FrancophonIA/ELRC3.0 huggingface dataset:
English: • With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder (see Diagram 9).
Slovenian: Medtem ko je brizga še vedno v viali, nekajkrat nežno krožno zavrtite vialo, da se prašek raztopi (glejte sliko 9).
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Slovenian: vaskulitis (vključno z vaskulitisom s pozitivnimi antinevtrofilnimi citoplazemskimi protitelesi)
English: Non-interactions
Slovenian: Medsebojno nedelovanje
English: If you forget to inject LIFMIOR
Slovenian: Če ste pozabili injicirati zdravilo LIFMIOR
English: In this study, 53 patients received placebo, 214 patients received 50 mg LIFMIOR once weekly and 153 patients received 25 mg LIFMIOR twice weekly.
Slovenian: V tej študiji je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg zdravila LIFMIOR enkrat na teden in 153 bolnikov 25 mg zdravila LIFMIOR dvakrat na teden.
English: There have been reports of hypoglycaemia following initiation of LIFMIOR in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Slovenian: Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni Po uvedbi zdravila LIFMIOR so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni, poročali o hipoglikemiji, zaradi katere je bilo treba pri nekaterih od teh bolnikov zmanjšati odmerek zdravila za zdravljenje sladkorne bolezni.
English: DSGA b, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving LIFMIOR 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Slovenian: b, čisto ali skoraj čisto *p  0,0001 v primerjavi s placebom a. V študijah 2 in 4 po 24 tednih niso opravili statističnih primerjav s placebom, ker je skupina, ki je prvotno dobivala placebo, začela dobivati 25 mg zdravila LIFMIOR dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna.
English: Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Slovenian: Zvišano koncentracijo TNF najdemo tudi v sinovijski tekočini in psoriatičnem plaku bolnikov s psoriatičnim artritisom ter v serumu in sinovijski tekočini bolnikov z ankilozirajočim spondilitisom.
English: In a study of 49 adult patients with rheumatoid arthritis treated with LIFMIOR, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Slovenian: Študija pri 49 odraslih bolnikih z revmatoidnim artritisom ni pokazala, da bi zdravljenje z zdravilom LIFMIOR zmanjšalo zapoznelo preobčutljivostno reakcijo, zmanjšalo raven imunoglobulinov ali spremenilo število efektorskih celic.
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their LIFMIOR dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Slovenian: V šudiji 3 je večina bolnikov (77 %), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila LIFMIOR po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
English: Mannitol (E421) Sucrose
Slovenian: Prašek manitol (E421) saharoza trometamol
English: LIFMIOR 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Slovenian: Učinek 25 mg odmerka zdravila LIFMIOR je bil pomembno boljši kot pri metotreksatu glede ocene erozije sklepov, tako po 12 kot po 24 mesecih.
English: • Remove the plastic cap from the LIFMIOR vial (see Diagram 1).
Slovenian: Z viale zdravila LIFMIOR odstranite plastično zaporko (glejte sliko 1).
English: • Use a new alcohol swab to clean the grey stopper on the LIFMIOR vial.
Slovenian: Z novo alkoholno blazinico očistite sivi gumijasti zamašek na viali.
English: Approximately 15% of subjects who received LIFMIOR achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Slovenian: Približno 15 % bolnikov, zdravljenih z zdravilom LIFMIOR, je do 3. in 6. meseca doseglo odziv ACR 70, v primerjavi z manj kot 5 % tistih, ki so prejemali placebo.
English: Step 1: Preparing for an LIFMIOR injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of the used MYCLIC pen
Slovenian: Korak 1: Priprava na injiciranje zdravila LIFMIOR Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila LIFMIOR Korak 4: Odstranjevanje uporabljenega peresnika MYCLIC
English: LIFMIOR has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Slovenian: Ugotovili so, da zdravilo LIFMIOR izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in upočasni hitrost napredovanja okvar perifernih sklepov, merjenih z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
English: Opportunistic infections have been reported in association with LIFMIOR, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Slovenian: V povezavi z zdravilom LIFMIOR so poročali o oportunističnih okužbah, vključno z invazivnimi glivičnimi, parazitskimi (vključno s protozojskimi), virusnimi (vključno s herpesom zoster), bakterijskimi (vključno z bakterijama Listeria in Legionella) in atipičnimi mikobakterijskimi okužbami.
English: Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Slovenian: Iz farmakokinetičnih podatkov (glejte poglavje 5.2) izhaja, da pri bolnikih z ledvično ali jetrno okvaro prilagajanje odmerka ni potrebno.
English: The long-term safety and effectiveness of LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Slovenian: Dolgoročna varnost in učinkovitost zdravila LIFMIOR, v odmerkih 0,8 mg/kg (do 50 mg) enkrat na teden, je bila ovrednotena v odprti podaljšani študiji, v kateri je sodelovalo 181 otrok s psoriazo v plakih, ki so se zdravili do 2 leti po zaključku 48-tedenske študije, navedene zgoraj.
English: After the 12-week double-blind treatment period, all patients received LIFMIOR 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Slovenian: Po 12-tedenskem obdobju dvojno slepega zdravljenja so vsi bolniki prejemali zdravilo LIFMIOR v odmerku 0,8 mg/kg (do 50 mg) enkrat na teden še dodatnih 24 tednov.
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in LIFMIOR-treated patients.
Slovenian: V kliničnih študijah z zdravilom LIFMIOR, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.
English: Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Slovenian: Etanercept je dimer himerne beljakovine, ustvarjen z genskim inženirstvom s spajanjem zunajcelične vezalne domene receptorja-2 za humani tumorje nekrotizirajoči faktor (TNFR2/p75) in domene Fc humanega imunoglobulina IgG1.
English: With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 3).
Slovenian: S hitrim in kratkim gibom potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte sliko 3).
English: The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Slovenian: Upočasnitev slabšanja okvar perifernih sklepov so ugotovili pri bolnikih s poliartikularno simetrično prizadetostjo sklepov.
English: If re-treatment with LIFMIOR is indicated, the above guidance on treatment duration should be followed.
Slovenian: Če je indicirano ponovno zdravljenje z zdravilom LIFMIOR, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
English: Elevated liver enzymes
Slovenian: Zvečane vrednosti jetrnih encimov
English: • Remove the protective cover from the syringe tip by breaking the white cap along the perforation.
Slovenian: S konice injekcijske brizge odstranite zaščitni pokrovček, tako da prelomite belo kapico na perforiranem delu.
English: Take the LIFMIOR carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Slovenian: Škatlo z napolnjenimi injekcijskimi brizgami zdravila LIFMIOR vzemite iz hladilnika in jo odložite na ravno delovno površino.
English: LIFMIOR is administered by an injection under the skin (by subcutaneous injection).
Slovenian: Zdravilo LIFMIOR se injicira pod kožo (subkutano injiciranje).
English: Instead, the safety and efficacy of LIFMIOR were assessed in four randomised, double-blind, placebo-controlled studies.
Slovenian: Namesto tega so varnost in učinkovitost zdravila LIFMIOR ocenili v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah.
English: Remove only the portion of liquid as directed by your child's doctor.
Slovenian: Izvlecite le toliko tekočine, kot vam je to naročil otrokov zdravnik.
English: There appears to be no correlation between antibody development and clinical response or adverse events.
Slovenian: Zdi se, da med nastajanjem protiteles na eni strani in kliničnim odzivom ali neželenimi učinki na drugi ni povezave.
English: The double-blind period was followed by an open-label period during which all patients receive LIFMIOR 50 mg weekly for up to an additional 92 weeks.
Slovenian: Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali zdravilo LIFMIOR v odmerku 50 mg na teden, kar je trajajo do 92 dodatnih tednov.
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Slovenian: Študija 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot študija 1, le da so imeli bolniki ob presejanju še vrednost indeksa PASI vsaj 10.
English: TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Slovenian: TNF in limfotoksin sta provnetna citokina, ki se vežeta na dva različna tipa receptorjev na površini celice: 55-kilodaltonske (p55) in 75-kilodaltonske (p75) receptorje TNF.
English: • With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
Slovenian: • Ko je brizga še vedno pritrjena na vialo in adapter, primite vialo obrnjeno na glavo, približno v višini oči.
English: Disposing of supplies
Slovenian: Odstranjevanje odpadkov
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with LIFMIOR (see sections 4.4 and 4.8).
Slovenian: Poleg tega so v dvojno slepem, s placebom nadzorovanem preskušanju pri odraslih bolnikih, ki so prejemali tudi metotreksat, opazili, da so imeli bolniki, zdravljeni z zdravilom LIFMIOR in anakinro, večjo stopnjo resnih okužb (7 %) in nevtropenije kot bolniki, zdravljeni z zdravilom LIFMIOR (glejte poglavji 4.4 in 4.8).
English: Remove one pre-filled syringe and one alcohol swab and place them on the work surface.
Slovenian: Iz škatle vzemite eno napolnjeno injekcijsko brizgo in eno alkoholno blazinico ter ju položite na delovno površino.
English: Adult patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either LIFMIOR or anakinra alone (historical data).
Slovenian: Pri odraslih bolnikih, zdravljenih z zdravilom LIFMIOR in anakinro, so opazili večjo stopnjo resnih okužb kot pri bolnikih, zdravljenih samo z zdravilom LIFMIOR ali samo z anakinro (retrospektivni podatki).
English: Administration of LIFMIOR should be discontinued if a patient develops a serious infection.
Slovenian: Zdravljenje z zdravilom LIFMIOR je treba prekiniti, če pride do resne okužbe.
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products as well as the parent compound.
Slovenian: Koncentracije etanercepta v serumu so bile določene z metodo encimskega imunskega testa (ELISA), ki zazna tako ELISA reaktivne razgradne produkte kot tudi izhodno snov.
English: Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with LIFMIOR (11%) than in placebo-treated patients (5%).
Slovenian: Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA), je bil odstotek tistih, ki so razvili nova pozitivna ANA ( 1:40), večji pri bolnikih, ki so prejemali zdravilo LIFMIOR (11 %), kot pri tistih, ki so prejemali placebo (5 %).
English: Whether used alone or in combination with methotrexate, LIFMIOR can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Slovenian: Zdravilo LIFMIOR samo ali v kombinaciji z metotreksatom lahko upočasni razvoj poškodb v sklepih zaradi revmatoidnega artritisa in izboljša sposobnost opravljanja vsakodnevnih opravil.
English: Posology and administration are the same as for adults 18-64 years of age.
Slovenian: Prilagajanje odmerka ni potrebno; odmerjanje in način uporabe sta enaka kot pri odraslih, starih od 18 do 64 let.
English: LIFMIOR, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Slovenian: Dokazali so, da zdravilo LIFMIOR samo ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
English: • The risk of Congestive Heart Failure (CHF).
Slovenian: • tveganje za kongestivno srčno popuščanje
English: Week 12 results are shown in the table below.
Slovenian: Rezultati po 12 tednih so prikazani v spodnji preglednici.
English: Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications).
Slovenian: Bolnikom, ki tehtajo manj kot 62,5 kg, je treba odmerek natančno izračunati na podlagi mg/kg in uporabiti zdravilo LIFMIOR v obliki praška in vehikla za raztopino za injiciranje ali praška za raztopino za injiciranje (za odmerjanje pri specifičnih indikacijah glejte nadaljevanje).
English: All subdomains of the HAQ were improved in patients treated with LIFMIOR compared to controls at 3 and 6 months.
Slovenian: Po vseh kriterijih vprašalnika HAQ je bilo vidno izboljšanje pri bolnikih na zdravilu LIFMIOR v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
English: Instructions for use and handling
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Significant advantages for LIFMIOR in combination with methotrexate compared with LIFMIOR monotherapy and methotrexate monotherapy were also observed after 24 months.
Slovenian: Pomembne prednosti zdravila LIFMIOR v kombinaciji z metotreksatom pred monoterapijo z zdravilom LIFMIOR ali monoterapijo z metotreksatom so ugotovili tudi po 24 mesecih.
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with LIFMIOR for up to approximately 6 years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Slovenian: Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z zdravilom LIFMIOR do približno 6 let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila LIFMIOR in metotreksata v dvoletni študiji, nadzorovani z učinkovino.
English: The dosage of LIFMIOR is based on body weight for paediatric patients.
Slovenian: Odmerjanje zdravila LIFMIOR za pediatrične bolnike temelji na njihovi telesni masi.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Slovenian: Učinkovitost zdravila LIFMIOR so ugotavljali v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 211 pediatričnih bolnikih, starih 4 do 17 let, z zmerno do hudo psoriazo v plakih (definirano z oceno sPGA ≥ 3, ki zajema ≥ 10 % telesne površine (BSA - Body Surface Area), in PASI ≥ 12).
English: ACR 70 Month 3
Slovenian: ACR 70 3. mesec 6. mesec
English: There have been rare reports of CNS demyelinating disorders in patients treated with LIFMIOR (see section 4.8).
Slovenian: Poročali so o redkih primerih demielinizirajočih obolenj centralnega živčnega sistema (CŽS) pri bolnikih, zdravljenih s tem zdravilom (glejte poglavje 4.8).
English: When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Slovenian: Ko se očiščeni predel kože posuši, ga z eno roko nežno stisnite in trdno primite.
English: If these signs occur, tell your doctor immediately, or take the child to the casualty department at your nearest hospital.
Slovenian: Če se ti znaki pojavijo, se nemudoma posvetujte z zdravnikom ali pa otroka odpeljite v ambulanto za nujno pomoč najbližje bolnišnice.
English: This is done by holding the collar of the white cap while grasping the end of the white cap with the other hand and bending it down and then up until it is broken (see Diagram 6).
Slovenian: To naredite tako, da držite omot in z drugo roko sukate belo kapico gor in dol, dokler se ne prelomi (glejte sliko 6).
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis
Slovenian: Revmatoidni artritis, psoriatični artritis in aksialni spondilartritis, vključno z ankilozirajočim spondilitisom
English: Results are summarised in the table below.
Slovenian: Izsledki so povzeti v spodnji preglednici.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including LIFMIOR, in the postmarketing setting.
Slovenian: Pri otrocih, mladostnikih in mladih odraslih (do 22. leta starosti), ki so se zdravili z antagonisti TNF (začetek zdravljenja ≤ 18 let), vključno z zdravilom LIFMIOR, so v obdobju trženja poročali o malignostih, med katerimi so bile tudi smrtne.
English: LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Slovenian: Zdravljenje z zdravilom LIFMIOR lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem juvenilnega idiopatskega artritisa ali otroške psoriaze v plakih.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
Slovenian: O različnih malignih obolenjih (vključno z rakom dojke in pljuč ter limfomi) so poročali tudi v obdobju trženja zdravila (glejte poglavje 4.4).
English: Soluble TNFRs are thought to regulate TNF biological activity.
Slovenian: Topni receptorji verjetno uravnavajo biološko aktivnost TNF.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the LIFMIOR group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Slovenian: V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz kateregakoli razloga izpadli iz študije, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z zdravilom LIFMIOR kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of LIFMIOR (n=57) or placebo (n=55) twice a week for 24 weeks.
Slovenian: Randomizirali so sto dvanajst (112) bolnikov, ki so 24 tednov dvakrat na teden dobivali 25 mg odmerek zdravila LIFMIOR (n = 57) ali placebo (n = 55).
English: Malignant melanoma (see section 4.4), lymphoma, leukaemia
Slovenian: nemelanomski kožni rak* (glejte poglavje maligni melanom (glejte poglavje 4.4), limfom, levkemija karcinom Merklovih celic (glejte poglavje
English: In the 2-year active-controlled study where patients were treated with either LIFMIOR alone, methotrexate alone or LIFMIOR in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Slovenian: V dveletni študiji, nadzorovani z učinkovino, v kateri so bili bolniki zdravljeni z zdravilom LIFMIOR, metotreksatom ali kombinacijo zdravila LIFMIOR in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Slovenian: V nadzorovanih delih kliničnih preskušanj z antagonisti TNF so pri bolnikih, ki so prejemali antagonist TNF, opazili več primerov limfomov kot pri kontrolni skupini bolnikov.
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Slovenian: Neželeni učinki pri otrocih in mladostnikih so bili po vrsti in pogostnosti podobni neželenim učinkom, opisanim zgoraj.
English: Step 2: Choosing an injection site
Slovenian: Korak 2: Izbira mesta injiciranja
English: Do not use the pen if it is dropped with the needle cap off.
Slovenian: Peresnika ne uporabljajte, če vam pade na tla, ko pokrovček igle ni nameščen.
English: LIFMIOR was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Slovenian: Zdravilo LIFMIOR se ni izkazalo za genotoksičnega v vrsti študij in vivo in in vitro.
English: A single 50 mg/ml injection of LIFMIOR was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Slovenian: Enkratna injekcija zdravila LIFMIOR v odmerku 50 mg/ml je bioekvivalentna dvema sočasnima injekcijama po 25 mg/ml.
English: Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
Slovenian: Bolniki, primerni za vključitev v študijo, so imeli v anamnezi fototerapijo ali sistemsko terapijo ali pa z lokalno terapijo njihove bolezni ni bilo mogoče zadostno obvladati.
English: However, the solution may be used for up to 6 hours when stored at a temperature up to 25°C.
Slovenian: Raztopina je uporabna največ 6 ur, če jo hranite pri temperaturi do 25 °C.