natgillin/translations-raw huggingface dataset:
Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i.e.] (480 mikrogramov) zdravila filgrastim v 0,8 ml (60 000 k.i.e./ml, 600 mikrogramov /ml).
The syringe has a scale on the syringe barrel.
Na telesu brizge je zarisano merilo.
Biograstim 48 MIU/0.8 mL solution for injection or infusion
IME ZDRAVILA Biograstim 48 000 k.i.e./0,8 ml raztopina za injiciranje ali infundiranje
The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Izkazalo se je, da s filgrastimom zbrane matične celice v periferni krvi zmanjšujejo resnost in trajanje trombocitopenije po mielosupresivni ali mieloablativni kemoterapiji.
Hepatobiliary disorders
Pogosti hepatomegalija
Very rare events of cutaneous vasculitis have been reported in patients treated with filgrastim.
Pri bolnikih, ki so prejemali filgrastim, so poročali o zelo redkih primerih kožnega vaskulitisa.
Biograstim 30 MIU/0.5 mL
PODATKI V BRAILLOVI PISAVI Biograstim 30 000 k.i.e./0.5 ml
The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
(10 μg)/kg/dan v obliki 24urne subkutane infuzije ali enkraten dnevni odmerek v obliki subkutane injekcije v obdobju od 5-ih do 7-ih dni zapored.
The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Zdravilo Biograstim in huda kronična nevtropenija Običajni odmerek na kilogram telesne mase je od 0,5 do 1,2 milijona mednarodnih enot (i.e.) dnevno, bodisi v enkratnem ali večkratnih odmerkih.
Solution for injection or infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
Skupno pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml.
Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,8 ml raztopine ali skupno pakiranje z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,5 ml raztopine.
9/L were reported and attributed to the leukapheresis procedure.
Med njimi so poročali o dveh primerih, pri katerih je bilo število trombocitov < 50 x 109/l, kar so pripisali postopku levkafereze.
Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod 0,2 x 106 i.e. (2 μg).
9/L, with the median dose frequency being 3 days per week.
(300 μg)/dan od 1 do 7 dni na teden, pri čemer so bolniki v povprečju prejemali 3 odmerke na teden.
Biograstim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
1 ml raztopine za injiciranje ali infundiranje vsebuje 60 milijonov mednarodnih enot [i.e.] (600 mikrogramov) zdravila filigrastim Biograstim 30 000 k.i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) zdravila filgrastim v 0,5 ml raztopine.
Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase and alkaline phosphatase.
Opazili so tudi prehodna povečanja sečne kisline, laktatne dehidrogenaze in alkalne fosfataze, ki pa jih niso spremljali klinični simptomi.
Long-term treatment with Biograstim may be required to maintain a normal number of white cells in your blood.
Zato da bi število belih krvničk v vaši krvi ostalo na običajni ravni, bo morda potrebno dolgotrajno zdravljenje z zdravilom Biograstim.
In clinical as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 10 studies, dosing with 30 MIU (300 μg)/day on 1 to 7 days per week was required to maintain the ANC
V kliničnih preskušanjih je bilo za to, da bi bilo absolutno število nevtrofilcev večje od 2,0 x 109/l, potrebno odmerjati 30 x 1 6i.e.
Solution for injection or infusion 5 pre-filled syringes containing 0.8 mL.
5 napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml.
For infusions, filgrastim should be diluted in 20 mL of glucose 50 mg/mL (5 %) solution for infusion (see section 6.6 for instructions on dilution).
Za infundiranje je potrebno filgrastim razredčiti v 20 ml glukoze 50 mg/ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6.6).
Do not use any Biograstim that is left in the syringe.
Zdravila Biograstim, ki morebiti ostane v injekcijski brizgi, ne smete več uporabiti.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
Če ni razredčeno v skladu z navodili v poglavju 6.6, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
Filgrastim should be diluted in 20 mL of glucose 50 mg/mL (5 %) solution for infusion (see section 6.6 for instructions on dilution).
Filgrastim je potrebno razredčiti v 20 ml glukoze 50 mg/ml (5%) raztopini za infundiranje (postopek redčenja je opisan v poglavju 6.6).
The recommended dose of filgrastim is 0.5 MIU (5 μg)/kg/day.
Priporočen odmerek filgrastima je 0,5 x 106i.e.
The long-term safety of filgrastim administration above 2.4 MIU (24 μg)/kg/day in patients with SCN has not been established.
Dolgoročna varnost odmerjanja filgrastima v odmerkih, večjih od 2,4 x 106i.e.
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection or infusion.
(480 µg) filgrastima v 0,8 ml raztopine za injiciranje ali infundiranje.
During long term use, cutaneous vasculitis has been reported in 2 % of SCN patients.
Pri 2 % bolnikov s hudo kronično nevtropenijo, ki so filgrastim prejemali dalj časa, so poročali o kožnem vaskulitisu.
Abdominal palpation should be sufficient to detect abnormal increases in splenic volume.
Za to, da ugotovimo povečanje vranice, zadostuje tipanje trebuha.
There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Pri bolnikih s hudo kronično nevtropenijo, ki so med kliničnim preskušanjem prejemali filgrastim, je bilo malo primerov (približno 3 %) mielodisplastičnih sindromov ali levkemije.
EU/1/08/450/007 2 x 5 pre-filled syringes
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/450/007 2 x 5 napolnjenih injekcijskih brizg
Common
Zbiranje
When the response has been obtained, the reached and can be maintained at more than 1.5 x 10 minimal effective dose to maintain this level should be established.
Ko je ta meja dosežena, je treba določi minimalen učinkovit odmerek, ki vzdržuje število nevtrofilcev na tej ravni.
For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μg)/kg/day subcutaneously for 4 to 5 consecutive days.
Za postopek zbiranja matičnih celic iz periferne krvi običajni darovalci 4 do 5 dni zapored prejmejo filgrastim v odmerku 1,0 x 106i.e.
Leukocytosis, thrombocytopenia Spleen disorder
Neželeni učinek levkocitoza, trombocitopenija
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection or infusion.
(300 µg) filgrastima v 0,5 ml raztopine za injiciranje ali infundiranje.
Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Občasno so pri bolnikih, ki so prejemali močno kemoterapijo po avtologni presaditvi kostnega mozga, poročali o boleznih srca in ožilja, vključno z okluzivno boleznijo ven in nepravilnostmi v pretoku krvi.
EU/1/08/450/003 2 x 5 pre-filled syringes
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/450/003 2 x 5 napolnjenih injekcijskih brizg
During intermittent dosing with 30 MIU (300 μg)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
(300 μg)/dan, so čez čas lahko opazna velika nihanja v absolutnem številu nevtrofilcev.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Če ni razredčen v skladu s spodnjimi navodili, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
Special precautions in sickle cell disease
Posebni previdnostni ukrepi pri bolnikih s srpasto anemijo
EXP After dilution use within 24 hours.
Po redčenju je zdravilo uporabno še 24 ur.
Hold the syringe and gently take the cover from the needle without twisting.
Pred injiciranjem zdravila Biograstim morate narediti naslednje: Primite injekcijsko brizgo ter nežno in brez sukanja potegnite pokrovček z igle.
Special precautions in cancer patients Leukocytosis
Posebni previdnostni ukrepi pri bolnikih z rakom
EXPIRY DATE
Pogosti diareja
Initial dose adjustment to alternate day dosing with 30 MIU (300 μg)/day by subcutaneous injection is recommended.
Priporoča se prilagoditev dnevnega odmerka v vrednosti 30 x 106i.e.
Your doctor will test your blood daily to see how well the treatment is working and to find the dose that is best for you.
Zato da bi ugotovil, kako dobro deluje zdravljenje in kakšen odmerek je najbolj primeren za vas, bo vaš zdravnik vsak dan analiziral vašo kri.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Posebni previdnostni ukrepi pri bolnikih s hudo kronično nevtropenijo
Neutrophil count
Število nevtrofilcev
Do not attempt to self-administer without this training.
Brez napotkov zdravnika ali sestre si ne poskušajte zdravila odmeriti sami.
Consideration should be given to intermittent cessation or decreasing the dose of filgrastim in patients who develop thrombocytopenia, i.e. platelets consistently < 100,000/mm
Pri bolnikih, pri katerih pride do trombocitopenije, kar pomeni, da je število trombocitov stalno < 100.000/mm3, je potrebno razmisliti o začasni prekinitvi zdravljenja ali o zmanjšanju odmerka filgrastima.
The recommendation of a minimum yield of 2.0 x 10
Priporočen začetni odmerek je 1,2 x 106i.e.
Water for injections
Napolnjena injekcijska brizga
Urinary abnormalities
Kongenitalna nevtropenija
9/L during the treatment period the dose of filgrastim should be reescalated according to the above steps
Če se med zdravljenjem absolutno število nevtrofilcev zmanjša, tako da je vrednost < 1,0 x 109/l, je treba odmerek filgrastima povečati, kot je opisano zgoraj.
Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has
Filgrastim je potrebno odmerjati dnevno v obliki subkutanih injekcij, dokler število nevtrofilcev ne doseže in ostane večje od 1,5 x 109/l.
Meta-analysis a
1986-2001a
Transient thrombocytopenia (platelets < 100 x 10 leukapheresis was observed in 35 % of subjects studied.
Levkocitozo (število belih krvničk > 50 x 109/l) so opazili pri 41 % darovalcev, prehodno trombocitopenijo (število trombocitov < 100 x 109/l) pa pri 35 % darovalcev po odmerjanju filgrastima in po levkaferezi.
Vascular disorders
Navodila za samoinjiciranje
Transformation to leukaemia or myelodysplastic syndrome
Neželeni učinek anemija, splenomegalija trombocitopenija
9/L to > 5.0 x 10
Zmanjšajte na 0,5 x 106i.e.
Your doctor will decide how many days treatment is needed.
Zdravnik bo odločil koliko dni zdravljenja potrebujete.
An updated RMP should be submitted:
Posodobljen RMP je treba predloţ iti:
Resistant (R >)
Odporen (R >)
• If you are a child or growing adolescent below 18 years of age.
• Če ste otrok ali mladostnik, mlajši od 18 let.
There is limited experience in patients aged > 75 years.
Izkušnje pri bolnikih, starih> 75 let, so omejene.
• Feeling tired
• občutek utrujenosti
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• Change in taste
• spremembe v okusu
The total duration of treatment is 5 to 14 days.
Celotno trajanje zdravljenja je od 5 do 14 dni.
Clinical efficacy against specific pathogens
Klinična učinkovitost proti specifičnim patogenim organizmom
Frequencies are defined as: very common (≥1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
(Any unused portion of the reconstituted solution should be discarded).
(Neuporabljen del rekonstituirane razopine je potrebno zavreči).
Each infusion will last about an hour.
Vsaka aplikacija infuzije bo trajala pribliţ no eno uro.
• Blood in urine
• kri v urinu
If less than 8 hours remain before the next dose, wait until the next scheduled dose.
Če je manj kot 8 ur do naslednjega odmerka, počakajte do naslednjega odmerka.
• Ringing or buzzing in the ears (tinnitus)
• zvenenje ali piskanje v ušesih (tinitus)
• You have diabetes.
• imate sladkorno bolezen.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predloţ itve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life-threatening.
To so lahko znaki in simptomi preobčutljivostne (alergijske) reakcije in so lahko smrtno nevarni.
The following information is intended for healthcare professionals only: For single use only.
Naslednje informacije so namenjene samo zdravstvenemu osebju:
• If you are pregnant, might become pregnant, or think you might be pregnant.
• Če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči.
In those cases your doctor will consider if this treatment is the best option for you.
V teh primerih bo zdravnik presodil, ali je to zdravljenje za vas najboljša moţ nost.
Children or growing adolescents below 18 years of age (see section 4.2).
Otroci ali mladostniki, mlajši od 18 let (glejte poglavje 4.2).
This medicine must not be used in children and adolescents, as it has not been studied enough in these groups.
Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih, ker pri tej populaciji ni bilo dovolj raziskano.
Via Sette Santi 3, 50131 Florence, Italy
Via Sette Santi 3, 50131 Florence, Italija
• Hearing things that do not exist (auditory hallucination)
• slišimo stvari, ki jih v resničnem svetu ni (slušne halucinacije)
Clinical response to treatment and renal function should be closely monitored in these patients.
Klinični odziv na zdravljenje in delovanje ledvic je pri teh bolnikih potrebno natančno spremljati.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neţ elenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neţ elenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila
• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become worse.
• imate miastenijo gravis (vrsta mišične oslabelosti), saj se simptomi lahko poslabšajo.
Other side effects may include:
Drugi neţ eleni učinki lahko vključujejo:
It works by blocking bacteria enzymes needed to copy and to repair their DNA.
Deluje z blokiranjem encimov bakterij, potrebnih za kopiranje in popravilo njihovih DNK.
Treatment of overdose with delafloxacin should consist of observation and general supportive measures.
Zdravljenje prevelikega odmerka delafloksacina mora vključevati opazovanje in splošne podporne ukrepe.
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows:
Mejne vrednosti minimalne inhibitorne koncentracije (MIK), kot jih je ugotovil Evropski odbor za testiranje protimikrobne občutljivosti (EUCAST - European Committee on Antimicrobial Susceptibility Testing), so kot sledi:
Therefore, concomitant use of corticosteroids should be avoided.
Sočasni uporabi kortikosteroidov se je zato potrebno izogibati.
From a microbiological point of view, the product should be used immediately after reconstitution and dilution.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji in razredčenju.
It belongs to a group of medicines called fluoroquinolones.
Spada v skupino zdravil, imenovanih fluorokinoloni.
Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you.
Ne vozite, ne upravljajte s stroji in ne izvajajte drugih dejavnosti, ki zahtevajo mentalno pozornost ali koordinacijo, dokler ne veste, kakšen vpliv ima na vas zdravilo Quofenix.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Poročanje o domnevnih neţ elenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
See the end of section 4 for how to report side effects.
Glejte na koncu poglavja 4, kako poročati o neţ elenih učinkih.
Hyperhidrosis Cold sweat Night sweat
Hiperhidroza Hladen znoj Nočno znojenje
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloţ enem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• The vial should be vigorously shaken until contents are completely dissolved.
• Vialo je treba močno stresati, dokler se vsebina popolnoma ne raztopi.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neţ elene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Pack-size: 10 vials.
Velikost pakiranja: 10 vial.
Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Ne jemljite nobenega zdravila za zdravljenje diareje, ne da bi se prej posvetovali z zdravnikom.
SX Via Morolense 5 03013 Ferentino (FR) Italy or
SX Via Morolense 5 03013 Ferentino (FR) Italija ali
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil doseţ en pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Delafloxacin is a probable substrate of BCRP.
Delafloksacin je verjetno substrat BCRP.
Excipient(s) with known effect:
Pomoţ na(e) snov(i) z znanim učinkom:
• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking antibiotics or up to 2 months afterwards.
• imate diarejo ali ste imeli diarejo med jemanjem antibiotikov ali do 2 meseca po jemanju.
Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Kemično in fizikalno stabilnost med uporabo so dokazovali 24 ur pri temperaturah 20 do 25 °C ali pri 2 do 8 °C.
• Dizziness or loss of balance (vertigo)
• omotičnost ali izguba ravnoteţja (vrtoglavica)
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake »EXP«.
Delafloxacin pharmacokinetic is comparable in patients with ABSSSI and healthy volunteers.
Farmakokinetika delafloksacina je primerljiva pri bolnikih z ABSSSI in zdravimi prostovoljci.
• Cloudy urine because of the presence of solid component
• moten urin zaradi prisotnosti trdih delcev
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Če se ne uporabi takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika in običajno ne smejo biti daljši od 24 ur pri 2 do 8 °C, razen če je bila rekonstitucija in redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
V epidemioloških študijah so poročali o povečanem tveganju za aortno anevrizmo in disekcijo po vnosu fluorokinolonov, zlasti pri starejši populaciji.
• You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic.
• ste prejeli dolgotrajno zdravljenje z antibiotiki, saj to lahko pomeni, da se bo pojavila še druga okuţ ba, ki jo povzroča bakterija, ki je ta antibiotik ne bo ozdravil (superinfekcija).
If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Če se to zgodi, prenehajte z jemanjem zdravila Quofenix in o tem takoj obvestite svojega zdravnika, da preprečite razvoj potencialno nepovratnega stanja.
• Swollen, red, irritated veins
• otečene, rdeče, razdraţene vene
The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment is not necessary based on age.
Farmakokinetika delafloksacina se ne spreminja pomembno glede na starost, zato prilagoditve odmerjanja glede na starost niso potrebne.
Administration of oral delafloxacin in patients with severe renal impairment and low body weight may lead to increased systemic exposures.
Apliciranje peroralnega delafloksacina pri bolnikih s hudo okvaro ledvic in nizko telesno maso lahko povzroči povečano sistemsko izpostavljenost.
Quofenix tablets should be taken at least 2 hours before or 6 hours after:
Quefenix tablete je treba vzeti najmanj 2 uri pred oziroma 6 ur po zauţ itju:
• Staphylococcus aureus (including methicillin-resistant [MRSA])
• Staphylococcus aureus (vključno z odpornim na meticilin [MRSA])
Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Tveganje se poveča, če ste starejši (stari več kot 60 let), imate presajen organ, imate teţ ave z ledvicami ali se zdravite s kortikosteroidi.
Delafloxacin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Delafloksacin se lahko daje takim bolnikom le, če pričakujemo, da klinična korist odtehta potencialno tveganje.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomoţ no snov, navedeno v poglavju 6.1.
There are no data available on severe cases of hypoglycaemia resulting in coma or death after delafloxacin use.
Podatkov o hudih primerih hipoglikemije, ki je povzročila komo ali smrt po uporabi delafloksacina, ni.