natgillin/translations-raw huggingface dataset:
In order to effectively minimise these risk the CMHP considered that in addition to the MAH proposal to evaluate the LVEF prior to each dose of mitoxantrone in multiple sclerosis patients, it should also be monitored yearly for up to 5 years after the end of therapy and the maximum cumulative dose should not be exceeded.
Da bi učinkovito zmanjšal ta tveganja, je odbor CHMP presodil, da je treba pri bolnikih z multiplo sklerozo LVEF meriti ne le pred vsakim odmerkom mitoksantrona, kot je predlagal imetnik dovoljenja za promet z zdravilom, ampak tudi vsako leto vsaj še pet let po končanem zdravljenju, poleg tega pa se ne sme preseči največji kumulativni odmerek.
The CHMP sought the advice of the SAG Neurology in order to gain insight into the current clinical use of mitoxantrone and clearly define the patient population which can benefit from this treatment.
Odbor CHMP se je za nasvet obrnil na znanstveno svetovalno skupino za nevrologijo, da bi dobil vpogled v trenutno klinično uporabo mitoksantrona in jasno opredelil populacijo bolnikov, ki bi ji to zdravljenje lahko koristilo.
• The Committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet.
• odbor je soglašal z uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
The SAG considered that mitoxantrone could be used in treatment of inflammatory active multiple sclerosis associated with accumulation of disability where no other treatment option is available.
Znanstvena svetovalna skupina je presodila, da bi se mitoksantron lahko uporabljal pri vnetno aktivni multipli sklerozi, povezani z napredovanjem invalidnosti, pri kateri ni na voljo nobena druga možnost zdravljenja.
These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL.
Te študije so pokazale učinkovitost mitoksantrona pri zdravljenju NHL v kombiniranem zdravljenju.
In some MS Novantrone was contraindicated for use as an adjuvant treatment for breast cancer, in relation to the possible risk of leukaemia.
V nekaterih državah članicah je bilo zdravilo Novantrone kontraindicirano pri adjuvantnem zdravljenju raka dojke zaradi potencialnega tveganja za levkemijo.
The results suggested a dose-response effect which forms supporting evidence of biological activity of mitoxantrone in multiple sclerosis.
Rezultati so nakazali odziv (učinek) v odvisnosti od odmerka, kar je podkrepilo dokaze o biološkem delovanju mitoksantrona pri multipli sklerozi.
There are currently three main indications, approved in all member states where Novantrone has a marketing authorisation (MA), with however divergences in their exact wording: treatment of metastatic breast cancer, treatment of non-Hodgkin's lymphoma, treatment of acute myeloid leukaemia (acute non-lymphocytic leukaemia).
Trenutno obstajajo tri glavne indikacije, ki so odobrene v vseh državah članicah, kjer ima zdravilo Novantrone dovoljenje za promet, pri čemer pa se njihovo besedilo nekoliko razlikuje: zdravljenje metastatskega raka dojke, zdravljenje ne-Hodgkinovega limfoma, zdravljenje akutne mieloične levkemije (akutne nelimfocitne levkemije).
It is also used to alleviate pain in prostate cancer in combination with corticosteroids and its immunosuppressant and immunomodulatory properties provide a rationale for use of mitoxantrone in highly active multiple sclerosis.
V kombinaciji s kortikosteroidi se uporablja tudi za lajšanje bolečine pri raku prostate, imunosupresivne in imunomodularne lastnosti mitoksantrona pa so razlog za njegovo uporabo pri visoko aktivni multipli sklerozi.
In addition, the CMHP requested the advice of the SAG and of the PRAC regarding the need for additional risk minimisation measures.
Poleg tega se je odbor CHMP za nasvet o potrebi po dodatnih dejavnostih za zmanjševanje tveganja obrnil na znanstveno svetovalno skupino in odbor PRAC.
The data indicate an effect of mitoxantrone, in combination with corticosteroids, for the palliation (e.g. pain relief) of patients with advanced castrate-resistant prostate cancer (CRPC).
Podatki kažejo, da je mitoksantron v kombinaciji s kortikosteroidi učinkovit pri lajšanju simptomov (npr. lajšanju bolečine) pri bolnikih z napredovalim, proti kastraciji odpornim rakom prostate (KORP).
• The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including clinical trials, open studies, published studies and reviews as well as evidence based and consensus guidelines.
• odbor je pregledal podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom, vključno s kliničnimi preizkušanji, odprtimi študijami,
The MAH has submitted an overview of studies performed in this indication including single agent studies and large randomised comparative studies using mitoxantrone in combination with other agents and comparing with other regimens.
Imetnik dovoljenja za promet z zdravilom je predložil pregled za to indikacijo izvedenih študij, vključno s študijami z eno samo učinkovino in velikimi randomiziranimi primerjalnimi študijami, v katerih so mitoksantron uporabili v kombinaciji z drugimi učinkovinami in primerjali z drugimi shemami.
The CHMP considered the clinical benefit of mitoxantrone demonstrated in adults and recommended the use of the term acute myeloid leukaemia rather than acute non-lymphocytic leukaemia.
Odbor CHMP je presodil, da so bile klinične koristi mitoksantrona pri odraslih dokazane, in namesto izraza „akutna nelimfocitna levkemija“ priporočil uporabo izraza „akutna mieloična levkemija“.
For acute myeloid leukaemia dosing recommendations were proposed as a single agent in relapses and in combination as induction, consolidation and salvage therapy.
Za akutno mieloično levkemijo so bila predlagana priporočila o odmerjanju pri samostojni uporabi pri relapsih in v kombinaciji v indukcijskem, konsolidacijskem in rešilnem zdravljenju.
The MAH presented an overview of studies of mitoxantrone, mainly in patients with relapsing remitting and secondary progressive multiple sclerosis.
Imetnik dovoljenja za promet z zdravilom je predložil pregled študij mitoksantrona, predvsem pri bolnikih z relapsno-remitentno in sekundarno progresivno multiplo sklerozo.
Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation.
Odbor CHMP je zato soglašal s predlagano indikacijo za lajšanje simptomov pri KORP.
Novantrone is indicated in adults in a number of malignancies, including breast carcinoma, acute leukaemia and non-Hodgkin's lymphoma.
Zdravilo Novantrone je indicirano pri odraslih za zdravljenje številnih vrst malignih bolezni, med drugim karcinoma dojke, akutne levkemije in neHodgkinovega limfoma.
In addition, indications in treatment of hepatoma/hepatocellular carcinoma, pain relief in patients with advanced, hormone-resistant prostate cancer (in combination with corticosteroids), reduction of neurologic disability and clinical relapses in secondary (chronic) progressive multiple sclerosis, treatment of blast crisis in (chronic) myeloid leukaemia and treatment of acute lymphocytic leukaemia are included in some of the MSs where Novantrone has a MA.
Poleg tega so v nekaterih državah članicah, kjer ima zdravilo Novantrone dovoljenje za promet, med indikacije vključeni tudi zdravljenje hepatoma/hepatocelularnega karcinoma, lajšanje bolečine pri bolnikih z napredovalim hormonsko odpornim rakom prostate (v kombinaciji s kortikosteroidi), zmanjševanje nevrološke invalidnosti in števila kliničnih relapsov pri sekundarni (kronični) progresivni multipli sklerozi, zdravljenje blastne krize pri (kronični) mieloični levkemiji in zdravljenje akutne limfocitne levkemije.
The cardiovascular and leukaemia risks were considered key to the benefit-risk balance in the multiple sclerosis indication and were reviewed in details as well as risk minimisation measures proposed to manage those.
Kot ključna za razmerje med tveganji in koristmi pri indikaciji za multiplo sklerozo so bila prepoznana in natančno pregledana kardiovaskularna tveganja in tveganja za levkemijo, pri čemer so bile za njihovo obvladovanje predlagane tudi dejavnosti za zmanjševanje tveganja.
The MAH also proposed to harmonise a contraindication present in a MS against the immunisation with a live attenuated vaccine.
Imetnik dovoljenja za promet z zdravilom je predlagal tudi uskladitev kontraindikacije pri imunizaciji z živim oslabljenim cepivom v eni od držav članic.
In addition to those described above, warnings related to incorrect route of administration, to cardiac risks, risk of leukaemia and bone marrow/haematological monitoring recommendations, reduced immunological response to infection, secondary AML and MDS were considered acceptable with some amendments.
Poleg opisanih opozoril so bila z nekaterimi spremembami kot sprejemljiva ocenjena opozorila v zvezi z nepravilno potjo uporabe, tveganji za srce, tveganjem za levkemijo, priporočila o spremljanju kostnega mozga/hematološkem spremljanju, zmanjšanem imunskem odzivu na okužbo, sekundarnih AML in MDS.
Finally, warnings relative to the mutagenic potential, to the potential discoloration of urine and other tissues, to the risk of tumour lysis syndrome and contraception recommendations, risk of transient or persistent amenorrhea, present in some members states were considered relevant.
Kot ustrezna so bila ocenjena v nekaterih državah članicah uporabljana opozorila o mutagenem potencialu, potencialnem obarvanju urina in tkiv, tveganju za sindrom tumorske lize in priporočila o kontracepciji ter tveganju za prehodno ali trajno amenorejo.
The MAH recalculated the frequencies as per the SmPC guideline and included details of the most important adverse reactions.
Imetnik dovoljenja za promet z zdravilom je ponovno izračunal pogostnosti po smernici o povzetku glavnih značilnosti zdravila in vključil podrobnosti o najpomembnejših neželenih učinkih.
The proposal of the MAH for this section was accepted with minor amendments in line with the rest of the SmPC and rearrangement of the information taking into account the QRD requirements.
Predlog imetnika dovoljenja za promet z zdravilom je bil sprejet z manjšimi spremembami v skladu s preostalim povzetkom glavnih značilnosti zdravila in prerazporeditvijo informacij z upoštevanjem zahtev za pregled kakovosti dokumentov.
The CHMP also considered that in the table of ADR in multiple sclerosis the footnote specifying that the events amenorrhea may be consistent with premature menopause and that the causal relationship between the cases of sudden death and mitoxantrone administration is uncertain should be left in the harmonised PI.
Odbor CHMP je presodil tudi, da je treba v usklajenih informacijah o zdravilu v preglednici neželenih učinkov pri multipli sklerozi pustiti opombo, v kateri je navedeno, da lahko pojav amenoreje nakazuje prezgodnjo menopavzo in da vzročno razmerje med primeri nenadne smrti in dajanjem mitoksantrona ni pojasnjeno.
Treatment of acute lymphocytic leukaemia
Zdravljenje akutne limfocitne levkemije
The MAH was asked to discuss the relevance of including four ADRs, which have been reported and are listed in the PI of other mitoxantrone-containing products.
Imetnik dovoljenja za promet z zdravilom je bil naprošen, naj obravnava smiselnost vključitve štirih neželenih učinkov, o katerih so poročali pri drugih zdravilih, ki vsebujejo mitokstantron, in ki so navedeni v informacijah o teh zdravilih.
The MAH presented four studies of mitoxantrone administered in combination with other cytostatic agents in the treatment of a blast crisis in chronic myeloid leukaemia.
Imetnik dovoljenja za promet z zdravilom je predložil štiri študije, v katerih je bil mitoksantron uporabljen v kombinaciji z drugimi citostatičnimi zdravili za zdravljenje blastne krize pri kronični mieloični levkemiji.
Based on the data provided, the MAH was asked to add dysgeusia in the table listing the ARDs reported in oncology.
Imetnik dovoljenja za promet z zdravilom je bil na osnovi predloženih podatkov naprošen, naj v preglednico neželenih učinkov, o katerih so poročali v onkologiji, doda disgevzijo.
The MAH presented an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with specific subgroups of NHL, pre-treated or treatment naïve.
Imetnik dovoljenja za promet z zdravilom je predstavil pregled študij, ki so bile izvedene z mitoksantronom samim ali v kombiniranih shemah za zdravljenje bolnikov s posameznimi podskupinami NHL, ki so bili predhodno zdravljeni ali pa še niso bili zdravljeni.
The CMHP was of the view that, in line with the SmPC guideline, as confusion and fatigue have been reported with mitoxantrone, it should be mentioned that the treatment has minor influence on those abilities.
Odbor CHMP je ocenil, da je treba v skladu s smernico o povzetku glavnih značilnosti zdravila omeniti, da mitoksantron blago vpliva na te sposobnosti, saj so pri njegovi uporabi poročali o zmedenosti in utrujenosti.
In addition, as multiple sclerosis is not a life threatening disease, mitoxantrone should be contraindicated in the treatment of multiple sclerosis in pregnant women.
Poleg tega mora biti mitoksantron kontraindiciran pri zdravljenju multiple skleroze v nosečnosti, saj multipla skleroza ni življenjsko nevarna bolezen.
The MAH provided a phase III study and several uncontrolled phase II studies in induction therapy as well as studies of mitoxantrone in combination regimens in relapsed/refractory ALL (including a study in children).
faze v zvezi z indukcijskim zdravljenjem ter študije, v katerih je bil mitoksantron uporabljen v kombiniranih shemah pri relapsni/refraktorni ALL (vključno s študijo pri otrocih).
These measures were considered adequate by the SAG and the PRAC, who further considered the numerous requirement and their importance for the safe use of the product in multiple sclerosis, educational material should be developed and a study should be conducted to ensure they are adhered to.
Ti ukrepi so bili po mnenju znanstvene svetovalne skupine in odbora PRAC, ki sta obravnavala tudi številne zahteve in njihov pomen za varno uporabo zdravila pri multipli sklerozi, zadostni.
The MAH provided several phase II studies and case studies reported in the literature where mitoxantrone was given to patients with HCC.
faze in študij primerov, objavljenih v literaturi, pri katerih so mitoksantron dajali bolnikom s hepatocelularnim karcinomom.
Further, as the potential additive risks of mitoxantrone in patients with long term exposure also to other immunosuppressants are not known, the CHMP was of the view that it should be mentioned that the safety and efficacy of mitoxantrone have not been demonstrated after other multiple sclerosis treatments approved more recently.
Poleg tega je odbor CHMP menil, da je treba omeniti, da varnost in učinkovitost mitoksantrona po uvedbi v zadnjem času odobrenih metod za zdravljenje multiple skleroze nista bili dokazani, saj ni znano, ali so pri bolnikih, ki so dolgotrajno izpostavljeni tudi drugim imunosupresivom, z mitoksantronom povezana potencialna aditivna tveganja.
In addition, a complete blood count should be obtained before each dose of mitoxantrone and 10 days following each administration.
Pred vsakim odmerkom mitoksantrona in 10 dni po njem je treba tudi pregledati celotno krvno sliko bolnika.
This was accepted by the MAH which therefore withdrew it from the proposed harmonised PI.
Imetnik dovoljenja za promet z zdravilom je to sprejel in indikacijo umaknil iz predlaganih usklajenih informacij o zdravilu.
Sections related to the unique identifier were added in line with the current QRD template (dated February 2016).
V skladu s trenutno predlogo za pregled kakovosti dokumentov (objavljeno februarja 2016) so bila dodana poglavja, povezana z edinstveno oznako.
The MAH provided several phase III studies and a phase II study investigating the effect of mitoxantrone in combination with corticosteroids on pain relief and on overall survival.
faze, v katerih je preučeval učinek mitoksantrona v kombinaciji s kortikosteroidi na lajšanje bolečine in skupni čas preživetja.
The MAH considered relevant to list Tumour lysis syndrome.
Imetnik dovoljenja za promet z zdravilom je ocenil, da je v preglednico smiselno vključiti sindrom tumorske lize.
In addition, the increased thrombotic or haemorrhage risk with concomitant Vitamin K antagonists with tumoural disease, widely described in the literature was considered relevant to be added by the CHMP.
Poleg tega je odbor CHMP presodil, da je smiselno dodati opozorilo o povečanem trombotičnem in hemoragičnem tveganju pri sočasni uporabi antagonistov vitamina K in prisotnosti tumorske bolezni.
For this reason also, it was specified that Novantrone should not be initiated for treatment of multiple sclerosis in patients who have already been treated with it. A dosing adjustment guide, based on bone marrow suppression was kept in the harmonised text in order to minimise the risk of leukaemia.
Tudi zato je bilo določeno, da se zdravilo Novantrone ne sme uvesti pri bolnikih z multiplo sklerozo, ki so bili z njim že zdravljeni.
The MAH submitted an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with advanced or metastatic breast cancer.
Imetnik dovoljenja za promet z zdravilom je predložil pregled študij, v katerih so bili bolniki z napredovalim ali metastatskim rakom dojke zdravljeni z mitoksantronom samim ali v kombiniranih shemah.
The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravniškemu ali zdravstvenemu osebju:
Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014
Datum prve odobritve: 02/07/2009 Datum zadnjega podaljšanja: 03/03/2014
Please inform your baby's doctor:
Obvestite otrokovega zdravnika:
The optimal duration of treatment has not been established.
Trajanje zdravljenja Optimalno trajanje zdravljenja ni bilo ugotovljeno.
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* Beginning 24 hours after the loading dose
* z začetkom 24 ur po začetnem odmerku
No support
brez podpore
Frequency is 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) and not known (cannot be estimated from the available data).
Pogostnost je opredeljena 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) in neznani (iz razpoložljivih podatkov jih ni možno oceniti).
This method is also known as “a drip”.
Ta način je znan tudi kot „kapalna infuzija“.
In newborn infants, the t1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days).
Pri novorojenčkih je t1/2 približno 3-4 dni in Ae približno 86 % (v 6 dneh).
Maintenance dose*
Vzdrževalni odmerek*
If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment.
Če je vaš otrok 5 do 7 dni brez napadov apneje, bo zdravnik prekinil zdravljenje.
EU/1/09/528/002 1 ml ampoules EU/1/09/528/001 3 ml ampoules
EU/1/09/528/002 1 ml ampule EU/1/09/528/001 3 ml ampule
If concurrent use is indicated, cardiac rhythm and blood pressure must be carefully monitored.
Če je indicirana sočasna uporaba, je treba skrbno nadzirati srčni ritem in krvni tlak.
Non invasive support
neinvazivna podpora
− infants with known and clinically significant cardiac disease
− dojenčki z znano in klinično pomembno boleznijo srca
Treatment of caffeine overdose is primarily symptomatic and supportive.
Zdravljenje prevelikega odmerka kofeina je predvsem simptomatično in podporno.
Clear, colourless, aqueous solution at pH=4.7.
Bistra, brezbarvna, vodna raztopina pri pH = 4,7.
Odds ratio (95% CI)
Razmerje verjetnosti (95 % IZ)
Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25ºC and at 2-8ºC.
Dokazana je 24-urna kemična in fizikalna združljivost razredčene raztopine pri 25 ºC in 2-8 ºC.
6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
6 POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out.
Čeprav ne kaže, da bi kofein poslabšal cerebralno hipoksijo ali poslabšal katere koli posledične poškodbe, te možnosti ni mogoče izključiti.
• If your newborn is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6).
• če je novorojenček alergičen na kofeinijev citrat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Blood samples for monitoring should be taken just before the next dose in the case of therapeutic failure and 2 to 4 hours after the previous dose when suspecting toxicity.
Vzorce krvi za nadziranje je treba vzeti tik pred naslednjim odmerkom v primeru, da zdravljenje ni bilo uspešno in 2 do 4 ure po predhodnem odmerku, če obstaja sum na toksičnost.
Death or disability according to subgroup of respiratory support at entry to study
Smrt ali invalidnost po podskupinah dihalne podpore ob vstopu v študijo:
In a recent large multicentre study on preterm newborn infants a median treatment period of 37 days was reported.
V pred kratkim opravljeni multicentrični študiji z nedonošenimi novorojenčki so poročali o 37-dnevnem srednjem obdobju zdravljenja.
Failure to respond to caffeine treatment (confirmed if necessary by measurement of plasma levels) could be an indication of another cause of apnoea.
Neodzivanje na zdravljenje s kofeinom (po potrebi potrjeno z izmerjenimi ravnmi v plazmi) lahko kaže na drugi vzrok za apnejo.
In clinical practice, treatment is usually continued until the infant has reached a post-menstrual age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously.
V klinični praksi se zdravljenje običajno nadaljuje, dokler dojenček ne doseže postmenstrualne starosti 37 tednov, do katere apneja zaradi nezrelosti običajno spontano izzveni.
Peyona should be used with caution.
Zdravilo Peyona je treba uporabljati previdno.
These effects are dose related and may necessitate measurement of plasma levels and dose reduction.
Ti učinki so odvisni od odmerka in bodo morda zahtevali merjenje ravni v plazmi in zmanjšanje odmerka.
Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy.
Zabeležili so prehodne upade tiroksina (T4) pri dojenčkih na začetku zdravljenja, ki pa se z vzdrževanjem terapije ne ohranijo.
The medicinal product must not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection.
Zdravila se ne sme dati z intramuskularno, subkutano, intratekalno ali intraperitonealno injekcijo.
Tell your baby's doctor if your newborn is taking, have recently taken or might take any other medicines.
Obvestite otrokovega zdravnika, če novorojenček prejema, je pred kratkim prejel ali pa bo morda začel prejemati katero koli drugo zdravilo.
Via Enrico Fermi IT-65020 Alanno (PE) Italy
Via Enrico Fermi IT-65020 Alanno (PE) Italija
It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack.
Priporoča se ukinitev dajanja kofeinijevega citrata, če bolnik 5-7 dni ne doživi znatnega napada apneje.
• If your newborn produces more urine than usual
• če vaš novorojenček odvaja več urina kot običajno
Dosage adjustments and monitoring
Prilagajanje odmerka in spremljanje
However, at high doses convulsions in rodents were induced.
Vendar pa so visoki odmerki sprožili konvulzije pri glodavcih.
Three of the infants who developed necrotising enterocolitis during the study died.
Trije dojenčki, pri katerih se je v času preskušanja razvil nekrotizirajoči enterokolitis, so umrli.
• If your newborn has frequent regurgitation
• če ima novorojenček pogoste regurgitacije
By 9 months of age, the metabolism of caffeine approximates to that seen in adults (t1/2 = 5 hours and Ae = 1%).
Pri 9 mesecih starosti je presnova kofeina približno enaka tisti pri odraslih (t1/2 = 5 ur in Ae = 1 %).