FrancophonIA/ELRC3.0 huggingface dataset:
English: PC: {number} SN: {number} NN: {number}
Slovenian: PC: {številka} SN: {številka} NN: {številka}
English: You may also need other treatments.
Slovenian: Morda boste potrebovali tudi druge vrste zdravljenj.
English: After Day 28, the next cycle will begin.
Slovenian: Po 28. dnevu se bo začel naslednji cikel.
English: Elderly patients (> 70 years of age)
Slovenian: Starejši bolniki (stari > 70 let)
English: Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Slovenian: Kapsule vzemite na prazen želodec, na primer vsaj eno uro pred načrtovanim zajtrkom.
English: Supportive measures should be provided as necessary.
Slovenian: Po potrebi uvedite podporne ukrepe.
English: In 43 patients stable disease was reported.
Slovenian: Pri 43 bolnikih so poročali o stabilnem stanju bolezni.
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: The reduction in blood cell counts is usually short-lived.
Slovenian: Zmanjšanje števila krvnih celic je običajno kratkotrajno.
English: Errors in how you take this medicine may have serious health consequences.
Slovenian: Napake pri načinu jemanja tega zdravila imajo lahko namreč resne posledice za vaše zdravje.
English: SL-1526 Ljubljana Slovenia
Slovenian: SL-1526 Ljubljana Slovenija
English: Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
Slovenian: Ko se radioterapija konča, boste zdravljenje prekinili za 4 tedne.
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Slovenian: V takem primeru vam bo zdravnik predpisal tudi zdravilo, ki bo pomagalo preprečiti to vrsto pljučnice (PCP).
English: 1 capsule
Slovenian: 1 kapsula
English: In the event of an overdose, haematological evaluation is needed.
Slovenian: V primeru prevelikega odmerjanja je potrebna hematološka ocena.
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Slovenian: Obvestite farmacevta, če opazite spremembo v izgledu kapsule.
English: During treatment patients should be monitored and managed appropriately.
Slovenian: Med zdravljenjem je treba bolnike spremljati in ustrezno obravnavati.
English: This leaflet was last revised in <{MM/YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano <{MM/LLLL}>.
English: Frequency groupings are defined according to the following convention:
Slovenian: Skupine pogostnosti so opredeljenje skladno s konvencijo:
English: • which days are your dosing days.
Slovenian: • kateri dnevi so vaši dnevi jemanja zdravila.
English: However, no unacceptable risks appear to be present in this patient group.
Slovenian: Vendar pa se v tej skupini niso pojavila nepričakovana tveganja.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Slovenian: V tem primeru ne smete voziti ali upravljati z orodji ali stroji ali se voziti s kolesom, dokler ne ugotovite, kako to zdravilo vpliva na vas (glejte poglavje 4).
English: These blood cells are important for fighting infection and for proper blood clotting.
Slovenian: Te celice so pomembne za boj proti okužbam in ustrezno strjevanje krvi.
English: • absent or heavy menstrual periods,
Slovenian: • odsotne ali močne menstruacije,
English: Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Slovenian: Doseganje objektivnega radiološkega odziva in ohranjanje stanja brez napredovanja bolezni je bilo močno povezano z ohranitvijo ali izboljšanjem kakovosti življenja.
English: For the eligible histology population, the efficacy results were similar.
Slovenian: Pri ustrezni histološki populaciji so bili izsledki učinkovitosti podobni.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Slovenian: Zdravnik bo pregledal vašo kri, da se prepriča, da imate dovolj teh celic, preden začnete zdravljenje.
English: The colour of the capsule cap is different for each strength (see in the table below).
Slovenian: Barva ovojnice kapsule je drugačna za vsako jakost (glejte spodnjo tabelo).
English: Opportunistic infections, including PCP
Slovenian: oportunistične okužbe, vključno s PCP
English: Do not give this medicine to children under the age of 3 years because it has not been studied.
Slovenian: Tega zdravila ne dajajte otrokom, mlajšim od 3 let, ker pri njih zdravila niso preučevali.
English: • ringing in the ears
Slovenian: • zvonjenje v ušesih,
English: Although the data is limited, tolerance in children is expected to be the same as in adults.
Slovenian: Čeprav je število podatkov omejeno, se pričakuje, da ga otroci prenašajo enako dobro kot odrasli.
English: Ask your doctor or pharmacist to write it down (including the colour).
Slovenian: Prosite zdravnika ali farmacevta, naj vam napiše potrebne podatke (vključno z barvo).
English: • change in taste.
Slovenian: • spremembe okusa.
English: The incidence of severe nausea and vomiting was 4 %.
Slovenian: Incidenca hude slabosti in bruhanja je bila 4 %.
English: • as you may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: • ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijo.
English: Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, razen če vam tako naroči zdravnik.
English: Each one lasts 28 days.
Slovenian: Vsako traja 28 dni.
English: Hypersensitivity to dacarbazine (DTIC).
Slovenian: Preobčutljivost na dakarbazin (DTIC).
English: In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Slovenian: V nekaterih primerih lahko traja dlje časa in lahko vodi do zelo hude oblike anemije (aplastične anemije).
English: Dosage and duration of treatment
Slovenian: Odmerjanje in trajanje zdravljenja
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Slovenian: Razpolovni čas (t1/2) v plazmi je približno 1,8 ure.
English: • increased sugar in the blood
Slovenian: • zvišan sladkor v krvi,
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: • anxiety/depression
Slovenian: • anksioznost/depresija,
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so izvedli le pri odraslih.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake „ EXP”.
English: The following side effects may occur, and may require medical attention.
Slovenian: Pojavijo se lahko naslednji neželeni učinki, zaradi katerih bo morda potrebna zdravniška pomoč.
English: Median overall survival was 14.6 months.
Slovenian: Mediana vrednost celotnega preživetja je bila 14,6 mesecev.
English: Side effects from clinical studies:
Slovenian: Neželeni učinki iz kliničnih študij:
English: The carton contains one bottle.
Slovenian: Ena škatla vsebuje eno steklenico.
English: • change in mental status or alertness
Slovenian: • spremembe duševnega stanja ali stopnje budnosti,
English: • if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na temozolomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Keep the bottles tightly closed in order to protect from moisture.
Slovenian: Shranjujte vsebnik tesno zaprt za zagotovitev zaščite pred vlago.
English: No evidence of cumulative myelosuppression was observed.
Slovenian: Opazili niso nobenih dokazov kumulativne mielosupresije.
English: The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
Slovenian: Kapsule mora bolnik pogoltniti cele s kozarcem vode in jih ne sme odpirati ali žvečiti.
English: This will give your body a chance to recover.
Slovenian: Tako si bo vaše telo lahkoopomoglo.
English: • allergic reactions.
Slovenian: • alergijske reakcije.
English: Excipient with known effect:
Slovenian: Pomožna snov z znanim učinkom:
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Slovenian: † vključno s primeri s smrtnim izidom * ocena pogostnosti temelji na ustreznih kliničnih preskušanjih
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 for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti 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: Hard capsule (capsule).
Slovenian: trda kapsula (kapsula)
English: • palpitations (when you can feel your heart beat)
Slovenian: • palpitacije (razbijanje srca, kadar lahko čutite svoj srčni utrip),
English: • dry or painful eyes
Slovenian: • suhe ali boleče oči,
English: TMZ monotherapy n=224
Slovenian: TMZ monoterapija n=224
English: Liver toxicity may occur several weeks or more after the last treatment with temozolomide.
Slovenian: Hepatotoksičnost se lahko pojavi nekaj ali več tednov po zadnjem zdravljenju s temozolomidom.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Slovenian: Mielosupresija je bila predvidljiva (ponavadi se je pojavila v prvih nekaj ciklih in je bila najizrazitejša med 21. in 28. dnem), okrevanje pa je bilo hitro, ponavadi v 1 do 2 tednih.
English: Capsules should not be opened.
Slovenian: Kapsul ne smete odpirati.
English: Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Slovenian: Glede na predpisani odmerek boste morda morali vzeti več kot eno kapsulo naenkrat, morda celo kapsule različnih jakosti (različnih vsebnosti zdravilne količine v miligramih).
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Slovenian: Pri bolnikih s pomembnimi nepravilnostmi jetrne funkcije, morajo zdravniki oceniti razmerje korist/tveganje nadaljnjega zdravljenja.
English: If a full day has gone by, check with your doctor.
Slovenian: Če je minil že ves dan, se posvetujte z zdravnikom.
English: Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment.
Slovenian: Moški bolniki morajo uporabljati učinkovite kontracepcijske metode in ne smejo spočeti otroka vsaj 6 mesecev po končanem zdravljenju.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Swallow the capsule(s) whole with a glass of water.
Slovenian: Kapsule pogoltnite cele s kozarcem vode.
English: If Temozolomid Sandoz comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride zdravilo Temozolomid Sandoz v stik s kožo ali sluznico, jo morate takoj in temeljito umiti z milom in vodo.
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Slovenian: Med simptomi diabetesa insipidusa sta izločanje večjih količin urina in občutek žeje.
English: Patients in the control arm received RT only.
Slovenian: Bolniki v kontrolnem delu študije so prejemali le RT.
English: • dose level -1 (100 mg/m2) still results in unacceptable toxicity
Slovenian: • raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Sandoz should be administered without food.
Slovenian: Ker ni mogoče izključiti možnosti, da bi bila sprememba Cmax lahko klinično pomembna, naj bolniki jemljejo zdravilo Temozolomid Sandoz brez hrane.
English: • sexual impotence
Slovenian: • spolna impotenca,
English: • radiation injury
Slovenian: • radiacijske poškodbe,
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Slovenian: Za podgane in pse je bolj toksičen kot za ljudi in njegov klinični odmerek je približno enak minimalnemu letalnemu odmerku za podgane in pse.
English: If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Slovenian: Če odmerka niste povečali v 2. ciklu, ga v naslednjih ciklih ne smete povečevati.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: In very rare cases, patients taking temozolomide and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Slovenian: V zelo redkih primerih pri bolnikih, ki jemljejo temozolomid in podobna zdravila, obstaja majhno tveganje za pojav sekundarnih vrst raka, vključno z levkemijo.
English: This daily dose depends on whether or not you have received chemotherapy before.
Slovenian: Ta dnevni odmerek je odvisen od tega, ali ste se v preteklosti zdravili s kemoterapijo.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
Slovenian: V kliničnih preskušanjih so bili najpogostnejši neželeni učinki, povezani z zdravljenjem, prebavne motnje, natančneje slabost (43 %) in bruhanje (36 %).
English: • hallucination and memory impairment
Slovenian: • halucinacije in motnje spomina,
English: A treatment cycle with Temozolomide Sandoz lasts 28 days.
Slovenian: Cikel zdravljenja z zdravilom Temozolomid Sandoz traja 28 dni.
English: Each hard capsule (capsule) is individually packed in a sachet.
Slovenian: Vsaka trda kapsula je posamezno pakirana v vrečico.
English: Plasma concentrations increase in a dose-related manner.
Slovenian: Koncentracije v plazmi se večajo sorazmerno z odmerkom.
English: • if you have liver or kidney problems.
Slovenian: • če imate težave z jetri ali ledvicami.
English: • red spots under the skin
Slovenian: • rdeče lise pod kožo,
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
Slovenian: Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben
English: In the tables undesirable effects are classified according to System Organ Class and frequency.
Slovenian: Neželeni učinki so v preglednicah razvrščeni glede na organski sistem in po pogostnosti.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome
Slovenian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom
English: Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Slovenian: Glede na rezultate vaše krvne slike bo zdravnik lahko prilagodil odmerek za naslednji cikel zdravljenja.
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Slovenian: Zdi se, da so podgane še posebej občutljive za onkogene učinke TMZ, saj se prvi tumorji pojavijo že v roku 3 mesecev od začetka dajanja zdravila.
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Slovenian: Ker pa so bili odmerki, ki naj bi povzročili degeneracijo mrežnice, v razponu letalnih odmerkov, in v kliničnih študijah niso opažali podobnih učinkov, so menili, da ta izsledek ni klinično pomemben.
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Slovenian: Izkušenj pri starejših otrocih in mladostnikih je malo (glejte poglavji 4.2 in 5.1).
English: Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration.
Slovenian: Pri večini toksičnih učinkov so bili vidni znaki reverzibilnosti, razen pri neželenih učinkih na moške reproduktivne organe in degeneracijo mrežnice.
English: Recurrent anaplastic astrocytoma
Slovenian: Ponavljajoči se anaplastični astrocitom
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Slovenian: Antiemetična profilaksa je priporočljiva pred začetnim odmerkom sočasne faze in je močno priporočljiva med fazo monoterapije.
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
Slovenian: TMZ ima blag vpliv na sposobnost vožnje in upravljanja s stroji zaradi utrujenosti in zaspanosti (glejte poglavje 4.8).
English: Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Austria
Slovenian: Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Avstrija
English: • double vision
Slovenian: • dvojni vid,
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Slovenian: Ni bilo študij za določitev učinka TMZ na presnovo ali izločanje drugih zdravil.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤ 1.
Slovenian: Če nastopi limfopenija, mora bolnik nadaljevati s profilakso, dokler se limfopenija ne povrne na stopnjo ≤ 1.
English: • if you have nausea (feeling sick in your stomach) and/or vomiting which are both very common side effects of Temozolomide Sandoz (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Slovenian: • če imate navzeo (občutek slabosti) in/ali bruhate, kar sta zelo pogosta neželena učinka zdravljenja z zdravilom Temozolomid Sandoz (glejte poglavje 4), vam bo zdravnik morda predpisal zdravilo (antiemetik), ki vam bo pomagalo preprečiti bruhanje.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Slovenian: Herpes simplex, herpes zoster, gripi podobni simptomi
English: This is because you must not be treated with Temozolomide Sandoz during pregnancy unless clearly indicated by your doctor.
Slovenian: To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temozolomid Sandoz, razen če vam je to izrecno predpisal zdravnik.
English: This latency period is very short even for an alkylating agent.
Slovenian: Ta doba latence je zelo kratka, tudi če upoštevamo, da gre za alkilirajočo snov.
English: • increased skin sensitivity to sunlight
Slovenian: • luščenje kože, • povečana občutljivost kože na sončno svetlobo,
English: (usual dose).You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Slovenian: Ta odmerek boste jemali 42 dni vsak dan (do 49 dni) v kombinaciji z radioterapijo.
English: Temozolomide Sandoz is used in these tumours if they return or get worse after standard treatment.
Slovenian: Zdravilo Temozolomid Sandoz se pri teh tumorjih uporablja, če se po standardnem zdravljenju ponovijo ali poslabšajo.
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Slovenian: Jemanje TMZ s hrano je povzročilo 33 % zmanjšanje Cmax in 9 % zmanjšanje površine pod krivuljo
English: • uncontrolled bleeding,
Slovenian: • nenadzorovana krvavitev.
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Slovenian: Ker pa se TMZ ne presnavlja v jetrih in se na beljakovine veže le v majhni meri, je malo verjetno, da bi vplival na farmakokinetiko drugih zdravil (glejte poglavje 5.2).
English: Each bottle contains either 5 or 20 capsules.
Slovenian: Vsaka steklenica vsebuje 5 ali 20 kapsul.
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Slovenian: Plazemski očistek, porazdelitveni volumen in razpolovna doba niso odvisni od odmerka.
English: Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Slovenian: Uporaba TMZ v kombinaciji z drugimi mielosupresivnimi učinkovinami lahko poveča verjetnost mielosupresije.
English: • if you develop fever or symptoms of an infection, contact your doctor immediately.
Slovenian: • če se vam zviša telesna temperatura ali opazite simptome okužbe, takoj obvestite zdravnika.
English: The lowest recommended dose is 100 mg/m2.
Slovenian: Najmanjši priporočeni odmerek je 100 mg/m2.
English: • change in skin colour
Slovenian: • spreminjanje barve kože,
English: • increased sweating
Slovenian: povečano znojenje
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Slovenian: Oba učinka sta bila ponavadi 1. ali 2. stopnje (od 0 do 5 epizod bruhanja v 24 urah) in sta prenehala sama ali pa ju je bilo mogoče hitro obvladati s standardnim antiemetičnim zdravljenjem.
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Sandoz until the vomiting is under control.
Slovenian: Če pred zdravljenjem ali med njim pogosto bruhate, se posvetujte z zdravnikom o tem, kateri je najprimernejši čas za jemanje zdravila Temozolomid Sandoz, dokler bruhanje ne bo pod nadzorom.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Slovenian: Sočasno jemanje z valprojsko kislino je bilo povezano z majhnim, a statistično značilnim zmanjšanjem očistka TMZ.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.