natgillin/translations-raw huggingface dataset:
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m² on day 1) in combination with cisplatin (C) (75 mg/m² on day 1) and 5-fluorouracil (F)
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/m² 1. dan) v kombinaciji s cisplatinom (C)
A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/m2 1. dan) in 5-fluorouracilom (F) (750 mg/m2 na dan, 5 dni), bodisi cisplatin (100 mg/m2 1. dan) in 5- fluorouracil (1000 mg/m2 na dan, 5 dni).
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3-urni infuziji.
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetaksel 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3- urni infuziji.
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Skupaj 449 bolnic so naključno razvrstili na monoterapijo z docetakselom 100 mg/m2 v enourni infuziji ali na paklitaksel 175 mg/m2 v triurni infuziji.
A total of 455 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314).
V 24-tedenski, randomizirani, dvojno-slepi, s placebom kontrolirani študiji je sodelovalo 455 bolnikov s sladkorno boleznijo tipa 2 z namenom oceniti učinkovitost in varnost saksagliptina v kombinaciji s stabilnim odmerkom insulina (povprečno izhodišče: 54,2 enoti) pri bolnikih z neustrezno urejeno glikemijo (HbA1c ≥ 7.5 % in ≤ 11 %) z zgolj insulinom (n = 141) ali z insulinom v kombinaciji s stabilnim odmerkom metformina (n = 314).
A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n = 150, methylnaltrexone bromide 12 mg every other day, n = 148, placebo, n = 162) were treated in the double-blind period.
Skupaj 460 bolnikov (metilnaltreksonijev bromid 12 mg enkrat na dan, n = 150, metilnaltreksonijev bromid 12 mg vsak drugi dan, n = 148, placebo, n = 162) je bilo zdravljenih v dvojno slepem obdobju.
A total of 460 patients (methylnaltrexone bromide 12 mg once daily, n=150, methylnaltrexone bromide 12 mg every other day, n=148, placebo, n=162) were treated in the double-blind period.
Skupaj 460 bolnikov (metilnaltreksonijev bromid 12 mg enkrat na dan, n = 150, metilnaltreksonijev bromid 12 mg vsak drugi dan, n = 148, placebo, n = 162) je bilo zdravljenih v dvojno slepem obdobju.
A total of 471 included patients had been maintained on a stable regimen of at least 400 mg per day of levodopa prior to entry into the trial.
Skupno 471 vključenih bolnikov je bilo pred vstopom v preskušanje na stabilnem zdravljenju z vsaj 400 mg levodope na dan.
A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 mcg/kg (maximum 0.
Vsega skupaj 493 pediatričnih bolnikov, starih od 64 dni do 16,9 let, ki so prejemali zmerno (69,2 %) ali visoko emetogeno kemoterapijo (30,8 %), so zdravili s palonosteronom
A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 µg/kg (maximum 0.75 mg), palonosetron 20 µg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Vsega skupaj 493 pediatričnih bolnikov, starih od 64 dni do 16,9 let, ki so prejemali zmerno (69,2 %) ali visoko emetogeno kemoterapijo (30,8 %), so zdravili s palonosteronom 10 µg/kg (največji odmerek 0,75 mg), palonosetronom 20 µg/kg (največji odmerek 1,5 mg) ali ondansetronom (3 x 0,15 mg/kg , največji celotni odmerek 32 mg) 30 minut pred začetkom emetogene kemoterapije med ciklom 1.
A total of 5 case reports all originating from the EU were identified.
Skupno je bilo zabeleženih 5 poročil o primerih, ki so vsa izvirala iz EU.
A total of 50 of the 72 subjects starting the study completed the 26-week treatment period that corresponds to a retention rate of 69.4% (see section 4.2 for information on elderly use).
Skupaj 50 od 72 oseb, ki so študijo začele, so 26-tedensko obdobje zdravljenja zaključile, kar ustreza stopnji zadržanja 69,4 % (glejte poglavje 4.2 za podatke o uporabi pri starejših).
A total of 50.0% of patients were female.
Skupno je bilo med bolniki 50 % žensk.
A total of 52 cases of invasive disease caused by vaccine serotypes had accumulated in a blinded follow- up period through April 20, 1999.
V obdobju slepega sledenja do 20. aprila 1999 so ugotovili 52 primerov IPD, ki so jih povzročili serotipi, vključeni v cepivo.
A total of 54 (39.7%) patients received treatment for > 12 months in the olaparib group compared with 14 (10.9%) patients in the placebo group.
V skupini z olaparibom je zdravljenje > 12 mesecev prejemalo skupaj 54 (39,7 %) bolnic, v skupini s placebom pa 14 (10,9 %) bolnic.
A total of 54% of patients were female.
Skupno je bilo med bolniki 54 % žensk.
A total of 55 patients died during treatment or during the follow-up after discontinuation of treatment. (21 in the nilotinib 300 mg twice daily group, 11 in the nilotinib 400 mg twice daily group and 23 in the imatinib 400 mg once daily group).
Skupno je v času zdravljenja oziroma spremljanja po prekinitvi zdravljenja umrlo 55 bolnikov (21 v skupini z nilotinibom 300 mg dvakrat dnevno, 11 v skupini z nilotinibom 400 mg dvakrat dnevno in 23 v skupini z imatinibom 400 mg enkrat dnevno).
A total of 573 patients were randomised to receive either TMZ + RT (n = 287) or RT alone (n = 286).
Skupaj 573 bolnikov so randomizirali v dve skupini, od katerih je ena prejemala TMZ + RT (n = 287), druga pa samo RT (n = 286).
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
573 bolnikov so naključno razvrstili v krak kombiniranega zdravljenja s temolozomidom in obsevanjem (n = 287) ali v krak s samim obsevanjem (n = 286).
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
573 bolnikov so naključno razvrstili v krak kombiniranega zdravljenja s TMZ in obsevanjem (n = 287) ali v krak s samim obsevanjem (n = 286).
A total of 573 patients with moderately to severely active Crohn’s disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Skupaj 573 bolnikov z zmerno do hudo aktivno Crohnovo boleznijo (CDAI ≥ 220 ≤ 400) je prejelo enkratno infuzijo odmerka 5 mg/kg v tednu 0.
A total of 573 patients with moderately to severely active Crohn’s disease (CDAI ≥220 ≤400) received a single infusion of 5 mg/kg at week 0.
Skupaj 573 bolnikov z zmerno do hudo aktivno Crohnovo boleznijo (CDAI ≥ 220 ≤ 400) je prejelo enkratno infuzijo odmerka 5 mg/kg v tednu 0.
A total of 59 out of 85 (69.4%) patients from the placebo arm crossed over to open-label sunitinib following disease progression or unblinding at study closure.
Skupno 59 od 85 (69,4 %) bolnikov iz skupine, ki je prejemala placebo, se je ob napredovanju bolezni ali razkritju šifre ob koncu študije vključilo v odprto študijo s sunitinibom.
A total of 6,804 patients have been treated with Cosentyx in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions).
V slepih in odprtih kliničnih študijah z različnimi indikacijami (psoriaza s plaki, psoriatični artritis, ankilozirajoči spondilitis in druge avtoimunske bolezni) je bilo z zdravilom Cosentyx skupno zdravljenih 6.804 bolnikov.
A total of 618 patients were randomized to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Skupaj so randomizirali 618 bolnikov in sicer 205 na prejemanje 7 mg teriflunomida, 216 na prejemanje 14 mg teriflunomida in 197 na prejemanje placeba.
A total of 7 PNH paediatric patients, with a median weight of 57.2 kg (range of 48.6 to 69.8 kg) and aged from 11 to 17 years (median age : 15.6 years), received Soliris in study M07-005.
V študiji M07-005 je bilo z zdravilom Soliris skupaj zdravljenih 7 pediatričnih bolnikiv s PNH, z mediano telesne mase 57,2 kg (razpon od 48,6 do 69,8 kg) in starih od 11 do 17 let (mediana starosti: 15,6 let).
A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Za pospešene režime so priporočili celotni odmerek 70 Gy, za hiperfrakcionirne režime pa 74 Gy.
A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below
Skupaj 70,4 % pediatričnih bolnikov, ki so prejemali zonisamid v kontrolirani študiji ali odprtem podaljšku študije, je imelo zaradi zdravljenja vsaj eno izmerjeno vrednost bikarbonata pod 22 mmol/l.
A total of 71 (12.8%) and 85 (15.4%) patients died in the imatinib and IFN+Ara-C groups, respectively.
Skupno je umrlo 71 (12,8 %) bolnikov iz skupine z imatinibom in 85 (15,4 %) iz skupine z IFN+Ara
A total of 73 patients (95%) randomised and treated with OZURDEX completed the 26-week study.
26-tedensko študijo je zaključilo skupno 73 bolnikov (95 %), naključno razporejenih v skupino, ki se je zdravila z zdravilom OZURDEX.
A total of 74 evaluable patients were administered dexamethasone in combination with VELCADE.
74 bolnikih, ki so prejeli deksametazon v kombinaciji z zdravilom VELCADE.
A total of 75 (72.1%) treatments were reported with a successful outcome.
Za skupaj 75 (72,1 %) zdravljenj poročajo o uspešnem izidu.
A total of 752 patients  65 years of age, including 163 patients  75 years of age, were studied in clinical trials.
V kliničnih preskušanjih so proučili skupaj 752 bolnikov, starih 65 let ali več, med njimi je bilo 163 bolnikov, starih 75 let ali več.
A total of 752 RA patients  65 years of age, including 163 patients  75 years of age, were studied in clinical trials.
V kliničnih preskušanjih so proučili skupaj 752 bolnikov z RA, starih 65 let ali več, med njimi je bilo 163 bolnikov, starih 75 let ali več.
A total of 76.4% of patients were previously treated with only small-molecule DMARDs and 22.4% of patients were previously treated with biologic DMARDs, which includes 7.8% who had a therapeutic failure with a prior biologic DMARD.
Skupno 76,4 % bolnikov je bilo že prej zdravljenih samo z nizkomolekularnimi DMARDs, 22,4 % bolnikov pa se je prej zdravilo z biološkimi DMARDs, kar vključuje 7,8 % bolnikov, ki so imeli odpoved zdravljenja s predhodnim biološkim DMARD.
A total of 78 cases of acute pancreatitis in children with Exjade have been retrieved during the clinical review cumulatively.
Pri kumulativnem pregledu kliničnih podatkov so pri otrocih, ki so prejemali zdravilo Exjade, odkrili skupno 78 primerov akutnega pankreatitisa.
A total of 781 patients were randomized 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone.
V celoti so 781 bolnikov v razmerju 2 : 2 : 1 randomizirali na prejemanje kombinacije zdravila Gazyvaro in klorambucila, kombinacije rituksimaba in klorambucila ali samega klorambucila.
A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies.
V kliničnih študijah so s hidrokortizonom s prirejenim sproščanjem zdravili skupno 80 bolnikov (173 bolnikov-let zbiranja podatkov).
A total of 81 cUTI patients (7.4%) had bacteraemia at baseline.
Bakteriemijo je imelo izhodiščno 81 bolnikov (7,4 %) z zapleteno okužbo sečil.
A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 2a and Table 2b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 3) were analysed for efficacy.
810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 2a ter 2b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 3).
A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 8a and Table 8b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 9) were analysed for efficacy.
810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 8a ter 8b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 9).
A total of 821 patients were randomised to receive either nivolumab 3 mg/kg (n=410) administered intravenously over 60 minutes every 2 weeks or everolimus (n=411) 10 mg daily, administered orally.
Skupno 821 bolnikov so randomizirali na zdravljenje z nivolumabom v odmerku 3 mg/kg (n=410) v obliki 60-minutne intravenske infuzije vsaka 2 tedna ali na zdravljenje z everolimusom (n=411) v odmerku 10 mg peroralno enkrat na dan.
A total of 836 patients from six clinical studies were tested at multiple time points for anti-therapeutic antibody (ATA) responses to trastuzumab emtansine.
V šestih kliničnih študijah so skupno 836 bolnikov ob različnih časih testirali zaradi odziva protiteles proti zdravilu (ATA – anti-therapeutic antibody) na trastuzumab emtanzin.
A total of 85 patients (15.2%) who started treatment at </= 500 mg (n= 558) received dose escalations to 600 mg of bosutinib.
Do povečanja odmerka na 600 mg bosutiniba je prišlo pri skupno 85 bolnikih (15,2 %), ki so začeli zdravljenje z odmerkom, manjšim ali enakim 500 mg (n = 558).
A total of 870 Ph+ leukaemia patients received at least 1 dose of single-agent bosutinib.
Skupno 870 bolnikov s Ph+ levkemijo je prejelo vsaj 1 odmerek bosutiniba kot samostojno zdravilo.
A total of 915 subjects with severe refractory eosinophilic asthma have received either a subcutaneous or an intravenous dose of mepolizumab during clinical studies of 24 to 52 weeks duration.
V kliničnih študijah, ki so trajale od 24 do 52 tednov, je skupno 915 bolnikov s težko trdovratno eozinofilno astmo prejemalo mepolizumab subkutano ali intravensko.
A total of 92 women were breast-feeding during the vaccination period of the clinical studies of Gardasil 9.
V kliničnih študijah s cepivom Gardasil 9 je v obdobju cepljenja dojilo skupno 92 žensk.
A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Nuwiq.
Skupno so zabeležili 986 krvavitev, ki so se večinoma zaustavile po enem injiciranju zdravila Nuwiq.
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers,
Skupno 99,7 % bolnikov je dobivalo fibrinolitike (fibrinsko specifične: 68,7 %, nefebrinsko specifične: 31,1 %), 89,5 % heparin, 78,7 % zaviralce adrenergičnih receptorjev beta, 54,7
A total of 991 patients were randomised to trastuzumab emtansine or lapatinib plus capecitabine as follows:
V celoti je bilo 991 bolnikov randomiziranih v dve skupini – skupino s trastuzumabom emtanzinom in skupino s kombinacijo lapatiniba in kapecitabina:
A total wound area of not more than 15% TBSA can be treated by NexoBrid.
V enem postopku se lahko zdravilo NexoBrid nanese na največ 15 % CPT.
A tourniquet should be applied to the proximal limb.
Na proksimalno okončino namestimo zažemko.
A TP53 mutation is present in 20 to 25% of lower-risk MDS Del 5q patients and is associated with a higher risk of progression to acute myeloid leukaemia (AML).
Mutacija TP53 je prisotna pri 20 % do 25 % bolnikov z MDS z manjšim tveganjem del(5q) in je povezana z večjim tveganjem napredovanja v akutno mieloično levkemijo (AML).
A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the medicinal product.
izobraževalni tečaj za nevrokirurge, katerega namen je zmanjševanje tveganja in podpiranje varne in učinkovite uporabe zdravila.
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2- fold overdose.
4 ure po dvakratnem prekomernem odmerjanju se lahko pojavi prehodno povečanje telesne temperature (v povprečju 0,8°C).
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose.
4 ure po dvakratnem prekomernem odmerjanju se lahko pojavi prehodno povečanje telesne temperature (v povprečju 0,8°C).
A transient increase in body temperature (on average 1 °C) is very common during the first 24 hours after vaccination.
V prvih 24 urah po cepljenju je zelo pogosto prehodno povišanje telesne temperature (v povprečju 1°C).
A transient increase in body temperature of 0.2 to 1.7 °C was observed during the 24 hours after administration, returning to normal after two days.
Prehodno povišanje telesne temperature za 0,2 do 1,7°C je bilo opaženo v 24 urah po dajanju, po dveh dneh pa se je vrnila na normalno.
A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours.
prehodno povišanje telesne temperature v prvih 6 urah po cepljenju, ki spontano izzveni v 24 urah.
A transient increase in body temperature, normally not exceeding 1 °C, may occur until 2 days after vaccination.
Do dva dni po cepljenju se lahko prehodno, običajno ne za več kot 1 °C, poveča telesna temperatura.
A transient increase in body temperature, normally not exceeding 1 °C, may occur until 2 days after vaccination.
Do dva dni po cepljenju se lahko prehodno, običajno ne za več kot 1°C, poveča telesna temperatura.
A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
Do dva dni po cepljenju se lahko prehodno, običajno ne za več kot 1
A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C may be observed during the 24- hours period post vaccination.
Prehodno povišanje rektalne temperature (post vakcinalna hipertermija) okoli 0,5 °C se lahko opazi v obdobju 24 ur po cepljenju.
A transient increase in rectal temperature (post-vaccination hyperthermia) of around 0.5 °C may be observed during the 24-hours period post vaccination.
Prehodno povišanje rektalne temperature (post vakcinalna hipertermija) okoli 0,5 °C se lahko opazi v obdobju 24 ur po cepljenju.
A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Do 24 ur po dajanju dvakrat prevelikega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °C.
A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2°.
A transient increase in rectal temperature, not exceeding 2.7 °C, may occur during the 48 hours following vaccination.
48 ur po cepljenju se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 2,7 °C. Lokalne reakcije, manjše od 2 cm so zelo pogoste.
A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines.
Občasno se lahko pojavi prehodna reakcija na lokalnem mestu (otekanje), kot je običajno za cepiva, kjer je dodatek olje.
A transient reduced weight gain may be observed during the first week after vaccination.
V prvem tednu po cepljenju lahko pride do prehodnega zmanjšanja pridobivanja telesne mase.
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human- equivalent exposures.
V raziskavah genotoksičnosti preko placente so na opicah primerjali zidovudin sam s kombinacijo zidovudina in lamivudina v odmerkih, kakršnim so izpostavljeni ljudje.
a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding. b Patients with missing values were exluded from the analysis. c N and % include withdrawn patients d Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 2 months of a treatment course.
a Ocena 2. cikla zdravljenja ustreza 2. ciklu zdravljenja in eni menstruacijski krvavitvi. b Bolnice z manjkajočimi vrednostmi so bile izključene iz analize. c N in % vključujeta bolnice, ki so se prenehale zdraviti. d Nadzorovana krvavitev je bila opredeljena kot odsotnost epizod močnih krvavitev in največ 8 dni krvavitve (ne vključuje dni pojavljanja madežev) v zadnjih 2 mesecih cikla zdravljenja.
A treatment cycle comprises 28 days.
Cikel zdravljenja obsega 28 dni.
A treatment cycle with Temomedac lasts 28 days.
Cikel zdravljenja z zdravilom Temomedac traja 28 dni.
A treatment cycle with Temozolomide Hexal lasts 28 days.
Cikel zdravljenja z zdravilom Temozolomid Hexal traja 28 dni.
A treatment decision should be made based upon the assessment of individual patient’s benefit/risk.
Odločitev o uvedbi zdravljenja je treba sprejeti na osnovi ocene razmerja med koristjo in tveganjem pri vsakem posameznem bolniku.
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
Zdravljenje bolnikov v trajanju od 6-14 dni je bilo klinično preučeno (glejte poglavje 5.1)
A treatment effect was observed as early as
Učinek zdravljenja so opazili že pri 6 mesecih, pri čemer je dajanje zdravila Plegridy
A treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg ter 14 filmsko obloženimi tabletami CHAMPIX 1 mg in 1 prozoren pretisni omot z 28 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
A treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg v škatli.
A treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Priporoča se zdravljenje do 12 mesecev, razen, če je prekinitev zdravila Efient klinično indicirana (glejte poglavji 4.4 in 5.1).
A treatment period of 12 weeks is recommended after which treatment effect should be evaluated.
Priporočajo obdobje zdravljenja je 12 tednov, po katerem je treba oceniti učinek zdravljenja.