FrancophonIA/ELRC3.0 huggingface dataset:
English: In a double-blind, controlled clinical study to evaluate the safety and biochemical efficacy of Respreeza 44 subjects were randomized to receive 60 mg / kg bw intravenous dose of Respreeza once weekly for 24 weeks.
Danish: I et dobbeltblindet, kontrolleret klinisk studie, der evaluerede sikkerheden og den biokemiske virkning af Respreeza blev 44 forsøgspersoner randomiseret til at få Respreeza 60 mg/kg kropsvægt intravenøst en gang ugentlig i 24 uger.
English: The population pharmacokinetic analysis did not indicate that there were any significant effects of age, gender, weight, or baseline serum antigenic alpha1-proteinase inhibitor concentrations on the clearance of Respreeza.
Danish: Den farmakokinetiske populationsanalyse indikerede ikke, at alder, køn, vægt eller serumkoncentrationen af antigen alfa-1-proteinasehæmmer ved baseline havde signifikante indvirkninger på Respreezas clearance.
English: What you need to know before you use Respreeza
Danish: Det skal du vide, før du begynder at tage Respreeza
English: Respreeza contains sodium
Danish: Respreeza indeholder natrium
English: Geriatric population
Danish: Geriatrisk population
English: Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed).
Danish: Information om sikkerhed med hensyn til infektioner Respreeza er fremstillet ud fra humant blodplasma (den flydende del af blodet, efter blodlegemerne er fjernet).
English: This medicine is used in adults with known severe alpha1-proteinase inhibitor deficiency (an inherited condition also called alpha1 antitrypsin deficiency) who have developed a lung condition called emphysema.
Danish: Dette lægemiddel anvendes til voksne med kendt alvorlig alfa-1-proteinasehæmmer-mangel (en arvelig lidelse, der også kaldes alfa-1-antitrypsin-mangel), som har udviklet en lungelidelse kaldet emfysem.
English: After reconstitution, Respreeza is given by infusion into a vein.
Danish: Efter rekonstitution (opløsning) skal Respreeza gives som infusion i en vene.
English: Dizziness may occur following the administration of Respreeza (see section 4.8).
Danish: Der kan forekomme svimmelhed efter administration af Respreeza (se pkt.
English: Hypersensitivity reactions may occur, including in patients who have tolerated previous treatment with human alpha1-proteinase inhibitor.
Danish: Overfølsomhedsreaktioner kan forekomme, herunder hos patienter, der tidligere har tålt behandling med human alfa-1-proteinasehæmmer.
English: No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials.
Danish: Der er ikke blevet udført fertilitetsstudier med Respreeza, og dets virkning på human fertilitet er ikke blevet klarlagt i kontrollerede, kliniske forsøg.
English: It is strongly recommended that every time that Respreeza is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Danish: Det anbefales på det kraftigste at registrere præparatets navn og batchnummer, hver gang Respreeza administreres til en patient, for at kunne bibeholde forbindelsen mellem patienten og den anvendte batch af præparatet.
English: The mean trough serum alpha1-proteinase inhibitor levels at steady state (Weeks 7-11) were maintained above 11 M.
Danish: Den gennemsnitlige dal-koncentration af alfa-1proteinasehæmmer i serum ved steady state (uge 7-11) blev fastholdt over 11 M.
English: Use a separate, unused Mix2Vial set, and a water for injections vial for each Respreeza vial.
Danish: Brug et separat, ubrugt Mix2Vial-sæt og et hætteglas med vand til injektionsvæsker til hvert hætteglas med Respreeza.
English: Free elastase was immeasurably low in all samples.
Danish: Indholdet af fri elastase var så lavt, at det ikke kunne måles i alle prøver.
English: Gently swirl the Respreeza vial until the powder is completely dissolved (Figure 6).
Danish: Hvirvl forsigtigt hætteglasset med Respreeza, indtil pulveret er helt opløst (Figur 6).
English: Nine subjects received a single 60 mg / kg bw dose of Respreeza followed by a comparator product, and 9 subjects received comparator product followed by a single 60 mg / kg bw dose of Respreeza, with a wash-out period of 35 days between doses.
Danish: Ni forsøgspersoner fik en enkelt dosis Respreeza på 60 mg/kg kropsvægt efterfulgt af komparator, og 9 forsøgspersoner fik komparator efterfulgt af en enkelt dosis Respreeza på 60 mg/kg kropsvægt med en udvaskningsperiode på 35 dage mellem doserne.
English: The model predicted mean steady-state concentration was 21.8 µM after a 60 mg /kg bw / week dose.
Danish: Modellen forudså, at den gennemsnitlige koncentration ved steady state var 21,8 µM ved en ugentlig dosis på 60 mg/kg kropsvægt.
English: No animal reproduction studies have been conducted with Respreeza and its safety for use in human pregnancy has not been established in controlled clinical trials.
Danish: Der er ikke blevet udført dyrestudier med Respreeza, og sikker anvendelse ved graviditet er ikke blevet klarlagt i kontrollerede, kliniske forsøg.
English: Pediatric population
Danish: Pædiatrisk population
English: OUTER BOX
Danish: YDRE ÆSKE
English: One-hundred forty subjects (76 Respreeza-treated subjects and 64 subjects treated with placebo in the RAPID Study) continued into the RAPID extension study and were treated with a weekly 60 mg / kg bw intravenous dose of Respreeza for up to 24 months.
Danish: 140 forsøgsdeltagere (76 i Respreeza-armen og 64 i placebo-armen i RAPID-studiet) fortsatte i RAPID-forlængelsesstudiet og blev behandlet med en ugentlig intravenøs dosis af Respreeza på 60 mg/kg i op til 24 måneder.
English: Such side effects may occur even if you previously received human alpha1-proteinase inhibitors and had tolerated them well.
Danish: Sådanne bivirkninger kan opstå, selv om du tidligere har fået human alfa-1-proteinasehæmmer og godt kunne tåle det.
English: Asthenia, infusion-site reactions (including infusion site hematoma)
Danish: Asteni, reaktioner på infusionsstedet (herunder hæmatom på infusionsstedet)
English: This medicine contains the active substance human alpha1-proteinase inhibitor, which is a normal component of the blood and is found in the lung.
Danish: Dette lægemiddel indeholder det aktive stof human alfa-1-proteinasehæmmer, som er en normal bestanddel i blodet, og som findes i lungerne.
English: It is strongly recommended that every time you receive a dose of Respreeza the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt at registrere præparatets navn og batchnummer, hver gang du får en dosis Respreeza, for at have en fortegnelse over de anvendte batcher.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the vial labels after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Bend the entire Mix2Vial set to the side until it disconnects from the Respreeza vial (Figure 5).
Danish: • Bøj hele Mix2Vial-sættet til siden, indtil det frakobles hætteglasset med Respreeza (Figur 5).
English: Normal healthy individuals produce sufficient alpha1-proteinase inhibitor to control the NE produced by activated neutrophils and are thus able to prevent inappropriate proteolysis of lung tissue by NE.
Danish: Normale raske mennesker producerer tilstrækkeligt alfa-1proteinasehæmmer til at kontrollere NE, der produceres af aktiverede neutrofiler, og er således i stand til at forebygge utilsigtet NE-medieret proteolyse af lungevæv.
English: After it has been reconstituted with water for injections, the solution should be clear, colourless to slightly yellow and free from visible particles.
Danish: Når det er blevet opløst i vand til injektionsvæsker, skal opløsningen være klar, farveløs til let gul og uden synlige partikler.
English: Human alpha1-proteinase inhibitor is understood to be the primary anti-protease in the lower respiratory tract, where it inhibits neutrophil elastase (NE).
Danish: Human alfa-1-proteinasehæmmer menes at være den primære anti-protease i de nedre luftveje, hvor det hæmmer neutrofil elastase (NE).
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in specific clinical trials.
Danish: Respreezas sikkerhed og virkning hos ældre patienter (65 år og ældre) er ikke blevet klarlagt i specifikke kliniske forsøg.
English: Commonly (may affect up to 1 in 10 people) Dizziness, headache, shortness of breath (dyspnea), nausea.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 mennesker) Svimmelhed, hovedpine, kortåndethed (dyspnø), kvalme.
English: First infusions should be administered under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Danish: De første infusioner skal indgives under supervision af en læge, der har erfaring med behandling af alfa-1-proteinasehæmmer-mangel.
English: The studies investigated the effect of Respreeza on the progression of emphysema, assessed by the decline of lung density, measured by computer tomography (CT).
Danish: Studierne undersøgte virkningen af Respreeza på progression af emfysem, vurderet ud fra faldet i lungedensitet, målt vha. CT-tomografi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Respreeza in all subsets of the pediatric population in chronic obstructive pulmonary disease (COPD) due to alpha1-proteinase inhibitor deficiency (see section 4.2 for information on pediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Respreeza i alle undergrupper af den pædiatriske population med kronisk obstruktiv lungesygdom (KOL) pga. alfa-1-proteinasehæmmer-mangel (se pkt.
English: Emphysema develops when the lack of alpha1-proteinase inhibitor results in a condition in which neutrophil elastase is not being properly controlled, damaging the tiny air sacs in the lungs through which oxygen passes into the body.
Danish: Emfysem udvikles, når manglen på alfa-1-proteinasehæmmer resulterer i en lidelse, hvor neutrofil elastase ikke bliver korrekt kontrolleret, og som resulterer i beskadigelse af de meget små luftsække i lungerne, som ilten passerer igennem ud i kroppen.
English: The mean (Standard Deviation) of the steady state trough serum alpha1-proteinase inhibitor level for Respreeza-treated subjects was 17.7 M (2.5).
Danish: Den gennemsnitlige (standardafvigelse) dal-koncentration af alfa-1-proteinasehæmmer i serum hos Respreeza-behandlede forsøgspersoner var 17,7 (2,5) M.
English: Since human alpha1-proteinase inhibitor is a protein and a physiological constituent of human blood, it is not expected to present carcinogenic, genotoxic, or teratogenic effects.
Danish: Da human alfa1-proteinasehæmmer er et protein og en fysiologisk bestanddel i humant blod, forventes det ikke at have karcinogene, genotoksiske eller teratogene virkninger.
English: Ensure that the Respreeza vial and water for injections vial are at room temperature (up to 25°C).
Danish: Sørg for, at hætteglasset med Respreeza og hætteglasset med vand til injektionsvæsker har stuetemperatur (op til 25 °C).
English: If any reaction takes place that might be related to the administration of Respreeza, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient.
Danish: Hvis der opstår reaktioner, der kan være forbundet med indgivelsen af Respreeza, skal infusionshastigheden sættes ned eller indgivelsen stoppes, alt efter patientens kliniske tilstand.
English: Other medicines and Respreeza
Danish: Brug af anden medicin sammen med Respreeza
English: A total of 180 subjects with alpha1-proteinase inhibitor deficiency characterized by a serum alpha1-proteinase inhibitor level < 11 μM (i.e. < 50 mg/dL as determined by nephelometry) and clinical evidence of emphysema, were randomized to receive a weekly 60 mg / kg bw intravenous dose of either Respreeza (93 subjects) or placebo (87 subjects) for up to 24 months.
Danish: Der blev i alt randomiseret 180 forsøgspersoner med alfa-1proteinasehæmmer-mangel (kendetegnet ved serum-alfa-1-proteinasehæmmer < 11 μM (< 50 mg/dl) bestemt ved nefelometri) og kliniske tegn på emfysem til at få en ugentlig dosis af Respreeza på 60 mg/kg kropsvægt intravenøst (93 forsøgspersoner) eller placebo (87 forsøgspersone) i op til 24 måneder.
English: The subjects ranged in age from 31 to 67 years (median age 54 years) with average baseline alpha1-proteinase inhibitor levels of approximately 6.15 µM, and average volume-adjusted CT lung density of 47 g/L / 50 g/L for Respreeza and placebo subjects, respectively.
Danish: Forsøgspersonerne var i alderen 31 til 67 år (median alder 54 år) med gennemsnitlige alfa-1-proteinasehæmmerniveauer ved baseline på ca. 6,15 µM og en gennemsnitlig volumenjusteret CT-lungedensitet på henholdsvis 47 g/l og 50 g/l for forsøgspersoner i Respreeza-armen og placeboarmen.
English: Your doctor will inform you about signs of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) (see also section 4).
Danish: Din læge vil informere dig om tegn på allergiske reaktioner (for eksempel kulderystelser, blussen, hurtigere hjerteslag, fald i blodtrykket, svimmelhed, udslæt, allergiknopper, kløe, vejrtræknings- eller synkebesvær samt hævelse af hænder, ansigt eller mund) (se også punkt 4).
English: Solvent: Water for injections.
Danish: Solvens: Vand til injektionsvæsker.
English: This analysis revealed an inverse linear relationship between trough serum alpha1-proteinase inhibitor levels and the annual decline in lung density as measured by volume adjusted CT scans for subjects receiving 60 mg / kg bw intravenous dose of Respreeza.
Danish: Denne analyse afslørede et omvendt proportionalt forhold mellem lavt serumniveau af alfa-1-proteinasehæmmer og årligt fald i lungedensitet bestemt ved volumenjusterede CT-scanninger hos forsøgspersoner, der fik Respreeza 60 mg/kg kropsvægt intravenøst.
English: There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose.
Danish: Der er ingen data vedrørende indvirkning på frugtbarhed, men da alfa-1-proteinasehæmmer er en normal bestanddel i blodet, forventes der ingen negative virkninger på din frugtbarhed, hvis du anvender Respreeza i den anbefalede dosis.
English: • 1°transfer set 20/20 (Mix2Vial set) for reconstitution
Danish: • 1 overføringssæt 20/20 (Mix2Vial-sæt) til rekonstitution
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in clinical trials.
Danish: Sikkerheden og virkningen af Respreeza hos ældre patienter (65 år og derover) er ikke klarlagt i kliniske studier.
English: Human alpha1-proteinase inhibitor is a normal constituent of human blood.
Danish: Human alfa-1-proteinasehæmmer er en normal bestanddel i humant blod.
English: Sodium dihydrogen phosphate monohydrate Mannitol
Danish: Natriumdihydrogenphosphatmonohydrat Mannitol
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Danish: Fjern forsigtigt blisterpakningen fra Mix2Vial-sættet ved at holde på kanten og trække lodret opad.
English: Remove the plastic flip-top cap from the water for injections vial.
Danish: Fjern flip-off-hætten af plast fra hætteglasset med vand til injektionsvæsker.
English: Tell your doctor or healthcare professional if you think you have used more Respreeza as you should.
Danish: Fortæl din læge eller sundhedspersonalet, hvis du tror, du har taget for meget Respreeza.
English: Depending on the nature and severity of the reaction, your doctor or healthcare professional may decide whether to slow or stop the administration completely and give appropriate treatment for the reaction.
Danish: Afhængigt af reaktionens beskaffenhed og alvorlighedsgrad kan din læge eller sundhedspersonalet bestemme, om infusioinsvæsken skal indgives langsommere, eller infusionen helt standses samt give den relevante behandling for reaktionen.
English: Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: ELF levels of antigenic alpha1-proteinase inhibitor and alpha1-proteinase inhibitor: NE complexes increased from baseline.
Danish: ELF-niveauer af antigen alfa-1-proteinasehæmmer og af alfa-1-proteinasehæmmer: NEkomplekser steg fra baseline.
English: One vial contains approximately 1,000 mg, 4,000 mg or 5,000 mg of alpha1-proteinase inhibitor.
Danish: Et hætteglas indeholder ca. 1000 mg, 4.000 mg eller 5.000 mg alfa1-proteinasehæmmer.
English: Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia).
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 mennesker) Nedsat følesanssom svie, snurren eller følelsesløshed i hænder, arme, ben eller fødder (hypæstesi), stærkt øget svedtendens(hyperhidrose), kløe, brystsmerter, kulderystelser,feber.
English: The powder is white to off-white.
Danish: Pulveret er hvidt til cremefarvet.
English: • The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles.
Danish: • Den rekonstituerede opløsning skal være klar, farveløs til svagt gul og uden synlige partikler.
English: - If you get any side effects, talk to your doctor or healthcare professional.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Post authorisation efficacy study (PAES): A randomized, long-term PAES has been agreed to study the dose-relationship if the higher API levels achieved in the blood might influence the rate of lung density decline and whether that would support an increased dose of 120mg/kg the MAH should conduct and submit the results of a randomized, long term, efficacy study conducted according to an agreed protocol.
Danish: Virkningsstudie efter tilladelse til markedsføring (PAES): Et randomiseret, langvarigt PAES er blevet aftalt for at undersøge dosisforholdet med hensyn til, hvorvidt de højere API-niveauer, der opnås i blodet, påvirker hastigheden af faldet i lungedensitet, og om det vil understøtte en højere dosis på 120 mg/kg.
English: Presentations
Danish: Indgivelse
English: Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution.
Danish: Respreeza indeholder ca. 1,9 mg (<1 mmol) natrium pr. ml infusionsvæske.
English: The total protein content is approximately 5,500 mg per vial.
Danish: Indholdet af totalprotein er cirka 5.500 mg pr. hætteglas.
English: Table 1: Pharmacokinetic parameters for alpha1-proteinase inhibitor following a single 60 mg / kg bw dose of Respreeza Pharmacokinetic Parameter
Danish: Tabel 1: Farmakokinetiske parametre for alfa-1-proteinasehæmmer efter en enkelt dosis Respreeza på 60 mg/kg kropsvægt Farmakokinetisk parameter Gennemsnit (standardafvigelse)* Areal under kurven (AUC0-∞)
English: In a subgroup of subjects enrolled in this study (10 Respreeza-treated subjects) broncho-alveolar lavage was performed.
Danish: Der blev udført bronko-alveolær udskylning hos en undergruppe af forsøgspersoner, der var tilmeldt dette studie (10 Respreeza-behandlede forsøgspersoner).
English: A healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency will supervise the first infusions.
Danish: En læge eller sygeplejerske med erfaring i behandlingen af alfa-1-proteinasehæmmer-mangel vil overvåge dig under de første infusioner.
English: • With the other hand tightly grasp the water for injections vial and the blue part of the Mix2Vial set.
Danish: • Tag med den anden hånd godt fat om hætteglasset med vand til injektionsvæsker og den blå del af Mix2Vial-sættet.
English: 6.5 Nature and contents of container and special equipment for administration
Danish: 6.5 Emballagetype og pakningsstørrelser og specielt udstyr til anvendelse, administration eller implantation
English: Excipients : Sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol.
Danish: Hjælpestoffer: Natriumchlorid, natriumdihydrogenphosphat-monohydrat, mannitol.
English: Tell your doctor or healthcare professional immediately if you notice any sign of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands,
Danish: Fortæl straks din læge eller sundhedspersonalet, hvis du bemærker tegn på allergiske reaktioner (for eksempel kulderystelser, blussen, hurtigere hjerteslag, fald i blodtryk, svimmelhed, udslæt, nældefeber, kløe, vejrtræknings- eller synkebesvær samt hævelse af hænder, i ansigt eller mund) under indgivelse af Respreeza.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren af det biologisk aktive stof
English: Follow steps below to remove entire Mix2Vial set from Respreeza vial:
Danish: Følg nedenstående trin for at fjerne hele Mix2Vial-sættet fra hætteglasset med Respreeza:
English: Using this medicine regularly increases the blood and lung levels of alpha1-proteinase inhibitor, thus slowing the progression of emphysema.
Danish: Regelmæssig anvendelse af dette lægemiddel øger lungernes og blodets indhold af alfa-1proteinasehæmmer og forsinker således udviklingen af emfysem.
English: The administration of Respreeza increases and maintains serum levels and lung epithelial lining fluid (ELF) levels of alpha1-proteinase inhibitor leading to a slowdown of the progression of emphysema.
Danish: Administration af Respreeza øger og bibeholder niveauet af alfa-1-proteinasehæmmer i serum og bronkievæske (lung epithelial lining fluid - ELF), hvilket medfører forsinket progression af emfysem.
English: Posology The recommended dose of Respreeza is 60 mg / kg body weight (bw) administered once weekly.
Danish: Dosering Den anbefalede dosis Respreeza er 60 mg/kg kropsvægt en gang ugentligt.
English: The active substance is alpha1-proteinase inhibitor.
Danish: - Aktivt stof: alfa1-proteinasehæmmer.
English: Place the water for injections vial on an even, clean surface and hold the vial tight.
Danish: Anbring hætteglasset med vand til injektionsvæsker på en plan, ren flade, og hold fast på hætteglasset.
English: Since alpha1-proteinase inhibitor is an endogenous human protein, it is considered unlikely that Respreeza will cause harm to the foetus when given at recommended doses.
Danish: Da alfa-1-proteinasehæmmer er et endogent humant protein, anses det for usandsynligt, at Respreeza vil skade fosteret, når det gives i de anbefalede doser.
English: The total protein content is approximately 4,400 mg per vial.
Danish: Indholdet af totalprotein er cirka 4.400 mg pr. hætteglas.
English: Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg powder and solvent for solution for infusion
Danish: Respreeza 1.000 mg pulver og solvens til infusionsvæske, opløsning Respreeza 4.000 mg pulver og solvens til infusionsvæske, opløsning Respreeza 5.000 mg pulver og solvens til infusionsvæske, opløsning
English: The total protein content is approximately 1,100 mg per vial.
Danish: Indholdet af totalprotein er cirka 1.100 mg pr. hætteglas.