FrancophonIA/ELRC3.0 huggingface dataset:
English: Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes'.
Slovenian: Paklitaksel spada v skupino zdravil za zdravljenje raka, imenovanih „taksani“.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States', in this instance Germany, the Netherlands and the UK).
Slovenian: To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Portugalska) oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah, v
English: Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol and that their active substances behave in the same way in the body.
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov je agencija zaključila, da ti ne zadoščajo kot dokaz, da je zdravilo Paclitaxel Hetero bioekvivalentno zdravilu Taxol in da se njuni učinkovini v telesu obnašata enako.
English: Why was Paclitaxel Hetero reviewed?
Slovenian: Zakaj je bilo zdravilo Paclitaxel Hetero pregledano?
English: The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.
Slovenian: Učinkovina paklitaksel v zdravilih Paclitaxel Hetero in Taxol je vključena v majhne delce, imenovane micele, ki pripomorejo k boljšemu raztapljanju v raztopini.
English: Paclitaxel Hetero was developed as a generic medicine.
Slovenian: Zdravilo Paclitaxel Hetero je bilo razvito kot „generično zdravilo“.
English: This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in EU called Taxol.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Taxol.
English: Paclitaxel Hetero is a medicine that contains the active substance paclitaxel.
Slovenian: Paclitaxel Hetero je zdravilo, ki vsebuje učinkovino paklitaksel.
English: The Agency therefore concluded that the benefits of Paclitaxel Hetero do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Slovenian: Agencija je zaključila, da koristi zdravila Paclitaxel Hetero ne odtehtajo z njim povezanih tveganj, in priporočila, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne izda.
English: What is Paclitaxel Hetero?
Slovenian: Kaj je zdravilo Paclitaxel Hetero?
English: EMA/712446/2018 Rev.1
Slovenian: (paklitaksel, 6 mg/ml koncentrat za raztopino za infundiranje) EMA/712446/2018 Rev.1
English: This may take between 30 to 60 minutes.
Slovenian: To lahko traja od 30 do 60 minut.
English: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Slovenian: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italija <{tel.}> <{faks}>
English: • water for injections or,
Slovenian: • vode za injekcije ali
English: Blood pressure usually normalizes within a few hours after cessation of the infusion.
Slovenian: Krvni tlak se po navadi normalizira v nekaj urah po prenehanju infuzije.
English: • high blood pressure • low blood pressure
Slovenian: • visok krvni tlak • nizek krvni tlak
English: All steps of preparation must be carried out under Laminar Air Flow conditions.
Slovenian: Vse korake priprave je treba opraviti v sistemu z laminarnim pretokom zraka.
English: The safety profile between paediatric patients and adults is expected to be similar.
Slovenian: Pričakuje se, da sta varnostna profila pediatričnih bolnikov in odraslih enaka.
English: <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Slovenian: <Datum prve odobritve: <{DD. mesec LLLL}> <Datum zadnjega podaljšanja: <{DD. mesec LLLL}>
English: Exact measuring must be ensured for withdrawal.
Slovenian: Za odvzem je treba zagotoviti natančno merjenje.
English: However, if this does occur your doctor will treat any symptoms that follow.
Slovenian: Če bi kljub temu prišlo do tega, bo zdravnik zdravil morebitne simptome, ki bi sledili.
English: Bleeding has been reported.
Slovenian: Poročali so o krvavitvah.
English: The doctor may sometimes prescribe a different dose particularly if you are receiving, or have received, other treatments for your cancer or if you have kidney problems.
Slovenian: Zdravnik lahko včasih predpiše drugačen odmerek, še zlasti, če prejemate ali ste prejemali druga zdravila za zdravljenje raka ali če imate težave z ledvicami.
English: The mean volumes of distribution at steady state range from 18 to 29 liters .
Slovenian: Srednji volumen porazdelitve v stanju dinamičnega ravnovesja je od 18 do 29 litrov.
English: The stock solution should be used as soon as possible (see section 6.3).
Slovenian: Osnovno raztopino je treba uporabiti takoj, ko je mogoče (glejte poglavje 6.3).
English: The safety and efficacy of ETOPOPHOS and associated names below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila ETOPOPHOS in povezana imena pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: It will be given as a slow infusion into a vein.
Slovenian: Prejeli ga boste v obliki počasne infuzije v veno.
English: If spikes are used they should be equipped with particle filters or other measures should be taken (e.g. inline-filters) to ensure that only particle free solutions are administered.
Slovenian: Ob uporabi prebodnih igel morajo biti te opremljene s filtri za delce ali pa je treba uporabiti druge ukrepe (npr. linijske filtre) za zagotovitev, da dajemo samo raztopine brez delcev.
English: • changes in skin colour (pigmentation)
Slovenian: • spremembe barve kože (pigmentacija) • zaprtje
English: Care should be taken to avoid extravasation.
Slovenian: Paziti je treba, da ne pride do ekstravazacije.
English: The stock solution should be used as soon as possible.
Slovenian: Osnovno raztopino je treba uporabiti takoj, ko je mogoče.
English: Tell your doctor or nurse immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Slovenian: Takoj obvestite zdravnika ali medicinsko sestro, če se pri vas pojavijo naslednji simptomi: otekanje jezika ali grla, težave z dihanjem, hiter srčni utrip, vročinski oblivi ali izpuščaj.
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients treated with etoposide phosphate.
Slovenian: O reverzibilni alopeciji, ki je včasih napredovala do popolne plešavosti, so poročali pri do 44 % bolnikov, ki so se zdravili z etopozid fosfatom.
English: The stock solution should be withdrawn under aseptic conditions according to the physician's prescription and transferred to the infusion bottles and/or syringes for the individual patients.
Slovenian: Osnovno raztopino je treba odvzeti v aseptičnih pogojih po navodilih zdravnika in jo prenesti v infuzijske stekleničke in/ali brizge za posamezne bolnike.
English: Hypotension usually responds to cessation of infusion of etoposide phosphate and/or other supportive therapy as appropriate.
Slovenian: Hipotenzija se po navadi odzove na prenehanje infundiranja etopozid fosfata in/ali drugo podporno zdravljenje, kot je ustrezno.
English: These adverse reactions are presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Facial flushing was reported in 2% of patients and skin rashes in 3%.
Slovenian: O vročinskih oblivih so poročali pri 2 % bolnikov, o kožnih izpuščajih pa pri 3 % bolnikov.
English: • damage to the liver (hepatotoxicity)
Slovenian: • poškodbe jeter (hepatotoksičnost)
English: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Slovenian: Če opazite kakršno koli obarvanost ali delce, je treba rekonstituirano raztopino zavreči.
English: The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNAtopoisomerase II or by the formation of free radicals.
Slovenian: Ključno delovanje etopozida na makromolekule je povzročanje zlomov DNA vijačnice z interakcijo z DNA topoizomerazo II ali s formiranjem prostih radikalov.
English: In clinical studies in which ETOPOPHOS and associated names was administered as a single agent at a total dose of ≥450 mg/m2 the most frequent adverse reactions of any severity were leucopenia (91%), neutropenia (88%), anaemia (72%) thrombocytopenia (23%), asthenia (39%), nausea and/or vomiting (37%), alopecia (33%) and chills and/or fever (24%).
Slovenian: V kliničnih študijah, kjer so dajali zdravilo ETOPOPHOS in povezana imena v monoterapiji v skupnem odmerku ≥ 450 mg/m2, so bili najpogostejši neželeni učinki katere koli resnosti levkopenija (91 %), nevtropenija (88 %), anemija (72 %) trombocitopenija (23 %), astenija (39 %), navzea in/ali bruhanje (37 %), alopecija (33 %) in mrzlica in/ali vročina (24
English: Solutions should be prepared under aseptic conditions.
Slovenian: Raztopine je treba pripraviti v aseptičnih pogojih.
English: Apnoea with spontaneous resumption of breathing following cessation of infusion have also been reported.
Slovenian: Poročali so tudi o apneji s spontano ponovno vzpostavitvijo dihanja po prekinitvi infundiranja.
English: • tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Slovenian: • sindrom tumorske lize (zapleti ob sproščanju snovi iz zdravljenih rakavih celic v krvni obtok)
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake Uporabno do/EXP.
English: Before use the content of each vial must be reconstituted with 5 ml or 10 ml of:
Slovenian: Pred uporabo je treba vsebino vsake viale rekonstituirati s 5 ml ali z 10 ml:
English: Effect of etoposide phosphate on the pharmacokinetics of other drugs
Slovenian: Učinek etopozid fosfata na farmakokinetiko drugih zdravil
English: ETOPOPHOS and associated names SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Slovenian: Zdravila ETOPOPHOS in povezana imena SE NE SME DAJATI V HITRI INTRAVENSKI INJEKCIJI.
English: Given its mechanism of action, etoposide phosphate should be considered a possible carcinogen in humans.
Slovenian: Glede na mehanizem delovanja lahko sklepamo, da je etopozid fosfat potencialno karcinogen za človeka.
English: Both male and female patients who are considering having a child after having treatment with ETOPOPHOS and associated names should discuss this with their doctor or nurse.
Slovenian: Bolniki in bolnice, ki razmišljajo o spočetju otroka po zdravljenju z zdravilom ETOPOPHOS in povezana imena, naj se o tem posvetujejo z zdravnikom ali medicinsko sestro.
English: Infections and infestations common infection
Slovenian: Infekcijske in parazitske bolezni pogosti okužba
English: If clinically significant hypertension occurs in patients receiving etoposide phosphate, appropriate supportive therapy should be initiated.
Slovenian: Če se pri bolnikih, ki prejemajo etopozid fosfat, pojavi klinično pomembna hipertenzija, je potrebno uvesti ustrezno podporno zdravljenje.
English: The role that concentration or rate of infusion plays in the development of anaphylactic reactions is uncertain.
Slovenian: Vloga koncentracije ali hitrosti infundiranja pri nastanku reakcij anafilaktičnega tipa ni povsem jasna.
English: • reactions at the site of infusion
Slovenian: • reakcije na mestu infundiranja
English: Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
Slovenian: Zaradi možnosti za ekstravazacijo je treba mesto infundiranja med dajanjem zdravila natančno kontrolirati glede infiltracije.
English: ETOPOPHOS and associated names should not be physically mixed with any other drug.
Slovenian: Zdravila ETOPOPHOS in povezana imena se ne sme fizično mešati z drugimi zdravili.
English: The exact reason why you have been prescribed ETOPOPHOS and associated names is best discussed with your doctor.
Slovenian: O natančnem razlogu, zakaj so vam predpisali zdravilo ETOPOPHOS in povezana imena, se pogovorite s svojim zdravnikom.
English: Bacterial infections should be brought under control before treatment with ETOPOPHOS and associated names.
Slovenian: Bakterijske okužbe morajo biti pod nadzorom pred pričetkom zdravljenja z zdravilom ETOPOPHOS in povezana imena.
English: ETOPOPHOS and associated names 1000 mg is intended to be handled by pharmaceutical staff in central hospital units for the preparation of cytostatics.
Slovenian: Zdravilo ETOPOPHOS in povezana imena 1000 mg je namenjeno za rokovanje s strani farmacevtskega osebja v osrednjih bolnišničnih enotah za pripravo citostatikov.
English: Both male patients and female patients of child-bearing age should use an effective contraceptive method (e.g., the barrier method or condoms) during treatment and for at least 6 months after the end of treatment with ETOPOPHOS and associated names.
Slovenian: Tako moški kot ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo (npr. pregradno metodo ali kondome) med zdravljenjem in še vsaj 6 mesecev po zaključku zdravljenja z zdravilom ETOPOPHOS in povezana imena.
English: Total doses of 2.4 g/m to 3.5 g/m administered intravenously over three days have resulted in severe mucositis and myelotoxicity.
Slovenian: Celokupni odmerki od 2,4 g/m2 do 3,5 g/m2 dani intravensko v treh dneh so povzročili hud mukozitis in mielotoksičnost.
English: ETOPOPHOS and associated names solutions must be prepared under aseptic conditions.
Slovenian: Zdravilo ETOPOPHOS in povezana imena je treba pripraviti v aseptičnih pogojih.
English: As etoposide phosphate is converted in vivo to etoposide by phosphorylation, caution should be exercised when administering etoposide phosphate with drugs that are known to inhibit phosphatase activity as such combination may reduce efficacy of etoposide phosphate.
Slovenian: Ker se etopozid fosfat in vivo pretvori v etopozid s fosforilacijo, je potrebna previdnost pri dajanju etopozid fosfata skupaj z zdravili, za katera je znano, da zavirajo delovanje fosfataze, saj tovrstna kombinacija lahko zmanjša učinkovitost etopozid fosfata.
English: • a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
Slovenian: • sončnim opeklinam podoben izpuščaj, ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena radioterapiji in je lahko hud
English: In clinical studies involving etoposide phosphate, episodes of hypertension have been reported.
Slovenian: V kliničnih študijah, ki so vključevale etopozid fosfat, so poročali o epizodah hipertenzije.
English: ETOPOPHOS and associated names should be given only by slow intravenous infusion (usually over a 30 to 60 minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Slovenian: Zdravilo ETOPOPHOS in povezana imena se sme dajati le v počasni intravenski infuziji (običajno v obdobju od 30 do 60 minut), saj so poročali o hipotenziji kot možnem neželenem učinku hitrega intravenskega injiciranja.
English: The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Slovenian: Glavni učinek je njegovo delovanje na pozno S in zgodnjo G2 fazo delitve celice pri celicah sesalcev.
English: ETOPOPHOS and associated names must not be used during pregnancy unless clearly indicated by your doctor.
Slovenian: Zdravila ETOPOPHOS in povezana imena se med nosečnostjo ne sme uporabljati, razen če vam tako izrecno naroči vaš zdravnik.
English: In the paragraphs below the incidences of adverse events, given as the mean percent, are derived from studies that utilized single agent ETOPOPHOS and associated names therapy.
Slovenian: V spodnjih odstavkih navedene incidence neželenih učinkov, prikazane kot povprečni odstotek, izvirajo iz študij, v katerih so zdravilo ETOPOPHOS in povezana imena uporabljali kot monoterapijo.
English: What ETOPOPHOS and associated names is and what it is used for What you need to know before you are given ETOPOPHOS and associated names How you will be given ETOPOPHOS and associated names Possible side effects
Slovenian: Kaj je zdravilo ETOPOPHOS in povezana imena in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo ETOPOPHOS in povezana imena Kako boste prejeli zdravilo ETOPOPHOS in povezana imena Možni neželeni učinki
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}> Izpolni država članica.
English: There are no or limited amount of data from the use of etoposide phosphate in pregnant women.
Slovenian: Podatkov o uporabi etopozid fosfata pri nosečnicah ni oziroma so omejeni.
English: ETOPOPHOS and associated names should not be used during pregnancy unless the clinical condition of the woman requires treatment with etoposide.
Slovenian: Zdravila ETOPOPHOS in povezana imena se med nosečnostjo ne sme uporabljati, razen kadar klinično stanje nosečnice zahteva zdravljenje z etopozidom.
English: Etoposide phosphate is administered by slow intravenous infusion (usually over a 30 to 60 minute period) (see section 4.4).
Slovenian: Etopozid fosfat se daje v počasni intravenski infuziji (običajno v obdobju 30 do 60 minut) (glejte poglavje 4.4).
English: The content of each injection vial of ETOPOPHOS and associated names 1000 mg has to be diluted in 100 ml of:
Slovenian: Vsebino vsake injekcijske viale zdravila ETOPOPHOS in povezana imena 1000 mg je treba razredčiti v 100 ml:
English: A decision must be made whether to discontinue breast-feeding or to discontinue ETOPOPHOS and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Slovenian: Odločiti se je treba med prenehanjem dojenja in prekinitvijo zdravljenja z zdravilom ETOPOPHOS in povezana imena, pri čemer je treba upoštevati korist dojenja za otroka in pomembnost zdravljenja za mater (glejte poglavje
English: Hodgkin's lymphoma; non-Hodgkin's lymphoma; acute myeloid leukaemia
Slovenian: Hodgkinov limfom; ne-Hodgkinov limfom; akutna mieloblastna levkemija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT [Izpolni država članica.]
English: It is supplied in a glass vial with a butyl rubber stopper and flip-off aluminium seal.
Slovenian: Pakiran je steklenih vialah, zaprtih z zamaškom iz butilne gume in zapečatenih s snemno aluminijsko prekrivno zaporko.
English: Co-administration of antiepileptic drugs and ETOPOPHOS and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Slovenian: Sočasno dajanje antiepileptikov in zdravila ETOPOPHOS in povezana imena lahko vodi v zmanjšan nadzor nad konvulzijami zaradi farmakokinetičnih medsebojnih delovanj med zdravili.
English: As ETOPOPHOS and associated names is given to you by a doctor or nurse, overdose is unlikely.
Slovenian: Ker vam bo zdravilo ETOPOPHOS in povezana imena dal zdravnik ali medicinska sestra, je malo verjetno, da bi dobili nepravilen odmerek.
English: • sore lips, mouth or throat ulcers
Slovenian: • boleče ustnice, razjede v ustih ali grlu
English: The treatment regimen should be chosen according to the local standard of care.
Slovenian: Za ustrezen režim zdravljenja je treba upoštevati trenutne lokalne smernice zdravljenja.
English: ****Postmarketing complications reported for extravasation included local soft tissue toxicity, swelling, pain, cellulitis, and necrosis including skin necrosis.
Slovenian: ****Med zapleti, opisani v zvezi z ekstravazacijo med obdobjem trženja zdravila, so lokalni toksični učinki na mehko tkivo, otekanje, bolečine, celulitis in nekroza, vključno z nekrozo kože.
English: High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase in etoposide exposure (AUC) with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Slovenian: Sočasno dajanje visokih odmerkov ciklosporina, ki povzroči plazemsko koncentracijo nad 2.000 ng/ml, in peroralnega etopozida poveča izpostavljenost etopozidu za 80 % (AUC) in zmanjša celotni telesni očistek etopozida za 38 % v primerjavi z dajanjem samega etopozida.
English: Etoposide phosphate may cause adverse reactions that affect the ability to drive or use machines such as fatigue, somnolence, nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension.
Slovenian: Etopozid fosfat lahko povzroči neželene učinke, ki vplivajo na sposobnost vožnje in upravljanja s stroji, npr. utrujenost, somnolenca, navzea, bruhanje, kortikalna slepota, preobčutljivostne reakcije s hipotenzijo.
English: ETOPOPHOS and associated names will be given to you by a doctor or nurse.
Slovenian: Zdravilo ETOPOPHOS in povezana imena vam bo dal zdravnik ali medicinska sestra.
English: Male patients treated with ETOPOPHOS and associated names are advised not to father a child during treatment and for up to 6 months after treatment.
Slovenian: Bolnikom, zdravljenim z zdravilom ETOPOPHOS in povezana imena, je treba svetovati, naj med zdravljenjem in še 6 mesecev po zaključku zdravljenja ne spočnejo otroka.
English: The mechanism of action of etoposide phosphate is considered to be the same as that of etoposide.
Slovenian: Mehanizem delovanja etopozid fosfata se šteje za enakega mehanizmu delovanja etopozida.
English: For children being treated for cancer of the blood or lymphatic system the dose used is 75 to 150 mg/m2 body surface area daily for 2 to 5 days.
Slovenian: Za otroke, zdravljene zaradi krvnega raka ali raka limfnega sistema, je uporabljeni odmerek 75 do 150 mg/m2 telesne površine na dan 2 do 5 dni.
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients (see section 4.4).
Slovenian: Pri bolnikih z očistkom kreatinina, manjšim od 15 ml/min, ki prejemajo dializo, bo morda potrebno nadaljnje zmanjšanje odmerka, saj je pri teh bolnikih očistek etopozida dodatno zmanjšan (glejte poglavje 4.4).
English: Effects of other drugs on the pharmacokinetics of etoposide phosphate
Slovenian: Učinki drugih zdravil na farmakokinetiko etopozid fosfata
English: Cloudy or discolored solutions must be discarded.
Slovenian: Motne ali razbarvane raztopine je treba zavreči.
English: Respiratory, thoracic and mediastinal disorders rare interstitial pneumonitis, pulmonary fibrosis not known bronchospasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora redki intersticijski pnevmonitis, pljučna fibroza neznana bronhospazem
English: Nervous system disorders common dizziness uncommon neuropathy peripheral rare cortical blindness transient, neurotoxicities (e.g., somnolence and fatigue), optic neuritis, seizure***
Slovenian: Bolezni živčevja pogosti omotica občasni periferna nevropatija redki prehodna kortikalna slepota, nevrotoksičnost (npr. somnolenca in utrujenost), optični nevritis, konvulzije***
English: • skin problems such as itching or rash
Slovenian: • težave s kožo, kot so npr. srbenje ali izpuščaj