FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Slovenian: Pomembno je, da zdravnike svojega otroka in druge zdravstvene delavce obvestite, da ste prejemali zdravilo Remicade, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
English: After the first year of the study, 53 patients continued into an open-label extension to week 102.
Slovenian: Po prvem letu študije je skupaj 53 bolnikov nadaljevalo z odprtim podaljškom študije do 102. tedna.
English: Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
Slovenian: Od 573 randomiziranih bolnikov jih je 335 (58 %) doseglo klinični odziv že v 2. tednu.
English: Antibodies to infliximab cannot always be detected in serum samples.
Slovenian: Protiteles na infliksimab ni vedno mogoče odkriti v vzorcih seruma.
English: Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up.
Slovenian: Bolniki, ki se do 8. tedna niso odzvali na infliksimab (n = 15), niso več prejemali zdravila in so se vrnili na kontrolni pregled glede varnosti.
English: Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Slovenian: Ključni izsledki o učinkovitosti zdravila iz študij IMPACT in IMPACT 2 so prikazani v spodnji Preglednici 9:
English: The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered.
Slovenian: Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Remicade.
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Slovenian: Okužba zgornjih dihal (7/60 [12 %]) in faringitis (5/60 [8 %]) sta bili najpogosteje zabeleženi okužbi dihal.
English: There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Slovenian: Ni zadostnih predkliničnih podatkov, da bi lahko sklepali o učinkih infliksimaba na plodnost in splošno sposobnost razmnoževanja (glejte poglavje 5.3).
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Podatki, ki so na voljo, kažejo, da klinični odziv običajno dosežemo v 12 tednih zdravljenja.
English: Before reconstitution: 3 years at 2 °C - 8 °C.
Slovenian: Pred rekonstitucijo: 3 leta pri temperaturi 2 °C - 8 °C
English: While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups.
Slovenian: V mlajši starostni skupini je bil večji tudi delež bolnikov z okužbami, toda kar zadeva resne okužbe, sta bila deleža v obeh starostnih skupinah podobna.
English: This will depend on your disease, weight and how well you respond to Remicade.
Slovenian: To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Remicade.
English: Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment.
Slovenian: Bistvenega pomena je tudi zgodnja prepoznava atipičnih kliničnih slik resnih okužb in tipičnih kliničnih slik redkih in neobičajnih okužb, da bi lahko čimbolj zmanjšali zamude pri njihovi diagnozi in zdravljenju.
English: • Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
Slovenian: • Bolniki s hudo obliko revmatoidnega artritisa, ki imajo to bolezen že dolgo časa, imajo lahko večje tveganje za nastanek limfoma.
English: Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Slovenian: Remicade je na voljo v pakiranjih po 1, 2, 3, 4 ali 5 vial.
English: Your doctor will test you to see if you have TB.
Slovenian: Zdravnik vas bo testiral, da bo ugotovil ali imate tuberkulozo.
English: Experimental data show that TNF is essential for the clearing of intracellular infections.
Slovenian: Eksperimentalni podatki kažejo, da je TNF bistven za odpravljanje znotrajceličnih okužb.
English: There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Slovenian: Obstajajo tudi poročila iz obdobja trženja o novonastalem srčnem popuščanju, vključno s srčnim popuščanjem pri bolnikih brez znane predhodne srčnožilne bolezni.
English: No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Slovenian: Pri bolnikih specifične oftalmološke preiskave za oceno pomembnosti tega izsledka za človeka niso bile izvedene.
English: After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Slovenian: Po 54 tednih zdravljenja so oba odmerka infliksimaba in metotreksat povzročili statistično značilno večje izboljšanje znakov in simptomov v primerjavi s samim metotreksatom, kar so merili z odstotkom bolnikov, ki so dosegli odzive ACR 20, 50 in 70.
English: Most aminotransferase abnormalities were transient; however, a small number of patients experienced more prolonged elevations.
Slovenian: Večinoma so bili nenormalni izvidi aminotransferaz prehodni, pri majhnem številu bolnikov pa je prišlo do dlje časa trajajočega zvišanja.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Slovenian: V primeru diagnoze neaktivne (latentne) tuberkuloze, morate uvesti zdravljenje za latentno tuberkulozo z antituberkulozno terapijo, še pred uvedbo zdravila Remicade, v skladu z lokalnimi priporočili.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Manjše število prospektivno zbranih podatkov o izpostavljenosti infliksimabu med nosečnostjo, ki se je končala z rojstvom živorojenega otroka z znanimi izidi, vključno s približno 1.100 primeri izpostavljenosti infliksimabu v prvem trimesečju, ne kaže na zvečano stopnjo malformacij pri novorojencih.
English: • Hepatitis B infection when you have had hepatitis B in the past
Slovenian: • okužba s hepatitisom B, če ste ga že preboleli v preteklosti
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Slovenian: Pri pediatričnih bolnikih, starih od 2 leti do manj kot 6 let, je bila napovedana mediana vrednost AUCss 40 % nižja kot pri odraslih, vendar je število bolnikov, zajetih v to oceno, omejeno.
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Slovenian: Po in utero izpostavitvi infliksimabu imajo dojenčki lahko povečano tveganje za okužbe, vključno z resno razsejano okužbo, ki je lahko smrtna.
English: Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Slovenian: Pri nekaterih bolnikih je za ohranjanje koristnih kliničnih učinkov zdravljenja lahko potreben krajši razmik med odmerki, pri drugih pa lahko zadoščajo infuzije ob daljših časovnih razmikih.
English: Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Slovenian: Vzdrževalno zdravljenje z infliksimabom na vsakih 8 tednov je bistveno zmanjšalo število z boleznijo povezanih hospitalizacij in kirurških posegov v primerjavi s placebom.
English: Name patient:
Slovenian: Ime bolnika:
English: EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg
Slovenian: EU/1/99/116/001 1 viala 100 mg EU/1/99/116/002 2 viali 100 mg EU/1/99/116/003 3 viale 100 mg EU/1/99/116/004 4 viale 100 mg EU/1/99/116/005 5 vial 100 mg
English: 38 weeks
Slovenian: 38 tednov
English: The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
Slovenian: Primarni končni rezultat v obeh študijah je bil odstotek bolnikov, ki so dosegli ≥ 75 % izboljšanje ocene PASI od začetne vrednosti v 10. tednu.
English: The solution may develop a few fine translucent particles, as infliximab is a protein.
Slovenian: V raztopini se lahko pojavi nekaj drobnih prosojnih delcev, saj je infliksimab beljakovina.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remicade in the infusion bag only.
Slovenian: Shranjevanje pri temperaturi 2 °C - 8 °C, ki presega 24 ur, se nanaša samo na pripravo zdravila Remicade v infuzijski vrečki.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Slovenian: Primarni cilji študije so bili zmanjšanje znakov in simptomov bolezni, kar so ocenjevali po merilih Ameriškega revmatološkega združenja (ACR-American College of Rheumatology criteria) (ACR 20 za ATTRACT, mejna vrednost ACR-N za ASPIRE), preprečevanje strukturne okvare sklepov in izboljšanje njihove funkcije.
English: 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: 6-merkaptopurin (6-MP) ali azatioprin (AZA), ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
English: • Melanoma (a type of skin cancer)
Slovenian: • melanom (vrsta kožnega raka)
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Slovenian: Bolniki v obeh študijah so imeli psoriazo s plaki (telesna površina [BSA] ≥ 10 % in indeks površine in jakosti psoriaze [PASI] ≥ 12).
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Slovenian: Ti bolniki so bili razvrščeni v skupino z odzivom v 2. tednu zdravljenja in so bili vključeni v primarno analizo (glejte preglednico 5).
English: Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
Slovenian: Razpoložljivi podatki kažejo, da klinični odziv običajno dosežemo v 14 tednih zdravljenja, to je s tremi odmerki.
English: The median time to onset of response in the infliximab-treated group was 2 weeks.
Slovenian: Mediani čas do nastopa odziva v skupini, zdravljeni z infliksimabom, je bil 2 tedna.
English: ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
Slovenian: ACR-N temelji na istih merilih kot ACR 20, kar se izračuna z upoštevanjem najmanjšega odstotnega izboljšanja števila oteklih sklepov, števila bolečih sklepov in mediane vrednosti preostalih 5 komponent odziva ACR.
English: This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Slovenian: To velja tako za bolnike s Crohnovo boleznijo kot za tiste z revmatoidnim artritisom.
English: Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth.
Slovenian: Infliksimab prehaja skozi posteljico in so ga vse do 6 meseca po rojstvu zaznali v serumu dojenčkov.
English: In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Slovenian: V skupini za prejemanje infliksimaba pa je ostala srednja vrednost spremembe skupnega modificiranega rezultata vdH-S pod vrednostjo 0 v časovni točki 54. tedna.
English: Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.
Slovenian: Poročali so tudi o treh primerih pljučnice (v enem primeru je šlo za resno pljučnico) in dveh primerih herpes zostra (noben od njiju ni bil resen).
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Slovenian: Pri tem morate opraviti podrobno zdravstveno anamnezo in osebno anamnezo v zvezi s tuberkulozo ali morebitnimi prejšnjimi stiki s tuberkuloznimi bolniki in v zvezi z morebitno prejšnjo in/ali sedanjo imunosupresivno terapijo.
English: Remicade should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Slovenian: Zdravilo Remicade se sme pri otrocih uporabljati samo za zdravljenje Crohnove bolezni ali ulceroznega kolitisa.
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Slovenian: Pri 178 od 580 v študijo vključenih bolnikov (30,7 %) so ugotovili hudo obliko bolezni (ocena CDAI > 300 in sočasna uporaba kortikosteroidov in /ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
English: What Remicade is and what it is used for What you need to know before you use Remicade How Remicade will be given Possible side effects
Slovenian: Kaj je zdravilo Remicade in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Remicade Kako uporabljati zdravilo Remicade Možni neželeni učinki
English: • Provision to record the type, date, and result of TB screenings
Slovenian: • Prostor za beleženje tipa, datuma in rezultata presejalnih testov na TB.
English: In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Slovenian: V študijah IMPACT in IMPACT 2 so opazili klinični odziv že v 2. tednu, ohranjen pa je bil tudi še v 98. tednu in 54. tednu.
English: What you need to know before you use Remicade
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Remicade
English: The antibody incidence was 2-3 fold higher for patients treated episodically.
Slovenian: Pojavnost protiteles je bila 2 do 3-krat večja pri bolnikih, ki so bili zdravljeni občasno.
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54
Slovenian: Izboljšanje z začetne vrednosti za HAQ -časovno povprečje od 30. do 54. tedna
English: Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Slovenian: Klinična remisija v 8. tednu je bila 33,3 % (17/51) (merjeno z indeksom aktivnosti ulceroznega kolitisa pri pediatričnih bolnikih PUCAI [Paediatric Ulcerative Colitis Activity Index]).
English: Week-14 responders (195/282) were analysed for the primary endpoint, which was time from randomisation to loss of response (see Table 7).
Slovenian: Pri bolnikih z odzivom v 14. tednu (195/282) so analizirali primarni končni rezultat, ki je bil čas od randomizacije do izginotja odziva (glejte Preglednico 7).
English: In all situations described below, the benefit/risk balance of Remicade therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah, je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Remicade.
English: One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.
Slovenian: Pojavila se je ena resna z infuzijo povezana reakcija (< 1 %), in sicer pri bolniku na monoterapiji z infliksimabom.
English: • Feeling forgetful, irritable, confused, nervous
Slovenian: • občutek pozabljivosti, razdražljivosti, zmedenosti, živčnosti
English: CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline.
Slovenian: CDAI < 150 tako v 30. tednu kot v 54. tednu, brez prejemanja kortikosteroidov v 3 mesecih pred 54. tednom pri bolnikih, ki so prejemali kortikosteroide na začetku študije
English: • You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
Slovenian: • če imate tuberkulozo (TBC) ali katero drugo hudo okužbo, npr. pljučnico ali sepso,
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
Slovenian: Bolniki s tuberkulozo ali z drugimi hudimi okužbami, kot so sepsa, abscesi in oportunistične okužbe (glejte poglavje 4.4).
English: Patients who responded at week 4 were followed to week 12.
Slovenian: Bolnike z odzivom v 4. tednu so spremljali do 12. tedna.
English: If your baby has continual fevers or infections, contact your baby's doctor immediately.
Slovenian: Če ima vaš dojenček pogosto zvišano telesno temperaturo ali okužbe, takoj obvestite njegovega zdravnika.
English: However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including Remicade, may elicit a lower immune response than in patients not receiving anti-TNF therapy.
Slovenian: Vseeno pa študije iz objavljene literature za različne indikacije (npr. revmatoidni artritis, psoriaza, Crohnova bolezen) nakazujejo, da cepljenja z neživimi cepivi med prejemanjem anti-TNF terapije, vključno z zdravilom Remicade, lahko izzovejo manjši imunski odgovor kot pri bolnikih, ki ne prejemajo anti-TNF terapije.
English: Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Slovenian: Rezultati za 54. teden (za ACR 20, skupni rezultat po metodi van der Heijde, modificirani po Sharpu in HAQ) so prikazani v preglednici 3.
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Slovenian: Približno 93 % teh bolnikov je pred tem prejemalo antibiotike ali zdravila za zaviranje imunske odzivnosti.
English: • Pain in the joints, muscles or back
Slovenian: • bolečine v sklepih, mišicah ali hrbtu
English: Remicade must be given concomitantly with methotrexate.
Slovenian: Zdravilo Remicade morate uporabljati sočasno z metotreksatom.
English: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Slovenian: Na začetku študije je 27,4 % bolnikov prejemalo sistemske kortikosteroide, 14,2 % bolnikov je prejemalo budezonid in 54,3 % bolnikov je prejemalo spojine 5-ASA.
English: • Children and adults taking Remicade may have an increased risk of developing lymphoma or another cancer.
Slovenian: • Otroci in odrasli, ki prejemajo zdravilo Remicade, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
English: If you received Remicade while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Slovenian: Če ste v času nosečnosti prejeli zdravilo Remicade, lahko cepljenje dojenčka s cepivom BCG (uporablja se za preprečevanje tuberkuloze) v obdobju 6 mesecev po rojstvu povzroči okužbo z resnimi zapleti, vključno s smrtjo.
English: The storage details should you need them are as follows:
Slovenian: Pogoji shranjevanja so naslednji:
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Slovenian: Na začetku je 87 % bolnikov imelo perianalne fistule, 14 % jih je imelo abdominalne fistule in 9 % rektovaginalne fistule.
English: • Talk to you doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Slovenian: • Obvestite zdravnika, če ste pred kratkim prejeli ali boste prejeli povzročitelje okužb v terapevtske namene (kot je uporaba BCG za zdravljenje raka).
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at week 26, SONIC
Slovenian: Preglednica 6 Odstotek bolnikov, ki so dosegli klinično remisijo brez jemanja kortikosteroidov v 26. tednu, SONIC
English: • Some patients receiving Remicade have developed symptoms of an immune system disorder called lupus.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo zdravilo Remicade, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
English: Low blood counts
Slovenian: Nizko število krvnih celic
English: There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Slovenian: Ni bilo bistvene razlike med placebom in infliksimabom v odstotku bolnikov z ohranjenim zaprtjem vseh fistul do 54. tedna, za simptome, kot so proktalgija, abscesi in okužba sečil ali za število med zdravljenjem novonastalih fistul.
English: Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available.
Slovenian: Na voljo morajo biti sredstva za nujno pomoč, npr. adrenalin, antihistaminiki, kortikosteroidi in oprema za umetno ventilacijo.
English: Ulcerative colitis (6 to 17 years)
Slovenian: Ulcerozni kolitis (od 6 do 17 let)
English: Remicade may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Remicade ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Your doctor will record these tests on your patient reminder card.
Slovenian: Zdravnik bo vpisal te preiskave na vašo opozorilno kartico za bolnika.
English: The majority of serious infusion reactions occurred during the second infusion at week 2.
Slovenian: Večina resnih z infuzijo povezanih reakcij se je pojavila v času, ko so prejemali drugo infuzijo zdravila v 2. tednu zdravljenja.
English: Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Slovenian: Zabodite iglo skozi osrednji del gumijastega zamaška viale in usmerite curek vode za injekcije proti stekleni steni viale.
English: The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Slovenian: Podatke o odstotku preiskovancev, ki so jim opravili kolektomijo kadarkoli v času 54 tednov po prvi infuziji proučevanega zdravila iz študij ACT 1 in ACT 2 ter njihovih podaljšanj, so zbrali in jih združili.
English: • Tuberculosis
Slovenian: • tuberkuloza
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Slovenian: Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/ml, respectively.
Slovenian: Po enkratnem odmerku 3, 5 ali 10 mg/kg so bile mediane vrednosti Cmaks 77, 118 in 277 mikrogramov/ml.