FrancophonIA/ELRC3.0 huggingface dataset:
English: What Quofenix looks like and contents of the pack
Slovenian: Izgled zdravila Quofenix in vsebina pakiranja
English: Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with other fluoroquinolones.
Slovenian: Pri uporabi drugih fluorokinolonov so poročali o primerih buloznih koţ nih reakcij, kot je StevensJohnsonov sindrom ali toksična epidermalna nekroliza.
English: After reconstitution each ml contains 25 mg of delafloxacin.
Slovenian: Po rekonstituciji en ml vsebuje 25 mg delafloksacina.
English: After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Slovenian: Po rekonstituciji: Kemično in fizikalno stabilnost med uporabo so dokazovali 24 ur pri 20 do 25 °C ali pri 2 do 8 ° C. Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji in razredčenju.
English: If these reactions occur in patients receiving delafloxacin, delafloxacin should be discontinued immediately and appropriate measures should be instituted.
Slovenian: Če se pri bolnikih, ki prejemajo delafloksacin, pojavijo ti neţ eleni učinki, je treba zdravljenje z delafloksacinom takoj prekiniti in uvesti ustrezne ukrepe.
English: If you experience any of these side effects after taking Quofenix, contact your doctor immediately prior to continuing treatment.
Slovenian: Če se po jemanju zdravila Qufenix pojavi kateri koli od teh neţ elenih učinkov, se takoj posvetujte z zdravnikom, preden nadaljujete z zdravljenjem.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Slovenian: Zdravstvene delavce naprošamo, da poročajo o katerem koli domnevnem neţ elenem učinku zdravila.
English: If you stop taking Quofenix
Slovenian: Če ste prenehali jemati zdravilo Quofenix
English: In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit cytochrome P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5 nor UDP glucuronosyl transferases isoforms UGT1A1 and UGT2B7.
Slovenian: In vitro podatki kaţ ejo, da delafloksacin v klinično pomembnih koncentracijah ne zavira citokromov P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 in CYP3A4/5, niti izoform encima UDP-glukuronoziltransferaze UGT1A1 in UGT2B7.
English: • Heartburn/acid regurgitation
Slovenian: • zgaga/regurgitacija kisline
English: Blood creatine phosphokinase increased
Slovenian: Povišana vrednost kreatin-fosfokinaze v krvi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŢENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 mg
English: • High blood glucose levels
Slovenian: • visoka vrednost glukoze v krvi
English: Following oral administration of 450 mg of delafloxacin every 12 hours, steady state concentrations are achieved after approximately 5 days with about 36% accumulation after multiple administrations.
Slovenian: Po peroralni uporabi 450 mg delafloksacina vsakih 12 ur je stanje dinamičnega ravnovesja doseţ eno po pribliţ no 5 dneh s pribliţ no 36 % kopičenjem po večkratnem apliciranju.
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: Oedema peripheral Local swelling Fatigue
Slovenian: Pireksija Periferni edem Lokalna oteklina Utrujenost Mrzlica
English: Tablets should be swallowed and can be taken with or without food.
Slovenian: Tablete se zauţ ije skupaj s hrano ali brez nje.
English: • Haematocrit decreased (reduction of an indicator of amount of blood cells)
Slovenian: • zniţan hematokrit (zmanjšanje kazalca količine krvnih celic)
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: Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid, concentrated.
Slovenian: Meglumin, natrijev sulfobutilbetaciklodekstrin, dinatrijev edetat, natrijev hidroksid, koncentrirana klorovodikova kislina.
English: Thrombocytopenia Haematocrit decreased White blood cell count decreased Haemoglobin decreased Red blood cell count decreased
Slovenian: Zniţ ano število belih krvnih celic Zniţ ane vrednosti hemoglobina Zmanjšano število rdečih krvnih celic
English: Quofenix must not be used in women of childbearing potential not using contraception.
Slovenian: Zdravila Quofenix se ne sme uporabljati pri ţ enskah v rodni dobi, ki ne uporabljajo učinkovito kontracepcijo.
English: MIC breakpoints (mg/L) Susceptible (S ≤)
Slovenian: Mejne vrednosti MIK (mg/l)
English: • You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
Slovenian: • ste imeli med preteklim zdravljenjem s fluorokinolonskim ali kinolonskim antibiotikom teţ ave s tetivami.
English: • Loss of tactile sensation at the mouth
Slovenian: • izguba občutljivosti za dotik v ustih
English: • Reduced kidneys function
Slovenian: • zmanjšano delovanje ledvic
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje tablete
English: No dose adjustment is required.
Slovenian: Odmerka ni potrebno prilagajati.
English: Before you are given this medicine
Slovenian: Preden boste prejeli to zdravilo
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Slovenian: Pri bolnikih, ki so prejemali kinolone in fluorokinolone, so poročali o primerih senzorične ali senzorično-motorične polinevropatije, ki je privedla do parestezije, hipestezije, disestezije ali šibkosti.
English: No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2).
Slovenian: Pri bolnikih z blago do hudo okvarjenim delovanjem ledvic prilagoditev odmerka ni potrebna (glejte poglavji 4.4 in 5.2).
English: Talk to your doctor if you have any concerns or questions about this and using Quofenix.
Slovenian: Če imate v zvezi s tem in uporabo zdravila Quofenix kakršne koli pomisleke ali vprašanja, se posvetujte z zdravnikom.
English: The use of delafloxacin is not recommended in patients with known history of myasthenia gravis.
Slovenian: Uporaba delafloksacina ni priporočljiva pri bolnikih z miastenijo gravis v anamnezi.
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Slovenian: Bolnike je treba opozoriti, naj se v primeru pojava reakcij na koţ i in/ali sluznici, pred nadaljevanjem zdravljenja nemudoma obrnejo na zdravnika.
English: The recommended regimen of delafloxacin is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of the physician.
Slovenian: Priporočen reţ im odmerjanja delafloksacina je 450 mg peroralno vsakih12 ur v celotnem trajanju zdravljenja 5 do 14 dni, po presoji zdravnika.
English: Hypertension Hypotension Flushing Phlebitis
Slovenian: Hipertenzija Hipotenzija Vročinski oblivi Flebitis
English: Fluoroquinolone-insusceptible microorganisms may result in superinfection with the use of delafloxacin.
Slovenian: Ob uporabi delafloksacina lahko pride do superinfekcije z mikroorganizmi, neobčutljivimi na fluorokinolone.
English: - The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).
Slovenian: - Druge pomoţne snovi so meglumin, natrijev sulfobutilbetaciklodekstrin, dinatrijev edetat, natrijev hidroksid (za uravnavanje pH), koncentrirana klorovodikova kislina (za uravnavanje pH).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (TABLETS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (TABLETE)
English: Switch to delafloxacin 450 mg tablet orally every 12 hours is possible at the discretion of the physician.
Slovenian: Prehod na 450-mg tableto peroralno vsakih 12 ur je moţ en po presoji zdravnika.
English: Clostridioides difficile infection (see section 4.4)
Slovenian: Okuţ ba s Clostridioides difficile (glejte poglavje 4.4) Okuţ be sečil
English: Following a single oral (400 mg) administration to patients with mild, moderate or severe renal impairment, mean total exposure (AUCt) was about 1.5-fold higher for subjects with moderate and severe renal impairment compared with healthy subjects, whereas total systemic exposures were comparable to subjects with mild renal impairment.
Slovenian: Po enkratni peroralni (400-mg) aplikaciji bolnikom z blago, zmerno ali hudo okvaro ledvic je bila pri bolnikih z zmerno in hudo okvaro povprečna skupna izpostavljenost delafloksacina (AUCt) 1,5-krat višja kot vrednosti primerljivih zdravih oseb, medtem ko je bila skupna izpostavljenost primerljiva pri osebah z zmerno ledvično okvaro.
English: • Reduced tactile sensation at the mouth
Slovenian: • zmanjšana občutljivost za dotik v ustih
English: Description of selected adverse drug reactions
Slovenian: Opis izbranih neţ elenih učinkov
English: If you miss a dose of Quofenix
Slovenian: Če ste izpustili odmerek zdravila Quofenix
English: Plasma protein binding of delafloxacin is not significantly affected by the degree of renal impairment.
Slovenian: Stopnja okvare ledvic ne vpliva pomembno na vezavo delafloksacina s plazemskimi beljakovinami.
English: No clinical trials have been conducted with delafloxacin in paediatric patients.
Slovenian: Kliničnih študij z delafloksacinom pri pediatrični populaciji niso opravili.
English: Τηλ: +30 210 8316111-13
Slovenian: MENARINI HELLAS AE Τηλ: +30 210 8316111-13
English: EU/1/19/1393/002-007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/19/1393/002-007
English: In addition increases in serum ALT and ALP, and reduced total protein and globulin values were recorded at the end of the treatment period in the pivotal 4-week IV dog study at the high dose (75 mg/kg) in individual dogs.
Slovenian: Poleg tega so na koncu obdobja zdravljenja v 4-tedenski ključni študiji pri psih pri intravenskih visokih odmerkih (75 mg/kg) pri posameznih zabeleţ ili povišanje vrednosti ALT in ALP v serumu ter zmanjšanje vrednosti skupnih beljakovin in globulina.
English: • Reduced tactile sensation
Slovenian: • zmanjšana občutljivost za dotik
English: (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue and severe sleep disorders.
Slovenian: ţ gečkanje, odrevenelost ali ţ arenje (parestezija), motnje delovanja čutil, vključno z okvaro vida, okusa, voha in sluha, depresijo, motnje spomina, hudo utrujenost in hude motnje spanja.
English: Nonclinical studies conducted with delafloxacin in rats do not indicate harmful effects with respect to fertility or reproductive performance (see section 5.3).
Slovenian: Predklinične študije z delafloksacinom na podganah, ne kaţ ejo škodljivih učinkov na plodnost ali sposobnost razmnoţ evanja (glejte poglavje
English: Tablets
Slovenian: ZDRAVILA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (VIALE)
English: Common side effects (may affect up to 1 in 10 people):
Slovenian: Pogosti neţ eleni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: Clostridioides difficileassociated disease must be considered in all patients who present with diarrhoea.
Slovenian: Moţ nost pojava bolezni, povezane s Clostridioides difficile je treba upoštevati pri vseh bolnikih, pri katerih po uporabi antibiotikov nastopi huda diareja.
English: Patients with toxic shock, neutropenia (neutrophil counts < 500 cells/mm3) or severely immunocompromised patients were not included in the studies.
Slovenian: V študije niso bili vključeni bolniki s toksičnim šokom, nevtropenijo (število nevtrofilcev < 500 celic/mm
English: • Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Slovenian: • mišično-skeletna bolečina (npr. bolečina v okončinah, bolečina v hrbtu, bolečina v vratu),
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTER (TABLETS)
Slovenian: ALUMINIJ/ALUMINIJ PRETISNI OMOT (TABLETE)
English: Reporting of suspected adverse reactions
Slovenian: Poročanje o domnevnih neţ elenih učinkih
English: • Allergic skin reaction
Slovenian: • alergijske koţne reakcije
English: EU/1/19/1393/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1393/001
English: • Low red blood cell count (reduction of amount of blood cells)
Slovenian: • nizko število rdečih krvnih celic (zmanjšanje količine krvnih celic)
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neţ eleni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: • sucralfate
Slovenian: • sukralfata
English: Pregnancy, women of childbearing potential not using contraception and breast-feeding (see section
Slovenian: Nosečnost, ţ enske v rodni dobi, ki ne uporabljajo kontracepcije in dojenje (glejte poglavje 4.6).
English: Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje megluminijev delafloksacin, ki ustreza 450 mg delafloksacina.
English: Hypertransaminasaemia Blood alkaline phosphatase increased Blood albumin decreased
Slovenian: Povišane ravni alkalne fosfataze v krvi Zniţ ane ravni albumina v krvi
English: The mean systemic exposure (AUC) increased 2.2-fold, 5.3-fold, 8.5-fold and 29.8-fold for patients with moderate impairment, severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Slovenian: Povprečna sistemska izpostavljenost (AUC) se je pri bolnikih z zmerno okvaro, hudo okvaro in s končno ledvično odpovedjo s hemodializo in brez nje po apliciranju povišala za 2,2-krat, 5,3-krat, 8,5krat in 29,8-krat, v primerjavi z zdravo kontrolno skupino.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning
Slovenian: To vključuje bolečine v tetivah, mišicah in sklepih zgornjih in spodnjih okončin, teţ ave pri hoji, nenormalne občutke, kot so mravljinčenje, ščemenje,
English: The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of your doctor.
Slovenian: Priporočen peroralni odmerek je 450 mg vsakih 12 ur, po priporočilu zdravnika v skupnem času trajanja zdravljenja 5 do 14 dni.
English: How to use Quofenix
Slovenian: Kako uporabljati zdravilo Quofenix
English: - If you have any further questions, ask your doctor or pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and colour.
Slovenian: FARMACEVTSKA SESTAVA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Prašek svetlo rumen do koţ nate barve, lahko z rahlimi razpokami in znaki krčenja ter manjšimi razlikami vteksturi in barvi.
English: • Pain and swelling of the tendons
Slovenian: • bolečina in otekanje kit
English: These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
Slovenian: Ti resni neţ eleni učinki so občasni in se lahko pojavijo pri največ 1 od 100 bolnikov.
English: What you need to know before you are given Quofenix 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Quofenix
English: Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
Slovenian: Luxembourg/Luxemburg Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
English: Abdominal pain
Slovenian: Abdominalna bolečina Dispepsija
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na ţ ivalih so pokazale vpliv na sposobnost razmnoţ evanja (glejte poglavje 5.3).
English: Talk to your doctor or pharmacist or nurse before taking Quofenix if:
Slovenian: Pred začetkom jemanja zdravila Quofenix se posvetujte z zdravnikom ali farmacevtom, če:
English: If you accidentally take more tablets than you should, tell a doctor or get other medical advice.
Slovenian: Če ste vzeli večji odmerek zdravila Quofenix, kot bi smeli Če ste pomotoma vzeli preveč tablet, se takoj posvetujte z zdravnikom ali poiščite medicinsko pomoč.
English: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Slovenian: Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product.
Slovenian: Preobčutljivost na katero koli protibakterijsko zdravilo, ki vsebuje fluorokinolon ali kinolon.
English: Obese patients (≥ 30 kg/m2 BMI)
Slovenian: Bolniki s prekomerno telesno maso (≥ 30 kg/m
English: Hepatic impairment No dosage adjustment is necessary (see section 5.2).
Slovenian: Okvarjeno delovanje jeter Prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Fungal infection
Slovenian: Glivična infekcija
English: • Anxiety
Slovenian: • nespečnost
English: What you need to know before you take Quofenix 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Quofenix
English: Dose adjustment is needed in patients with severe renal impairment (see section 4.2).
Slovenian: Za bolnike s hudo okvarjenim delovanjem ledvic je odmerek treba prilagoditi (glejte poglavje 4.2).
English: The mean peak exposure (Cmax) increased about 2-fold, 5-fold and 7-fold for patients with severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Slovenian: Povprečna najvišja izpostavljenost (Cmax) se je pri bolnikih s hudo okvaro in s končno ledvično odpovedjo s hemodializo po apliciranju in brez nje, povišala za pribliţ no 2-krat, 5-krat in 7-krat, v primerjavi z zdravo kontrolno skupino.
English: In this situation, you should inform your doctor as soon as possible.
Slovenian: Preden prejmete to zdravilo, morate o tem obvestiti svojega zdravnika:
English: • Abnormal hair loss
Slovenian: • nenormalno izpadanje las
English: • Low white blood cell count (reduction of amount of blood cells)
Slovenian: • nizko število belih krvnih celic (zmanjšanje količine krvnih celic)
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: V primeru dodatnih vprašanj o uporabi zdravila, se obrnite na zdravnika ali medicinsko sestro.
English: For dosing instructions in subjects with renal impairment refer to section 4.2.
Slovenian: Za navodila o odmerjanju zdravila pri osebah z okvaro ledvic, glejte poglavje 4.2.
English: • Medical device occlusion
Slovenian: • zapora medicinskega pripomočka
English: If you miss a dose, you should take it as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Slovenian: Če ste pozabili vzeti odmerek zdravila Quofenix Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, do 8 ur do naslednjega odmerka.
English: Known fluoroquinolones-associated possible interactions shall be considered.
Slovenian: Upoštevati je treba znane moţ ne interakcije, povezane s fluorokinoloni.
English: No clinically meaningful changes in delafloxacin Cmax and AUC∞ were observed, following administration of a single 300 mg intravenous dose of delafloxacin into patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Slovenian: Po apliciranju enkratnega 300-mg intravenskega odmerka delafloksacina bolnikom z blago, zmerno ali hudo okvaro jeter (razred A, B in C po Child-Pughu) niso opazili klinično pomembnih sprememb v Cmax in AUC delafloksacina v primerjavi z ujemajočimi se zdravimi kontrolnimi osebami.
English: Sodium hydrogen carbonate Sodium dihydrogen phosphate monohydrate Citric acid
Slovenian: 6.1 Seznam pomoţnih snovi mikrokristalna celuloza povidon krospovidon natrijev hidrogenkarbonat natrijev dihidrogenfosfat monohidrat citronska kislina magnezijev stearat
English: Quofenix 450 mg tablets
Slovenian: IME ZDRAVILA Quofenix 450 mg tablete
English: No clinically meaningful changes in delafloxacin pharmacokinetics when administered delafloxacin in patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Slovenian: Po dajanju delafloksacina bolnikom z blago, zmerno ali hudo okvaro jeter (razred A, B in C po ChildPughu) niso opazili klinično pomembnih sprememb v farmakokinetiki delafloksacina v primerjavi z ujemajočimi se zdravimi kontrolnimi osebami.
English: Quofenix 300 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA Quofenix 300 mg prašek za koncentrat za raztopino za infundiranje
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving fluoroquinolone antibacterial medicinal products.
Slovenian: Pri uporabi fluorokinolonskih protibakterijskih zdravil so poročali o resnih in občasno smrtnih preobčutljivostnih (anafilaktičnih) reakcijah.
English: Presyncope
Slovenian: Presinkopa
English: - The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.
Slovenian: - Druge sestavine so mikrokristalna celuloza, povidon, krospovidon, natrijev hidrogenkarbonat,
English: How to take Quofenix
Slovenian: Kako jemati zdravilo Quofenix
English: This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
Slovenian: Ta resni neţ eleni učinek je občasen in se lahko pojavi pri največ 1 od 100 bolnikov.
English: Each tablet contains 450 mg of delafloxacin (as meglumine).
Slovenian: Ena tableta vsebuje 450 mg delafloksacina (v obliki meglumina).
English: If you stop taking Quofenix without the advice of your doctor, your symptoms may get worse.
Slovenian: Ne prenehajte z jemanjem zdravila prej, kakor vam je predpisal zdravnik, saj se lahko vaši simptomi poslabšajo.
English: Quofenix 300 mg powder for concentrate delafloxacin
Slovenian: Quofenix 300 mg prašek za koncentrat za raztopino za infundiranje delafloksacin
English: Unit dose laminated aluminium/aluminium foil blisters.
Slovenian: Deljiv laminirani aluminij/aluminij pretisni omoti s posameznimi odmerki.
English: Talk to your doctor or pharmacist or nurse before you are given Quofenix if:
Slovenian: Pred začetkom prejemanja zdravila Quofenix se posvetujte z zdravnikom ali medicinsko sestro, če:
English: Central Nervous System Effects
Slovenian: Učinki na centralno ţ ivčevje
English: No adverse effects were seen in rats at exposures about 2-fold higher than humans, or in dogs at exposures approximately equal to humans.
Slovenian: Pri podganah, ob izpostavljenosti, ki so bile pribliţ no dvakrat višje kot pri ljudeh, ali pri psih, ob izpostavljenosti, ki so bile pribliţ no enake izpostavljenosti človeka, niso opazili neţ elenih učinkov.
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.
Slovenian: Če ste prejeli večji odmerek zdravila Quofenix, kot bi smeli Če vas skrbi, da ste morda prejeli preveč zdravila Quofenix, se takoj posvetujte z zdravnikom ali medicinsko sestro.
English: Each vial of powder contains 300 mg of delafloxacin (as meglumine).
Slovenian: Ena viala praška vsebuje 300 mg delafloksacina (v obliki meglumina).