FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended loading dose and maintenance doses of caffeine citrate are provided in the following table which clarifies the relationship between injection volumes and administered doses expressed as caffeine citrate.
Croatian: Preporučene udarne doze i doze održavanja kofeincitrata prikazane su u sljedećoj tablici koja objašnjava odnos između ubrizganih volumena i primijenjenih doza izraženih u obliku kofeincitrata.
English: 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.
Croatian: Ako su prije rođenja djeteta prisutni neobični poremećaji ritma na kardiotokografiji (CTG-u), kofeincitrat treba primijeniti s oprezom.
English: It may be needed that your baby's doctor decides to check the levels of caffeine in a blood test periodically throughout treatment to avoid toxicity.
Croatian: Liječnik Vašeg djeteta možda će odlučiti povremeno provjeravati razine kofeina pomoću krvnih pretraga tijekom cijelog trajanja liječenja kako bi se izbjegla toksičnost.
English: 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].
Croatian: Veličina i smjer učinka kofeina na smrt i invaliditet razlikovao se ovisno o stupnju respiratorne potpore koja je nedonoščadi bila potrebna u trenutku randomizacije, ukazujući na veću korist za nedonoščad na respiratornoj potpori [omjer šansi (95% CI) za smrt i invaliditet, vidjeti tablicu niže].
English: Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.
Croatian: Najčešće su bili prijavljeni srčani poremećaji (tahikardija, uključujući jedan slučaj aritmije).
English: 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.
Croatian: U slučaju terapijskog neuspjeha uzorke krvi za određivanje kofeina treba uzeti neposredno prije sljedeće doze, a kad se sumnja na toksičnost 2 do 4 sata nakon prethodne doze.
English: - If you have further questions, please ask your baby's doctor.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku Vašeg djeteta.
English: 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.
Croatian: Nedavno veliko, placebom kontrolirano multicentrično ispitivanje (n=2006), provjeravalo je kratkotrajne i dugotrajne (18-21 mjeseci) ishode u nedonoščadi liječene kofeincitratom.
English: Caffeine may suppress erythropoietin synthesis and hence reduce haemoglobin concentration with prolonged treatment.
Croatian: Kofein može potisnuti sintezu eritropoetina i tako smanjiti koncentraciju hemoglobina kod dugotrajnijeg liječenja.
English: Plasma caffeine concentrations have been shown to decrease after exchange transfusion.
Croatian: Pokazalo se da se koncentracije kofeina u plazmi smanjuju nakon zamjenske transfuzije.
English: Plasma potassium and glucose concentrations should be monitored and hypokalaemia and hyperglycaemia corrected.
Croatian: Potrebno je pratiti koncentracije kalija i glukoze u plazmi i korigirati hipokalemiju i hiperglikemiju.
English: 20 mg/kg body weight Intravenous infusion (over 30 minutes)
Croatian: 20 mg/kg tjelesne težine intravenska infuzija (tijekom 30 minuta)
English: 0.73 (0.57 to 0.94)
Croatian: 0,73 (0,57 do 0,94)
English: − infants who have previously been treated with theophylline, which is metabolized to caffeine.
Croatian: − novorođenčadi koja su prethodno bila liječena teofilinom, koji se metabolizira do kofeina.
English: The protocol allowed infants to be “rescued” with open-label caffeine citrate treatment if their apnoea remained uncontrolled.
Croatian: Plan ispitivanja dopuštao je da dojenčad bude “spašena” otvorenim tipom liječenja kofeincitratom ako se apneja nije mogla staviti pod kontrolu.
English: If your newborn receives more Peyona than he/she should
Croatian: Ako Vaše novorođenče primi više Peyone nego što je trebalo
English: Plasma concentrations of caffeine may need to be monitored periodically throughout treatment in cases of incomplete clinical response or signs of toxicity.
Croatian: Možda će biti potrebno povremeno određivati koncentracije kofeina u plazmi tijekom cijelog trajanja liječenja u slučaju nepotpunog kliničkog odgovora ili znakova toksičnosti.
English: Dose of caffeine citrate (Volume)
Croatian: Doza kofeincitrata (volumen)
English: 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.
Croatian: Međutim, ta granica u pojedinim slučajevima može biti i promijenjena sukladno kliničkoj procjeni, ovisno o odgovoru na liječenje, upornom ponavljanju epizoda apneje unatoč liječenju ili drugim kliničkim razlozima.
English: Dose of caffeine citrate (mg/kg body weight)
Croatian: Doza kofeincitrata (mg/kg tjelesne težine)
English: 0.73 (0.52 to 1.03)
Croatian: 0,73 (0,52 do 1,03)
English: MM/YYYY
Croatian: {MM/GGGG}
English: Inter-conversion between caffeine and theophylline has been reported in preterm newborn infants; caffeine levels are approximately 25% of theophylline levels after theophylline administration and approximately 3-8% of caffeine administered would be expected to convert to theophylline.
Croatian: U nedonoščadi je zabilježena interkonverzija kofeina i teofilina; razine kofeina iznose približno 25% razine teofilina nakon primjene teofilina te se očekuje da će se približno 3-8% primijenjenog kofeina konvertirati u teofilin.
English: In the presence of significant renal impairment, considering the increased potential for accumulation, a reduced daily maintenance dose of caffeine is required and the doses should be guided by blood caffeine measurements.
Croatian: Ako je prisutno značajno oštećenje funkcije bubrega, a uzimajući u obzir povećanu mogućnost nakupljanja, potrebna je snižena dnevna doza održavanja kofeina i doze se trebaju određivati prema mjerenjima kofeina u krvi.
English: Your baby's doctor will decide exactly how long your newborn must continue therapy with Peyona.
Croatian: Trajanje liječenja Liječnik Vašeg djeteta će odlučiti točno koliko dugo će Vaše novorođenće morati primati terapiju lijekom Peyona.
English: The onset of action of caffeine from caffeine citrate is within minutes of commencement of infusion.
Croatian: Kofein iz kofeincitrata počinje djelovati unutar nekoliko minuta nakon početka infuzije.
English: Caffeine is structurally related to the methylxanthines theophylline and theobromine.
Croatian: Kofein je strukturno sličan metilksantinima teofilinu i teobrominu.
English: In the event of this happening treatment with Peyona should be stopped immediately and your baby's doctor should treat the overdose.
Croatian: U to slučaju treba odmah prekinuti liječenje lijekom Peyona, a liječnik Vašeg djeteta treba liječiti predoziranje.
English: Available evidence does not indicate any adverse long-term reactions of neonatal caffeine therapy as regards neurodevelopmental outcome, failure to thrive or on the cardiovascular, gastrointestinal or endocrine systems.
Croatian: Dostupni dokazi ne pokazuju da postoje ikakve dugotrajne nuspojave terapije kofeinom u novorođenčadi u pogledu ishoda neurološkog razvoja, izostanka napredovanja ili učinaka na kardiovaskularni, probavni ili endokrini sustav.
English: Peyona is a clear, colourless solution, supplied in glass ampoules.
Croatian: Peyona je bistra, bezbojna otopina u staklenim ampulama.
English: 0.25 ml/kg body weight
Croatian: 0,25 ml/kg tjelesne težine
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. u osnovi ne sadrži natrij.
English: Caffeine is a central nervous system stimulant and seizures have been reported in cases of caffeine overdose.
Croatian: Kofein je stimulans središnjeg živčanog sustava pa su zabilježeni napadaji u slučajevima predoziranja kofeinom.
English: Talk to your baby's doctor before your newborn is given Peyona.
Croatian: Obratite se liječniku Vašeg djeteta prije davanja Peyone novorođenčetu.
English: Peyona contains sodium
Croatian: Peyona sadrži natrij
English: Following overdose, published plasma caffeine levels have ranged from approximately 50 mg/l to 350 mg/l.
Croatian: Raspon objavljenih razina kofeina u plazmi nakon predoziranja bio je približno 50 mg/l do 350 mg/l.
English: The adverse reactions described in the short- and long-term published literature and obtained from a post-authorisation safety study that can be associated with caffeine citrate are listed below by System Organ Class and Preferred Term (MedDRA).
Croatian: Nuspojave opisane u kratkotrajno i dugotrajno objavljenoj literaturi i dobivene iz ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet koje mogu biti povezane s kofeincitratom navedene su niže prema klasifikaciji organskih sustava i standardnim izrazima (MedDRA).
English: If you (the mother) are breast-feeding while your infant is treated with Peyona, you should not drink coffee or take any other high caffeine product as caffeine passes into breast milk.
Croatian: Ako Vi (majka) dojite svoje dijete dok se liječi Peyonom, ne biste smjeli piti kavu niti uzimati bilo koje druge proizvode bogate kofeinom, jer kofein prelazi u majčino mlijeko.
English: The clinical efficacy of caffeine citrate was assessed in a multicentre, randomised, double-blind study that compared caffeine citrate to placebo in 85 preterm infants (gestational age 28 to <33 weeks) with apnoea of prematurity.
Croatian: Klinička djelotvornost kofeincitrata procijenila se u multicentričnom, randomiziranom, dvostruko slijepom ispitivanju u kojem se kofeincitrat uspoređivao s placebom u 85-ero nedonoščadi (gestacijska dob 28 do <33 tjedna) s apnejom nedonoščeta.
English: • If your newborn produces more urine than usual
Croatian: • Vaše novorođenče mokri veće količine mokraće nego obično
English: After opening the ampoules, the medicinal product should be used immediately.
Croatian: Nakon otvaranja ampule, lijek se mora odmah primijeniti.
English: How to store Peyona
Croatian: Kako čuvati Peyonu
English: If the patient has recurrent apnoea, caffeine citrate administration can be restarted with either a maintenance dose or a half loading dose, depending upon the time interval from stopping caffeine citrate to recurrence of apnoea.
Croatian: Ako bolesnik ima rekurentnu apneju, može se ponovno započeti s primjenom kofeincitrata u dozi održavanja ili polovicom udarne doze, ovisno o vremenskom razdoblju od prestanka primjene kofeincitrata do ponovne pojave apneje.
English: Where doubt exists about possible interactions, plasma caffeine concentrations should be measured.
Croatian: U slučajevima kad se sumnja na mogućnost interakcije potrebno je mjeriti koncentracije kofeina u plazmi.
English: Via Enrico Fermi IT-65020 Alanno (PE) Italy
Croatian: Alfasigma S.p.A. Via Enrico Fermi IT-65020 Alanno (PE) Italija
English: In the presence of renal impairment, there is increased potential for accumulation.
Croatian: U slučaju kad je prisutno oštećenje funkcije bubrega postoji povećana mogućnost njegova nakupljanja.
English: − infants with hepatic and renal impairment (see sections 4.4 and 5.2)
Croatian: − novorođenčad s oštećenjem funkcije jetre ili bubrega (vidjeti dijelove 4.4 i 5.2)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA AMPULI
English: Immune system disorders Hypersensitivity reaction
Croatian: Poremećaji imunološkog sustava reakcija preosjetljivosti rijetko
English: Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25ºC and at 2-8ºC.
Croatian: Pokazalo se da je razrijeđena otopina kemijski i fizikalno stabilna 24 sata na temperaturi od 25ºC i od
English: A large multicentre study (n=2006) investigating long-term outcome of premature infants treated with caffeine citrate (see section 5.1) did not show an increased frequency of necrotising enterocolitis in the caffeine group when compared to placebo.
Croatian: Veliko multicentrično ispitivanje (n=2006) koje je istraživalo dugotrajni ishod u nedonoščadi liječene kofeincitratom (vidjeti dio 5.1) nije pokazalo povećanu učestalost nekrotizirajućeg enterokolitisa u skupini koja je primala kofein u usporedbi s placebom.
English: The maintenance dose is 5 mg per kg body weight (equivalent to 0.25 ml per kg body weight) every 24 hours.
Croatian: Doza održavanja je 5 mg po kilogramu tjelesne težine (što odgovara 0,25 ml po kg tjelesne težine) svaka 24 sata.
English: Breast-feeding mothers of newborn infants treated with caffeine citrate should not ingest caffeinecontaining foods, beverages or medicinal products containing caffeine.
Croatian: Majke koje doje novorođenčad liječenu kofeincitratom, ne bi smjele konzumirati hranu, pića i lijekove koji sadrže kofein.
English: Unused portions should not be saved for later administration.
Croatian: Neuptrijebljeni dio lijeka se ne smije čuvati za kasniju primjenu.
English: Peyona is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature newborns).
Croatian: Peyona se primjenjuje u liječenju prekida disanja u nedonoščadi (primarna apneja nedonoščeta).
English: Although a therapeutic plasma concentration range of caffeine has not been determined in the literature, caffeine levels in studies associated with clinical benefit ranged from 8 to 30 mg/l and no safety concerns have normally been raised with plasma levels below 50 mg/l.
Croatian: Iako u literaturi nije utvrđen terapijski raspon koncentracije kofeina u plazmi, u ispitivanjima su se razine kofeina povezane s kliničkom koristi kretale u rasponu od 8 do 30 mg/l i obično nije bilo nedoumica u pogledu sigurnosti kod razina nižih od 50 mg/l.
English: Peyona is a solution for infusion and oral solution.
Croatian: Peyona je otopina za infuziju i oralna otopina.
English: These effects are dose related and may necessitate measurement of plasma levels and dose reduction.
Croatian: Ovi učinci ovisni su o dozi i zbog njih može biti potrebno mjeriti razine kofeina u plazmi i sniziti dozu.
English: From a microbiological point of view, when administered with solutions for infusion the medicinal product should be used immediately after dilution by aseptic technique.
Croatian: S mikrobiološkog stajališta, kad se primjenjuje s otopinama za infuziju, lijek se mora primijeniti aseptičkom tehnikom odmah nakon razrjeđivanja.
English: Aseptic technique must be strictly observed throughout handling of the medicinal product since no preservative is present.
Croatian: Tijekom rukovanja lijekom potrebno se strogo pridržavati aseptičke tehnike, budući da lijek ne sadrži konzervanse.
English: Caffeine in animal studies, at high doses, was shown to be embryotoxic and teratogenic.
Croatian: U ispitivanjima na životinjama, kofein je u visokim dozama pokazao embriotoksične i teratogene učinke.
English: Although few data exist on interactions of caffeine with other active substances in preterm newborn infants, lower doses of caffeine citrate may be needed following co-administration of active substances which are reported to decrease caffeine elimination in adults (e.g., cimetidine and ketoconazole) and higher caffeine citrate doses may be needed following co-administration of active substances that increase caffeine elimination (e.g., phenobarbital and phenytoin).
Croatian: Iako je premalo podataka o interakcijama kofeina s drugim djelatnim tvarima u nedonoščadi, kod istovremene primjene djelatnih tvari za koje je zabilježeno da smanjuju uklanjanje kofeina u odraslih (npr., cimetidin i ketokonazol) mogu biti potrebne niže doze kofeincitrata, a više doze kofeincitrata mogu biti potrebne nakon istovremene primjene djelatnih tvari koje povećavaju uklanjanje kofeina (npr. fenobarbital i fenitoin).
English: Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants.
Croatian: Nekrotizirajući enterokolitis česti je uzrok pobola i smrtnosti u nedonoščadi.
English: The recommended dose regimen in previously untreated infants is a loading dose of 20 mg caffeine citrate per kg body weight administered by slow intravenous infusion over 30 minutes, using a syringe infusion pump or other metered infusion device.
Croatian: Preporučeni režim doziranja u prethodno neliječene novorođenčadi je udarna doza od 20 mg kofein citrata po kilogramu tjelesne težine primijenjena sporom intravenskom infuzijom u trajanju od 30 minuta pomoću infuzijske pumpe za štrcaljku ili drugog infuzijskog sustava s mjernom napravom.
English: Signs and symptoms reported in the literature after caffeine overdose in preterm infants include hyperglycaemia, hypokalaemia, fine tremor of the extremities, restlessness, hypertonia, opisthotonus, tonic clonic movements, seizures, tachypnoea, tachycardia, vomiting, gastric irritation, gastrointestinal haemorrhage, pyrexia, jitteriness, increased blood urea and increased white blood cell count, non-purposeful jaw and lip movements.
Croatian: Znakovi i simptomi zabilježeni u literaturi nakon predoziranja kofeinom u nedonoščadi uključuju hiperglikemiju, hipokalemiju, fini tremor ruku i nogu, nemir, hipertoniju, opistotonus, toničkokloničke kretnje, napadaje, tahipneju, tahikardiju, povraćanje, nadraženost želuca, gastrointestinalno krvarenje, pireksiju, nervozu, povišenu ureju u krvi i povećan broj bijelih krvnih stanica, nevoljne pokrete čeljusti i usnica.
English: Caffeine citrate can be administered by intravenous infusion and by the oral route.
Croatian: Kofeincitrat može se primijeniti intravenskom infuzijom i peroralnim putem.
English: Gastrointestinal disorders Regurgitation, increased gastric aspirate, necrotising enterocolitis
Croatian: Poremećaji probavnog sustava regurgitacija, povećani želučani aspirat, nekrotizirajući enterokolitis nepoznato
English: The starting dose is 20 mg per kg body weight (equivalent to 1 ml per kg body weight).
Croatian: Početna doza je 20 mg po kilogramu tjelesne težine (što odgovara 1 ml po kg tjelesne težine).
English: 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Caffeine citrate should be used with caution in infants suffering gastro-oesophageal reflux, as the treatment may exacerbate this condition.
Croatian: Kofeincitrat treba primjenjivati s oprezom u novorođenčadi koja boluje od gastroezofagealnog refluksa, jer liječenje može pogoršati ovu bolest.
English: Treatment should be administered only in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring.
Croatian: Liječenje se smije provoditi samo u jedinici neonatalne intenzivne skrbi u kojoj je dostupna prikladna oprema za nadzor i praćenje bolesnika.
English: Breast-feeding mothers of newborn infants treated with caffeine citrate should not ingest caffeinecontaining foods and beverages or medicinal products containing caffeine (see section 4.6), since caffeine is excreted into breast milk (see section 5.2).
Croatian: Majke koje doje svoju novorođenčad liječenu kofeincitratom ne smiju konzumirati hranu i pića koja sadrže kofein ili lijekove koji sadrže kofein (vidjeti dio 4.6), jer se kofein izlučuje u majčino mlijeko (vidjeti dio 5.2).
English: In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment.
Croatian: 506 nedonoščadi liječene Peyonom, podaci o sigurnosti primjene prikupljeni su u 31 vrlo rano rođenog nedonoščeta s oštećenjem bubrega/jetre.
English: Therefore, caffeine citrate should be used with caution in newborns with known cardiovascular disease.
Croatian: Stoga se kofeincitrat mora primjenjivati s oprezom u novorođenčadi s poznatom kardiovaskularnom bolešću.
English: The active substance is caffeine citrate.
Croatian: Djelatna tvar je kofeincitrat.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characterisitcs, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: If you have any further questions on the use of this medicinal product, ask your baby's doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku Vašeg djeteta.
English: One case of caffeine overdose complicated by development of intraventricular haemorrhage and long-term neurological sequelae has been reported.
Croatian: Zabilježen je jedan slučaj predoziranja kofeinom kompliciran razvojem intraventrikularnog krvarenja i dugotrajnih neuroloških posljedica.
English: In a double-blind placebo-controlled study of caffeine citrate in 85 preterm infants (see section 5.1), necrotising enterocolitis was diagnosed in the blinded phase of the study in two infants on active treatment and one on placebo, and in three infants on caffeine during the open-label phase of the study.
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju kofeincitrata u 85-ero nedonoščadi (vidjeti dio 5.1), nekrotizirajući enterokolitis bio je dijagnosticiran u slijepoj fazi ispitivanja u dvoje nedonoščadi liječene djelatnom tvari i jednog koje je primalo placebo te u troje nedonoščadi koje je primalo kofein tijekom otvorene faze ispitivanja.
English: 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.
Croatian: U kliničkoj praksi, liječenje obično traje sve dok nedonošče ne dosegne gestacijsku dob od 37 tjedana,
English: In very premature infants, clearance of caffeine does not depend on hepatic function.
Croatian: U vrlo nezrele nedonoščadi, klirens kofeina ne ovisi o funkciji jetre.
English: 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.
Croatian: A1 i podvrstu A2A, kakvo se pokazalo u testovima vezanja na receptor i opaženo je pri koncentracijama kakve se postižu kod terapijske primjene u ovoj indikaciji.
English: For storage conditions of the diluted medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka,vidjeti u dijelu 6.3.
English: Hepatic caffeine metabolism develops progressively in the weeks following birth and for the older infants, hepatic disease may indicate a need for monitoring caffeine plasma levels and may require dose adjustments (see sections 4.4 and 5.2).
Croatian: Metabolizam kofeina u jetri progresivno se razvija u tjednima nakon rođenja i kod starije novorođenčadi, bolest jetre može ukazati na potrebu praćenja razine kofeina u plazmi i zahtijevati prilagodbu doze (vidjeti dijelove 4.4 i 5.2).
English: If apnoeas persisted, the daily maintenance dose could be increased to a maximum of 10 mg/kg of caffeine citrate.
Croatian: dnevna doza održavanja mogla se povisiti do najviše 10 mg/kg kofeincitrata.
English: Caffeine metabolism in preterm newborn infants is very limited due to their immature hepatic enzyme systems and most of the active substance is eliminated in urine.
Croatian: Metabolizam kofeina u nedonoščadi vrlo je ograničen zbog nezrelosti enzimskog sustava jetre pa se većina djelatnih tvari uklanja mokraćom.
English: Any unused portions must be discarded.
Croatian: Neiskorišteni dio lijeka mora se baciti.
English: For detailed information refer to the enclosed Summary of Product Characteristics of PEYONA.
Croatian: Za detaljne informacije vidjeti priložen Sažetak opisa svojstava lijeka PEYONA.