natgillin/translations-raw huggingface dataset:
INFORMATION IN BRAILLE Kovaltry 3000 
16. PODACI NA BRAILLEOVOM PISMU Kovaltry 3000
Dysgeusia uncommon 
• disgeuzija (poremećaj osjeta okusa)
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 2000 IU sadrži (2000 IU / 5 ml) = 400 IU oktokoga alfa po ml nakon pripreme za primjenu.
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 500 IU sadrži (500 IU / 2,5 ml) = 200 IU oktokoga alfa po ml nakon pripreme za primjenu.
EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml))
• syringe plunger rod 
• navale crvenila (crvenilo lica)
EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml))
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (octocog alfa) (100 IU/mL after reconstitution). 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 IU (oktokoga alfa) (100 IU/ml nakon rekonstitucije).
Kovaltry 250 IU powder and solvent for solution for injection One mL Kovaltry 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. 
• Jedan ml lijeka Kovaltry 250 IU nakon rekonstitucije s vodom za injekcije sadrži približno 100 IU (250 IU / 2,5 ml) rekombinantnog ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
Kovaltry 3000 IU powder and solvent for solution for injection One mL Kovaltry 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. 
• Jedan ml lijeka Kovaltry 3000 IU nakon rekonstitucije s vodom za injekcije sadrži približno 600 IU (3000 IU / 5 ml) rekombinantnog ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
How Kovaltry is given 
Kako se daje lijek Kovaltry
Kovaltry 500 IU powder and solvent for solution for injection One mL Kovaltry 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. 
• Jedan ml lijeka Kovaltry 500 IU nakon rekonstitucije s vodom za injekcije sadrži približno 200 IU (500 IU / 2,5 ml) rekombinantnog ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution). 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3000 IU (oktokoga alfa) (600 IU/ml nakon rekonstitucije).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (octocog alfa) (200 IU/mL after reconstitution). 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU (oktokoga alfa) (200 IU/ml nakon rekonstitucije).
Now remove and discard the adapter housing (E). 
Sada skinite plastično pakiranje s nastavka za bočicu i bacite ga (E).
Kovaltry 2000 IU powder and solvent for solution for injection One mL Kovaltry 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. 
• Jedan ml lijeka Kovaltry 2000 IU nakon rekonstitucije s vodom za injekcije sadrži približno 400 IU (2000 IU / 5 ml) rekombinantnog ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
Kovaltry 1000 IU powder and solvent for solution for injection One mL Kovaltry 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections. 
• Jedan ml lijeka Kovaltry 1000 IU nakon rekonstitucije s vodom za injekcije sadrži približno 400 IU (1000 IU / 2,5 ml) rekombinantnog ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (octocog alfa) (400 IU/mL after reconstitution). 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU (oktokoga alfa) (400 IU/ml nakon rekonstitucije).
Detailed instructions for reconstitution and administration of Kovaltry 
Detaljne upute za pripremu za primjenu i primjenu lijeka Kovaltry uz pomoć bočice s nastavkom za bočicu:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (octocog alfa) (400 IU/mL after reconstitution). 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU (oktokoga alfa) (400 IU/ml nakon rekonstitucije).
Kovaltry is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed. 
- 1 pojedinačno pakiranje - 1 višestruko pakiranje s 30 pojedinačnih pakiranja.
Type of surgical procedure 
Veliki kirurški zahvat
NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 250 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
Look to check there are no particles or discoloration before you use the solution. 
Prije primjene otopine provjerite da ne sadrži čestice i da nije promijenila boju.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 250 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use. 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Kovaltry 250 IU prašak za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) Intravenska primjena.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 500 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use. 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Kovaltry 500 IU prašak za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) Intravenska primjena.
NAME OF THE MEDICINAL PRODUCT Kovaltry 500 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 500 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) 13. BROJ SERIJE
Hold the pre filled syringe of solvent upright. 
Ubodite venu te pričvrstite pribor za venepunkciju flasterom.
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution. 
Kovaltry 1000 IU sadrži (1000 IU / 2,5 ml) = 400 IU oktokoga alfa po ml nakon pripreme za primjenu.
EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml))
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) 13. BROJ SERIJE
NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 3000 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
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. 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Kovaltry 3000 IU prašak za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) Intravenska primjena.
EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml))
EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml))
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 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml))
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) 13. BROJ SERIJE
The following symptoms could be an early warning of these reactions: chest tightness/general feeling of being unwell dizziness a reduction in blood pressure, which may make you feel faint upon standing) feeling sick (nausea) 
• sniženje krvnog tlaka zbog čega prilikom ustajanja možete imati osjećaj da ćete se onesvijestiti
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/1/15/1076/021 - 30 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (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 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml))
NAME OF THE MEDICINAL PRODUCT Kovaltry 1000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 1000 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) 13. BROJ SERIJE
Histidine 
• mučnina
NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 2000 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
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. 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Kovaltry 1000 IU prašak za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) Intravenska primjena.
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. 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Kovaltry 2000 IU prašak za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa) Intravenska primjena.
- a blood clot in the blood vessel. 
Provjerite da u štrcaljku ne ulazi krv.
• vial adapter 
• omaglica
Insomnia common 
Limfadenopatija često
Oral use bottle (HDPE) 
Peroralna primjena bočica (HDPE) 150 ml
Clinical aspects 
Klinički aspekti
These should be included in a risk management plan. 
Te je mjere potrebno uključiti u plan upravljanja rizikom.
These recommendations were considered appropriate. 
Zaključeno je da su te preporuke odgovarajuće.
Treatment of multiple sclerosis (MS) 
Liječenje multiple skleroze (MS)
Information of lesser relevance was removed in order to focus on the main information. 
Uklonjene su informacije od manje važnosti radi usredotočivanja na glavne informacije.
Other sections have only been partially harmonised as it is considered that these should be adapted nationally. 
Ostali su dijelovi samo djelomično usklađeni jer se smatra da ih je potrebno prilagoditi na nacionalnoj razini.
Patients should be advised to seek medical attendance if signs or symptoms develop, including over five years after end of treatment. 
Bolesnike je potrebno savjetovati da zatraže medicinsku pomoć u slučaju pojave znakova ili simptoma, uključujući i nakon pet godina od završetka liječenja.
Section 5 - Pharmacological properties 
Dio 5. - Farmakološka svojstva
However, no benefit in overall survival or other clinically relevant endpoints has been reported. 
Međutim, nisu zabilježene koristi u pogledu ukupnog vijeka preživljavanja ili drugih klinički bitnih krajnjih točaka.
Further it was considered that the interaction with immunosuppressive medicines should be mentioned. 
Nadalje, Odbor je smatrao da je potrebno spomenuti interakciju s imunosupresivnim lijekovima.
The CHMP concluded that the level of evidence provided is limited. 
CHMP je zaključio da su dostavljeni dokazi ograničeni.
This section was restructured according to guidelines. 
Ovaj je dio restrukturiran sukladno uputama.
In conclusion, the CHMP considered that the indication was not acceptable. 
CHMP je u konačnici zaključio da ta indikacija nije prihvatljiva.
In addition, the committee considered the advice of the Scientific Advisory Group Neurology and of the Pharmacovigilance Risk Assessment Committee. 
Osim toga, Odbor je razmotrio savjete Znanstvene savjetodavne skupine za neurologiju i Odbora za procjenu rizika u području farmakovigilancije.
In most studies no comparator was used or, when a comparator was used it appeared to be more effective. 
U većini ispitivanja nije se koristio usporedni lijek, a u slučajevima kada se koristio, uspostavilo se da je djelotvorniji.
Treatment of non-Hodgkin's lymphoma (NHL) 
Liječenje ne-Hodgkinova limfoma (NHL)
In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2. 
Osim toga, zbog rizika od kardiotoksičnosti koji ovisi o primljenim dozama, najveća dopuštena kumulativna doza za jedan životni vijek ograničena je na 72 mg/m2.
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. 
U nekim su državama članicama bile uključene dodatne informacije o nepostojanju interakcija ili farmakokinetičkim i farmakodinamičkim interakcijama bez kliničke relevantnosti, a smatralo se da to nije bitno te da stoga ne treba biti uključeno u usklađene informacije o proizvodu.
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. 
CHMP je bio mišljenja da ne postoje čvrste znanstvene osnove za takvu preporuku te da je bolje da informacije o rasporedu cijepljenja budu uključene u dijelove 4.4. i 4.5. u skladu s preporukama o uputama za kliničku praksu.
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. 
Informacije o izlučivanju mitoksantrona u majčino mlijeko i potrebi da se prekine s dojenjem prije početka liječenja bile su usklađene u državama članicama.
The use of mitoxantrone for the treatment of breast cancer is included in current hospital guidelines. 
Uporaba mitoksantrona za liječenje raka dojke uključena je u postojeće bolničke upute.
Most of the existing statements on interactions across the MSs were supported. 
Dokazana je većina postojećih navoda o interakcijama u državama članicama.
The CMHP followed the advice of the SAG and agreed on an operational definition for the indication in the harmonised product information. 
CMHP je prihvatio savjet Znanstvene savjetodavne skupine i dogovorio radnu definiciju za indikaciju u usklađenim informacijama o proizvodu.
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. 
Uzimajući u obzir rizike od kardiotoksičnosti i leukemije, CHMP je bio mišljenja da je primjenu mitoksantrona potrebno ograničiti na populaciju u kojoj koristi nadmašuju te ozbiljne rizike.
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. 
Za multiplu sklerozu dogovoren je prilagodljiv raspored doziranja radi usklađivanja s rasporedima koji su se primjenjivali u kliničkim ispitivanjima i praksama u različitim državama članicama.
Further, mitoxantrone is not recommended in any treatment guidelines for hepatocellular carcinoma. 
Nadalje, mitoksantron se ne preporučuje ni u jednim uputama za liječenje hepatocelularnog raka.
Separate dosing recommendations were also proposed for treatment of blast crisis and prostate cancer. 
Zasebne preporuke o doziranju predložene su i za liječenje blastnih kriza i raka prostate.
Relevant information available on risks of infertility was also harmonised. 
Usklađene su i bitne dostupne informacije o riziku od neplodnosti.
In addition, a complete blood count should be obtained before each dose of mitoxantrone and 10 days following each administration. 
Osim toga, potrebno je napraviti uvid u cjelokupnu krvnu sliku prije davanja svake doze mitoksantrona i 10 dana nakon svake doze.
• 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 pregledao podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet u korist predloženog usklađenja informacija o proizvodu, uključujući podatke o kliničkim ispitivanjima, otvorenim studijama, objavljenim studijama i pregledanim radovima te smjernicama temeljenim na dokazima i prihvaćenima konsenzusom.
The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients. 
CMHP je bio mišljenja da su dostavljeni podaci, ukupno gledajući, nedostatni, a posebno s obzirom na veliku heterogenost među bolesnicima s akutnom leukemijom.
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. 
Kako je riječ o usklađenoj indikaciji za liječenje metastatskog raka dojke, smatralo se da je upozorenje u dijelu 4.4. o malom riziku od leukemije i manjku podataka o djelotvornosti u adjuvantnom (pomoćnom) liječenju raka dojke dovoljno.
No significant differences between the national SmPCs were present in this section. 
U ovom dijelu nisu postojale nikakve značajne razlike u nacionalnim sažecima opisa svojstava lijeka.
Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate. 
Preporuka o razrjeđivanju i upute o odabiru vena te upozorenje o ekstravazaciji smatrane su prikladnima.
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. 
Nadalje, budući da mogući zbrojni rizici pri primjeni mitoksantrona u bolesnika s dugotrajnom izloženošću i drugim imunosupresivima nisu poznati, CHMP je bio mišljenja da je potrebno spomenuti da nije dokazana sigurnost i djelotvornost mitoksantrona u primjeni nakon drugih nedavno odobrenih terapija za liječenje multiple skleroze.
In addition, as multiple sclerosis is not a life threatening disease, mitoxantrone should be contraindicated in the treatment of multiple sclerosis in pregnant women. 
Osim toga, kako multipla skleroza nije bolest opasna po život, mitoksantron bi trebao biti kontraindiciran u liječenju trudnica s multiplom sklerozom.
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). 
Lijek Novantrone i srodni lijekovi odobreni su za stavljanje u promet kao koncentrat od 2 mg/ml za pripremu otopine za intravensku infuziju u većini država članica Europske unije.
The CMHP considered that mitoxantrone should be contraindicated in breastfeeding mothers as it is a potential human teratogen. 
CMHP je smatrao da bi mitoksantron trebao biti kontraidiciran u dojilja jer je potencijalni humani teratogen.
• The Committee considered the referral under Article 30 of Directive 2001/83/EC. 
• Odbor je razmotrio postupak upućivanja u skladu s člankom 30.
The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies. 
CHMP je smatrao da je u tim ispitivanjima dokazana djelotvornost mitoksantrona.
The restrictions regarding the use of mitoxantrone in pregnant women was harmonised to reflect the information available. 
Usklađene su informacije o ograničenjima u pogledu primjene mitoksantrona u trudnica, i to tako da odražavaju sve dostupne informacije.
Sections related to the unique identifier were added in line with the current QRD template (dated February 2016). 
Dodani su dijelovi koji se odnose na jedinstveni identifikator u skladu s trenutačno važećim predloškom za pregled kvalitete dokumentacije (datira od veljače 2016.).
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. 
CHMP je zatražio savjet Znanstvene savjetodavne skupine za neurologiju kako bi dobio uvid u trenutačnu kliničku primjenu mitoksantrona i jasno odredio populaciju bolesnika koja može imati koristi od ovakvog liječenja.
The studies presented included in majority patients with metastatic breast cancer, this patient population was therefore considered acceptable for the harmonised indication. 
Predočena ispitivanja uglavnom su uključivala bolesnike s metastatskim rakom dojke i stoga se smatralo da je ta populacija bolesnika prihvatljiva za usklađenu indikaciju.
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. 
Te je mjere potrebno uključiti u plan upravljanja rizicima (RMP), pri čemu je potrebno posebno se usredotočiti na primjenu u bolesnika s multiplom sklerozom radi osiguravanja usklađenog minimalnog standarda upravljanja rizicima u državama članicama.