FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget or miss an appointment to receive Zessly, make another appointment as soon as possible.
Slovenian: Če ste pozabili ali izpustili odmerek zdravila Zessly Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Zessly, se čim prej dogovorite za naslednjega.
English: The combination of Zessly with other biological therapeutics used to treat the same conditions as Zessly, including anakinra and abatacept, is not recommended (see section 4.4).
Slovenian: Kombiniranje zdravila Zessly z drugimi biološkimi zdravili za zdravljenje enakih bolezni kot z zdravilom Zessly, vključno z anakinro in abataceptom, ni priporočljivo (glejte poglavje 4.4).
English: Table 6 Percent of patients with Crohn's disease achieving corticosteroid-free clinical remission at week 26
Slovenian: Odstotek bolnikov s Chronovo boleznijo, ki so dosegli klinično remisijo brez jemanja kortikosteroidov v 26. tednu
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
English: Further treatment with Zessly must not be given if a patient develops a serious infection or sepsis.
Slovenian: Bolnika ne smete več zdraviti s tem zdravilom, če dobi resno okužbo ali sepso.
English: Investigations Uncommon:
Slovenian: Preiskave občasni:
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Zessly.
Slovenian: Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati, preden prejmete zdravilo Zessly pa termed zdravljenjem z njim.
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50.
Slovenian: Preglednica 10 Povzetek odzivov PASI,vrednosti PGA in delež bolnikov z nohti brez psoriatičnih sprememb v 10., 24. in 50. tednu.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Zessly and is positive for antibodies against double-stranded DNA, further treatment with Zessly must not be given (see section 4.8).
Slovenian: Če se po zdravljenju z zdravilom Zessly pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvojnoverižni DNA, ne sme več prejeti tega zdravila (glejte poglavje 4.8).
English: Zessly treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Slovenian: Zdravljenje z zdravilom Zessly mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
English: • You should receive recommended vaccinations before starting Zessly treatment.
Slovenian: • Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Zessly.
English: Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Slovenian: V študiji 12 so ocenjevali učinkovitost uvodne terapije z infliksimabom pri 249 bolnikih s psoriazo s plaki, ki so pred tem prejemali PUVA ali sistemsko terapijo.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Zessly treatment.
Slovenian: • Bolniki s KOPB in tisti, ki veliko kadijo, imajo lahko povečano tveganje za nastanek raka pri zdravljenju z zdravilom Zessly.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Zessly.
Slovenian: Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in pri katerih je bil test na latentno tuberkulozo negativen, premislite, ali bi bilo treba pri njih pred uvedbo zdravila Zessly najprej zdraviti tuberkulozo.
English: Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis (studies 10 and 11).
Slovenian: Učinkovitost in varnost zdravila so ocenjevali v dveh multicentričnih, dvojno slepih in s placebom kontroliranih študijah pri bolnikih z aktivnim psoriatičnim artritisom (študiji 10 in 11).
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: NEMČIJA Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: • Circulation problems such as low or high blood pressure,
Slovenian: • težave s krvnim obtokom, na primer nizek ali visok krvni tlak
English: ACR response (% of patients)
Slovenian: Odziv ACR (% bolnikov) N
English: a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Slovenian: Kontrolna skupina: Vsi bolniki so imeli aktivni revmatoidni artritis kljub zdravljenju s stalnimi odmerki metotreksata že 6 mesecev pred vključitvijo v študijo; te odmerke so prejemali še naprej ves čas študije.
English: The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulas that were of at least 3 months' duration.
Slovenian: Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Zessly therapy.
Slovenian: Priporočljivo je, da se pri pediatričnih bolnikih pred uvajanjem zdravila Zessly, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi smernicami za cepljenje.
English: Infusion reactions following re-administration of infliximab
Slovenian: Z infuzijo povezane reakcije po ponovni uvedbi infliksimaba
English: During Zessly treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Slovenian: Med zdravljenjem z zdravilom Zessly je treba optimizirati druge sočasne terapije, npr. s kortikosteroidi in zdravili za zaviranje imunske odzivnosti.
English: • Small red or purple spots caused by bleeding under the skin
Slovenian: • majhne rdeče ali vijoličaste pike zaradi podkožnih krvavitev
English: The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (clinical Study 5).
Slovenian: Učinkovitost večkratnih infuzij infliksimaba pri bolnikih s Crohnovo boleznijo s fistulami so raziskovali v enoletni klinični študiji (klinična študija 5).
English: a Week 98 data for study 10 includes combined placebo crossover and infliximab patients who entered the open-label extension.
Slovenian: Podatki za 98. teden iz študije 10 vključujejo seštevek bolnikov, ki so prešli s placeba na infliksimab, in tiste bolnike na infliksimabu, ki so jih vključili v odprt podaljšek študije.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Slovenian: (glejte poglavje 5.1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10,7 %), kri v blatu (9,7 %), levkopenija (8,7 %), zardevanje (8,7 %), virusne okužbe (7,8 %), nevtropenija (6,8 %), bakterijske okužbe (5,8 %), alergijske reakcije dihal (5,8 %).
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Slovenian: Protitelesa na infliksimab so ugotovili pri 3 pediatričnih bolnikih (2,9 %).
English: Concurrent administration of TNF-alpha inhibitor and abatacept
Slovenian: Sočasna uporaba zaviralcev TNF-alfa in abatacepta
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in study 11.
Slovenian: Ugotovili so tudi bistveno izboljšanje kakovosti življenja v zvezi z zdravjem, kar so merili na podlagi delnih ocen, to je seštevkov za telesne in duševne komponente SF36 v študiji 11.
English: What Zessly is and what it is used for What you need to know before you use Zessly How Zessly will be given Possible side effects
Slovenian: Kaj je zdravilo Zessly in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zessly Kako uporabljati zdravilo Zessly
English: Upon removal from refrigerated storage, Zessly must not be returned to refrigerated storage.
Slovenian: Ko zdravilo Zessly enkrat vzamete iz hladilnika, ga ne smete vrniti nazaj v hladilnik.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, study 1
Slovenian: Preglednica 3 Učinki na ACR 20, strukturno okvaro sklepov in funkcijo sklepov v 54. tednu, študija 1
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing
Slovenian: • vneta pljučna mrena, ki povzroča ostre bolečine v prsnem košu, ki so močnejše ob dihanju
English: • Some patients receiving treatment with medicines containing infliximab have developed symptoms of an immune system disorder called lupus.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo infliksimab, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
English: Side effects may also occur after your treatment with Zessly has stopped.
Slovenian: Neželeni učinki se lahko pojavijo tudi po koncu zdravljenja z zdravilom Zessly.
English: In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a reinduction regimen is not recommended (see section 4.8).
Slovenian: Ponovna uporaba zdravila za vse indikacije V primeru prekinitve vzdrževalnega zdravljenja in potrebe po ponovni uvedbi zdravljenja ni priporočljiva ponovna uporaba uvodne sheme (glejte poglavje 4.8).
English: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Slovenian: limfom, ne-Hodgkinov limfom, Hodgkinova bolezen, levkemija,
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Zessly.
Slovenian: • Povejte zdravniku, če imate ali ste kdaj prej že imeli kakršne koli nevrološke težave, preden se začnete zdraviti z zdravilom Zessly.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, study 2
Slovenian: Učinki na ACRn, strukturno poškodbo sklepov in funkcijo sklepov v 54. tednu, študija 2
English: Zessly works by selectively attaching to TNF alpha and blocking its action.
Slovenian: Zdravilo Zessly deluje tako, da se selektivno veže na TNF-alfa in zavira njegovo delovanje.
English: The usual dose is 3 mg for every kg of body weight.
Slovenian: Običajni odmerek je 3 mg na kg telesne mase.
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Slovenian: Pri otrocih so se pogosteje pojavili naslednji neželeni učinki: nizko število rdečih krvnih celic (anemija), kri v blatu, nizko celokupno število belih krvnih celic (levkopenija), rdečica ali zardevanje, virusne okužbe, nizka raven belih krvnih celic, ki se borijo proti okužbi (nevtropenija), zlom kosti, bakterijska okužba in alergijske reakcije v dihalih.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Slovenian: predvsem pa za tiste bolnike z dejavniki tveganja za kožnega raka.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Slovenian: Priporočljivo je, da bolniki pred uvajanjem zdravljenja z infliksimabom, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi veljavnimi smernicami za cepljenje.
English: Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Zessly therapy until a source for possible infection, specifically abscess, has been excluded (see section
Slovenian: Pri bolnikih s fistulirajočo Crohnovo boleznijo z akutnimi gnojnimi fistulami ne smete uvesti terapije z zdravilom Zessly, dokler ne izključite možnosti, da obstaja nekje vir okužbe, na primer absces
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies 12 and 13.
Slovenian: Učinkovitost infliksimaba so ocenjevali v dveh multicentričnih, randomiziranih, dvojno slepih študijah 12 in 13.
English: Zessly should be administered intravenously over a 2 hour period.
Slovenian: Zdravilo Zessly je treba dajati intravensko v času 2 ur.
English: The pooled data analysis from study 6 and study 7 and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
Slovenian: Analiza združenih podatkov iz študije 6 in študije 7 ter njunih podaljšanj, ki je zajela obdobje od začetka vsake študije do konca 54. tedna študije, je pokazala zmanjšanje pogostnosti hospitalizacij in kirurških posegov zaradi ulceroznega kolitisa med zdravljenjem z infliksimabom.
English: infliximab + MTX
Slovenian: placebo + MTX
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for study 1 (described below), landmark ACR-N for study 2 (described below)), 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 študijo 1 (opisano spodaj), mejna vrednost ACR-N za študijo 2 (opisano spodaj)),
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Slovenian: Med najresnejše, z uporabo zaviralcev TNF povezane neželene učinke zdravila, o katerih so poročali pri uporabi infliksimaba, sodijo reaktivacija HBV, kongestivno srčno popuščanje (CHF, congestive heart failure), resne okužbe (vključno s sepso, oportunističnimi okužbami in TB), serumska bolezen (zapoznele preobčutljivostne reakcije), hematološke reakcije, sistemski eritematozni lupus/lupusu podoben sindrom, demielinizirajoče bolezni, dogodki povezani z jetri ali žolčnikom, limfom, hepatosplenični limfom celic T (HSTCL), levkemija, karcinom Merklovih celic, melanom, pojav malignomov pri otrocih, sarkoidoza/sarkoidozi podobne reakcije, črevesni ali perianalni absces (pri Crohnovi bolezni) ter resne z infuzijo povezane reakcije (glejte poglavje 4.4).
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Zessly treatment should be carefully considered before initiation of Zessly therapy.
Slovenian: Pri bolnikih, ki so živeli ali potovali v kraje, kjer so endemične invazivne glivične okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, je treba skrbno pretehtati koristi in tveganja zdravljenja z zdravilom Zessly, preden bolniku uvedete to zdravilo.
English: infliximab 5 mg/kg
Slovenian: infliksimab 5 mg/kg
English: Infections and infestations Very common:
Slovenian: Infekcijske in parazitske bolezni zelo pogosti:
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure,
Slovenian: Zmanjšanje znakov in simptomov so opredelili kot najmanj 20 % izboljšanje (ACR 20) števila bolečih in oteklih sklepov ter 3 od naslednjih 5 meril: (1) zdravnikove splošne ocene, (2) bolnikove splošne ocene, (3) merila funkcionalne prizadetosti/neprizadetosti, (4) vizualne analogne lestvice bolečine in (5) hitrosti sedimentacije eritrocitov ali C-reaktivnega proteina.
English: • It is important that you tell your baby's doctors and other health care professionals about your Zessly use before your baby is given any vaccine.
Slovenian: • Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Zessly, še preden dojenček dobi katero koli cepivo.
English: Zessly may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Zessly ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Can be stored at temperatures up to 30°C for a single period up to 6 months, but not exceeding the original expiry date.
Slovenian: Lahko se shranjuje pri temperaturi do 30 °C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6, and 14 weeks) following disease flare.
Slovenian: Pri bolnikih z zmerno do hudo psoriazo je bila načrtovana klinična študija za oceno učinkovitosti in varnosti dolgotrajnega vzdrževalnega zdravljenja v primerjavi s ponovnim dajanjem uvodne sheme zdravljenja z infliksimabom (največ štiri infuzije v 0., 2., 6. in 14. tednu) po izbruhu bolezni.
English: b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
Slovenian: b Z upoštevanjem bolnikov s PASI > 2,5 na začetku študije 10 in tistih s psoriatično prizadetostjo kože > 3 % BSA na začetku študije 11
English: • Tell your doctor before you are given Zessly if you are a carrier of hepatitis B or have ever had it.
Slovenian: • Preden prejmete zdravilo Zessly, povejte zdravniku, če ste prenašalec hepatitisa B ali če ste ga imeli kdaj v preteklosti.
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Slovenian: • znaki težav z jetri (vključno z okužbo s hepatitisom B, če ste imeli hepatitis B v preteklosti), na primer porumenelost kože ali oči, temno rjavo obarvan urin bolečina ali oteklina na zgornji desni strani želodčnega predela, bolečine v sklepih, kožni izpuščaji ali zvišana telesna temperatura;
English: Number of patients evaluated for ALT.
Slovenian: 3 Število bolnikov, pri katerih so ovrednotili vrednost ALT.
English: Zessly must be given concomitantly with methotrexate.
Slovenian: Zdravilo Zessly morate uporabljati sočasno z metotreksatom.
English: Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Slovenian: 1 Bolniki iz placebo skupine so prejemali metotreksat, medtem ko so bolniki iz infliksimabove skupine prejemali tako infliksimab kot metotreksat.
English: A patient who requires surgery while on Zessly should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, pri katerem je med zdravljenjem z zdravilom Zessly potreben kirurški poseg, morate skrbno spremljati, da ugotovite morebitne okužbe, in uvesti ustrezne ukrepe.
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Slovenian: • znaki alergijske reakcije, na primer otekanje obraza, ustnic, ust ali žrela, ki lahko povzročijo težave pri požiranju ali dihanju, kožni izpuščaj, koprivnica, otekanje dlani, stopal ali gležnjev.
English: Study 13 evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Slovenian: V študiji 13 so ovrednotili učinkovitost uvodne in vzdrževalne terapije z infliksimabom pri 378 bolnikih, ki so imeli psoriazo s plaki.
English: Median follow-up is based on patients treated.
Slovenian: 4 Mediana dolžine spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
English: Do not use Zessly if any of the above applies to you.
Slovenian: Ne uporabljajte zdravila Zessly, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
English: In the paediatric Crohn's disease study 14, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Slovenian: V študiji 14 Crohnove bolezni pri pediatričnih bolnikih so 112 bolnikom (starim od 6 do 17 let, mediana starost 13,0 let) z zmerno do hudo aktivno Crohnovo boleznijo (mediana vrednost PCDAI = 40) in nezadostnim odzivom na običajne načine zdravljenja dajali 5 mg/kg infliksimaba v tednu 0 ter v 2. in 6. tednu.
English: • Merkel cell carcinoma (a type of skin cancer)
Slovenian: • odpoved jeter • karcinom Merklovih celic (vrsta kožnega raka)
English: In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Slovenian: V kliničnih študijah je bila sočasna uporaba antagonistov TNF in abatacepta povezana z večjim tveganjem za okužbe (vključno z resnimi okužbami) kot pa uporaba samih antagonistov TNF, čeprav ni prišlo do povečanja kliničnega učinka.
English: PATIENT REMINDER CARD
Slovenian: OPOZORILNA KARTICA ZA BOLNIKA
English: If you are not sure, talk to your doctor before you are given Zessly.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete prejemati zdravilo Zessly.
English: Placebo patients in the two Phase III studies in Crohn's disease, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Slovenian: 2 V dveh preskušanjih tretje faze pri Crohnovi bolezni so bolniki iz placebo skupine na začetku obeh študij prejeli začetni odmerek infliksimaba 5 mg/kg, v fazi vzdrževalnega zdravljenja pa so prejemali placebo.
English: Change from baseline (Mean ± SDc) Median (Interquartile range)
Slovenian: ± SDc) mediana (interkvartilni razmik)
English: • Signs of a nervous system problem (including eye problems) such as fits, tingling or numbness in any part of your body, weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Slovenian: • znaki težav z živčevjem (vključno s težavami z očmi), na primer epileptični napadi, mravljinci ali občutek odrevenelosti v katerem koli delu telesa, šibkost rok ali nog, spremembe vida, na primer dvojni vid ali druge težave z očmi;
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Slovenian: KG Birkendorfer Strasse 65