natgillin/translations-raw huggingface dataset:
The Physican’s Educational Material should contain the following key messages:
Izobraževalno gradivo za zdravnike mora vsebovati naslednja ključna sporočila:
The Physician and patient “DVDs/leaflet forms” should contain the following key elements and messages:
»DVD/podatki v obliki brošure z navodili« za zdravnike in bolnike morajo vsebovati naslednje bistvene elemente in sporočila:
The physician educational material package should also contain:
Paket izobraževalnega gradiva za zdravnike mora vsebovati tudi:
The Physician Educational Materials (PEM)
izobraževalno gradivo za zdravnike,
The physician educational pack should contain:
Paket z izobraževalnim gradivom mora vsebovati naslednje:
The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Izobraževalni paket za zdravnika mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in priročnik za predpisovanje zdravila.
The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Izobraževalno gradivo za zdravnike mora obsegati povzetek glavnih značilnosti zdravila, navodilo za uporabo in vodnik za predpisovanje.
The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Izobraževalno gradivo za zdravnike mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in priporočilo za zdravnike.
The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Izobraževalno gradivo za zdravnike mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in vodnik za zdravnike.
The Physician information about MabThera should contain the following key elements:
Gradivo za zdravnika o zdravilu MabThera mora vsebovati naslednje ključne vsebine:
The Physician Information pack should contain the following key elements:
Izobraževalno gradivo za zdravnike mora vključevati naslednje glavne vsebine:
The physician information should contain the following key elements:
Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključna sporočila:
The physician information should contain the following key elements:
Navodila za zdravnika morajo vsebovati sledeče ključne vsebine:
The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
Besedilo gradiva za zdravnike in bolnike ter opozorilne kartice za bolnika mora biti pred razdelitvijo dogovorjeno z nacionalnim organom, pristojnim za zdravila.
The Physician Leaflet
Navodilo za uporabo za zdravnike
The physician must therefore weigh the benefit of treatment with ImmunoGam against potential risk of hypersensitivity reactions.
Zdravnik mora zato pretehtati korist zdravljenja z zdravilom ImmunoGam in možno tveganje preobčutljivostnih reakcij.
The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including:
V kontrolnem seznamu za zdravnike (pred predpisovanjem) morajo biti posebej poudarjene kontraindikacije za uporabo ambrisentana in pomembna ovrednotenja, potrebna pred predpisovanjem, vključno s:
The physician safety brochure should contain the following key elements:
Brošura z informacijami o varnosti zdravila, namenjena zdravnikom, mora vključevati naslednje ključne elemente o:
The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is co- administered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measles- mumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of
Zdravnik se mora zavedati, da je delež febrilnih reakcij večji, če je cepivo Infanrix hexa uporabljeno sočasno s konjugiranim pnevmokoknim cepivom (PCV7, PCV10, PCV13) ali s cepivom MMRV
The physician should be consulted when using other medications in addition to Humalog (see section 4.4).
Pri sočasni uporabi zdravila Humalog in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Humalog BASAL (see section 4.4).
Pri sočasni uporabi zdravila Humalog BASAL in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Humalog BASAL 100 U/ml KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Humalog BASAL 100 i.e./ml KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Humalog KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Humalog KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Humalog Mix25 KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Humalog Mix25 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Humalog Mix50 KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Humalog Mix50 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog (see section 4.4).
Pri sočasni uporabi zdravila Liprolog in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog Basal (see section 4.4).
Pri sočasni uporabi zdravila Liprolog Basal in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog Basal 100 units/ml KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Liprolog Basal 100 enot/ml KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog KwikPen (see section 4.4).
Pri sočasni uporabi zdravila Liprolog KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog Mix25 (see section 4.4).
Pri sočasni uporabi zdravila Liprolog Mix25 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should be consulted when using other medications in addition to Liprolog Mix50 (see section 4.4).
Pri sočasni uporabi zdravila Liprolog Mix50 KwikPen in drugih zdravil se je potrebno posvetovati z zdravnikom (glejte poglavje 4.4).
The physician should continue to assess the patient’s progress in reducing alcohol consumption, overall functioning, treatment adherence, and any potential side effects.
Zdravnik mora še naprej ocenjevati bolnikov napredek pri zmanjševanju uživanja alkohola, celotno delovanje, vztrajanje pri zdravljenju in morebitne stranske učinke.
The physician should discuss the risk of hepatic injury with the patient and provide them with a Patient Card.
Zdravnik se mora o tveganju za poškodbe jeter pogovoriti z bolnikom in mu izročiti Opozorilno kartico za bolnika.
The physician who elects to use guanfacine for extended periods (over 12 months) should re-evaluate the usefulness of guanfacine every 3 months for the first year and then at least yearly based on clinical judgement (see section 4.4), and consider trial periods off medication to assess the patient’s functioning without pharmacotherapy, preferably during times of school holidays.
Zdravnik, ki se odloči za dolgotrajno uporabo gvanfacina (več kot 12 mesecev), mora ponovno ocenjevati koristnost gvanfacina prvo leto vsake 3 mesece, nato pa vsaj enkrat na leto na podlagi klinične presoje (glejte poglavje 4.4), in pretehtati možnost poskusnih obdobij brez zdravila, da se oceni bolnikovo funkcioniranje brez farmakoterapije, po možnosti v času šolskih počitnic.
The physician’s checklist shall contain the following key messages:
Seznam previdnostnih ukrepov za zdravnika mora vsebovati naslednja ključna sporočila:
The physician’s educational material should contain the following key elements:
Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne elemente:
The physician’s global assessment of disease activity, as measured on a 0-100 mm scale, showed a greater reduction in disease activity for tocilizumab compared to placebo (adjusted mean changes of -45.2 mm vs -35.2 mm, p=0.0031).
Zdravnikova celokupna ocena aktivnosti bolezni izmerjena po lestvici 0–100 mm je pokazala večje zmanjšanje aktivnosti bolezni za tocilizumab v primerjavi s placebom (prilagojeni povprečni spremembi: -45,2 mm v primerjavi z - 35,2 mm; p = 0,0031).
The Physician’s guide to prescribing should contain the following key messages:
Priročnik o predpisovanju za zdravnike mora vsebovati naslednja ključna sporočila:
The physico-chemical stability of the drug product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively
Fizikalno-kemična stabilnost raztopine zdravila po redčenju v raztopinah za infundiranje (0,9 % NaCl in 5 % glukoza) je dokazana za 4 ure pri sobni temperaturi v normalnih svetlobnih pogojih, na vzorcih pripravljenih in shranjenih za 12 ur oz.
The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
Pigmentacija se spremeni zaradi povečane vsebnosti melanina v melantocitih in ne zaradi povečanega števila melantocitov.
The pigs to be treated should be weighed to calculate the correct dose of Econor oral powder to be given and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight for growing pigs.
Prašiča, ki bo prejemal zdravilo, je treba stehtati za izračun pravilnega odmerka zdravila za uporabo v veterinarski medicini; na podlagi dnevne količine zaužite krme, ki je enaka 5 % telesne mase za rastoče prašiče, pa je treba oceniti količino krme, ki jo bo prašič verjetno zaužil.
The pipette consists of a blister film (polypropylene/cyclic-olefin- copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium sachets.
Merilna kapalka je sestavljena iz pretisnega filma (polipropilen/ciklični olefin kopolimer/polipropilen) in pokrovčka iz folije (stisnjen aluminij/polipropilen) in zavarjena v aluminijasto vrečko.
The pipette is open and ready for application when the breaking of the seal is felt.
Kapalka je odprta in pripravljena za uporabo, ko začutite, da je tesnilo počilo.
The pipette to use is selected on the basis of the dog or cat’s weight.
Merilno kapalko, ki jo boste uporabili, izberete na podlagi telesne mase psa ali mačke.
The pivotal clinical evaluation of Diacomit was in children of 3 years of age and over with SMEI.
Ključne raziskave uporabe zdravila Diacomit so bile opravljene pri otrocih starih 3 leta in več, ki so imeli SMEI.
The pivotal clinical evaluation of Diacomit was in children of 3 years of age and over with SMEI.
Ključne raziskave uporabe zdravila stiripentola so bile opravljene pri otrocih starih 3 leta in več, ki so imeli SMEI.
The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period.
Kontrolirane klinične študije, ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6089 bolnikov, ki so med kontroliranim obdobjem dobivali zdravilo Humira, in 3801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
The pivotal study of tafamidis meglumine was an 18-month, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of once-daily 20 mg tafamidis meglumine in 128 patients with TTR amyloid polyneuropathy with the V30M mutation and primarily stage 1 disease (do not routinely require assistance with ambulation).
Ključna študija tafamidis meglumina je bila 18 mesecev trajajoča, multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija za oceno varnosti in učinkovitost enkratnega dnevnega 20 mg odmerka tafamidis meglumina pri 128 bolnikih s TTR amiloidno polinevropatijo z mutacijo V30M, pri katerih je bila bolezen primarno v stadiju 1 (taki bolniki običajno ambulantne pomoči ne potrebujejo).
The pivotal study was a randomised, two-period 12-week crossover multi-centre trial in 64 patients with primary adrenal insufficiency, 11 of whom had concomitant diabetes mellitus and 11 had hypertension.
Ključna študija je bilo randomizirano navzkrižno multicentrično 12-tedensko preskušanje v dveh obdobjih, v katerem je sodelovalo 64 bolnikov s primarno adrenalno insuficienco, od katerih jih je 11 imelo sočasno sladkorno bolezen in 11 hipertenzijo.
The pivotal trial BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus treatment with Herceptin intravenous formulation based on co- primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) (See Section 5.1. of Herceptin subcutaneous formulation SmPC).
Ključno preskušanje BO22227 so zasnovali, da bi dokazali neinferiornost zdravljenja s subkutano obliko zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin glede na soprimarni farmakokinetični končni cilj (Ctrough trastuzumaba pred odmerkom 8. cikla) in končni cilj, povezan z učinkovitostjo (delež pCR ob definitivni operaciji) (glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila za subkutano obliko zdravila Herceptin).
The pivotal trial of Zavesca was conducted in patients unable or unwilling to receive ERT.
Ključno preskušanje zdravila Zavesca so opravili pri bolnikih, ki se niso mogli ali hoteli zdraviti z ERT.
The pivotal trial was a 38 week, randomised, double-blind, active-controlled trial designed to establish the efficacy, safety, and tolerability of this medicinal product administered as monthly injections compared to once daily oral aripiprazole tablets 10-30 mg as maintenance treatment in adult patients with schizophrenia.
Osrednje preskušanje je bilo 38-tedensko randomizirano dvojno slepo aktivno nadzorovano preskušanje, ki je bila zasnovano za ugotavljanje učinkovitosti, varnosti in prenašanja tega zdravila, injiciranega v enkrat mesečnih odmerkih v primerjavi z aripiprazolom v 10–30 mg peroralnih tabletah, danih enkrat dnevno, kot vzdrževalno zdravljenje pri odraslih bolnikih s shizofrenijo.
The PK of decitabine have not been formally studied in patients with hepatic impairment.
Pri bolnikih z okvaro jeter niso formalno proučevali farmakokinetike decitabina.
The PK of decitabine have not been formally studied in patients with renal insufficiency.
Pri bolnikih z okvaro ledvic niso formalno proučevali farmakokinetike decitabina.
The PK of glycopyrronium has been shown to be essentially independent of age in children in the age range 0.19 – 14 years administered a 5 µg/kg i.v. single-dose.
Farmakokinetika glikopironija je pokazala, da je pri otrocih v starostni skupini od 0,19 do 14 let, pri katerih je bil uporabljen enkraten intravenski odmerek 5 µg/kg, pravzaprav neodvisna od starosti.
The PK of pertuzumab in these studies was comparable to those observed in single-agent studies.
Farmakokinetika pertuzumaba je bila v teh študijah primerljiva s farmakokinetiko, ki so jo opažali v raziskavah z monoterapijo.
The PK of trifluridine and tipiracil hydrochloride have not been studied in patients with moderate or severe hepatic impairment (NCI Criteria Group C and D) (see section 4.4).
Farmakokinetike trifluridina in tipiracilijevega klorida pri bolnikih z zmerno ali hudo jetrno okvaro (C in D skupina kriterijev po NCI) niso preučevali (glejte poglavje 4.4).
The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, and cancer patients.
Farmakokinetične lastnosti nintedaniba so bile pri zdravih prostovoljcih podobne kot pri bolnikih z IPF in bolnikih z rakom.
The PK results of pertuzumab in the NEOSPHERE study are consistent with the predictions from the previous population PK model.
Pertuzumabovi farmakokinetični rezultati v študiji NEOSPHERE so skladni z napovedmi prejšnjega populacijskega farmakokinetičnega modela.
The PL will be updated accordingly, in order to reflect the SmPC changes.
Tudi navodilo za uporabo mora odražati spremembe povzetka glavnih značilnosti zdravila, zato bo ustrezno posodobljeno.
The placebo- adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
Placebu prirejeno povprečno največje podaljšanje QTc, glede na izhodišče po 800, 1200 in 1600 mg vorikonazola, je bilo 5,1; 4,8 in 8,2 milisekunde ter 7,0 milisekund po 800 mg ketokonazola.
The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in ARIES 1 and 2 respectively.
V skupini, ki je prejemala 5 mg odmerek, je v študiji ARIES-1 na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu v primerjavi z izhodiščem znašalo 30,6 m (95 % interval zaupanja: 2,9 do 58,3; p = 0,008), v študiji ARIES-2 pa 59,4 m (95 % interval zaupanja: 29,6 do 89,3; p < 0,001).
The placebo-adjusted median increase in 6MWD was 17 metres (p=0.09; 95 % CI: : -7.1, 43.0; Pre- specified Hodges-Lehman method) (mean 23 metres, 95 % CI; -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n=39), and was 39 metres (p<0.01, 95 % CI:13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95 % CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n=37).
Placebo korigirano povečanje povprečne razdalje na 6-minutnem testu hoje je bilo pri bolnikih, ko so prejemali tadalafil 40 mg sočasno z bosentanom (n=39), 17 metrov (p=0,09; 95 % interval zaupanja: -7,1, 43,0; predhodno določena Hodges- Lehmanova metoda) (povprečna vrednost 23 metrov, 95 % interval zaupanja: -2,4, 47,8) in pri bolnikih, ki so prejemali samo 40 mg tadalafila (n=37), 39 metrov (p<0,01; 95 % interval zaupanja: 13,0, 66,0; predhodno določena Hodges-Lehmanova metoda) (povprečna vrednost 44 metrov, 95 % interval zaupanja: 19,7, 69,0).
the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below)
s placebom nadzorovane študije faze II in faze III (združeni podatki) so vključevale 1.346 s HCV okuženih bolnikov stopnje pogostnosti temeljijo na stopnjah poročil o neželenih učinkih (dodatno glejte Nenormalni laboratorijski izvidi v nadaljevanju)
The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple sclerosis (CDMS), whichever came first.
S placebom nadzorovano obdobje je trajalo 2 leti ali dokler se ni pri bolniku razvila klinično potrjena multipla skleroza (CDMS), odvisno do česa je prišlo prej.
The placebo-controlled pooled analysis was based on 2047 patients with Relapsing Multiple Sclerosis treated with teriflunomide once daily.
S placebom kontrolirana združena analiza je temeljila na 2.047 bolnikih z recidivno multiplo sklerozo, ki so bili zdravljeni s teriflunomidom enkrat dnevno.
The placebo-controlled trials included 791 patients that were predominantly female (72%), Caucasian (82%), with a mean age of 45-54 years (range, 18-90 years), and primarily comprised of surgeries including lower abdominal (including pelvic) and orthopedic bone procedures.
S placebom nadzorovana preskušanja so vključevala 791 bolnikov, pretežno žensk (72 %), bele rase (82 %), s povprečno starostjo 45–54 let (razpon 18–90 let), večinoma po kirurških posegih na spodnjem delu trebuha (vključno z medenico) in ortopedskih posegih.
The placebo-corrected increases in walk distance compared to baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively.
Za placebo popravljeno podaljšanje prehojene razdalje v primerjavi z izhodiščno vrednostjo je bilo 76 metrov (p = 0,02; t-test) za prvo študijo oziroma 44 metrov (p = 0,0002; Mann-Whitney U test) za drugo študijo.
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min (see also section 4.2.).
Plazemska AUC zonisamida se je pri bolnikih z očistkom kreatinina <20 ml/min povečala za 35 % (glejte poglavje 4.2).
The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance <20 ml/min (see also section 4.2.).
Plazemska AUC zonisamida se je pri bolnikih z očistkom kreatinina <20 ml/min povečala za 35 % (glejte tudi poglavje 4.2).
The plasma clearance of apremilast is on average about 10 L/hr in healthy subjects, with a terminal elimination half-life of approximately 9 hours.
Povprečni plazemski očistek apremilasta je pri zdravih preiskovancih okrog 10 l/h, končni razpolovni čas izločanja pa približno 9 ur.
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/min) was 40% lower when compared with patients with normal renal function (see section 4.4).
Očistek AsIII v plazmi bolnikov s hudo okvaro delovanja ledvic (očistek kreatinina pod 30 mL/min) je bil 40 % nižji v primerjavi z bolniki z normalnim delovanjem ledvic (glejte poglavje 4.4).
The plasma clearances of canrenone and 7-α- thiomethyl-spironolactone are 1.5 l/h/kg bw and 0.9 l/h/kg bw respectively.
Plazemski klirens kanrenona in 7-α-tiometil- spironolaktona je 1.5 l/h/kg in 0.9 l/h/kg.
The plasma concentration increases proportionally with dose after oral (100-800 mg) and i.v. (50-300 mg) administration.
Plazemska koncentracija narašča sorazmerno z odmerkom pri peroralni (100 - 800 mg) in intravenski (50 - 300 mg) uporabi.
The plasma concentration of AsIII declines from peak plasma concentration in a biphasic manner with a mean terminal elimination half-life of 10 to 14 hours.
Koncentracija AsIII v plazmi upada od najvišje koncentracije v plazmi na bifazni način s srednjo vrednostjo razpolovnega časa 10 do 14 ur.
The plasma concentration of O-desmethyl-lacosamide is approximately 15% of the concentration of lacosamide in plasma.
Plazemska koncentracija O-desmetil-lakozamida predstavlja približno 15 % plazemske koncentracije lakozamida.
The plasma concentration-time profile of intravenously administered gadofosveset conforms to a two- compartment open model.
Profil koncentracija - čas v plazmi intravensko uporabljenega gadofosveseta ustreza dvodelnemu odprtemu modelu.
The plasma concentration-time profiles were not significantly altered in the early stages after dosing when most pharmacologic effects are observed.
Profile plazemske koncentracije v odvisnosti od časa se niso značilno spremenili v zgodnjih stopnjah po odmerjanju, ko so opazili večino farmakoloških učinkov.
the plasma concentrations of
elvitegravirja v plazmi.
the plasma concentrations of
koncentracije elvitegravirja v
The plasma concentrations of ertapenem are comparable in men and women.
Plazemske koncentracije ertapenema so pri moških in ženskah primerljive.
The plasma concentrations of metabolite PpIX were generally low in all patients and in none of the patients an obvious increase of PpIX plasma concentrations was observed after Ameluz application.
Koncentracije presnovka PpIX v plazmi so bile na splošno nizke pri vseh bolnikih in pri nobenem od bolnikov niso opazili očitnega povečanja koncentracij PpIX v plazmi po nanosu zdravila Ameluz.