FrancophonIA/ELRC3.0 huggingface dataset:
English: You will hear and feel a click at the end.
Danish: Du vil høre og mærke et klik til sidst.
English: The average half-life is of about 1.5 hours.
Danish: Den gennemsnitlige halveringstid er omkring 1,5 time.
English: The results for these subjects were not different from the results in the study as a whole.
Danish: Resultaterne for denne gruppe var ikke forskellige fra resultaterne for hele studiet.
English: You will hear a “click” (see picture).
Danish: Du vil høre et ”klik” (se billede).
English: Never inject more than one dose in the same day.
Danish: Tag aldrig mere end én indsprøjtning på samme dag.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/339/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/339/003
English: “click”
Danish: “klik”
English: Each pen should be used by only one patient.
Danish: Hver pen må kun bruges af samme patient.
English: DK-4000 Roskilde Denmark
Danish: DK-4000 Roskilde Danmark
English: The disease progresses gradually so you may not feel any symptoms at first.
Danish: Sygdommen udvikler sig gradvist og kan derfor være uden symptomer i begyndelsen.
English: Wash your hands with soap and water before you handle the pre-filled pen.
Danish: Vask dine hænder med vand og sæbe, før du håndterer pennen
English: Until further clinical data becomes available the recommended treatment time of 24 months should not be exceeded.
Danish: Indtil yderligere kliniske data bliver tilgængelige, bør den anbefalede behandlingsvarighed på 24 måneder ikke overskrides.
English: The steps you have to go through for each of the 14 injections:
Danish: Dette skal du gøre ved hver af de 14 injektioner:
English: • Do not share your medication with others.
Danish: • Del ikke din medicin med andre.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24.04.2006
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 24.04.2006
English: Gender The medicinal product has only been studied in postmenopausal women.
Danish: Køn Lægemidlet er kun undersøgt hos postmenopausale kvinder.
English: There is no specific antidote for Preotact.
Danish: Der findes ingen specifik antidot mod Preotact.
English: To prevent one or more new vertebral fractures, 48 women had to be treated for a median of 18 months for the total population.
Danish: For at forebygge en eller flere nye vertebralfrakturer skal 48 kvinder fra den totale population, gennemsnitligt behandles i 18 måneder.
English: If no underlying condition is found, the following management procedures should be followed:
Danish: Hvis der ikke konstateres anden tilgrundlæggende lidelse skal følgende procedurer følges:
English: Continued treatment for up to 24 months in an open-label extension of this study resulted in a continued increase in BMD.
Danish: Fortsat behandling i op til 24 måneder i en åben-label forlængelse af studiet resulterede i en fortsat stigning i BMD.
English: Interindividual variability in systemic clearance is about 15%.
Danish: Den interindividuelle variation i den systemiske clearance ligger omkring 15 %.
English: No potential for drug interactions was identified in the clinical program.
Danish: Der er ikke identificeret potentiale for lægemiddelinteraktioner i det kliniske program.
English: Date of latest renewal: 24.04.2011
Danish: Dato for seneste fornyelse af markedsføringstilladelsen: 24.04.2011
English: Monitoring of patients during treatment
Danish: Monitorering af patienter under behandling
English: You can choose to continue and take your daily injection now or store the pre-filled pen in the refrigerator, as described under ‘Practical information', at the end of the Instructions for use.
Danish: Du kan vælge at fortsætte og tage din daglige injektion nu, eller du kan opbevare pennen i køleskabet som beskrevet under ”Praktisk information” til sidst i brugervejledningen.
English: • Some medic may come out - this is normal.
Danish: • Der kan sive lidt medicin ud - det er normalt
English: Consequently, no interaction with other medicinal products would be anticipated and no specific drug-drug interactions studies were performed.
Danish: Derfor forventes der ikke interaktion med andre lægemidler og der er ikke udført specifikke studier med henblik på at undersøge interaktioner med andre lægemidler.
English: No differences in Preotact pharmacokinetics were detected with regard to age (range 47-88 years).
Danish: Der er ikke registreret forskelle i farmakokinetikken i forhold til alder (47 - 88 år).
English: Parathyroid hormone N=1341
Danish: Parathyreoideahormon N=1341
English: • Check that the medicine is clear.
Danish: • Tjek, at medicinen er klar (gennemsigtig)
English: Dosage adjustment based on age is not required.
Danish: Dosisjustering baseret på alder er ikke nødvendig.
English: • Do not shake the pre-filled pen (neither before nor after injection) as it may destroy the effect of the medicine.
Danish: • Ryst ikke den fyldte pen (hverken før eller efter indsprøjtning), da det kan ødelægge medicinen.
English: Cartridge: Glass Type I.
Danish: Cylinderampul: Glas Type I.
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Danish: På grund af de knoglefysiologiske forskelle mellem mennesker og rotter er den kliniske relevans af disse fund sandsynligvis underordnet.
English: Package leaflet: Information for the user
Danish: Indlægsseddel: Information til forbrugeren
English: Manufacturer Nycomed Danmark ApS Langebjerg 1
Danish: Nycomed Danmark ApS Langebjerg 1
English: • Always attach a new needle before use
Danish: • Sæt altid en ny nål på før brug
English: • A small air bubble may remain in the pre-filled pen - this is normal.
Danish: • Der kan måske være en lille luftboble tilbage i pennen - det er normalt
English: Preotact has been administered in single doses up to 5 micrograms/kg and in repeated doses of up to 3 micrograms/kg/day for 3 days and up to 2.5 micrograms/kg/day for 7 days.
Danish: Preotact er blevet administreret som enkeltdosis op til 5 mikrogram/kg og som gentagne doser op til 3 mikrogram/kg/dag i 3 dage og op til 2,5 mikrogram/kg/dag i 7 dage.
English: There are no studies of foetal, developmental, perinatal or postnatal toxicity.
Danish: Der er ikke gennemført studier på føtal, udviklingsmæssig, perinatal eller postnatal toksicitet.
English: Preotact should not be used in children or adolescents under 18 years old.
Danish: Preotact må ikke anvendes til børn eller unge under 18 år.
English: The only other very commonly reported ADR was nausea.
Danish: Den eneste anden meget almindelige rapporterede bivirkning var kvalme.
English: Name and address of the manufacturer responsible for batch release Nycomed Danmark ApS
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Nycomed Danmark ApS
English: Like all medicines, Preotact can cause side effects, although not everybody gets them.
Danish: Preotact kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Patients with urolithiasis
Danish: Patienter med urolithiasis
English: • The pre-filled pen has an expiration date printed on it; do not use the medicine after this date.
Danish: • Udløbsdatoen er printet på den fyldte pen; brug ikke medicinen efter denne dato.
English: If you forget to take Preotact (or cannot take Preotact at your usual time), take it as soon as possible on that day.
Danish: Hvis du glemmer at sprøjte dig med Preotact (eller hvis du ikke kan sprøjte dig på det tidspunkt, du plejer), så gør det, så snart det er muligt.
English: These carboxy-terminal fragments are thought to play a role in the regulation of parathyroid hormone activity.
Danish: Disse carboxyterminale fragmenter menes at spille en rolle i regulering af parathyreoideahormonaktiviteten.
English: Similar increases occurred at the femoral neck, trochanter, and intertrochanter.
Danish: Lignende stigninger sås ved lårbenshals, trochanter, og intertrochanter.
English: Preotact should not be used if the reconstituted solution is cloudy, coloured or contains particles.
Danish: Preotact må ikke anvendes, hvis den rekonstituerede opløsning er uklar, farvet eller indeholder partikler.
English: No osteosarcomas have been observed in clinical trials.
Danish: Der er ikke observeret osteosarkomer i de kliniske afprøvninger.
English: • loss of appetite,
Danish: • manglende appetit,
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Press the blue injection button until it is fully depressed -then count slowly to 10 and remove the needle from your skin.
Danish: Tryk den blå injektionsknap helt i bund - tæl derefter langsomt til 10 og træk nålen ud af huden.
English: • Protect the medicine and pre-filled pen against direct sunlight.
Danish: • Beskyt medicinen og den fyldte pen mod direkte sollys.
English: • fast or irregular heart beats,
Danish: • hurtig eller uregelmæssig hjerterytme (puls),
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen modul 1.8.1, er på plads og fungerer, før og mens produktet markedsføres.
English: The Preotact pre-filled pen has been designed especially to make it easy for you to take your osteoporosis treatment.
Danish: Den fyldte Preotact-pen er designet specielt for at gøre det nemt for dig at behandle din knogleskørhed.
English: Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
Danish: Data støtter kontinuerlig behandling med Preotact i op til 24 måneder (se pkt.
English: Inclusion criteria were; women between 55 and 85 years of age with BMD T-scores below -2.5 or below -2 and at least one additional risk factor for fracture.
Danish: Inklusionkriterierne var kvinder mellem 55 og 85 år med BMD T-score under ÷2,5 eller under ÷2 og mindst en yderligere risikofaktor for fraktur.
English: A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Danish: Der er påvist en signifikant reduktion i forekomsten af vertebrale frakturer, men ikke i hoftefrakturer.
English: Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse.
Danish: Lav en hudfold på maveskindet og tag injektionen i en 90° vinkel, som din læge eller sygeplejerske har vist dig.
English: INFORMATION ON BRAILLE Preotact
Danish: INFORMATION I BRAILLE-SKRIFT Preotact
English: Furthermore, parathyroid hormone is not protein bound and has a low volume of distribution.
Danish: Parathyreoideahormonet er ikke proteinbundet og har et lille distributionsvolumen.
English: Keep the product protected from light.
Danish: Opbevar produktet beskyttet mod lys.
English: The dose counter now shows 14 and the pre-filled pen is ready to use.
Danish: Dosistælleren viser nu 14, og pennen er klar til brug.
English: It is unknown whether recombinant human parathyroid hormone is excreted in the milk of lactating animals.
Danish: Det er uvist om rekombinant human parathyreoideahormon udskilles i mælken hos diegivende dyr.
English: • receive heart medicine (e.g. digoxin also known as digitalis).
Danish: • får hjertemedicin (f.eks. digoxin også kendt som digitalis)
English: Parathyroid hormone is a natural peptide that is not metabolised by, and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g. cytochrome P450 isoenzymes).
Danish: Parathyreoideahormon er et naturligt forekommende peptid, som ikke metaboliseres af og ikke hæmmer mikrosomale lægemiddelmetaboliserende leverenzymer (f.eks. cytochrom P450 isoenzymer).
English: A new sterile needle must be used for every injection.
Danish: Der skal bruges en ny steril kanyle ved hver injektion.
English: Preotact is contraindicated in patients
Danish: Preotact er kontraindiceret til patienter:
English: The combination was effective regardless of age, baseline rate of bone turnover, or baseline BMD.
Danish: Kombinationen viste sig effektiv uafhængig af alder, knogle-turnover og baseline-BMD.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: • If elevated levels continue, Preotact therapy should be stopped and the patient monitored until the abnormal values have reverted to normal
Danish: • hvis de forhøjede værdier vedbliver, afbrydes behandlingen og patienten monitoreres indtil normalisering af værdierne
English: • if you have high levels of alkaline phosphatase (an enzyme produced by the organism; may signal certain medical conditions, related to bones and liver);
Danish: • har et højt indhold af alkalisk fosfatase i blodet (et enzym, der produceres i organismen; forhøjet indhold kan være tegn på visse medicinske tilstande relateret til knogler og lever).
English: • The medicine should not be used for more than 28 days after it has been mixed.
Danish: • Medicinen må ikke anvendes længere end 28 dage efter, at den er blandet.
English: • If you have just mixed a new pre-filled pen you can use the needle already on.
Danish: • Hvis du lige har blandet medicin i en ny fyldt pen, kan du bruge den allerede påsatte nål.
English: Precautions to be taken before handling or administering the medicinal product For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: Sikkerhedsforanstaltninger før håndtering og administation af lægemidlet For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Parathyroid hormone is the principal regulator of serum calcium homeostasis.
Danish: Parathyreoideahormonet er den vigtigste regulator af serumcalciumhomeostasen.
English: Be careful not to push the yellow release button while you handle the pre-filled pen - if you accidentally do so, the blue injection button will pop out.
Danish: Pas på ikke at trykke på den gule udløserknap, mens du klargør pennen - hvis du ved et uheld kommer til det, vil den blå injektionsknap poppe ud.
English: The pen can be used with standard injection pen needles.
Danish: Pennen kan anvendes sammen med standardkanyler.
English: • Gently rotate the pre-filled pen back and forth a few times to mix the medicine.
Danish: • Vip pennen forsigtigt frem og tilbage nogle få gange for at blande medicinen
English: Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Danish: Preotact indeholder rekombinant humant parathyreoideahormon, som er identisk med det intakte humane 84-aminosyrepolypeptid.
English: Due to the relatively short duration of the pharmacological activity of Preotact further measures should not be necessary.
Danish: På grund af den relativt korte farmakologiske virkning af Preotact er yderligere støttebehandling ikke nødvendig.
English: The dose is administered as a subcutaneous injection into the abdomen.
Danish: Indgivelsesmåde Dosis indgives som subkutan injektion i abdomen.
English: All women were given calcium (400-500 mg) and vitamin D (400 IU) supplements.
Danish: Alle kvinder fik calcium- (400 - 500 mg) og D-vitamintilskud (400 IE).
English: • Calcium and vitamin D supplementation should be withdrawn
Danish: • tilskud af calcium og D-vitamin afbrydes
English: Before taking your first injection with a new pre-filled pen you have to add a needle and mix the medicine by following the instructions in this leaflet.
Danish: Før du tager den første injektion med en ny pen, skal du påsætte en nål og blande medicinen ved at følge denne brugervejledning.
English: The pre-filled pen contains medicine for 14 days.
Danish: Pennen indeholder medicin til 14 dages behandling.
English: Stopper (center and end): Bromobutyl rubber, grey.
Danish: Prop (midter og bund): Brombutylgummi, grå.
English: It has not been shown that Preotact reduces the risk of breaking your hip.
Danish: Det er ikke påvist, at Preotact mindsker risikoen for hoftebrud.
English: Sodium chloride, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Danish: Natriumchlorid, mannitol, citronsyremonohydrat, saltsyre, metacresol, natriumhydroxid, vand til injektionsvæsker.
English: If, by accident, you inject more than one dose of Preotact in a day, contact immediately your doctor or pharmacist.
Danish: Hvis du kommer til at sprøjte dig med Preotact mere end én gang på samme dag, skal du kontakte din læge eller apoteket med det samme.
English: Caution should be exercised in
Danish: Der bør udvises forsigtighed ved behandling af
English: If you feel dizzy, do not drive or operate any machines until you feel better.
Danish: Hvis du føler dig svimmel, skal du vente med at køre bil eller betjene maskiner, til du føler dig bedre tilpas.
English: White to off-white powder and clear, colourless solvent.
Danish: Hvidt til råhvidt pulver og klar farveløs solvens.
English: Discuss with your doctor if you consider stopping the treatment with Preotact before you finish the prescribed period.
Danish: Tal med din læge, hvis du overvejer at stoppe med at tage Preotact, før den planlagte behandlingsperiode er afsluttet.
English: The effects of Preotact on bone architecture were evaluated using quantitative computed tomography (QCT) and peripheral QCT.
Danish: Preotacts effekt på knoglestrukturen blev evalueret ved brug af kvantitativ computertomografi (QCT) og perifer QCT.
English: Reconstituted solution: chemical and physical in-use stability has been demonstrated for 28 days at 28°C.
Danish: Rekonstitueret opløsning: Kemisk og fysisk in-use stabilitet er dokumenteret ved 28 dages opbevaring ved 2 - 8 °C.
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar pennen i den ydre karton for at beskytte mod lys.
English: • Mix the medicine
Danish: • Blande medicinen
English: • Do not use this medicine for more than 28 days after it has been mixed.
Danish: • Brug ikke medicinen i mere end 28 dage, efter den er blandet.
English: Please read the information in these boxes carefully - they contain important information for you.
Danish: Læs informationen i felterne omhyggeligt, da den er vigtig for dig
English: The needle pre-filled pen is full number of index outer needle cover needle inner needle cover
Danish: Træk hætten, der sidder i forenden af pennen, lige af pre-filled pen is full number of doses left pre-filled pen is empty index outer needle cover needle inner needle cover
English: Every day you have to check that the medicine is clear, add a new needle, take the injection in your abdomen and then throw away the needle before storing your pre-filled pen in the refrigerator (2-8°C).
Danish: Hver dag skal du tjekke, at medicinen i pennen er klar og gennemsigtig, påsætte en ny nål, tage injektionen i maveskindet og smide nålen væk, inden du lægger pennen tilbage i køleskabet (2-8 °C).
English: • Throw away the needle as you have been instructed by your doctor or nurse
Danish: • Bortskaf nålen, som din læge eller sygeplejerske har vist dig, du skal gøre
English: • Let it sit for about one minute until the medicine is completely mixed.
Danish: • Lad pennen hvile et minuts tid, så medicinen blandes fuldstændigt
English: Therefore if any blood samples are taken from a patient for monitoring of calcium levels, this should be done at least 20 hours after the most recent injection.
Danish: I tilfælde af monitorering af calcium bør blodprøven derfor tidligst tages 20 timer efter seneste injektion.
English: • flu,
Danish: • influenza,
English: Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
Danish: Hypercalcæmi blev rapporteret hos 25,3 % og hypercalcuri forekom hos 39,3 % af de patienter, der var i Preotactbehandling.
English: A user manual is included in the box to instruct patients on the correct use of the pen.
Danish: I pakningen findes en brugervejledning, der beskriver korrekt anvendelse af pennen.
English: After reconstitution the liquid should be clear and colourless.
Danish: Efter rekonstitution skal opløsningen være klar og farveløs.
English: Monitoring beyond 6 months is not recommended for patients whose total serum calcium is within the normal limits at 6 months.
Danish: Monitorering ud over 6 måneder er ikke nødvendigt, hvis totalserumcalcium efter 6 måneders behandling ligger indenfor normalområdet.
English: When the dose counter is at 0, the pre-filled pen is empty and you must take a new pre-filled pen.
Danish: Når tælleren står på 0, er pennen tom, og du skal tage en ny fyldt pen i brug.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 03, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: At baseline a total of 165 women (69%) had a T-score below -2.5, and 112 (47%) reported at least one fracture after menopause.
Danish: Ved baseline havde 165 kvinder (69 %) en T-score under ÷2,5 og 112 kvinder (47 %) havde rapporteret minimum 1 fraktur efter menopause.
English: There was no significant difference between the treatment groups in the incidence of any non-vertebral clinical fracture: 5.52% for Preotact vs. 5.86% for placebo.
Danish: Der var ingen signifikant forskel mellem forekomsten af non-vertebrale kliniske frakturer i de to behandlingsgrupper: 5,52 % i Preotactgruppen og 5,86 % i placebogruppen.
English: Preparing the new pre-filled pen for use - releasing air (priming)
Danish: Klargøring af ny fyldt pen - frigørelse af luft (klargøring)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (2 fyldte penne)
English: Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Danish: Behandling af mistænkt overdosering skal omfatte midlertidig afbrydelse af behandlingen, monitorering af serumcalcium samt iværksættelse af passende støttebehandling som for eksempel væsketilskud.
English: Osteoporosis is a disease that causes bones to become thin and fragile.
Danish: Knogleskørhed er en sygdom, der gør knoglerne tynde og skrøbelige.
English: This will release most of the air in the pre-filled pen and is called ‘priming'.
Danish: Dette vil frigøre det meste af den overskudsluft, der er i pennen (klargøring).
English: You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Danish: Du skal anvende Preotact med forsigtighed, hvis du er i behandling med hjertemedicin (f.eks. digoxin også kendt som digitalis).
English: It is especially common in women after the menopause.
Danish: Det opstår især hos kvinder efter overgangsalderen.
English: The pivotal study was an 18-month double-blind, placebo-controlled, phase III study (TOP) of the effect of Preotact on fracture incidence in women with postmenopausal osteoporosis.
Danish: Det primære studie var et 18 måneders dobbelt-blindet og placebokontrolleret fase III studie (TOP), der skulle undersøge Preotacts effekt på forekomsten af frakturer hos postmenopausale kvinder med osteoporose.
English: • with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism
Danish: • med præ-eksisterende hypercalcæmi eller andre forstyrrelser i calcium- og fosfatmetabolismen