FrancophonIA/ELRC3.0 huggingface dataset:
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: Rapporterede bivirkninger er angivet nedenfor efter system organklasse og efter hyppighed.
English: - Pedea should not be given in the first 6 hours of life.
Danish: Pedea bør ikke gives i løbet af de første 6 timer af livet.
English: With the exception of an acute toxicity study, no further studies have been carried out in juvenile animals with Pedea.
Danish: Med undtagelse af en undersøgelse af akut toksicitet er der ikke udført yderligere undersøgelser hos juvenile dyr med Pedea.
English: The first injection should be given after the first 6 hours of life.
Danish: Den første injektion bør gives efter de første 6 levetimer.
English: In vivo and in vitro studies indicate that the S(+) isomer is responsible for the clinical activity.
Danish: In vivo og in vitro undersøgelser indikerer, at S(+) isomeren er ansvarlig for den kliniske aktivitet.
English: However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Danish: Det er imidlertid vanskeligt at adskille dem fra ofte forekommende komplikationer hos præmature børn og komplikationer grundet sygdommen.
English: The clearance of both enantiomers increases with gestational age, at least in the range of 24 to 28 weeks.
Danish: Clearance af begge enantiomerer øges med gestationsalderen, i det mindste i intervallet fra 24 til 28 uger.
English: Ibuprofen is a racemic mixture of S(+) and R(-) enantiomers.
Danish: Ibuprofen er en racemisk blanding af S(+) og R(-) enantiomerer.
English: If this is significant, your baby's treatment may be stopped until the volume of urine returns to normal.
Danish: Hvis dette er signifikant, kan behandlingen af Deres barn blive stoppet, indtil urinmængden vender tilbage til normal.
English: After opening, Pedea should be administered immediately.
Danish: Efter åbning bør Pedea anvendes med det samme.
English: It may harm them, even if their symptoms are the same as your baby's.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som Deres barn har.
English: There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.
Danish: Der er ingen prækliniske data, der kan betragtes som relevante for klinisk sikkerhed udover de data, der er inkluderet i andre afsnit af dette produktresumé.
English: Elimination rate is markedly lower than in older children and adults, with an elimination half-life estimated at approximately 30 hours (16-43).
Danish: Eliminationshastigheden er markant lavere end hos ældre børn og voksne, med en eliminationshalveringstid estimeret til cirka 30 timer (16-43).
English: The dose to be administered will be calculated from the weight of your baby.
Danish: Den givne dosis vil blive udregnet ud fra Deres barns vægt.
English: Pedea must therefore be used cautiously in the presence of an infection (see also section 4.3).
Danish: Pedea skal derfor anvendes med forsigtighed ved tilstedeværelsen af en infektion (se også pkt.
English: It is 10 mg/kg for the first administration and 5 mg/kg for the second and the third administrations.
Danish: Det er 10 mg/kg for den første administration og 5 mg/kg for den anden og tredje administration.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: While a baby is inside its mother's womb it does not need to use its lungs.
Danish: Medens barnet er inde i sin moders mave, har det ingen brug for sine lunger.
English: Solution for injection.
Danish: Opløsning til injektion.
English: Certain medicines, if given together with Pedea, may cause side effects.
Danish: Visse lægemidler kan, hvis de gives sammen med Pedea, medføre bivirkninger.
English: Pharmacotherapeutic group: other cardiac preparations, ATC code: C01 EB16
Danish: Farmakoterapeutisk gruppe: Andre kardielle midler, ATC-kode: C01 EB16
English: For intravenous use only.
Danish: Kun til intravenøs brug.
English: Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea.
Danish: Der foreligger for øjeblikket data på cirka 1.000 præmature nyfødte fra både litteraturen med ibuprofen og kliniske afprøvninger med Pedea.
English: - If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby's condition.
Danish: Hvis Deres barn allerede lider af en infektion, der bliver behandlet, vil lægen kun behandle Deres barn med Pedea efter omhyggelig overvejelse af Deres barns tilstand.
English: As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection.
Danish: Som et non-steroidt anti-inflammatorisk lægemiddel (NSAID), kan ibuprofen maskere de sædvanlige tegn og symptomer på infektion.
English: To detect this, your baby's stools and urine may be tested to determine if there is any blood present in them.
Danish: For at opdage dette skal Deres barns afføring og urin måske testes for at afgøre, om de indeholder noget blod.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler med undtagelse af dem, der er nævnt under pkt.
English: This condition is much more frequent in premature newborn than in full-term newborn infants.
Danish: Denne tilstand forekommer langt oftere hos for tidligt fødte nyfødte end hos spædbørn, der har gået tiden ud.
English: Only one recorded death has been published: after an overdose of 469 mg/kg, a 16-month old child developed an apnoeic episode with seizures and a fatal aspiration pneumonia.
Danish: Der er kun offentliggjort ét registreret dødsfald: efter en overdosis på 469 mg/kg, udviklede et 16 måneders gammelt barn en apnøisk episode med kramper og en fatal aspirationspneumoni.
English: - If your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes.
Danish: Hvis der er mistanke om, at Deres barn har en leverlidelse, hvorpå tegn og symptomer omfatter gulfarvning af huden og øjnene.
English: OUTER CARTON TEXT
Danish: TEKST PÅ YDERKARTON
English: Careful monitoring of both renal and gastrointestinal function is recommended.
Danish: Ligesom med andre NSAID'er anbefales omhyggelig monitorering af både renal og gastrointestinal funktion.
English: This calculated amount will be given by infusion in a vein over a period of 15 minutes.
Danish: Denne beregnede mængde vil blive givet som infusion i en vene over en periode på 15 minutter.
English: In vitro studies suggest that, similarly to other NSAIDs, ibuprofen is highly bound to plasma albumin, although this seems to be significantly lower (95 %) compared with adult plasma (99 %).
Danish: In vitro undersøgelser antyder, at ligesom med andre NSAID'er, er ibuprofen kraftigt bundet til plasma-albumin, selvom denne synes at være signifikant lavere (95 %) sammenlignet med plasma hos voksne (99 %).
English: No case of overdose has been reported with intravenous ibuprofen in preterm newborn infants.
Danish: Ingen tilfælde af overdosering er blevet rapporteret med intravenøs ibuprofen hos præmature nyfødte spædbørn.
English: Plasma concentrations of the S-enantiomer are much higher than those of the R-enantiomer, which reflects a rapid chiral inversion of the R- to the S-form in a proportion similar to adults (about 60%).
Danish: Plasmakoncentrationer af S-enantiomeren er meget højere end dem for R-enantiomer, hvilket afspejler en hurtig chiral inversion af R- til S-formen i et forhold magen til voksne (omkring 60%).
English: A rinse of the infusion line must be performed between each product administration (see section 6.6).
Danish: Der skal foretages en skylning af infusionsslangen mellem administration af hvert produkt (se pkt.
English: The medical term for this condition is ‘patent ductus arteriosus', i.e. an open ductus arteriosus.
Danish: Den medicinske betegnelse for denne tilstand er ‘persisterende ductus arteriosus', dvs. en åben ductus arteriosus.
English: - other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the increased risk of adverse reactions.
Danish: - andre NSAID'er: samtidig anvendelse af mere end ét NSAID bør undgås på grund af den øgede risiko for bivirkninger.
English: Since prostaglandins are involved in the persistence of the ductus arteriosus after birth, this effect is believed to be the main mechanism of action of ibuprofen in this indication.
Danish: Da prostaglandiner er involverede i vedholdenheden af ductus arteriosus efter fødslen, menes denne virkning at være hovedvirkningsmekanismen for ibuprofen ved denne indikation.
English: - Pedea may be less effective in very premature babies less than 27 weeks of gestational age.
Danish: Pedea kan være mindre effektivt hos meget præmature spædbørn i de første 27 svangerskabsuger.
English: Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100).
Danish: Hyppigheder er defineret som: meget almindelige (>1/10), almindelige (>1/100 til <1/10) og ikke almindelige (>1/1.000 til <1/100).
English: To avoid any possible microbiological contamination, the product should be used immediately after first opening.
Danish: For at undgå enhver mulig mikrobiologisk kontaminering bør præparatet anvendes umiddelbart efter anbrud.
English: The management of ibuprofen overdose is primarily supportive.
Danish: Behandlingen af en overdosering med ibuprofen er primært understøttende.
English: The active substance in Pedea is ibuprofen.
Danish: Det aktive stof i Pedea er ibuprofen.
English: 2 ml solution in a colourless type 1 glass ampoule.
Danish: 2 ml opløsning i en farveløs type 1 glasampul.
English: Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution.
Danish: Chlorhexidin må ikke bruges til at desinficere ampullens hals da det ikke er foreneligt med Pedeaopløsningen.
English: Ibuprofen is a NSAID that possesses anti-inflammatory, analgesic and antipyretic activity.
Danish: Ibuprofen er et NSAID, der besidder antiinflammatorisk, analgesisk og antipyretisk aktivitet.
English: Pedea should be administered carefully to avoid extravasation and potential resultant irritation to tissues.
Danish: Pedea bør administreres omhyggeligt for at undgå extravasation og potentielt resulterende irritation af væv.
English: An unborn baby has a blood vessel called the ductus arteriosus near the heart which allows the baby's blood to bypass the lungs and circulate to the rest of the body.
Danish: Et ufødt barn har et blodkar, der hedder ductus arteriosus nær hjertet, hvilket giver barnets blod mulighed for at køre uden om lungerne og cirkulere til resten af kroppen.
English: Massive overdose (up to more than 1000 mg/kg) has been reported to induce coma, metabolic acidosis, and transient renal failure.
Danish: Massiv overdosering (op til mere end 1000 mg/kg) er blevet rapporteret at inducere koma, metabolisk acidose og forbigående nyresvigt.
English: When the baby is born and starts using its lungs the ductus arteriosus normally closes.
Danish: Når barnet fødes og begynder at bruge sine lunger, lukker ductus arteriosus normalt.
English: - nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory increase the risk of bleeding.
Danish: - nitrogenoxid: da begge lægemidler hæmmer trombocytfunktionen, kan deres kombination teoretisk øge risikoen for blødning.
English: - your baby may be given aminosides (one family of antibiotics) to treat infection.
Danish: Din baby kan blive behandlet med aminosider (en antibiotikafamilie) mod infektion.
English: This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide.
Danish: Dette forekom indenfor én time efter den første infusion og blev vendt indenfor 30 min efter påbegyndt inhalation af nitrogenoxid.
English: Detailed information on this product is available on the web site of the European medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu.
English: Do not use Pedea after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke Pedea efter den udløbsdato, der står på pakningen.
English: Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Danish: Pedea lukker ductus arteriosus ved at hæmme produktionen af prostaglandin, et naturligt forekommende kemikalie i kroppen, der holder ductus arteriosus åben.
English: Like all medicines, Pedea can cause side effects, although not everybody gets them.
Danish: Pedea kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Residual concentrations are around 1015 mg/l 24 hours after the last dose of 5 mg/kg.
Danish: Tilbageværende koncentrationer er på omkring 10-15 mg/l 24 timer efter den sidste dosis på 5 mg/kg.
English: - Pedea may reduce the amount of urine your baby passes.
Danish: Pedea kan nedsætte mængden af urin, som Deres barn lader.
English: Intravenous use as short infusion Read the package leaflet before use
Danish: Intravenøs anvendelse som kortvarig infusion Læs indlægssedlen inden brug
English: There have also been post-marketing reports of pulmonary hypertension where Pedea was administered to premature neonates in the therapeutic setting.
Danish: Efter markedsføring er der også rapporter om pulmonal hypertension, hvor Pedea blev administreret til for tidligt fødte børn i behandlingsregi.
English: If hypoxaemia occurs during or following Pedea infusion, close attention should be paid to pulmonary pressure.
Danish: Hvis der opstår hypoxæmi i løbet af eller efter infusion af Pedea, skal pulmonaltrykket overvåges nøje.
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Danish: Hyppigheden af mulige bivirkninger er angivet efter ved at bruge følgende definitioner: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter) Almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter) Ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 patienter) Meget sjældne (forekommer hos færre end 1 ud af 10.000 patienter) Ukendte (hyppigheden kendes ikke ud fra de tilgængelige data)
English: Clear, colourless to slightly yellow solution.
Danish: Klar, farveløs til let gul opløsning.
English: Very common: Thrombocytopenia, Neutropenia
Danish: Meget almindelige: Trombocytopeni, neutropeni
English: Pedea, when given to your baby, can help to close the ductus arteriosus.
Danish: Pedea kan, når det gives til Deres barn, hjælpe til med at lukke ductus arteriosus.
English: Pedea solution must not be in contact with any acidic solution such as certain antibiotics or diuretics.
Danish: Pedea opløsningen må ikke komme i kontakt med syrlig opløsning såsom visse antibiotika eller diuretika.
English: - Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.
Danish: Pedea bør gives til Deres barn omhyggeligt af sundhedsmedarbejderen, for at undgå beskadigelse af huden og det omkringliggende væv.
English: Although a great variability is observed in the premature population, peak plasma concentrations are measured around 35-40 mg/l after the initial loading dose of 10 mg/kg as well as after the last maintenance dose, whatever gestational and postnatal age.
Danish: Selvom der er observeret en stor variabilitet i den præmature population, måles der peak plasmakoncentrationer omkring 35-40 mg/l efter den indledende ladningsdosis på 10 mg/kg såvel som efter den sidste vedligeholdelsesdosis, uanset gestationsuge og postnatal alder.
English: Common: Necrotizing enterocolitis, Intestinal perforation
Danish: Almindelige: Nekrotiserende enterocolitis, intestinal perforation
English: Before administration of Pedea an adequate echocardiographic examination should be performed in order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary hypertension and ductal-dependent congenital heart disease.
Danish: Inden administration af Pedea bør der udføres en adækvat ekkokardiografisk undersøgelse for at kunne detektere en hæmodynamisk signifikant åben ductus arteriosus og for at udelukke pulmonær hypertension og ductal-afhængig medfødt hjertesygdom.
English: Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen.
Danish: Årsagssammenhængen for bivirkninger rapporteret hos den præmature nyfødte er vanskelige at vurdere, da de kan være relaterede til de hæmodynamiske konsekvenser af den åbne ductus arteriosus såvel som direkte virkninger af ibuprofen.
English: If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.
Danish: Hvis der opstår anuria eller manifest oliguria efter den første eller den anden dosis, bør den næste dosis først gives, når urinmængde er vendt tilbage til normalt niveau.
English: Ibuprofen competes with bilirubin for albumin binding in newborn infant serum and, as a consequence, the free fraction of bilirubin may be increased at high ibuprofen concentrations.
Danish: Ibuprofen konkurrerer med bilirubin om albuminbinding i serum hos nyfødte spædbørn og som en konsekvens af dette, kan den frie fraktion af bilirubin være forøget ved høje koncentrationer af ibuprofen.
English: The required volume to be given to the infant should be determined according to body weight, and should be injected intravenously as a short infusion over 15 minutes, preferably undiluted.
Danish: Den krævede mængde, der skal gives til spædbarnet, bør bestemmes i henhold til kropsvægten og bør injiceres intravenøst som en kortvarig infusion over 15 minutter, fortrinsvis ufortyndet.
English: - your baby may be given corticosteroids to prevent inflammation.
Danish: Deres barn får måske kortikosteroider for at forhindre inflammation.
English: Ibuprofen is a non selective inhibitor of cyclooxygenase, leading to reduced synthesis of prostaglandins.
Danish: Ibuprofen er en non-selektiv hæmmer af cyklo-oxygenase, ledende til nedsat syntese af prostaglandiner.
English: - your baby may have problems passing urine and may have been prescribed diuretics.
Danish: - Deres barn kan have problemer med at lade vandet og har måske fået ordineret diuretika.
English: Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
Danish: Det anbefales derfor at der bruges etanol 60% eller isopropyl alkohol 70% til aseptik inden brug.
English: Not known: - Perforation of the stomach
Danish: Ukendte: - Perforation af mavesækken
English: Very Common: Blood creatinine increased, Blood sodium decreased
Danish: Meget almindelige: Blod kreatinin forøget, Blod natrium nedsat
English: - The active substance is ibuprofen.
Danish: - Aktivt stof: Ibuprofen.
English: Any unused portion of the solution should be discarded.
Danish: Enhver ubrugt del af opløsningen bør kasseres.
English: Ibuprofen may increase the anti-clotting effect of this product.
Danish: Ibuprofen kan øge den anti-størkende virkning af dette produkt.
English: What Pedea contains
Danish: Pedea indeholder:
English: Ibuprofen may reduce the effect of these medicines.
Danish: Ibuprofen kan nedsætte virkningen af disse lægemidler.
English: - Your baby may develop some bleeding from the intestines and the kidneys.
Danish: Deres barn kan udvikle nogen blødning fra tarmene og nyrerne.
English: However, overdose has been described in infants and children administered oral ibuprofen: CNS depression, seizures, gastrointestinal disturbances, bradycardia, hypotension, apnoea, abnormal renal function, haematuria have been observed.
Danish: Overdosering er imidlertid beskrevet hos spædbørn og børn, der har fået oral ibuprofen: CNS depression, kramper, gastrointestinale forstyrrelser, bradykardi, hypotension, apnø (eller respirationsophør), abnorm nyrefunktion og hæmaturi er blevet observeret.
English: Read all of this leaflet carefully before this medicine is administered to your baby.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge medicinen.
English: - your baby may be given nitric oxide to improve blood oxygenation.
Danish: - Deres barn får måske nitrogenoxid for at forbedre blodets iltning.
English: As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels is recommended during co-administration with ibuprofen.
Danish: Da ibuprofen kan mindske clearance af aminoglykosider, anbefales nøje overvågning af deres serumniveauer under samtidig indgift med ibuprofen.
English: Ampoules are intended for single use only, any unused portions must be discarded.
Danish: Ampullerne er kun beregnet til éngangsbrug, al ubrugt opløsning skal kasseres.
English: Uncommon: Gastrointestinal haemorrhage Unknown: Gastric perforation
Danish: Ualmindelig: Gastrointestinal blødning Ukendt: Gastrisk perforation
English: As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use.
Danish: Som ved alle parenterale produkter bør ampuller med Pedea inspiceres visuelt for småpartikler og emballagens integritet forud for anvendelsen.
English: Solution for injection 4 x 2 ml ampoules
Danish: Opløsning til injektion 4 x 2 ml ampuller
English: If after this first course of treatment, the ductus arteriosus is not closed or re-opens, your baby's doctor may decide to give a second course of treatment.
Danish: Hvis, efter dette første behandlingsforløb, ductus arteriosus ikke er lukket eller åbner sig igen, kan Deres barns læge beslutte at give endnu et behandlingsforløb.
English: Since ibuprofen was shown in vitro to displace bilirubin from its binding site to albumin, the risk of bilirubin encephalopathy in premature newborn infants may be increased (see section 5.2).
Danish: Da ibuprofen har vist sig in vitro at forskyde bilirubin fra dets bindingssteder på albumin, kan risikoen for bilirubin encefalopati hos præmature nyfødte spædbørn være øget (se pkt.
English: This medicinal product contains less than 1 mmol sodium (15 mg) per 2 ml, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (15 mg) per 2 ml, dvs. stort set ”natriumfrit”.
English: GLASS AMPOULE LABEL
Danish: ETIKET PÅ GLASAMPUL
English: - your baby may be given anticoagulants (medicine preventing blood clotting).
Danish: - Deres barn får måske antikoagulantia (medicin, der forhindrer blodet i at størkne).
English: In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy.
Danish: Især blev der rapporteret svær hypoxæmi med pulmonær hypertension hos 3 spædbørn indenfor én time efter den første infusion, hvilket blev vendt indenfor 30 min efter påbegyndt inhalation af nitrogenoxid.
English: Pedea should be administered as a short infusion over 15 minutes, preferably undiluted.
Danish: Pedea bør gives som en kort infusion over 15 minutter, fortrinsvis ufortyndet.