FrancophonIA/ELRC3.0 huggingface dataset:
English: Opportunistic infections have been reported in association with etanercept, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Slovenian: V povezavi z etanerceptom 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: • Vaccinations: If possible, children should be up to date with all vaccinations before using Benepali.
Slovenian: • Cepljenja: Najbolje je, da otrok pred začetkom zdravljenja z zdravilom Benepali opravi vsa predvidena cepljenja.
English: • Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
Slovenian: • znaki živčnih motenj, npr. omrtvelost ali mravljinčenje, spremembe vida, bolečina v očesu ali pojav šibkosti v roki ali nogi;
English: Biogen Belgium NV/SA Tél/Tel: +35 227 772 038
Slovenian: Luxembourg/Luxemburg Biogen Belgium NV/SA Tél/Tel: +35 227 772 038
English: In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly.
Slovenian: V tej študiji je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg etanercepta enkrat na teden in 153 bolnikov 25 mg etanercepta dvakrat na teden.
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 etanercept, 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 etanerceptom, so v obdobju trženja poročali o malignostih, med katerimi so bile tudi smrtne.
English: If re-treatment with Benepali is indicated, the same guidance on treatment duration should be followed.
Slovenian: Če je indicirano ponovno zdravljenje z zdravilom Benepali, se moramo ravnati po istih smernicah glede trajanja zdravljenja.
English:  Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more.
Slovenian: • poliartritisa (pozitivnega ali negativnega za revmatoidni faktor) in razširjenega oligoartritisa pri bolnikih, starejših od 2 let in s telesno maso 62,5 kg ali več.
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Benepali in case the infection worsens.
Slovenian: • Hepatitis C: Povejte zdravniku, če imate vi ali vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom Benepali za primer, če bi se okužba poslabšala.
English: Administration of Benepali should be discontinued if a patient develops a serious infection.
Slovenian: Zdravljenje z zdravilom Benepali je treba prekiniti, če pride do resne okužbe.
English: Dispose of the empty pen in an approved sharps container.
Slovenian: Prazen peresnik odstranite v odobren vsebnik za ostre odpadke.
English: Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Slovenian: Pri bolnikih, ki so prejemali etanercept v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score) in HAQ tako po 24 kot po 52 tednih statistično pomembno večji kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji preglednici).
English: In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident.
Slovenian: V študijah toksičnosti etanercepta ni bilo opaziti toksičnosti, ki bi omejevala odmerjanje, niti toksičnosti za tarčne organe.
English: Soluble TNFRs are thought to regulate TNF biological activity.
Slovenian: Topni receptorji TNF verjetno uravnavajo biološko aktivnost TNF.
English: Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Slovenian: Pokazali so, da je etanercept od izhodišča do 12 tednov statistično pomembno izboljšalo večino ocen z zdravjem povezane kakovosti življenja in telesne funkcije, vključno z BASFI (BASFI - Bath Ankylosing Spondylitis Functional Index; indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa), rezultatom splošnega zdravstvenega stanja EuroQol 5D in rezultatom telesne komponente SF-36, v primerjavi s placebom.
English: Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies.
Slovenian: Namesto tega so varnost in učinkovitost etanercepta ocenili v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah.
English: Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Slovenian: Zdravilo Benepali je v kombinaciji z metotreksatom indicirano za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, kadar odziv na zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili, vključno z metotreksatom (če ta ni kontraindiciran), ni zadosten.
English: • Swelling of the face, throat, hands, or feet
Slovenian: • otekanje obraza, žrela, rok ali nog;
English: The double-blind period was followed by an open-label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks.
Slovenian: Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali etanercept v odmerku 50 mg na teden, kar je trajajo do 92 dodatnih tednov.
English: 70b a 25 mg etanercept SC twice weekly b p < 0.001, etanercept vs. placebo c p < 0.01, etanercept vs. placebo
Slovenian: 70b a 25 mg etanercepta subkutano dvakrat na teden b p < 0,001, etanercept v primerjavi s placebom c p < 0,01, etanercept v primerjavi s placebom
English: Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Slovenian: Učinek 25 mg odmerka etanercepta je bil pomembno boljši kot pri metotreksatu glede ocene erozije sklepov, tako po 12 kot 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 etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year activecontrolled study.
Slovenian: Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z etanerceptom do približno 6 let,
English: Samsung Bioepis NL B.V. Olof Palmestraat 10
Slovenian: Samsung Bioepis NL B.V.
English: • The risk of Congestive Heart Failure (CHF)
Slovenian: • Tveganje za kongestivno srčno odpoved
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake "EXP".
English: All subdomains of the HAQ were improved in patients treated with etanercept compared to controls at 3 and 6 months.
Slovenian: Po vseh kriterijih vprašalnika HAQ je bilo vidno izboljšanje pri bolnikih na etanerceptu v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
English: In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive etanercept for up to 10 years.
Slovenian: Varnost uporabe zdravila so spremljali v odprtem podaljšku študije, v katerem se je 58 otrok iz zgoraj omenjene študije (v času vključitve so bili stari 4 leta ali več) z etanerceptom zdravilo do 10 let.
English: If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Slovenian: Če se pri vas ali otroku razvijejo simptomi okužbe, na primer vročina, mrzlica ali kašelj, nemudoma obvestite zdravnika.
English: Responses were measured using the ACR Pedi 30, defined as 30% improvement in at least three of six and 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Slovenian: Odzive so merili po lestvici ACR Pedi 30; izboljšanje je bilo določeno kot 30 % izboljšanje v vsaj treh od šestih glavnih kazalcev aktivnosti bolezni JRA in 30 % poslabšanje največ enega od šestih glavnih kazalcev aktivnosti bolezni JRA (število aktivno prizadetih sklepov, omejenost gibanja, zdravnikova splošna ocena, splošna ocena s strani bolnika ali staršev, ocena funkcionalnosti in hitrost sedimentacije eritrocitov).
English: Gently stretch the skin at the cleaned injection site.
Slovenian: Nežno napnite kožo na očiščenem mestu injiciranja.
English: The solution is clear to slightly opalescent, colourless or pale yellow, and is formulated at pH 6.2 ± 0.3.
Slovenian: Raztopina je bistra do nekoliko opalescentna, brezbarvna ali bledorumena in ima pH 6,2 ± 0,3.
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled pen after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjenega injekcijskega peresnika poleg oznake "EXP".
English: • Do not throw the sharps container in household bin.
Slovenian: • Vsebnika za ostre odpadke ne mečite med gospodinjske odpadke.
English: Adult patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either etanercept or anakinra alone (historical data).
Slovenian: Pri odraslih bolnikih, zdravljenih z etanerceptom in anakinro, so opazili večjo stopnjo resnih okužb kot pri bolnikih, zdravljenih samo z etanerceptom ali samo z anakinro (retrospektivni podatki).
English: disodium hydrogen phosphate heptahydrate, and water for injections.
Slovenian: natrijev hidrogenfosfat heptahidrat in voda za injekcije.
English: The efficacy of etanercept in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg etanercept with placebo.
Slovenian: Učinkovitost etanercepta pri bolnikih z ankilozirajočim spondilitisom je bila ocenjena v 3 randomiziranih dvojno slepih študijah, kjer so primerjali uporabo 25 mg etanercepta dvakrat tedensko s placebom.
English: Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Slovenian: Sočasna uporaba etanercepta in anakinre je bila povezana s povečanim tveganjem za pojav resnih okužb in nevtropenije v primerjavi z zdravljenjem samo z etanerceptom.
English: Do not mix the Benepali solution with any other medicine.
Slovenian: Raztopine zdravila Benepali ne smete mešati z nobenim drugim zdravilom.
English: These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly.
Slovenian: Te povprečne koncentracije so bile podobne koncentracijam, ki so jih opazili pri odraslih bolnikih s psoriazo v plakih, zdravljenih s 25 mg etanercepta dvakrat na teden.
English: • Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Slovenian: • Raztopine ne uporabljajte, če je drugačne barve, motna, ali če so prisotni delci, ki ne ustrezajo opisu zgoraj.
English: Inspect the pre-filled syringe:
Slovenian: Preglejte napolnjen injekcijski peresnik:
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
Slovenian: Tudi odstotek bolnikov, ki so razvili nova pozitivna avtoprotitelesa proti dvojno vijačni DNK, je bil večji, merjeno z radioimunskimi testi (15 % pri etanerceptu in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri etanerceptu, in 0 % pri placebu).
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (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 etanercepta (n = 57) ali placebo (n = 55).
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Slovenian: V kliničnih študijah zdravljenja z etanerceptom, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.
English: • psoriatic arthritis; • severe axial spondyloarthritis including ankylosing spondylitis;
Slovenian: • hud aksialni spondilartritis, vključno z ankilozirajočim spondilitisom;
English: ACR Responsesa
Slovenian: Odzivi ACRa
English: • Do not reuse the Benepali pre-filled syringe.
Slovenian: • Napolnjene injekcijske igle zdravila Benepali ne uporabite ponovno.
English: Radiographic progression: Comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration
Slovenian: Radiografsko napredovanje: Primerjava etanercepta in metotreksata pri bolnikih z RA, ki je trajal < 3 leta
English: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Slovenian: Priporočeni odmerek je 0,4 mg/kg telesne mase (do največ 25 mg na odmerek) 2-krat na teden v obliki subkutane injekcije z razmikom med odmerki od 3 do 4 dni ali 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden.
English: In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks.
Slovenian: V dvojno slepem obdobju so bolniki prejemali etanercept v odmerku 50 mg na teden ali placebo 12 tednov.
English: Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF.
Slovenian: Etanercept je kompetitivni antagonist vezave TNF na receptorje na površini celice in torej zavira biološko aktivnost TNF.
English: • Do not rub the injection site.
Slovenian: • Mesta injiciranja ne drgnite.
English: In the 2-year activecontrolled study where patients were treated with either etanercept alone, methotrexate alone or etanercept 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 etanerceptom, metotreksatom ali kombinacijo enteracepta in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
English: Benepali is a biosimilar medicinal product.
Slovenian: Zdravilo Benepali je podobno biološko zdravilo.
English: Icepharma hf. Sími: + 354 800 9836
Slovenian: Genesis Pharma S.A. Sími: + 354 800 9836
English: Check the expiry date on the pre-filled syringe label.
Slovenian: Preverite datum izteka roka uporabnosti na nalepki napolnjenega injekcijskega peresnika.
English: • moderate or severe rheumatoid arthritis;
Slovenian: • zmeren ali hud revmatoidni artritis;
English: Merkel cell carcinoma (see section 4.4)
Slovenian: Merklovih celic (glejte poglavje 4.4)
English: Adult patients with non-radiographic axial spondyloarthritis The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Slovenian: Odrasli bolniki z radiografsko nezaznavnim aksialnim spondilartritisom Učinkovitost etanercepta so pri bolnikih z radiografsko nezaznavnim aksialnim spondilartritisom (nr-AxSpa) ocenili v randomizirani 12-tedenski, dvojno slepi, s placebom nadzorovani študiji.
English: Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Slovenian: Bolniki s pediatrično psoriazo v plakih (stari od 4 do 17 let) so prejemali po 0,8 mg/kg (do največjega odmerka 50 mg na teden) etanercepta enkrat na teden do 48 tednov.
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 etanercept 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 katerega koli 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 enteraceptom kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
English: Pull the needle cover straight off and dispose of it in the bin or sharps container.
Slovenian: Pokrov igle povlecite naravnost navzdol in ga zavrzite v koš za smeti ali vsebnika za ostre odpadke.
English: The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and rubber plunger.
Slovenian: Injekcijska brizga v peresniku je izdelana iz prozornega stekla tipa I z iglo velikost 27 iz nerjavečega jekla, gumijastim pokrovčkom igle in gumijastim batom.
English: The safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Slovenian: Varnost in učinkovitost 50 mg etanercepta (dve subkutani injekciji po 25 mg) enkrat na teden so ocenili v dvojno slepi, s placebom nadzorovani študiji pri 420 bolnikih z aktivnim revmatoidnim artritisom.
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
Slovenian: V študijah 3. faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli etanercept, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS OF 8 AND 24 (WITH BLUE BOX)
Slovenian: VEČODMERNO PAKIRANJA S PO 8 IN 24 (Z BLUE BOX)
English: The device will click when the injection begins.
Slovenian: Ko se začne injiciranje, boste zaslišali klik.
English: In each case Benepali is used, usually when other widely used treatments have not worked well enough or are not suitable for you.
Slovenian: V vseh primerih se zdravilo Benepali običajno uporablja šele po neuspešnem zdravljenju z drugimi običajnimi oblikami zdravljenja, ali če te oblike zdravljenja za vas niso primerne.
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
Slovenian: • znaki lupusa ali lupusu podobnega sindroma, kot so spremembe telesne mase, trdovraten kožni izpuščaj, vročina, bolečina v sklepih ali mišicah ali utrujenost;
English: • Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
Slovenian: • znaki srčnega popuščanja ali poslabšanja srčnega popuščanja, npr. utrujenost ali kratka sapa pri telesnem naporu, otekanje gležnjev, občutek polnosti v vratu ali trebuhu, kratka sapa ali kašelj ponoči, modrikasti nohti ali ustnice;
English: Components inside the pre-filled syringe may be broken.
Slovenian: Deli v napolnjeni injekcijski igli so se morda zlomili.
English: Mean (SE) annualized change from baseline in total sharp score Time
Slovenian: Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto Čas
English: • Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Slovenian: • za zdravljenje hude psoriaze pri bolnikih, starejših od 6 let in s telesno maso 62,5 kg ali več, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
English: Benepali, 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 Benepali ali samo ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
English: In another open-label single-arm study, 60 patients with extended oligoarthrits (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Slovenian: V drugi odprti študiji z eno skupino se je z etanerceptom v odmerku 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden zdravilo 60 bolnikov z razširjenim oligoartritisom (15 bolnikov, starih od 2 do 4 leta, 23 bolnikov, starih od 5 do 11 let, in 22 bolnikov, starih od 12 do 17 let), 38 bolnikov z artritisom, povezanim z entezitisom (starih od 12 do 17 let) in 29 bolnikov s psoriatičnim artritisom (starih od 12 do 17 let).
English: • Trouble swallowing or breathing
Slovenian: • težave pri požiranju ali dihanju;
English: Responses of patients with psoriatic arthritis in a placebo-controlled trial
Slovenian: Odzivi bolnikov s psoriatičnim artritisom v preskušanju, nadzorovanem s placebom
English: • Signs of blood disorders, such as bleeding, bruising, or paleness;
Slovenian: • znaki krvnih bolezni, npr. krvavitve, podplutbe ali bledica;
English: Caution should be exercised in patients being treated with Benepali who have a previous history of blood dyscrasias.
Slovenian: Previdnost je potrebna pri bolnikih, zdravljenih z zdravilom Benepali, ki imajo krvno diskrazijo v anamnezi.
English:  Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.
Slovenian: • psoriatičnega artritisa pri bolnikih, starejših od 12 let in s telesno maso 62,5 kg ali več.
English: No information is available if the use of Benepali effects the ability to drive or use machines.
Slovenian: Ni informacij o tem, ali uporaba zdravila Benepali vpliva na sposobnost upravljanja vozil in strojev.