natgillin/translations-raw huggingface dataset:
Zonegran can cause children to sweat less and overheat and if the child is not treated this can lead to brain damage and death. 
Zdravilo Zonegran lahko povzroči, da se otroci manj znojijo in se pregrejejo.
Zonegran 50 mg hard capsules zonisamide 
Zonegran 50 mg trde kapsule zonisamid
EU/1/04/307/010 14 capsules EU/1/04/307/009 28 capsules EU/1/04/307/003 56 capsules EU/1/04/307/012 84 capsules 
EU/1/04/307/010 14 kapsul EU/1/04/307/009 28 kapsul EU/1/04/307/003 56 kapsul EU/1/04/307/012 84 kapsul
300 mg / day (once a day) 
300 mg/dan (enkrat na dan)
A dietary supplement or increased food intake should be considered if the patient is failing to gain weight in accordance with growth charts, otherwise Zonegran should be discontinued. 
Če bolnik ne pridobiva telesne mase v skladu z rastnimi krivuljami, je treba razmisliti o uporabi prehranskih dopolnil ali zvečanem uživanju hrane ali pa zdravljenje z zdravilom Zonegran prekiniti.
Pneumonia Urinary tract infection 
Infekcijske in parazitske bolezni pljučnica okužba sečil
EU/1/04/307/001 14 capsules EU/1/04/307/005 28 capsules EU/1/04/307/002 56 capsules EU/1/04/307/013 84 capsules 
EU/1/04/307/001 14 kapsul EU/1/04/307/005 28 kapsul EU/1/04/307/002 56 kapsul EU/1/04/307/013 84 kapsul
Be especially careful while driving or operating machinery, if Zonegran affects you in this way. 
Če zdravilo Zonegran vpliva na vas na ta način, bodite med vožnjo in upravljanjem strojev še posebno previdni.
Urinary tract infection Pneumonia 
Infekcijske in parazitske bolezni okužba sečil pljučnica
Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential. 
Ženskam v rodni dobi, zdravljenih z zonisamidom, mora svetovati zdravnik specialist.
A white opaque body and a red opaque cap printed with a logo and “ZONEGRAN 100” in black. 
Bel, neprozoren spodnji del kapsule z rdečim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 100'' v črni barvi.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora motnje dihanja
A white opaque body and a grey opaque cap printed with a logo and “ZONEGRAN 50” in black. 
Bel, neprozoren spodnji del kapsule s sivim neprozornim zgornjim delom kapsule, na katerem je natisnjen logo in ''ZONEGRAN 50'' v črni barvi.
Patients must not take this medicinal product if they are allergic to peanut or soya. 
Če so bolniki alergični na arašide ali sojo, ne smejo jemati tega zdravila.
• have eye problems such as glaucoma. 
• če imate težave z očmi, na primer glavkom;
Zonisamide is 40 - 50 % bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i.e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate). 
In vitro študije so pokazale, da prisotnost drugih antiepileptičnih zdravil (npr. fenitoina, fenobarbitona, karbamazepina in natrijevega valproata) ne vpliva na vezavo na proteine.
Twelve months seizure freedom PP-population ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period 
≤ 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem > 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem zonisamid karbamazepin n (populacija ITT) Podtip epileptičnega napada (6 mesecev brez epileptičnega napada - populacija PP) Vsi parcialni
Withdrawal 
Odtegnitev
Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash. 
Pri bolnikih, pri katerih se razvije izpuščaj, ki ga ni mogoče razložiti na noben drug način, je treba pretehtati možnost ukinitve zdravila Zonegran.
Six months seizure freedom 
6.3 Rok uporabnosti
Respiratory disorder 
Okvarjeno delovanje jeter
Withdrawal seizures 
Pretisni omot
Adverse reactions associated with Zonegran obtained from adjunctive use clinical studies and post-marketing surveillance 
Preglednica 4 Neželeni učinki, povezani z zdravilom Zonegran, iz kliničnih študij adjuvantnega zdravljenja in opazovanja v času trženja zdravila Organski sistem (po MedDRA klasifikaciji)
Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome 
Bolezni živčevja ataksija omotica okrnjene spominske sposobnosti somnolenca bradifrenija motnje pozornosti nistagmus parestezije motnje govora tremor konvulzije amnezija koma epileptični napad grand mal miastenijski sindrom nevroleptični maligni sindrom epileptični status
Investigations Decreased bicarbonate 
Odtegnitev zdravila Zonegran
Diff 
MedDRA†)
Status epilepticus 
Epileptični napadi ob odtegnitvi
EMA Number 
Številka postopka EMA
It is available as tablets (25 mg). 
Na voljo je v obliki tablet (25 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Edurant, veljavno po vsej Evropski uniji, izdala 28. novembra 2011.
What measures are being taken to ensure the safe and effective use of Edurant? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Edurant?
In all studies, the main measure of effectiveness was based on the reduction in viral load. 
V vseh študijah je glavno merilo učinkovitosti temeljilo na zmanjšanju virusnega bremena.
The full EPAR for Edurant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Edurant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A risk management plan has been developed to ensure that Edurant is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Edurant je bil pripravljen načrt obvladovanja tveganj.
Other information about Edurant 
Druge informacije o zdravilu Edurant
This is a summary of the European public assessment report (EPAR) for Edurant. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Edurant.
The recommended dose of Edurant is one tablet once a day. 
Priporočeni odmerek zdravila Edurant je ena tableta enkrat na dan.
For more information about treatment with Edurant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Edurant preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Edurant. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected. 
Zavira dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV-1, kar mu omogoča proizvodnjo več virusov v okuženih celicah.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edurant, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What benefit has Edurant shown during the studies? 
Kakšne koristi je zdravilo Edurant izkazalo med študijami?
Edurant does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Edurant ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Edurant was also effective in adolescents, with around 72% of patients responding to treatment after 48 weeks. 
Zdravilo Edurant je bilo učinkovito tudi pri mladostnikih, saj se je po 48 tednih na zdravljenje odzvalo okoli 72 % bolnikov.
Treatment with Edurant should be started by a doctor experienced in treating HIV infection. 
Zdravljenje z zdravilom Edurant mora uvesti zdravnik z izkušnjami z zdravljenjem okužbe z virusom HIV.
What is the risk associated with Edurant? 
Kakšna tveganja so povezana z zdravilom Edurant?
It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml. 
Uporablja se samo pri bolnikih, ki zaradi okužbe z virusom HIV predhodno še niso bili zdravljeni in pri katerih ravni virusa HIV v krvi (virusno breme) niso višje od 100 000 HIV-1 RNK kopij/ml.
However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load. 
Kljub temu je ugotovil, da obstaja manjše tveganje za razvoj odpornosti virusa HIV-1 za rilpivirin in da se zdi, da je to tveganje manjše pri bolnikih z manjšim virusnim bremenom.
The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes). 
Najpogostejši neželeni učinki zdravila Edurant (opaženi pri več kot 1 bolniku od 10) so glavobol, nespečnost, omotica, navzeja (slabost) ter povišane ravni skupnega holesterola, holesterola LDL (lipoproteina majhne gostote), pankreazne amilaze (encima, ki se tvori v trebušni slinavki in razgradi škrob na sladkorje) in transaminaz (jetrnih encimov).
If Edurant is given together with rifabutin, the doctor should increase the dose of Edurant to two tablets once a day during rifabutin treatment. 
Če se zdravilo Edurant daje skupaj z rifabutinom, mora zdravnik med jemanjem rifabutina povečati odmerek zdravila Edurant na dve tableti enkrat na dan.
Edurant must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Edurant: 
Zdravilo Edurant se ne sme uporabljati skupaj z naslednjimi zdravili, ki lahko povzročijo znižane ravni rilpivirina v krvi in posledično zmanjšajo njegovo učinkovitost:
Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients. 
Zato je zaključil, da so koristi zdravila Edurant večje od z njim povezanih tveganj pri bolnikih z majhnim virusnim bremenom HIV-1, in priporočil, da se zanj izda dovoljenje za promet pri tej skupini bolnikov.
Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz. 
V obeh študijah skupaj se je po enem letu na zdravljenje odzvalo 84 % bolnikov, ki so jemali zdravilo Edurant, in 82 % bolnikov, ki so jemali efavirenz.
• rifampicin, rifapentine (antibiotics); 
• rifampicin in rifapentin (antibiotični zdravili);
The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). 
Zdravilna učinkovina zdravila Edurant, rilpivirin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
Edurant is an antiviral medicine. 
Zdravilo Edurant je protivirusno zdravilo.
Why has Edurant been approved? 
Zakaj je bilo zdravilo Edurant odobreno?
For the full list of all side effects reported with Edurant, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Edurant, glejte navodilo za uporabo.
Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1. 
Zdravilo Edurant so proučevali v dveh glavnih študijah pri 1 368 predhodno nezdravljenih bolnikih, ki so bili okuženi z virusom HIV-1.
The Committee noted that Edurant causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day. 
Ugotovil je, da zdravilo Edurant povzroča manj neželenih učinkov v zgodnjih fazah zdravljenja in je priročnejše, saj se jemlje v obliki ene tablete na dan.
Edurant is a medicine that contains the active substance rilpivirine. 
Edurant je zdravilo, ki vsebuje zdravilno učinkovino rilpivirin.
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits); 
• karbamazepin, okskarbazepin, fenobarbital, fenitoin (zdravila za zdravljenje epileptičnih napadov);
Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Edurant se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1. 
Zdravilo Edurant so proučevali še v eni študiji pri 36 predhodno nezdravljenih mladostnikih (starih med 12 in 18 let), ki so bili okuženi z virusom HIV-1.
Edurant must be taken with a meal. 
Zdravilo Edurant je treba vzeti med jedjo.
In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors. 
V drugi študiji so zdravilo Edurant primerjali z efavirenzom, pri čemer sta bili obe zdravili uporabljeni v kombinaciji s fiksno shemo jemanja protivirusnih zdravil, ki je vključevala tenofovirdizoproksilat in emtricitabin ali dva druga nukleozidna ali nukleotidna zaviralca reverzne transkriptaze.
In the first study, Edurant was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine. 
V prvi študiji so zdravilo Edurant primerjali z drugim zdravilom NNRTI, imenovanim efavirenz, pri čemer sta bili obe zdravili uporabljeni v kombinaciji s fiksno shemo jemanja protivirusnih zdravil, ki je vključevala tenofovirdizoproksilat in emtricitabin.
By blocking this enzyme, Edurant, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Edurant, ki se jemlje v kombinaciji z drugimi protivirusnimi zdravili, z zaviranjem tega encima zmanjša količino virusov HIV v krvi in jo ohranja na nizki ravni.
Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment. 
To zdravilo je bilo uporabljeno v kombinaciji s fiksno shemo jemanja protivirusnih zdravil in ga niso primerjali z nobenim drugim zdravilom.
How has Edurant been studied? 
Kako je bilo zdravilo Edurant raziskano?
In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood. 
Pri odraslih je bilo zdravilo Edurant v kombinaciji z drugimi protivirusnimi zdravili pri zniževanju ravni virusa HIV-1 v krvi enako učinkovito kot primerjalno zdravilo.
The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age. 
CHMP je zaključil, da je zdravilo Edurant v kombinaciji z drugimi protiretrovirusnimi zdravili enako učinkovito kot glavna zdravila NNRTI, ki se trenutno uporabljajo kot zdravljenje prve izbire pri odraslih bolnikih, okuženih z virusom HIV-1.
How is Edurant used? 
Kako se zdravilo Edurant uporablja?
What is Edurant used for? 
Za kaj se zdravilo Edurant uporablja?
• St John's wort (a herbal antidepressant medicine). 
• šentjanževka (antidepresiv rastlinskega izvora).
What is Edurant? 
Kaj je zdravilo Edurant?
How does Edurant work? 
Kako zdravilo Edurant deluje?
AsV is present in plasma only at relatively low levels. 
AsV je prisoten v plazmi samo v relativno nizki ravni.
This syndrome can be fatal. 
Ta sindrom je lahko smrten.
The same dose is recommended for adults and elderly. 
Isti odmerek se priporoča za odrasle in starejše bolnike.
Observation is the recommended approach with intervention only in selected cases. 
Priporočen pristop je opazovanje, poseg pa le v izbranih primerih.
Monitoring and management for these patients should be as described above. 
Nadzor in zdravljenje pri teh pacientih morata biti takšna, kot je opisano zgoraj.
At Risk 
S tveganjem
From a microbiological point of view, the product must be used immediately. 
Z mikrobiološkega vidika morate zdravilo porabiti takoj.
Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007 
Datum prve odobritve: 05. 03. 2002 Datum zadnjega podaljšanja: 05. 03. 2007
The results are summarised in the table 4 below. 
Rezultati so povzeti v tabeli 4 spodaj.
Caution is needed in these patients. 
Pri teh bolnikih je potrebna posebna previdnost.
The response rate was similar for both genders. 
Stopnja odzivnosti je bila podobna pri obeh spolih.
This accumulation was slightly more than expected based on single-dose results. 
Ta akumulacija je bila nekoliko višje od pričakovanega na podlagi rezultatov enkratnega odmerka.
Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki pri otrocih, starih od 5 do 16 let, so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
18-Month survival 
18-mesečno preživetje
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zaradi odsotnosti študij inkompatibilnosti tega zdravila ne smete mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
If you are not sure, show the bottle or pack to your doctor. 
Če niste prepričani, zdravniku pokažite stekleničko ali embalažo.
Development of second primary malignancies 
Razvoj drugega primarnega malignoma
Monitor patients for the development of second primary malignancies. 
Spremljajte bolnike glede razvoja drugega primarnega malignoma.
2-Year overall survival (OS) 
2-letno celokupno preživetje (OS)
Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy. 
Konsolidacijsko zdravljenje se mora začeti 3-4 tedne po koncu indukcijskega zdravljenja.
Confidence interval (CI) 
Interval zaupanja (IZ)
Months 
Mesecev
2-Year cumulative incidence of relapse (CIR) 
2-letna kumulativna pojavnost relapsa (CIR)
Vd is also weight dependent, increasing with increasing body weight. 
Vd je odvisen tudi od telesne mase in z naraščanjem telesne mase narašča.
• cisapride (a medicine used to relieve certain stomach problems). 
cisaprid (zdravilo, ki se uporablja za lajšanje nekaterih želodčnih težav).
Post-marketing experience suggests that a similar syndrome may occur in patients with other types of malignancy. 
Izkušnje po začetku trženja navajajo, da do podobnega sindroma lahko pride pri pacientih z drugimi vrstami malignosti.
95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX 
95-% IZ za razliko, 2-22 odstotnih točk p < 0,001 za neinferiornost p = 0,02 za superiornost ATRA+TRISENOX
Do not save any unused portions for later administration. 
Ne shranjujte neporabljenega zdravila za poznejšo uporabo.
The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs. 
Dnevni odmerek lahko zvečate na 100 % prvotnega odmerka, če ne pride do podaljšanja.
Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing. 
Osebje mora biti poučeno o rokovanju z arzenovim trioksidom in njegovim redčenjem, ter pri tem nositi ustrezna zaščitna oblačila.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you. 
Preden boste dobili to zdravilo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
No data are available for children under 5 years. 
Podatki o uporabi pri otrocih, mlajših od 5 let, niso na voljo.
The diluted solution must be clear and colourless. 
Razredčena raztopina mora biti bistra in brezbarvna.
Some cases recovered with vitamin B1 supplementation. 
Pri nekaterih primerih je ob dodajanju vitamina B1prišlo do okrevanja.
A central venous catheter is not required. 
Centralni venski kateter ni potreben.
Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring. 
Bolniki morajo biti ob začetku zdravljenja zaradi bolezenskih simptomov in zagotovitve ustreznega nadzora sprejeti v bolnišnico.
CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml) 
POZOR, NOVA KONCENTRACIJA (2 mg/ml)
Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding. 
Volumen porazdelitve (Vd) za AsIII je velik (> 400 l), kar kaže na značilno porazdelitev v tkivu z zanemarljivo vezavo na beljakovine.
If clinically justified/required, concomitant diuretic therapy is also recommended. 
Če je klinično upravičeno/potrebno, je priporočeno tudi sočasno diuretično zdravljenje.
These include: 
Ta zdravila vključujejo:
Procedure for proper disposal 
Postopek za ustrezno odlaganje
Responses were seen across all age groups tested, ranging from 6 to 75 years. 
Odzive so opazili pri vseh starostnih skupinah, od 6 do 75 let.
However all cases were successfully managed with hydroxyurea therapy. 
Toda vsi primeri so bili uspešno nadzorovani z zdravljenjem s hidroksisečnino.
ECG and electrolyte monitoring recommendations 
Priporočila za nadzor EKG in elektrolitov
Haematologic complete remission (HCR) 
Popolna hematološka remisija (HCR)
- you have any liver problems. 
imate okvarjeno delovanje ledvic, imate kakršne koli težave z jetri.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leucocytosis, and no standard approach has proven effective. 
Zdravila za zmanjševanje števila belih krvnih celic pogosto poslabšajo toksične učinke, povezane z levkocitozo, in nobena izmed standardnih metod se ni pokazala kot učinkovita.
TRISENOX is normally given by a doctor or a nurse. 
Zdravilo TRISENOX vam bo običajno dal zdravnik ali medicinska sestra.
Hepatotoxicity (grade 3 or greater) 
Hepatotoksičnost (stopnje 3 ali več)
The extent of accumulation of these metabolites is dependent on the dosing regimen. 
Obseg nalaganja teh presnovkov je odvisen od režima odmerjanja.
Grades ≥ 3 
Stopnje ≥ 3
If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na arzenov trioksid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
P-value 
P-vrednost
This medicine must not be used if you notice foreign particulate matter or if the solution is discoloured. 
Ne uporabljate tega zdravila, če opazite tuje delce ali če je raztopina obarvana.
One was a single investigator clinical study (n=12) and the other was a multicentre, 9-institution study (n=40). 
Ena je bila klinična študija z enim raziskovalcem (n = 12), druga pa multicentrična študija, ki je potekala v 9 zavodih (n = 40).