natgillin/translations-raw huggingface dataset:
Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution. 
Zdravilo Kovaltry se injicira v veno 2 do 5 minut, odvisno od skupne količine in vašega počutja.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock). 
Opažene so bile preobčutljivost ali alergijske reakcije (le-te lahko vključujejo angioedem, pekoč občutek in občutek zbadanja na mestu infundiranja, mrzlico, pordelost, generalizirano urtikarijo,
CL (dL/h/kg) Vss (dL/kg) 
očistek (dl/h/kg)
Haemorrhage 
oteklino
Allergic type hypersensitivity reactions are possible with Kovaltry. 
Po uporabi zdravila Kovaltry se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
Kovaltry contains sodium 
Zdravilo Kovaltry vsebuje natrij
Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections. 
Pomožne snovi: saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, koncentrirana ocetna kislina (ledocet) in voda za injekcije.
The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII , this risk being highest within the first 20 exposure days. 
Tveganje za nastanek inhibitorjev je odvisno od stopnje bolezni in izpostavljenosti faktorju VIII.
• whether you have inhibitors and how high their level is 
• prisotnost inhibitorjev faktorja VIII in njihova raven
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. 
Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev
This result is similar to the reported values for factor VIII derived from human plasma. 
Ti izsledki so bili v okviru vrednosti, o katerih so poročali za faktor VIII,
Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 500 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 1000 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 2000 i.e. prašek in vehikel za raztopino za injiciranje Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
Bayer AG 51368 Leverkusen Germany 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG 51368 Leverkusen Nemčija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA S 30 POSAMEZNIMI PAKIRANJI (S PODATKI ZA MODRO OKENCE)
Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels. 
Za zagotavljanje ustreznih ravni faktorja VIII je zelo priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave.
previously developed factor VIII inhibitors to a different product. 
• so pri vas že kdaj nastali inhibitorji faktorja VIII pri uporabi drugih zdravil s faktorjem VIII.
More extensive haemarthrosis, muscle bleeding or haematoma 
mišice ali hematomi
Grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C). 
Napolnjeno injekcijsko brizgo z vehiklom držite navpično, primite bat brizge kot je narisano in ga z močnim privijanjem v smeri urinega kazalca pritrdite v navojni zamašek (C).
Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F). 
Z obračanjem v smeri urinega kazalca pritrdite napolnjeno injekcijsko brizgo v navoj adapterja za vialo (F).
How Kovaltry is prepared for administration 
Kako se pripravi zdravilo Kovaltry za uporabo
Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Kovaltry did not indicate any relevant changes in PK characteristics after long-term treatment. 
Kovaltry niso pokazale pomembnih sprememb farmakokinetičnih parametrov po dolgotrajnem zdravljenju.
Bayer HealthCare LLC 800 Dwight Way Berkeley 
Bayer HealthCare LLC
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution. 
Zdravilo Kovaltry 2000 i.e. vsebuje (2000 i.e. / 5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo, ki je priložen zdravilu
Detailed instructions for preparation and administration are contained in the package leaflet provided with Kovaltry. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Kovaltry
6.5 Nature and contents of container and special equipment for use, administration or implantation 
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo Vsako posamezno pakiranje zdravila Kovaltry vsebuje:
Calcium chloride dihydrate Polysorbate 80 
Prašek saharoza histidin glicin natrijev klorid kalcijev klorid dihidrat polisorbat 80 koncentrirana ocetna kislina (ledocet) (za uravnavanje pH)
Treatment monitoring 
Trajanje zdravljenja
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution. 
Zdravilo Kovaltry 250 i.e. vsebuje (250 i.e. / 2,5 ml) = 100 i.e. oktokoga alfa na ml po rekonstituciji.
• syringe plunger rod 
Bayer Hungária KFT
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution. 
Zdravilo Kovaltry 3000 i.e. vsebuje (3000 i.e. / 5 ml) = 600 i.e. oktokoga alfa na ml po rekonstituciji.
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution. 
Zdravilo Kovaltry 500 i.e. vsebuje (500 i.e. / 2,5 ml) = 200 i.e. oktokoga alfa na ml po rekonstituciji.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution). 
3000 i.e. (oktokog alfa) (600 i.e./ml po rekonstituciji)
How to store Kovaltry 
Shranjevanje zdravila Kovaltry
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (octocog alfa) (100 IU/mL after reconstitution). 
250 i.e. (oktokog alfa) (100 i.e./ml po rekonstituciji)
STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution. 
Zdravilo Kovaltry 1000 i.e. vsebuje (1000 i.e. / 2,5 ml) = 400 i.e. oktokoga alfa na ml po rekonstituciji.
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. 
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 250 i.e. približno 100 i.e. (250 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
OTHER Bayer-Logo 
Logotip Bayer
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. 
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 500 i.e. približno 200 i.e. (500 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. 
Zdravilo za paranteralno uporabo je treba pred uporabo vizualno pregledati, če so v njem delci ali se je spremenila barva.
- a blood clot in the blood vessel. 
- lokalnimi okužbami, - prisotnostjo bakterij v krvi, - nastankom krvnih strdkov v krvnih žilah.
The most serious side effects are allergic reactions or severe allergic reaction.Stop injecting Kovaltry immediately and speak to your doctor at once if such reactions occur. 
Najbolj resni neželeni učinki so alergijske reakcije ali huda alergijska reakcija.
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. 
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 2000 i.e. približno 400 i.e. (2000 i.e./5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMEZNEGA PAKIRANJA (S PODATKI ZA MODRO OKENCE)
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. 
Po rekonstituciji z vodo za injekcije vsebuje 1 ml zdravila Kovaltry 1000 i.e. približno 400 i.e. (1000 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
SN 
V
Histidine 
OVOJNINAH
The adapter will snap over the vial cap. Do not remove the adapter housing at this point. 
Ohišja adapterja zaenkrat še ne odstranite.
Powder: solid, white to slightly yellow. 
Prašek: trden, bel do rahlo rumen
United Kingdom Bayer plc 
Deutschland Bayer Vital GmbH
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (octocog alfa) (200 IU/mL after reconstitution). 
500 i.e. (oktokog alfa) (200 i.e./ml po rekonstituciji)
Type of surgical procedure 
veliki kirurški posegi
- bacteria in the blood 
• mesto in obseg krvavitve
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) 
• omotica, • znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar vstanete,
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 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
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 i.e. - raztopina (5 ml); napolnjena injekcijska brizga (5 ml))
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (octocog alfa) (400 IU/mL after reconstitution). 
2000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji)
NAME OF THE MEDICINAL PRODUCT Kovaltry 500 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 500 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (octocog alfa) (400 IU/mL after reconstitution). 
1000 i.e. (oktokog alfa) (400 i.e./ml po rekonstituciji)
NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 250 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 2000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
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 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml))
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min). 
Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja:
NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
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. 
Kovaltry 250 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Bayer AB 
UAB Bayer
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 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml))
- local infections 
voda za injekcije
NAME OF THE MEDICINAL PRODUCT Kovaltry 1000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa) 
Kovaltry 1000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
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 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 i.e. - raztopina (2,5 ml); napolnjena injekcijska brizga (5 ml))
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. 
Kovaltry 500 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
Kaiser-Wilhelm-Allee 51368 Leverkusen Germany 
Keiser-Wilhelm Allee
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.