FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.
Danish: Din læge eller sundhedspersonalet vil have dette under overvejelse, hvis du er på en kontrolleret saltfattig diæt.
English: In the event of overdose, the patient should be observed closely for the occurrence of adverse reactions and supportive measures should be available as necessary.
Danish: Ved overdosering skal patienten overvåges nøje for forekomst af bivirkninger, og der skal være støttende foranstaltninger til rådighed efter behov.
English: A total of 13 post-infusion serum samples were taken at various time points up to Day 21.
Danish: Efter infusionen blev der taget i alt 13 serumprøver på forskellige tidspunkter op til dag 21.
English: They may progress in some very rare cases (may affect up to 1 in 10,000 people) to severe allergic reactions even when you have shown no signs of allergy on previous infusions.
Danish: De kan i meget sjældne tilfælde (hos op til 1 ud af 10.000 mennesker) udvikle sig til alvorlige allergiske reaktioner, selvom du ikke har udvist tegn på allergi ved tidligere infusioner.
English: Attach the administration set to the administration container.
Danish: Fastgør administrationssættet til administrationsbeholderen.
English: The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0.
Danish: Den rekonstituerede opløsning har en osmolalitet på ca. 279 mOsmol/kg og en pH på 7,0.
English: Do no stop using this medicine without consulting your doctor or healthcare professional.
Danish: Hold ikke op med at tage dette lægemiddel uden at rådføre dig med lægen eller sundhedspersonalet.
English: Do not use solutions that are discoloured, cloudy or have particles.
Danish: Brug ikke opløsninger, der er misfarvede, uklare eller har partikler.
English: If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.
Danish: Hvis symptomerne fortager sig straks efter, infusionen er stoppet, kan infusionen genoptages ved en lavere hastighed, der er behagelig for patienten.
English: Potential risks associated with home-treatment / self-administration are related to the handling and administration of the medicinal product as well as to the handling of adverse reactions, particularly hypersensitivity.
Danish: Potentielle risici forbundet med hjemmebehandling/selvadministration er relateret til håndteringen og indgivelsen af lægemidlet samt håndteringen af bivirkninger, særligt overfølsomhed.
English: Paediatric Population Safety and effectiveness in the paediatric population have not been established.
Danish: Pædiatrisk population Sikkerheden og virkningen i den pædiatriske population er ikke klarlagt.
English: Respreeza may contain trace amounts of IgA.
Danish: Respreeza kan indeholde spor af IgA.
English: Single doses of 120 mg / kg bw have been administered to 137 subjects treated with Respreeza.
Danish: Der er blevet administreret enkeltdoser på 120 mg/kg kropsvægt til 137 forsøgspersoner, der blev behandlet med Respreeza.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.
Danish: Din læge kan anbefale, at du overvejer vaccination mod hepatitis A og B, hvis du regelmæssigt/gentagne gange får proteinasehæmmerfremstillet ud fra plasmafra mennesker.
English: Neutrophil elastase can cause damage if its action is not controlled (for example, in case you have an alpha1-proteinase inhibitor deficiency).
Danish: Neutrofil elastase kan forårsage beskadigelse, hvis virkningen ikke kontrolleres (for eksempel i tilfælde af, at du har alfa-1proteinasehæmmer-mangel).
English: Information on allergic reactions: when slowing or stopping the infusion may be required?
Danish: Information om allergiske reaktioner: Hvornår kan det være nødvendigt at nedsætte hastigheden af infusionen eller standse den?
English: The adverse reactions (ARs) collected from six clinical studies in 221 patients and post-marketing experience are presented in the table below according to the MedDRA System organ classification (SOC and Preferred Term (PT) Level).
Danish: Bivirkninger indsamlet fra seks kliniske studier med 221 patienter og ved erfaring efter markedsføring vises i nedenstående tabel i henhold til MedDRA-systemorganklasse (SOC og Preferred Term (PT) Level).
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation / removal of viruses.
Danish: Standardforholdsregler til forebyggelse af infektioner forårsaget af lægemidler fremstillet af humant blod eller plasma omfatter: udvælgelse af donorer, screening af de enkelte donationer og plasmapuljer for infektionsmarkører samt inklusion af effektive trin under fremstillingen til inaktivering/fjernelse af vira.
English: • the testing of samples of donated blood and plasma to try to avoid use of material with signs of virus/infections,
Danish: • testning af prøver fra det donerede blod og plasma for at forsøge at undgå at anvende materiale med tegn på virus/infektioner,
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Danish: • nøje udvælgelse af donorer af blod og plasma for at sikre, at de, der har risiko for at overføre infektioner, ekskluderes,
English: What you need to know before you use Respreeza 3.
Danish: Det skal du vide, før du begynder at tage Respreeza 3.
English: Prime the chamber by squeezing the drip chamber until Respreeza has filled the chamber half-way.
Danish: Klargør kammeret ved at klemme på drypkammeret, indtil Respreeza har fyldt kammeret halvvejs.
English: 5.1 (±2.4) days
Danish: 5,1 (±2,4) dage
English: However chemical and physical in-use stability has been demonstrated for 3 h at room temperature (up to 25 °C).
Danish: Der er imidlertid påvist kemisk og fysisk brugsstabilitet i 3 timer ved stuetemperatur (op til 25 °C).
English: Subsequent infusions can be administered by a caregiver or by the patient (see section 4.4).
Danish: Efterfølgende infusioner kan indgives af en omsorgsperson eller af patienten selv (se pkt.
English: Frequency of Adverse Reactions (ARs) in clinical studies and post-marketing experience with Respreeza
Danish: Hyppigheden af bivirkninger for Respreeza i kliniske studier og ved erfaring efter markedsføring
English: The following information is intended for health-care professionals and for patients suitable for home-treatment / self-administration
Danish: Nedenstående oplysninger er til sundhedspersonale og til patienter, der er egnede til hjemmebehandling/selvindgivelse
English: Repeat dose toxicity studies longer than 5 days, reproductive toxicity studies and carcinogenicity studies, have not been performed.
Danish: Der er ikke blevet udført toksicitetsstudier efter gentagne doser af længere varighed end 5 dage eller studier af reproduktionstoksicitet og karcinogenicitet.
English: Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Danish: Patienter med selektiv eller svær IgA-mangel kan udvikle antistoffer mod IgA og har derfor en større risiko for at udvikle potentielt alvorlige overfølsomhedsreaktioner og anafylaktiske reaktioner.
English: Inspect visually the reconstituted solution.
Danish: Kontroller den rekonstituerede opløsning visuelt.
English: The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals.
Danish: Udskillelse af human alfa-1proteinasehæmmer i mælk er ikke blevet undersøgt hos dyr.
English: Home-treatment / self-administration
Danish: Hjemmebehandling/selvadministration
English: Inject/infuse the reconstituted solution into the vein following the instructions given to you by your doctor.
Danish: Injicér/infundér infusionsvæsken i venen efter anvisningerne, du har fået af din læge.
English: This medicine is a white to off-white powder.
Danish: Dette lægemiddel er et hvidt til cremefarvet pulver.
English: Elevate the administration container (if intravenous bag, hang on an intravenous pole).
Danish: Hæv administrationsbeholderen op (hvis den intravenøs pose, skal den hænges på et intravenøst stativ).
English: • if you are allergic to human alpha1-proteinase inhibitor or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for human alfa-1-proteinasehæmmer eller et af de øvrige indholdsstoffer i Respreeza (angivet i punkt 6).
English: Make sure that you only pull away the blister package and not the Mix2Vial set (Figure 3).
Danish: Pas på, at du kun trækker blisterpakningen af og ikke Mix2Vial-sættet (Figur 3).
English: If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Danish: Hvis dette ikke er muligt, kan infusionsvæsken opbevares i op til 3 timer ved stuetemperatur (op til 25 °C).
English: Since tobacco smoke is an important risk factor for the development and progression of emphysema, you are strongly advised to stop smoking and avoid passive smoking.
Danish: Da tobaksrygning er en vigtig risikofaktor for udvikling af og sygdomsforløb vedemfysem, rådes du på det kraftigste til at ophøre med at ryge og at undgå passiv rygning.
English: If you forget to use Respreeza
Danish: Hvis du har glemt at tage Respreeza
English: Suspected allergic or anaphylactic type reactions may require immediate discontinuation of the infusion, depending on the nature and severity of the reaction.
Danish: Mistanke om allergiske eller anafylaktiske reaktioner kan kræve øjeblikkelig afbrydelse af infusionen, afhængigt af reaktionens beskaffenhed og alvorlighedsgrad.
English: Four clinical studies were conducted with Respreeza in 89 subjects (59 males and 30 females) to evaluate the effect of Respreeza on serum levels of alpha1-proteinase inhibitor.
Danish: Fire kliniske studier blev udført med Respreeza med 89 forsøgspersoner (59 mænd og 30 kvinder) for at evaluere virkningen af Respreeza på serumniveauet af alfa-1-proteinasehæmmer.
English: Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor, ATC code: B02AB02
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, proteinasehæmmer, ATC-kode: B02AB02
English: If you stop using Respreeza
Danish: Hvis du holder op med at tage Respreeza
English: • the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: • brug af trin under forarbejdningen af blod og plasma, der kan inaktivere eller fjerne vira.
English: The water for injections will automatically flow into the Respreeza vial.
Danish: Vandet til injektionsvæsker vil automatisk løbe ned i hætteglasset med Respreeza.
English: In case of self-administration / home-treatment, stop the infusion immediately and contact your doctor or healthcare professional.
Danish: Ved selvadministration/hjemmebehandling skal du straks stoppe infusionen og kontakte lægen eller sundhedspersonalet.
English: The decision of whether a patient is suitable for home-treatment / self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of Mix2Vial set, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals.
Danish: Beslutningen om, hvorvidt en patient er egnet til hjemmebehandling/selvadministration træffes af den behandlende læge, der skal sikre relevant oplæring (f.eks. vedrørende rekonstitution, anvendelse af Mix2Vial-sættet, samling af den intravenøse slange, infusionsteknikker, registrering i en behandlingsdagbog, identifikation af bivirkninger og foranstaltninger, der skal træffes, hvis sådanne reaktioner opstår), samt at anvendelsen gennemgås med regelmæssige mellemrum.
English: For detailed information regarding the administration of the reconstituted solution, see the instructions at the end of section 6.6.
Danish: For instruktioner om administration af den rekonstituerede infusionsvæske, se anvisningerne sidst i pkt.
English: minutes (4 g and 5 g presentation).
Danish: g og 5 g pakning).
English: Connect the other end to the injection set (e.g. butterfly / winged infusion needle or infusion catheter).
Danish: Tilslut den anden ende til injektionssættet (f.eks. sommerfugl/infusionsnål m. vinger eller infusionskateter).
English: A double-blind, randomized, active-controlled, crossover pharmacokinetic study was conducted in 13 males and 5 females with alpha1-proteinase inhibitor deficiency, ranging in age from 36 to 66 years.
Danish: Et dobbeltblindet, randomiseret, farmakokinetisk overkrydsningsstudie med aktiv kontrol blev udført med 13 mænd og 5 kvinder med alfa-1-proteinasehæmmer-mangel i alderen 36 til 66 år.
English: Use aseptic technique to transfer the reconstituted solutions into the administration container (e.g., empty intravenous bag or glass bottle; (not supplied) via a commercially available intravenous fluid tubing transfer set (not supplied)).
Danish: Anvend aseptisk teknik til at overføre de rekonstituerede opløsninger til administrationsbeholderen (f.eks. en tom intravenøs pose eller glasflaske [ikke vedlagt]) via et kommercielt tilgængeligt slangesæt til overføring af intravenøse væsker [ikke vedlagt]).
English: • IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.
Danish: • Patienter med IgA-mangel med kendt antistofdannelse mod IgA på grund af risiko for alvorlige overfølsomhedsreaktioner og anafylaktiske reaktioner.
English: The annual rate of lung density decline, as measured by CT scan at total lung capacity (TLC) over 2 years was lower with Respreeza (-1.45 g/L) as compared with placebo (-2.19 g/L), reflecting a 34% reduction (p = 0.017, 1-sided).
Danish: Det årlige fald i lungedensitet målt ved CT-scanning ved total lungekapacitet (TLC) over 2 år var lavere med Respreeza (-1,45 g/l) sammenlignet med placebo (-2,19 g/l), hvilket afspejler et fald på 34 % (p = 0,017, 1-sidet).
English: Respreeza-treated subjects demonstrated a consistent pattern of slower lung density decline than those receiving placebo (see Figure 1).
Danish: Respreeza-behandlede forsøgspersoner udviste et konsistent mønster med et langsommere fald i lungedensitet end de forsøgspersoner, der fik placebo (se Figur 1).
English: There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase.
Danish: Der er dets hovedfunktion at beskytte lungevævet ved at begrænse virkningen af et bestemt protein kaldet neutrofil elastase.
English: Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ).
Danish: Respreeza er indiceret til vedligeholdelsesbehandling med henblik på at forhale progression af emfysem hos voksne med dokumenteret alvorlig alfa-1-proteinasehæmmer-mangel (f.eks. genotyperne PiZZ, PiZ(null), Pi(null,null), PiSZ).
English: Dizziness may occur after the administration of this medicine.
Danish: Der kan opstå svimmelhed efter indgivelse af dette lægemiddel.
English: Hypersensitivity reactions (including tachycardia, hypotension, confusion, syncope, oxygen consumption decreased and pharyngeal oedema)
Danish: Overfølsomhedsreaktioner (herunder takykardi, hypotension, konfusion, synkope, nedsat iltoptagelse og faryngealt ødem)
English: In the most serious cases, allergic reactions may progress to severe anaphylactic reactions even when the patient has shown no hypersensitivity to previous administrations (see section 4.4).
Danish: I de alvorligste tilfælde kan allergiske reaktioner progrediere til alvorlige anafylaktiske reaktioner, selv når patienten ikke har udvist overfølsomhed ved tidligere indgivelser (se pkt.
English: The safety and efficacy of Respreeza in the paediatric population (below 18 years) have not been established.
Danish: Respreezas sikkerhed og virkning hos den pædiatriske population (under 18 år) er ikke klarlagt.
English: Follow the steps provided below for the preparation and reconstitution of Respreeza:
Danish: Følg nedenstående trin ved klargøring og rekonstitution af Respreeza:
English: • Do not use provided sterile ancillaries for reconstitution if their package is opened or if they are damaged.
Danish: • Brug ikke de medfølgende sterile hjælpematerialer til rekonstitution, hvis emballagen er åbnet,
English: Human alpha1-proteinase inhibitor has a molecular weight of 51 kDa and belongs to the family of serine protease inhibitors.
Danish: Human alfa-1proteinasehæmmer har en molekylvægt på 51 kDa og tilhører familien serinproteasehæmmere.
English: Talk to your doctor or healthcare professional before using Respreeza.
Danish: Kontakt lægen eller sundhedspersonalet, før du tager Respreeza.
English: Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Danish: Patienten skal være i optimal farmakologisk og ikkefarmakologisk behandling og udvise tegn på progredierende lungesygdom (f.eks. lavere forceret eksspirationsvolumen pr. sekund (FEV1) end forventet, forringet gangkapacitet eller et øget antal eksacerbationer) ifølge evaluering af en læge, der har erfaring i behandling af alfa-1proteinasehæmmer-mangel.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived proteinase inhibitors.
Danish: Hensigtsmæssig vaccination (hepatitis A og B) skal overvejes for patienter, som regelmæssigt eller gentagne gange får proteinase-hæmmer, fremstillet ud fra humant plasma.
English: • With one hand tightly grasp the Respreeza vial as shown in Figure 5.
Danish: • Tag godt fat om hætteglasset med Respreeza med den ene hånd, som vist i Figur 5.
English: Following the completion of the RAPID study, an analysis of achieved median alpha1-proteinase inhibitor levels and lung density decline was conducted.
Danish: Efter afslutning af RAPID-studiet blev der udført en analyse af de opnåede median-niveauer af alfa-1proteinasehæmmer og af faldet i lungedensitet.
English: Because blood can carry infections, when medicines are made from human blood or plasma certain measures are put in place to prevent these from being present in the medicine and passed on to patients.
Danish: Da blod kan være bærer for infektioner, skal der tages visse forholdsregler, når medicin bliver fremstillet af blod eller plasma fra mennesker, for at hindre, at der er smitsomme stoffer til stede i lægemidlet, der kan blive overført til patienter.
English: Any unused medicinal product or waste material should be disposed as instructed by your doctor or healthcare professional.
Danish: Eventuelt ubrugt medicin eller medicinrester skal bortskaffes som anvist af din læge eller sundhedspersonalet.
English: The solution should be infused at an infusion rate of about 0.08 ml per kg body weight each min, as determined by your response and your comfort.
Danish: Infusionsvæsken skal infunderes ved en infusionshastighed på omkring 0,08 ml pr. kg kropsvægt i minuttet, som bestemt fra dit respons og din komfort.
English: Presentations Each pack contains:
Danish: Hver pakke indeholder:
English: The RAPID extension study demonstrated that the reduced rate in lung density decline was maintained for subjects continuously treated with Respreeza for 4 years (see Figure 1).
Danish: RAPID-forlængelsesstudiet viste, at det langsommere fald i lungedensitet blev fastholdt hos forsøgspersoner i kontinuerlig behandling med Respreeza i 4 år (se figur 1).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Respreeza should be made, taking into account the benefit of breast-feeding to the child and the benefit of human alpha1proteinase inhibitor therapy to the woman.
Danish: Det skal besluttes, om amning skal fortsætte/ophøre, eller behandling med Respreeza skal fortsætte/ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele ved behandling med human alfa1-proteinasehæmmer for moderen.
English: Respreeza should only be administered intravenously by infusion after reconstitution.
Danish: Respreeza må kun indgives intravenøst som infusion efter rekonstitution.
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate and mannitol (see last paragraph of section 2).
Danish: - Øvrige indholdsstoffer: natriumchlorid, natriumdihydrogenphosphatmonohydrat og mannitol (se sidste sætning i punkt 2).
English: Frequency not known (frequency cannot be estimated from the available data) Pain to the lymph glands (oval-shaped masses of tissue that are distributed throughout the body and which may be palpable for example in the armpit, groinor neck), swollen face, swollen eyes and lips.
Danish: Hyppighed ikke kendt (hyppigheden kan ikke vurderesud fra tilgængelige data) Smerter i lymfeknuder (ovale vævsmasser, der er fordelt i hele kroppen,og som man måske kan mærke i armhulen, lysken eller på halsen), hævet ansigt, hævede øjne og læber.
English: The measures taken are considered effective for viruses such as human immunodeficiency virus (HIV), hepatitis A virus, hepatitis B virus, hepatitis C virus, and parvovirus B19 virus.
Danish: De forholdsregler, der tages, anses for effektive over for vira som humant immundefektvirus (HIV), hepatitis A-virus, hepatitis B-virus, hepatitis C-virus og parvovirus B19.
English: Take care not to touch the rubber vial stopper.
Danish: Pas på ikke at berøre gummiproppen på hætteglasset.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A (HAV) and parvovirus B19 virus.
Danish: De forholdsregler, der tages, anses for effektive til indkapslede vira, såsom humant immundefektvirus (HIV), hepatitis B-virus (HBV) og hepatitis C-virus (HCV) og for de ikke-indkapslede vira hepatitis A (HAV) og parvovirus B19.
English: How to store Respreeza 6.
Danish: Sådan skal du tage Respreeza 4.
English: At screening, serum alpha1-proteinase inhibitor levels were between 3.2 and 10.1 M (mean of 5.6 M).
Danish: Ved screeningen var serumniveauerne for alfa-1proteinasehæmmer mellem 3,2 og 10,1 M (gennemsnitligt 5,6 M).
English: One vial of Respreeza is for single use only.
Danish: Et hætteglas Respreeza er kun til engangsbrug.
English: Do not remove the Mix2Vial set from the blister package.
Danish: Tag ikke Mix2Vial-sættet ud af blisterpakningen.
English: However, individuals deficient in endogenous alpha1-proteinase inhibitor are unable to maintain appropriate antiprotease defence and experience more rapid proteolysis of the alveolar walls starting prior to the development of clinically evident chronic obstructive lung disease in the third or fourth decade.
Danish: Mennesker, der mangler endogen alfa-1-proteinasehæmmer, er imidlertid ude af stand til at opretholde et passende forsvar mod antiprotease og oplever hurtigere proteolyse af de alveolære vægge, der starter før udvikling af klinisk signifikant kronisk obstruktiv lungesygdom i tredive- eller fyrre-årsalderen.