FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In adults, the mean plasma protein binding in vitro is reported to be approximately 36%.
Danish: Hos voksne rapporteres middelplasmaproteinbindingen in vitro at være cirka 36 %.
English: EU/1/09/528/002 1 ml ampoules EU/1/09/528/001 3 ml ampoules
Danish: EU/1/09/528/002 1 ml ampuller EU/1/09/528/001 3 ml ampuller
English: Unused portions should not be saved for later administration.
Danish: Ubrugte portioner må ikke gemmes til senere administration.
English: Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25ºC and at 2-8ºC.
Danish: Den fortyndede opløsnings kemiske og fysiske kompatibilitet er blevet påvist i 24 timer ved 25 ºC og ved 2-8 ºC.
English: Caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out.
Danish: Caffein synes hverken at forværre cerebral hypoksi eller at forværre nogen medfølgende skader, selvom muligheden ikke kan udelukkes.
English: In newborns this is usually a simple sinus tachycardia.
Danish: Hos nyfødte er dette sædvanligvis en simpel sinus-takykardi.
English: However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Danish: Det kan imidlertid være vanskeligt at skelne bivirkningerne fra hyppige komplikationer, der forekommer hos for tidligt fødte spædbørn og komplikationer på grund af sygdommen.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment.
Danish: Hvis Deres spædbarn har 5 til 7 dage uden apnø, stopper lægen behandlingen.
English: In newborn infants, the t1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days).
Danish: Hos nyfødte er t1/2 cirka 3-4 dage, og Ae er cirka 86 % (inden for 6 dage).
English: The diluted solution must be clear and colourless.
Danish: Den fortyndede opløsning skal være klar og farveløs.
English: Rare reported side effects (may affect up to 1 in 1,000 people) - allergic reactions
Danish: Sjældent indberettede bivirkninger (kan påvirke op til 1 ud af 1.000 mennesker) - allergiske reaktioner
English: Please inform your baby's doctor:
Danish: Fortæl det til Deres spædbarns læge:
English: The following other side effects may also be considered serious by your baby's doctor in the context of the global clinical evaluation.
Danish: Deres spædbarns læge kan også anse følgende andre bivirkninger for at være alvorlige i forbindelse med den globale kliniske vurdering.
English: Death or disability according to subgroup of respiratory support at entry to study
Danish: Dødsfald eller invaliditet inddelt i undergrupper efter respiratorisk støtte ved indtræden i forsøget
English: • If your newborn produces more urine than usual
Danish: • Hvis Deres nyfødte barn producerer mere urin end sædvanlig
English: Maintenance dose*
Danish: Vedligeholdelsesdosis *
English: Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.
Danish: Kardielle forstyrrelser (takykardi, herunder et enkelt tilfælde af arytmi) blev indberettet oftest.
English: Peyona contains sodium
Danish: Peyona indeholder natrium
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Dosage adjustments and monitoring
Danish: Dosisjusteringer og monitorering
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.
Danish: Der bør tages blodprøver med henblik på monitorering, lige inden næste dosis i tilfælde af manglende terapeutisk effekt, og 2 til 4 timer efter den forudgående dosis, når der er mistanke om toksicitet.
English: These short periods when premature babies stop breathing are due to the baby's breathing centres not being fully developed.
Danish: Disse korte perioder, hvor for tidligt fødte spædbørn holder op med at trække vejret, skyldes, at spædbarnets åndedrætscentre ikke er fuldt udviklede.
English: Failure to respond to caffeine treatment (confirmed if necessary by measurement of plasma levels) could be an indication of another cause of apnoea.
Danish: Manglende respons til caffeinbehandling (om nødvendigt bekræftet ved måling af plasmaniveau) kan være en indikation på en anden årsag til apnø.
English: Clear, colourless, aqueous solution at pH=4.7.
Danish: Klar, farveløs, vandig opløsning med pH=4,7.
English: − infants with known and clinically significant cardiac disease
Danish: − spædbørn med kendt og klinisk signifikant hjertesygdom
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.
Danish: De fleste af dets virkninger er tilskrevet antagonismen af adenosinreceptorer, både A1 og A2A undertyper, påvist i receptorbindingsanalyser og observeret ved koncentrationer, der nærmer sig de koncentrationer, der opnås terapeutisk i denne indikation.
English: Three of the infants who developed necrotising enterocolitis during the study died.
Danish: Tre af spædbørnene, som udviklede nekrotiserende enterocolitis under forsøget, døde.
English: If concurrent use is indicated, cardiac rhythm and blood pressure must be carefully monitored.
Danish: Hvis samtidig brug er indiceret, skal hjerterytmen og blodtrykket monitoreres nøje.
English: Plasma protein binding data are not available for newborn infants or infants.
Danish: Data vedrørende plasmaproteinbinding er hverken tilgængelige for nyfødte eller spædbørn.
English: Necrotising enterocolitis
Danish: Nekrotiserende enterocolitis
English: By 9 months of age, the metabolism of caffeine approximates to that seen in adults (t1/2 = 5 hours and Ae = 1%).
Danish: Ved 9 måneders alderen nærmer caffeins metabolisme sig det, der ses hos voksne (t1/2 = 5 timer og Ae = 1 %).
English: The maintenance doses were adjusted weekly for changes in body weight and could be given orally once an infant tolerated full enteral feedings.
Danish: Vedligeholdelsesdoserne blev justeret en gang om ugen i forhold til ændringer i kropsvægt og kunne gives oralt, når spædbarnet kunne tåle fuldstændig enteral ernæring.
English: Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Danish: Caffein har derfor potentiale til at interagere med aktive stoffer, der er substrater for CYP1A2, at hæmme CYP1A2 eller inducere CYP1A2.
English: These effects are dose related and may necessitate measurement of plasma levels and dose reduction.
Danish: Disse virkninger er dosisrelaterede og kan nødvendiggøre måling af plasmaniveau og dosisreduktion.
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.
Danish: I klinisk praksis fortsættes behandlingen sædvanligvis, indtil spædbarnet har nået en postmenstruel alder på 37 uger, hvor præmatur-betinget apnø sædvanligvis forsvinder spontant.
English: Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy.
Danish: Der er registreret forbigående fald i thyroxin (T4) hos spædbørn i starten af behandlingen, men de opretholdes ikke i forbindelse med vedvarende behandling.
English: In a recent large multicentre study on preterm newborn infants a median treatment period of 37 days was reported.
Danish: I et nyligt, stort, multicenterforsøg med præmature nyfødte børn blev der rapporteret en gennemsnitlig behandlingsperiode på 37 dage.
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.
Danish: Denne grænse kan dog ændres på baggrund af klinisk vurdering i enkelte tilfælde afhængigt af patientens respons på behandlingen, fortsat tilstedeværelse af episoder med apnø trods behandlingen eller andre kliniske overvejelser.
English: The medicinal product must not be administered by intramuscular, subcutaneous, intrathecal or intraperitoneal injection.
Danish: Lægemidlet må ikke administreres ved intramuskulær, subkutan, intratekal eller intraperitoneal injektion.
English: The following information is intended for medical or healthcare professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale.
English: Peyona is a clear, colourless solution, supplied in glass ampoules.
Danish: Peyona er en klar, farveløs opløsning, der leveres i glasampuller.
English: Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.
Danish: På grund af den langsomme elimination af caffein i denne patientpopulation er der ingen krav om gradvis nedsættelse af dosis i forbindelse med behandlingsophør.
English: Side effects where the frequency cannot be estimated from the available data - serious intestinal disease with bloody stools (necrotising enterocolitis)
Danish: Bivirkninger, hvor hyppigheden ikke kan vurderes ud fra tilgængelige data - alvorlig tarmsygdom med blod i afføringen (nekrotiserende enterocolitis)
English: While under treatment with Peyona, your newborn may experience some of the following reactions:
Danish: Mens Deres nyfødte spædbarn er i behandling med Peyona, kan han/hun få nogle af følgende reaktioner:
English: Brain injury, convulsion and deafness were observed but they were more frequent in the placebo group.
Danish: Hjerteskade, krampeanfald og døvhed blev observeret, men var hyppigere i placebogruppen.
English: Any unused portions must be discarded.
Danish: Alle eventuelt ubrugte portioner skal bortskaffes.
English: Infections and infestations Sepsis
Danish: Infektioner og parasitære Sepsis
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).
Danish: Middelfordelingsvolumenet (Vd) af caffein hos spædbørn (0,8-0,9 l/kg) er lidt højere end hos voksne (0,6 l/kg).
English: The protocol allowed infants to be “rescued” with open-label caffeine citrate treatment if their apnoea remained uncontrolled.
Danish: Protokollen tillod, at spædbørnene blev “reddet” med en åben fase-caffeincitratbehandling, hvis deres apnø vedblev at være ukontrolleret.
English: However, at high doses convulsions in rodents were induced.
Danish: Ved højere doser blev der imidlertid hos gnavere induceret krampeanfald.
English: Apnoea of prematurity is a diagnosis of exclusion.
Danish: Præmatur-betinget apnø er en eksklusionsdiagnose.
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].
Danish: Omfanget og typen af caffeinets virkning på dødsfald og invaliditet var forskellig afhængigt af, hvilket omfang af respiratorisk støtte spædbarnet havde behov for ved randomiseringen, hvilket indikerede mere gavn for de understøttede spædbørn [odds ratio (95 % CI) for død og invaliditet, se tabellen nedenfor].
English: Via Enrico Fermi IT-65020 Alanno (PE) Italy
Danish: Via Enrico Fermi IT-65020 Alanno (PE) Italien
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.
Danish: Da der er risiko for tilbagefald med apnøer efter afbrydelse af behandlingen med caffeincitrat, bør patienten fortsat monitoreres i cirka én uge.
English: It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack.
Danish: Det anbefales, at administrationen med caffeincitrat afbrydes, når patienten ikke har haft signifikant attak af apnø i 5-7 dage.
English: • If your newborn is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis Deres nyfødte spædbarn er allergisk over for caffeincitrat eller et af de øvrige indholdsstoffer i dette lægemiddel (se punkt 6).
English: Non-clinical data revealed no major hazard for humans based on studies of repeated dose toxicity of caffeine.
Danish: Ikke-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser af caffein.
English: Plasma potassium and glucose concentrations should be monitored and hypokalaemia and hyperglycaemia corrected.
Danish: Kalium- og glukosekoncentrationerne i plasma bør monitoreres, og hypokaliæmi og hyperglykæmi bør korrigeres.
English: 1.32 (0.81 to 2.14)
Danish: 1,32 (0,81 til 2,14)
English: Caffeine is rapidly distributed into the brain following caffeine citrate administration.
Danish: Caffein distribueres hurtigt i hjernen efter administration af caffeincitrat.
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)].
Danish: Caffeinbehandlingen reducerede hyppigheden af bronkopulmonal dysplasi [odds ratio (95 % CI) 0,63 (0,52 til 0,76)] og forbedrede overlevelsesraten uden invaliderende neuroudvikling [odds ratio (95 % CI) 0,77 (0,64 til 0,93)].
English: Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment.
Danish: Bivirkninger syntes at forekomme hyppigere hos denne undergruppe med nedsat organfunktion end hos andre observerede spædbørn uden nedsat organfunktion.
English: Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants.
Danish: Nekrotiserende enterocolitis er en almindelig årsag til morbiditet og mortalitet hos præmature nyfødte børn.
English: The onset of action of caffeine from caffeine citrate is within minutes of commencement of infusion.
Danish: Virkningen af caffein fra caffeincitrat starter inden for få minutter efter påbegyndelse af infusionen.
English: Your baby's doctor will prescribe the right amount of Peyona based on your baby's weight.
Danish: Deres spædbarns læge vil ordinere den mængde Peyona, der passer til Deres spædbarns vægt.
English: Where doubt exists about possible interactions, plasma caffeine concentrations should be measured.
Danish: Hvis der er tvivl om mulige interaktioner, bør caffeinkoncentrationerne i plasma måles.
English: Caffeine citrate causes a generalised increase in metabolism, which may result in higher energy and nutrition requirements during therapy.
Danish: Caffeincitrat medfører en generel øget metabolisme, som kan resultere i større energi- og ernæringskrav under behandlingen.
English: Plasma caffeine concentrations have been shown to decrease after exchange transfusion.
Danish: Caffeinkoncentrationerne i plasma har vist sig at falde efter udskiftningstransfusion.
English: This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Danish: Det er påvist, at dette lægemiddel reducerer antallet af episoder med afbrudt åndedræt hos for tidligt fødte spædbørn.
English: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italy
Danish: Alfasigma S.p.A., Via Enrico Fermi 1, Alanno (PE) Italien
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKETTE TIL AMPUL
English: Increased left ventricular output and increased stroke volume
Danish: Øget output fra venstre ventrikelfunktion og øget slagvolumen
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:
Danish: Kortet skal indeholde følgende hovedelementer og skal ved lancering af produktet leveres til alle neonatale intensivafdelinger, hvor det er sandsynligt, at lægemidlet vil blive anvendt:
English: In the event of this happening treatment with Peyona should be stopped immediately and your baby's doctor should treat the overdose.
Danish: Hvis dette sker, skal behandlingen med Peyona omgående afbrydes, og Deres læge vil behandle overdoseringen.
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:
Danish: Endvidere kan det være nødvendigt at justere doserne ifølge lægens vurdering efter rutinemæssig monitorering af caffeinkoncentrationerne i plasma ved følgende eksempler på risikosituationer:
English: This medicinal product does not require any special storage condition.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Caffeine may suppress erythropoietin synthesis and hence reduce haemoglobin concentration with prolonged treatment.
Danish: Caffein kan undertrykke erythropoietin-syntesen og derved reducere hæmoglobinkoncentrationen ved forlænget behandling.
English: Dose of caffeine citrate (Volume)
Danish: Dosis af caffeincitrat (volumen)
English: If apnoeas persisted, the daily maintenance dose could be increased to a maximum of 10 mg/kg of caffeine citrate.
Danish: Hvis apnøerne vedblev, kunne den daglige vedligeholdelsesdosis øges til maksimalt 10 mg/kg caffeincitrat.
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.
Danish: Der er ingen indikationer på langvarige reaktioner på neonatal caffeinbehandling med hensyn til neuroudvikling eller manglende evne til at trives eller på de kardiovaskulære, gastrointestinale eller endokrine systemer.
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.
Danish: Ved terapeutiske doser blev der observeret visse adfærdsmæssige ændringer hos nyfødte rotter; sandsynligvis som resultat af øget adenosinreceptoraktivitet, der vedvarede i voksenlivet.
English: These effects are not relevant with regard to short term administration in the preterm infant population (see section
Danish: Disse virkninger er ikke relevante i forbindelse med kortvarig administration hos præmature nyfødte børn (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis; dvs. at det kan betragtes som ‘natrium-frit'.
English: 20 mg/kg body weight Intravenous infusion (over 30 minutes)
Danish: 20 mg/kg legemsvægt Intravenøs infusion (over 30 minutter)
English: Manufacturer (Batch release)
Danish: Fremstiller (batchfrigivelse)
English: Pharmacotherapeutic group: Psychoanaleptics, xanthine derivatives ATC code: N06BC01 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, xantinderivater, ATC-kode: N06BC01
English: − infants whose mothers consume caffeine while providing breast milk for feeding.
Danish: − spædbørn hvis mødre indtager caffein, mens de producerer brystmælk til barnet.
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.
Danish: Peyona indeholder det aktive stof caffeincitrat, som stimulerer centralnervesystemet og tilhører en gruppe lægemidler, der kaldes metylxantiner.
English: Do not use the following medicines during the treatment with Peyona without talking to your baby's doctor.
Danish: Deres spædbarn må ikke få følgende lægemidler under behandlingen med Peyona, uden at De først har talt med Deres spædbarns læge herom.
English: 5 mg/kg body weight Intravenous infusion (over 10 minutes) or by oral administration
Danish: 5 mg/kg legemsvægt Intravenøs infusion (over 10 minutter) eller ved oral administration
English: Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans.
Danish: Cytokrom P450 1A2 (CYP1A2) er det vigtigste enzym, der er involveret i metaboliseringen af caffein hos mennesker.
English: Read all of this leaflet carefully before treatment with this medicine because it contains important information for your newborn
Danish: Læs denne indlægsseddel grundigt, inden Deres nyfødte barn begynder at få behandling med dette lægemiddel, da den indeholder vigtige oplysninger.
English: Caffeine citrate should be used with caution in infants suffering gastro-oesophageal reflux, as the treatment may exacerbate this condition.
Danish: Caffeincitrat bør anvendes med forsigtighed hos spædbørn, der lider af gastroøsofageal refluks, da behandlingen kan forværre denne tilstand.
English: The active substance is caffeine citrate.
Danish: Aktivt stof: caffeincitrat.
English: There is limited experience in patients with renal and hepatic impairment.
Danish: Der er begrænsede erfaringer hos patienter med nedsat nyre- og leverfunktion.
English: Your baby's doctor will decide exactly how long your newborn must continue therapy with Peyona.
Danish: Deres spædbarns læge vil tage stilling til, nøjagtigt hvor længe Deres nyfødte spædbarn skal fortsætte behandlingen med Peyona.
English: The diuresis and electrolyte loss induced by caffeine citrate may necessitate correction of fluid and electrolyte disturbances.
Danish: Væske- og elektrolyttab på grund af caffeincitrat kan gøre det nødvendigt at korrigere væske- og elektrolytforstyrrelserne.
English: If your newborn gets any side effects, talk to your baby's doctor.
Danish: Hvis Deres nyfødte barn får bivirkninger, bør De tale med Deres spædbarns læge.
English: Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardiorespiratory and central nervous system.
Danish: Samtidig brug af caffein og doxapram kan forstærke disse stoffers stimulerende virkninger på det kardiorespiratoriske system og centralnervesystemet.
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.
Danish: Indehaveren af markedsføringstilladelsen skal indgå en aftale med CHMP (og om nødvendigt med de relevante nationale myndigheder) om teksten til et introduktionsbrev til sundhedsprofessionelle forud for lanceringen af lægemidlet og skal sikre, at det modtages af alle læger med erfaring i intensiv neonatal behandling forud for eller samtidig med lanceringen af lægemidlet i hver enkelt medlemsstat.
English: Irritability, jitteriness, restlessness, brain injury
Danish: Irritabilitet, anspændthed, rastløshed, hjerneskade