FrancophonIA/ELRC3.0 huggingface dataset:
English: Meloxicam 5 mg/ml.
Slovenian: Meloksikam 5 mg/ml.
English: Do not use after the expiry date stated on the carton and the vial.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), navedenega na zunanji ovojnini in viali.
English: Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgium
Slovenian: Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgija
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri prevelikem odmerjanju uvedemo simptomatsko zdravljenje.
English: Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Slovenian: Lajšanje pooperativne bolečine (v 24-urnem obdobju): enkratna intravenska ali podkožna injekcija pred operacijo, na primer ob indukciji anestezije.
English: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Slovenian: Lajšanje pooperativne bolečine po ovariohisterektomiji in manjših operacijah mehkega tkiva: enkratna podkožna injekcija pred operacijo, na primer ob indukciji anestezije.
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: − zelo redki (manj kot 1 od 10.000 živali, vključno s posameznimi poročili).
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Psi:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA Imetnik dovoljenja za promet z zdravilom
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Slovenian: B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Ethanol anhydrous 150 mg/ml.
Slovenian: Etanol 150 mg/ml.
English: In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Slovenian: Pri psih so zelo redko poročali o hemoragični driski, hematemezi in razjedi prebavil.
English: In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
Slovenian: Pri živalih, pri katerih je večja verjetnost, da bodo potrebovale anestezijo (npr. pri starejših živalih), je treba presoditi o potrebi po intravenskem ali podkožnem dajanju tekočine med anestezijo.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Slovenian: Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z zveterinarjem.
English: Do not use in pregnant or lactating animals.
Slovenian: Ne uporabite pri brejih živalih ali živalih v obdobju laktacije.
English: Metabolism
Slovenian: Etanol
English: Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Slovenian: Občasno so poročali o značilnih nežželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), letargija in ledvična odpoved.
English: − common (more than 1 but less than 10 animals in 100 animals)
Slovenian: − pogosti (več kot 1, a manj kot 10 od 100 živali)
English: MARKETING AUTHORISATION NUMBER
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Slovenian: − zelo pogosti (neželeni učinki se med enim ciklom zdravljenja pokažejo pri več kot 1 od 10
English: This veterinary product does not require any special storage conditions.
Slovenian: Za shranjevanje ni posebnih navodil.
English: C. STATEMENT OF THE MRLs
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA( MRL)
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Slovenian: − redki (več kot 1, a manj kot 10 od 10.000 živali)
English: Concurrent administration of potential nephrotoxic drugs should be avoided.
Slovenian: Sočasnega dajanja zdravil, ki lahko imajo nefrotoksične učinke, se je treba izogibati.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: Izdelovalec, odgovoren za sproščanje serij
English: Active substance: Meloxicam 5 mg.
Slovenian: Zdravilna(e) učinkovina(e): Meloksikam 5 mg.
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals)
Slovenian: − občasni (več kot 1, a manj kot 10 od 1.000 živali)
English: EXP {month/year} Shelf life after first opening the container: 28 days
Slovenian: EXP {mesec/leto} Rok uporabnosti odprte viale: 28 dni.
English: Excipients: Ethanol, anhydrous 150 mg.
Slovenian: Pomožna(pomožne) snov(i): Etanol, brezvodni 150 mg.
English: Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Slovenian: Psi: Enkratni odmerek po 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg).
English: Shelf-life after first opening the immediate packaging: 28 days.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
English: QUANTITY OF THE ACTIVE SUBSTANCE
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
English: METHOD AND ROUTES OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Slovenian: Zaradi nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Slovenian: Meloksikam je nesteroidno protivnetno zdravilo iz skupine oksikamov.
English: Dogs
Slovenian: živali)
English: Marketing authorisation holder
Slovenian: IMETNIK(I) DOVOLJENJ(A) ZA PROMET
English: MA (EU) Number
Slovenian: Številka postopka MA (EU)
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika
English: 3 inhalers (3 x 30 doses) (multipack)
Slovenian: 3 inhalatorji (3 x 30 odmerkov) (skupno pakiranje)
English: A Decision was issued by the European Commission on 9 August 2005.
Slovenian: Odločbo je Evropska Komisija izdala 9. avgusta 2005.
English: SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR
Slovenian: POVZETEK INFORMACIJ O MNENJU V ZVEZI Z NAPOTITVIJO PO ARBITRAŽNEM POSTOPKU V SKLADU S ČLENOM 30 DIREKTIVE SVETA 2001/83/ES
English: 9 August 2005 EMEA/CHMP/289490/2005
Slovenian: 9. avgust 2005 EMEA/CHMP/289490/2005
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI
English: The referral procedure started on 21 October 2004
Slovenian: Napotitveni postopek se je začel 21. oktobra 2004.
English: An overall summary of the scientific evaluation is provided in Annex II together with the harmonised summary of product characteristics in Annex III.
Slovenian: Celoten povzetek znanstvenega vrednotenja je na voljo v Dodatku II skupaj z usklajenim povzetkom glavnih značilnosti zdravila v Dodatku III.
English: Medicinal products containing calcium lactate gluconate and calcium carbonate have been nationally authorised in EU Member States, resulting in different Summaries of Product Characteristics based on individual national decisions.
Slovenian: Zdravila, ki vsebujejo kalcijev laktat glukonat in kalcijev karbonat so bila odobrena po nacionalnih postopkih v državah članicah EU, zaradi česar je nastalo več različic povzetka glavnih značilnosti zdravila, ki temeljijo na posameznih nacionalnih odločbah.
English: Novartis Consumer Health SA presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national SPCs of the medicinal product Calcium Sandoz Effervescent tablets, 500/1000 mg and associated names and additionally to harmonise the pharmaceutical documentation.
Slovenian: Novartis Consumer Health SA je EMEA predložil napotitev po členu 30 Direktive 2001/83/ES, da bi uskladil nacionalne povzetke glavnih značilnosti zdravila Calcium Sandoz šumeče tablete, 500/1000 mg in sorodna imena ter dodatno uskladil farmacevtsko dokumentacijo.
English: Calcium Sandoz and associated names International Non-Proprietary Name (INN): Calcium lactate gluconate, Calcium carbonate
Slovenian: Mednarodno nelastniško ime (INN): Kalcijev laktat glukonat, kalcijev karbonat
English: A dossier in CTD format and a proposal for a harmonised SPC were submitted by the MAH on 22 September 2004.
Slovenian: Imetnik dovoljenja za promet z zdravilom je 22. septembra 2004 predložil dokumentacijo v CTD formatu in predlog usklajenega povzetka glavnih značilnosti zdravila.
English: The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, and scientific discussion within the Committee was of the opinion that the benefit/risk ratio of Calcium
Slovenian: Ob upoštevanju poročil o oceni, ki sta jih podala poročevalec in so-poročevalec, ter znanstvene razprave znotraj Odbora, je CHMP menil, da je razmerje med koristmi in tveganji za Calcium Sandoz šumeče tablete, 500/1000 mg in sorodna imena ugodno.
English: -Rickets and osteomalacia, in addition to vitamin D3 therapy
Slovenian: - dodatek kalcija kot dopolnilo specifični terapiji pri preprečevanju in zdravljenju osteoporoze - pri rahitisu in osteomalaciji kot dodatek zdravljenju z vitaminom D3
English: CHMP issued a positive opinion, on 21 April 2005, recommending the harmonisation of the SPC for
Slovenian: CHMP je 21. aprila 2005 izdal pozitivno mnenje ter predlagal uskladitev povzetka glavnih značilnosti zdravila Calcium Sandoz šumeče tablete, 500/1000 mg in sorodna imena za naslednje odobrene terapevtske indikacije:
English: 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
Slovenian: 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tabletami
English: (Invented) name Strength Pharmaceutical form
Slovenian: (Izmišljeno) ime
English: Route of administration
Slovenian: Farmacevtska oblika Pot uporabe
English: Memantine Accord 5 mg + 10 mg +
Slovenian: Filmsko obložene tablet Peroralna uporaba pretisni (PVC/PE/PVDCaluminijev)
English: • if you think you might be pregnant.
Slovenian: • če mislite, da ste morda noseči.
English: This can be repeated if necessary.
Slovenian: Po potrebi se to lahko ponovi.
English: Date of first authorisation: 23 August 2018
Slovenian: Datum prve odobritve: 23. avgusta 2018
English: If this happens, do not drive or use any tools or machines.
Slovenian: Če se to zgodi, ne vozite avtomobila in ne upravljajte nobenih orodij ali strojev.
English: • excessive sweating at night
Slovenian: • čezmerno znojenje ponoči;
English: Each consolidation
Slovenian: Vsaka konsolidacija
English: • if you are to be given a vaccine.
Slovenian: • če boste prejeli cepivo.
English: Tel: +44 8450305089 Email: medinfo-int@jazzpharma.com
Slovenian: Tel.: +44 8450305089 E-pošta: medinfo-int@jazzpharma.com
English: • The infusion is given over one and a half hours (90 minutes).
Slovenian: • Infundiranje traja eno uro in pol (90 minut).
English: • if you have any allergic (hypersensitivity) reactions.
Slovenian: • če imate kakršne koli alergijske (preobčutljivostne) reakcije.
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Slovenian: Lahko se uporabijo mrtva ali inaktivirana cepiva, vendar bo odziv nanje morda zmanjšan.
English: Cardiac function should be closely monitored.
Slovenian: Delovanje srca je treba natančno spremljati.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne porabi takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika.
English: This leaflet was last revised in October 2019 Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano oktobra 2019
English: Stability of reconstituted suspension in the vial
Slovenian: Stabilnost rekonstituirane suspenzije v viali
English: Vyxeos liposomal N=153
Slovenian: Vyxeos liposomski N = 153
English: The primary endpoint was overall survival measured from the date of randomisation to death from any cause.
Slovenian: Primarni opazovani dogodek je bilo skupno preživetje, merjeno od datuma randomizacije do smrti iz katerega koli vzroka.
English: Death (Grade 5) is used for some of the criteria to denote a fatality.
Slovenian: Smrtna toksičnost (5. stopnja) se uporablja pri nekaterih merilih za označevanje smrtnih primerov.
English: The incidence of fatal infections was 6.9%.
Slovenian: Incidenca smrtnih okužb je bila 6,9 %.
English: EU/1/18/1308/001 1 vial EU/1/18/1308/002 2 vials EU/1/18/1308/003 5 vials
Slovenian: EU/1/18/1308/001 1 viala EU/1/18/1308/002 2 viali EU/1/18/1308/003 5 vial
English: • cancer medicines that can affect your heart, such as doxorubicin.
Slovenian: • zdravila za zdravljenje raka, ki lahko vplivajo na vaše srce, kot je doksorubicin;
English: Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
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); not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (od ≥ 1/10.000 do < 1/1.000); neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov).
English: • chills, low body temperature, or high body temperature
Slovenian: • mrzlica, nizka telesna temperatura ali visoka telesna temperatura;
English: The demographic and baseline disease characteristics were generally balanced between the study arms.
Slovenian: Demografske in izhodiščne značilnosti bolezni so bile na splošno uravnotežene med študijskima skupinama.
English: The mechanism of action is not completely understood, but it appears that ara-CTP acts primarily through inhibition of DNA synthesis.
Slovenian: Način delovanja še ni popolnoma razjasnjen, vendar se zdi, da ara-CTP deluje predvsem z zaviranjem sinteze DNK.
English: Plasma protein binding was not evaluated.
Slovenian: Vezava na beljakovine v plazmi ni bila ocenjena.
English: • if you have low numbers of platelets, red or white blood cells in your blood (you will have a blood test before starting treatment).
Slovenian: • če imate v krvi majhno število trombocitov, rdečih ali belih krvnih celic (pred začetkom zdravljenja boste opravili preiskavo krvi).
English: Dosing should be delayed or permanently discontinued, if necessary, as described below.
Slovenian: Po potrebi se odmerjanje preloži na poznejši čas ali trajno opusti, kot je opisano spodaj.
English: Therefore, caution is recommended when driving or operating machines.
Slovenian: Zato je pri vožnji in upravljanju strojev priporočena previdnost.
English: There is no specific experience in the management of overdose in patients.
Slovenian: Specifičnih izkušenj z zdravljenjem prevelikega odmerjanja pri bolnikih ni.
English: • After reconstitution, let it rest for 15 minutes.
Slovenian: • Po rekonstituciji naj raztopina 15 minut počiva.
English: The infusion should not be restarted.
Slovenian: Infundiranje se ne sme ponovno začeti.
English: • increased blood pressure or a fall in blood pressure
Slovenian: • zvišanje ali znižanje krvnega tlaka;
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Slovenian: Še zlasti morate obvestiti zdravnika ali medicinsko sestro, če jemljete katero od naslednjih zdravil:
English: The study included 2 phases, 1) Treatment Phase during which patients received up to 2 induction and 2 consolidation courses, and 2) a Follow-up Phase, which began 30 days after the last induction or consolidation course and continued for up to 5 years from randomisation.
Slovenian: Študija je vključevala 2 fazi: 1) fazo zdravljenja, v kateri so bolniki prejeli do 2 indukcijska in 2 konsolidacijska kroga zdravljenja, ter 2) fazo spremljanja, ki se je začela 30 dni po zadnjem indukcijskem ali konsolidacijskem krogu in nadaljevala še največ 5 let po randomizaciji.
English: A second induction was highly recommended for patients who did not achieve a CR or CRi in the first induction course and was mandatory for patients achieving greater than 50% reduction in percent blasts.
Slovenian: Druga indukcija je bila zelo priporočljiva za bolnike, ki v prvem indukcijskem krogu niso dosegli CR ali CRi, in obvezna za bolnike, ki so dosegli več kot 50-odstotno zmanjšanje odstotka blastov.
English: It must not be administered via an intramuscular, intrathecal, or subcutaneous route.
Slovenian: Ne sme se dajati po intramuskularni, intratekalni ali subkutani poti.
English: • if you have ever had a heart problem or heart attack, or you have previously taken ‘anthracycline' cancer medicines.
Slovenian: • če ste kdaj imeli težave s srcem ali srčni infarkt ali če ste že prejemali zdravila, imenovana »antraciklini«, za zdravljenje raka.
English: ADRs have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical studies.
Slovenian: Neželeni učinki so razvrščeni v ustrezne kategorije v spodnji preglednici glede na največjo pogostnost, opaženo v kateri koli od glavnih kliničnih študij.
English: The first consolidation cycle should be administered 5 to 8 weeks after the start of the last induction.
Slovenian: Priporočeni razpored odmerjanja za konsolidacijo Prvi konsolidacijski krog je treba dati od 5 do 8 tednov po začetku zadnje indukcije.
English: Tell your doctor immediately if you get any of the side effects listed above.
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli od zgoraj naštetih neželenih učinkov.
English: The efficacy of Vyxeos liposomal in the treatment of high risk AML was evaluated in 1 controlled study.
Slovenian: Učinkovitost zdravila Vyxeos liposomski pri zdravljenju AML z visokim tveganjem so ocenili v eni nadzorovani študiji.
English: • on days 1 and 3 as subsequent course of induction therapy, if needed.
Slovenian: • na 1. in 3. dan kot dodaten krog indukcijskega zdravljenja, če je potrebno.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vyxeos liposomal in one or more subsets of the paediatric population in AML (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vyxeos liposomski za eno ali več podskupin pediatrične populacije z AML (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • increased sweating
Slovenian: • močnejše znojenje.
English: Therefore you must tell your doctor immediately if you experience:
Slovenian: Zato morate takoj povedati zdravniku, če imate naslednje težave:
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: Your treatment will be given in ‘courses'.
Slovenian: Zdravilo boste dobivali v »krogih zdravljenja«.
English: • fever, often with other signs of infection, due to very low white blood cells (febrile neutropenia)
Slovenian: • zvišana telesna temperatura, pogosto z drugimi znaki okužbe, zaradi zelo majhnega števila belih krvnih celic (febrilna nevtropenija);
English: This limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum.
Slovenian: Videti je, da je ta meja nižja (400 mg/m2) pri bolnikih, ki so se zdravili z obsevanjem mediastinuma.
English: Although central nervous system (CNS) and cardiovascular system parameters were included in these studies, given the observed morbidity and mortality, there was insufficient information to arrive at an integrated assessment of safety pharmacology of Vyxeos liposomal.
Slovenian: Čeprav so bili parametri osrednjega živčevja in srčno-žilnega sistema vključeni v te študije, zaradi ugotovljene obolevnosti in smrtnosti ni bilo na voljo dovolj informacij za celostno oceno farmakološke varnosti zdravila Vyxeos liposomski.
English: Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved.
Slovenian: Toksičnost je ocenjena kot blaga (1. stopnja), zmerna (2. stopnja), huda (3. stopnja) ali življenjsko nevarna (4. stopnja), s specifičnimi parametri glede na prizadeti organski sistem.
English: • Do not throw away any medicines via wastewater.
Slovenian: • Zdravila ne smete odvreči v odpadne vode.
English: The accumulation ratio was 1.3 for daunorubicin and 1.4 for cytarabine.
Slovenian: Razmerje kopičenja je bilo 1,3 za daunorubicin in 1,4 za citarabin.
English: These active substances act in different ways to kill cancer cells by stopping them from growing and dividing.
Slovenian: Ti učinkovini na različne načine uničujeta rakave celice tako, da ustavita njihovo rast in delitev.
English: • The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visual particulates.
Slovenian: • Rekonstituirano zdravilo mora biti neprozorna, vijoličasta, homogena disperzija, ki praktično ne vsebuje vidnih delcev.
English: The number of inductions and consolidations a patient received depended upon Complete Response (CR) or Complete Response with incomplete recovery (CRi), which was confirmed by bone marrow assessment.
Slovenian: Število indukcij in konsolidacij, ki jih je prejel bolnik, je bilo odvisno od popolnega odziva (CR, complete response) ali popolnega odziva z nepopolnim okrevanjem (CRi, complete response with incomplete recovery), potrjenega z oceno stanja kostnega mozga.
English: Do not administer via an intramuscular, intrathecal, or subcutaneous route (see section 4.2).
Slovenian: Ne dajajte ga po intramuskularni, intratekalni ali subkutani poti (glejte poglavje 4.2).
English: Unopened vials 2 years.
Slovenian: Neodprte viale 2 leti
English: Applicable special handling and disposal procedures should be followed.
Slovenian: Pri ravnanju z njim in odstranjevanju je treba upoštevati posebne postopke.
English: Age, sex, race, body weight, body mass index, and white blood cell count do not have a clinically important effect on the exposure of total daunorubicin or cytarabine after adjusting dose by body surface area.
Slovenian: Starost, spol, rasa, telesna masa, indeks telesne mase in število belih krvnih celic nimajo klinično pomembnega učinka na izpostavljenost skupnemu daunorubicinu ali citarabinu po prilagoditvi odmerka glede na telesno površino.
English: No dose adjustment is required in elderly patients (≥65 years) (see section 5.2).
Slovenian: Starejši bolniki Pri starejših bolnikih (≥ 65 let) prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: The frequency of fatal hypersensitivity events was 0 (see section 4.4).
Slovenian: Pogostnost preobčutljivostnih dogodkov s smrtnim izidom je bila 0 (glejte poglavje 4.4).
English: Overall survival
Slovenian: Skupno preživetje
English: Packaging them in liposomes prolongs their action in the body and helps them to enter and kill the cancer cells.
Slovenian: Vključitev učinkovin v liposome podaljša njuno delovanje v telesu ter jima pomaga prodreti v celice in jih uničiti.