FrancophonIA/ELRC3.0 huggingface dataset:
English: In a dose-response study of Pedea in 40 preterm newborn infants, the ductus arteriosus closure rate associated to the 10-5-5 mg/kg dose regimen was 75% (6/8) in neonates of 27-29 weeks' gestation and 33% (2/6) in neonates of 24-26 weeks' gestation.
Danish: I en dosis-respons undersøgelse af Pedea hos 40 præmature nyfødte spædbørn, var lukningshastigheden for ductus arteriosus forbundet med det 10-5-5 mg/kg dosisregimen 75% (6/8) hos neonater efter 27-29 ugers svangerskab og 33% (2/6) hos neonater efter 24-26 ugers svangerskab.
English: Pedea is supplied in packs of 4 x 2 ml ampoules.
Danish: Pedea leveres i pakninger på 4 x 2 ml ampuller.
English: As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of bleeding.
Danish: Da ibuprofen kan hæmme trombocytaggregation, bør præmature neonater monitoreres for tegn på blødning.
English: Excipients: each ml contains 7.5 mg of sodium.
Danish: Hjælpestoffer: hver ml indeholder 7,5 mg natrium.
English: Very common: - Decrease in the number of platelets in the blood (thrombocytopenia), - Decrease in white blood cells called neutrophils (neutropenia), - Increase in creatinine level in the blood, - Decrease in sodium level in the blood, - Breathing problems (bronchopulmonary dysplasia),
Danish: Meget almindelige - Fald i antallet af blodplader i blodet (trombocytopeni), - Fald i antaller af de hvide blodceller, der hedder neutrofile celler (neutropeni), - Stigning i kreatininniveau i blodet, - Fald i natriumniveau i blodet, - Åndedrætsbesvær (bronkopulmonal dysplasi),
English: If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.
Danish: Hvis ductus arteriosus ikke lukker sig 48 timer efter den sidste injektion, eller hvis den åbner sig igen, kan der gives endnu et behandlingsforløb på 3 doser som ovenfor.
English: Conversely, a lower incidence of neonatal grade III-IV intraventricular haemorrhage and of surgical ligation was associated with prophylactic use of Pedea.
Danish: Omvendt var en lavere incidens af neonatal grad IIIIV intraventrikulær blødning og kirurgisk suturering forbundet med profylaktisk brug af Pedea.
English: Please tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis Deres barn bruger anden medicin eller har brugt det for nylig.
English: In preterm newborn infants less than 27 weeks of gestational age, the closure rate of the ductus arteriosus (33 to 50%) was shown to be low at the recommended dose regimen (see section 5.1).
Danish: Hos præmature, nyfødte spædbørn under 27. gestationsuge, viste lukningshastigheden af ductus arteriosus (33 til 50%) sig at være lav ved det anbefalede dosisregimen (se pkt.
English: Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure
Danish: Almindelige: Oliguri, væskeretention, hæmaturi Usædvanlig: akut nyresvigt
English: In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/81 (16%) for indomethacin versus 23/94 (24%) for ibuprofen.
Danish: I en klinisk kurativ afprøvning omfattende 175 præmature nyfødte spædbørn før 35. gestationsuge, var incidensen af bronkopulmonær dysplasi ved 36 uger efter undfangelse 13/81 (16%) for indomethacin versus 23/94 (24%) for ibuprofen.
English: - aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their coadministration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).
Danish: - aminoglykosider: da ibuprofen kan mindske clearance af aminoglykosider, kan samtidig indgift øge risikoen for nefrotoksicitet og ototoksicitet (se pkt.
English: Therefore, ibuprofen should not be used in infants with marked elevated bilirubin concentration.
Danish: Ibuprofen bør derfor ikke anvendes hos spædbørn med hyperbilirubinæmi.
English: In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age.
Danish: I en klinisk afprøvning, hvor Pedea blev givet profylaktisk i løbet af livets første 6 timer, blev der rapporteret kraftig hypoxæmi med pulmonær hypertension hos 3 nyfødte spædbørn før 28. gestationsuge.
English: If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.
Danish: Hvis tilstanden er uændret efter det andet behandlingsforløb, kan operation af PDA derefter blive nødvendig
English: - anticoagulants: ibuprofen may increase the effect of anticoagulants and enhance the risk of bleeding.
Danish: - antikoagulantia: ibuprofen kan øge virkningen af antikoagulantia og forstærke risikoen for blødning.
English: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Danish: Behandling af en hæmodynamisk signifikant åbentstående ductus arteriosus hos præmature nyfødte spædbørn før 34. gestationsuge.
English: Excipients: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid 25%, water for injections.
Danish: Hjælpestoffer: Trometamol, natriumchlorid, natriumhydroxid, saltsyre 25%, vand til injektion.
English: When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.
Danish: Når ampullens hals desinficeres med antiseptik, bør den blive helt tør inden den åbnes, for at undgå interaktion med Pedeaopløsningen.
English: - corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding.
Danish: - kortikosteroider: ibuprofen kan øge risikoen for gastrointestinal blødning.
English: This medicine has been prescribed for your baby.
Danish: - Lægen har ordineret Pedea til Deres barn.
English: Prophylactic use of Pedea in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased incidence of renal failure and pulmonary adverse events including hypoxia, pulmonary hypertension, pulmonary haemorrhage, as compared to curative use.
Danish: Profylaktisk brug af Pedea i løbet af livets 3 første dage (startende indenfor 6 timer efter fødslen) hos præmature, nyfødte spædbørn med mindre en 28 ugers svangerskab var forbundet med øget incidens af nyresvigt og pulmonære bivirkninger, inklusive hypoxi, pulmonær hypertension, pulmonær blødning, sammenlignet med kurativ anvendelse.
English: - Hypersensitivity to the active substance or to any of the excipients; - Life-threatening infection; - Active bleeding, especially intracranial or gastrointestinal haemorrhage; - Thrombocytopenia or coagulation defects; - Significant impairment of renal function; - Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); - Known or suspected necrotising enterocolitis;
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne: - Livstruende infektion; - Aktiv blødning, især intrakraniel eller gastrointestinal blødning; - Trombocytopeni eller koagulationsdefekter; - Signifikant nedsat nyrefunktion; - Medfødt hjertelidelse, hvor åbenheden af ductus arteriosus er nødvendig for tilfredsstillende pulmonær eller systemisk blodgennemstrømning (f.eks. pulmonær atresi, svær acyanotisk Fallot,
English: Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.
Danish: Pedea 5mg/ml opløsning til injektion leveres i æsker af 4ampuller a 2 ml.
English: A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day.
Danish: Dette kan så progressivt blive øget i de følgende 1-2 uger (omkring 20 ml/kg fødselsvægt/dag) op til en maksimal mængde på 180 ml/kg fødselsvægt/dag.
English: Take special care with Pedea - Before treatment with Pedea, your baby's heart will be examined to confirm that the ductus arteriosus is open.
Danish: Inden Pedea bliver givet til Deres barn, vil Deres barns hjerte blive undersøgt for at bekræfte, at ductus arteriosus er åben.
English: Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professionals.
Danish: Pedea vil kun blive givet til Deres barn på en særlig neonatal intensivafdeling af uddannet sundhedspersonale.
English: Ibuprofen may increase the risk of bleeding in the stomach and intestines.
Danish: Ibuprofen kan øge risikoen for blødning i maven og tarmsystemet.
English: Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Danish: Behandling med Pedea bør kun foretages på en neonatal intensivafdeling under overvågning af en erfaren neonatolog.
English: After first opening of an ampoule, any unused portions must be discarded.
Danish: Efter at en ampul er åbnet første gang, skal al ubrugt opløsning kasseres.
English: HOW TO STORE PEDEA
Danish: SÅDAN VIL DERES BARN FÅ PEDEA
English: The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
Danish: Den totale mængde af opløsning, der injiceres hos præmature spædbørn bør tages i betragtning ved den totale daglige mængde væske, der gives.
English: Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Danish: Behandling med Pedea må kun foregå på en neonatal intensivafdeling under overvågning af en erfaren neonatolog.
English: Ibuprofen may increase the risk of bleeding.
Danish: Ibuprofen kan øge risikoen for blødning.
English: Common: - Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia), - Bleeding in the lung, - Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis), - Reduced volume of urine passed, blood in the urine, fluid retention
Danish: Almindelige: - Blødning inde i kraniet (intraventrikulær hæmoragi) og hjerneskade (periventriculær leukomalaci), - Blødning i lungerne, - Huller i og skade på tarmvæv (nekrotiserende enterocolitis), - Nedsat ladt urinmængde, blod i urinen, væskeophobning.
English: Ibuprofen may increase blood concentrations and thus increase the risk of toxicity on kidney and ear
Danish: Ibuprofen kan øge blodkoncentrationen og derfor kan risikoen for bivirkninger på nyrer og ører stige.
English: Posology and method of administration (see also section 3)
Danish: Dosering og indgivelsesmåde (se pkt.
English: Since prophylactic use in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased pulmonary and renal adverse events, Pedea should not be used prophylactically at any gestational age (see sections 4.8 and 5.1).
Danish: Da profylaktisk anvendelse i livets 3 første dage (begyndende indenfor 6 timer efter fødslen) hos præmature nyfødte spædbørn før 28. gestationsuge blev forbundet med øgede pulmonære og renale bivirkninger, bør Pedea ikke anvendes profylaktisk i nogen gestationsuge (se pkt.
English: - The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: Trometamol, natriumchlorid, natriumhydroxid (til justering af pH), saltsyre 25% (til justering af pH) og vand til injektion.
English: - Ibuprofen may reduce the ability of your baby's blood to clot.
Danish: Ibuprofen kan nedsætte Deres barns blods evne til at koagulere.
English: In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Danish: For at kunne undgå enhver væsentlig variation i pH på grund af tilstedeværelsen af sure lægemidler, der kunne være tilbage i infusionsslangen, skal denne skylles før og efter indgivelsen af Pedea med 1,5 til 2 ml enten 9 mg/ml (0,9%) natriumchloridopløsning til injektion eller 50 mg/ml (5%) glukoseopløsning.
English: If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.
Danish: Hvis tilstanden er uændret efter det andet behandlingsforløb, kan det derefter blive nødvendigt med operation af den åbne ductus arteriosus.
English: Each ml contains 5 mg ibuprofen Each ampoule of 2 ml contains 10 mg ibuprofen
Danish: Hver ml indeholder 5 mg ibuprofen Hver ampul a 2 ml indeholder 10 mg ibuprofen
English: Method of administration:
Danish: Indgivelsesmåde:
English: The total volume of solution injected should take into account the total daily fluid volume administered.
Danish: Den totale mængde af injiceret opløsning bør regnes med i den indgivne, totale, daglige væskemængde.
English: Pedea 5 mg/ml solution for injection
Danish: Pedea 5 mg/ml opløsning til injektion
English: Before and after administration of Pedea, to avoid contact with any acidic solution, rinse the infusion line over 15 minutes with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%), solution for injection.
Danish: Før og efter administration af Pedea bør man, for at undgå kontakt med en sur opløsning, skylle infusionsslangen over 15 minutter med 1,5 til 2 ml opløsning til injektion af enten 9 mg/ml (0,9%) natriumchlorid eller 50 mg/ml (5%) glukose.
English: In preterm newborns ibuprofen significantly reduced plasma concentrations of prostaglandins and their metabolites, particularly PGE2 and 6-keto-PGF-1-alpha. Low levels were sustained up to 72 hours in neonates who received 3 doses of ibuprofen, whereas subsequent re-increases were observed at 72 hours after only 1 dose of ibuprofen.
Danish: Lave niveauer blev opretholdt op til 72 timer hos neonater, der fik 3 doseringer ibuprofen, medens efterfølgende genstigninger blev observeret ved 72 timer efter kun 1 dosis ibuprofen.
English: Very common: Bronchopulmonary dysplasia* Common: Pulmonary haemorrhage Uncommon: Hypoxemia*
Danish: Luftveje, thorax og mediastinum Meget almindeligt: Bronkopulmonær dysplasi* Almindelig: Pulmonær blødning
English: This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler med undtagelse af 9 mg/ml (0,9%) natriumchloridopløsning til injektion eller 50 mg/ml (5%) glukoseopløsning.
English: Each ml contains 5 mg ibuprofen.
Danish: Hver ml indeholder 5 mg ibuprofen.
English: Use only sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution to adjust injection volume.
Danish: Anvend kun 9 mg/ml (0,9%) natriumchloridopløsning til injektion eller 50 mg/ml (5%) glucoseopløsning til at justere injektionsmængden.
English: If you have further questions, please ask your doctor or your pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
Danish: Et behandlingsforløb defineres som tre intravenøse doser Pedea givet med 24 timers interval.
English: If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.
Danish: Hvis ductus arteriosus ikke er lukket efter det andet behandlingsforløb, vil lægen muligvis foreslå operation.
English: Trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment), water for injections.
Danish: Natriumhydroxid (til justering af pH), Saltsyre 25% (til justering af pH), Vand til injektion.
English: Pedea 5 mg/ml solution for injection Ibuprofen
Danish: Pedea 5 mg/ml opløsning til injektion Ibuprofen
English: A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals.
Danish: Et behandlingsforløb defineres som tre intravenøse injektioner med Pedea givet med 24 timers intervaller.
English: Each ampoule of 2 ml contains 10 mg ibuprofen.
Danish: Hver ampul a 2 ml indeholder 10 mg ibuprofen.
English: What Pedea looks like and contents of the pack Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution.
Danish: Pedea 5mg/ml opløsning til injektion, klar, farveløs til let gul opløsning.
English: If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Danish: Om nødvendigt kan injektionsmængden justeres med enten 9 mg/ml (0,9%) natriumchloridopløsning til injektion eller 50 mg/ml (5%) glukoseopløsning til injektion.
English: Do not use Pedea - if your baby is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Pedea; - if your baby has a life-threatening infection which has not been treated; - if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines; - if your baby has a decrease of blood cells called platelets (thrombocytopenia) or other problems with their blood clotting; - if your baby has kidney problems; - if your baby has other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained; - if your baby has or is suspected to have certain problems with their intestines (a condition called necrotising enterocolitis);
Danish: - hvis Deres barn har en livstruende infektion, der ikke er blevet behandlet; - hvis Deres barn bløder, især hvis blødningen er inde i kraniet eller i tarmene; - hvis Deres barn har et nedsat antal af de blodceller, der hedder blodplader (trombocytopeni)
English: Each ml of the solution contains 5 mg ibuprofen.
Danish: Hver ml af opløsningen indeholder 5 mg ibuprofen.
English: See leaflet
Danish: - Tarmblødning.
English: The concomitant use of Pedea with the following medicinal products is not recommended: - diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients.
Danish: Diuretika kan øge risikoen for nefrotoksicitet af NSAID'er hos dehydrerede patienter.
English: What Pedea is and what it is used for Before Pedea is administered to your baby How Pedea is used
Danish: Det skal De vide, før Deres barn begynder at få Pedea Sådan vil Deres barn få Pedea Bivirkninger
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux France
Danish: Indehaver af markedsføringstilladelsen Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F- 92800 Puteaux,
English: Uncommon: - Acute failure of the kidney's functions - Bleeding in the intestine - Below normal oxygen content in the arterial blood (hypoxemia)
Danish: - Unormal lav iltmætning i det arterielle blod (hypoksi).
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France or
Danish: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Frankrig eller
English: rd injections: 5 mg/kg.
Danish: Ibuprofendosis justeres efter legemsvægt som følger: - 1. injektion: 10 mg/kg, - 2. og 3. injektion: 5 mg/kg.
English: Posology
Danish: Indgivelsesmåde
English: Keep out of reach and sight of children.
Danish: Opbevares utilgængeligt for børn.
English: Common: Intraventricular haemorrhage, Periventricular leukomalacia
Danish: Almindelige: Intraventrikulær blødning,
English: Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du Général de Gaulle F- 92800 Puteaux France
Danish: Recordati Rare Diseases Immeuble “Le Wilson“ 70, avenue du Général de Gaulle F- 92800 Puteaux.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby's doctor or your pharmacist.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller Deres barn får bivirkninger, som ikke er nævnt her.
English: Gastrointestinal disorders
Danish: Periventrikulær leukomalaci
English: London, 29 May 2009 Doc.
Danish: London, den 29. maj 2009 Dok.
English: The company presented the results of eight main studies involving over 4,000 adults to support its application.
Danish: Virksomheden fremlagde resultaterne af otte hovedundersøgelser med deltagelse af 4 000 voksne til støtte for ansøgningen.
English: However, the Committee had also concluded that eszopiclone could not be considered to be a new active substance.
Danish: Udvalget konkluderede imidlertid også, at eszopiclon ikke kunne anses for at være et nyt aktivt stof.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig denne behandling.
English: Zopiclone has been available in the European Union (EU) as a treatment for insomnia since the mid-1980s.
Danish: Zopiclon har været på markedet i Den Europæiske Union (EU) som behandling mod søvnløshed siden midten af 80'erne.
English: The CHMP had no major concerns and the application could have been approved.
Danish: CHMP havde ingen større betænkeligheder, og ansøgningen kunne være blevet godkendt.
English: The effects of Lunivia were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Lunivia blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measures of effectiveness were how long it took for the patients to fall asleep or how long the patients were awake during the night after first falling asleep.
Danish: Det primære effektmål var, hvor lang tid det tog for patienterne at falde i søvn, eller hvor længe patienterne var vågne i løbet af natten, efter at de først var faldet i søvn.
English: Questions and answers on the withdrawal of the marketing authorisation application for Lunivia eszopiclone
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Lunivia eszopiclon
English: What is Lunivia?
Danish: Hvad er Lunivia?
English: As a consequence, Lunivia would not have been able to benefit from 10 years of ‘market exclusivity'.
Danish: Som følge heraf ville det ikke have været muligt for Lunivia at opnå “eksklusivret på markedet” i en tiårig periode.
English: What was Lunivia expected to be used for?
Danish: Hvad forventedes Lunivia anvendt til?
English: It is a purified form of one of the two ‘enantiomers' (mirror-image forms) of the substance zopiclone.
Danish: Det er en renset form at en af de to “enantiomerer” (spejlbilledformer) af stoffet zopiclon.
English: The evaluation had finished and the CHMP had given a positive opinion.
Danish: Vurderingen var afsluttet, og CHMP havde afgivet en positiv udtalelse.
English: By activating these receptors, eszopiclone can help patients with insomnia to sleep.
Danish: Ved at aktivere disse receptorer kan eszopiclon hjælpe patienter, der lider af søvnløshed, med at falde i søvn.