FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the CHMP agreed to the proposed indication in CRPC intended specifically for palliation.
Croatian: Stoga je CHMP prihvatio predloženu indikaciju za liječenje raka prostate rezistentnog na kastraciju namijenjenu posebno za ublažavanje simptoma bolesti.
English: 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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je pregled rezultata četiriju ispitivanja mitoksantrona koji se primjenjivao u kombinaciji s drugim citostatičkim agensima u liječenju blastnih kriza u bolesnika s kroničnom mijeloičnom leukemijom.
English: Section 4.2 - Posology and method of administration
Croatian: Dio 4.2. - Doziranje i način primjene
English: These studies demonstrate the efficacy of mitoxantrone, in combination therapy, in the treatment of NHL.
Croatian: U tim je ispitivanjima dokazana djelotvornost mitoksantrona, u kombiniranoj terapiji, u liječenju ne-Hodgkinova limfoma.
English: The MAH considered relevant to list Tumour lysis syndrome.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet smatrao je da je važno uvrstiti sindrom lize tumora.
English: In addition, due to the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy.
Croatian: Osim toga, potrebno je odrediti omjer rizika i koristi mitoksantrona prije početka terapije zbog rizika od razvoja sekundarnih malignoma.
English: 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).
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je rezultate jednog ispitivanja III. faze i rezultate nekoliko nekontroliranih ispitivanja II. faze indukcijske terapije te rezultate ispitivanja djelovanja mitoksantrona u kombiniranim režimima u bolesnika s akutnom limfocitnom leukemijom koja se ponovno pojavila ili koja ne reagira na lijekove (uključujući rezultate ispitivanja u djece).
English: For acute myeloid leukaemia dosing recommendations were proposed as a single agent in relapses and in combination as induction, consolidation and salvage therapy.
Croatian: Za akutnu mijeloičnu leukemiju, u preporukama o doziranju predloženo je da se mitoksantron primjenjuje kao monoterapijski agens u slučaju ponovne pojave bolesti te u kombinaciji za potrebe indukcijske i konsolidacijske terapije te terapije spašavanja.
English: The MAH also proposed to harmonise a contraindication present in a MS against the immunisation with a live attenuated vaccine.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet iznio je i prijedlog o usklađivanju kontraindikacije za multiplu sklerozu u vezi s imunizacijom živim oslabljenim cjepivom.
English: 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.
Croatian: Osim toga, CHMP je smatrao da je važno dodati informacije o povećanom riziku od tromboze ili krvarenja u slučaju istodobne primjene s antagonistima vitamina K u bolesnika s tumorskom bolesti, što je opširno opisano u literaturi.
English: Information on the need for contraception in men was added to that already included for women and both were adjusted considering mitoxantrone half-life and respective gamete cycles length in men and women.
Croatian: Te su informacije prilagođene u pogledu vremena poluraspada mitoksantrona i duljine razvojnog ciklusa gameta u muškaraca i žena.
English: 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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je pregled rezultata ispitivanja mitoksantrona koji se primjenjivao kao monoterapijski agens ili u kombiniranim režimima u bolesnika s uznapredovalim ili metastatskim rakom dojke.
English: 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.
Croatian: Budući da je zabilježeno da se u bolesnika liječenih mitoksantronom javljaju konfuzija i umor, CMHP je bio mišljenja da je, u skladu s uputama o sažetku opisa svojstava lijeka, potrebno spomenuti da liječenje mitoksantronom može blago utjecati na te sposobnosti.
English: 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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je pregled rezultata ispitivanja mitoksantrona koji se primjenjivao kao monoterapijski agens ili u kombiniranim režimima za liječenje bolesnika iz određenih podskupina oboljelih od ne-Hodgkinova limfoma, bolesnika koji su prethodno već liječeni ili bolesnika koji prethodno nisu bili liječeni.
English: This was accepted by the MAH which therefore withdrew it from the proposed harmonised PI.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet prihvatio je to mišljenje te je stoga povukao tu indikaciju iz predloženih usklađenih informacija o proizvodu.
English: The MAH recalculated the frequencies as per the SmPC guideline and included details of the most important adverse reactions.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet napravio je ponovni izračun učestalosti sukladno uputama o sažetku opisa svojstava lijeka te je uključio pojedinosti o najvažnijim nuspojavama.
English: 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.
Croatian: Iz istog je razloga posebno navedeno da se lijek Novantrone ne smije propisivati za liječenje bolesnika s multiplom sklerozom koji su prethodno već liječeni tim lijekom.
English: The optimal duration of treatment has not been established.
Croatian: Optimalno trajanje liječenja nije ustanovljeno.
English: The following information is intended for medical or healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo liječnicima ili zdravstvenim djelatnicima:
English: This method is also known as “a drip”.
Croatian: Taj način se još zove “drip”.
English: Some of the doses (maintenance doses) may be given by mouth.
Croatian: Neke se doze (doze održavanja) mogu davati kroz usta.
English: Non invasive support
Croatian: Neinvazivna potpora
English: Peyona should be used with caution.
Croatian: Peyona se treba primjenjivati s oprezom.
English: Maintenance dose*
Croatian: Doza održavanja*
English: Odds ratio (95% CI)
Croatian: Omjer šansi (95% CI)
English: Read all of this leaflet carefully before treatment with this medicine because it contains important information for your newborn
Croatian: Pažljivo pročitajte cijelu uputu prije početka liječenja ovim lijekom jer sadrži važne informacije za Vaše novorođenče.
English: Other medicines and Peyona
Croatian: Drugi lijekovi i Peyona
English: Death or disability according to subgroup of respiratory support at entry to study
Croatian: Smrt ili invaliditet prema podskupinama respiratorne potpore na ulasku u ispitivanje
English: While under treatment with Peyona, your newborn may experience some of the following reactions:
Croatian: Za vrijeme liječenja Peyonom, Vaše novorođenče može imati neke od sljedećih reakcija:
English: Please inform your baby's doctor:
Croatian: Molimo obavijestite liječnika Vašeg djeteta ako:
English: In newborn infants, the t1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days).
Croatian: U novorođenčadi je t1/2 približno 3-4 dana, a Ae je približno 86% (unutar 6 dana).
English: * Beginning 24 hours after the loading dose
Croatian: * Počinje 24 sata nakon udarne doze.
English: This medicinal product must not be mixed or concomitantly administered in the same intravenous line with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati niti primjenjivati istovremeno kroz isti intravenski put s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Contents of the pack and other information What Peyona contains
Croatian: Sadržaj pakiranja i druge informacije Što Peyona sadrži
English: Caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out.
Croatian: Čini se da kofein ne pogoršava cerebralnu hipoksiju niti pogoršava ikakvo posljedično oštećenje, iako se ta mogućnost ne može isključiti.
English: EU/1/09/528/002 1 ml ampoules EU/1/09/528/001 3 ml ampoules
Croatian: EU/1/09/528/002 ampule od 1 ml EU/1/09/528/001 ampule od 3 ml
English: If concurrent use is indicated, cardiac rhythm and blood pressure must be carefully monitored.
Croatian: Ako je indicirana istovremena primjena, srčani ritam i krvni tlak moraju se pažljivo nadzirati.
English: Three of the infants who developed necrotising enterocolitis during the study died.
Croatian: Troje nedonoščadi koje je razvilo nekrotizirajući enterokolitis tijekom ispitivanja je umrlo.
English: In newborns this is usually a simple sinus tachycardia.
Croatian: U novorođenčadi je to obično jednostavna sinusna tahikardija.
English: What Peyona is and what it is used for
Croatian: Što je Peyona i za što se koristi
English: − very premature infants (< 28 weeks gestational age and/or body weight <1000 g) particularly when receiving parenteral nutrition
Croatian: − vrlo nezrela nedonoščad (gestacijske dobi < 28 tjedna i/ili tjelesne težine < 1000 g) osobito kad primaju parenteralnu prehranu
English: • If your newborn is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako je Vaše novorođenče alergično na kofeincitrat ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: By 9 months of age, the metabolism of caffeine approximates to that seen in adults (t1/2 = 5 hours and Ae = 1%).
Croatian: Do dobi od 9 mjeseci, metabolizam kofeina približava se onom opaženom u odraslih (t1/2 = 5 sati i Ae = 1%).
English: However, at high doses convulsions in rodents were induced.
Croatian: Međutim, visoke su doze izazvale konvulzije u glodavaca.
English: Your baby's doctor will prescribe the right amount of Peyona based on your baby's weight.
Croatian: Liječnik Vašeg djeteta propisat će ispravnu količinu Peyone na temelju tjelesne težine djeteta.
English: Plasma protein binding data are not available for newborn infants or infants.
Croatian: Podaci o vezanju za proteine plazme nisu dostupni za novorođenčad i dojenčad.
English: If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment.
Croatian: Ako Vaše dijete neće imati napadaje apneje tijekom 5 do 7 dana, liječnik će prekinuti liječenje.
English: In adults, the mean plasma protein binding in vitro is reported to be approximately 36%.
Croatian: U odraslih je zabilježeno da je prosječno vezanje za proteine plazme in vitro približno 36%.
English: Clear, colourless, aqueous solution at pH=4.7.
Croatian: Bistra, bezbojna, vodena otopina s pH=4,7.
English: What Peyona looks like and content of the pack
Croatian: Kako Peyona izgleda i sadržaj pakiranja
English: Brain injury, convulsion and deafness were observed but they were more frequent in the placebo group.
Croatian: Primijećeni su oštećenje mozga, konvulzije i gluhoća, ali bili su češći u placebo skupini.
English: Non-clinical data revealed no major hazard for humans based on studies of repeated dose toxicity of caffeine.
Croatian: Neklinički podaci ne ukazuju na veliki rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza kofeina.
English: 1.32 (0.81 to 2.14)
Croatian: 1,32 (0,81 do 2,14)
English: Do not use the following medicines during the treatment with Peyona without talking to your baby's doctor.
Croatian: Nemojte primjenjivati sljedeće lijekove tijekom liječenja Peyonom a da prethodno niste razgovarali s liječnikom Vašeg djeteta.
English: Caffeine consumption
Croatian: Konzumacija kofeina
English: The medicinal product must not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection.
Croatian: Lijek se ne smije primijeniti intramuskularnom, supkutanom, intratekalnom ili intraperitonealnom injekcijom.
English: It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack.
Croatian: Preporučuje se prekinuti primjenu kofeincitrata kad bolesnik tijekom 5-7 dana nema značajniji napad apneje.
English: Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment.
Croatian: Činilo se da su nuspojave češće u ove podskupine s oštećenjem organa nego u druge promatrane nedonoščadi bez oštećenja organa.
English: The card shall contain the following key elements and be provided to all neonatal intensive care units where the medicinal product is likely to be used at launch of the medicinal product:
Croatian: Kartica će sadržavati sljedeće ključne elemente i bit će dostavljena jedinicama neonatalne intenzivne skrbi u kojima će se lijek vjerojatno koristiti kod puštanja lijeka u promet:
English: Tell your baby's doctor if your newborn is taking, have recently taken or might take any other medicines.
Croatian: Obavijestite liječnika Vašeg djeteta ako Vaše novorođenče prima, ako je nedavno primilo ili ako bi moglo primiti druge lijekove.
English: There is evidence that caffeine causes tachyarrhythmias in susceptible individuals.
Croatian: Postoje dokazi da kofein uzrokuje tahiaritmije u osjetljivih pojedinaca.
English: Dosage adjustments and monitoring
Croatian: Prilagođavanje doze i praćenje
English: No support
Croatian: Bez potpore
English: 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.
Croatian: Terapijske su doze izazvale neke promjene ponašanja u novorođenih štakora, najvjerojatnije kao posljedica povišene ekspresije adenozinskih receptora koja se zadržala do odrasle dobi.
English: In a recent large multicentre study on preterm newborn infants a median treatment period of 37 days was reported.
Croatian: U najnovijem velikom multicentričnom ispitivanju u prerano rođene dojenčadi zabilježen je medijan vremena trajanja liječenja od 37 dana.
English: Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014
Croatian: Datum posljednje obnove : 03/03/2014.
English: These short periods when premature babies stop breathing are due to the baby's breathing centres not being fully developed.
Croatian: Ta kratka razdoblja u kojima nedonošče prestane disati nastaju zato što mu centar za disanje nije potpuno razvijen.
English: However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Croatian: Međutim, teško ih je razlikovati od čestih komplikacija koje nastaju u nedonoščadi i komplikacija same bolesti.
English: 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.
Croatian: Budući da postoji rizik od ponavljanja apneja nakon prestanka liječenja kofeincitratom, bolesnike treba nastaviti pratiti još približno tjedan dana.
English: Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Croatian: Stoga kofein može ulaziti u interakcije s djelatnim tvarima koje su supstrati CYP1A2, inhibiraju CYP1A2 ili induciraju CYP1A2.
English: These active substances should not be used concurrently.
Croatian: Ove djelatne tvari ne smiju se istovremeno primjenjivati.
English: Treatment of caffeine overdose is primarily symptomatic and supportive.
Croatian: Predoziranje kofeinom prvenstveno se liječi simptomatski i potpornim mjerama.
English: Peyona contains the active substance caffeine citrate, which is a stimulant of the central nervous system, belonging to a group of medicines called methylxanthines.
Croatian: Peyona sadrži djelatnu tvar kofeincitrat, koji je stimulans središnjeg živčanog sustava, pripada skupini lijekova po imenu metilksantini.
English: Additionally, doses may need to be adjusted according to medical judgment following routine monitoring of caffeine plasma concentrations in at risk situations such as:
Croatian: Uz to, možda će biti potrebna prilagodba doze sukladno medicinskoj procjeni nakon rutinskog određivanja koncentracije kofeina u plazmi u rizičnim situacijama kao što su:
English: Caffeine was shown to be devoid of mutagenic and oncogenic risk.
Croatian: Pokazalo se da kofein nema mutageni niti onkogeni rizik.
English: Teratogenic potential and effects on reproductive performance observed in animals are not relevant to its indication in the preterm infant population.
Croatian: Mogući teratogeni učinak i utjecaj na reproduktivno ponašanje opaženi u životinja nisu važni za njegovu primjenu u populaciji prerano rođene dojenčadi.
English: The MAH shall agree the text of a Dear Healthcare Professional letter with the CHMP (and if necessary with the National Competent Authorities) prior to launch of the medicinal product and shall ensure that it is provided to all physicians experienced in neonatal intensive care prior to or at the launch of the medicinal product in each Member State.
Croatian: Nositelj odobrenja dogovorit će sadržaj pisma liječnicima s CHMP-om (i, ako je potrebno, s nacionalnim nadležnim tijelom) prije stavljanja lijeka u promet i osigurat će da ga dobiju svi liječnici s iskustvom u neonatalnoj intenzivnoj skrbi prije ili u vrijeme stavljanja lijeka u promet u svakoj državi članici.
English: Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardiorespiratory and central nervous system.
Croatian: Istovremena primjena kofeina i doksaprama može pojačati njihov stimulacijski učinak na kardiorespiratorni i središnji živčani sustav.
English: Endotracheal tube
Croatian: Endotrahealni tubus
English: Doses should be adjusted by monitoring of caffeine plasma concentrations to avoid toxicity in this population.
Croatian: Doze treba prilagoditi sukladno praćenju koncentracije kofeina u plazmi kako bi se izbjegla toksičnost u ove populacije.
English: Infections and infestations Sepsis
Croatian: Infekcije i infestacije sepsa nepoznato
English: There were more days without any apnoea under caffeine citrate treatment (3.0 days, versus 1.2 days for placebo; p=0.005); also, there was a higher percentage of patients with no apnoeas for > 8 days (caffeine 22% versus placebo 0%).
Croatian: Bilo je više dana bez apneje uz liječenje kofeincitratom (3,0 dana nasuprot 1,2 dana uz placebo; p=0,005); također, postotak bolesnika bez apneja bio je viši tijekom > 8 dana (kofein 22% nasuprot placebo 0%).
English: In young infants, the elimination of caffeine is much slower than that in adults due to immature hepatic and/or renal function.
Croatian: U mlade dojenčadi, eliminacija kofeina puno je sporija nego u odraslih zbog nezrele funkcije jetre i/ili bubrega.
English: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italy
Croatian: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italija
English: The maintenance doses were adjusted weekly for changes in body weight and could be given orally once an infant tolerated full enteral feedings.
Croatian: Doze održavanja prilagođivale su se svakog tjedna sukladno promjeni tjelesne težine i mogle su se davati peroralno nakon što bi nedonošče počelo potpuno podnositi enteralnu prehranu.
English: Please inform your baby's doctor if your newborn has been previously treated with theophylline.
Croatian: Molimo obavijestite liječnika Vašeg djeteta ako je Vaše novorođenče ranije bilo liječeno teofilinom.
English: Caffeine citrate causes a generalised increase in metabolism, which may result in higher energy and nutrition requirements during therapy.
Croatian: Kofeincitrat uzrokuje opće pojačanje metabolizma, koje može rezultirati većim energetskim i nutritivnim potrebama tijekom terapije.
English: The mean volume of distribution (Vd) of caffeine in infants (0.8-0.9 l/kg) is slightly higher than that in adults (0.6 L/kg).
Croatian: Prosječni volumen distribucije (Vd) kofeina u nedonoščadi (0,8-0,9 l/kg) nešto je veći nego u odraslih (0,6 l/kg).
English: Convulsions may be treated with intravenous administration of anticonvulsants (diazepam or a barbiturate such as pentobarbital sodium or phenobarbital).
Croatian: Konvulzije se mogu liječiti intravenskom primjenom antikonvulziva (diazepama ili barbiturata kao što je pentobarbital natrij ili fenobarbital).
English: Each carton contains 10 ampoules.
Croatian: Jedna kutija sadrži 10 ampula.
English: Necrotising enterocolitis
Croatian: Nekrotizirajući enterokolitis
English: Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy.
Croatian: Prolazno sniženje tiroksina (T4) zabilježeno je u dojenčadi na početku terapije, ali nije se zadržalo kod dugotrajnije terapije.
English: 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)].
Croatian: Terapija kofeinom smanjila je stopu bronhopulmonalne displazije [omjer šansi (95% CI) 0,63 (0,52 do 0,76)] i poboljšala stopu preživljenja bez neurorazvojnog invaliditeta [omjer šansi (95% CI) 0,77 (0,64 do 0,93)].
English: 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).
Croatian: rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Once
Croatian: jedanput
English: Mean half-life (t1/2) and fraction excreted unchanged in urine (Ae) of caffeine in infants are inversely related to gestational / postmenstrual age.
Croatian: Prosječni poluvijek (t1/2) i udio izlučenog neizmijenjenog kofeina u mokraći (Ae) u dojenčadi obrnuto su povezani s gestacijskom/postmenstrualnom dobi.
English: This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Croatian: Pokazalo se da ovaj lijek smanjuje broj epizoda prekida disanja u nedonoščadi.
English: Solution for infusion Oral solution 10 ampoules
Croatian: Otopina za infuziju Oralna otopina 10 ampula
English: − infants with known and clinically significant cardiac disease
Croatian: − novorođenčad s poznatom ili klinički značajnom srčanom bolešću
English: The MAH shall agree with the National Competent Authorities the final text of a card suitable for display in neonatal intensive care units.
Croatian: Nositelj odobrenja dogovorit će s nacinonalnim nadležnim tijelima konačni tekst kartice pogodne za prikazivanje u jedinicama neonatalne intenzivne skrbi.
English: Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.
Croatian: Zbog spore eliminacije kofeina u ove populacije bolesnika, nije potrebno postupno smanjivati dozu da bi se prekinulo liječenje.
English: Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans.
Croatian: Citokrom P450 1A2 (CYP1A2) glavni je enzim uključen u metabolizam kofeina u ljudi.