natgillin/translations-raw huggingface dataset:
Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or MUGA is recommended prior to administration of the initial dose of mitoxantrone and prior to each dose in multiple sclerosis patients and yearly for up to 5 years after the end of therapy.
(MUGA) je priporočljiva pred dajanjem začetnega odmerka mitoksantrona in pred vsakim dajanjem pri bolnikih z multiplo sklerozo in vsako leto do 5 let po koncu zdravljenja.
Infections and Infestations Very common
Infekcijske in parazitske bolezni Zelo pogosti
When pregnant rabbits were treated during organogenesis, an increased incidence of premature delivery was observed at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Dajanje zdravila brejim kunčjim samicam v obdobju organogeneze je pokazalo incidenco prezgodnjega poroda pri odmerkih > 0,01-kratnika priporočenega odmerka za človeka na osnovi mg/m2.
Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY} [To be completed nationally]
Datum zadnjega podaljšanja: {dan mesec leto}
Very Common (may affect more than 1 in 10 people) - Infections.
Za bolnike, ki se zdravijo zaradi raka: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): - okužbe,
(MEC) showed antileukaemic activity as salvage therapy for refractory AML.
je pokazal protilevkemično delovanje kot reševalno zdravljenje za refraktorno AML.
In clinical trials cancer patients who received cumulative doses of 140 mg/m either alone or in combination with other chemotherapeutic agents had a cumulative 2.6% probability of clinical congestive heart failure.
V kliničnih raziskavah so pri rakavih bolnikih, ki so prejeli kumulativne odmerke 140 mg/m2 bodisi samostojno bodisi v kombinaciji z drugimi kemoterapevtiki, beležili 2,6 % kumulativne verjetnosti kliničnega kongestivnega srčnega popuščanja.
- Infections, including infections of the upper airways and urinary tract.
- okužbe, vključno z okužbami zgornjih dihal in sečil,
Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitoxantrone.
Cepljenje Pri bolnikih z zmanjšano imunokompetenco, na primer med zdravljenjem z mitoksantronom, imunizacija z živim cepivom (npr. proti rumeni mrzlici) povečuje tveganje za okužbo in druge neželene učinke, kot so vaccinia gangrenosum in generalizirana vakcinija.
- Abnormal number of white blood cells.
Granulocitopenija Nenormalno število belih krvnih celic
Single Agent Therapy in Relapse
Zdravljenje z enim odmerkom pri relapsu
Some side effects could be serious If any of the following happen, tell the doctor immediately: - If your skin becomes pale and you feel weak or experience sudden shortness of breath, this can be sign of a reduction in red blood cells.
Nekateri neželeni učinki so lahko resni Nemudoma sporočite zdravniku, če se zgodi kar koli od naslednjega: - vaša koža postane bleda in se počutite šibkega ali nenadoma začnete težko dihati, je to lahko znak zmanjšanja števila rdečih krvnih celic, - pojavijo se neobičajne modrice ali krvavitve, kot so izkašljevanje krvi, kri v bruhanju ali urinu ali črno blato (potencialni znak zmanjšanja krvnih ploščic), - novo poslabšanje ali poslabšanje težav z dihanjem,
Fatigue Pyrexia
Astenija Utrujenost Pireksija
If Novantrone is used alone:
Novantrone ali:
You must not breast-feed while using mitoxantrone and for up to one month after the last administration.
Med uporabo mitoksantrona in še en mesec po zadnjem odmerku ne smete dojiti.
Mitoxantrone administered at any dose can cause myelosuppression.
Mitoksantron v katerem koli odmerku lahko povzroči mielosupresijo.
- Taste disturbances.
Izogibajte se zanositvi.
Women of child-bearing potential should have a negative pregnancy test prior to each dose and must practise effective contraception for at least 4 months after stopping the treatment with Novantrone.
Ženske v rodni dobi morajo imeti negativen test nosečnosti pred vsakim odmerkom ter uporabljati učinkovito kontracepcijo še vsaj 4 mesece po koncu zdravljenja z zdravilom Novantrone.
Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally] Mitoxantrone
Novatrone in z njim povezana imena (glej Prilogo I) koncentrat 2 mg/ml za raztopino za infundiranje [glejte Prilogo I - izpolni država članica] mitoksantron intravenska uporaba
Acute myeloid leukemia (AML) and Myelodysplastic syndrome A group of anticancer medicines (topoisomerase II inhibitors), including Novantrone, may cause the following diseases when used alone but especially in combination with other chemotherapy and/or radiotherapy:
Skupina zdravil proti raku (zaviralci topoizomeraze II), vključno z zdravilom Novantrone, lahko povzroči naslednje bolezni, kadar se uporablja samostojno, zlasti pa v kombinaciji z drugo kemoterapijo in/ali obsevanje:
Mitoxantrone is indicated in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer.
Mitoksantron je v kombinaciji s kortikosteroidi indiciran za lajšanje simptomov, npr. bolečin, povezanih z napredovalim rakom prostate, ki se ni odzval na kastracijo.
- Severe allergic reaction (anaphylactic reaction including anyphylactic shock) - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, and you may feel you are going to faint).
- huda alergijska reakcija (anafilaktična reakcija, vključno z anafilaktičnim šokom) - lahko pride do nenadnega hudega srbečega izpuščaja (koprivnice), otekanja dlani, stopal, gležnjev, obraza, ustnic, ust ali žrela (kar lahko povzroči težave pri požiranju ali dihanju in občutek, da boste omedleli),
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the vial contains 2 mg mitoxantrone (as hydrochloride).
En ml vsebuje 2 mg mitoksantrona (v obliki klorida).
Men must not father a child and should use contraceptive measures during and at least 6 months after therapy.
Moški ne sme spočeti otroka in mora uporabljati kontracepcijo med zdravljenjem in vsaj 6 mesecev po njem.
- Low number of special white blood cells (neutrophils and leukocytes) - Nausea (feeling sick).
v takšnih primerih je potrebna transfuzija krvi, - nizko število posebnih belih krvnih celic (nevtrofilcev in levkocitov), - slabost, - bruhanje, - izpadanje las.
Acute myeloid leukaemia, myelodysplastic syndrome, acute leukaemia
Akutna mieloična levkemija, mielodisplastični sindrom,
You should stop breast-feeding before taking Novantrone.
Pred jemanjem zdravila Novantrone morate prenehati dojiti.
You are more prone to these side effects if you take higher doses of Novantrone or:
Bolj ste nagnjeni k neželenim učinkom, če jemljete večje odmerke zdravila
Signs and symptoms of infection and differential blood count with WHO grade 4: following dose 8 mg/m²
Znaki in simptomi okužbe ter diferencialna krvna slika skladno s 4. stopnjo po SZO: naslednji odmerek 8 mg/m²
If mitoxantrone is administered repeatedly dosing adjustments should be guided by extent and duration of bone marrow suppression.
Če mitoksantron dajemo večkrat, je treba dajanje po obsegu in trajanju prilagajati glede na supresijo kostnega mozga.
A lower initial dosage (12 mg/m2 or less) is recommended in patients with low bone marrow reserves e.g. due to prior chemotherapy or poor general condition.
Nižji začetni odmerek (12 mg/m2 ali manj) se priporoča pri bolnikih s nizkimi rezervami kostnega mozga,
Women of childbearing potential must be advised to avoid becoming pregnant; should have a negative pregnancy test prior to each dose and use effective contraception during therapy and for at least 4 months after cessation of therapy.
Ženskam v rodni dobi je treba odsvetovati zanositev; morajo imeti negativen test nosečnosti pred vsakim odmerkom ter uporabljati učinkovito kontracepcijo med zdravljenjem in vsaj še 4 mesece po koncu zdravljenja.
This infection should be treated before taking Novantrone; if you plan a vaccination or immunisation during treatment.
- če načrtujete cepljenje in imunizacijo med zdravljenjem.
Treatment of blast crisis in (chronic) myeloid leukaemia Used alone for recurrence
Zdravljenje blastne krize pri (kronični) mieloični levkemiji
Anxiety Confusion Paraesthesia Lethargy
Tesnoba Zmedenost Parestezija Letargija
Weight fluctuations Tumour lysis syndrome*
Nihanja v telesni masi Sindrom tumorske lize*
Severe local tissue damage may occur if there is extravasation during administration.
V primeru ekstravazacije med dajanjem lahko pride do hudih lokalnih poškodb tkiva.
Blood and lymphatic system disorders Very common
Bolezni krvi in limfatičnega sistema
Severe injury with permanent sequelae can result from intrathecal administration.
Intratekalno dajanje lahko povzroči hude poškodbe s trajnimi posledicami.
Mitoxantrone is considered a potential human teratogen because of its mechanism of action and the developmental effects demonstrated by related agents.
Mitoksantron zaradi svojega mehanizma delovanja in vpliva na razvoj, kot je bil dokazan pri sorodnih učinkovinah, velja za potencialno teratogenega za ljudi.
Therefore, mitoxantrone has the potential to be carcinogenic in humans.
Zato je mitoksantron potencialno rakotvoren pri človeku.
Severe local tissue damage may occur if Novantrone leaks in surrounding tissue (extravasation) during administration.
V primeru uhajanja zdravila Novantrone iz žile (ekstravazacije) med dajanjem lahko pride do hudih poškodb okoliškega tkiva.
Nausea Vomiting
Žilne bolezni
- Infections caused by microorganisms which do not normally cause diseases with a healthy immune system (opportunistic infections).
- okužbe, ki jih povzročajo mikroorganizmi in običajno ne povzročajo bolezni pri zdravem imunskem sistemomu (priložnostne okužbe), - rak belih krvnih celic (akutna mieloidna levkemija; AML),
Reproductive system and breast disorders Very common
Motnje reprodukcije in dojk Zelo pogosti
• if you have a low count of a specific type of white blood cells (neutrophils) (less than
• če imate majhno število specifičnih belih krvnih celic (nevtrofilcev) (manj kot 1.500 celic/mm3),
- Bone marrow abnormality which causes the formation of abnormal blood cells which leads to leukaemia (myelodisplastic syndrome (MDS)).
- nenormalnosti kostnega mozga, ki povzročijo nastanek nenormalnih krvnih celic, kar povzroči levkemijo (mielodisplastični sindrom; MDS),
Novantrone should be administered under the supervision of a doctor experienced in the use of cancer medicines that are toxic to your cells (cytotoxic chemotherapy agents).
Zdravilo Novantrone boste prejeli pod nadzorom zdravnika, izkušenega v uporabi zdravil za zdravljenje raka, ki so toksična za celice (citotoksični kemoterapevtiki).
- Abnormal absence of menstruation (amenorrhoea).
- slabost, - izpadanje las, - nenormalen izostanek menstruacije (amenoreja).
Women of childbearing potential should have a negative pregnancy test prior to each dose, and use effective contraception during therapy and for at least 4 months after cessation of therapy.
Ženske v rodni dobi morajo imeti negativen test nosečnosti pred vsakim odmerkom ter uporabljati učinkovito kontracepcijo med zdravljenjem in vsaj še 4 mesece po koncu zdravljenja.
If WBC nadir > 1,500 µl and platelet nadir > 50,000 µl
Če je najnižja raven belih krvnih celic > 1.500 µl in trombocitov > 50.000 µl
There is no relevant use of mitoxantrone in the paediatric population.
Mitoksantron ni namenjen za uporabo pri pediatrični populaciji.
Urinary tract infection Upper respiratory tract infection Sepsis
Okužba sečil Okužba zgornjih dihal Sepsa
Mitoxantrone has been given as part of combination therapy.
Kombinirano zdravljenje Mitoksantron so uporabljali pri kombiniranem zdravljenju.
Talk to your doctor or, pharmacist or nurse before using Novantrone:
Pred uporabo zdravila Novantrone se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro:
[To be completed nationally] OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally] EXPIRY DATE [To be completed nationally] SPECIAL STORAGE CONDITIONS [To be completed nationally] SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Constipation Diarrhoea Stomatitis
Zaprtje Driska Stomatitis Bruhanje
You should avoid contact with Novantrone, especially with the skin, mucous membranes (moist body surfaces, such as the lining of the mouth) and eyes.
Izogibajte se stiku z zdravilom Novantrone, zlasti s kožo, sluznico
The treatment with mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapeutic agents for the treatment of multiple sclerosis.
Mitoksantron je treba dajati pod nadzorom zdravnika, izkušenega v uporabi citotoksičnih kemoterapevtikov za zdravljenje multiple skleroze.
Nervous system disorders
Induktorji prenašalca
Novantrone should be given by slow and freely flowing infusion into the vein.
Zdravilo Novantrone je treba počasi injicirati v prosto tekočo intravensko infuzijo.
Urinary tract infection Upper respiratory tract infection
Okužba sečil Okužba zgornjih dihal
o Swelling.
AML.
Cases of tumour lysis syndrome were reported with the use of mitoxantrone.
Pri uporabi mitoksantrona so zabeleženi primeri sindroma tumorske lize.
The recommended dosage in relapse is 10 to 12 mg/m2 body surface area given as a single intravenous dose daily over 5 consecutive days (total of 50 to 60 mg/m2).
Priporočeni odmerek pri relapsu je 10 do 12 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku 5 dni zaporedoma (skupaj 50 do 60 mg/m2).
[See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[glejte Prilogo I - izpolni država članica]
• a bone marrow disorder that causes abnormally shaped blood cells and leads to leukaemia (myelodysplastic syndrome)
• bolezen kostnega mozga, ki povzroča neobičajno oblikovane krvne celice in povzroča levkemijo (mielodisplastični sindrom).
- Tingling sensation.
- če dojite.
Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or multiple-gated acquisition (MUGA) is recommended prior to administration of the initial dose of mitoxantrone in cancer patients.
(MUGA) je priporočljiva pred dajanjem začetnega odmerka mitoksantrona pri bolnikih z rakom.
If WBC nadir < 1,500 µl or platelet nadir < 50,000 µl
Če je najnižja raven belih krvnih celic < 1.500 µl ali trombocitov < 50.000 µl
Novantrone will be given to you under the supervision of a doctor experienced in the use of cytotoxic chemotherapeutic agents for the treatment of multiple sclerosis.
Zdravilo Novantrone boste prejemali pod nadzorom zdravnika, izkušenega v uporabi citotoksičnih kemoterapevtikov pri zdravljenju multiple skleroze.
Mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents.
Mitoksantron je treba dajati pod nadzorom zdravnika, izkušenega v uporabi citotoksičnih kemoterapevtikov.
Therefore men under therapy must be advised not to father a child and to use contraceptive measures during and at least 6 months after therapy.
Zato je treba moškemu, ki se zdravi, odsvetovati spočetje otroka ter svetovati uporabo kontracepcije med zdravljenjem in vsaj 6 mesecev po njem.
The pathways leading to the metabolism of mitoxantrone have not been elucidated.
Poti presnove mitoksantrona niso pojasnjene.
The recommended dosage for remission induction is 12 mg/m2 of body surface area, given as a single intravenous dose daily for five consecutive days (total of 60 mg/m2 per 5 days).
Priporočeni odmerek za indukcijo remisije je 12 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku 5 dni zaporedoma (skupaj 60 mg/m2 v 5 dneh).
The recommended dosage for remission induction is 12 mg/m2 of body surface area, given as a single intravenous dose daily for five consecutive days (total of 60 mg/m2).
Priporočeni odmerek za indukcijo remisije je 12 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku 5 dni zaporedoma (skupaj 60 mg/m2).
Anxiety Confusion Headache Paraesthesia
Tesnoba Zmedenost Glavobol Parestezija
If WBC nadir < 1,000 µl or platelet nadir < 25,000 µl
Če je najnižja raven belih krvnih celic < 1.000 µl ali trombocitov < 25.000 µl
Treatment with mitoxantrone is not recommended in the paediatric population.
Pediatrična populacija Zdravljenje pediatrične populacije z mitoksantronom ni priporočljivo.
- Severe itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), or if you feel you like you are going to faint, these may be signs of severe allergic reaction.
- bolečine v prsih, zasoplost, spremembe srčnega utripa (hitro ali počasi), zastajanje tekočine (otekanje) v gležnjih ali nogah (morebitni znaki ali simptomi težav s srcem), - hud srbeč izpuščaj (koprivnica), otekanje dlani, stopal, gležnjev, obraza, ustnic, ust ali žrela (kar lahko povzroči težave pri požiranju ali dihanju), ali če se vam zdi, da boste omedleli, so to lahko znaki hude alergijske reakcije, - povišana telesna temperatura ali okužbe.
Not all pack sizes may be marketed.
6.5 Vrsta ovojnine in vsebina Na trgu morda ni vseh navedenih pakiranj.
- Heart attack.
- nereden srčni utrip,
It is advised to use live virus vaccines with caution after stopping chemotherapy, and vaccinate not sooner than 3 months after the last dose of chemotherapy (see section
Po koncu kemoterapije je živa cepiva priporočljivo uporabljati previdno in cepiti ne prej kot 3
Advanced castrate-resistant prostate cancer The recommended dosage of Novantrone is 12 to 14 mg/m2 given as a short intravenous infusion every
Napredovali rak prostate, ki se ni odzval na kastracijo Priporočeni odmerek zdravila Novantrone je 12 do 14 mg/m2 v obliki kratke intravenske infuzije vsakih 21 dni, v kombinaciji z nizkimi peroralnimi odmerki kortikosteroidov (hormonskih zdravil, ki zavirajo imunski sistem).
Rare (may affect up to 1 in 1,000 people) - Lung inflammation (pneumonia).
Redki (lahko se pojavijo pri največ 1 od 1 000 bolnikov): - vnetje pljuč (pljučnica), - poškodbe srčne mišice, ki ji preprečujejo pravilno črpanje (kardiomiopatija).
Subsequent dosing
Nadaljnji odmerki
Very Common (may affect more than 1 in 10 people)
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
Ordinarily, patients with multiple sclerosis should
Bolniki z multiplo sklerozo
- Abnormal results of blood tests to check liver and kidney functions (raised aspartate aminotransferase levels, elevated creatinine and urea nitrogen concentration in the blood).
o odmiranje tkivnih celic, kar lahko pripelje do potrebe po odstranitvi odmrlih celic in presaditvi kože, - nenormalni rezultati krvnih preiskav za preverjanje delovanja jeter in ledvic (povišane vrednosti aspartat aminotransferaze, povišan kreatinin in vrednosti dušika sečnine v krvi), - poškodbe ledvic, kar povzroči otekanje in šibkost (nefropatija),
- Shortness of breath.
- vnetje pljuč (pljučnica),
- Diarrhoea.
Pljučnica.
OTHER [To be completed nationally]
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [izpolni država članica]
o cancer of white blood cells (acute myeloid leukaemia, AML);
Ti lahko povzročijo: o raka belih krvnih celic (akutno mieloidno levkemijo; AML),
WBC and platelet nadir
Kardiomiopatija Sinusna bradikardija
What you need to know before you use Novantrone
To morate zdraviti, preden začnete jemati zdravilo Novantrone,
Abdominal pain Gastrointestinal haemorrhage Mucosal inflammation Pancreatitis
Odpoved kostnega mozga Mielosupresija Trombocitopenija Nevtropenija
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
IME ZDRAVILA Novatrone in povezana imena (glej Prilogo I) 2 mg/ml koncentrat za raztopino za infundiranje
- Insufficient production of blood cells in the bone marrow (bone marrow failure).
- nezadostna proizvodnja krvnih celic v kostnem mozgu (odpoved kostnega mozga), - zmanjšana aktivnost kostnega mozga.
- Nail abnormalities (e.g. detachment of the nail fro the nail bed, changes in nail texture and structure).
- vnetje sluznice, - vnetje trebušne slinavke, - nenormalnosti pri jetrih, - vnetja kože (eritem), - nenormalnosti pri nohtih (npr. odstopanje nohta od podnohtja, spremembe v teksturi in strukturi),
Novantrone is used in the treatment of: advanced stage (metastatic form) of breast cancer; a form of lymph node cancer (non-Hodgkin's lymphoma); a cancer of the blood in which the bone marrow (the spongy tissue inside the large bones) makes too many white blood cells (acute myeloid leukaemia); a cancer of the white blood cells (chronic myeloid leukaemia) at a stage where it is difficult to control the number of white blood cells (blast crisis).
- raka belih krvnih celic (kronična mieloična levkemija) v fazi, v kateri je težko nadzorovati število belih krvnih celic (blastna kriza).
Elevated serum creatinine Elevated blood urea nitrogen levels
Zvišane vrednosti dušika sečnine v krvi Toksična nefropatija
- Urine discolouration.
- Navodilo shranite.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo!
Constipation Diarrhoea Stomatitis Vomiting
Krvavitev iz prebavil Vnetje sluznice Pankreatitis
Novantrone has been given as part of combination therapy.
Zdravilo Novantrone se pri tem uporablja v kombinaciji z drugimi zdravili,
Novantrone concentrate also can be administered as a short infusion (15 to 30 minutes) diluted in 50 to 100 ml isotonic saline or 5% glucose solution.
Koncentrat zdravila Novantrone je prav tako mogoče dajati v obliki kratkih infuzij (15 do 30 minut),
Myelosuppression Bone marrow failure White blood cell count
Mielosupresija Odpoved kostnega mozga Nenormalno število belih krvnih celic
- Tiredness, weakness and lack of energy.
nevtropenija, okužbe, amenoreja, alopecija, slabost in bruhanje.
Cardiac disorders Common
Kongestivno srčno popuščanje
Tell your doctor or pharmacist or nurse immediately if you get any of the following signs or symptoms during treatment with Novantrone: - fever, infections, unexplained bleeding or bruising, weakness and easy fatigability; - breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the ankles or legs , heart fluttering (irregular heart beat).
Novantrone opazite kateri koli spodaj navedeni neželeni učinek: - zvišana telesna temperatura, okužbe, nepojasnjena krvavitev ali podplutbe, šibkost in hitra utrujenost,
The safety and efficacy of mitoxantrone have not been studied after treatment with natalizumab, fingolimod, alemtuzumab, dimethyl fumarate, or teriflunomide.
Uporaba po drugih zdravljenjih, specifičnih za multiplo sklerozo Varnost in učinkovitost mitoksantrona po zdravljenju z natalizumabom, fingolimodom, alemtuzumabom,
Precautions to be taken before handling or administering the medicinal product Mitoxantrone should be given slowly into a freely flowing intravenous infusion.
Mitoksantron je treba počasi injicirati v prosto tekočo intravensko infuzijo.
Signs and symptoms of infection and differential blood count with WHO grade 1: following dose 9 mg/m² Signs and symptoms of infection and differential blood count with WHO grade 2: following dose 6 mg/m²
Znaki in simptomi okužbe ter diferencialna krvna slika skladno s 2. stopnjo po SZO: naslednji odmerek 6 mg/m²
PHARMACEUTICAL FORM Concentrate for solution for infusion [To be completed nationally]
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje
Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
Novatrone in povezana imena (glejte Prilogo I) koncentrat 2 mg/ml za raztopino za infundiranje