should be instituted.
Slovenian: Če pri uporabi zdravila Quofenix pride do anafilaktične reakcije, je treba zdravljenje z zdravilom nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Chelation active substance: antacids, sucralfate, metal cations, multivitamins There are no data concerning an interaction of intravenous delafloxacin with multivitamins, didanosine, or metal cations.
Slovenian: Kelacijske učinkovine: antacidi, sukralfat, kovinski kationi, multivitamini Podatkov o interakciji intravenskega delafloksacina z multivitamini, didanozinom ali kovinskimi kationi, ni.
English: • Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
Slovenian: • oteklina, rdečina ali bolečina okoli mesta dajanja injekcije v veno (reakcija na mestu infundiranja)
English: Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloţ eno navodilo!
English: Effect of delafloxacin on other medicinal products
Slovenian: Učinek delafloksacina na druga zdravila
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Delafloxacin does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5.
Slovenian: Delafloksacin ne inducira encima CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 ali CYP3A4/5.
English: Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with other quinolones.
Slovenian: Bolniki z druţ insko anamnezo ali dokazanim pomanjkanjem glukoze-6-fosfat dehidrogenaze so nagnjeni k hemolitičnim reakcijam med zdravljenjem z drugimi kinoloni.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.
Slovenian: Črevesna okuţ ba (okuţ ba z bakterijo Clostridioides difficile) je občasni neţ eleni učinek in se lahko pojavi pri največ 1 od 100 bolnikov.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neporabljeno zdravilo ali odpadni material je potrebno odstraniti v skladu z lokalnimi predpisi.
English: Unchanged parent drug is the predominant component in plasma.
Slovenian: Prevladujoča oblika v plazmi je nespremenjeno matično zdravilo.
English: • Low haemoglobin level (anaemia)
Slovenian: • nizek hemaglobin (anemija)
English: Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.
Slovenian: 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.
English: Psychiatric disorders*
Slovenian: Psihiatrične motnje*
English: Women of childbearing potential have to use effective contraception during treatment with delafloxacin.
Slovenian: Ţenske v rodni dobi morajo med zdravljenjem z delafloksacinom uporabljati učinkovito kontracepcijo.
English: Tendonitis (see section 4.4) Musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness Muscle spasm
Slovenian: Tendonitis (glejte poglavje 4.4) Mišično-skeletne bolečine (npr. bolečina v okončinah, v hrbtu, v vratu), mišična šibkost Mišični krči
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po redčenju glejte poglavje 6.3.
English: Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length, with RX3341 debossed on one side.
Slovenian: 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.
English: • Burning sensation in the mouth
Slovenian: • pekoč občutek v ustih
English: Previous history of tendon disorders related to fluoroquinolone administration.
Slovenian: Pretekle bolezni tetiv, povezane z uporabo fluorokinolonov.
English: • Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Slovenian: • Redko se lahko pojavijo bolečina in otekanje sklepov ter vnetje ali pretrganje tetiv.
English: Peripheral neuropathy (including paraesthesia and hypoaesthesia) (see section 4.4)
Slovenian: Periferna nevropatija (vključno s parestezijo in hipestezijo) (glejte poglavje 4.4)
English: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Slovenian: Fluorokinoloni blokirajo ţ ivčno-mišične povezave in pri bolnikih z miastenijo gravis lahko poslabšajo šibkost mišic.
English: The half-life of IV delafloxacin is approximately 10 hours.
Slovenian: Razpolovni čas intravensko danega delafloksacina je pribliţ no 10 ur.
English: In patients with moderate to severe renal impairment, accumulation of cyclodextrins occurs.
Slovenian: Pri bolnikih z zmerno do hudo okvaro ledvic se lahko pojavi kopičenje ciklodekstrinov.
English: Quofenix contains sodium
Slovenian: Zdravilo Quofenix vsebuje natrij
English: 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.
Slovenian: 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.
English: The 450-mg tablet and 300-mg IV formulations are bioequivalent with regard to total exposure (AUC).
Slovenian: 450-mg tableta in 300-mg intravenska oblika sta bioekvivalentni glede na skupno izpostavljenost (AUC).
English: The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC).
Slovenian: 300-mg intravenska oblika in 450-mg tableta sta bioekvivalentni glede na skupno izpostavljenost (AUC).
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neţ elene učinke, ki niso navedeni v tem navodilu.
English: Medical device complication
Slovenian: Zapleti z medicinskim pripomočkom
English: Each vial contains 2480 mg of sulfobutylbetadex sodium.
Slovenian: Ena viala vsebuje 2480 mg natrijevega sulfobutilbetaciklodekstrina.
English: Dermatitis allergic Urticaria
Slovenian: Alergijski dermatitis Urtikarija
English: In patients with moderate, or severe renal impairment or ESRD on haemodialysis, accumulation of the intravenous vehicle sulfobutylbetadex sodium occurs.
Slovenian: Pri bolnikih z zmerno ali hudo prizadetim delovanjem ledvic ali s končno ledvično odpovedjo na hemodializi, se pojavi kopičenje intravenskega nosilca natrijevega sulfobutilbetaciklodekstrina.
English: If a common intravenous line is being used to administer other medicinal products in addition to Quofenix the line should be flushed before and after each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W.
Slovenian: Če se za uporabo drugih zdravil poleg zdravila Quofenix uporablja skupna intravenska linija, je potrebno linijo pred in po vsaki infuziji Quofenixa izprati z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali D5W.
English: Gastrooesophageal reflux disease Paraesthesia oral Hypoaesthesia oral Glossodynia
Slovenian: Gastroezofagealna refluksna bolezen Oralna parestezija
English: The half-life of oral delafloxacin is approximately 14 hours.
Slovenian: Razpolovni čas peroralnega delafloksacina je pribliţ no 14 ur.
English: The plasma protein binding of delafloxacin is approximately 84%; it primarily binds to albumin.
Slovenian: Vezava delafloksacina na plazemske beljakovine je pribliţ no 84 %, veţ e se predvsem na albumin.
English: • You have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Slovenian: • imate druţinsko zdravstveno zgodovino aortne disekcije ali druge dejavnike tveganja ali stanja, ki povečajo nagnjenost k nastanku teh bolezni (npr. vezivnotkivne bolezni, kot je Marfanov sindrom, ali ţ ilne oblike Ehlers-Danlosovega sindroma ali ţ ilne bolezni, kot so Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, visok krvni tlak ali znana ateroskleroza).
English: Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial.
Slovenian: Quofenix prašek za koncentrat za raztopino za infundiranje je na voljo v 20-ml prozornih steklenih vialah.
English: • The required dose of Quofenix reconstituted solution should be aseptically transferred from the vial to a 250 mL intravenous bag.
Slovenian: • Potreben odmerek rekonstituirane razopine zdravila Quofenix je treba aseptično prenesti iz viale v 250-ml vrečo za intravensko infudiranje.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of delafloxacin/metabolites in milk (see section 5.3).
Slovenian: Razpoloţ ljivi farmakodinamični/toksikološki podatki pri ţ ivalih kaţ ejo na izločanje delafloksacina/presnovkov v mleko (glejte poglavje 5.3).
English: Vertigo Tinnitus
Slovenian: Vrtoglavica Tinitus
English: Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Slovenian: Dolgotrajni, onsesposabljajoči, potencialno nepopravljivi resni neţeleni učinki Protibakterijska zdravila, ki vsebujejo fluorokinolone/kinolone, so bila povezana z zelo redkimi, a resnimi neţ elenimi učinki, od katerih so bili nekateri dolgotrajni (trajali so več mesecev ali let), onesposabljajoči ali potencialno nepopravljivi.
English: • You have kidney problems.
Slovenian: • imate teţave z ledvicami.
English: The required dose of Quofenix reconstituted solution should be aseptically transferred from the vial to a 250 mL intravenous bag.
Slovenian: Potreben odmerek rekonstituirane raztopine Quofenix je treba aseptično prenesti iz viale v 250ml vrečko za intravensko infudiranje.
English: Tendinitis and tendon rupture
Slovenian: Tendinitis in ruptura tetive
English: Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg vial.
Slovenian: Rekonstitucijo zdravila Quofenix je treba opravljati v aseptičnih pogojih z uporabo 10,5 ml dekstroze 50 mg/ml (5 %) za injiciranje (D5W) ali natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, za eno 300-mg vialo.
English: After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity is excreted in the urine and 28% is excreted in the faeces.
Slovenian: C, se 65 % radioaktivnosti izloči z urinom in 28 % z blatom.
English: Patients with renal impairment
Slovenian: Bolniki z okvarjenim delovanjem ledvic
English: • Low blood glucose levels
Slovenian: • nizke vrednosti glukoze v krvi
English: Following single intravenous (300 mg) administration to patients with mild, moderate, or severe renal impairment or ESRD on haemodialysis with and without haemodialysis after dosing, mean total exposure (AUCt) were 1.3, 1.7, 2.1, 3.5 and 4.1-fold higher than values for matched control subjects.
Slovenian: Po enkratni intravenski (300-mg) aplikaciji bolnikom z blago, zmerno ali hudo okvaro ledvic ali s končno ledvično odpovedjo na hemodializi, s hemodializo po aplikaciji ali brez nje, je bila povprečna skupna izpostavljenost (AUCt) 1,3-krat, 1,7-krat, 2,1-krat, 3,5-krat in 4,1-krat višja kot vrednosti primerljivih zdravih kontrolnih oseb.
English: You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Slovenian: Protibakterijskih zdravil, ki vsebujejo fluorokinolone/kinolone, vključno z zdravilom Quofenix, ne smete prejeti, če ste v preteklosti ţ e imeli kakršne koli resne neţ elene učinki med jemanjem kinolona ali fluorokinolona.
English: • After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using a total infusion time of 60 minutes.
Slovenian: • Po rekonstituciji in razredčitvi je treba zdravilo Quofenix aplicirati z intravenskim infundiranjem, ki traja skupaj 60 minut.
English: • Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial.
Slovenian: • Pripravite potreben odmerek za intravensko infuzijo, tako da iz rekonstituirane viale odvzamete 12 ml za pripravo zdravila Quofenix 300 mg ali 8 ml za pripravo zdravila Quofenix 200 mg.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neţ elenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
English: Peripheral neuropathy (including paraesthesia and hypoaesthesia) (see section 4.4) Dizziness
Slovenian: Periferna nevropatija (vključno s parestezijo in hipestezijo) (glejte poglavje 4.4) Omotica
English: The patient should drink a sufficient amount of fluids while taking Quofenix.
Slovenian: Med jemanjem zdravila Quofenix mora bolnik piti zadostno količino tekočine.