natgillin/translations-raw huggingface dataset:
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
Medicines that can damage your heart (e.g. anthracyclines). 
- zdravila, ki lahko poškodujejo vaše srce (npr. antraciklini), - zdravila, ki zavirajo nastajanje krvnih celic in krvnih ploščic v kostnem mozgu (mielosupresivne učinkovine),
- Infections of the upper airways. 
- okužbe zgornjih dihal,
o a bone marrow disorder that causes abnormally shaped blood cells and leads to leukaemia 
o bolezen kostnega mozga, ki povzroča neobičajno oblikovane krvne celice in povzroča levkemijo (mielodisplastični sindrom).
Treatment of blast crisis in (chronic) myeloid leukaemia Single dose therapy in relapse 
Akutna mieloična levkemija Zdravljenje z eno učinkovino pri relapsu
- Mucosal inflammation. 
in poliploidije.
The recommended initial dosage of mitoxantrone used as a single agent is 14 mg/m2 of body surface area, 
Zdravljenje z eno učinkovino Priporočeni začetni odmerek mitoksantrona kot edine učinkovine je 14 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku, ki se ga lahko ponovi v 21-dnevnih presledkih.
DATE OF REVISION OF THE TEXT 
POSTOPEK UPORABE
Pregnancy, breast-feeding and fertility 
Bolezni jeter, žolčnika in žolčevodov
- Fever or infections. 
- okužbe sečil,
In metastatic breast cancer, combinations of Novantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective. 
Pri metastatskem raku dojke so se kombinacije zdravila Novantrone z drugimi citotoksičnimi učinkovinami, vključno s ciklofosfamidom in
Antivitamin K, in particular if you are taking Novantrone because you have cancer. 
- zdravila, ki zavirajo imunski sistem (imunosupresivna zdravila), - antivitamin K, zlasti ob jemanju zdravila Novantrone v primeru raka,
Novantrone will be given to you under supervision of a doctor experienced in the use of cytotoxic chemotherapy agents. 
Odmerjanje in način uporabe Zdravilo Novantrone boste prejemali pod nadzorom zdravnika, izkušenega v uporabi citotoksičnih kemoterapevtikov.
- Chest pain, breathlessness, changes in your heartbeat (fast or slow), fluid retention (swelling) in the ankles or legs (potential signs or symptoms of heart problems). 
- zadihanost (vključno s težkim dihanjem ponoči), kašelj, zadrževanje tekočine (otekanje) v gležnjih ali nogah, atrijska fibrilacija (nepravilen srčni utrip).
- Abnormal results of blood tests to check liver and kidney functions (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 (povišani kreatinin in vrednosti dušika sečnine v krvi), - poškodbe ledvic, kar povzroči otekanje in šibkost (nefropatija),
Erythema 
Levkopenija
4.9 Overdose 
navedenem v Prilogi V. 4.9 Preveliko odmerjanje
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above. 
Če niste prepričani, ali je vaše zdravilo eno od zgoraj naštetih, se posvetujte s svojim zdravnikom ali farmacevtom.
Repeat this cleaning process 3 times. 
Postopek čiščenja trikrat ponovite.
After first opening: 2 months 
3 leta Po prvem odprtju: 2 mesece
Juvenile animals studies 
Študije pri mladih živalih
• Ringing in the ears; 
• zvenenje v ušesih,
Date of first authorisation: 21.04.2009 Date of latest renewal: 22.01.2014 
Datum prve odobritve: 21. april 2009 Datum zadnjega podaljšanja: 22. januar 2014
In the double-blind period of the phase II study, evaluation of efficacy was a secondary objective. 
V dvojno slepem obdobju študije faze II je bila ocenitev učinkovitosti sekundarni cilj.
• Inability to speak or write or understand spoken or written language; 
• nezmožnost govora, pisanja ali razumevanja izgovorjenih ali napisanih besed,
Once you have opened the bottle, you must not use it longer than 2 months 
Odprte steklenice ne uporabljajte dlje kot 2 mesece.
Not to be sold separatley. 
Ni namenjen ločeni prodaji.
However, due to inter-individual variability, the effect may be clinically relevant in some individuals. 
Vendar je lahko zaradi velikih razlik med posamezniki ta učinek pri nekaterih posameznih klinično pomemben.
At this age the intrinsic activity of the elimination process has not yet reached maturation. 
V tej starosti intrinzična dejavnost procesa izločanja še ni dozorela.
You may need to apply some pressure to insert it securely. 
Morda boste za varno vstavitev morali nekoliko pritisniti.
Tell your doctor if you are taking: 
Povejte zdravniku, če jemljete:
The median relative change was larger in the previous placebo group (-51.4%) than in the previous ESL group ( 
ki je prej prejemala placebo (-51,4 %), kot v skupini, ki je prej prejemala eslikarbazepinacetat (
Do not stop taking your oral suspension suddenly. 
Peroralne suspenzije ne prenehajte jemati nenadoma.
Body weight was shown to have an effect on volume of distribution and clearance. 
Pokazalo se je, da ima telesna masa učinek na razdelitveni volumen in očistek.
• Difficulty in concentration; 
• težave pri koncentraciji,