natgillin/translations-raw huggingface dataset:
Particular care should be given to assuring full haematological recovery before undertaking consolidation therapy (if this treatment is used) and patients should be monitored closely during this phase.
Posebno pozornost je treba nameniti zagotavljanju popolnega hematološkega okrevanja, preden se začne konsolidacijsko zdravljenje (če je to zdravljenje načrtovano), in bolnike je v tej fazi treba skrbno spremljati.
A reduction of neurologic disability worsening and frequency of clinical relapses was observed.
Opaženo je bilo zmanjšanje poslabšanja nevrološke prizadetosti in pogostnosti kliničnih relapsov.
If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Če jemljete katero od teh zdravil, vam bo vaš zdravnik morda moral predpisati drugo zdravilo.
Cardiac function for cancer patients should be carefully monitored during treatment.
Srčno funkcijo pri bolnikih z rakom je treba med zdravljenjem skrbno spremljati.
Repeat prior dose
Ponovite predhodni odmerek
In addition your blood will be tested regularly during the treatment.
Poleg tega boste med zdravljenjem redno opravljali krvne teste.
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so rezultat postopka predložitve, na katerega se nanaša odločitev Komisije.
Opportunistic infections
Oportunistična okužba
Also the time course over which the cumulative dose was given ranged from 3 to 24 months.
Tudi časovni potek, v katerem je bilo dano zdravilo, je bil v razponu od 3 do 24 mesecev.
Of the material recovered in urine, 65 % was unchanged active substance.
Od materiala v urinu je bilo 65 % nespremenjene zdravilne učinkovine.
Withhold until recovery, then repeat prior dose.
Ne dajajte do izboljšanja, potem ponovite predhodni odmerek.
This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Na splošno gre za prehodno nevtropenijo z najnižjim številom levkocitov na 10. dan po infuziji in z okrevanjem okoli 20. dneva.
The table below is based on safety data derived from clinical trials and spontaneous reporting in oncological indications and from clinical trials, post authorisation safety studies and spontaneous reporting for patients treated for multiple sclerosis.
Spodnja tabela temelji na podatkih o varnosti, ki izhajajo iz kliničnih raziskav in spontanih poročil o onkoloških indikatorjih, ter iz kliničnih raziskav, študij o varnosti zdravila po pridobitvi dovoljenja in spontanih poročil o bolnikih, zdravljenih zaradi multiple skleroze.
If this happens, the infusion must be stopped and restarted in another vein.
V tem primeru je treba infuzijo prekiniti in jo namestiti v drugo veno.
Your doctor will decide precisely which subsequent dosage you need.
Zdravnik bo natančno določil, kateri naslednji odmerek potrebujete.
Your doctor may need to adjust your treatment or stop Novantrone temporarily or permanently.
Zdravnik bo morda moral prilagoditi vaše zdravljenje z zdravilom Novatrone ali ga začasno ali trajno ustaviti.
Patients should be informed about risks, symptoms and signs of acute leukaemia and prompted to seek medical attendance if any such symptoms should occur even after the five year period has passed.
Bolnike je treba poučiti o tveganjih, simptomih in znakih akutne levkemije ter jim naročiti, naj poiščejo zdravniško pomoč, če se pojavijo takšni simptomi, tudi po petih letih.
No effects were observed on pup development or fertility in the two generation study in rats.
Učinkov na razvoj mladičev ali plodnost v študijah dveh generacij podgan niso ugotovili.
There is little experience in children and adolescents.
Izkušenj z zdravljenjem otrok in mladostnikov je malo.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
Haematological parameters should be regularly monitored (see section 4.4).
Hematološke parametre je treba redno spremljati (glejte poglavje 4.4).
There does not seem to be relevant differences in pharmacokinetics of mitoxantrone between elderly and young adult patients.
Ni opaziti pomembnih razlik v farmakokinetiki mitoksantrona med starejšimi in mlajšimi odraslimi bolniki.
LVEF evaluation is recommended at regular intervals and/or if signs or symptoms of congestive heart failure develop.
Ocena LVEF se priporoča v rednih časovnih presledkih in/ali pri znakih ali simptomih razvoja kongestivnega srčnega popuščanja.
The remaining 35 % was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates.
Preostalih 35 % so sestavljali derivati monokarboksilne in dikarboksilne kisline ter njihovih glukuronidnih konjugatov.
4.7 Effects on ability to drive and use machines Mitoxantrone has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Mitoksantron nima vpliva na sposobnost vožnje in upravljanja s stroji.
You should also tell your doctor if you are already taking Novantrone and you are prescribed a new medicine that you have not already taken at the same time as Novantrone.
Prav tako morate svojemu zdravniku povedati, če že prejemate zdravilo Novantrone in vam želi predpisati novo zdravilo, ki ga še niste jemali istočasno kot zdravilo Novantrone.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, vključno s sulfiti, ki lahko nastanejo med proizvodnjo mitoksantrona.
A cumulative dose of 72 mg/m² is still effective and associated with less cardiotoxicity than higher cumulative doses.
Kumulativni odmerek 72 mg/m² je še vedno učinkovit in povezan z manjšo kardiotoksičnostjo kot višji kumulativni odmerki.
The medicine also suppresses the immune system and is used because of this effect to treat a specific form of multiple sclerosis when there are no alternative treatment options.
Zdravilo zavira tudi imunski sistem in se zaradi tega učinka uporablja za zdravljenje posebne oblike multiple skleroze, kadar ni druge možnosti zdravljenja.
• if you use Novantrone in high doses (>14 mg/m2 per day x 3 days).
• če jemljete zdravilo Novantrone v velikih odmerkih (> 14 mg/m2 na dan x 3 dni).
Your doctor will decide exactly what dosage you need.
Zdravnik bo natančno določil, kakšen odmerek potrebujete.
Differences in the estimates may be due to the availability of data at late times after doses, weighing of the data and assay sensitivity.
Razlog za razlike v ocenah so lahko razpoložljivost podatkov kasneje po prejetih odmerkih, presoja podatkov in občutljivost analiz.
Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey.
Študije toksičnosti po enkratnih in ponavljajočih odmerkih so bile opravljene na miših, podganah, psih, kuncih in opicah.
Your doctor will carry out blood tests more often, in which he will in particular monitor the number of white blood cells (neutrophilic leucocytes) in the blood:
Vaš zdravnik bo pogosteje opravljal krvne preiskave, v katerih bo zlasti spremljal število belih krvnih celic (nevtrofilnih levkocitov):
This treatment should be used only after assessment of the benefit-risk, particularly concerning the haematological and cardiac risks (see section 4.4).
To zdravljenje se lahko uvede le po oceni koristi in tveganj, zlasti hematoloških tveganj in tveganj za srce (glejte poglavje 4.4).
Novantrone may cause damage to your unborn child.
Zdravilo Novantrone lahko škoduje vašemu nerojenemu otroku.
Therapy with mitoxantrone should be accompanied by close and frequent monitoring of haematological and chemical laboratory parameters, as well as frequent patient observation.
Zdravljenje z mitoksantronom mora spremljati natančno in pogosto spremljanje hematoloških in kemijskih laboratorijskih parametrov, kot tudi pogosto opazovanje s strani bolnika.
Many of the reported half-life values for the elimination phase are between 10 and 40 hours, but several other authors have reported much longer values of between 7 and 12 days.
Številni avtorji študij so poročali o razpolovni dobi faze izločanja med 10 in 40 urami, medtem ko je več drugih poročalo o veliko daljši razpolovni dobi 7 do 12 dni.
This is caused by possible side effects, such as confusion or feeling tired (see section 4).
Tako je zaradi morebitnih neželenih učinkov, kot sta zmedenost ali utrujenost (glejte poglavje 4).
The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.
Prvi krog zdravljenja so dali približno 6 tednov po zadnjem krogu indukcijskega zdravljenja; drugi je bil običajno 4 tedne po prvem.
very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Pogostnost je bila določena skladno z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Women of childbearing potential should be informed about increased risk of transitory or persistent amenorrhoea (see section 4.6).
Ženske v rodni dobi je treba seznaniti s povečanim tveganjem za prehodno ali trajno amenorejo (glejte poglavje 4.6).
Novantrone must not be used during pregnancy for treatment of multiple sclerosis (specifically in the first three months of the pregnancy).
Novantrone se ne sme uporabljati med nosečnostjo za zdravljenje multiple skleroze (še posebej v prvih treh mesecih nosečnosti).
This may occur either during or months to years after therapy with Novantrone.
To se lahko zgodi bodisi med zdravljenjem ali več mesecev in let po zdravljenju z zdravilom Novantrone.
This dosage is given in 21 day-cycles, for induction therapy in AML during three consecutive days, for consolidation therapy during two days.
Ta odmerek je bil dan v 21-dnevnih ciklih, pri indukcijskem zdravljenju AML v treh zaporednih dneh, za konsolidacijsko zdravljenje tekom dveh dni.
A neutropenia can occur after each administration.
Nevtropenija se lahko pojavi po vsakem dajanju.
In the several studies in multiple sclerosis the effective cumulative dose ranged from 36 mg/m to 120 mg/m2.
V več raziskavah pri multipli sklerozi je bil učinkoviti kumulativni odmerek v razponu od 36 mg/m2 do 120 mg/m2.
Other medicines and Novantrone
Druga zdravila in zdravilo Novantrone
Cases of congestive heart failure with left-ventricular ejection fraction (LVEF) < 50 % have also been reported (see section 4.4).
Poročali so tudi o primerih kongestivnega srčnega popuščanja z iztisno frakcijo levega ventrikla (LVEF) < 50 % (glejte poglavje 4.4).
If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.
Če je mogoče, se izogibajte žilam v sklepih ali okončinah z ogroženimi venami ali z limfno drenažo.
Therefore, live virus vaccines should not be administered during therapy.
Zato se živa cepiva med zdravljenjem ne smejo uporabljati.
- Changes to the colour of the whites of the eyes.
- izpuščaj, - spremembe v barvi beločnic,
When mitoxantrone is used in high doses (> 14 mg/m2/d x 3 days) such as indicated for the treatment of leukaemia, severe myelosuppression will occur.
Ko se mitoksantron uporablja v visokih odmerkih (> 14 mg/m2/d x 3 dni), kot je indicirano za zdravljenje levkemije, se pojavi huda mielosupresija.
The recommended dose is based on your body surface area, which is calculated in square metres (m2) using your height and weight.
Priporočeni odmerek je odvisen od vaše telesne površine, ki se izračuna v kvadratnih metrih (m2) z uporabo vaše višine in telesne mase.
The active substance was carcinogenic in experimental animals at doses below the proposed clinical dose.
Zdravilna učinkovina je rakotvorna pri poskusnih živalih pri odmerkih, nižjih od predlaganih kliničnih odmerkov.
In comparative oncology trials, the overall cumulative probability rate of moderate or severe decreases in LVEF at this dose was 13%.
V primerjalnih onkoloških raziskavah je pri tem odmerku skupna kumulativna stopnja verjetnosti za zmerno ali resno zmanjšanje LVEF znašala 13 %.
There are very limited data on the use of mitoxantrone in pregnant women.
Nosečnost Podatkov o uporabi mitoksantrona pri nosečnicah je zelo malo.
The medicinal product must also not be given by intrathecal injection.
Zdravila se prav tako ne sme dajati z intratekalno injekcijo.
Mitoxantrone should be used with caution.
Mitoksantron je treba uporabljati zelo previdno.
This leaflet was last revised in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec leto}.
A reversible thrombocytopenia can also be observed.
Opažena je tudi reverzibilna trombocitopenija.
Novantrone belongs to the group of medicines known as antineoplastic or anti-cancer medicines.
Zdravilo Novantrone spada v skupino zdravil, znanih kot antineoplastična zdravila ali zdravila proti raku.
It also belongs to the subgroup of anti-cancer medicines called anthracyclines.
Prav tako spada v podskupino zdravil proti raku, imenovanih antraciklini.
Oedema Extravasation* Dysgeusia
Ekstravazacija* Disgevzija
It must always be administered as an intravenous infusion (in a vein) and must always be diluted before.
Zdravilo mora biti vedno dano v obliki intravenske infuzije (v veno) in pred tem vedno razredčeno.
Its therapeutic efficacy has been reported in numerous malignancies.
O njegovih zdravilnih učinkih so poročali v primerih številnih malignih bolezni.
Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2.
Porazdelitev Porazdelitev v tkiva je obsežna: porazdelitveni volumen v stanju ravnovesja presega 1.000 l/m2.
Amongst the 80 enrolled patients the median values for the lowest white blood cell count and platelet count were 400/μl (WHO grade 4), and 9.500/μl (WHO grade 4),
Med 80 vključenimi bolniki so mediane vrednosti za najnižje število belih krvnih celic in trombocitov znašale 400/μl (4. stopnja po SZO) oz. 9,500/μl (4. stopnja po SZO).
This risk increases with cumulative dose.
Tveganje se povečuje s kumulativnim odmerkom.
The effect of gender, race, and renal impairment on mitoxantrone pharmacokinetics is unknown.
Učinek spola, rase in okvare ledvic na farmakokinetiko mitoksantrona ni znan.
In the absence of sufficient efficacy data in the adjuvant treatment of breast cancer and accounting for the increased risk of leukaemia, mitoxantrone should only be used for metastatic breast cancer.
Zaradi pomanjkanja zadostnih podatkov o učinkovitosti pri adjuvantnem zdravljenju raka dojke in povečanega tveganja za levkemijo se sme mitoksantron uporabljati samo v primeru metastatskega raka dojke.
These medicines should be used with care or may need to be avoided during your treatment with Novantrone.
Ta zdravila je treba uporabljati previdno ali se jim izogniti med zdravljenjem z zdravilom Novantrone.
A lower initial dosage
Nižji začetni odmerek
- Reduction of the volume of blood that the left ventrical can pump, with no symptoms.
- zmanjšanje obsega krvi, ki ga lahko črpa levi prekat, brez simptomov,
If used with other agents against cancer:
Pri uporabi z drugimi zdravili proti raku:
Inhibitors of the BCRP transporter (e.g. eltrombopag, gefitinib) could result in an increased bioavailability.
Zaviralci prenašalca BCRP (npr. eltrombopag, gefitinib) lahko povzročijo povečano biološko uporabnost.
There have been reports of neuropathy and neurotoxicity, both central and peripheral, following intrathecal injection.
Obstajajo poročila o nevropatiji in nevrotoksičnosti, tako centralni kot periferni, zaradi intratekalnega injiciranja.
The infusion liquid can leak out of the vein into the tissue (extravasation).
Tekočina infuzije lahko uhaja iz vene v tkivo (ekstravazacija).
For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to normal levels after 21 days.
V naslednjih ciklih se predhodni odmerek običajno lahko ponovi, če se je število belih krvnih celic in trombocitov po 21 dneh vrnilo na normalno raven.
Haematopoietic, gastrointestinal, hepatic or renal toxicity may be seen, depending on the dosage given and the physical condition of the patient.
Lahko se pojavijo hematopoetska, gastrointestinalna, jetrna ali ledvična toksičnost, odvisno od odmerka in fizičnega stanja bolnika.
It is recommended that frequent peripheral blood cell counts are performed on all patients receiving mitoxantrone in order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection.
Priporočljivo je pogosto spremljanje periferne krvne slike pri vseh bolnikih, ki prejemajo mitoksantron, z namenom nadzorovanja pojava supresije kostnega mozga, predvsem nevtropenije, ki je lahko huda in povzroči okužbo.
The tubing should be inserted preferably into a large vein.
Cevko je treba po možnosti vstaviti v veliko veno.
Levels of uric acid, electrolytes and urea should be monitored.
Spremljati je treba raven sečne kisline, elektrolitov in sečnine.
- Heavy bleeding.
- močne krvavitve,
Adjustments of the anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
Za ohranitev želene ravni antikoagulantov bo morda treba prilagoditi odmerek antikoagulantov .
For this reason, patients should be monitored for evidence of cardiac toxicity and questioned about symptoms of heart failure prior to the initiation of and during treatment.
Zato je treba biti pri bolnikih pozoren na znake srčne toksičnosti in jih spraševati o simptomih srčnega popuščanja pred začetkom zdravljenja in med njim.
Novantrone must also not be injected into the space under the brain or spinal cord (intrathecal injection) as this can result in severe injury with permanent impairment.
Zdravilo Novantrone se prav tako ne sme injicirati v prostor pod možgani ali v hrbtenjačo (intratekalno injiciranje), saj to lahko povzroči hude poškodbe s trajnimi okvarami.
What Novantrone is and what it is used for
Kaj je zdravilo Novantrone in za kaj ga uporabljamo
Haematological toxicity is difficult to evaluate in acute leukaemia because traditional parameters of bone marrow depression such as white blood cell and platelet counts are confounded by marrow replacement with leukemic cells.
Hematološko toksičnost je pri akutni levkemiji težko oceniti, ker so tradicionalni parametri depresije kostnega mozga, kot je število belih krvnih celic in trombocitov, zamegljeni zaradi zamenjave mozga z levkemičnimi celicami.
Patients who receive immunosuppressive agents like mitoxantrone have a reduced immunological response to infection.
Bolniki, ki prejemajo imunosupresivna zdravila, kot je mitoksantron, beležijo zmanjšan imunski odziv na okužbo.
Because of the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding is contraindicated (see section 4.3) and must be discontinued before starting treatment.
Zaradi možnosti resnih neželenih učinkov pri dojenčkih zaradi mitoksantrona je dojenje kontraindicirano (glejte poglavje 4.3) in ga je treba prekiniti pred začetkom zdravljenja.
What Novantrone is and what it is used for What you need to know before you use Novantrone How to use Novantrone
Kaj vsebujejo ta navodila Kaj je zdravilo Novantrone in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Novantrone Kako uporabljati zdravilo Novantrone
Your doctor will do heart function tests before you start Novantrone and at regular intervals during therapy.
Vaš zdravnik bo opravljal teste delovanja srca preden se začnete zdraviti z zdravilom Novantrone in v rednih časovnih presledkih med zdravljenjem.
The treatment must not be initiated in patients who have been previously treated with mitoxantrone.
Zdravljenja se ne sme začeti pri bolnikih, ki so bili predhodno zdravljeni z mitoksantronom.
No teratogenic effects were observed in these studies, but the maximum doses tested were well below the recommended human dose (0.02 and 0.05 times in rats and rabbits, respectively, on an mg/m2
V teh študijah ni bilo opaziti teratogenih učinkov, vendar so bili največji preizkušeni odmerki nižji od priporočenega odmerka za človeka (0,02- in 0,05-kratnik pri podganah in kuncih oziroma na osnovi mg/m2).
Heart function tests prior and during treatment with Novantrone Novantrone may damage your heart and cause a deterioration of your heart function or in more severe cases heart failure.
Testi srčne funkcije pred in med zdravljenjem z zdravilom Novantrone Zdravilo Novantrone lahko poškoduje vaše srce in povzroči poslabšanje vaše srčne funkcije ter v hujših primerih srčno popuščanje.
Vaccinations and immunisation (protection against the vaccination substances) may not work during treatment with Novantrone and for three months after the end of treatment.
Cepljenje in imunizacija (zaščita pred cepilnimi snovmi) morda ne bosta učinkovita med zdravljenjem z zdravilom Novantrone in še 3 mesece po koncu zdravljenja.
Mutagenicity and carcinogenicity
Mutagenost in rakotvornost
In case of non-haematological toxicities WHO grade 2 to 3 the following dose should be adjusted to 10 mg/m2, in case of non-haematological toxicity grade 4 the treatment should be discontinued.
V primeru nehematološke toksičnosti 2. do 3. stopnje po SZOje treba naslednji odmerek prilagoditi na 10 mg/m2, v primeru nehematološke toksičnosti 4. stopnje pa je treba zdravljenje prekiniti.
Dosage modification and the timing of subsequent dosing should be determined by clinical judgment depending on the degree and duration of myelosuppression.
Prilagajanje odmerjanja in čas nadaljnjega odmerka je treba določiti na podlagi klinične ocene, odvisno od stopnje in trajanja mielosupresije.
If you become pregnant during the treatment with Novantrone, you must tell your doctor immediately and stop treatment with Novantrone.
Če zanosite med zdravljenjem z zdravilom Novantrone, morate o tem nemudoma obvestiti svojega zdravnika in prekiniti zdravljenje z zdravilom Novantrone.
It has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting lack of cell cycle phase specificity and activity against rapidly proliferating and slow-growing neoplasms.
Ima citocidno delovanje na deleče in nedeleče se človeške celice v kulturi, kar kaže na pomanjkanje specifičnosti za fazo celičnega cikla in na aktivnost tako proti hitro delečim se kot počasi rastočim novotvorbam.
Treatment with mitoxantrone 12 mg/m² administered every three months was superior to 5 mg/m² and placebo in one clinical study with highly active inflammatory active MS disease.
Zdravljenje z 12 mg/m² mitoksantrona vsake tri mesece je bilo boljše od 5 mg/m² in placeba v eni klinični študiji z visoko aktivno vnetno MS.
Before you start Novantrone and during treatment, your doctor will do a blood test to count the number of your blood cells.
Preden začnete jemati zdravilo Novantrone in med zdravljenjem bo zdravnik opravil krvne teste, da bi preveril število krvnih celic.
The combination of mitoxantrone with other immunosuppressive agents may increase the risk of excessive immunodepression and lymphoproliferative syndrome.
Kombinacija mitoksantrona in drugih imunosupresivnih zdravil lahko poveča tveganje za prekomerno imunosupresijo in limfoproliferativni sindrom.
Mitoxantrone blocks the cell cycle in G2-phase leading to an increase of cellular RNA and polyploidy.
Mitoksantron zavira cikel celic v fazi G2, kar vodi v povečanje količine celične RNA
Mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 4.2, 4.4 and 5.1).
Mitoksantron je indiciran za zdravljenje bolnikov z zelo aktivno recidivno multiplo sklerozo, povezano s hitro razvijajočo se invalidnostjo, ko ni drugih možnosti zdravljenja (glejte poglavja 4.2, 4.4 in 5.1).