FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with CNS metastases not requiring steroids and with stable neurologic status for at least two weeks after completion of the definitive therapy and steroids were eligible to be randomised in the FLAURA study.
Slovenian: Podatki o učinkovitosti pri metastazah v osrednjem živčevju (CNS) v študiji FLAURA Za randomizacijo v študiji FLAURA so bili primerni bolniki z metastazami v CNS, ki niso zahtevale uporabe steroidov, če so imeli stabilno nevrološko stanje vsaj dva tedna po dokončanju definitivnega zdravljenja in steroidov.
English: Up to month 9, there were no clinically meaningful differences between the TAGRISSO and EGFR TKI comparator groups in functioning or HRQL.
Slovenian: Do 9. meseca med skupino z zdravilom TAGRISSO in skupino s primerjalnim EGFR TKI ni bilo klinično pomembnih razlik v funkciji ali z zdravjem povezani kakovosti življenja.
English: How to take TAGRISSO
Slovenian: Kako jemati zdravilo TAGRISSO
English: Serial ECGs were collected following a single dose and at steady-state to evaluate the effect of osimertinib on QTc intervals.
Slovenian: Po enkratnem odmerku in v stanju dinamičnega ravnovesja so snemali zaporedne EKG za oceno učinka osimertiniba na interval QTc.
English: Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
Slovenian: Kemoterapija (pemetreksed/cisplatin ali pemetreksed/karboplatin)
English: Very common (20%) 0.2%
Slovenian: stomatitis zelo pogosti (20 %)
English: Includes cases reported within the clustered terms for rash AEs: Rash, rash generalised, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.
Slovenian: f Združuje primere, poročane z izrazi za neželene učinke z izpuščajem: izpuščaj, generaliziran izpuščaj, eritematozen izpuščaj, makularen izpuščaj, makulo-papulozen izpuščaj, papulozen izpuščaj, pustulozen izpuščaj, pruritičen izpuščaj, vezikularen izpuščaj, folikularen izpuščaj, eritem, folikulitis, akne, dermatitis, akneiformni dermatitis, medikamentozen izpuščaj, erozija kože.
English: Reproductive toxicity
Slovenian: Toksičen vpliv na sposobnost razmnoževanja
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO.
Slovenian: Ženskam v rodni dobi je treba povedati, da med zdravljenjem z zdravilom TAGRISSO ne smejo zanositi.
English: Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event; DCR definedas the proportion of patients with response (complete response or partial response), or stable disease ≥ 6 weeks CNS Progression Free Survival determined by RECIST v1.1 by CNS BICR in the full analysis set population (CNS measurable and non-measurable lesions at baseline by BICR) n=75 for TAGRISSO and n=41 for Chemotherapy
Slovenian: Le na podlagi bolnikov z odzivom; DoR je bilo opredeljeno kot čas od datuma prvega dokumentiranega odziva (popoln odziv ali delni odziv) do napredovanja ali smrti; DCR je bilo opredeljeno kot delež bolnikov z odzivom (popoln odziv ali delni odziv) ali stabilno boleznijo ≥ 6 tednov.
English: months (%) (95% CI)
Slovenian: (%) (95 % IZ)
English: The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Slovenian: Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni (PFS) po raziskovalčevi oceni.
English: The geometric mean ratio (90% CI) of osimertinib AUC and Cmax was 63.3% (47.3, 84.5) and 51.4% (36.6, 72.3) in patients with mild hepatic impairment and 68.4% (49.6, 94.2) and 60.7% (41.6, 88.6) in patients with moderate hepatic impairment; for the metabolite AZ5104 the AUC and Cmax were 66.5% (43.4, 101.9) and 66.3% (45.3, 96.9) in patients with mild hepatic impairment and 50.9% (31.7, 81.6) and 44.0% (28.9, 67.1) in patients with moderate hepatic impairment, compared to the exposure in patients with normal hepatic function.
Slovenian: Geometrično povprečje razmerja izpostavljenosti v primerjavi z izpostavljenostjo pri bolnikih z normalnim delovanjem jeter (90 % IZ) je bilo pri bolnikih z blago okvaro jeter 63,3 % (47,3; 84,5) za vrednost AUC osimertiniba in 51,4 % (36,6; 72,3) za Cmax, pri bolnikih z zmerno okvaro jeter pa 68,4 % (49,6; 94,2) za vrednost AUC osimertiniba in 60,7 % (41,6; 88,6) za Cmax.
English: Osimertinib penetrated the intact blood-brain barrier of the cynomolgus monkey (i.v.
Slovenian: Osimertinib je prehajal nepoškodovano krvno-možgansko pregrado pri opicah cynomolgus (intravenska aplikacija), podganah in miših (peroralna aplikacija).
English: Concomitant use of St. John's Wort is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba šentjanževke je kontraindicirana (glejte poglavje
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in FLAURA
Slovenian: Učinkovitost v CNS po BICR pri bolnikih, ki so imeli v študiji FLAURA na izhodiščnih posnetkih možganov metastaze v CNS
English: TAGRISSO 40 mg tablets
Slovenian: TAGRISSO 40 mg tablete
English: Tell your doctor straight away while taking this medicine if:
Slovenian: Med jemanjem tega zdravila morate zdravnika takoj obvestiti:
English: Uncommon (0.7%)
Slovenian: Očesne bolezni keratitis občasni (0,7 %)
English: TAGRISSO 40 mg tablets Each tablet contains 40 mg osimertinib (as mesylate).
Slovenian: TAGRISSO 40 mg tablete Ena tableta vsebuje 40 mg osimertiniba (v obliki mesilata).
English: TAGRISSO 80 mg tablets
Slovenian: TAGRISSO 80 mg tablete
English: Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Slovenian: Okrogla, 9 mm velika bikonveksna tableta bež barve z vtisnjenima oznakama “AZ” in “40” na eni strani in brez oznak na drugi strani.
English: 0.63 (0.45, 0.88); P=0.0068 (NS)
Slovenian: 0,63 (0,45; 0,88), p = 0,0068 (NZ)
English: Median TFST, months (95% CI)
Slovenian: Mediani TFST, meseci (95 % IZ)
English: Includes cases reported within the clustered terms: pruritus, pruritus generalised, eyelid pruritus.
Slovenian: Združuje primere, poročane z izrazi: srbenje, generalizirano srbenje, srbenje vek.
English: 13.9 (8.3, NC)
Slovenian: 13,9 (8,3; NI)
English: CNS progression free and alive at 6 months (%) (95% CI) CNS progression free and alive at 12
Slovenian: Brez napredovanja v CNS in živi po 6 mesecih (%) (95 % IZ)
English: TAGRISSO 80 mg tablets Each tablet contains 80 mg osimertinib (as mesylate).
Slovenian: TAGRISSO 80 mg tablete Ena tableta vsebuje 80 mg osimertiniba (v obliki mesilata).
English: In repeat dose toxicity studies, an increased incidence of anoestrus, corpora lutea degeneration in the ovaries and epithelial thinning in the uterus and vagina were seen in rats exposed to osimertinib for ≥1 month at clinically relevant plasma concentrations.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov so pri podganah, izpostavljenih osimertinibu ≥ 1 mesec v klinično pomembnih plazemskih koncentracijah, ugotavljali večjo pojavnost anestrusa, degeneracije rumenih telesc v jajčnikih in stanjšanja epitelija v maternici in nožnici.
English: Median TSST, months (95% CI)
Slovenian: Mediani TSST, meseci (95 % IZ)
English: QTc interval prolongation occurs in patients treated with TAGRISSO.
Slovenian: Bolnikom, zdravljenim z zdravilom TAGRISSO, se pojavi podaljšanje intervala QTc.
English: The primary efficacy outcome measure of these two trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR).
Slovenian: Vsi bolniki so prejemali zdravilo TAGRISSO v odmerku 80 mg enkrat na dan. Primarno merilo izida učinkovitosti v teh dveh preizkušanjih je bil objektivni delež odziva ORR po merilih RECIST v1.1, kot je bil ocenjen s slepljenim neodvisnim centralnim pregledom (BICR - Blinded Independent Central Review).
English: The findings present following 1 month of dosing were largely reversible within 1 month of cessation of dosing with the exception of partial recovery for some of the corneal changes.
Slovenian: To so opažali pri plazemskih koncentracijah, nižjih od tistih pri bolnikih, ki prejemajo terapevtski odmerek 80 mg. Izsledki, ugotovljeni po 1 mesecu uporabe, so bili v veliki meri reverzibilni v 1 mesecu po prenehanju uporabe z izjemo le delnega okrevanja nekaterih sprememb roženice.
English: Breast-feeding should be discontinued during treatment with TAGRISSO.
Slovenian: Med zdravljenjem z zdravilom TAGRISSO je treba dojenje prekiniti.
English: CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in AURA3
Slovenian: Učinkovitost v CNS po BICR pri bolnikih, ki so imeli v študiji AURA3 na izhodiščnih posnetkih možganov metastaze v CNS
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
Slovenian: TAGRISSO 40 mg filmsko obložene tablete TAGRISSO 80 mg filmsko obložene tablete
English: Safety findings in the single-arm Phase 2 AURAex and AURA2 studies were generally consistent with those observed in the AURA3 TAGRISSO arm. No additional or unexpected toxicity has been observed and adverse events have been aligned in type, severity and frequency.
Slovenian: Izsledki o varnosti v študijah 2. faze z eno samo skupino AURAex in AURA2 so se na splošno ujemali s tistimi, ki so jih ugotovili v skupini z zdravilom TAGRISSO v študiji AURA3.
English: CNS Progression-free survival Number of Events (%) Median, Months (95% CI)
Slovenian: Preživetje brez napredovanja bolezni (PFS) Število dogodkov (% dozorelosti) Mediana, meseci (95 % IZ) ROg (95 % IZ), vrednost p
English: Pre-treated T790M positive NSCLC patients-AURA3
Slovenian: Predhodno zdravljeni bolniki z NSCLC, pozitivnim za mutacijo T790M - AURA3
English: Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Slovenian: Pri bolnikih z rakom pljuč in pozitivno mutacijo T790M EGFR, pri katerih je bolezen napredovala med enim ali več predhodnih sistemskih zdravljenj (vključno z EGFR TKI), so izvedli dve odprti klinični študiji z enim samim krakom (eno samo skupino): AURAex (kohorta v podaljšani študiji 2. faze (n = 201)) in AURA2 (n = 210).
English: Number of responses (n), Response Rate (95% CI)
Slovenian: Objektivni delež odziva Število odzivov (n), delež odziva (95 % IZ) Razmerje obetov (95 % IZ), vrednost p
English: • TAGRISSO is taken by mouth.
Slovenian: • Zdravilo TAGRISSO se zaužije.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE35.
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz.
English: TAGRISSO 40 mg tablets osimertinib
Slovenian: TAGRISSO 40 mg tablete osimertinib
English: Your doctor may wish to stop TAGRISSO if you get this side effect.
Slovenian: Če se vam pojavi ta neželeni učinek, bo zdravnik morda končal vaše zdravljenje z zdravilom TAGRISSO.
English: TAGRISSO 80 mg tablets osimertinib
Slovenian: TAGRISSO 80 mg tablete osimertinib
English: Median, Months (95% CI)
Slovenian: Mediana, meseci (95 % IZ)
English: Number of responses, Response Rate (95% CI)
Slovenian: Objektivni delež odziva Število odzivov, delež odziva (95 % IZ) Razmerje obetov (95 % IZ), vrednost p
English: Very common (67%) 7.2%
Slovenian: zmanjšano število limfocitov zelo pogosti (67 %)
English: Very common (31%) 0.3%
Slovenian: paronihija zelo pogosti (31 %)
English: Each tablet contains 40 mg osimertinib (as mesylate).
Slovenian: Ena tableta vsebuje 40 mg osimertiniba (v obliki mesilata).
English: Osimertinib has also been demonstrated to bind covalently to rat and human plasma proteins, human serum albumin and rat and human hepatocytes.
Slovenian: Delež vezave osimertiniba na plazemske beljakovine in vitro znaša 94,7 % (5,3 % prostega).Dokazano je tudi, da se osimertinib kovalentno veže na podganje in humane plazemske beljakovine, humani serumski albumin ter podganje in humane jetrne celice.
English: Each tablet contains 80 mg osimertinib (as mesylate).
Slovenian: Ena tableta vsebuje 80 mg osimertiniba (v obliki mesilata).
English: Very common (68%) 1.5%
Slovenian: zmanjšano število levkocitov zelo pogosti (68 %)
English: HR=Hazard Ratio; CI=Confidence Interval, NC=Not Calculable A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO
Slovenian: ROg < 1 je v korist zdravila TAGRISSO, razmerje obetov > 1 je v korist zdravila TAGRISSO.
English: At the time of the interim analysis of overall survival (25% maturity), a HR of 0.63 favoured TAGRISSO (95% CI:
Slovenian: V času vmesne analize celokupnega preživetja (25 % dozorelost) je bilo ROg 0,63 v korist zdravila TAGRISSO (95 % IZ: 0,45; 0,88; p = 0,0068), vendar ni doseglo formalne statistične značilnosti.
English: Chemotherapy
Slovenian: Kemote rapija
English: NC
Slovenian: Z
English: How to store TAGRISSO
Slovenian: Shranjevanje zdravila TAGRISSO
English: Severe, life-threatening or fatal Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies.
Slovenian: V kliničnih študijah so pri bolnikih, zdravljenih z zdravilom TAGRISSO, opažali hude, življenjsko ogrožujoče in včasih smrtne primere intersticijske bolezni pljuč (IBP) ali neželenih učinkov, podobnih IBP (npr. pnevmonitisa).
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
Slovenian: TAGRISSO 40 mg filmsko obložene tablete TAGRISSO 80 mg filmsko obložene tablete osimertinib
English: A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO Based on an interim analysis with 25% maturity a P-value < 0.0015 was required to achieve statistical significance ORR results by Blinded Independent Central Review (BICR) were consistent with those reported via investigator assessment; ORR by BICR assessment was 78% (95% CI:73, 83) on TAGRISSO and 70% (95% CI:65, 76) on EGFR TKI
Slovenian: Rezultati ORR po oceni slepljenega neodvisnega centralnega pregleda (BICR) so se skladali s tistimi po oceni raziskovalca; ORR po oceni BICR je bilo 78 % (95 % IZ: 73, 83) z zdravilom TAGRISSO in 70 (95 % IZ: 65, 76) s primerjalnim EGFR TKI.
English: NC (16.5, NC)
Slovenian: NI (16,5; NI)
English: At baseline, no differences in patient reported symptoms, function or HRQL were observed between TAGRISSO and EGFR TKI comparator (gefitinib or erlotinib) arms.
Slovenian: Izhodiščno med skupino z zdravilom TAGRISSO in skupino s primerjalnim EGFR TKI (gefitinib ali erlotinib) ni bilo razlik v simptomih, funkciji ali z zdravjem povezani kakovosti življenja po navedbi bolnikov.
English: Very common (35%) 4.1%
Slovenian: suha koža zelo pogosti (33 %)
English: NC (23.7, NC)
Slovenian: NI (23,7; NI)
English: TAGRISSO 80 mg film-coated tablets osimertinib
Slovenian: TAGRISSO 80 mg filmsko obložene tablete osimertinib
English: TAGRISSO 40 mg film-coated tablets osimertinib
Slovenian: TAGRISSO 40 mg filmsko obložene tablete osimertinib
English: Very common (54%) 1.6%
Slovenian: zmanjšano število trombocitov zelo pogosti (54 %)
English: Gastrointestinal effects
Slovenian: Učinki na prebavilih
English: Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
Slovenian: Pred začetkom jemanja zdravila TAGRISSO se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: NC (20.5, NC)
Slovenian: NI (20,5; NI)
English: Rare (0.02%)
Slovenian: Stevens-Johnsonov sindrom redki (0,02 %)
English: Dry skin
Slovenian: Okvara jeter
English: HRQL and physical functioning improvement analysis Patients on TAGRISSO had significantly greater chances of achieving a clinically meaningful improvement of greater than or equal to 10 points on the global health status and physical functioning of the EORTC-C30 questionnaire compared with chemotherapy during the study period Odds Ratio (OR) global health status: 2.11, (95% CI 1.24, 3.67, p=0.007); OR physical functioning 2.79 (95% CI 1.50, 5.46, p=0.002).
Slovenian: Razmerje obetov (RO) za splošno zdravstveno stanje: 2,11 (95 % IZ 1,24; 3,67; p = 0,007), RO za telesno delovanje 2,79 (95 % IZ 1,50; 5,46; p = 0,002).
English: Lusduna is used once a day at the same time each day.
Slovenian: Zdravilo Lusduna se uporablja enkrat na dan, vsak dan ob istem času.
English: Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes).
Slovenian: Sladkorna bolezen je bolezen, pri kateri je raven sladkorja v krvi visoka, bodisi zato, ker telo ne more proizvajati insulina (sladkorna bolezen tipa 1), bodisi zato, ker telo ne proizvede dovolj insulina oziroma ga ne more učinkovito izrabljati (sladkorna bolezen tipa 2).
English: This means that Lusduna is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t.i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: The full EPAR for Lusduna 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 Lusduna 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 Lusduna?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lusduna?
English: This is a summary of the European public assessment report (EPAR) for Lusduna.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lusduna.
English: It is given by injection under the skin in the belly, the thigh, or the upper arm.
Slovenian: Daje se z injekcijo pod kožo na trebuhu, stegnu ali nadlakti.
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Slovenian: Z uravnavanje ravni glukoze v krvi se simptomi sladkorne bolezni zmanjšajo, zapletom pa se izognemo.
English: Because Lusduna is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Slovenian: Ker je zdravilo Lusduna podobno biološko zdravilo, študije o učinkovitosti in varnosti niso bile potrebne, ker sta za insulin glargin dobro raziskani.
English: Lusduna is a medicine used in patients aged at least 2 years for the treatment of diabetes.
Slovenian: Lusduna je zdravilo, ki se uporablja pri bolnikih, starih vsaj dve leti, za zdravljenje sladkorne bolezni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna has been shown to have a comparable quality, safety and effectiveness to Lantus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Lusduna po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Lantus.
English: In the second study, involving 531 patients with type 2 diabetes, the average reduction in HbA1c was from 8.3 to 7.2% with Lusduna and from 8.4 to 7.2% with Lantus.
Slovenian: V drugi študiji, ki je vključevala 531 bolnikov s sladkorno boleznijo tipa 2, je bilo povprečno zmanjšanje rezultata HbA1c z 8,3 na 7,2 % pri zdravilu Lusduna in z 8,4 na 7,2 % pri zdravilu Lantus.
English: The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Slovenian: Najpogostejši neželeni učinek zdravila Lusduna (ki se lahko pojavi pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: What benefits of Lusduna have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lusduna izkazalo v študijah?
English: It contains the active substance insulin glargine.
Slovenian: Vsebuje zdravilno učinkovino insulin glargin.
English: Other information about Lusduna
Slovenian: Druge informacije o zdravilu Lusduna
English: Insulin glargine, the active substance in Lusduna, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Slovenian: Insulin glargin, zdravilna učinkovina v zdravilu Lusduna, po injiciranju vstopa v krvni obtok počasneje kot humani insulin, zato deluje dlje.
English: What is Lusduna and what is it used for?
Slovenian: Kaj je zdravilo Lusduna in za kaj se uporablja?
English: In the first supportive study, involving 506 patients with type 1 diabetes, the average HbA1c score was reduced from 8.0 to 7.4% with both Lusduna and Lantus.
Slovenian: V prvi podporni študiji, ki je vključevala 506 bolnikov s sladkorno boleznijo tipa 1, se je povprečni rezultat HbA1c pri zdravilu Lusduna in zdravilu Lantus zmanjšal z 8,0 na 7,4 %.
English: For more information about treatment with Lusduna, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lusduna preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The dose of Lusduna is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Slovenian: Odmerek zdravila Lusduna se prilagodi posameznemu bolniku in je odvisen od bolnikove ravni glukoze (sladkorja) v krvi in zdravljenja z drugimi insulinskimi zdravili.
English: The reference medicine for Lusduna is Lantus.
Slovenian: Referenčno zdravilo za zdravilo Lusduna je zdravilo Lantus.
English: For practical information about using Lusduna, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lusduna naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The Committee recommended that Lusduna be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Lusduna izda dovoljenje za promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lusduna have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: In both studies, the main measure of effectiveness was the change after 24 weeks of treatment in the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti sprememba ravni glikoziliranega hemoglobina (HbA1c) v krvi, snovi, ki označuje uspešnost uravnavanja glukoze v krvi, po 24 tednih zdravljenja.
English: What are the risks associated with Lusduna?
Slovenian: Kakšna tveganja so povezana z zdravilom Lusduna?
English: Lusduna is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Slovenian: Zdravilo Lusduna je nadomestni insulin, ki deluje enako kot telesu lastni insulin in pomaga glukozi pri vstopanju iz krvi v celice.
English: Two additional studies showed that Lusduna is absorbed into the body and works on blood glucose in the same way as the reference medicine, Lantus.
Slovenian: Dve dodatni študiji sta pokazali, da se zdravilo Lusduna absorbira v telo in deluje na glukozo v krvi enako kot referenčno zdravilo Lantus.
English: For the full list of all side effects and restrictions with Lusduna, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lusduna glejte navodilo za uporabo.