natgillin/translations-raw huggingface dataset:
- That the dose of caffeine expressed as caffeine base is one half the dose of caffeine expressed as caffeine citrate (20mg caffeine citrate is equivalent to 10mg caffeine base) and that prescriptions should clearly indicate that caffeine citrate is to be administered. 
- Da doza kofeina izražena kao kofein baza iznosi polovicu doze kofeina izraženog kao kofeincitrat (20 mg kofeincitrata odgovara 10 mg kofeina u obliku baze) i da na receptima mora biti jasno navedeno da treba primijeniti kofeincitrat.
Failure to respond to caffeine treatment (confirmed if necessary by measurement of plasma levels) could be an indication of another cause of apnoea. 
(ako je potrebno, potvrđuje se mjerenjem razine u plazmi) može biti pokazatelj drugog uzroka apneje.
Any unused portion left in the ampoule should be discarded. 
Bacite sav neiskorišteni dio lijeka koji je preostao u ampuli.
Extreme caution must be exercised if caffeine citrate is used in newborns with seizure disorders. 
Nužan je krajnji oprez ako se kofeincitrat primjenjuje u novorođenčadi s konvulzijskim poremećajima.
There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis. 
Zabilježena je moguća povezanost između primjene metilksantina i razvoja nekrotizirajućeg enterokolitisa.
After oral administration of 10 mg caffeine base/kg body weight to preterm newborn infants, the peak plasma caffeine concentration (Cmax) ranged from 6 to 10 mg/l and the mean time to reach peak concentration (tmax) ranged from 30 min to 2 h. The extent of absorption is not affected by formula feeding but tmax may be prolonged. 
Nakon peroralne primjene 10 mg kofeina u obliku baze /kg tjelesne težine u nedonoščadi, raspon vršnih koncentracija kofeina u plazmi (Cmax) bio je između 6 i 10 mg/l, a prosječno vrijeme do postizanja vršne koncentracije (tmax) kretalo se u rasponu od 30 min do 2 h.
− infants with seizure disorders 
− novorođenčad s konvulzijskim poremećajima
No deaths associated with caffeine overdose have been reported in preterm infants. 
Nije zabilježen niti jedan smrtni slučaj povezan s predoziranjem kofeinom u nedonoščadi.
Manufacturer (Batch release) 
Proizvođač (puštanje serije lijeka u promet)
The medicinal product must be used immediately after diluting by aseptic technique 
Lijek se mora primijeniti aseptičkom tehnikom odmah nakon razrjeđivanja.
Peyona will be infused by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device. 
Put i način primjene Peyona će se davati kontroliranom intravenskom infuzijom pomoću infuzijske pumpe za štrcaljku ili druge infuzijske naprave s mjernim mehanizmom.
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy 
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italija
Other causes of apnoea (e.g., central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) should be ruled out or properly treated prior to initiation of treatment with caffeine citrate. 
Prije početka liječenja kofeincitratom potrebno je isključiti druge uzroke apneje (npr., poremećaji središnjeg živčanog sustava, primarna bolest pluća, anemija, sepsa, metabolički poremećaji, kardiovaskularne abnormalnosti ili opstruktivna apneja) ili ih pravilno liječiti.
Studies examining the pharmacokinetics of caffeine in newborn infants with hepatic or renal insufficiency have not been conducted. 
Nisu provedena ispitivanja farmakokinetike kofeina u novorođenčadi s insuficijencijom jetre ili bubrega.
What you need to know before your baby is given Peyona Do not use Peyona: 
Vaše dijete počne primati Peyonu Nemojte primjenjivati Peyonu:
The diuresis and electrolyte loss induced by caffeine citrate may necessitate correction of fluid and electrolyte disturbances. 
Možda će biti potrebno korigirati poremećaj tekućine i elektrolita zbog diureze i gubitka elektrolita izazvanih kofeincitratom.
In newborn infants, caffeine clearance is almost entirely by renal excretion. 
U novorođenčadi se klirens kofeina odvija gotovo potpuno izlučivanjem putem bubrega.
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. 
(4) pojačan odgovor na hiperkapniju, (5) povišen tonus skeletnih mišića, (6) smanjen umor dijafragme, (7) povećana brzina metabolizma i (8) povećana potrošnja kisika.
Undiluted and diluted parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration. 
Nerazrijeđene i razrijeđene otopine moraju se prije primjene vizualno pregledati na čestice i promjenu boje.
Caffeine has a prolonged half-life in premature newborn infants and there is potential for accumulation which may necessitate monitoring infants treated for an extended period (see section 
Poluvijek kofeina je produljen u prerano rođene dojenčadi i postoji mogućnost njegova nakupljanja, zbog čega može biti nužno nadzirati dojenčad koja se liječi dulje vrijeme (vidjeti dio 5.2).
There is limited experience in patients with renal and hepatic impairment. 
Iskustvo s primjenom u bolesnika s oštećenjem bubrega i jetre je ograničeno.
When given intravenously, caffeine citrate should be administered by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device only. 
Kad se kofeincitrat daje intravenski, primjenjuje se samo kontroliranom intravenskom infuzijom pomoću infuzijske pumpe za štrcaljku ili drugog infuzijskog sustava s mjernom napravom.
In premature infants with cholestatic hepatitis a prolonged caffeine elimination half-life with an increase of plasma levels above the normal limit of variation has been found suggesting a particular caution in the dosage of these patients (see sections 4.2 and 4.4). 
U prerano rođene dojenčadi s kolestatskim hepatitisom pronađeno je produljeno poluvrijeme eliminacije kofeina, s povišenima razinama u plazmi iznad normalne granice varijacije, što znači da je potreban osobit oprez kod doziranja u tih bolesnika (vidjeti dijelove 4.2 i
Pharmacotherapeutic group: Psychoanaleptics, xanthine derivatives ATC code: N06BC01 Mechanism of action 
ATK oznaka: N06BC01 Mehanizam djelovanja
Peyona should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. 
Kako primjenjivati Peyonu Peyona se smije primjenjivati samo u jedinici neonatalne intenzivne skrbi u kojoj je dostupna prikladna oprema za nadzor i praćenje bolesnika.
Treatment with caffeine citrate should be initiated under the supervision of a physician experienced in neonatal intensive care. 
Liječenje kofeincitratom treba započeti pod nadzorom liječnika s iskustvom u neonatalnoj intenzivnoj skrbi.
Tel.: +385 (1) 48 74 500 
Providens d.o.o. Tel.: +385 (1) 48 74 500
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
CHIESI Farmaceutici SpA Via Palermo 26/A 43122 PARMA-ITALY 
CHIESI Farmaceutici SpA Via Palermo 26/A 43122 PARMA-ITALIJA
As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section 4.8). 
Što se tiče sve nedonoščadi, onu liječenu kofeincitratom treba pažljivo nadzirati zbog mogućeg razvoja nekrotizirajućeg enterokolitisa (vidjeti dio 4.8).
Package leaflet: Information for the user Peyona 20 mg/ml solution for infusion and oral solution caffeine citrate 
Uputa o lijeku: Informacija za korisnika Peyona 20 mg/ml otopina za infuziju i oralna otopina kofeincitrat
Caffeine is excreted into breast milk and readily crosses the placenta into the foetal circulation (see section 5.2). 
Dojenje Kofein se izlučuje u majčino mlijeko, dobro prolazi posteljicu i ulazi u fetalni krvotok (vidjeti dio 5.2).
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate (see section 4.4). 
U novorođenčadi majki koje su uzimale velike količine kofeina prije porođaja potrebno je izmjeriti koncentracije kofeina u plazmi prije početka liječenja kofeincitratom (vidjeti dio 4.4).
The following other side effects may also be considered serious by your baby's doctor in the context of the global clinical evaluation. 
- teška crijevna bolest s krvavom stolicom (nekrotizirajući enterokolitis) Liječnik Vašeg djeteta može, u kontekstu opće kliničke ocjene, smatrati ozbiljnima i sljedeće nuspojave.
Caffeine readily crosses the placenta into the fetal circulation and is excreted into breast milk. 
Kofein brzo prolazi posteljicu, ulazi u fetalni krvotok i izlučuje se u majčino mlijeko.
Nervous system disorders Convulsion 
- stimulacija središnjeg živčanog sustava poput konvulzija
5 mg/kg body weight Intravenous infusion (over 10 minutes) or by oral administration 
5 mg/kg tjelesne težine intravenska infuzija (tijekom 10 minuta) ili peroralna primjena svaka 24 sata*
The solution must not be used if it is discoloured or foreign particulate matter is present. 
Otopina se ne smije upotrijebiti ako je promijenila boju ili sadrži strane čestice.
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%), or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule (see section 6.6). 
otopina glukoze (50 mg/ml), 0,9% otopina natrijevog klorida (9 mg/ml) ili 10% otopina kalcijevog glukonata (100 mg/ml) neposredno nakon izvlačenja iz ampule (vidjeti dio 6.6).
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010 Wien 
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16,
Peyona 20 mg/ml solution for infusion and oral solution 
Peyona 20 mg/ml otopina za infuziju i oralna otopina
In newborn infants born to mothers who consumed large quantities of caffeine prior to delivery, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate, since caffeine readily crosses the placenta into the foetal circulation (see sections 4.2 and 5.2). 
U novorođenčadi majki koje su konzumirale velike količine kofeina prije porođaja treba izmjeriti početne koncentracije kofeina u plazmi prije početka liječenja kofeincitratom, zato što kofein lako prolazi kroz posteljicu i ulazi u fetalni krvotok (vidjeti dio 4.2 i 5.2).
Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia. 
Opisani učinci uključuju stimulaciju središnjeg živčanog sustava (SŽS) kao što su konvulzije, razdražljivost, nemir i nervoza, učinke na srce poput tahikardije,
Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration. 
Sve parenteralne otopine u ampulama moraju se prije primjene vizualno pregledati da ne sadrže čestice.
Urine output increased, urine sodium and calcium increased, haemoglobin decreased, thyroxine decreased 
Pretrage povećana količina proizvedene mokraće, povišeni natrij i kalcij u mokraći, sniženi hemoglobin, sniženi tiroksin nepoznato
ITALY 
Italija
Hypoglycaemia, failure to thrive, feeding intolerance 
Poremećaji metabolizma i hiperglikemija često prehrane hipoglikemija, izostanak napredovanja, intolerancija na hranu nepoznato
In a post authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic imparment appeared to be higher as compared to premature infants without organ impairment (see sections 4.4 and 4.8). 
U ispitivanju sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet, učestalost nuspojava u malog broja vrlo rano rođene nedonoščadi s oštećenjem bubrega/jetre činila se višom nego u nedonoščadi bez oštećenja organa (vidjeti dijelove 4.4 i 4.8).
Alternatively, maintenance doses of 5 mg per kg body weight may be administered by oral administration, such as through a nasogastric tube every 24 hours. 
Drugi je način da se doze održavanja od 5 mg po kg tjelesne težine primjenjuju peroralno, npr. kroz nazogastričnu sondu, svaka 24 sata.
Rare reported side effects (may affect up to 1 in 1,000 people) - allergic reactions 
- srčani poremećaji poput nepravilnih otkucaja srca (aritmija) Rijetke nuspojave (mogu se javiti kod do 1 na 1000 osoba): - alergijske reakcije
Caffeine's main action is as a CNS stimulant. 
Glavno djelovanje kofeina jest da je on stimulans središnjeg živčanog sustava.
Keep out of the sightand reach of children. 
Čuvati izvan pogleda i dohvata djece.
These effects are not relevant with regard to short term administration in the preterm infant population (see section 
S obzirom na kratkotrajnu primjenu u populacije nedonoščadi, ti učinci nisu važni (vidjeti dio
In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment (see sections 4.2, 4.8 and 5.2). 
učestalost nuspojava u malog broja vrlo rano rođene nedonoščadi s oštećenjem bubrega/jetre činila se višom nego u nedonoščadi bez oštećenja organa (vidjeti dijelove 4.2, 4.8 i 5.2).
Peyona can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) or calcium gluconate 100 mg/ml (10%) immediately after withdrawal from the ampoule. 
otopina glukoze (50 mg/ml), 0,9% otopina natrijevog klorida (9 mg/ml) ili 10% otopina kalcijevog glukonata (100 mg/ml) odmah nakon izvlačenja iz ampule.
Common reported side effects (may affect up to 1 in 10 people) - local inflammatory reactions at the infusion site - cardiac disorders such as fast heart beat (tachycardia) - changes of sugar in blood or serum (hyperglycaemia) 
- srčani poremećaji poput ubrzanih otkucaja srca (tahikardija) - promjene razine šećera u krvi ili serumu (hiperglikemija)
CHIESI FARMACEUTICI SpA Via Palermo 26/A 43122 Parma 
SpA Via Palermo 26/A 43122 Parma
In preterm newborn infants with insufficient clinical response to the recommended loading dose, a second loading dose of 10 -20 mg/kg maximum may be given after 24 hours. 
U nedonoščadi s nedostatnim kliničkim odgovorom na preporučenu udarnu dozu može se nakon 24
Caffeine citrate should be administered with caution in preterm newborn infants with impaired renal or hepatic function. 
Kofeincitrat treba primjenjivati s oprezom u nedonoščadi s oštećenom funkcijom bubrega ili jetre.
The dose expressed as caffeine base is one-half the dose when expressed as caffeine citrate (20 mg caffeine citrate are equivalent to 10 mg caffeine base). 
Doza kofeina izražena u obliku baze iznosi polovicu doze izražene u obliku kofeincitrata (20 mg kofeincitrata ekvivalentno je 10 mg kofeina u obliku baze).
This medicine may increase the risk for serious intestinal disease with bloody stools (necrotising enterocolitis) when administered with medicines used to treat gastric disease (such as antihistamine H2 receptor blockers or proton-pump inhibitors that reduces gastric acid secretion). 
Kad se primjenjuje s lijekovima za liječenje želučane bolesti (kao što su antihistaminski blokatori H2 receptora ili inhibitori protonske pumpe koji smanjuju lučenje želučane kiseline), ovaj lijek može povećati rizik od ozbiljne crijevne bolesti s krvavim stolicama (nekrotizirajući enterokolitis).
Effects on reproductive performance observed in animals are not relevant to its indication in the preterm newborn infants (see section 5.3). 
Učinci na reproduktivnost uočeni kod životinja nisu relevantni za njegovu indikaciju u nedonoščadi
Caffeine citrate readily dissociates in aqueous solution. 
Kofeincitrat brzo se otapa u vodenoj otopini.
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) 
Peyona 20 mg/ml otopina za infuziju i oralna otopina kofeincitrat (odgovara 10 mg/ml kofeina u obliku baze)
Infants received 20 mg/kg caffeine citrate loading dose intravenously. 
Dojenčad je intravenski primila udarnu dozu od 20 mg/kg kofeincitrata.
Peyona 20 mg/ml solution for infusion and oral solution Caffeine citrate (equivalent to 10 mg/ml of caffeine base) IV/oral use 
Peyona 20 mg/ml otopina za infuziju i oralna otopina kofeincitrat (odgovara 10 mg/ml kofeina u obliku baze) i.v./ primjena kroz usta
Your newborn may experience fever, rapid breathing (tachypnoea), jitteriness, muscular tremor vomiting, high blood levels of sugar (hyperglycemia), low blood levels of potassium (hypokalaemia), high blood levels of certain chemicals (urea), elevated number of certain cells (leukocyte) in blood and seizures if he/she receives more caffeine citrate than he/she should. 
(tahipneja), postati nervozno, imati drhtanje (tremor) mišića, povraćati, imati povišene razine šećera u krvi (hiperglikemija), niske razine kalija u krvi (hipokalemija), visoke razine određenih tvari u krvi (ureja), povećan broj nekih krvnih stanica (leukocita) i napadaje
Caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. 
U objavljenim ispitivanjima pokazano je da kofein povećava frekvenciju srca, minutni volumen lijevog ventrikla i udarni volumen.
Side effects where the frequency cannot be estimated from the available data - bloodstream infection (sepsis) - changes of sugar in blood or serum (hypoglycaemia ), failure to grow, feeding intolerance - stimulation of central nervous system such as irritability, nervousness and restlessness; brain injury - deafness - regurgitation, increase in stomach aspirate - increase of urine flow, increase of certain urine components (sodium and calcium) - changes in blood tests (reduced levels of haemoglobin after prolonged treatment and reduced thyroid hormone at the start of treatment) 
- gluhoća - regurgitacija (vraćanje hrane iz želuca), povećanje učestalosti udisaja želučanog sadržaja, - pojačano mokrenje, povećanje određenih sastojaka mokraće (natrija i kalcija) - promjene krvnih nalaza (snižena razina hemoglobina nakon produljenog liječenja i snižen hormon štitne žlijezde na početku liječenja)
Alfasigma S.p.A. 
Chiesi Farmaceutici S.p.A.
• If your newborn has frequent regurgitation 
• Vaše novorođenče često ima vraćanje hrane iz želuca
- That Peyona is for the treatment of primary apnoea - That treatment with Peyona must be provided in a neonatal intensive care unit and initiated and supervised by a physician experienced in neonatal intensive care - Details of the loading and maintenance dosages and that caffeine may accumulate in premature newborn infants because of its long half-life. 
Da liječenje lijekom Peyona mora biti provedeno u jedinicama neonatalne intenzivne skrbi i da ga mora započeti i nadzirati liječnik s iskustvom u neonatalnoj intenzivnoj skrbi.
As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section 
Što se tiče sve nedonoščadi, onu liječenu kofeincitratom potrebno je pažljivo nadzirati zbog mogućnosti razvoja nekrotizirajućeg enterokolitisa (vidjeti dio 4.4).
As bacterial overgrowth in the gut is associated with the development of necrotising enterocolitis, coadministration of caffeine citrate with medicinal products that suppress gastric acid secretion (antihistamine H2 receptor blockers or proton-pump inhibitors) may in theory increase the risk of necrotising enterocolitis (see section 4.4 and 4.8). 
(antihistaminski blokatori H2 receptora ili inhibitori protonske pumpe) može, teoretski, povisiti rizik od nekrotizirajućeg enterokolitisa (vidjeti dio 4.4 i 4.8).
Caffeine is rapidly distributed into the brain following caffeine citrate administration. 
Nakon primjene kofeincitrata, kofein se brzo raspodjeljuje u mozak.
Hepatic cytochrome P450 1A2 (CYP1A2) is involved in caffeine biotransformation in older individuals. 
U biotransformaciji kofeina u starijih osoba sudjeluje jetreni citokrom P450 1A2 (CYP1A2).
− infants whose mothers consume caffeine while providing breast milk for feeding. 
(vidjeti dio 4.5) − novorođenčad čije majke konzumiraju kofein u razdoblju dojenja djeteta.
If your newborn gets any side effects, talk to your baby's doctor. 
Ako se kod Vašeg djeteta jave bilo kakve nuspojave, potrebno je obavijestiti liječnika Vašeg djeteta.
In that case, infants received a second loading dose of 20 mg/kg caffeine citrate after treatment day 1 and before treatment day 8. 
U tom slučaju, dojenčad bi primila drugu udarnu dozu od 20 mg/kg kofeincitrata nakon
Apnoea of prematurity is a diagnosis of exclusion. 
Dijagnoza apneje nedonoščeta postavlja se isključivanjem drugih uzroka.
The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate. 
Sažetak profila sigurnosti Vjerojatne nuspojave kofeincitrata mogu se predvidjeti na temelju poznavanja farmakologije i toksikologije kofeina i drugih metilksantina.
Each 3 ml ampoule contains 60 mg caffeine citrate (equivalent to 30 mg of caffeine base). 
Jedna ampula od 3 ml sadrži 60 mg kofeincitrata (što odgovara 30 mg kofeina).
Arrhythmia 
Apsorpcija
Tel: +386-1-43 00 901 
Chiesi Slovenija d.o.o. Tel: +386-1-43 00 901
Oral solution. 
Oralna otopina.
Chiesi Hungary Kft. Tel.:+36-1-429 1060 
Tel.:+36-1-429 1060
Tel: +421 259300060 
Chiesi Slovakia s.r.o. Tel: +421 259300060
Each ml contains 20 mg caffeine citrate (equivalent to 10 mg/ml of caffeine base). 
Jedan ml sadrži 20 mg kofeincitrata (što odgovara 10 mg/ml kofeina u obliku baze).
Each ml contains 20 mg caffeine citrate (equivalent to 10 mg caffeine). 
Jedan ml sadrži 20 mg kofeincitrata (što odgovara 10 mg kofeina).
− infants whose mothers may have ingested large quantities of caffeine prior to delivery (see section 
Savjetuje se izmjeriti početne koncentracije kofeina u: − novorođenčadi čije su majke unijele u organizam velike količine kofeina prije porođaja (vidjeti dio
Infants randomised to caffeine citrate received an intravenous loading dose of 20 mg/kg, followed by a daily maintenance dose of 5 mg/kg. 
Nedonoščad randomizirana u skupinu koja je primala kofeincitrat dobila je intravenski udarnu dozu od 20 mg/kg,
The diagnosis of apnoea of prematurity may need to be reconsidered if patients do not respond adequately to a second loading dose or maintenance dose of 10 mg/kg/day (see section 4.4). 
možda će biti potrebno ponovno razmotriti dijagnozu apneje u nedonoščadi (vidjeti dio 4.4).
Type I clear glass 1 ml ampoule Type I clear glass 3 ml ampoule Pack size of 10 ampoules. 
I od 1 ml Ampula od prozirnog stakla tipa