natgillin/translations-raw huggingface dataset:
EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/004 - 1 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml))
EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/002 - 1 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml))
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 1000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Kovaltry 1000 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 2000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Kovaltry 2000 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Kovaltry 3000 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Headache, dizziness common
• bolečina ali neprijeten občutek v trebuhu
Early haemarthrosis, muscle bleeding or oral bleeding
mišice ali ustno votlino
Surgery
OKENCE)
Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Kaj je zdravilo Kovaltry in za kaj ga uporabljamo Zdravilo Kovaltry vsebuje učinkovino humani rekombinantni koagulacijski faktor VIII, imenovan tudi oktokog alfa.
Icepharma hf.
PC SN NN
System Organ Class
• telesna masa
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
EU/1/15/1076/008 - 1 x (Kovaltry 2000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection
koncentrirana ocetna kislina (ledocet) in voda za injekcije.
For 250/500/1000 IU strength
Vsebnost natrija Kovaltry 250/500/1000 i.e.
Dysgeusia uncommon
• glavobol • omotica
EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/023 - 30 x (Kovaltry 2000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml)) EU/1/15/1076/024 - 30 x (Kovaltry 3000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
Sucrose
Kovaltry.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
EU/1/15/1076/0010 - 1 x (Kovaltry 3000 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
Oral use bottle (HDPE)
100 mg/ml peroralna raztopina peroralna uporaba steklenica (HDPE)
Oral solution
Jakost
These recommendations were considered appropriate.
Ta priporočila so bila ocenjena kot primerna.
These should be included in a risk management plan.
Te je treba vključiti v načrt za obvladovanje tveganj.
• The Committee considered the referral under Article 30 of Directive 2001/83/EC.
• odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
This section was restructured according to guidelines.
To poglavje je bilo preoblikovano v skladu s smernicami.
Treatment of multiple sclerosis (MS)
Zdravljenje multiple skleroze (MS)
Information of lesser relevance was removed in order to focus on the main information.
Manj pomembne informacije so bile odstranjene, da bi izpostavili glavne informacije.
Overall summary of the scientific evaluation of Novantrone and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Novantrone in povezanih imen (glejte Prilogo I)
In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2.
Poleg tega je bil zaradi od odmerka odvisnega tveganja za kardiotoksičnost največji vseživljenjski kumulativni odmerek omejen na 72 mg/m2.
Patients should be advised to seek medical attendance if signs or symptoms develop, including over five years after end of treatment.
Bolnikom je treba svetovati, da v primeru pojava znakov ali simptomov poiščejo zdravniško pomoč, tudi če je od konca zdravljenja preteklo že več kot pet let.
Further it was considered that the interaction with immunosuppressive medicines should be mentioned.
Ocenjeno je bilo tudi, da mora biti omenjena interakcija z imunosupresivnimi zdravili.
The restrictions regarding the use of mitoxantrone in pregnant women was harmonised to reflect the information available.
Omejitve uporabe mitoksantrona pri nosečnicah so bile usklajene tako, da so odražale razpoložljive informacije.
In addition, the committee considered the advice of the Scientific Advisory Group Neurology and of the Pharmacovigilance Risk Assessment Committee.
Poleg tega je odbor upošteval nasvet znanstvene svetovalne skupine za nevrologijo in Odbora za oceno tveganja na področju farmakovigilance;
These should be included in a risk management plan (RMP) with a particular focus on the use in multiple sclerosis to ensure a consistent minimum standard of management of the risks across MSs.
To je treba vključiti v načrt za obvladovanje tveganj (RMP), s posebnim poudarkom na uporabi pri multipli sklerozi, da bi se v vseh državah članicah zagotovil dosleden minimalni standard obvladovanja tveganj.
Due to the divergent national decisions taken by MSs concerning the authorisation of the abovementioned product (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Product Information (PI) and thus to harmonise the PI across the EU.
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z navedenim zdravilom (in povezanimi imeni), je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave neskladij med nacionalno odobrenimi informacijami o zdravilu in uskladitve različnih informacij o zdravilu po vsej EU.
Most of the existing statements on interactions across the MSs were supported.
Podprta je bila večina v državah članicah obstoječih stavkov o interakcijah.
Other sections have only been partially harmonised as it is considered that these should be adapted nationally.
Druga poglavja so bila usklajena samo delno, saj je treba besedilo v njih sprejeti na nacionalni ravni.
In conclusion, the CHMP considered that the indication was not acceptable.
Odbor CHMP je tako zaključil, da indikacija ni sprejemljiva.
The use of mitoxantrone for the treatment of breast cancer is included in current hospital guidelines.
Uporaba mitoksantrona za zdravljenje raka dojke je del trenutnih bolnišničnih smernic.
Relevant information available on risks of infertility was also harmonised.
Usklajene so bile tudi ustrezne razpoložljive informacije o tveganjih za neplodnost.
The CHMP was of the view that the scientific basis for this recommendation was weak and that information regarding vaccination schedule should rather be included in section 4.4 and 4.5, in line with clinical practice guidelines recommendations.
Odbor CHMP je presodil, da je znanstvena osnova za to priporočilo šibka in da bi morali biti podatki o programu cepljenja v skladu s priporočili smernic za klinično prakso podani v poglavjih 4.4 in 4.5.
Treatment of non-Hodgkin's lymphoma (NHL)
Zdravljenje ne-Hodgkinovega limfoma (NHL)
Information on the excretion of mitoxantrone in breast milk and the need to interrupt breastfeeding prior to treatment initiation was consistently reflected across member states.
Informacija o izločanju mitoksantrona z materinim mlekom in o tem, da je treba z dojenjem pred začetkom zdravljenja prenehati, je bila v državah članicah dosledno prisotna.
Separate dosing recommendations were also proposed for treatment of blast crisis and prostate cancer.
Ločena priporočila o odmerjanju so bila predlagana tudi za zdravljenje blastne krize in raka prostate.
However, no benefit in overall survival or other clinically relevant endpoints has been reported.
Niso pa poročali o podaljšanju preživetja ali koristnem vplivu na druge klinično pomembne izide.
In most studies no comparator was used or, when a comparator was used it appeared to be more effective.
Primerjalno zdravilo v večini študij ni bilo uporabljeno oziroma se je zdelo učinkovitejše, kadar je bilo uporabljeno.
The CHMP concluded that the level of evidence provided is limited.
Odbor CHMP je zaključil, da je stopnja dokazov nizka.
Further, mitoxantrone is not recommended in any treatment guidelines for hepatocellular carcinoma.
Poleg tega mitoksantrona ne priporočajo nobene smernice za zdravljenje hepatocelularnega karcinoma.
In view of the above, the Committee concluded that the benefit-risk balance of Novantrone and associated names remains favourable, subject to the agreed condition to the marketing authorisations set out in Annex IV, and taking into account the agreed amendments to the product information and other risk minimisation measures.
Glede na navedeno je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Novantrone in povezanih imen še naprej ugodno, ob upoštevanju dogovorjenega pogoja za dovoljenja za promet z zdravilom, opredeljenega v Prilogi IV, in ob upoštevanju dogovorjenih sprememb informacij o zdravilu in drugih dejavnosti za zmanjševanje tveganja.
The MAH proposed that only the administration via intravenous infusion should be retained, which was accepted.
Imetnik dovoljenja za promet z zdravilom je predlagal, da se ohrani le dajanje z intravensko infuzijo, kar je bilo sprejeto.
Considering the risks of cardiotoxicity and leukaemia, the CHMP was of the view that mitoxantrone use should be limited to the population in which the benefits would outweigh these serious risks.
Ob upoštevanju tveganja za kardiotoksičnost in levkemijo je odbor CHMP menil, da mora biti uporaba mitoksantrona omejena na populacije, pri katerih bi koristi odtehtale ta resna tveganja.
In some member states, additional information was included on absence of interactions or pharmacokinetic and pharmacodynamic interactions without clinical relevance, this was not considered relevant to be included in the harmonised PI.
Za v nekaterih državah članicah vključene dodatne podatke o odsotnosti interakcij ali farmakokinetičnih in farmakodinamičnih interakcijah brez kliničnega pomena je bilo ocenjeno, da jih v usklajene informacije o zdravilu ni smiselno vključiti.
As the harmonised indication is in the treatment of metastatic breast cancer, a warning in section 4.4 informing of the small risk of leukaemia and of the paucity of efficacy data in the adjuvant treatment of breast cancer was considered sufficient.
Ker je zdravljenje metastatskega raka dojke usklajena indikacija, se je opozorilo v poglavju 4.4 o majhnem tveganju za levkemijo in pomanjkanju podatkov o učinkovitosti pri adjuvantnem zdravljenju raka dojke štelo za zadostno.
The studies presented included in majority patients with metastatic breast cancer, this patient population was therefore considered acceptable for the harmonised indication.
Predstavljene študije so v glavnem vključevale bolnike z metastatskim rakom dojke, zato je bila ta populacija bolnikov ocenjena kot sprejemljiva za usklajeno indikacijo.
Novantrone and associated names are approved for marketing as a 2mg/ml concentrate for solution for infusion for intravenous use in most European Union (EU) Member States (MS).
Zdravilo Novantrone in povezana imena so kot 2 mg/ml koncentrat za raztopino za infundiranje za intravensko uporabo odobrena v večini držav članic Evropske unije (EU).
The CMHP followed this advice and considered that given their importance for the safe use of the product, the RMP and educational materials should be imposed as a condition to the MA while the study should be included in the RMP as a category 3.
Odbor CHMP je temu nasvetu sledil in presodil, da morata biti zaradi svojega pomena za varno uporabo zdravila RMP in izobraževalno gradivo pogoj za imetnika dovoljenja za promet z zdravilom, študijo pa je treba v RMP vključiti kot kategorijo 3.
Current guidelines for treatment of AML recommend an induction therapy with regimens containing an anthracycline (such as mitoxantrone) administered for 3 days and cytarabine administered for 7 days.
Trenutne smernice za zdravljenje AML priporočajo indukcijsko zdravljenje s shemami, pri katerih se antraciklin (npr. mitoksantron) daje tri dni in citarabin sedem dni.
Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate.
Priporočilo o redčenju in navodilo za izbiro ven ter opozorilo o ekstravazaciji so bili ocenjeni kot primerni.
Although mitoxantrone is not one of the most frequently used chemotherapy regimens in NHL, the CHMP acknowledged that it could represent an alternative treatment option and considered the proposed harmonised wording acceptable.
Čeprav mitoksantron ni med najpogosteje uporabljanimi kemoterapevtskimi shemami za zdravljenje NHL, je odbor CHMP menil, da bi lahko bil alternativna možnost zdravljenja, in je predlagano usklajeno besedilo ocenil kot sprejemljivo.
The CMHP considered that mitoxantrone should be contraindicated in breastfeeding mothers as it is a potential human teratogen.
Odbor CHMP je presodil, da mora biti mitoksantron kontraindiciran pri doječih materah, saj je potencialni humani teratogen.
General dose lowering for other serious toxicity, including recommendation to discontinue treatment in case of WHO grade 4 toxicity, were also accepted.
Sprejeto je bilo tudi splošno znižanje odmerka pri drugi resni toksičnosti, vključno s priporočilom, da se zdravljenje v primeru toksičnosti 4. stopnje po lestvici SZO prekine.
This indication is currently authorised in only two MSs and current clinical practice guidelines do not support the use of mitoxantrone in ALL.
Ta indikacija je trenutno odobrena le v dveh državah članicah, uporabe mitoksantrona pri ALL pa tudi ne podpirajo trenutne smernice za klinično prakso.
The CHMP as a consequence, recommends the variation to the terms of the marketing authorisations for Novantrone and associated names (see Annex I).
Odbor CHMP zato priporoča spremembo pogojev dovoljenj za promet z zdravilom Novantrone in povezanimi imeni (glejte Prilogo I).
Contraindications against the incorrect routes of administration, due to the risk of extravasation and other contraindications in place in a few member states were also considered more adequately addressed by wording in other sections of the PI.
Tudi za kontraindikacijo za nepravilne poti uporabe zaradi tveganja ekstravazacije in za druge kontraindikacije v nekaterih državah članicah je bilo ocenjeno, da jih je primerneje obravnavati v drugih poglavjih informacij o zdravilu.
Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, vendar je treba večino poglavij dopolniti na nacionalni ravni.
The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies.
Odbor CHMP je presodil, da je bila s temi študijami dokazana učinkovitost mitoksantrona.
The MAH's proposal including the fatal cases reported with overdosage was accepted with the addition of the types of toxicities observed and general recommended actions.
Predlog imetnika dovoljenja za promet z zdravilom, vključno s poročili o primerih smrti pri prevelikem odmerjanju, je bil sprejet, pri čemer so bili dodani opažene vrste toksičnosti in splošni priporočeni ukrepi.
• The Committee considered the identified divergences for Novantrone and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet.
• odbor je upošteval ugotovljene razlike za zdravilo Novantrone in povezana imena za indikacije, odmerjanje, kontraindikacije, posebna opozorila in previdnostne ukrepe ter preostala poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
The standard contraindication in case of hypersensitivity to the active substance or any of the excipients (including sulphite, as already mentioned in some member states) was kept in the harmonised text.
V usklajenem besedilu je ostala standardna kontraindikacija pri preobčutljivosti na zdravilno učinkovino ali katero koli pomožno snov (tudi sulfit, kot je bilo v nekaterih državah članicah že omenjeno).
Information on the need for contraception in men was added to that already included for women and both were adjusted considering mitoxantrone half-life and respective gamete cycles length in men and women.
Poleg informacije, da je potrebna kontracepcija pri ženskah, je bila dodana tudi informacija o potrebi po kontracepciji pri moških, obe pa sta bili posodobljeni na podlagi podatkov o razpolovni dobi mitoksantrona in dolžinah gametnega ciklusa pri moških in ženskah.
Although the level of evidence is limited, the CHMP recognised that in selected cases and at the discretion of the treating physician the addition of mitoxantrone to combination regimens could be of benefit to this patient population, and accepted the indication.
Čeprav je stopnja dokazov nizka, je odbor CHMP ugotovil, da bi v izbranih primerih in po presoji lečečega zdravnika dodatek mitoksantrona h kombiniranim shemam tej populaciji bolnikov lahko koristil, in sprejel indikacijo.
Treatment of metastatic breast cancer
Zdravljenje metastatskega raka dojke
In the studies presented, albeit, limited in number and in heterogeneous populations, mitoxantrone demonstrated a consistent effect on relapses as well as disability.
V predloženih študijah, ki so bile po številu in heterogenosti populacij sicer omejene, se je mitoksantron dosledno izkazal kot učinkovit za zdravljenje relapsov in zmanjševanje invalidnosti.
Pain relief in patients with advanced, castrate-resistant prostate cancer, in combination with corticosteroids
Lajšanje bolečine pri bolnikih z napredovalim, proti kastraciji odpornim rakom prostate, v kombinaciji s kortikosteroidi
In multiple sclerosis a flexible dosing schedule was agreed in order to reflect those used in clinical trials and practices in the different member states.
Pri multipli sklerozi je bil zaradi upoštevanja shem odmerjanja v kliničnih preizkušanjih in praks v različnih državah članicah sprejet dogovor o fleksibilni shemi odmerjanja.
The CHMP considered the level of evidence currently available insufficient to support the use of mitoxantrone in hepatocellular carcinoma, which the MAH accepted and therefore withdrew this indication from the proposed harmonised PI.
Odbor CHMP je stopnjo trenutno razpoložljivih dokazov ocenil kot nezadostno, da bi bilo mogoče podpreti uporabo mitoksantrona pri hepatocelularnem karcinomu, kar je imetnik dovoljenja za promet z zdravilom sprejel in je zato to indikacijo umaknil iz predlaganih usklajenih informacij o zdravilu.
The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information.
Odbor CHMP je upošteval nasvet znanstvene svetovalne skupine in podal soglasje k operativni opredelitvi za to indikacijo v usklajenih informacijah o zdravilu.
The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients.
Po mnenju odbora CHMP v celoti gledano predloženi dokazi, zlasti ob upoštevanju velike heterogenosti bolnikov z akutno levkemijo, niso bili zadostni.
It is also authorised in a few EU MS as 2mg/ml concentrate for solution for injection or solution for intrapleural or intraperitoneal use and as concentrate for solution for injection/infusion.
V nekaterih državah članicah EU je zdravilo Novantrone odobreno tudi kot 2 mg/ml koncentrat za raztopino za injiciranje za intraplevralno ali intraperitonealno uporabo in kot koncentrat za raztopino za injiciranje/infundiranje.
It is recognised that mitoxantrone is currently given in clinical practice to patients with CRPC to achieve palliation after exhaustion of other available treatment options.
Znano je, da se mitoksantron v trenutni klinični praksi daje bolnikom s KORP z namenom lajšanja simptomov po izčrpanju drugih razpoložljivih možnosti zdravljenja.
Novantrone contains mitoxantrone, a synthetic anthracenedione antineoplastic agent that has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting activity against rapidly proliferating and slow-growing neoplasms.
Zdravilo Novantrone vsebuje mitoksantron, sintetično antracendionsko antineoplastično snov, ki citocidno učinkuje na proliferacijske in neproliferacijske gojene človeške celice, kar kaže na delovanje proti hitro proliferacijskim in počasi rastočim novotvorbam.
Palliation of non-resectable primary hepatocellular carcinoma
Lajšanje simptomov pri neresektabilnem primarnem hepatocelularnem karcinomu
The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and a general recommendation to monitor cardiac toxicity in cancer patients.
Imetnik dovoljenja za promet z zdravilom je predlagal usklajena priporočila za odmerjanje na osnovi odmerkov, ki so jih preučevali v kliničnih preizkušanjih, in splošno priporočilo o spremljanju kardiotoksičnosti pri bolnikih z rakom.
Common dosing recommendations were proposed for metastatic breast cancer and non-Hodgkin's lymphoma including dose reduction guidance for use in combination therapy and in case of myelosuppression.
Predlagana so bila skupna priporočila o odmerjanju za metastatski rak dojke in ne-Hodgkinov limfom, vključno z navodili za zmanjševanje odmerka pri kombiniranem zdravljenju in ob mielosupresiji.
In addition, due to the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy.
Poleg tega je treba zaradi tveganja za razvoj sekundarnih malignih bolezni pred začetkom zdravljenja z mitoksantronom določiti razmerje med tveganji in koristmi zdravljenja.
No significant differences between the national SmPCs were present in this section.
V tem poglavju ni bilo večjih razlik med nacionalnimi povzetki glavnih značilnosti zdravila.
• The Committee considered that additional risk minimisation measures in the form of educational materials for the use of Novantrone and associated names in multiple sclerosis were necessary.
• odbor je ocenil, da so za uporabo zdravila Novantrone in povezanih imen pri multipli sklerozi potrebne dodatne dejavnosti za zmanjševanje tveganja v obliki izobraževalnega gradiva.
Remission-induction treatment of blast crisis in chronic myeloid leukaemia, in combination regimen
Indukcijsko zdravljenje blastne krize pri kronični mieloični levkemiji v kombinirani shemi