FrancophonIA/ELRC3.0 huggingface dataset:
English: Where clinically indicated, caffeine plasma levels should be monitored.
Slovenian: Kjer je klinično indicirano, je treba nadzorovati ravni kofeina v plazmi.
English: If you have any further questions on the use of this medicinal product, ask your baby's doctor.
Slovenian: Če imate kakršna koli nadaljnja vprašanja glede uporabe tega zdravila, vprašajte zdravnika svojega otroka.
English: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italy
Slovenian: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italija
English: Plasma protein binding data are not available for newborn infants or infants.
Slovenian: Podatek o vezavi na beljakovine v plazmi ni na voljo za novorojenčke in dojenčke.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: Če obstajajo znaki neobičajne motnje ritma na kardiotokografu (CTG) pred rojstvom dojenčka, je treba kofeinijev citrat dajati previdno.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: In newborns this is usually a simple sinus tachycardia.
Slovenian: Pri novorojenčkih gre običajno za preprosto sinusno tahikardijo.
English: Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardiorespiratory and central nervous system.
Slovenian: Sočasna uporaba kofeina in doksaprama lahko poveča njun stimulativni učinek na srčno-respiratorni in osrednji živčni sistem.
English: Other medicines and Peyona
Slovenian: Druga zdravila in zdravilo Peyona
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:
Slovenian: 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:
English: Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.
Slovenian: Zaradi počasnega izločanja kofeina v tej skupini bolnikov ni treba počasi manjšati odmerka, ko se zdravljenje preneha.
English: There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis.
Slovenian: Obstajajo poročila o morebitni povezanosti med uporabo metilksantinov in razvojem nekrotizirajočega enterokolitisa.
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.
Slovenian: 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.
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].
Slovenian: 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].
English: Necrotising enterocolitis
Slovenian: Nekrotizirajoči enterokolitis
English: Caffeine was shown to be devoid of mutagenic and oncogenic risk.
Slovenian: Pokazalo se je, da kofein nima mutagenih in onkogenih učinkov.
English: Studies examining the pharmacokinetics of caffeine in newborn infants with hepatic or renal insufficiency have not been conducted.
Slovenian: Študij, s katerimi bi preučevali farmakokinetiko kofeina pri novorojenčkih z jetrno ali ledvično insuficienco, niso izvedli.
English: • If your newborn suffers from any heart disease
Slovenian: • če ima novorojenček kakršno koli bolezen srca
English: In young infants, the elimination of caffeine is much slower than that in adults due to immature hepatic and/or renal function.
Slovenian: Pri majhnih dojenčkih je izločanje kofeina veliko počasnejše kot pri odraslih zaradi nezrelega delovanja jeter in/ali ledvic.
English: Aseptic technique must be strictly observed throughout handling of the medicinal product since no preservative is present.
Slovenian: Ves čas ravnanja z zdravilom je treba strogo uporabljati aseptično tehniko, saj zdravilo ne vsebuje nobenih konzervansov.
English: This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Slovenian: Pokazalo se je, da to zdravilo zmanjšuje število epizod prekinitve dihanja pri nedonošenih novorojenčkih.
English: Convulsions may be treated with intravenous administration of anticonvulsants (diazepam or a barbiturate such as pentobarbital sodium or phenobarbital).
Slovenian: Konvulzije je mogoče zdraviti z intravenskim dajanjem antikonvulzivov (diazepamom ali barbiturati kot sta natrijev pentobarbital ali fenobarbital).
English: What Peyona is and what it is used for
Slovenian: Kaj je zdravilo Peyona in za kaj ga uporabljamo
English: Plasma concentrations of caffeine may need to be monitored periodically throughout treatment in cases of incomplete clinical response or signs of toxicity.
Slovenian: Morda bo treba treba periodično ves čas zdravljenja nadzirati koncentracije kofeina v plazmi v primeru nepopolnega kliničnega odziva ali znakov toksičnosti.
English: Doses should be adjusted by monitoring of caffeine plasma concentrations to avoid toxicity in this population.
Slovenian: Odmerke je treba prilagoditi z nadziranjem koncentracij kofeina v plazmi, da se prepreči toksičnost v tej skupini bolnikov.
English: Following overdose, published plasma caffeine levels have ranged from approximately 50 mg/l to 350 mg/l.
Slovenian: Po prevelikem odmerjanju so objavljeni razponi ravni kofeina v plazmi od približno 50 mg/l do 350 mg/l.
English: Where doubt exists about possible interactions, plasma caffeine concentrations should be measured.
Slovenian: V primeru dvoma o možnem medsebojnem delovanju je treba meriti koncentracije kofeina v plazmi.
English: − infants with hepatic and renal impairment (see sections 4.4 and 5.2)
Slovenian: − dojenčki z okvarjenim delovanjem jeter ali ledvic (glejte poglavji 4.4 in 5.2)
English: These short periods when premature babies stop breathing are due to the baby's breathing centres not being fully developed.
Slovenian: Do teh kratkih obdobij, ko nedonošenček preneha dihati, pride zaradi tega, ker njegov dihalni center še ni povsem razvit.
English: Caffeine is structurally related to the methylxanthines theophylline and theobromine.
Slovenian: Kofein je strukturno povezan z metilksantinoma teofilinom in teobrominom.
English: There is evidence that caffeine causes tachyarrhythmias in susceptible individuals.
Slovenian: Ni znakov, da bi kofein povzročal tahiaritmije pri občutljivih posameznikih.
English: Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans.
Slovenian: Citokrom P450 1A2 (CYP1A2) je glavni encim, ki sodeluje pri presnovi kofeina pri ljudeh.
English: In adults, the mean plasma protein binding in vitro is reported to be approximately 36%.
Slovenian: Pri odraslih poročajo o približno 36 % povprečni vezavi na beljakovine v plazmi in vitro.
English: Your baby's doctor will prescribe the right amount of Peyona based on your baby's weight.
Slovenian: Otrokov zdravnik bo predpisal pravilno količino zdravila Peyona na podlagi otrokove telesne mase.
English: The diuresis and electrolyte loss induced by caffeine citrate may necessitate correction of fluid and electrolyte disturbances.
Slovenian: Zaradi diureze in izgube elektrolitov, ki ju povzroči kofeinijev citrat, bo morda treba odpraviti motnje s tekočino in elektroliti.
English: This is the basis of caffeine's effect in apnoea of prematurity, for which several mechanisms have been proposed for its actions including: (1) respiratory centre stimulation, (2) increased minute ventilation, (3) decreased threshold to hypercapnia, (4) increased response to hypercapnia, (5) increased skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7) increased metabolic rate, and (8) increased oxygen consumption.
Slovenian: To je osnova učinkovanja kofeina pri apneji zaradi nezrelosti s številnimi predlaganimi mehanizmi za ta način delovanja, vključno s/z: (1) spodbujanjem dihalnega centra, (2) zvišanjem vdihov na minuto, (3) znižanjem praga za hiperkapnijo, (4) zvišanjem odziva na hiperkapnijo, (5) zvišanjem skeletnega mišičnega tonusa, (6) znižanjem diafragmatične utrujenosti, (7) povečanjem hitrosti presnove in (8) zvišano poraba kisika.
English: Plasma caffeine concentrations have been shown to decrease after exchange transfusion.
Slovenian: Pokazalo se je, da se koncentracije kofeina po izmenjalni transfuziji znižajo.
English: Caffeine may suppress erythropoietin synthesis and hence reduce haemoglobin concentration with prolonged treatment.
Slovenian: Kofein lahko zavre sintezo eritropoetina in s tem pri daljšem zdravljenju zniža koncentracijo hemoglobina.
English: Please inform your baby's doctor if your newborn has been previously treated with theophylline.
Slovenian: Obvestite otrokovega zdravnika, če je bil novorojenček predhodno zdravljen s teofilinom.
English: Plasma potassium and glucose concentrations should be monitored and hypokalaemia and hyperglycaemia corrected.
Slovenian: Nadzirati je treba ravni kalija in glukoze v plazmi in popraviti hipokalemijo in hiperglikemijo.
English: Caffeine citrate causes a generalised increase in metabolism, which may result in higher energy and nutrition requirements during therapy.
Slovenian: Kofeinijev citrat povzroča splošno povečanje presnove, kar lahko povzroči večjo potrebo po energiji in prehranjevanju v času zdravljenja.
English: Unused portions should not be saved for later administration.
Slovenian: Neporabljenega zdravila ne hranite za kasnejšo uporabo.
English: In the presence of renal impairment, there is increased potential for accumulation.
Slovenian: V prisotnosti okvarjenega delovanja ledvic se možnost kopičenja poveča.
English: For storage conditions of the diluted medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
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.
Slovenian: Zdravila ne smemo mešati ali dajati sočasno v isti intravenski liniji z drugimi zdravili razen s tistimi,
English: Effects on reproductive performance observed in animals are not relevant to its indication in the preterm newborn infants (see section 5.3).
Slovenian: Učinki na plodnost, ki so jih opazili pri živalih, niso pomembni za indikacijo pri nedonošenih novorojenčkih (glejte poglavje 5.3).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni, da je zdravilo „brez natrija“.
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.
Slovenian: Dokazi, ki so na voljo, ne kažejo nikakršnih dolgoročnih neželenih učinkov zdravljenja novorojenčkov s kofeinom glede izida razvojne nevrologije, nenapredovanja ali na srčnožilni, prebavni ali endokrini sistem.
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.
Slovenian: Zdravilo Peyona vsebuje zdravilno učinkovino kofeinijev citrat, ki je spodbujevalec osrednjega živčnega sistema in sodi v skupino zdravil, imenovanih metilksantini.
English: The onset of action of caffeine from caffeine citrate is within minutes of commencement of infusion.
Slovenian: Absorpcija Začetek delovanja kofeina iz kofeinijevega citrata je v nekaj minutah po uvedbi infundiranja.
English: 0.73 (0.57 to 0.94)
Slovenian: 0,73 (0,57 do 0,94)
English: − very premature infants (< 28 weeks gestational age and/or body weight <1000 g) particularly when receiving parenteral nutrition
Slovenian: − zelo zgodaj rojeni nedonošenčki (< 28 tedni nosečnostne starosti in/ali s telesno maso < 1000 g),
English: The requirements for submission of periodic safety update reports for this medicinal products are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: For detailed information refer to the enclosed Summary of Product Characteristics of PEYONA.
Slovenian: Za podrobne podatke glejte priložen povzetek glavnih značilnosti zdravila PEYONA.
English: Read all of this leaflet carefully before treatment with this medicine because it contains important information for your newborn
Slovenian: Pred začetkom zdravljenja novorojenčka s tem zdravilom natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Peyona is a clear, colourless solution, supplied in glass ampoules.
Slovenian: Zdravilo Peyona je bistra, brezbarvna raztopina, polnjena v steklene ampule.
English: What Peyona is and what it is used for What you need to know before your baby is given Peyona How to use Peyona
Slovenian: Kaj je zdravilo Peyona in za kaj ga uporabljamo Kaj morate vedeti, preden boste zdravilo Peyona uporabili pri otroku Kako uporabljati zdravilo Peyona
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.
Slovenian: V študiji o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom, v katero je bilo vključenih 506 nedonošenčkov, ki so bili zdravljeni z zdravilom Peyona, so podatke o varnosti zbrali pri 31 zelo zgodaj rojenih nedonošenčkih z okvaro ledvic/jeter.
English: 0.73 (0.52 to 1.03)
Slovenian: 0,73 (0,52 do 1,03)
English: Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants.
Slovenian: Nekrotizirajoči enterokolitis je pogost vzrok obolevnosti in smrtnosti pri nedonošenih novorojenčkih.
English: Caffeine is a central nervous system stimulant and seizures have been reported in cases of caffeine overdose.
Slovenian: Kofein je stimulans osrednjega živčnega sistema in v primerih prevelikega odmerjanja so poročali o epileptičnih napadih.
English: Mean half-life (t1/2) and fraction excreted unchanged in urine (Ae) of caffeine in infants are inversely related to gestational / postmenstrual age.
Slovenian: Povprečna razpolovna doba (t1/2) in frakcija kofeina, ki se nespremenjena izloči skozi urin (Ae) pri dojenčkih, je obratno sorazmerna gestacijski/postmenstruacijski starosti.
English: Apnoea of prematurity is a diagnosis of exclusion.
Slovenian: Apneja zaradi prezgodnjega rojstva se diagnosticira z izločevanjem.
English: 20 mg/kg body weight Intravenous infusion (over 30 minutes)
Slovenian: 20 mg/kg telesne mase intravenska infuzija (30-minutna)
English: Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.
Slovenian: Najpogosteje so poročali o boleznih srca (tahikardija, vključno z enim primerom aritmije).
English: Contents of the pack and other information What Peyona contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Peyona
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).
Slovenian: Neželeni učinki, iz kratkotrajnih in dolgotrajnih študij, opisanih in objavljenih v literaturi ter pridobljenih iz študije o varnosti zdravila po pridobitvi dovoljenja za promet, ki jih je mogoče povezati s kofeinijevim citratom, so navedeni spodaj glede na organske sisteme po dogovorjeni terminologiji (MedDRA).
English: Caffeine in animal studies, at high doses, was shown to be embryotoxic and teratogenic.
Slovenian: Študije na živalih so pokazale, da je kofein v visokih odmerkih embriotoksičen in teratogen.
English: While under treatment with Peyona, your newborn may experience some of the following reactions:
Slovenian: V času zdravljenja z zdravilom Peyona se lahko pri novorojenčku pojavijo nekateri od naslednjih učinkov:
English: Uncommon reported side effects (may affect up to 1 in 100 people) - stimulation of central nervous system such as convulsion - cardiac disorders such as irregular heart beat (arrhythmia)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - spodbujanje osrednjega živčnega sistema, kot je konvulzija - srčne bolezni, kot je nepravilen srčni utrip (aritmija)
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.
Slovenian: V dvojno slepem s placebom nadziranem preskušanju kofeinijevega citrata pri 85 nedonošenčkih (glejte poglavje 5.1) so nekrotizirajoči enterokolitis diagnosticirali v slepi fazi študije pri dveh aktivno zdravljenih dojenčkih, pri enem, ki je prejemal placebo, in pri treh dojenčkih, ki so dobivali kofein v odprti fazi študije.
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.
Slovenian: Pri nedonošenih novorojenčkih so poročali o interkonverziji med kofeinom in teofilinom; ravni kofeina so približno 25 % ravni teofilina po dajanju teofilina in pričakuje se, da se približno 3-8 %
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:
Slovenian: Kartica bo vsebovala naslednje ključne elemente, ob sprostitvi zdravila na trg pa se jo bo priskrbelo vsem oddelkom za intenzivno nego novorojenčkov, kjer se bo zdravilo verjetno uporabljalo:
English: If apnoeas persisted, the daily maintenance dose could be increased to a maximum of 10 mg/kg of caffeine citrate.
Slovenian: Če apneje vztrajajo, se lahko dnevni vzdrževalni odmerek prilagodi do največ 10 mg/kg kofeinijevega citrata.
English: Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010 Wien
Slovenian: Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010 Dunaj
English: Manufacturer (Batch release)
Slovenian: Izdelovalec (sproščanje serije)
English: Peyona is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature newborns).
Slovenian: Zdravilo Peyona se uporablja za zdravljenje prekinitev v dihanju pri nedonošenčkih (primarna apneja pri nedonošenih novorojenčkih).
English: In very premature infants, clearance of caffeine does not depend on hepatic function.
Slovenian: Pri zelo zgodaj rojenih nedonošenčkih očistek kofeina ni odvisen od delovanja jeter.
English: The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate.
Slovenian: Povzetek varnostnega profila Znana farmakologija in toksikologija kofeina in drugih metilksantinov napoveduje verjetne neželene učinke na kofeinijev citrat.
English: The other ingredients are citric acid, sodium citrate and water for injections.
Slovenian: Druge sestavine so citronska kislina, natrijev citrat in voda za injekcije.
English: However, a causal relationship between caffeine or other methylxanthine use and necrotising enterocolitis has not been established.
Slovenian: Vendar pa vzročnega razmerja med kofeinom ali drugo uporabo metilksantina in nekrotizirajočim enterokolitisom niso dokazali.
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.
Slovenian: Klinični učinek kofeinijevega citrata je bil ocenjen v multicentrični, randomizirani, dvojno slepi študiji, v kateri so primerjali kofeinijev citrat s placebom pri 85 nedonošenčkih (gestacijska starost 28 do < 33 tednov) z apnejo zaradi nezrelosti.
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).
Slovenian: Povprečni porazdelitveni volumen (Vd) kofeina pri dojenčkih (0,8-0,9 l/kg) je nekoliko višji kot pri odraslih
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.
Slovenian: Iz mikrobiološkega vidika je treba zdravilo, dajano z raztopino za infundiranje, porabiti takoj po redčenju z uporabo aseptične tehnike.
English: Caffeine is rapidly distributed into the brain following caffeine citrate administration.
Slovenian: Kofein se hitro porazdeli v možganih po dajanju kofeinijevega citrata.
English: The maintenance dose is 5 mg per kg body weight (equivalent to 0.25 ml per kg body weight) every 24 hours.
Slovenian: Vzdrževalni odmerek je 5 mg na kg telesne mase (kar ustreza 0,25 ml na kg telesne mase) vsakih 24 ur.
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.
Slovenian: Presnova kofeina pri nedonošenih novorojenčkih je zelo omejena zaradi njihovih nezrelih jetrnih encimskih sistemov in večina zdravilne učinkovine se izloča v urin.
English: Caffeine consumption
Slovenian: Uživanje kofeina
English: Caffeine is excreted into breast milk and readily crosses the placenta into the foetal circulation (see section 5.2).
Slovenian: Kofein se izloča v mleko in hitro prehaja skozi placento v zarodkov obtok (glejte poglavje 5.2).
English: Do not use the following medicines during the treatment with Peyona without talking to your baby's doctor.
Slovenian: Med zdravljenjem z zdravilom Peyona ne uporabljajte spodaj naštetih zdravil, ne da bi se o tem pogovorili z otrokovim zdravnikom.
English: • If your newborn has kidney or liver problems
Slovenian: • če ima novorojenček težave z ledvicami ali jetri