natgillin/translations-raw huggingface dataset:
The proposal of the MAH for this section was accepted with minor amendments in line with the rest of the SmPC and rearrangement of the information taking into account the QRD requirements. 
Predlog imetnika dovoljenja za promet z zdravilom je bil sprejet z manjšimi spremembami v skladu s preostalim povzetkom glavnih značilnosti zdravila in prerazporeditvijo informacij z upoštevanjem zahtev za pregled kakovosti dokumentov.
The CHMP also considered that in the table of ADR in multiple sclerosis the footnote specifying that the events amenorrhea may be consistent with premature menopause and that the causal relationship between the cases of sudden death and mitoxantrone administration is uncertain should be left in the harmonised PI. 
Odbor CHMP je presodil tudi, da je treba v usklajenih informacijah o zdravilu v preglednici neželenih učinkov pri multipli sklerozi pustiti opombo, v kateri je navedeno, da lahko pojav amenoreje nakazuje prezgodnjo menopavzo in da vzročno razmerje med primeri nenadne smrti in dajanjem mitoksantrona ni pojasnjeno.
Treatment of acute lymphocytic leukaemia 
Zdravljenje akutne limfocitne levkemije
The MAH was asked to discuss the relevance of including four ADRs, which have been reported and are listed in the PI of other mitoxantrone-containing products. 
Imetnik dovoljenja za promet z zdravilom je bil naprošen, naj obravnava smiselnost vključitve štirih neželenih učinkov, o katerih so poročali pri drugih zdravilih, ki vsebujejo mitokstantron, in ki so navedeni v informacijah o teh zdravilih.
The MAH presented four studies of mitoxantrone administered in combination with other cytostatic agents in the treatment of a blast crisis in chronic myeloid leukaemia. 
Imetnik dovoljenja za promet z zdravilom je predložil štiri študije, v katerih je bil mitoksantron uporabljen v kombinaciji z drugimi citostatičnimi zdravili za zdravljenje blastne krize pri kronični mieloični levkemiji.
Based on the data provided, the MAH was asked to add dysgeusia in the table listing the ARDs reported in oncology. 
Imetnik dovoljenja za promet z zdravilom je bil na osnovi predloženih podatkov naprošen, naj v preglednico neželenih učinkov, o katerih so poročali v onkologiji, doda disgevzijo.
The MAH presented an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with specific subgroups of NHL, pre-treated or treatment naïve. 
Imetnik dovoljenja za promet z zdravilom je predstavil pregled študij, ki so bile izvedene z mitoksantronom samim ali v kombiniranih shemah za zdravljenje bolnikov s posameznimi podskupinami NHL, ki so bili predhodno zdravljeni ali pa še niso bili zdravljeni.
The CMHP was of the view that, in line with the SmPC guideline, as confusion and fatigue have been reported with mitoxantrone, it should be mentioned that the treatment has minor influence on those abilities. 
Odbor CHMP je ocenil, da je treba v skladu s smernico o povzetku glavnih značilnosti zdravila omeniti, da mitoksantron blago vpliva na te sposobnosti, saj so pri njegovi uporabi poročali o zmedenosti in utrujenosti.
In addition, as multiple sclerosis is not a life threatening disease, mitoxantrone should be contraindicated in the treatment of multiple sclerosis in pregnant women. 
Poleg tega mora biti mitoksantron kontraindiciran pri zdravljenju multiple skleroze v nosečnosti, saj multipla skleroza ni življenjsko nevarna bolezen.
The MAH provided a phase III study and several uncontrolled phase II studies in induction therapy as well as studies of mitoxantrone in combination regimens in relapsed/refractory ALL (including a study in children). 
faze v zvezi z indukcijskim zdravljenjem ter študije, v katerih je bil mitoksantron uporabljen v kombiniranih shemah pri relapsni/refraktorni ALL (vključno s študijo pri otrocih).
These measures were considered adequate by the SAG and the PRAC, who further considered the numerous requirement and their importance for the safe use of the product in multiple sclerosis, educational material should be developed and a study should be conducted to ensure they are adhered to. 
Ti ukrepi so bili po mnenju znanstvene svetovalne skupine in odbora PRAC, ki sta obravnavala tudi številne zahteve in njihov pomen za varno uporabo zdravila pri multipli sklerozi, zadostni.
The MAH provided several phase II studies and case studies reported in the literature where mitoxantrone was given to patients with HCC. 
faze in študij primerov, objavljenih v literaturi, pri katerih so mitoksantron dajali bolnikom s hepatocelularnim karcinomom.
Further, as the potential additive risks of mitoxantrone in patients with long term exposure also to other immunosuppressants are not known, the CHMP was of the view that it should be mentioned that the safety and efficacy of mitoxantrone have not been demonstrated after other multiple sclerosis treatments approved more recently. 
Poleg tega je odbor CHMP menil, da je treba omeniti, da varnost in učinkovitost mitoksantrona po uvedbi v zadnjem času odobrenih metod za zdravljenje multiple skleroze nista bili dokazani, saj ni znano, ali so pri bolnikih, ki so dolgotrajno izpostavljeni tudi drugim imunosupresivom, z mitoksantronom povezana potencialna aditivna tveganja.
In addition, a complete blood count should be obtained before each dose of mitoxantrone and 10 days following each administration. 
Pred vsakim odmerkom mitoksantrona in 10 dni po njem je treba tudi pregledati celotno krvno sliko bolnika.
This was accepted by the MAH which therefore withdrew it from the proposed harmonised PI. 
Imetnik dovoljenja za promet z zdravilom je to sprejel in indikacijo umaknil iz predlaganih usklajenih informacij o zdravilu.
Sections related to the unique identifier were added in line with the current QRD template (dated February 2016). 
V skladu s trenutno predlogo za pregled kakovosti dokumentov (objavljeno februarja 2016) so bila dodana poglavja, povezana z edinstveno oznako.
The MAH provided several phase III studies and a phase II study investigating the effect of mitoxantrone in combination with corticosteroids on pain relief and on overall survival. 
faze, v katerih je preučeval učinek mitoksantrona v kombinaciji s kortikosteroidi na lajšanje bolečine in skupni čas preživetja.
The MAH considered relevant to list Tumour lysis syndrome. 
Imetnik dovoljenja za promet z zdravilom je ocenil, da je v preglednico smiselno vključiti sindrom tumorske lize.
In addition, the increased thrombotic or haemorrhage risk with concomitant Vitamin K antagonists with tumoural disease, widely described in the literature was considered relevant to be added by the CHMP. 
Poleg tega je odbor CHMP presodil, da je smiselno dodati opozorilo o povečanem trombotičnem in hemoragičnem tveganju pri sočasni uporabi antagonistov vitamina K in prisotnosti tumorske bolezni.
For this reason also, it was specified that Novantrone should not be initiated for treatment of multiple sclerosis in patients who have already been treated with it. A dosing adjustment guide, based on bone marrow suppression was kept in the harmonised text in order to minimise the risk of leukaemia. 
Tudi zato je bilo določeno, da se zdravilo Novantrone ne sme uvesti pri bolnikih z multiplo sklerozo, ki so bili z njim že zdravljeni.
The MAH submitted an overview of studies performed with mitoxantrone as single agent or in combination regimens for the treatment of patients with advanced or metastatic breast cancer. 
Imetnik dovoljenja za promet z zdravilom je predložil pregled študij, v katerih so bili bolniki z napredovalim ali metastatskim rakom dojke zdravljeni z mitoksantronom samim ali v kombiniranih shemah.
The following information is intended for medical or healthcare professionals only: 
Naslednje informacije so namenjene samo zdravniškemu ali zdravstvenemu osebju:
Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014 
Datum prve odobritve: 02/07/2009 Datum zadnjega podaljšanja: 03/03/2014
Please inform your baby's doctor: 
Obvestite otrokovega zdravnika:
The optimal duration of treatment has not been established. 
Trajanje zdravljenja Optimalno trajanje zdravljenja ni bilo ugotovljeno.
1010 Wien 
1010 Dunaj
* Beginning 24 hours after the loading dose 
* z začetkom 24 ur po začetnem odmerku
No support 
brez podpore
Frequency is defined as: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
Pogostnost je opredeljena kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznani (iz razpoložljivih podatkov jih ni možno oceniti).
This method is also known as “a drip”. 
Ta način je znan tudi kot „kapalna infuzija“.
In newborn infants, the t1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days). 
Pri novorojenčkih je t1/2 približno 3-4 dni in Ae približno 86 % (v 6 dneh).
Maintenance dose* 
Vzdrževalni odmerek*
If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment. 
Če je vaš otrok 5 do 7 dni brez napadov apneje, bo zdravnik prekinil zdravljenje.
EU/1/09/528/002 1 ml ampoules EU/1/09/528/001 3 ml ampoules 
EU/1/09/528/002 1 ml ampule EU/1/09/528/001 3 ml ampule
If concurrent use is indicated, cardiac rhythm and blood pressure must be carefully monitored. 
Če je indicirana sočasna uporaba, je treba skrbno nadzirati srčni ritem in krvni tlak.
Non invasive support 
neinvazivna podpora
− infants with known and clinically significant cardiac disease 
− dojenčki z znano in klinično pomembno boleznijo srca
Treatment of caffeine overdose is primarily symptomatic and supportive. 
Zdravljenje prevelikega odmerka kofeina je predvsem simptomatično in podporno.
Clear, colourless, aqueous solution at pH=4.7. 
Bistra, brezbarvna, vodna raztopina pri pH = 4,7.
Odds ratio (95% CI) 
Razmerje verjetnosti (95 % IZ)
Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25ºC and at 2-8ºC. 
Dokazana je 24-urna kemična in fizikalna združljivost razredčene raztopine pri 25 ºC in 2-8 ºC.
6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN 
6 POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out. 
Čeprav ne kaže, da bi kofein poslabšal cerebralno hipoksijo ali poslabšal katere koli posledične poškodbe, te možnosti ni mogoče izključiti.
• If your newborn is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6). 
• če je novorojenček alergičen na kofeinijev citrat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Blood samples for monitoring should be taken just before the next dose in the case of therapeutic failure and 2 to 4 hours after the previous dose when suspecting toxicity. 
Vzorce krvi za nadziranje je treba vzeti tik pred naslednjim odmerkom v primeru, da zdravljenje ni bilo uspešno in 2 do 4 ure po predhodnem odmerku, če obstaja sum na toksičnost.
Death or disability according to subgroup of respiratory support at entry to study 
Smrt ali invalidnost po podskupinah dihalne podpore ob vstopu v študijo:
In a recent large multicentre study on preterm newborn infants a median treatment period of 37 days was reported. 
V pred kratkim opravljeni multicentrični študiji z nedonošenimi novorojenčki so poročali o 37-dnevnem srednjem obdobju zdravljenja.
Failure to respond to caffeine treatment (confirmed if necessary by measurement of plasma levels) could be an indication of another cause of apnoea. 
Neodzivanje na zdravljenje s kofeinom (po potrebi potrjeno z izmerjenimi ravnmi v plazmi) lahko kaže na drugi vzrok za apnejo.
In clinical practice, treatment is usually continued until the infant has reached a post-menstrual age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously. 
V klinični praksi se zdravljenje običajno nadaljuje, dokler dojenček ne doseže postmenstrualne starosti 37 tednov, do katere apneja zaradi nezrelosti običajno spontano izzveni.
Peyona should be used with caution. 
Zdravilo Peyona je treba uporabljati previdno.
These effects are dose related and may necessitate measurement of plasma levels and dose reduction. 
Ti učinki so odvisni od odmerka in bodo morda zahtevali merjenje ravni v plazmi in zmanjšanje odmerka.
Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy. 
Zabeležili so prehodne upade tiroksina (T4) pri dojenčkih na začetku zdravljenja, ki pa se z vzdrževanjem terapije ne ohranijo.
The medicinal product must not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection. 
Zdravila se ne sme dati z intramuskularno, subkutano, intratekalno ali intraperitonealno injekcijo.
Tell your baby's doctor if your newborn is taking, have recently taken or might take any other medicines. 
Obvestite otrokovega zdravnika, če novorojenček prejema, je pred kratkim prejel ali pa bo morda začel prejemati katero koli drugo zdravilo.
Via Enrico Fermi IT-65020 Alanno (PE) Italy 
Via Enrico Fermi IT-65020 Alanno (PE) Italija
It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack. 
Priporoča se ukinitev dajanja kofeinijevega citrata, če bolnik 5-7 dni ne doživi znatnega napada apneje.
• If your newborn produces more urine than usual 
• če vaš novorojenček odvaja več urina kot običajno
Dosage adjustments and monitoring 
Prilagajanje odmerka in spremljanje
However, at high doses convulsions in rodents were induced. 
Vendar pa so visoki odmerki sprožili konvulzije pri glodavcih.
Three of the infants who developed necrotising enterocolitis during the study died. 
Trije dojenčki, pri katerih se je v času preskušanja razvil nekrotizirajoči enterokolitis, so umrli.
• If your newborn has frequent regurgitation 
• če ima novorojenček pogoste regurgitacije
By 9 months of age, the metabolism of caffeine approximates to that seen in adults (t1/2 = 5 hours and Ae = 1%). 
Pri 9 mesecih starosti je presnova kofeina približno enaka tisti pri odraslih (t1/2 = 5 ur in Ae = 1 %).
Teratogenic potential and effects on reproductive performance observed in animals are not relevant to its indication in the preterm infant population. 
Teratogeni potencial in učinki na sposobnost razmnoževanja, ki so jih opazili pri živalih, niso pomembni za indikacijo v skupini nedonošenčkov.
Pharmacotherapeutic group: Psychoanaleptics, xanthine derivatives ATC code: N06BC01 Mechanism of action 
Farmakoterapevtska skupina: psihoanaleptiki, derivati ksantina, oznaka ATC: N06BC01 Mehanizem delovanja
Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2. 
Zato ima kofein potencial medsebojnega delovanja z zdravilnimi učinkovinami, ki so substrati za CYP1A2, da zavira CYP1A2 ali spodbudi CYP1A2.
Each carton contains 10 ampoules. 
Ena škatla vsebuje 10 ampul.
Caffeine therapy reduced the rate of bronchopulmonary dysplasia [odds ratio (95% CI) 0.63 (0.52 to 0.76)] and improved the rate of survival without neurodevelopmental disability [odds ratio (95 %CI) 0.77 (0.64 to 0.93)]. 
Zdravljenje s kofeinom je zmanjšalo stopnjo bronhopulmonalne displazije [razmerje verjetnosti (95 % IZ) 0,63 (0,52 do 0,76)] in izboljšalo stopnjo preživetja brez prizadetosti v razvojni nevrologiji [razmerje verjetnosti (95 % IZ) 0,77 (0,64 do 0,93)].
Your baby's doctor will decide exactly how long your newborn must continue therapy with Peyona. 
Otrokov zdravnik bo natančno odločil, kako dolgo mora vaš novorojenček nadaljevati zdravljenje z zdravilom Peyona.
The maintenance doses were adjusted weekly for changes in body weight and could be given orally once an infant tolerated full enteral feedings. 
Vzdrževalni odmerki so bili prilagojeni tedensko zaradi sprememb v telesni masi, zdravilo pa je bilo mogoče dajati peroralno, ko je dojenček enkrat prenašal popolno enteralno prehranjevanje.
Most of its effects have been attributed to antagonism of adenosine receptors, both A1 and A2A subtypes, demonstrated in receptor binding assays and observed at concentrations approximating those achieved therapeutically in this indication. 
Večino učinkov pripisujejo antagonizmu na receptorjih za adenozin, na podtipu A1 in A2A, kar se kaže v vsebnosti vezave receptorjev, opazovanih pri koncentracijah, ki so približno enake terapevtsko doseženim koncentracijam pri tej indikaciji.
Brain injury, convulsion and deafness were observed but they were more frequent in the placebo group. 
Opazili so možganske poškodbe, konvulzije in gluhost, ki so bili pogostejši v skupini, ki je dobivala placebo.
As there is a risk for recurrence of apnoeas after cessation of caffeine citrate treatment monitoring of the patient should be continued for approximately one week. 
Ker obstaja tveganje za ponovitev apnej po prenehanju dajanja kofeinijevega citrata, je treba z nadziranjem bolnika nadaljevati še približno en teden.
Where clinically indicated, caffeine plasma levels should be monitored. 
Kjer je klinično indicirano, je treba nadzorovati ravni kofeina v plazmi.
If you have any further questions on the use of this medicinal product, ask your baby's doctor. 
Če imate kakršna koli nadaljnja vprašanja glede uporabe tega zdravila, vprašajte zdravnika svojega otroka.
Plasma protein binding data are not available for newborn infants or infants. 
Podatek o vezavi na beljakovine v plazmi ni na voljo za novorojenčke in dojenčke.
This limit may however be revised according to clinical judgment in individual cases depending on the response to treatment, the continuing presence of apnoeic episodes despite treatment, or other clinical considerations. 
Vendar pa je mogoče to mejo v posamičnih primerih premakniti glede na klinično presojo odziva na zdravljenje, nadaljevanje prisotnosti epizod apneje kljub zdravljenju in glede na druge klinične dejavnike.
At therapeutic doses some behavioural changes in newborn rats were induced, most likely as a consequence of increased adenosine receptor expression that persisted into adulthood. 
V terapevtskih odmerkih so sprožili nekatere vedenjske spremembe pri novorojenih podganjih mladičih, najverjetneje kot posledica večje izraženosti receptorjev za adenozin, ki so se ohranili do odraslosti.
If there have been any unusual rhythm disturbances on a cardiotocograph (CTG) trace before the baby is born, caffeine citrate should be administered with caution. 
Če obstajajo znaki neobičajne motnje ritma na kardiotokografu (CTG) pred rojstvom dojenčka, je treba kofeinijev citrat dajati previdno.
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
In newborns this is usually a simple sinus tachycardia. 
Pri novorojenčkih gre običajno za preprosto sinusno tahikardijo.
Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardiorespiratory and central nervous system. 
Sočasna uporaba kofeina in doksaprama lahko poveča njun stimulativni učinek na srčno-respiratorni in osrednji živčni sistem.
Other medicines and Peyona 
Druga zdravila in zdravilo Peyona
Additionally, doses may need to be adjusted according to medical judgment following routine monitoring of caffeine plasma concentrations in at risk situations such as: 
Dodatno bo morda treba prilagoditi tudi odmerke v skladu z medicinsko presojo po rutinskem nadziranju koncentracij kofeina v plazmi v primeru tveganih situacij kot so na primer naslednje:
Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment. 
Zaradi počasnega izločanja kofeina v tej skupini bolnikov ni treba počasi manjšati odmerka, ko se zdravljenje preneha.
There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis. 
Obstajajo poročila o morebitni povezanosti med uporabo metilksantinov in razvojem nekrotizirajočega enterokolitisa.
A recent large placebo-controlled multicentre study (n=2006) investigated short-term and long-term (18-21 months) outcomes of premature infants treated with caffeine citrate. 
Pred kratkim izvedena velika s placebom nadzirana multicentrična študija (n = 2006) je raziskovala kratkoročne in dolgoročne (18-21 mesecev) izide zdravljenja nedonošenčkov s kofeinijevim citratom.
The size and direction of caffeine effect on death and disability differed depending on the degree of respiratory support infants needed at randomisation, indicating more benefit for the supported infants [odds ratio (95%CI) for death and disability, see table below]. 
Velikost in smer učinkov kofeina na smrt in invalidnost se je razlikovala glede na stopnjo dihalne podpore, ki so jo dojenčki ob naključni razvrstitvi potrebovali, in je nakazovala več prednosti za dojenčke s podporo [razmerje verjetnosti (95 % IZ) za smrt in invalidnost, glejte spodnjo preglednico].
Necrotising enterocolitis 
Nekrotizirajoči enterokolitis
Caffeine was shown to be devoid of mutagenic and oncogenic risk. 
Pokazalo se je, da kofein nima mutagenih in onkogenih učinkov.
Studies examining the pharmacokinetics of caffeine in newborn infants with hepatic or renal insufficiency have not been conducted. 
Študij, s katerimi bi preučevali farmakokinetiko kofeina pri novorojenčkih z jetrno ali ledvično insuficienco, niso izvedli.
• If your newborn suffers from any heart disease 
• če ima novorojenček kakršno koli bolezen srca
In young infants, the elimination of caffeine is much slower than that in adults due to immature hepatic and/or renal function. 
Pri majhnih dojenčkih je izločanje kofeina veliko počasnejše kot pri odraslih zaradi nezrelega delovanja jeter in/ali ledvic.
Aseptic technique must be strictly observed throughout handling of the medicinal product since no preservative is present. 
Ves čas ravnanja z zdravilom je treba strogo uporabljati aseptično tehniko, saj zdravilo ne vsebuje nobenih konzervansov.
This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns. 
Pokazalo se je, da to zdravilo zmanjšuje število epizod prekinitve dihanja pri nedonošenih novorojenčkih.
Convulsions may be treated with intravenous administration of anticonvulsants (diazepam or a barbiturate such as pentobarbital sodium or phenobarbital). 
Konvulzije je mogoče zdraviti z intravenskim dajanjem antikonvulzivov (diazepamom ali barbiturati kot sta natrijev pentobarbital ali fenobarbital).
What Peyona is and what it is used for 
Kaj je zdravilo Peyona in za kaj ga uporabljamo
Plasma concentrations of caffeine may need to be monitored periodically throughout treatment in cases of incomplete clinical response or signs of toxicity. 
Morda bo treba treba periodično ves čas zdravljenja nadzirati koncentracije kofeina v plazmi v primeru nepopolnega kliničnega odziva ali znakov toksičnosti.
Doses should be adjusted by monitoring of caffeine plasma concentrations to avoid toxicity in this population. 
Odmerke je treba prilagoditi z nadziranjem koncentracij kofeina v plazmi, da se prepreči toksičnost v tej skupini bolnikov.
Following overdose, published plasma caffeine levels have ranged from approximately 50 mg/l to 350 mg/l. 
Po prevelikem odmerjanju so objavljeni razponi ravni kofeina v plazmi od približno 50 mg/l do 350 mg/l.
Where doubt exists about possible interactions, plasma caffeine concentrations should be measured. 
V primeru dvoma o možnem medsebojnem delovanju je treba meriti koncentracije kofeina v plazmi.
− infants with hepatic and renal impairment (see sections 4.4 and 5.2) 
− dojenčki z okvarjenim delovanjem jeter ali ledvic (glejte poglavji 4.4 in 5.2)