FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that you record the date that Benepali is removed from the refrigerator and the date after which Benepali should be discarded (no more than 4 weeks following the removal from the refrigerator).
Slovenian: Priporočljivo si je zabeležiti datum odvzema zdravila Benepali iz hladilnika in datum, po katerem je treba zdravilo Benepali zavreči (do 4 tedne po odvzemu iz hladilnika).
English: What Benepali looks like and contents of the pack
Slovenian: Izgled zdravila Benepali in vsebina pakiranja
English: If needed, cover the injection site with a plaster.
Slovenian: Po potrebi na mesto injiciranja nalepite obliž.
English: The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg.
Slovenian: Razlike v ocenah TSS in JSN med metotreksatom in 25 mg etanercepta niso bile statistično pomembne.
English: After discontinuation of etanercept, symptoms of arthritis generally returned within a month.
Slovenian: Po prekinitvi zdravljenja z etanerceptom so se simptomi artritisa največkrat ponovno pojavili že v enem mesecu.
English: ASAS partial remission
Slovenian: Delna remisija ASAS
English: You can let go of the skin that you are pinching after the needle is completely inserted.
Slovenian: Kožo, ki jo držite, lahko izpustite, ko je igla do konca vstavljena.
English: If you feel that the effect of Benepali is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Benepali premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defenses against infection and cancer.
Slovenian: Antagonisti TNF, kot je etanercept, vplivajo na imunski sistem in lahko zmanjšajo sposobnost organizma za obrambo pred okužbami in rakom.
English: Recapping could lead to a needle stick injury.
Slovenian: Ponovno natikanje pokrovčka lahko povzroči vbodno poškodbo.
English: Although no clinical trials have been performed evaluating etanercept therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Slovenian: Čeprav niso opravili kliničnih preskušanj za ovrednotenje zdravljenja z etanerceptom pri bolnikih z multiplo sklerozo, so klinična preskušanja drugih antagonistov TNF pri teh bolnikih pokazala zvečano aktivnost bolezni.
English: DSGAb, 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 etanercept 25 mg BIW or 50 mg once weekly from week 13 to week 24. b Dermatologist Static Global Assessment.
Slovenian: 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 etanercepta dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna b Dermatološka statična splošna ocena.
English: Biogen (Czech Republic) s.r.o.
Slovenian: Česká republika Biogen (Czech Republic) s.r.o.
English: However, it cannot be excluded that the combination of etanercept with methotrexate could be associated with an increase in the rate of infections.
Slovenian: Vendar pa ni mogoče izključiti možnosti, da se lahko stopnja pogostnosti okužb pri zdravljenju s kombinacijo etanercepta in metotreksata poveča.
English: After 12 weeks of treatment, patients in the placebo group began treatment with blinded etanercept (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Slovenian: Po 12 tednih zdravljenja so bolniki v skupini s placebom začeli slepo zdravljenje z etanerceptom (25 mg dvakrat na teden), bolniki v skupinah z aktivnim zdravljenjem pa so do 24. tedna nadaljevali z odmerkom, na katerega so bili prvotno randomizirani.
English: • Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Slovenian: • občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ali občutek toplote;
English: • Wegener's granulomatosis: Benepali is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Slovenian: • Wegenerjeva granulomatoza: Zdravilo Benepali ni priporočljivo za zdravljenje redke vnetne bolezni Wegenerjeve granulomatoze.
English: In patients who develop HBV infection, Benepali should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, pri katerih se razvije okužba s HBV, je treba zdravljenje z zdravilom Benepali prekiniti in uvesti učinkovito protivirusno ter ustrezno podporno zdravljenje.
English: Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on etanercept continued to improve from month 3 through month 7, while those who received placebo did not improve.
Slovenian: Od bolnikov, ki so dosegli klinični odziv do 90. dneva in se vključili v drugi del študije, se je pri nekaterih bolnikih, ki so ostali na etanerceptu, klinično stanje nadalje izboljševalo od 3. do 7. meseca zdravljenja, pri tistih, ki so v drugem delu študije prejemali placebo, pa izboljšanja ni bilo.
English: If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Slovenian: Če ste na predvideni odmerek pozabili, ga morate injicirati takoj, ko se spomnite, razen če je naslednji odmerek predviden za naslednji dan.
English: • Do not release pressure against the injection site before the injection is complete.
Slovenian: • Ne popuščajte s pritiskanjem na mesto injiciranja, dokler ni injiciranje končano.
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 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 obliko praška in vehikla za raztopino za injiciranje ali praška za raztopino za injiciranje (za odmerjanje pri specifičnih indikacijah glejte nadaljevanje).
English: Instructions for use
Slovenian: Navodila za uporabo
English: Failure of the bone marrow to produce crucial blood cells; damage to nerves, including Guillain-Barré syndrome (a serious condition which can affect breathing and damage body organs); toxic epidermal necrolysis (a life-threatening skin condition).
Slovenian: Prenehanje tvorbe osnovnih krvnih celic v kostnem mozgu; poškodbe živcev, vključno z Guillain-Barréjevim sindromom (resno stanje, ki lahko vpliva na dihanje ali poškoduje telesne organe); toksična epidermalna nekroliza (življenje ogrožajoča kožno stanje).
English: Benepali is not recommended for the treatment of Wegener's granulomatosis.
Slovenian: Zdravila Benepali ni priporočljivo uporabljati za zdravljenje Wegenerjeve granulomatoze.
English: However, any of the above symptoms may indicate an allergic reaction to Benepali, so you should seek immediate medical attention.
Slovenian: Resne alergijske reakcije so redke, vendar pa lahko kateri koli od zgoraj navedenih simptomov kaže na pojav alergijske reakcije na zdravilo Benepali, zato morate nemudoma poiskati zdravniško pomoč.
English: No dose adjustment is required.
Slovenian: Prilagajanje odmerka ni potrebno.
English: The safety and efficacy of etanercept in patients with chronic infections have not been evaluated.
Slovenian: Varnost in učinkovitost etanercepta pri bolnikih s kroničnimi okužbami nista bili ovrednoteni.
English: Disposal:
Slovenian: Odstranjevanje:
English: Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Slovenian: Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor Pridobljen je z rekombinantno DNK tehnologijo v sesalskem ekspresijskem sistemu, in sicer v ovarijskih celicah kitajskega hrčka (CHO - Chinese Hamster Ovary).
English: Ewopharma AG Representative Office
Slovenian: Ewopharma AG Representative Office Teл.
English: In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
Slovenian: V drugi opazovalni registrski študiji, ki so jo izvajali v več državah in v kateri so primerjali tveganje za neželene izide nosečnosti pri ženskah, izpostavljenih etanerceptu v prvih 90 dneh nosečnosti (n = 425), in pri ženskah, ki so bile izpostavljene nebiološkim zdravilom (n = 3.497), niso opazili povečanega tveganja za resne prirojene napake (grobo razmerje obetov [OR - Odds Ratio] = 1,22, 95-% IZ: 0,79-1,90; prilagojeno OR = 0,96, 95-% IZ: 0,58-1,60 po prilagoditvi glede na državo, materino bolezen, pariteto, starost matere in kajenje v zgodnji nosečnosti).
English: Slowly push down the plunger to inject all of the Benepali solution.
Slovenian: Bat počasi potiskajte navzdol, da injicirajte celotno raztopino zdravila Benepali.
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Slovenian: (19 %, 1,7 dogodka na bolnik-leto), navzea (9 %, 1,0 dogodek na bolnik-leto), bolečine v trebuhu (19 %, 0,74 dogodka na bolnik-leto) in bruhanje (13 %, 0,74 dogodka na bolnik-leto).
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents.
Slovenian: Študij kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti z entanerceptom pri glodalcih niso opravili zaradi tvorbe nevtralizirajočih protiteles.
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 etanercept (11%) than in placebotreated 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 etanercept (11 %), kot pri tistih, ki so prejemali placebo (5 %).
English: Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød Denmark
Slovenian: Proizvajalec Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød
English: The known side effects of Benepali include the following in groups of decreasing frequency:
Slovenian: Znani neželeni učinki zdravila Benepali so v nadaljevanju navedeni v skupinah po padajoči pogostnosti:
English: Read the instructions for use before you start using Benepali and each time you get a refill of your prescription.
Slovenian: Navodila za uporabo Preden začnete uporabljati zdravilo Benepali in vsakič, ko dobite novo pakiranje, preberite ta navodila za uporabo.
English: Disease flare was defined as a 30% worsening in three of six JRA core set criteria and 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Slovenian: Ponoven izbruh bolezni je bil definiran kot 30 % poslabšanje treh od šestih osnovnih kazalcev JRA in 30 % izboljšanje največ enega od šestih glavnih kazalcev JRA ter najmanj dva aktivno prizadeta sklepa.
English: In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Slovenian: V skupini 7.416 bolnikov, zdravljenih z etanerceptom v kliničnih preskušanjih revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, so poročali o 18 limfomih.
English: 28b a p < 0.001, etanercept vs. placebo b p = 0.002, etanercept vs. placebo
Slovenian: 28b a p < 0,001, etanercept proti placebu b p = 0,002, etanercept proti placebu
English: Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response.
Slovenian: Zdravnik bo na podlagi vašega odziva na zdravilo določil, koliko časa morate uporabljati zdravilo Benepali in ali je potrebno ponovno zdravljenje.
English: Results:
Slovenian: Rezultati:
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Slovenian: Stevens-Johnsonov sindrom, kožni vaskulitis (vključno z preobčutljivostnim vaskulitisom), multiformni eritem,
English: Autoantibody formation Treatment with Benepali may result in the formation of autoimmune antibodies (see section 4.8).
Slovenian: Zdravljenje z zdravilom Benepali lahko sproži nastajanje avtoimunskih protiteles (glejte poglavje 4.8).
English: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which etanercept was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with etanercept or sulfasalazine alone.
Slovenian: V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bil dodan etanercept, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično pomembno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z etanerceptom ali samo s sulfasalazinom.
English: The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Slovenian: Ni dokazano, da bi bila kombinacija etanercepta in anakinre klinično koristnejša, zato ni priporočljiva.
English: The long-term safety and effectiveness of etanercept 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 etanercepta, v odmerkih 0,8 mg/kg (do 50 mg) enkrat na teden, je bila ovrednotena v odprti podaljšani študiji, v kateri je sodelovalo 181 pediatričnih bolnikov s psoriazo v plakih, ki so se zdravili do 2 leti po zaključku 48-tedenske študije, navedene zgoraj.
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with etanercept and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept (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 etanerceptom in anakinro, večjo stopnjo resnih okužb (7 %) in nevtropenije kot bolniki, zdravljeni z etanerceptom (glejte poglavji 4.4 in 4.8).
English: ● If you have congestive heart failure, and you think your symptoms (e.g., shortness of breath or swelling of the feet) are becoming worse, or you experience new onset of such symptoms, seek medical attention immediately.
Slovenian: ● Če imate kongestivno srčno popuščanje in menite, da se vaši simptomi (npr. zasoplost ali otekanje stopal) slabšajo ali če se ti simptomi pojavijo ponovno, takoj poiščite zdravniško pomoč.
English: If Benepali has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Slovenian: Če zdravilo Benepali po 12 tednih nima nobenega učinka na otrokovo stanje, vam bo zdravnik morda naročil, da prenehajte uporabljati to zdravilo.
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Slovenian: Alergijske reakcije; vročina; izpuščaj; srbenje; protitelesa proti normalnemu tkivu (nastanek avtoprotiteles).
English: After a single subcutaneous dose of 25 mg etanercept, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 μg/ml, and the area under the curve was 235 ± 96.6 μg × hr/ml.
Slovenian: Po enkratnem subkutanem odmerku 25 mg etanercepta je bila povprečna največja koncentracija zdravila v serumu pri zdravih prostovoljcih 1,65 ± 0,66 μg/ml, površina pod krivuljo pa 235 ± 96,6 μg × h/ml.
English: • Do not touch the plunger rod while removing the needle cover.
Slovenian: • Ne dotikajte se bata, medtem ko odstranjujete pokrov igle.
English: Compared to placebo, treatment with etanercept resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Slovenian: V primerjavi s placebom je po dajanju etanercepta prišlo do izboljšanja pri ASAS 20, ASAS 50 in ASAS 70 že v 2 tednih od začetka zdravljenja.
English: It is recommended that the conduct of these tests should be recorded in the patient's alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravnike predpisovalce opominjamo na nevarnost lažno negativnih rezultatov tuberkulinskega kožnega testa, še zlasti pri bolnikih, ki so hudo bolni ali imunokompromitirani.
English: Remove the empty pen from the skin.
Slovenian: Prazen injekcijski peresnik izvlecite iz kože.
English: • Never recap the needle.
Slovenian: • Pokrovčka nikoli ne natikajte nazaj na iglo.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, ”Instructions for use”.
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo".
English: In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months.
Slovenian: faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z etanerceptom ali placebom zaradi zmernega do hudega alkoholnega hepatitisa, etanercept ni bil učinkovit in stopnja smrtnosti bolnikov, zdravljenih z etanerceptom, je bila po 6 mesecih pomembno večja.
English: Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Slovenian: Zdravilo Benepali je indicirano tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa pri odraslih, ki še niso dobivali metotreksata.
English: Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose.
Slovenian: Zato dajanje zdravila Benepali pediatričnim bolnikom, ki potrebujejo odmerek, manjši kot je polnih 25 mg ali 50 mg, ni mogoče.
English: The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Slovenian: Primarni opazovani dogodek učinkovitosti v vseh štirih študijah je bil tisti delež bolnikov v vsaki zdravljeni skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75-% izboljšanje indeksa PASIPsoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
English: The efficacy of etanercept 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 an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Slovenian: Učinkovitost etanercepta 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: These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Slovenian: Te okužbe so povzročali bakterije, mikobakterije, glivice, virusi in paraziti (vključno s protozoji).
English: Benepali may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Slovenian: Zdravilo Benepali lahko shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their etanercept dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Slovenian: V študiji 3 je večina bolnikov (77 %), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek etanercepta po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
English: cysts and polyps)
Slovenian: (vključno s cistami in polipi)
English: Patients who develop a new infection while undergoing treatment with Benepali should be monitored closely.
Slovenian: Bolnike, pri katerih se med zdravljenjem z zdravilom Benepali pojavi nova okužba, je treba skrbno spremljati.
English: Worsening of symptoms of dermatomyositis
Slovenian: sarkoidoza poslabšanje simptomov dermatomiozitisa
English: However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Slovenian: Vendar pa omejeni podatki o varnosti iz registra bolnikov nakazujejo, da je varnostni profil pri subkutani uporabi zdravila v odmerku 0,8 mg/kg enkrat na teden pri otrocih, starih od 2 do 3 let, podoben profilu pri odraslih in otrocih, starih 4 leta in več (glejte poglavje 5.1).
English: • Sharps disposal container
Slovenian: • vsebnik za odstranjevanje ostrih predmetov
English: • Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Slovenian: • Okužbe/sladkorna bolezen: Povejte zdravniku, če imate vi ali otrok ponavljajoče se okužbe, sladkorno bolezen ali kakšno drugo stanje, pri katerem je tveganje za okužbo večje.
English: Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%).
Slovenian: V primerjavi s placebom je bila pri bolnikih z revmatskimi obolenji, zdravljenih z etanerceptom, incidenca reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
English: For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities.
Slovenian: Pri bolnikih s psoriatičnim artritisom in prizadetostjo več sklepov lahko zdravilo Benepali izboljša sposobnost opravljanja običajnih vsakdanjih dejavnosti.
English: Detailed instructions on how to inject Benepali are provided in section 7, “Instructions for use”.
Slovenian: Podrobna navodila o injiciranju zdravila Benepali so v poglavju 7, "Navodila za uporabo".
English: • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Benepali.
Slovenian: • Rak: Preden boste prejeli zdravilo Benepali, povejte zdravniku, če imate ali ste kdaj imeli limfom (vrsta krvnega raka) ali drugo obliko raka.
English: Uncommon ≥ 1/1,000 to
Slovenian: Občasni ≥ 1/1.000 do