FrancophonIA/ELRC3.0 huggingface dataset:
English: Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and unscheduled DNA synthesis assay.
Slovenian: Fosamilceftarolin in ceftarolin sta bila klastogena v preizkusu kromosomskih aberacij in vitro, a Amesov test, preizkus z mišjim limfomom in preizkus nenačrtne sinteze DNA niso pokazali znakov mutagenega delovanja.
English: Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients.
Slovenian: Dojene podgane, ki so bile od 7 do 20 dni po skotitvi, so dobro prenašale intravensko bolusno uporabo fosamilceftarolina ob plazemski izpostavljenosti, ki je bila približno 2-krat večja kot pri pediatričnih bolnikih.
English: • Feeling sick (nausea) or being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzea) ali bruhanje
English: Appropriate infusion diluents include: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer's solution.
Slovenian: Med primernimi vehikli so: natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje, glukoza 50 mg/ml (5 %) raztopina za injiciranje, natrijev klorid 4,5 mg/ml in glukoza 25 mg/ml raztopina za injiciranje (0,45 % natrijev klorid in 2,5 % glukoza) ali raztopina Ringerjevega laktata.
English: • Pain and irritation of the veins
Slovenian: • bolečina in vnetje ven
English: The mean plasma ceftaroline M-1 to ceftaroline AUC ratio following a single 600 mg intravenous infusion of ceftaroline fosamil in healthy subjects is approximately 20-30%.
Slovenian: Povprečno razmerje med AUC ceftarolina M-1 in ceftarolina v plazmi je pri zdravih preiskovancih po enkratni intravenski infuziji 600 mg fosamilceftarolina približno 20 do 30 %.
English: Zinforo should not be mixed with or physically added to solutions containing other drugs.
Slovenian: Zdravila Zinforo se ne sme mešati z raztopinami, ki vsebujejo druga zdravila, in se ga ne sme fizično dodajati takšnim raztopinam.
English: The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 11.2% in the five pooled pivotal studies with administration every 12 hours (600 mg administered over 60 minutes every 12 hours) and 32.3% in a study in patients receiving ceftaroline fosamil every 8 hours (600 mg administered over 120 minutes every 8 hours), (see section 4.8).
Slovenian: Kumulativno je bila incidenca serokonverzije DAGT v petih ključnih študijah pri bolnikih, zdravljenih s fosamilceftarolinom na 12 ur (600 mg v 60 minutah na 12 ur), 11,2 % in v študiji pri bolnikih, zdravljenih s fosamilceftarolinom na 8 ur (600 mg v 120 minutah na 8 ur), 32,3 % (glejte poglavje 4.8).
English: Pyrexia, infusion site reactions (erythema, phlebitis, pain)
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, reakcije na mestu infundiranja (eritem, flebitis, bolečina)
English: 10 mg/kg to a maximum of 400 mg
Slovenian: 10 mg/kg do največ 400 mg
English: • If you have ever had any non-severe allergic reactions to other antibiotics like penicillin or carbapenem
Slovenian: • če ste imeli kdaj blažjo obliko alergijske reakcije na druge antibiotike, npr. penicilin ali karbapenem,
English: Non-susceptible organisms Superinfections may occur during or following treatment with Zinforo.
Slovenian: Neobčutljivi organizmi Med zdravljenjem z zdravilom Zinforo ali po njem se lahko pojavi superinfekcija.
English: The reconstituted solution is a pale yellow solution that is free of any particles.
Slovenian: Pripravljena raztopina je bledorumene barve in brez delcev.
English: Dosage adjustments are required in adults, adolescents and children with CrCL ≤ 50 mL/min (see section 4.2).
Slovenian: Odmerek je treba prilagoditi pri odraslih, mladostnikih in otrocih z očistkom kreatinina ≤ 50 ml/min (glejte poglavje 4.2).
English: Interaction with other antibacterial agents
Slovenian: Medsebojna delovanja z drugimi zdravili za zdravljenje bakterijskih okužb
English: Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M-1.
Slovenian: S hidrolizo betalaktamskega obroča ceftarolina nastane ceftarolin M-1, mikrobiološko neaktiven presnovek z razklenjenim obročem.
English: • Complicated skin and soft tissue infections (cSSTI) • Community-acquired pneumonia (CAP)
Slovenian: • zapletenih okužb kože in mehkih tkiv (cSSTI - complicated skin and soft tissue infections) • zunajbolnišnične pljučnice (ZBP)
English: Refers to dosing of adults or adolescents (from 12 years and 33 kg) with ceftaroline every 12 hours using 1hour infusions (see section 4.2).
Slovenian: Velja za odmerjanje ceftarolina pri odraslih in mladostnikih (od 12 let in 33 kg) na 12 ur v 1-urni infuziji (glejte poglavje 4.2).
English: • Each vial contains 600 mg of ceftaroline fosamil.
Slovenian: • Ena viala vsebuje 600 mg fosamilceftarolina.
English: 8 mg/kg to a maximum of 300 mg
Slovenian: 8 mg/kg do največ 300 mg
English: • Staphylococcus aureus (methicillin-susceptible strains only)
Slovenian: • Staphylococcus aureus (samo sevi, občutljivi za meticilin)
English: What Zinforo looks like and contents of the pack Zinforo is a pale yellowish-white to light yellow powder for concentrate for solution for infusion in a vial.
Slovenian: Izgled zdravila Zinforo in vsebina pakiranja Zdravilo Zinforo je bledo rumenkastobel do svetlo rumen prašek za koncentrat za raztopino za infundiranje v viali.
English: 8 mg/kg to a maximum of 300 mg c/every 8 hours
Slovenian: od 8 mg/kg do največ 300 mg c/vsakih 8 ur
English: Therefore, no dosage adjustment is recommended for patients with hepatic impairment.
Slovenian: Zato bolnikom z okvaro jeter odmerka ni treba prilagoditi.
English: No cases of CAP due to MRSA were enrolled into the studies.
Slovenian: V študije ni bil vključen noben primer zunajbolnišnične pljučnice zaradi MRSA.
English: Total volume
Slovenian: Količina za uporabo celotna količina
English: High dose cSSTI confirmed or suspected to be caused by S. aureus with an MIC = 2 mg/L or 4 mg/L to ceftaroline
Slovenian: 200 mg velik odmerek cSSTI, ki jih potrjeno ali domnevno povzroča S. aureus z MIK = 2 mg/l ali 4 mg/l za ceftarolin
English: In pooled human liver microsomes, metabolic turnover was low for ceftaroline, indicating that ceftaroline is not metabolised by hepatic CYP450 enzymes.
Slovenian: Kumulativno je bil presnovni obrat ceftarolina v humanih jetrnih mikrosomih majhen, kar kaže, da se ceftarolin ne presnavlja z jetrnimi encimi CYP450.
English: Infusion times of less than 60 minutes are based on pharmacokinetic and pharmacodynamic analyses only.
Slovenian: Časi infundiranja, krajši od 60 minut, temeljijo samo na farmakokinetičnih in farmakodinamičnih analizah.
English: You may get another infection caused by another bacteria during or following treatment with Zinforo.
Slovenian: Med zdravljenjem z zdravilom Zinforo ali po njem je možno, da boste dobili drugo okužbo, povzročeno z drugimi bakterijami.
English: Gram-positive micro-organisms
Slovenian: Grampozitivni mikroorganizmi
English: Note that: There are no clinical trial data regarding the use of ceftaroline to treat CAP due to S. aureus with ceftaroline MICs > 1 mg/L 2.
Slovenian: Opozorilo: Iz kliničnih preskušanj ni podatkov o uporabi ceftarolina za zdravljenje zunajbolnišnične pljučnice zaradi S. aureus, pri katerih so MIK ceftarolina > 1 mg/l.
English: Zinforo 600 mg powder for concentrate for solution for infusion
Slovenian: Zinforo 600 mg prašek za koncentrat za raztopino za infundiranje
English: Table 1 Dosage in adults with normal renal function, creatinine clearance (CrCL) > 50 mL/min Indications
Slovenian: Preglednica 1 Odmerjanje pri odraslih z normalnim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) > 50 ml/min
English: Hypersensitivity to the cephalosporin class of antibacterials.
Slovenian: Preobčutljivost na cefalosporinska zdravila za zdravljenje bakterijskih okužb.
English: For single use only.
Slovenian: intravenska uporaba samo za enkratno uporabo
English: PC:
Slovenian: EXP:
English: Ceftaroline is haemodialyzable; thus Zinforo should be administered after haemodialysis on haemodialysis days.
Slovenian: Ceftarolin je mogoče odstraniti s hemodializo, zato je treba zdravilo Zinforo na dan hemodialize uporabiti po hemodializi.
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins.
Slovenian: Med zdravljenjem s cefalosporini se lahko pojavi pozitiven izvid direktnega antiglobulinskega testa (DAGT - direct antiglobulin test).
English: • Anaemia
Slovenian: • anemija (slabokrvnost)
English: No dosage adjustment is required for the elderly with creatinine clearance values > 50 mL/min (see section 5.2).
Slovenian: Starejši Starejšim z očistkom kreatinina > 50 ml/min odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: When ceftaroline was administered during organogenesis, minor changes in foetal weight and delayed ossification of the interparietal bone were observed in the rat at exposures below that observed clinically.
Slovenian: Če je bil ceftarolin uporabljen med organogenezo, so pri podganah ob izpostavljenosti, ki so bile nižje od klinično opaženih, ugotovili manjše spremembe telesne mase plodov in zapoznelo osifikacijo interparietalne kosti.
English: Creatinine shows how well your kidneys are working.
Slovenian: • povečana koncentracija kreatinina v krvi; kreatinin kaže, kako dobro vam delujejo ledvice
English: What Zinforo contains
Slovenian: Kaj vsebuje zdravilo Zinforo
English: • infections of the skin and the tissues below the skin
Slovenian: • okužbami kože in podkožnih tkiv,
English: The kidney was the primary target organ of toxicity in both the monkey and rat.
Slovenian: Pri opicah in podganah so bile primarni tarčni organ toksičnosti ledvice.
English: There are limited clinical trial data on the use of ceftaroline to treat cSSTI caused by S. aureus with an MIC of > 1 mg/L.
Slovenian: Iz kliničnih preskušanj je malo podatkov o uporabi ceftarolina za zdravljenje zapletenih okužb kože in mehkih tkiv s S. aureus z MIK > 1 mg/l.
English: Zinforo dose adjustment is not required in elderly patients with creatinine clearance above 50 mL/min.
Slovenian: Starejšim bolnikom z očistkom kreatinina nad 50 ml/min odmerka zdravila Zinforo ni treba prilagoditi.
English: Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure.
Slovenian: V celoti pri podganah med izpostavljenostjo, ki je bila 5-krat tolikšna kot je opažena klinična izpostavljenost, niso opazili učinkov na plodnost ali postnatalni razvoj.
English: Dosage strength (mg)
Slovenian: Velikost odmerka (mg)
English: If you are not sure, talk to your doctor or nurse before using Zinforo.
Slovenian: Če ste noseči, se posvetujte z zdravnikom, preden uporabite zdravilo Zinforo.
English: The Cmax and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg. No appreciable accumulation of ceftaroline is observed following multiple intravenous infusions of 600 mg every 8 or 12 hours in healthy adults with CrCL > 50 mL/min.
Slovenian: Pri zdravih odraslih s CrCL > 50 ml/min niso zabeležili opaznega kopičenja ceftarolina po večkratnih intravenskih infuzijah 600 mg na 8 ali 12 ur.
English: What Zinforo is and what it is used for What you need to know before you use Zinforo How to use Zinforo
Slovenian: Kaj je zdravilo Zinforo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zinforo Kako uporabljati zdravilo Zinforo Možni neželeni učinki
English: Adolescents aged from 12 years to < 18 years bodyweight < 33 kg and children ≥ 2 years to < 12 years
Slovenian: 200 mg mladostniki, stari od 12 let do < 18 let, s telesno maso < 33 kg, in otroci, stari od ≥ 2 leti do < 12 let
English: No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil.
Slovenian: Študije medsebojnega delovanja zdravil s fosamilceftarolinom niso bile izvedene.
English: Renal clearance of ceftaroline is approximately equal, or slightly lower than the glomerular filtration rate in the kidney, and in vitro transporter studies indicate that active secretion does not contribute to the renal elimination of ceftaroline.
Slovenian: Ledvični očistek ceftarolina je približno enak ali malenkost manjši kot hitrost glomerularne filtracije v ledvicah in študije prenašalcev in vitro kažejo,
English: The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo.
Slovenian: V kliničnih preskušanjih z zdravilom Zinforo in v izkušnjah v obdobju trženja so ugotovili naslednje neželene učinke.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi arginin
English: Investigations Coombs Direct Test
Slovenian: Preiskave pozitiven direktni Coombsov test (glejte poglavje 4.
English: The resulting solution should be administered according to the dose selected over 5 to 60 minutes for standard dose or 120 minutes for high dose in infusion volumes of 50 mL, 100 mL or 250 mL.
Slovenian: Nastalo raztopino infuzijskih volumnov 50 ml, 100 ml ali 250 ml je treba aplicirati glede na izbrani odmerek od 5 do 60 minut pri običajnem odmerku ali 120 minut pri velikem odmerku.
English: Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only.
Slovenian: Časi infundiranja, krajši od 60 minut, in priporočila za velike odmerke temeljijo samo na farmakokinetičnih in farmakodinamičnih analizah.
English: Zinforo should not be used to treat cSSTI due to S. aureus for which the ceftaroline MIC is > 4 mg/L.
Slovenian: Zdravila Zinforo se ne sme uporabljati za zdravljenje zapletenih okužb kože in mehkih tkiv s S. aureus, pri katerih je MIK ceftarolina > 4 mg/l.
English: Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil.
Slovenian: Ena viala vsebuje 600 mg fosamilceftarolina v obliki fosamilceftarolinijevega monoacetata monohidrata.
English: Refers to dosing of adults or adolescents (from 12 years and 33 kg) with ceftaroline every 8 hours using 2hour infusions to treat cSSTI (see section 4.2).
Slovenian: Velja za odmerjanje ceftarolina pri odraslih in mladostnikih (od 12 let in 33 kg) na 8 ur v 2-urnih infuzijah za zdravljenje zapletenih okužb kože in mehkih tkiv (glejte poglavje 4.2).
English: Ceftaroline administration to pregnant rabbits resulted in an increased foetal incidence of angulated hyoid alae, a common skeletal variation in rabbit fetuses, at exposures similar to those observed clinically.
Slovenian: Uporaba ceftarolina pri brejih samicah kuncev je ob podobni izpostavljenosti, kot je opažena klinično, pri plodovih povečala incidenco ukrivljenosti krila podjezičnice, ki je pogosta skeletna sprememba pri plodovih kuncev.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI02
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, drugi cefalosporini in penemi.
English: Rash was observed at a common frequency in both the pooled Phase III studies in cSSTI with administration of Zinforo every 12 hours (600 mg administered over 60 minutes every 12 hours) and the study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 8 hours).
Slovenian: Izpuščaj so s pogostnostjo pogosti opažali tako kumulativno v študiji III. faze pri bolnikih z zapletenimi okužbami kože in mehkih tkiv, zdravljenih z zdravilom Zinforo na 12 ur (600 mg v 60 minutah na 12 ur), kot v študiji pri bolnikih z zapletenimi okužbami kože in mehkih tkiv, zdravljenih z uporabo na 8 ur (600 mg v 120 minutah na 8 ur).
English: Zinforo 600 mg powder for concentrate for solution for infusion ceftaroline fosamil
Slovenian: Zinforo 600 mg prašek za koncentrat za raztopino za infundiranje fosamilceftarolin
English: (agranulocytosis).
Slovenian: (levkopenija in nevtropenija)
English: The active moiety after Zinforo administration is ceftaroline.
Slovenian: Zdravilna učinkovina po uporabi zdravila Zinforo je ceftarolin.
English: Infusion times of less than 60 minutes, neonatal and high dose recommendations are based on pharmacokinetic and pharmacodynamic analyses only.
Slovenian: Časi infundiranja, krajši od 60 minut, in priporočila za novorojenčke in velike odmerke temeljijo samo na farmakokinetičnih in farmakodinamičnih analizah.
English: Zinforo is administered by intravenous infusion over 5 to 60 minutes for standard dose or 120 minutes for high dose (for cSSTI caused by S. aureus with MIC of 2 or 4 mg/L to ceftaroline) in infusion volumes of 50 mL, 100 mL or 250 mL (see section 6.6).
Slovenian: ali 4 mg/l za ceftarolin) pri infuzijskih volumnih 50 ml, 100 ml ali 250 ml (glejte poglavje 6.6).
English: Table 2 Dosage in paediatric patients with normal renal function, creatinine clearance (CrCL)
Slovenian: Preglednica 2 Odmerjanje pri pediatričnih bolnikih z normalnim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) > 50 ml/min*
English: There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to < 18 years with bodyweight < 33 kg and in children aged from 2 to 12 years with End-stage renal disease (ESRD).
Slovenian: Pri mladostnikih, starih od 12 do < 18 let s telesno maso < 33 kg, in otrocih, starih od 2 do 12 let, s končno odpovedjo ledvic (ESRD - end-stage renal disease) ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
English: MIC breakpoints (mg/L) Susceptible (≤ S)
Slovenian: Mejne vrednosti MIK (mg/l)
English: Communityacquired pneumonia (CAP)
Slovenian: zunajbolnišnična pljučnica (ZBP)
English: A greater incidence of rash in Asian patients (see below) and a greater incidence of DAGT seroconversion (see section 4.4) were observed in a study of adult patients with cSSTI conducted with Zinforo 600 mg administered over 120 minutes every 8 hours.
Slovenian: V študiji pri odraslih bolnikih z zapletenimi okužbami kože in mehkih tkiv, ki so jo izvedli z zdravilom Zinforo 600 mg, apliciranim v 120 minutah na 8 ur, je bila opažena večja incidenca izpuščaja pri azijskih bolnikih (glejte spodaj) in večja incidenca serokonverzije DAGT (glejte poglavje 4.4).
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening.
Slovenian: Med uporabo fosamilceftarolina sta bila opisana z zdravili za zdravljenje bakterijskih okužb povezana kolitis in psevdomembranski kolitis; segata lahko od blagega do smrtno nevarnega.
English: • Bleeding or bruising more than usual.
Slovenian: • več krvavitev ali podplutb kot po navadi; vzrok tega je lahko zmanjšanje števila trombocitov v krvi
English: Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment:
Slovenian: Morda boste potrebovali nujno zdravniško pomoč:
English: Infants ≥ 2 months to < 2 years
Slovenian: 120/vsakih 8 ur dojenčki, stari od ≥ 2 meseca do < 2 leti
English: Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. penicillins or carbapenems).
Slovenian: Pri bolnikih z anamnezo blagih preobčutljivostnih reakcij za katere koli druge betalaktamske antibiotike (npr. peniciline ali karbapeneme) je potrebna previdnost pri uporabi ceftarolina.
English: Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil.
Slovenian: Vsebuje zdravilno učinkovino, ki se imenuje fosamilceftarolin.
English: • Streptococcus pneumoniae
Slovenian: Grampozitivni mikroorganizmi • Streptococcus pneumoniae
English: Zinforo 600 mg powder for concentrate ceftaroline fosamil
Slovenian: Zinforo 600 mg prašek za koncentrat fosamilceftarolin i.v.
English: There is insufficient information to recommend dosage adjustments in paediatric patients < 2 years with moderate or severe renal impairment or ESRD.
Slovenian: Za pediatrične bolnike do < 2 leti z zmerno ali hudo okvaro ledvic ali končno odpovedjo ledvic ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
English: What Zinforo is
Slovenian: Kaj je zdravilo Zinforo
English: Table 4 Dosage in paediatric patients with impaired renal function, creatinine clearance
Slovenian: Preglednica 4 Odmerjanje pri pediatričnih bolnikih z okvarjenim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) ≤ 50 ml/min
English: Community-acquired pneumonia
Slovenian: Zunajbolnišnična pljučnica
English: • Raised itchy rash (hives)
Slovenian: • dvignjen srbeč izpuščaj (koprivnica)
English: Hepatobiliary disorders
Slovenian: Žilne bolezni flebitis
English: Genetic toxicology
Slovenian: Genotoksičnost
English: There is insufficient information to recommend dosage adjustments in paediatric patients aged < 2 years with moderate or severe renal impairment or ESRD.
Slovenian: Za pediatrične bolnike, stare < 2 leti, z zmerno ali hudo okvaro ledvic ali končno odpovedjo ledvic, ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
English: Talk to your doctor or nurse before using Zinforo:
Slovenian: Pred začetkom uporabe zdravila Zinforo se posvetujte z zdravnikom ali medicinsko sestro:
English: There is insufficient information to recommend dosage adjustments in adolescents with ESRD aged from 12 to < 18 years and with bodyweight < 33 kg and in children with ESRD aged from 2 to < 12 years.
Slovenian: Pri mladostnikih s končno odpovedjo ledvic, starih od 12 do < 18 let in s telesno maso < 33 kg, ter pri otrocih s končno odpovedjo ledvic, starih od 2 do < 12 let, ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
English: Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL)
Slovenian: Preglednica 3 Odmerjanje pri odraslih z okvarjenim delovanjem ledvic, očistek kreatinina (CrCL - creatinine clearance) ≤ 50 ml/min
English: • Itching, skin rash
Slovenian: • srbenje, izpuščaj na koži
English: The patient will usually take their medicine for at least 6 to 12 months, and treatment may last several years.
Slovenian: Bolnik običajno jemlje zdravilo vsaj 6 do 12 mesecev, zdravljenje pa lahko traja tudi več let.
English: The full EPAR for Vemlidy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vemlidy je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Vemlidy?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vemlidy?
English: This is a summary of the European public assessment report (EPAR) for Vemlidy.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vemlidy.
English: For the full list of side effects and restrictions see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev glejte navodilo za uporabo.
English: The most common side effects with Vemlidy are headache (11% of patients), nausea (6% of patients) and tiredness (6% of patients).
Slovenian: Najpogostejši neželeni učinki zdravila Vemlidy so glavobol (11 % bolnikov), navzea (6 % bolnikov) in utrujenost (6 % bolnikov).
English: Vemlidy tenofovir alafenamide
Slovenian: Vemlidy alafenamidtenofovirat
English: These results suggest that the comparator medicine might be more effective in ‘e-antigen positive' cases but differences seen are small.
Slovenian: Ti rezultati kažejo, da je primerjalno zdravilo pri primerih, pozitivnih za antigen e, morda učinkovitejše, vendar so razlike majhne.