natgillin/translations-raw huggingface dataset:
After reconstitution, chemical and physical in-use stability has been demonstrated for 4 days at 2 to 8°C.
Po rekonstituciji sta kemična in fizikalna stabilnost med uporabo dokazani za 4 dni pri temperaturi od 2 °C do 8 °C.
If super infection occurs during or following treatment, appropriate measures should be taken.
Če se med ali po zdravljenju pojavi superinfekcija, je treba ustrezno ukrepati.
Minimum inhibitory concentration breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Mejne vrednosti minimalnih inhibitornih koncentracij, ki jih je določil Evropski odbor za testiranje občutljivosti za protimikrobna zdravila (EUCAST - European Committee on Antimicrobial Susceptibility Testing), so:
The safety and efficacy of ceftolozane/tazobactam in children and adolescents below 18 years of age have not yet been established.
Varnost in učinkovitost ceftolozana/tazobaktama pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
The dose depends on the type of infection that you have, where the infection is in your body and how serious the infection is.
Odmerek je odvisen od vrste okužbe in od tega, kje v telesu je okužba in kako resna je.
This leaflet was last revised in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne
Mechanisms of resistance
Mehanizmi odpornosti
Your doctor or other healthcare professional will give you this medicine into one of your veins through an infusion (a drip) lasting one hour.
To zdravilo vam bo dal zdravnik ali drug zdravstveni delavec v eno izmed ven z infuzijo (kapalno), ki bo trajala eno uro.
One of these 60 patients had bacteraemia at baseline.
Eden od 60 bolnikov je imel v izhodišču bakteriemijo.
Variations in colour within this range do not affect the potency of the product.
Razlike v barvi v tem okviru ne vplivajo na učinkovitost zdravila.
The dose of medicine given to you depends on whether or not you have kidney problems.
Odmerek zdravila, ki ga boste prejeli, je odvisen od tega, ali imate kakšne težave z ledvicami ali ne.
Treatment with Zerbaxa sometimes causes production of antibodies that react with your red blood cells.
Zdravljenje z zdravilom Zerbaxa včasih povzroči nastanek protiteles, ki reagirajo z rdečimi krvnimi celicami.
These include: - Probenecid (a medicine for gout).
Med takšnimi je: - probenecid (zdravilo za protin).
Non-susceptible micro-organisms
Neobčutljivi mikroorganizmi
Treatment with Zerbaxa normally lasts between 4 and 14 days, depending on the severity and location of the infection and on how your body responds to the treatment.
Zdravljenje z zdravilom Zerbaxa po navadi traja od 4 do 14 dni, odvisno od tega, kako huda je okužba, kje v telesu je in kako se telo odzove na zdravljenje.
However, active substances that inhibit OAT1 or OAT3 (e.g., probenecid) may increase tazobactam plasma concentrations.
Vendar pa lahko zdravilne učinkovine, ki zavrejo OAT1 ali OAT3 (npr. probenecid), povečajo koncentracijo tazobaktama v plazmi.
Zerbaxa should only be used during pregnancy if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Zdravilo Zerbaxa se sme med nosečnostjo uporabiti le, če pričakovane prednosti odtehtajo možna tveganja za nosečnico in plod.
AmpC enzymes (produced by Enterobacterales)
encimov AmpC (ki jih tvorijo Enterobacterales)
Zerbaxa is indicated for the treatment of the following infections in adults (see section 5.1):
Zdravilo Zerbaxa je indicirano za zdravljenje naslednjih okužb (glejte poglavje 5.1) pri odraslih:
If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
Zerbaxa is a medicine used to treat a range of bacterial infections.
Zdravilo Zerbaxa je zdravilo, ki se uporablja za zdravljenje različnih bakterijskih okužb.
Environmental Risk Assessment (ERA)
Ocena tveganja za okolje
These types of infection may range in severity from mild to life-threatening.
Resnost takšnih okužb je lahko od blage do življenjsko nevarne.
In such circumstances, the discontinuation of therapy with ceftolozane/tazobactam and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
V takšnih primerih je treba razmisliti o prenehanju zdravljenja s ceftolozanom/tazobaktamom in o uporabi podpornih ukrepov skupaj s specifičnim zdravljenjem okužbe s Clostridioides difficile.
Environmental risk assessment studies have shown that one of the active ingredients, ceftolozane, may pose a risk to surface water organisms (see section 6.6).
Študije ocene tveganja za okolje so pokazale, da lahko ena od učinkovin, ceftolozan, predstavlja tveganje za organizme površinskih voda (glejte poglavje 6.6).
Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment: - Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Nemudoma obvestite zdravnika, če se pojavijo naslednji simptomi, saj boste morda potrebovali nujno zdravljenje: - nenadno otekanje ustnic, obraza, žrela ali jezika, hud izpuščaj in težave s požiranjem ali dihanjem.
Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia
Serokonverzija direktnega antiglobulinskega testa (Coombsov test) in možno tveganje za hemolitično anemijo
Do not take Zerbaxa - if you are allergic to ceftolozane, tazobactam or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Zerbaxa - če ste alergični na ceftolozan, tazobaktam ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If a severe allergic reaction occurs during treatment with ceftolozane/tazobactam, the medicinal product should be discontinued and appropriate measures taken.
Če se med zdravljenjem s ceftolozanom/tazobaktamom pojavi huda alergijska reakcija, je treba zdravljenje s tem zdravilom prekiniti in ustrezno ukrepati.
Frequency categories are derived according to the following conventions: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) (see Table 3).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) (glejte preglednico 3).
What you need to know before you take Zerbaxa
Kaj morate vedeti, preden boste prejeli zdravilo Zerbaxa
8-14 days
8 do 14 dni
If you are told that you have an abnormal blood test (called Coombs test) tell your doctor that you are having or have recently had Zerbaxa.
Če vam je zdravnik povedal, da imate nenormalen izvid laboratorijskega krvnega testa (imenovan Coombsov test), zdravniku povejte, da se zdravite oziroma ste se pred kratkim zdravili z zdravilom Zerbaxa.
If you think you have not been given a dose of Zerbaxa, tell your doctor or other healthcare professional immediately.
Če menite, da niste prejeli odmerka zdravila Zerbaxa, to nemudoma povejte zdravniku ali drugemu zdravstvenemu delavcu.
Your doctor will advise if you should receive Zerbaxa during pregnancy.
Zdravnik vam bo povedal, ali lahko prejemate zdravilo Zerbaxa med nosečnostjo.
- if you are allergic to medicines known as “cephalosporins”.
- če ste alergični na zdravila, imenovana cefalosporini.
- if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing) to certain other antibiotics (e.g., penicillins or carbapenems).
- če ste kdaj imeli hudo alergijsko reakcijo (npr. hudo luščenje kože, oteklost obraza, dlani, stopal, ustnic, jezika ali žrela, oziroma težave s požiranjem ali dihanjem) na določene druge antibiotike (npr. peniciline ali karbapeneme).
Frequency Infusion time
Pogostnost Čas infundiranja
Adverse reactions are classified according to MedDRA system organ class and frequency.
Neželeni učinki so razvrščeni po organskih sistemih MedDRA in pogostnosti.
This can increase the time it takes for tazobactam to leave your body.
To zdravilo lahko podaljša čas, potreben, da se tazobaktam odstrani iz telesa.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible (see sections 4.3 and 4.8).
Možne so resne preobčutljivostne (anafilaktične) reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
4-14 days
4 do 14 dni
Other medicines and Zerbaxa
Druga zdravila in zdravilo Zerbaxa
Augmented renal clearance
Povečan ledvični očistek
Approximately 82% of all patients in the trial had APACHE II (Acute Physiology and Chronic Health Evaluation II) scores of < 10 and 2.3% had bacteraemia at baseline.
Pri približno 82 % vseh bolnikov v preskušanju je bila ocena APACHE II (Acute Physiology and Chronic Health Evaluation II) < 10, 2,3 % bolnikov je imelo bakteriemijo v izhodišču.
The use of ceftolozane/tazobactam may promote the overgrowth of non-susceptible micro-organisms.
Uporaba ceftolozana/tazobaktama lahko spodbudi razrast neobčutljivih mikroorganizmov.
In patients with moderate or severe renal impairment, and in patients with end stage renal disease on haemodialysis, the dose should be adjusted as listed in Table 2 (see sections 5.1 and 6.6).
Pri bolnikih z zmerno ali hudo okvaro ledvic in bolnikih s končno odpovedjo ledvic na hemodializi je odmerek treba prilagoditi, kot je prikazano v preglednici 2 (glejte poglavji 5.1 in 6.6).
Pharmacokinetic/pharmacodynamic relationships
Farmakokinetično/farmakodinamično razmerje
Your doctor may need to reduce the dose of Zerbaxa or decide how often Zerbaxa is given to you.
Zdravnik vam bo morda moral zmanjšati odmerek zdravila Zerbaxa, ali presoditi, kako pogosto boste prejemali zdravilo Zerbaxa.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V predkliničnih študijah so učinke opazili samo pri izpostavljenostih, bistveno večjih od največje izpostavljenosti pri človeku, kar kaže na majhen pomen za klinično uporabo.
What Zerbaxa is and what it is used for
Kaj je zdravilo Zerbaxa in za kaj ga uporabljamo
For intravenous use after reconstitution and dilution.
Za intravensko uporabo po rekonstituciji in redčenju.
The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of tazobactam in in vitro and in vivo non-clinical models.
Čas nad mejno vrednostjo koncentracije se je izkazal kot parameter, ki najbolje napove učinkovitost tazobaktama v nekliničnih modelih in vitro in in vivo.
More than 80% of tazobactam was excreted as the parent compound with the remaining amount excreted as the tazobactam M1 metabolite.
Več kot 80 % tazobaktama se je izločilo v obliki matične spojine, preostala količina pa kot presnovek tazobaktama M1.
One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment.
Ena od učinkovin, ceftolozan, ima lahko škodljiv učinek, če pride v vodno okolje.
In the clinically evaluable (CE) patients, the clinical cure rates for ceftolozane/tazobactam were 95.9% in 293 patients aged less than 65 years and 87.8% in 82 patients aged 65 years or more.
Pri klinično ocenljivih bolnikih je bila stopnja klinične ozdravitve za ceftolozan/tazobaktam 95,9 % pri 293 bolnikih, starih manj kot 65 let, in 87,8 % pri bolnikih, starih 65 let ali več.
Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI54.
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, drugi cefalosporini in penemi, oznaka ATC: J01DI54
There is no experience with overdose of Zerbaxa.
Izkušenj s prevelikim odmerjanjem zdravila Zerbaxa ni.
1, abdominal distension dyspepsia
1, abdominalna distenzija
Mechanisms of bacterial resistance to ceftolozane/tazobactam include: i.
Mehanizem bakterijske odpornosti proti ceftolozanu/tazobaktamu vključuje: i.
In vitro data indicate that the following species are not susceptible to ceftolozane/tazobactam: Staphylococcus aureus
Podatki in vitro kažejo, da naslednje vrste niso občutljive na ceftolozan/tazobaktam: Staphylococcus aureus
The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial.
Dobljena koncentracija je približno 132 mg/ml (88 mg/ml ceftolozana in 44 mg/ml tazobaktama) na vialo.
If you stop taking Zerbaxa
Če ste prenehali prejemati zdravilo Zerbaxa
CrCL (mL/min)*
Ocenjeni očistek kreatinina (ml/min)*
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zerbaxa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prekinitvijo/prenehanjem zdravljenja z zdravilom Zerbaxa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
This medicine contains 230 mg sodium (main component of cooking/table salt) in each vial.
Zdravilo vsebuje 230 mg natrija (ki je glavna sestavina kuhinjske/namizne soli) na vialo.
Ceftolozane is eliminated in the urine as unchanged parent substance and thus does not appear to be metabolised to any appreciable extent.
Ceftolozan se izloča v urin kot nespremenjena matična spojina, tako da ni videti, da bi se presnavljal v znatni meri.
Clinical efficacy data in patients with complicated lower urinary tract infection are limited.
Kliničnih podatkov o učinkovitosti pri bolnikih z zapletenimi okužbami spodnjih sečil je malo.
In the event of overdose, Zerbaxa should be discontinued and general supportive treatment given.
V primeru prevelikega odmerjanja je treba prekiniti uporabo zdravila Zerbaxa in bolniku nuditi splošno podporno zdravljenje.
Carcinogenicity studies with ceftolozane/tazobactam have not been conducted.
Študije kancerogenosti s ceftolozanom/tazobaktamom niso bile opravljene.
Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Grampozitivne bakterije Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP.” The expiry date refers to the last day of that month.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake "EXP".
Type of infection
Vrsta okužbe
Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death.
Ceftolozan deluje baktericidno z vezavo na pomembne beljakovine, ki vežejo penicilin (PBP - penicillin-binding proteins), ter s tem zavre sintezo bakterijske celične stene in posledično povzroči celično smrt.
Zerbaxa may have a minor influence on the ability to drive and use machines.
Zdravilo Zerbaxa ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Elderly (≥ 65 years of age) No dose adjustment is necessary for the elderly based on age alone (see section 5.2).
Starejši bolniki (starost ≥ 65 let) Prilagoditev odmerka pri starejših bolnikih zgolj zaradi starosti ni potrebna (glejte poglavje 5.2).
Alanine aminotransferase increased aspartate aminotransferase increased transaminases increased
Preiskave zvišana alanin-aminotransferaza zvišana aspartat-aminotransferaza zvišane transaminaze
Atrial fibrillation 1, tachycardia angina pectoris
Srčne bolezni atrijska fibrilacija 1, tahikardija angina pektoris
Zerbaxa solution for infusion is clear and colourless to slightly yellow.
Raztopina zdravila Zerbaxa za infundiranje je bistra in brezbarvna do rahlo rumena.
The binding of ceftolozane and tazobactam to human plasma proteins is low (approximately 16% to 21% and 30%, respectively).
Vezava ceftolozana in tazobaktama na plazemske beljakovine pri človeku je majhna (ceftolozan približno 16-21 %, tazobaktam približno 30 %).
What Zerbaxa is and what it is used for What you need to know before you take Zerbaxa How to take Zerbaxa
Kaj je zdravilo Zerbaxa in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Zerbaxa Kako uporabljati zdravilo Zerbaxa Možni neželeni učinki
Unopened vials: Store in a refrigerator (2°C - 8°C).
Neodprte viale: Shranjujte v hladilniku (2 °C - 8 °C).
It contains two active substances: - ceftolozane, an antibiotic that belongs to the group of “cephalosporins” and which can kill certain bacteria that can cause infection; - tazobactam, which blocks the action of certain enzymes called beta-lactamases.
Vsebuje dve zdravilni učinkovini: - ceftolozan, antibiotik iz skupine cefalosporinov, ki uničuje določene bakterije, ki lahko povzročajo okužbe, - tazobaktam, ki zavre delovanje določenih encimov, imenovanih betalaktamaze.
For tazobactam the PD index associated with efficacy was determined to be the percentage of the dose interval during which the plasma concentration of tazobactam exceeds a threshold value (%T > threshold).
Za tazobaktam je bil farmakodinamični indeks, povezan z učinkovitostjo, določen kot odstotek odmernega intervala, v katerem plazemska koncentracija tazobaktama preseže mejno vrednost (% t > mejna vrednost).
In patients with mild renal impairment (estimated creatinine clearance [CrCL] > 50 mL/min), no dose adjustment is necessary, see section 5.2.
Pri bolnikih z blago okvaro ledvic (ocenjeni očistek kreatinina > 50 ml/min) prilagoditev odmerka ni potrebna, glejte poglavje 5.2.
In vitro, tazobactam inhibited human OAT1 and OAT3 transporters with IC50 values of 118 and 147 mcg/mL, respectively.
In vitro je tazobaktam zavrl humana prenašalca OAT1 in OAT3 z IC50 118 µg/ml za prvega in 147 µg/ml za drugega.
However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately.
Toda če vas kar koli skrbi, morate to takoj povedati zdravniku, medicinski sestri ali farmacevtu.
Patients who were immunocompromised, patients with severe neutropenia, and patients with end stage renal disease on haemodialysis were excluded from clinical trials.
Bolniki s pomanjkljivo imunostjo, bolniki s hudo nevtropenijo in bolniki s končno odpovedjo ledvic na hemodializi niso bili vključeni v klinična preskušanja.
Pack size of 10 vials.
Velikost pakiranja je 10 vial.
Patients with renal impairment at baseline should be monitored frequently for any changes in renal function during treatment and the dose of ceftolozane/tazobactam should be adjusted as necessary.
Bolnike z okvaro ledvic v izhodišču je treba med zdravljenjem redno spremljati glede sprememb v delovanju ledvic in jim po potrebi prilagoditi odmerek ceftolozana/tazobaktama.
In a trial in patients with complicated intra-abdominal infections, the most common diagnosis was appendiceal perforation or peri-appendiceal abscess (420/970 [43.3%] patients), of which 137/420 (32.6%) had diffuse peritonitis at baseline.
V preskušanju pri bolnikih z zapletenimi okužbami v trebušni votlini je bila najpogostejša diagnoza predrtje slepiča ali periapendikalni absces (pri 420/970 [43,3 %] bolnikov), pri kateri je imelo 137/420 (32,6 %) bolnikov difuzni peritonitis v izhodišču.
1, diarrhoea
1, diareja
Some medicines may interact with ceftolozane and tazobactam.
Nekatera zdravila lahko medsebojno delujejo s ceftolozanom in tazobaktamom.
Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects.
Študije tazobaktama na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) brez znakov teratogenosti.
The Cmax and AUC of ceftolozane/tazobactam increase in proportion to dose.
Cmax in AUC ceftolozana/tazobaktama se povečujeta sorazmerno odmerku.
Co-administration of ceftolozane/tazobactam with OAT1 and OAT3 substrate furosemide in a clinical study did not significantly increase furosemide plasma exposures (geometric mean ratios of 0.83 and 0.87 for Cmax and AUC, respectively).
Sočasna uporaba ceftolozana/tazobaktama s substratom OAT1 in OAT3 furosemidom v klinični študiji ni pomembno povečala izpostavljenosti furosemidu v plazmi (razmerje geometričnih sredin 0,83 za Cmax in 0,87 za AUC).
Free plasma ceftolozane concentrations were greater than 8 mcg/mL over 70% of an 8-hour period; free tazobactam concentrations were greater than 1 mcg/mL over 60% of an 8-hour period.
Koncentracija prostega ceftolozana v plazmi je bila nad 8 mcg/ml v 70 % 8-urnega obdobja; koncentracija prostega tazobaktama je bila nad 1 mcg/ml v 60 % 8-urnega obdobja.
Production of beta-lactamases that can hydrolyse ceftolozane and which are not inhibited by tazobactam (see below)
nastajanje betalaktamaz, ki lahko hidrolizirajo ceftolozan in ki jih tazobaktam ne zavira (glejte spodaj)
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to ceftolozane/tazobactam.
Bolniki, ki imajo v anamnezi preobčutljivost na cefalosporine, peniciline ali druge betalaktamske antibiotike, so lahko preobčutljivi tudi na ceftolozan/tazobaktam.
Powder for concentrate for solution for infusion 10 vials
prašek za koncentrat za raztopino za infundiranje 10 vial
This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 13,3 % največjega priporočenega dnevnega prehranskega vnosa natrija za odrasle.
Limitations of the clinical data
Pomanjkanje kliničnih podatkov
The infusion time is 1 hour for all doses of Zerbaxa.
Čas infundiranja za vse odmerke zdravila Zerbaxa je 1 ura.
This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult.
To ustreza 11,5 % največjega priporočenega dnevnega prehranskega vnosa natrija za odrasle.
Inflammation of the large intestine due to C. difficile bacteria, inflammation of the stomach, abdominal distension, indigestion, excessive gas in stomach or bowel, obstruction of the intestine, yeast infection in the mouth (thrush), yeast infection of female genitalia, fungal urinary tract infection, increase in sugar (glucose) levels (from blood tests), decrease in magnesium levels (from blood tests), decrease in phosphate levels (from blood tests), ischemic stroke (stroke caused by reduced blood flow in brain), irritation or inflammation of a vein at injection site, venous thrombosis (blood clot in a vein), low red blood cell counts, atrial fibrillation (rapid or irregular heartbeat), fast heart beat, angina pectoris (chest pain or feeling of tightness, pressure or heaviness in chest), itchy rash or swellings on the skin, hives, Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells), kidney problems, kidney disease, shortness of breath
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): vnetje debelega črevesa zaradi bakterije C. difficile, vnetje želodca, napihnjenost trebuha, prebavne motnje, nabiranje plinov v želodcu ali črevesju, zapora črevesja, glivična okužba v ustih (soor), glivična okužba ženskih spolovil, glivna okužba sečil, zvišanje vrednosti sladkorja (glukoze) (na preiskavah krvi), znižanje vrednosti magnezija (na preiskavah krvi), znižanje vrednosti fosfata (na preiskavah krvi), ishemična možganska kap (kap zaradi zmanjšanega pretoka krvi v možganih), draženje ali vnetje vene na mestu injiciranja, venska tromboza (krvni strdek v veni), majhno število rdečih krvnih celic, atrijska fibrilacija (hitro ali neredno bitje srca), hitro bitje srca, angina pektoris (bolečina v prsnem košu oziroma občutek tiščanja, pritiska ali teže v prsnem košu), srbeč izpuščaj ali oteklina na koži, koprivnica, pozitiven Coombsov test (preiskava krvi za odkrivanje protiteles, ki lahko delujejo proti rdečim krvnim celicam), težave z ledvicami, bolezen ledvic, kratka sapa.
Excipient with known effect Each vial contains 10 mmol (230 mg) of sodium.
Pomožna snov z znanim učinkom Ena viala vsebuje 10 mmol (230 mg) natrija.
To maintain similar systemic exposures to those with normal renal function, dosage adjustment is required (see section 4.2).
Za vzdrževanje podobne sistemske izpostavljenosti, kot je dosežena pri normalnem delovanju ledvic, je potrebna prilagoditev odmerka (glejte poglavje 4.2).