FrancophonIA/ELRC3.0 huggingface dataset:
English: • The other ingredient is arginine.
Slovenian: • Druga sestavina zdravila je arginin.
English: • If you have kidney problems (your doctor may have to prescribe a lower dose)
Slovenian: • če imate težave z ledvicami (zdravnik vam bo morda moral predpisati manjši odmerek),
English: If the level of your red blood cells fall your doctor may check to see if these antibodies have caused this.
Slovenian: Če bo vrednost rdečih krvnih celic padla, bo vaš zdravnik morda preveril ali so to povzročila ta protitelesa.
English: The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Slovenian: Celotni čas med začetkom in koncem priprave intravenske infuzije ne sme preseči 30 minut.
English: Do not use this medicine during pregnancy unless your doctor has told you to.
Slovenian: Tega zdravila ne uporabljajte med nosečnostjo, če vam ne naroči zdravnik.
English: There is limited experience in treating patients with diabetic foot infections.
Slovenian: Na voljo so le omejene izkušnje pri zdravljenju bolnikov z okužbami diabetičnega stopala.
English: Carcinogenicity studies have not been conducted.
Slovenian: Študij kancerogenosti niso izvedli.
English: One or more of these mechanisms may co-exist in a single bacterial isolate.
Slovenian: V istem bakterijskem izolatu lahko soobstaja eden ali več teh mehanizmov.
English: ≥ 15 to ≤ 30
Slovenian: ≥ 15 do ≤ 30
English: Arginine
Slovenian: arginin
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Slovenian: • Skupina Streptococcus anginosus (vključuje S. anginosus, S. intermedius in S. constellatus)
English: Gram-negative micro-organisms • Fusobacterium spp.
Slovenian: Gramnegativni mikroorganizmi • Fusobacterium spp.
English: There was a 33% increase in AUC0-∞ in the elderly that was mainly attributable to age-related changes in renal function.
Slovenian: Pri starejših je bila ugotovljena 33 % večja AUC0-∞; povečanje je bilo predvsem posledica s starostjo povezanih sprememb delovanja ledvic.
English: ≥ 15 to ≤ 30 300 mg ESRD, including haemodialysis
Slovenian: ≥ 15 do ≤ 30 300 mg ESRD, vključno s hemodializo
English: Staphylococcus aureus Streptococcus pneumoniae Streptococcus Groups A, B, C, G
Slovenian: Staphylococcus aureus Streptococcus pneumoniae Streptokoki skupine A, B, C, G
English: This test looks for certain antibodies which may act against your red blood cells.
Slovenian: Ta preiskava odkriva določena protitelesa, ki lahko delujejo proti rdečim krvnim celicam.
English: Infusion related reactions (such as phlebitis) can be managed by prolonging the infusion duration.
Slovenian: Z infuzijo povezane reakcije (kot je flebitis) je mogoče obvladati s podaljšanjem časa infundiranja.
English: Undesirable effects e.g. dizziness may occur and this may have an effect on the ability to drive and use of machines (see section 4.8).
Slovenian: Pojavijo se lahko neželeni učinki, kot je omotica in to lahko vpliva na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
English: From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če sta bila priprava in razredčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne smernice za ustrezno uporabo zdravil za zdravljenje bakterijskih okužb.
English: > 30 to ≤ 50
Slovenian: > 30 do ≤ 50
English: 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 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2 do 8 °C, razen če je priprava/redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: Overall, the adverse events reported in these studies were consistent with the known safety profile for Zinforo.
Slovenian: Na splošno so bili neželeni dogodki, o katerih so poročali v teh študijah, skladni z znanim varnostnim profilom zdravila Zinforo.
English: Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room temperature.
Slovenian: Študije so pokazale, da so raztopine za infundiranje Zinforo na sobni temperaturi stabilne do 6 ur.
English: Antibacterial activity against other relevant pathogens
Slovenian: Protibakterijska aktivnost proti drugim relevantnim patogenom
English: • If you have had severe diarrhoea whilst taking antibiotics in the past
Slovenian: • če ste imeli hudo drisko ob jemanju antibiotikov v preteklosti.
English: The usual recommended dose for children depends on the age and weight of the child and is given every 8 or 12 hours.
Slovenian: Običajen priporočeni odmerek za otroke je odvisen od otrokove starosti in telesne mase ter se uporablja na 8 ali 12 ur.
English: • If you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na fosamilceftarolin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: • Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zinforo.
Slovenian: • driska, ki postane huda ali ne izgine, ali blato, ki vsebuje kri ali sluz, med zdravljenjem z zdravilom Zinforo ali po njem.
English: When stored as recommended, the product potency is not affected.
Slovenian: Če je zdravilo shranjeno, kot je priporočeno, se njegova moč ne zmanjša.
English: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Slovenian: Prašek je treba pripraviti z vodo za injekcije, tako nastali koncentrat pa redčiti tik pred uporabo.
English: Adverse reactions are classified according to System Organ Class and frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
English: The usual recommended dose for adults is 600 mg every 12 hours.
Slovenian: Običajen priporočeni odmerek za odrasle je 600 mg na 12 ur.
English: Once the intravenous solution is prepared with diluents listed in section 6.6 it should be administered within 6 hours of preparation.
Slovenian: Ko je intravenska raztopina pripravljena z vehikli, navedenimi v poglavju 6.6, jo je treba aplicirati v 6 urah po pripravi.
English: After reconstitution: The reconstituted vial should be diluted immediately.
Slovenian: Po rekonstituciji Pripravljeno vialo je treba razredčiti takoj.
English: 120/every 8 hours
Slovenian: 120/vsakih 8 ur
English: * Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.
Slovenian: * Izračunano z uporabo Schwartzove formule (v ml/min/1,73 m2) za pediatrične bolnike.
English: Treatment of overdose should follow standard medical practice;
Slovenian: Pri zdravljenju prevelikega odmerjanja je treba upoštevati standardno medicinsko prakso.
English: If a severe allergic reaction occurs during treament with Zinforo, the medicinal product should be discontinued and appropriate measures taken.
Slovenian: Če se med zdravljenjem z zdravilom Zinforo pojavi huda alergijska reakcija, je treba uporabo zdravila prekiniti in ustrezno ukrepati.
English: Juvenile toxicity
Slovenian: Toksičnost pri mladičih
English: Do not use Zinforo if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Zinforo, če kaj od naštetega velja za vas.
English: Relative overdosing could occur in patients with moderate renal impairment.
Slovenian: Relativno preveliko odmerjanje se lahko pojavi pri bolnikih z zmerno okvaro ledvic.
English: It is free of any particles.
Slovenian: Raztopina je brez delcev.
English: Therefore, Zinforo should be used with caution in this patient population.
Slovenian: Zato je treba zdravilo Zinforo v tej skupini bolnikov uporabljati previdno.
English: • More enzymes produced by your liver (as shown in blood tests)
Slovenian: • večje nastajanje encimov v jetrih (to pokažejo preiskave krvi)
English: The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints for susceptibility testing are presented below.
Slovenian: Spodaj so prikazane mejne vrednosti za testiranje občutljivosti po EUCAST (European Committee on Antimicrobial Susceptibility Testing).
English: Infusion volumes for paediatric patients will vary according to the weight of the child.
Slovenian: Volumen infuzije za pediatrične bolnike se razlikuje glede na otrokovo telesno maso.
English: You may experience fever, flu-like symptoms, sore throat, or any other infection which may be serious.
Slovenian: Pojavijo se vam lahko zvišana telesna temperatura, gripi podobni simptomi, boleče žrelo ali kakšna druga okužba, ki je lahko resna.
English: The MAH shall perform the 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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: The plasma protein binding of ceftaroline is low (approximately 20%) and ceftaroline is not distributed into erythrocytes.
Slovenian: Vezava ceftarolina na beljakovine v plazmi je majhna (približno 20 %) in ceftarolin se ne porazdeli v eritrocite.
English: • Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Slovenian: • nenadna oteklost ustnic, obraza, žrela ali jezika, hud izpuščaj, težave s požiranjem ali dihanjem.
English: Patients with pre-existing seizure disorder
Slovenian: Bolniki z obstoječo konvulzivno motnjo
English: • Redness, pain or swelling where the injection was given.
Slovenian: • pordelost, bolečina ali oteklost na mestu, kjer ste dobili injekcijo
English: Each vial is for single use only.
Slovenian: Vsaka viala je namenjena samo za enkratno uporabo.
English: The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.5 hours.
Slovenian: Povprečni končni razpolovni čas izločanja ceftarolina je pri zdravih odraslih približno 2,5 ure.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zinforo therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Zinforo, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Slovenian: Pomembno: Pred predpisovanjem tega zdravila glejte Povzetek glavnih značilnosti zdravila.
English: Lab Test
Slovenian: Laboratorijske preiskave
English: ESRD, including haemodialysis
Slovenian: ESRD, vključno s hemodializo
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening;
Slovenian: To so lahko znaki hude alergijske reakcije (anafilaksije) in so lahko smrtno nevarni.
English: Mix gently to reconstitute and check to see that the contents have dissolved completely.
Slovenian: Previdno premešajte, da pripravite raztopino, in se prepričajte, ali se je celotna vsebina povsem raztopila.
English: Therefore, interactions of ceftaroline with medicinal products that are substrates or inhibitors (e.g. probenecid) of these transporters would not be expected.
Slovenian: Zato ni pričakovati medsebojnih delovanj ceftarolina z zdravili, ki so substrati ali zaviralci (npr. probenecid) teh prenašalcev.
English: The cysts involved a small portion of the kidney and ocurred in the absence of significant changes in either renal function or urinary parameters.
Slovenian: Ciste so zajele majhen del ledvice in so se pojavile brez pomembnih sprememb delovanja ledvic ali urinskih parametrov.
English: Other important toxicologic findings noted in the rat and monkey included histopathologic changes in the bladder and spleen.
Slovenian: Med drugimi pomembnimi toksikološkimi izsledki pri podganah in opicah so bile histopatološke spremembe v mehurju in vranici.
English: ACS Dobfar S.p.A. Nucleo Industriale S. Atto 64100 Teramo Italy
Slovenian: Nucleo Industriale S. Atto 64100 Teramo Italija
English: Approximate ceftaroline concentration (mg/mL)
Slovenian: Približna koncentracija ceftarolina (mg/ml)
English: Caution is advised when treating such patients.
Slovenian: Pri zdravljenju takšnih bolnikov je potrebna previdnost.
English: Organisms that express these enzymes and which are therefore resistant to ceftaroline occur at very variable rates between countries and between healthcare facilities within countries.
Slovenian: Stopnja pojavnosti organizmov, ki tvorijo te encime in so zaradi tega odporni na ceftarolin, se spreminja med državami in med zdravstvenimi ustanovami znotraj držav.
English: If ceftaroline is commenced before susceptibility test results are available then local information on the risk of encountering organisms that express these enzymes should be taken into consideration.
Slovenian: Če ceftarolin uvedemo preden so na voljo rezultati občutljivostnih testov, moramo upoštevati lokalne informacije o verjetnosti prisotnosti organizmov, ki tvorijo te encime.
English: Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations.
Slovenian: Študije na živalih, izvedene pri podganah in kuncih, ne kažejo škodljivih učinkov glede vpliva na sposobnost razmnoževanja pri izpostavljenosti, podobni kot je pri terapevtskih koncentracijah.
English: Paediatric population As with adults, the interaction potential is expected to be low in paediatrics.
Slovenian: Tako kot pri odraslih lahko tudi pri pediatrični populaciji pričakujemo majhno možnost za medsebojno delovanje.
English: What you need to know before you use Zinforo
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zinforo
English: > 30 to ≤ 50 400 mg c/every 12 hours
Slovenian: > 30 do ≤ 50 400 mg c/vsakih 12 ur
English: CrCL should be closely monitored and the dose adjusted according to changing renal function.
Slovenian: Očistek kreatinina je treba skrbno spremljati in odmerek prilagoditi glede na spreminjajoče se delovanje ledvic.
English: Clostridium difficile-associated disease (CDAD) and severe hypersensitivity reactions may also occur.
Slovenian: Lahko se pojavi tudi okužba z bakterijo Clostridium difficile (CDADClostridium difficile-associated disease) in hude preobčutljivostne reakcije.
English: In such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Slovenian: V takšnih okoliščinah pride v poštev prenehanje zdravljenja s fosamilceftarolinom in uporaba podpornih ukrepov, obenem z uporabo specifičnega zdravljenja proti Clostridium difficile.
English: Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a given dose was recovered in the dialysate.
Slovenian: Ceftarolin je mogoče odstraniti s hemodializo; med 4-urno dializo se je v dializatu pojavilo približno 74 % danega odmerka.
English: Furthermore, in vivo micronucleus assays in rat and mouse were negative.
Slovenian: Poleg tega so bili mikrojedrni preizkusi pri podganah in miših in vivo negativni.
English: Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Slovenian: Preobčutljivostne reakcije Možne so resne preobčutljivostne reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
English: In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Slovenian: V kliničnih študijah ni bilo znakov hemolize pri bolnikih, pri katerih se je med zdravljenjem razvil pozitiven DAGT.
English: In addition, the safety assessment in neonates is based on the safety data from 2 trials in which 34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo.
Slovenian: Dodatno ocena varnosti pri novorojenčkih temelji na podatkih o varnosti iz 2 preskušanj, v katerih je zdravilo Zinforo prejemalo 34 bolnikov (starostni razpon od rojstva do manj kot 60 dni); 23 od teh bolnikov je prejelo samo en odmerek zdravila Zinforo.
English: The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions.
Slovenian: Barva raztopine za infundiranje Zinforo sega od bistre, svetle do temno rumene, odvisno od koncentracije in pogojev shranjevanja.
English: The compatibility of Zinforo with other medicines has not been established.
Slovenian: Kompatibilnost zdravila Zinforo z drugimi zdravili ni ugotovljena.
English: As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with Zinforo's antibacterial profile.
Slovenian: Zaradi previdnosti se je zdravilu Zinforo med nosečnostjo bolje izogniti, razen če klinično stanje ženske zahteva zdravljenje z antibiotikom, ki ima takšen protibakterijski profil kot zdravilo Zinforo.
English: Zinforo will be given to you by a doctor or nurse.
Slovenian: Zdravilo Zinforo vam bo dal zdravnik ali medicinska sestra.
English: The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.
Slovenian: Koncentracija raztopine za infundiranje med pripravo in dajanjem ne sme presegati 12 mg/ml fosamilceftarolina.
English: The medicinal product is supplied in packs of 10 vials.
Slovenian: Zdravilo je pakirano v pakiranje z 10 vialami.
English: A 250 mL, 100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Slovenian: Za pripravo infuzije se lahko uporabi 250 ml, 100 ml ali 50 ml infuzijsko vrečko, odvisno od bolnikovih zahtev glede infundiranega volumna.
English: Biochemical studies have shown that ceftaroline has high affinity for PBP2a of methicillin-resistant Staphylococcus aureus (MRSA) and PBP2x of penicillin non-susceptible Streptococcus pneumoniae (PNSP).
Slovenian: Biokemijske študije so pokazale, da ima ceftarolin visoko afiniteto za PBP2a proti meticilin odpornemu Staphylococcus aureus (MRSA - methicillin-resistant Staphylococcus aureus) in PBP2x za penicilin neobčutljivega Streptococcus pneumoniae (PNSPpenicillin non-susceptible Streptococcus pneumoniae).
English: Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m
Slovenian: Izračunano z uporabo Schwartzove formule za pediatrične bolnike (v ml/min/1,73 m2).
English: Therefore, these findings were not considered to be adverse.
Slovenian: Zato teh izsledkov niso uvrstili med neželene.
English: Histopathologic findings included pigment deposition and inflammation of the tubular epithelium.
Slovenian: Med histopatološkimi izsledki so bili odlaganje pigmenta in vnetje tubulnega epitelija.
English: For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable.
Slovenian: Pri bolnikih z ledvičnim očistkom nad normalno vrednostjo, ki prejemajo običajni odmerek, je bolj primeren 60 minutni čas infundiranja.
English: Table 5 Frequency of adverse reactions by system organ class from clinical trials and post marketing experience
Slovenian: Preglednica 5 Pogostnost neželenih učinkov iz kliničnih preskušanj in izkušenj v obdobju trženja po organskih sistemih
English: In vitro data indicate that the following species are not susceptible to ceftaroline:
Slovenian: Podatki in vitro kažejo, da naslednje vrste niso občutljive za ceftarolin:
English: However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out.
Slovenian: Vendar možnosti pojava hemolitične anemije v povezavi s cefalosporini, vključno z zdravilom Zinforo, ni mogoče izključiti.
English: Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and OAT3) in vitro.
Slovenian: Ceftarolin in vitro ni ne substrat ne zaviralec ledvičnih privzemnih prenašalcev (OCT2, OAT1 in OAT3).
English: Volume of diluent to be added (mL)
Slovenian: Količina vehikla, ki ga je treba dodati (ml)
English: • Changes in tests which measure how well your blood clots.
Slovenian: • spremembe izvidov preiskav, ki merijo sposobnost strjevanja krvi
English: Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).
Slovenian: Študije s fosamilceftarolinom na živalih ne kažejo škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: Do not use Zinforo:
Slovenian: Ne uporabljajte zdravila Zinforo:
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to ceftaroline in the absence of acquired mechanisms of resistance:
Slovenian: Klinična učinkovitost ni ugotovljena proti naslednjim patogenom, čeprav so študije in vitro nakazovale, da so občutljivi za ceftarolin, če ni pridobljenih mehanizmov odpornosti:
English: Dose recommendations for neonates, infants and children and adolescents are based on pharmacokinetic (PK) modelling.
Slovenian: Priporočila za odmerjanje pri novorojenčkih, dojenčkih, otrocih in mladostnikih temeljijo na farmakokinetičnem modeliranju.
English: Renal cortical cysts were oberved in all groups, including controls, on PND50.
Slovenian: Na PND50 so opažali ledvične kortikalne ciste v vseh skupinah, vključno s kontrolnimi živalmi.
English: The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Slovenian: Najpogostejši neželeni učinki, ki so se pojavili pri ≥ 3 % od približno 3242 bolnikov, ki so bili v kliničnih študijah zdravljeni z zdravilom Zinforo, so bili driska, glavobol, navzea in srbenje.
English: S. aureus with ceftaroline MICs ≥ 4 mg/L are rare.
Slovenian: S. aureus z MIK ceftarolina ≥ 4 mg/l so redki.
English: Posology (mg/infusion)
Slovenian: Odmerjanje (mg/infuzijo)
English: It is given as a drip into a vein lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose.
Slovenian: Zdravilo se daje s kapljično infuzijo v veno v obdobju od 5 do 60 minut, če prejmete običajni odmerek, ali 120 minut, če prejmete večji odmerek.
English: If you have kidney problems your doctor may lower your dose because Zinforo is removed from your body by the kidneys.
Slovenian: Če imate težave z ledvicami, vam bo zdravnik morda zmanjšal odmerek, ker se zdravilo Zinforo izloči iz telesa preko ledvic.
English: • If you are allergic to other cephalosporin antibiotics
Slovenian: • če ste alergični na druge cefalosporinske antibiotike,
English: What Zinforo is and what it is used for
Slovenian: Kaj je zdravilo Zinforo in za kaj ga uporabljamo
English: A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia.
Slovenian: Zdravljenje po navadi traja od 5 do 14 dni pri okužbah kože in od 5 do 7 dni pri pljučnici.