FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Slovenian: Nevarnost aritmije torsade de pointes je povezana s stopnjo podaljšanja intervala Q-T, sočasne uporabe zdravil za podaljšanje intervala Q-T, pojavljanjem aritmije torsade de pointes v preteklosti, že obstoječim podaljšanjem intervala Q-T, kongestivno srčno odpovedjo, uporabo diuretikov, ki ne varčujejo s kalijem ali drugimi stanji, ki lahko povzročijo hipokaliemijo ali hipomagneziemijo.
English: Arsenic trioxide Accord must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Slovenian: Zdravila Arzenov trioksid Accord ne smete mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili.
English: Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/µl) during induction, 4 of whom had values above 100,000/µl.
Slovenian: 27 bolnikov je med indukcijo imelo levkocitozo (WBC ≥ 10 x 103/µl).
English: are 32 hours and 70 hours, respectively.
Slovenian: ur in presnovka DMAV 70 ur.
English: How to store Arsenic trioxide Accord Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Arzenov trioksid Accord Vsebina pakiranja in dodatne informacije
English: Treatment with arsenic trioxide must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Slovenian: Zdravljenje z arzenovim trioksidom morate pred načrtovanim koncem terapije prekiniti v katerem koli trenutku, ko opazite hepatotoksičnost 3. stopnje ali več po merilih pogostih toksičnosti Nacionalnega inštituta za rakava obolenja.
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
Slovenian: Na novo diagnosticirana akutna promielocitna levkemija (APL) z nizkim do srednjim tveganjem
English: The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Slovenian: lahko trajanje infundiranja podaljšate na največ 4 ure.
English: Since no data are available across all renal impairment groups, caution is advised in the use of arsenic trioxide in patients with renal impairment.
Slovenian: Ker ni na voljo podatkov za nobeno skupino bolnikov z ledvično okvaro, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z ledvično okvaro.
English: Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.
Slovenian: Levkocitoza se je pojavila pri 50 % bolnikov z APL v relapsu ali refraktarni fazi.
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord.
Slovenian: Vaš zdravnik bo opravil naslednje previdnostne ukrepe: - pred prvim odmerkom zdravila Arzenov trioksid Accord bo opravil teste, da preveri raven kalija,
English: QT/QTc prolongation is expected during treatment with arsenic trioxide, and Torsade de pointes and complete heart block have been reported.
Slovenian: Med zdravljenjem z arzenovim trioksidom lahko pričakujete podaljšanje intervala Q-T/Q-Tc, poročali pa so tudi o aritmiji Torsade de pointes in popolnem srčnem bloku.
English: In newly diagnosed patients with low to intermediate risk APL leukocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Slovenian: Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je pri 35 od 74 (47 %) prišlo do levkocitoze med indukcijskim zdravljenjem (glejte poglavje 4.8).
English: Other medicines and Arsenic trioxide Accord
Slovenian: Druga zdravila in zdravilo Arzenov trioksid Accord
English: - fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Slovenian: - palpitacija (občutek močnega bitja srca, ki ga lahko čutite v prsnem košu)
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Slovenian: Bolniki s pomembnimi aritmijami, anomalijami EKG (kongenitalni sindrom podaljšanega intervala Q-T, v preteklosti ali sedanjosti prisotna pomembna prekatna ali atrijska tahiaritmija, klinično pomembna mirujoča bradikardija (< 50 utripov na minuto), QTc > 450 msec pri pregledu EKG,
English: Arsenic trioxide Accord must not be mixed with, or infused through the same tube with other medicines.
Slovenian: Zdravila Arzenov trioksid Accord ne smete mešati z drugimi zdravili ali infundirati po isti cevki z drugimi zdravili.
English: Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Slovenian: Rok uporabnosti po redčenju: kemijska in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur pri temperaturi 25 °C in 48 ur pri temperaturah 2 °C - 8 °C.
English: - If you have further questions, please ask your doctor or your pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The total clearance of AsIII over the single dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 L/h and the renal clearance is 9 L/h.
Slovenian: Skupni očistek AsIII v razponu enkratnega odmerka 7-32 mg (aplicirano kot 0,15 mg/kg) je
English: Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR.
Slovenian: Bolniki v skupini ATRA + arzenov trioksid so prejemali peroralno dnevni odmerek ATRA 45 mg/m2 in i.v.
English: Patients in the first study received a median dose of 0.16 mg/kg/day of arsenic trioxide (range 0.06
Slovenian: Bolniki v prvi študiji so prejemali mediano odmerka 0,16 mg/kg arzenovega trioksida na dan (v obsegu od 0,06 do 0,20 mg/kg/dan), bolniki v multicentrični študiji pa fiksni odmerek 0,15 mg/kg/dan.
English: What Arsenic trioxide Accord looks like and contents of the pack
Slovenian: Izgled zdravila Arzenov trioksid Accord in vsebina pakiranja
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA.
Slovenian: Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je pri 63,2 % prišlo do hepatotoksičnih učinkov stopnje 3 ali 4 med indukcijskim ali konsolidacijskim zdravljenjem z arzenovim trioksidom v kombinaciji z ATRA.
English: One ml contains 1 mg of arsenic trioxide.
Slovenian: En ml vsebuje 1 mg arzenovega trioksida.
English: The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated.
Slovenian: Multicentrična študija je vključevala 5 pediatričnih bolnikov (starih < 18 let).
English: Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Slovenian: Če ne pride do poslabšanja predhodne toksičnosti, lahko nadaljujete zdravljenje s polnim odmerkom arzenovega trioksida.
English: Arsenic trioxide Accord contains sodium
Slovenian: Zdravilo Arzenov trioksid Accord vsebuje natrij
English: - If you get any side effects, talk to your doctor or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
English: One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
Slovenian: En ml koncentrata za raztopino za infundiranje vsebuje 1 mg arzenovega trioksida.
English: One vial of 10 ml contains 10 mg of arsenic trioxide.
Slovenian: Ena viala (10 ml) vsebuje 10 mg arzenovega trioksida.
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
Slovenian: *V študiji CALGB C9710 so poročali o 2 primerih zvečane GGT stopnje≥ 3 med 200 bolniki, ki so prejeli konsolidirane cikle arzenovega trioksida (cikel 1 in cikel 2) v primerjavi z nobenim v kontrolnem kraku.
English: Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.
Slovenian: V ključnih študijah relapsa je bila umrljivost zaradi hemoragije, povezane z diseminirano intravaskularno koagulacijo (DIC - »disseminated intravascular coagulation«), zelo pogosta
English: Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population.
Slovenian: V tej skupini z APL v relapsu ali refraktarni fazi so bili resni neželeni učinki pogosti (1-10 %) in pričakovani.
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with Arsenic trioxide, caution is advised in the use of Arsenic trioxide in patients with hepatic impairment (see section 4.4 and 4.8).
Slovenian: Ker ni na voljo podatkov za nobeno skupino bolnikov z jetrno okvaro in lahko med zdravljenjem z arzenovim trioksidom pride do hepatotoksičnih učinkov, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z jetrno okvaro (glejte poglavji 4.4 in 4.8).
English: Prior to initiating therapy with arsenic trioxide, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Slovenian: Pred začetkom zdravljenja z arzenovim trioksidom morate opraviti 12-kanalni EKG in preglede ravni serumskih elektrolitov (kalija, kalcija in magnezija) ter kreatinina.
English: Cytogenetics after arsenic trioxide therapy
Slovenian: Citogenetika po zdravljenju z arzenovim trioksidom
English: There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleukocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Slovenian: Ni ugotovljene povezave med osnovno vrednostjo števila belih krvnih celic (WBC - white blood cell) in razvojem hiperlevkocitoze ali med osnovno in najvišjo vrednostjo WBC. Hiperlevkocitoze niso nikoli zdravili z dodatno kemoterapijo in ob nadaljevanju zdravljenja z arzenovim trioksidom ni bila ozdravljena.
English: Fertility studies have not been conducted with arsenic trioxide.
Slovenian: Z arzenovim trioksidom niso opravili študij plodnosti.
English: There is limited clinical data on the use of arsenic trioxide in the elderly population.
Slovenian: O uporabi arzenovega trioksida pri starejših bolnikih je na voljo malo kliničnih podatkov.
English: Use of Arsenic trioxide Accord
Slovenian: Uporaba zdravila Arzenov trioksid Accord
English: Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion
Slovenian: - okužba pljuč (pljučnica), okužba krvi - vnetje pljuč, ki povzroči bolečine v prsih in zasoplost; srčno popuščanje
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Slovenian: Arzenov trioksid Accord 1 mg/ml koncentrat za raztopino za infundiranje
English: The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24
Slovenian: Pentavalentni presnovki, MMAV in DMAV, se v plazmi pokažejo počasi (približno 10-24 ur po prvem dajanju arzenovega trioksida), vendar se zaradi daljšega razpolovnega časa bolj nalagajo po več odmerkih kot AsIII.
English: Thereafter, in absence of worsening of the previous toxicity, arsenic trioxide should be resumed at full dosage.
Slovenian: Če se prejšnja toksičnost ne poslabša, nadaljujte zdravljenje s polnim odmerkom arzenovega trioksida.
English: In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of arsenic trioxide application to the end of induction therapy in APL patients.
Slovenian: Za preprečitev nastanka sindroma diferenciacije APL med indukcijskim zdravljenjem, lahko odmerite prednizon (0,5 mg/kg telesne mase na dan med indukcijskim zdravljenjem) od 1. dne odmerjanja arzenovega trioksida do konca indukcijskega zdravljenja pri bolnikih z APL. Priporočamo, da med zdravljenjem s steroidi ne začnete kemoterapije, kajti nimamo izkušenj s skupno uporabo steroidov in kemoterapije med zdravljenjem sindroma aktivacije levkocitov, do katerega pride zaradi arzenovega trioksida.
English: If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Accord.
Slovenian: Če lahko zanosite, morate med zdravljenjem z zdravilom Arzenov trioksid Accord uporabljati zanesljivo kontracepcijsko sredstvo.
English: During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and arsenic trioxide was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Slovenian: Med konsolidacijo so ATRA dajali v enakem odmerku v času 2 tednov, ki sta jima sledila 2 tedna brez prejetega odmerka, pri čemer je bilo skupaj izvedenih 7 ciklov.
English: Pleural effusion
Slovenian: Okvarjeno delovanje ledvic
English: Patients with hepatic impairment Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with arsenic trioxide caution is advised in the use of arsenic trioxide in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8).
Slovenian: Ker ni na voljo podatkov za nobeno skupino bolnikov z jetrno okvaro in lahko med zdravljenjem z arzenovim trioksidom pride do hepatotoksičnih učinkov, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z jetrno okvaro (glejte poglavje 4.4 o hepatotoksičnosti in poglavje 4.8).
English: Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Slovenian: - omotica, mišične bolečine, odrevenelost ali mravljinčenje - izpuščaji ali srbečica - zvišana raven sladkorja v krvi, edem (oteklina zaradi prevelike količine tekočine) - zasoplost, hiter srčni utrip, nenormalen EKG - znižana koncentracija kalija ali magnezija v krvi, neobičajni rezultati testov delovanja jeter,
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Slovenian: Arzenov trioksid Accord 1 mg/ml koncentrat za raztopino za infundiranje arzenov trioksid
English: Pleuritic pain
Slovenian: OVOJNINAH VIALA
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during arsenic trioxide clinical trials in 52 patients with refractory/relapsed
Slovenian: Pogostnosti neželenih učinkov arzenovega trioksida v kliničnih preskušanjih pri 52 bolnikih z
English: Patients in the ATRA+chemotherapy treatment group received iv idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then iv mitoxantrone at 10 mg/m2 on days 1 to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
Slovenian: mitoksantron v odmerku 10 mg/m2 ob dneh 1 do 5 in znova ATRA v odmerku 45 mg/m2 dnevno 15 dni ter na koncu en odmerek idarubicina 12 mg/m2 in ATRA v odmerku 45 mg/m2 dnevno
English: APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
Slovenian: APL v relapsu ali refraktarni fazi so v preglednici 2 opredeljene kot: (zelo pogosti ≥ 1/10), (pogosti
English: During therapy with arsenic trioxide, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Slovenian: Med zdravljenjem z arzenovim trioksidom morate vzdrževati koncentracijo kalija nad 4 mEq/l in koncentracijo magnezija nad 1,8 mg/dl. Bolnike, ki dosežejo absolutno vrednost intervala Q-T > 500 ms, morate ponovno pregledati in nemudoma ukrepati, da bi popravili morebitne spremljajoče dejavnike tveganja.
English: Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Slovenian: Med zdravljenjem z zdravilom Arzenov trioksid Accord morajo tudi moški uporabljati učinkovito kontracepcijo.
English: 44% of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with arsenic trioxide.
Slovenian: 44 % bolnikov z APL v relapsu ali refraktarni fazi je imelo simptome, ki jih lahko povežemo z nevropatijo.
English: If your doctor gives you more Arsenic trioxide Accord than he/she should
Slovenian: Če vam je zdravnik dal večji odmerek zdravila Arzenov trioksid Accord, kot bi smel Morda boste čutili krče, mišično šibkost in zmedenost.
English: Patients with complete remission received consolidation therapy with arsenic trioxide for 25 additional doses over a 5 weeks period.
Slovenian: Bolnikom s popolno remisijo so odredili konsolidacijsko zdravljenje z arzenovim trioksidom.
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Slovenian: Bolniki z na novo diagnosticirano APL, potrjeno s prisotnostjo t(15; 17) ali PML-RAR
English: Preparation of Arsenic trioxide Accord Aseptic technique must be strictly observed throughout handling of Arsenic trioxide Accord since no preservative is present.
Slovenian: Priprava zdravila Arzenov trioksid Accord V zdravilu ni konzervansa, zato morate med delom z zdravilom Arzenov trioksidAccord strogo upoštevati aseptične pogoje.
English: Relapsed/refractory acute promyelocytic leukaemia (APL)
Slovenian: Akutna promielocitna levkemija (APL) v relapsu ali refraktarni fazi
English: No clinical or non-clinical fertility studies have been conducted with arsenic trioxide.
Slovenian: Arzenovega trioksida niso preskušali v kliničnih ali predkliničnih študijah plodnosti.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV
Slovenian: Srednja ocenjena vrednost razpolovnega časa presnovka MMAV je 32
English: Common (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Slovenian: - bolečine v prsih, krvavitev v pljučih, hipoksija (nizka raven kisika), nabiranje tekočine okoli srca ali pljuč, nizek krvni tlak, moten srčni ritem - krči, bolečine v sklepih ali kosteh, vnetje krvnih žil
English: Package leaflet: Information for the user Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Slovenian: Navodilo za uporabo Arzenov trioksid Accord 1 mg/ml koncentrat za raztopino za infuzijo arzenov trioksid
English: Musculoskeletal and connective tissue disorders
Slovenian: Infekcijske in parazitske bolezni herpes zoster sepsa pljučnica
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija levkocitoza nevtropenija pancitopenija trombocitopenija anemija levkopenija limfopenija
English: How to store Arsenic trioxide Accord
Slovenian: Shranjevanje zdravila Arzenov trioksid Accord
English: The following information is intended for healthcare professionals only:
Slovenian: Zlasti obvestite zdravnika:
English: Myalgia
Slovenian: - omedlevica
English: Gamma-glutamyltransferase increased*
Slovenian: zelo pogosti hiperbilirubinemija zvišana koncentracija kreatinina v krvi zvečana telesna masa zvišana raven gamaglutamiltransferaze*
English: • some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
Slovenian: zdravila za zdravljenje psihoz (izguba stika z realnostjo, npr. tioridazin) zdravila proti depresiji (npr. amitriptilin) nekatere vrste zdravil za zdravljenje bakterijskih okužb (npr. eritromicin in sparfloksacin) nekatere vrste zdravil za zdravljenje alergij, kot je seneni nahod, imenovana antihistaminiki (npr. terfenadin in astemizol)
English: Confusional state
Slovenian: Multicentrična študija
English: Leukocytosis
Slovenian: Citotoksično
English: Nervous system disorders
Slovenian: Psihiatrične motnje stanje zmedenosti
English: Abdominal pain
Slovenian: - bolečine v trebuhu (abdomnu)
English: This event is called extravasation.
Slovenian: Temu dogodku pravimo ekstravazacija.
English: CTC grade 3-4
Slovenian: CTC stopnja 3-4
English: All adverse reactions have been rapidly reversible.
Slovenian: Vsi neželeni učinki so bili hitro reverzibilni.
English: Treatment should be symptomatic.
Slovenian: Zdravljenje je simptomatsko.
English: Use an inactivated vaccine where this exists (poliomyelitis).
Slovenian: Uporabite inaktivirano cepivo, če obstaja (pri poliomielitisu).
English: In both studies the dosage regimen was the same.
Slovenian: V obeh študijah je bil režim odmerjanja enak.
English: Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1.
Slovenian: Zdravljenje je treba drugi in tretji dan začeti ob isti uri (+/- 3 ure), kot prvi dan.
English: Total urinary recovery of unchanged dexrazoxane is 34-60 %.
Slovenian: Skupni izplen nespremenjenega deksrazoksana v urinu je 34 - 60 %.
English: From a microbiological point of view the product should be used immediately.
Slovenian: Iz mikrobiološkega vidika je treba zdravilo uporabiti takoj.
English: The toxicity in combination with doxorubicin was additive and not synergistic.
Slovenian: Toksičnost v kombinaciji z doksorubicinom je bila aditivna in ne sinergistična.
English: RECOMMENDATION FOR THE SAFE HANDLING
Slovenian: PRIPOROČILA ZA VARNO RAVNANJE
English: Alopecia Pruritus
Slovenian: Alopecija Pruritus
English: Your doctor will calculate your body surface area in square meter (m2) to determine the dose you should receive.
Slovenian: Zdravnik bo izračunal površino vašega telesa v kvadratnih metrih (m2) in določil odmerek, ki ga morate prejeti.
English: • Other live attenuated vaccines: risk of systemic, possible fatal disease.
Slovenian: • Ostala živa oslabljena cepiva: Tveganje za sistemsko, možno smrtno bolezen.
English: Some side effects can be serious and need immediate medical attention.
Slovenian: Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravstveno pomoč.
English: • Infection (after an operation or other infections)
Slovenian: • okužba (po kirurškem posegu ali druge okužbe).