FrancophonIA/ELRC3.0 huggingface dataset:
English: Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.
Slovenian: Skupno pakiranje: 150 kapsul (25 pakiranj po 6 x 1) in 25 inhalatorjev.
English: Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ultibro Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment.
Slovenian: Glede na podatke o kliničnih farmakokinetičnih lastnostih posameznih učinkovin v monoterapiji je zdravilo Ultibro Breezhaler pri bolnikih z blago in zmerno okvaro jeter mogoče uporabljati v priporočenem odmerku.
English: • sore throat.
Slovenian: • vnetje žrela in grla
English: Inhale medicine deeply Hold the inhaler as shown in the picture.
Slovenian: Držite inhalator kot kaže slika.
English: After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting for about one third of total drug-related AUC over 24 hours.
Slovenian: V študiji absorpcije, porazdelitve, presnove in izločanja pri ljudeh je bila po peroralnem odmerjanju radioaktivno označenega indakaterola glavna učinkovina v serumu nespremenjeni indakaterol.
English: 10 x 1 capsules + 1 inhaler.
Slovenian: 10 x 1 kapsula + 1 inhalator.
English: How to use Ultibro Breezhaler
Slovenian: Kako uporabljati zdravilo Ultibro Breezhaler
English: In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Ultibro Breezhaler (contain similar active substances).
Slovenian: - če imate sladkorno bolezen, - če za svojo pljučno bolezen uporabljate katero od zdravil, ki vsebuje zdravilno učinkovino, ki je podobna (je iz iste skupine zdravil) kot učinkovini v zdravilu Ultibro Breezhaler (glejte poglavje
English: Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Slovenian: Skupno pakiranje: 150 kapsul (15 pakiranj po 10 x 1) in 15 inhalatorjev.
English: Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Slovenian: Skupno pakiranje vsebuje 150 trdih kapsul (25 pakiranj po 6x1) in 25 inhalatorjev.
English: You should hear a noise as the capsule is pierced.
Slovenian: Ko se kapsula predre, morate slišati zvok.
English: The components of Ultibro Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Slovenian: V okviru kliničnega odmerjanja učinkovini zdravila Ultibro Breezhaler ne sodita med učinkovini z znanim potencialom za podaljšanje intervala QT.
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ultibro Breezhaler and indacaterol monotherapy product.
Slovenian: Po podatkih dogajanj in vitro je mogoče pričakovati, da po uporabi zdravila Ultibro Breezhaler v pljuča prispe podoben odmerek indakaterola, kot pri uporabi zdravila, ki vsebuje samo indakaterol.
English: • Do not press the side buttons while inhaling through the mouthpiece.
Slovenian: • Ko vdihujete skozi ustnik, ne pritiskajte stranskih gumbov.
English: Rhinitis
Slovenian: Glikopironij
English: Anticholinergic effects related to glycopyrronium
Slovenian: Antiholinergično delovanje v povezavi z glikopironijem Glavkom zaprtega zakotja
English: • One Ultibro Breezhaler inhaler
Slovenian: • en inhalator Ultibro Breezhaler,
English: Each inhaler should be disposed of after all capsules have been used.
Slovenian: Odstranjevanje inhalatorja po uporabi Vsak inhalator je potrebno zavreči, ko porabite vse kapsule iz pakiranja.
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost pogosti angioedem občasni
English: Therefore Ultibro Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Slovenian: Antagonisti beta adrenergičnih receptorjev lahko oslabijo ali zavrejo učinke agonistov beta-2 adrenergičnih receptorjev, zato se zdravila Ultibro Breezhaler ne sme uporabljati skupaj z antagonisti beta adrenergičnih receptorjev (kar pomeni tudi s kapljicami za oči), razen če za sočasno uporabo obstajajo nujni razlogi.
English: Trough and peak FEV1:
Slovenian: Najnižje in najvišje vrednosti FEV1:
English: Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Slovenian: Skupno pakiranje vsebuje 150 trdih kapsul (15 pakiranj po 10x1) in 15 inhalatorjev.
English: Remove capsule Separate one of the blisters from the blister card.
Slovenian: Vzemite kapsulo Po perforaciji odtrgajte eno enoto s pretisnega omota.
English: CYP3A4 is concluded to be the predominant isoenzyme responsible for hydroxylation of indacaterol.
Slovenian: Ugotovili so, da je glavni encim za hidroksilacijo indakaterola izoencim CYP3A4.
English: PA/Alu/PVC - Alu perforated unit-dose blister.
Slovenian: Perforirani pretisni omoti z razdelki za enkratni odmerek iz PA/Alu/PVC - Alu.
English: Screen
Slovenian: Serija
English: Adverse reactions
Slovenian: Splošne težave
English: Glycopyrronium was not teratogenic in rats or rabbits following inhalation administration.
Slovenian: Pri podganah in kuncih glikopironij po inhalaciji ni deloval teratogeno.
English: The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (equivalent to 54 micrograms of glycopyrronium bromide).
Slovenian: Prejeti odmerek (ki pride skozi ustnik inhalatorja) ustreza 85 mikrogramom indakaterola (kar ustreza 110 mikrogramom indakaterolijevega maleata) in 43 mikrogramom glikopironija (kar ustreza 54 mikrogramom glikopironijevega bromida).
English: The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Slovenian: Inhalator vsakega pakiranja je treba zavreči, ko porabite vse kapsule tega pakiranja.
English: • cough.
Slovenian: • kašelj
English: Ultibro Breezhaler - glycopyrronium
Slovenian: Ultibro Breezhaler - glikopironij
English: 30 capsules + 1 inhaler
Slovenian: 30 kapsul + 1 inhalator
English: 6 capsules + 1 inhaler
Slovenian: 6 kapsul + 1 inhalator
English: • Do not swallow the capsule.
Slovenian: • Kapsule ne smete pogoltniti.
English: Inhalation use
Slovenian: za inhaliranje
English: 12 capsules + 1 inhaler
Slovenian: 12 kapsul + 1 inhalator
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
Slovenian: En odmerek, ki pride skozi ustnik inhalatorja, vsebuje 110 mikrogramov indakaterolijevega maleata, kar ustreza 85 mikrogramom indakaterola, in 54 mikrogramov glikopironijevega bromida, kar ustreza 43 mikrogramom glikopironija.
English: The amount of indacaterol and glycopyrronium inhaled is 85 micrograms (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms (equivalent to 54 micrograms of glycopyrronium bromide), respectively.
Slovenian: Količina inhaliranega indakaterola je 85 mikrogramov (kar ustreza 110 mikrogramom indakaterolijevega maleata), inhaliranega glikopironija pa 43 mikrogramov (kar ustreza 54 mikrogramom glikopironijevega bromida).
English: 10 capsules + 1 inhaler
Slovenian: 10 kapsul + 1 inhalator
English: • nose bleeds.
Slovenian: • krvavitve iz nosu
English: Renal and urinary disorders Bladder obstruction and urinary retention
Slovenian: Bolezni sečil zapora sečnega mehurja in zastoj urina pogosti
English: Ultibro Breezhaler:
Slovenian: Zdravilo Ultibro Breezhaler:
English: - Dispose of the inhaler in each pack after all capsules in that pack have been used.
Slovenian: - Inhalator vsakega pakiranja zavrzite, ko porabite vse kapsule tega pakiranja.
English: Posology
Slovenian: ustnik
English: Other medicines and Ultibro Breezhaler
Slovenian: Shranjevanje zdravila Ultibro Breezhaler
English: Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites.
Slovenian: Najbolj izrazit presnovek v serumu je bil hidroksiliran derivat, sledila pa sta mu fenolni O-glukuronid indakaterol in hidroksiliran indakaterol.
English: See package leaflet for further information.
Slovenian: Za več podatkov glejte navodilo za uporabo.
English: • tiredness.
Slovenian: • omotičnost
English: Do not swallow capsules.
Slovenian: Kapsule ne smete pogoltniti.
English: Hepatic impairment
Slovenian: Akutna poslabšanja KOPB
English: EXP The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Slovenian: Uporabno do Inhalator vsakega pakiranja je treba zavreči, ko porabite vse kapsule tega pakiranja.
English: Exercise tolerance
Slovenian: Prenašanje napora
English: • runny or stuffy nose.
Slovenian: • izcedek iz nosu ali zamašen nos
English: What Ultibro Breezhaler is
Slovenian: Kaj je zdravilo Ultibro Breezhaler
English: Do not swallow the capsule.
Slovenian: Odstranite prazno kapsulo
English: Dysphonia
Slovenian: Zadihanost:
English: Indacaterol administered to dogs alone or in Ultibro Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Slovenian: Pogostnost in izraženost poškodb miokarda pri psih sta bili pri odmerjanju indakaterola posamezno podobni kot pri njegovem odmerjanju v zdravilu Ultibro Breezhaler.
English: Ultibro Breezhaler showed similar adverse reactions to the individual components.
Slovenian: Neželeni učinki pri uporabi zdravila Ultibro Breezhaler so bili podobni kot pri uporabi posameznih učinkovin zdravila.
English: tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine - these may be signs of a condition called paradoxical bronchospasm.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti orofaringealna bolečina, vključno z draženjem žrela pogosti paradoksni bronhospazem občasni hripavost občasni krvavitev iz nosu občasni
English: Inhale deeply Check capsule is empty
Slovenian: vstavite predrite in izpustite globoko vdihnite preverite, da je kapsula prazna
English: It could take approximately 45 seconds.
Slovenian: To lahko traja približno 45 sekund.
English: This can lead to death.
Slovenian: To lahko povzroči smrt.
English: These effects were partially reversible after 8 weeks.
Slovenian: Ti učinki so bili po 8 tednih delno reverzibilni.
English: • you have ever had any allergies.
Slovenian: • če ste kdaj imeli kakšne alergije.
English: Your doctor may need to treat you.
Slovenian: Zdravnik vas bo morda moral zdraviti.
English: • You will usually have an infusion once every 3 weeks.
Slovenian: • Po navadi boste dobili eno infuzijo enkrat na 3 tedne.
English: It is normal for foam to persist after this time period.
Slovenian: Normalno je, da pena ostane tudi še po tem času.
English: Other appropriate symptomatic measures should be taken.
Slovenian: Uporabiti je treba druge ustrezne simptomatske ukrepe.
English: If this happens, do not drive or use any tools or machines until you feel better.
Slovenian: Če se vam to zgodi, ne upravljajte vozil, strojev ali orodij, dokler se ne počutite bolje.
English: However, limited efficacy data are available at this dose.
Slovenian: Vendar je za ta odmerek na voljo le malo podatkov o učinkovitosti.
English: 6/ 18 weeks
Slovenian: 6/ 18 tednov
English: How much and how often to have
Slovenian: Koliko zdravila boste dobili in kako pogosto
English: Median number of cycles/ median duration of treatment
Slovenian: Mediano število ciklusov/mediano trajanje zdravljenja
English: • The usual dose depends on your body surface area.
Slovenian: • Običajen odmerek je odvisen od telesne površine.
English: A risk to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenčka ni mogoče izključiti.
English: This information supplements sections 3 and 5 for the user.
Slovenian: Te informacije dopolnjujejo poglavji 3 in 5 navodila za uporabo.
English: 7/ 21 weeks
Slovenian: 7/ 21 tednov
English: See a doctor immediately if you notice any of the following side effects:
Slovenian: Nemudoma obiščite zdravnika, če opazite katerega od naslednjih neželenih učinkov:
English: Date of latest renewal: 19 November 2015
Slovenian: Datum zadnjega podaljšanja: 19.11.2015
English: The second dilution should be done immediately (within 1 hour) as detailed in Step 2.
Slovenian: Naslednje redčenje je treba opraviti takoj (v teku 1 ure), kot je podrobno opisano v koraku 2.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če nista uporabljeni takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
English: • trouble with balance
Slovenian: • težave z ravnotežjem
English: • you have recently received or are about to receive a vaccine against yellow fever.
Slovenian: • ste pred kratkim prejeli ali boste prejeli cepivo proti rumeni mrzlici.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/676/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/676/001
English: Your doctor will monitor your blood and general condition for signs of infections.
Slovenian: Zdravnik vam bo kontroliral kri in splošno stanje glede znakov okužbe.
English: Treatment should be delayed until improvement of symptoms.
Slovenian: Zdravljenje je treba odložiti, dokler se simptomi ne izboljšajo.
English: Paediatric population See section 4.2
Slovenian: Pediatrična populacija Glejte poglavje 4.2
English: • you experience any significant increase or decrease in daily urinary volume.
Slovenian: • če opazite kakršnokoli pomembno povečanje ali zmanjšanje dnevnega volumna urina.
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Slovenian: Uporabiti je mogoče mrtva ali oslabljena (inaktivirana) cepiva, toda odziv na takšna cepiva je lahko manjši.
English: Ethanol 96% Water for injections
Slovenian: Etanol, 96 % Voda za injekcije
English: Tell your doctor immediately if:
Slovenian: Zdravniku morate nemudoma povedati:
English: The patient should be advised to report any significant change in daily urinary volume immediately.
Slovenian: Bolniku je treba naročiti, da mora nemudoma sporočiti vsako pomembno spremembo dnevne količine urina.
English: • decrease or increase in blood pressure
Slovenian: • znižanje ali zvišanje krvnega tlaka
English: He/she may give you other medicines to maintain the number of your blood cells.
Slovenian: Morda vam bo dal druga zdravila za ohranitev števila krvnih celic.
English: • feeling tired, weak or lack of energy.
Slovenian: • utrujenost, šibkost ali pomanjkanje energije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 March 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMETZ ZDRAVILOM Datum prve odobritve: 17.03.2011
English: Dehydration is more common in patients aged 65 or older.
Slovenian: Dehidracija je pogostejša pri bolnikih, starih 65 let ali več.
English: • painful or frequent urination
Slovenian: • boleče ali pogosto uriniranje
English: Any of these events could cause severe dehydration.
Slovenian: Vse to lahko povzroči hudo dehidracijo.
English: * see detailed section below
Slovenian: *Glejte podroben opis spodaj.
English: Let this solution stand for approximately 5 minutes and check then that the solution is homogeneous and clear.
Slovenian: To raztopino pustite, naj stoji približno 5 minut, nato preverite, da je homogena in bistra.
English: Your doctor will calculate your body surface area in square meters (m²) and will decide the dose you should have.
Slovenian: Zdravnik bo izračunal vašo telesno površino v kvadratnih metrih (m2) in glede nanjo določil odmerek, ki ga morate dobiti.
English: • infections or risk of infections
Slovenian: • okužbe ali tveganje okužb
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročati tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: • severe loss of body fluids (dehydration).
Slovenian: • hudo izgubo telesnih tekočin (dehidracijo).
English: Prolonged grade ≥3 neutropenia (longer than 1 week) despite appropriate treatment including G-CSF
Slovenian: Dolgotrajna nevtropenija ≥ 3. stopnje (dlje kot 1 teden) kljub ustreznemu zdravljenju, vključno z G-CSF
English: Do not store above 30°C.
Slovenian: Ne shranjujte pri temperaturi nad 30°C.
English: • you have blood in your urine.
Slovenian: • če imate kri v urinu.
English: 14.5 (13.47 to 15.28)
Slovenian: 14,5 (13,47 do 15,28)
English: Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions.
Slovenian: Bolnike je treba natančno opazovati glede preobčutljivostnih reakcij, zlasti med prvim in drugim infundiranjem.
English: • short term hair loss (in most cases normal hair growth should return)
Slovenian: • kratkotrajna izguba las in dlak (večinoma se obnovi njihova normalna rast)
English: If the bleeding or pain is severe, your doctor will stop your treatment with JEVTANA.
Slovenian: Če so krvavitev ali bolečine hude, bo zdravnik končal vaše zdravljenje z zdravilom JEVTANA.
English: However, in-use storage time can be longer under specific conditions mentioned in section 6.3.
Slovenian: Vendar pa je lahko čas shranjevanja med uporabo daljši v specifičnih pogojih, omenjenih v poglavju 6.3.
English: 13.4 (12.19 to 14.88)
Slovenian: 13,4 (12,19 do 14,88)
English: • decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection)
Slovenian: • zmanjšanje števila rdečih krvnih celic (anemija) ali belih krvnih celic (ki so pomembne pri premagovanju okužb)
English: Frequencies are based on all grades and 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: Pogostnosti temeljijo na vseh stopnjah in so opredeljene kot: 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), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
English: The mean AUC was 991 ng.h/ml (CV: 34%).
Slovenian: Povprečna AUC je bila 991 ng.h/ml (KV: 34 %).
English: Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed.
Slovenian: Med 1. ciklusom so nujne kontrole celotne krvne slike vsak teden, potem pa pred vsakim ciklusom zdravljenja, tako da je mogoče odmerek prilagoditi, če je treba.
English: • ringing in the ear
Slovenian: • zvonjenje v ušesih
English: Figure 1: Kaplan Meier overall survival curves (EFC6193)
Slovenian: Slika 1: Kaplan-Meierjevi krivulji preživetja (EFC6193)
English: Step 2: Second (final) dilution for infusion
Slovenian: Korak 2: Drugo (končno) redčenje za infuzijo
English: Follow the preparation instructions provided below.
Slovenian: Upoštevajte spodnja navodila za pripravo.
English: Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Unopened vials 3 years.
Slovenian: Neodprte viale 3 leta
English: Physicians should assess for the presence or worsening of neuropathy before each treatment.
Slovenian: Zdravniki morajo pred vsakim zdravljenjem oceniti prisotnost ali poslabšanje nevropatije.
English: Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.
Slovenian: Med celotnim zdravljenjem je treba zagotoviti ustrezno hidracijo bolnika, da bi preprečili zaplete, kakršen je odpoved ledvic.
English: Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
Slovenian: Priporočljiva je profilaksa z antiemetiki; profilakso je mogoče dajati peroralno ali intravensko, kot je potrebno.
English: Inject the entire contents into the corresponding concentrate vial.
Slovenian: Injicirajte celotno vsebino v ustrezno vialo s koncentratom.
English: Patients should be advised not to drive or use machines if they experience these adverse reactions during treatment.
Slovenian: Bolnikom je treba naročiti, naj ne vozijo in ne upravljajo s stroji, če se jim med zdravljenjem pojavijo ti neželeni učinki.
English: Appropriate measures should be taken to re-hydrate patients.
Slovenian: Potrebni so ustrezni ukrepi za rehidracijo bolnikov.
English: From a microbiological point of view, the two-step dilution process must take place in controlled and aseptic conditions (see below “Preparation and administration precautions”).
Slovenian: Z mikrobiološkega stališča je treba dvostopenjski postopek redčenja opraviti v nadzorovanih in aseptičnih pogojih (glejte "Previdnostni ukrepi za pripravo in uporabo", spodaj).
English: Pregnant staff should not handle it.
Slovenian: Noseče članice osebja ne smejo ravnati z njim.
English: Anti-allergic medicines will be given to you before you have JEVTANA to reduce the risk of allergic reactions.
Slovenian: Preden boste dobili zdravilo JEVTANA, boste dobili zdravila proti alergiji za zmanjšanje tveganja alergijskih reakcij.
English: • high blood sugar
Slovenian: • visok sladkor v krvi
English: Preparation steps
Slovenian: Koraka za pripravo
English: This leads to the stabilisation of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
Slovenian: To povzroči stabilizacijo mikrotubulov s posledičnim zavrtjem celičnih funkcij v mitozi in interfazi.
English: • lack of white blood cells associated with fever and infection
Slovenian: • pomanjkanje belih krvnih celic, povezano z zvišano telesno temperaturo in okužbo
English: Cabazitaxel did not induce mutations in the bacterial reverse mutation (Ames) test.
Slovenian: Kabazitaksel ni povzročil mutacij v bakterijskem testu reverzne mutacije (Amesovem testu).
English: There are no data from the use of cabazitaxel in pregnant women.
Slovenian: Podatkov o uporabi kabazitaksela pri nosečnicah ni.
English: Neutropenia, and associated clinical events
Slovenian: Nevtropenija in povezani klinični dogodki
English: • decrease in the number of platelets (which results in increased risk of bleeding)
Slovenian: • zmanjšano število krvnih ploščic (kar se odraža kot povečano tveganje krvavitev)
English: • Neutrophil counts less than 1,500/mm3.
Slovenian: • Število nevtrofilcev manj kot 1.500/mm3.
English: Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness.
Slovenian: Kabazitaksel lahko vpliva na sposobnost vožnje in upravljanja s stroji, ker lahko povzroči utrujenost in omotico.
English: In case of overdose, the patient should be kept in a specialised unit and closely monitored.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika namestiti v posebno enoto in ga natančno kontrolirati.
English: What you need to know before you are given JEVTANA
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo JEVTANA
English: None were considered related by the investigator.
Slovenian: Po raziskovalčevi oceni noben dogodek ni bil povezan.