FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz GmbH.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Sandoz GmbH.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz GmbH on 19 June 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Sandoz GmbH, veljavno po vsej Evropski uniji, izdala 19. junija 2015.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz GmbH has been shown to have comparable quality and to be bioequivalent to Lyrica.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Sandoz GmbH primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
English: (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Slovenian: • epilepsijo, pri čemer se uporablja kot dodatek k obstoječemu zdravljenju pri bolnikih s parcialnimi napadi (epileptičnimi napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
English: Pregabalin Sandoz GmbH is a medicine used to treat adults with the following conditions:
Slovenian: Pregabalin Sandoz GmbH je zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The Committee recommended that Pregabalin Sandoz GmbH be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pregabalin Sandoz GmbH odobri za uporabo v EU.
English: The active substance in Pregabalin Sandoz GmbH, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Slovenian: Zdravilna učinkovina v zdravilu Pregabalin Sandoz GmbH, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Sandoz GmbH?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Sandoz GmbH?
English: For more information about treatment with Pregabalin Sandoz GmbH, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pregabalin Sandoz GmbH preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because Pregabalin Sandoz GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pregabalin Sandoz GmbH generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This means that Pregabalin Sandoz GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Lyrica.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Sandoz GmbH, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Stopping treatment with Pregabalin Sandoz GmbH should also be done gradually, over at least a week.
Slovenian: Največji dovoljeni odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Pregabalin Sandoz GmbH mora potekati postopno, in sicer mora trajati najmanj en teden.
English: For practical information about using Pregabalin Sandoz GmbH, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pregabalin Sandoz GmbH naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: A risk management plan has been developed to ensure that Pregabalin Sandoz GmbH is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Pregabalin Sandoz GmbH je bil pripravljen načrt obvladovanja tveganj.
English: Pregabalin Sandoz GmbH is a ‘generic medicine'.
Slovenian: Pregabalin Sandoz GmbH je „generično zdravilo“.
English: Because Pregabalin Sandoz GmbH is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Slovenian: Ker je zdravilo Pregabalin Sandoz GmbH generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Lyrica.
English: What are the benefits and risks of Pregabalin Sandoz GmbH?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Sandoz GmbH?
English: Other information about Pregabalin Sandoz GmbH
Slovenian: Druge informacije o zdravilu Pregabalin Sandoz GmbH
English: What is Pregabalin Sandoz GmbH and what is it used for?
Slovenian: Kaj je zdravilo Pregabalin Sandoz GmbH in za kaj se uporablja?
English: Why is Pregabalin Sandoz GmbH approved?
Slovenian: Zakaj je bilo zdravilo Pregabalin Sandoz GmbH odobreno?
English: Pregabalin Sandoz GmbH contains the active substance pregabalin.
Slovenian: Zdravilo Pregabalin Sandoz GmbH vsebuje zdravilno učinkovino pregabalin.
English: How has Pregabalin Sandoz GmbH been studied?
Slovenian: Kako je bilo zdravilo Pregabalin Sandoz GmbH raziskano?
English: How is Pregabalin Sandoz GmbH used?
Slovenian: Kako se zdravilo Pregabalin Sandoz GmbH uporablja?
English: How does Pregabalin Sandoz GmbH work?
Slovenian: Kako zdravilo Pregabalin Sandoz GmbH deluje?
English: • 18 months.
Slovenian: 18 mesecev.
English: Results on these end-points were supportive of the primary end-points results.
Slovenian: Rezultati teh končnih točk so podprli rezultate primarnih končnih točk.
English: The use of gloves is recommended.
Slovenian: Priporoča se uporaba zaščitnih rokavic.
English: 2003 RN Haarlem The Netherlands
Slovenian: 2003 RN Haarlem Nizozemska
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Slovenian: Zdravnik se bo z vami o njih pogovoril in vam pojasnil moţna tveganja in koristi vašega zdravljenja.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Iz mikrobiološkega vidika je treba zdravilo porabiti takoj.
English: 73% of the cutaneous reactions were reversible within 21 days.
Slovenian: 73 % koţnih reakcij je bilo reverzibilnih v 21 dneh.
English: The infusion will last approximately one hour during which you will be in the hospital.
Slovenian: Infundiranje bo trajalo pribliţno eno uro in med tem časom boste v bolnišnici.
English: Other appropriate symptomatic measures should be taken, as needed.
Slovenian: Po potrebi se uporabijo še drugi ustrezni simptomatski ukrepi.
English: Risk Management Plan (RMP) Not applicable.
Slovenian: Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
English: Such information will allow her/him to decide whether a dose reduction is needed.
Slovenian: Te informacije bodo zdravniku pomagale pri odločitvi, ali je treba odmerek zmanjšati.
English: During treatment, you may be given other medicines to maintain the number of your blood cells.
Slovenian: Med zdravljenjem boste morda dobivali zdravila za ohranjanje števila krvnih celic.
English: 747 70 Opava-Komárov Czech Republic
Slovenian: 747 70 Opava-Komárov Češka
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju.
English: In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika pridrţati v specializirani enoti in natančno spremljati njegove vitalne funkcije.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided fro under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predloţiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: 75 to 60 mg/m².
Slovenian: 75 na 60 mg/m 2.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne informacije!
English: If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Slovenian: Če bolnik tudi pri odmerku 60 mg/m še doţivlja te reakcije, je treba zdravljenje prekiniti.
English: Older people treated with TCF should be closely monitored.
Slovenian: Starejše osebe, ki dobivajo TCF, je treba natančno nadzirati.
English: This may be moderate to severe and has been associated with death (see section 4.8).
Slovenian: To je lahko zmerno do hudo in je bilo povezano s smrtjo (glejte poglavje 4.8).
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Slovenian: Med skupinami zdravljenja niso opazili statističnih razlik po oceni globalnega vprašalnika o kakovosti ţivljenja (»Global Quality of Life«).
English: Cardiac function should be further monitored during treatment (e.g. every three months) to help identify patients who may develop cardiac dysfunction.
Slovenian: Srčno funkcijo je med zdravljenjem treba nadalje nadzorovati (npr. vsake tri mesece), da bi prepoznali bolnice, pri katerih bi se lahko razvila srčna okvara.
English: Eruptions generally occurred within one week after the docetaxel infusion.
Slovenian: Izbruhi so se ponavadi pojavili v enem tednu po infuziji docetaksela.
English: Overall response rate (%):
Slovenian: celotni deleţ odziva (%):
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila, ima lahko tudi to zdravilo neţelene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se ne porabi takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, to pa ne bi smelo trajati dlje kot 24 ur pri 2 do 8°C, razen če se je redčenje opravilo v nadzorovanih in preverjeno aseptičnih pogojih.
English: Older people
Slovenian: Starejše osebe
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Slovenian: Farmakoterapevtska skupina: taksani; oznaka ATC: L01CD02.
English: Median time to progression (weeks)
Slovenian: srednji čas do napredovanja bolezni (tedni)
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva Pharma.
Slovenian: Zdravnik bo morda spremenil odmerek in pogostost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Docetaxel Teva Pharma.
English: Both regimens were administered every 3 weeks.
Slovenian: Oba reţima so aplicirali enkrat na 3 tedne.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Slovenian: Pri kombinaciji s trastuzumabom so predstavljeni neţeleni učinki (vseh stopenj), o katerih so poročali pri ≥ 10 %.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6.
Slovenian: Zdravilo se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite skladno z lokalnimi predpisi.
English: The incidence of serious adverse events was higher in older people compared to younger patients.
Slovenian: Incidenca resnih neţelenih učinkov je bila pri starejših osebah večja kot pri mlajših.
English: Obligation to conduct post-authorisation measures
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Slovenian: Zato je med sočasnim zdravljenjem s temi zdravili potrebna previdnost, saj obstaja moţnost pomembnega medsebojnega delovanja.
English: For more details see Summary of Product Characteristics of trastuzumab.
Slovenian: Za več podrobnosti glejte povzetek glavnih značilnosti trastuzumaba.
English: About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Slovenian: Pribliţno 80 % radioaktivnosti v blatu se izloči v prvih 48 urah v obliki enega pomembnega in treh manj pomembnih neaktivnih presnovkov; zelo malo zdravila se izloči nespremenjenega.
English: Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Slovenian: Glede na to, da je tedensko odmerjanje docetaksela pokazalo nekoliko boljši varnostni profil kot odmerjanje docetaksela vsake tri tedne, je moţno, da bi nekaterim bolnikom koristilo tedensko odmerjanje docetaksela.
English: Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia
Slovenian: Dodatna opozorila pri uporabi v adjuvantni terapiji raka dojke Zapletena nevtropenija
English: Pharmacokinetic parameters estimated by the model were very close to those estimated from Phase I studies.
Slovenian: Z modelom dobljeni farmakokinetični parametri so bili zelo blizu parametrom, ocenjenim v študijah I. faze.
English: CAUTION: Dilution of concentrate required using the entire contents of the solvent vial.
Slovenian: OPOZORILO: koncentrat je treba razredčiti s celotno vsebino viale z vehiklom.
English: The carcinogenic potential of docetaxel has not been studied.
Slovenian: Kancerogenega potenciala docetaksela niso raziskali.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostosti so opredeljene tako: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana ( ni mogoče oceniti iz razpoloţljivih podatkov).
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Slovenian: Med zdravljenjem morajo tako moški kot ţenske, moški pa še vsaj šest mesecev po njegovem koncu uporabljati kontracepcijsko zaščito (glejte poglavje 4.6).
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Slovenian: Profilaktični G-CSF (granulocitne kolonije stimulirajoči faktor) se lahko uporabi, da se ublaţi tveganje za hematološko toksičnost.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomoţno snov, navedeno v poglavju 6.1.
English: Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Slovenian: Najmanjše število nevtrofilcev se je pojavilo po mediani 7 dni, vendar je ta čas lahko krajši pri bolnikih, ki so se ţe intenzivno zdravili.
English: This medicine should not be used after the expiry date which is stated on the carton and vials.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli in vialah.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostosti so neţeleni učinki navedeni po padajoči resnosti.
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Slovenian: Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti ţivljenja z EuroQoL-5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Slovenian: Upoštevajte, da je to verjetno podcenjen deleţ, kajti znano je, da sam docetaksel v odmerku 100 mg/m povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najniţjega števila celic v krvi.
English: The safety and efficacy of Docetaxel Teva Pharma in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Docetaxel Teva Pharma za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloţeno navodilo.
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Slovenian: razlika zdravljenj: 7,1 % [95-% IZ: 0,7; 13,5] *: korigirano za več primerjav in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
English: If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.
Slovenian: Če imate glede uporabe tega zdravila še kakšna vprašanja, vprašajte zdravnika ali bolnišničnega farmacevta.
English: The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Slovenian: Pri ocenljivih bolnikih je bil celotni deleţ odziva 6,8 %, srednje trajanje odziva pa 26,1 tednov.
English: Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Slovenian: Simptomi, kot so abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z nevtropenijo ali brez nje, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
English: Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Slovenian: Docetaksel se ne sme uporabljati pri bolnikih s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
English: Before each treatment with Docetaxel Teva Pharma, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva Pharma.
Slovenian: Pred vsako uporabo zdravila Docetaxel Teva Pharma boste opravili preiskave krvi, da bo zdravnik preveril, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Docetaxel Teva Pharma.
English: If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Slovenian: Če se pojavijo akutne teţave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, teţko dihanje ali kašelj), takoj obvestite svojega zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Slovenian: Od 333 bolnikov z rakom prostate v študiji, ki so se zdravili z docetakselom vsake tri tedne, je bilo 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih več kot 75 let.
English: Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Slovenian: Bolezni imunskega sistema Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Slovenian: Docetaksel presnavlja CYP3A4, za prednizon pa je znano, da inducira CYP3A4.
English: Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Slovenian: Za te reakcije je bil značilen izpuščaj, vključno z lokaliziranimi izbruhi, predvsem na dlaneh in stopalih (vključno z resnim sindromom roka/noga), pa tudi na rokah, obrazu in prsnem košu; pogosto jih je spremljalo srbenje.
English: Discard unused contents appropriately
Slovenian: Neporabljeno vsebino ustrezno zavrzite.
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Slovenian: Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate so ocenili v randomizirani multicentrični študiji faze III.
English: 1-year Survival (%)
Slovenian: enoletno preţivetje (%)
English: Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Slovenian: Podatki o preţivetju, srednji čas do napredovanja bolezni in deleţ odziva v dveh krakih te raziskave so prikazani v naslednji razpredelnici:
English: Between infusions of Docetaxel Teva Pharma the following may occur, and the frequency may vary with the combinations of medicines that are received:
Slovenian: Med infuzijami zdravila Docetaxel Teva Pharma se lahko pojavi naslednje in pogostost se lahko razlikuje glede na kombinacijo uporabljenih zdravil.
English: For cisplatin dose adjustments, see the corresponding summary of product characeteristics.
Slovenian: Za prilagoditve odmerkov cisplatina glejte ustrezni povzetek glavnih značilnosti zdravila.
English: Docetaxel is administered as a one-hour infusion every three weeks.
Slovenian: Docetaksel se aplicira v enourni infuziji vsake tri tedne.
English: In cases of overdose, exacerbation of adverse events may be expected.
Slovenian: Pri prevelikih odmerkih je mogoče pričakovati eksacerbacijo neţelenih učinkov.