FrancophonIA/ELRC3.0 huggingface dataset:
English: Preotact in combination with hormone replacement therapy (HRT) in 180 postmenopausal women has been shown to significantly increase lumbar spine BMD at 12 months compared with HRT alone (7.1 % vs. 1.1%, p<0.001).
Danish: Kombinationsbehandling med Preotact og hormonsubstitutionsterapi (HRT) er afprøvet hos 180 postmenopausale kvinder og viste en signifikant stigning i BMD for lumbal columna efter 12 måneders behandling i forhold til HRT alene (7,1 % i forhold til 1,1 %, p<0,001).
English: In response to subcutaneous doses of Preotact (100 micrograms parathyroid hormone), serum total calcium levels increase gradually and reach peak concentration (mean increase in 129 patients, 0.15 mmol/l) at approximately 6 to 8 hours after dosing.
Danish: Ved subkutan administration af Preotact (100 mikrogram parathyreoidieahormon) stiger den totale serumcalciumkoncentration gradvist og når maksimal koncentration 6 - 8 timer efter indgivelse (gennemsnitlig stigning hos 129 patienter var 0,15 mmol/l).
English: There are no data available from the use of parathyroid hormone in women of childbearing potential, during pregnancy and breast feeding.
Danish: Der foreligger ingen kliniske data om brug af parathyreoideahormon hos kvinder i den fertile alder, under graviditet og i forbindelse med amning.
English: Transient elevations in parathyroid hormone levels after subcutaneous injection of Preotact stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
Danish: Efter subkutan injektion stimulerer de forbigående stigninger i parathyreoideahormonkoncentrationen til dannelse af nyt knoglevæv på trabekulære og kortikale (periostale og/eller endostale) knogleoverflader ved fortrinsvis stimulering af den osteoblastiske aktivitet frem for den osteoclastiske aktivitet.
English: Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/or urinary calcium.
Danish: Patienter initieret til behandling med Preotact bør monitoreres for forhøjet calciumindhold i serum og/eller urin efter 1, 3 og 6 måneders behandling.
English: • Screw the needle off.
Danish: • Skru nålen af
English: Hypercalcemia
Danish: Hypercalcuri
English: Similarly, volumetric trabecular BMD at the total hip increased by 4.7%.
Danish: Tilsvarende sås en 4,7 % stigning i volumetrisk trabekulær BMD for totalhofte.
English: Parathyroid hormone is not excreted from the body in its intact form.
Danish: Det udskilles ikke fra kroppen i dets intakte form.
English: Following a subcutaneous dose of Preotact, C-terminal fragments make up about 60-90% of the circulating forms of the molecule.
Danish: Efter en subkutan dosis parathyreoideahormon vil 60 - 90 % af de cirkulerende former af molekylet være C-terminal-fragmenter.
English: • Use a new needle for each injection and throw the needle away after each use.
Danish: • Brug en ny nål hver gang, du sprøjter dig, og smid nålen i en kanyleboks efter hver indsprøjtning.
English: Preotact contains less than 1 mmol sodium (23 mg) per dose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Preotact Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: Injection site irritation
Danish: Irritation ved injektionssted
English: Other medicines and Preotact
Danish: Brug af anden medicin sammen med Preotact
English: Parathyroid hormone is metabolised in the liver and to a lesser degree in the kidney.
Danish: Parathyreoideahormonet metaboliseres i leveren og i mindre grad i nyrerne.
English: • smell disturbance, taste disturbance.
Danish: • forstyrrelser i lugte- og smagssans.
English: Caution should be exercised in patients receiving cardiac glucosides due to the risk of digitalis toxicity if hypercalcemia develops (see section 4.5).
Danish: Der skal udvises forsigtighed ved behandling af personer, der er i samtidig behandling med hjerteglykosider på grund af risikoen for digitalis toksicitet hvis patienter udvikler hypercalcæmi (se pkt.
English: The pre-filled pen after mixing:
Danish: Pennen efter blanding :
English: Put the cap back on the pre-filled pen and place it in the refrigerator.
Danish: Sæt hætten på pennen og læg den i køleskabet
English: Point the needle straight up and press the blue injection button until it is fully depressed.
Danish: Lad nålen pege lige op og tryk den blå injektionsknap helt i bund.
English: The dose counter has now decreased by one.
Danish: Dosistælleren har nu flyttet sig en enhed ned.
English: • sodium chloride,
Danish: • natriumchlorid,
English: The mean baseline lumbar T score was approximately -3.0 in each treatment group.
Danish: Den gennemsnitlige T-score ved baseline var ca. ÷3,0 i begge behandlingsgrupper.
English: Before mixing
Danish: Før blanding
English: Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig Hypercalcæmi
English: Peel off the protective paper from the needle cover.
Danish: Fjern beskyttelsespapiret fra nålehylsteret
English: • You can store the unmixed pre-filled pen at temperatures between 2-25°C.
Danish: • Du kan opbevare pennen med ublandet medicin ved temperaturer mellem 2-25 °C.
English: The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone.
Danish: De registrerede bivirkningsdata (ADR) er baseret på to placebokontrollerede studier, hvor der indgik 2642 postmenopausale kvinder med osteoporose.
English: • with unexplained elevations of bone-specific alkaline phosphatase
Danish: • med uforklaret stigning i knoglespecifik alkalisk phosphatase
English: • constipation, diarrhoea,
Danish: • forstoppelse, diare,
English: The steps you have to go through with a new pre-filled pen:
Danish: Dette skal du gøre én gang med en ny pen:
English: Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Danish: Dyrestudier på rotter indikerer en øget forekomst af osteosarkomer ved langvarig behandling med Preotact (se pkt.
English: • increased level of alkaline phosphatase in the blood ,
Danish: • øget indhold af alkalisk fosfatase i blodet,
English: No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
Danish: Det er ikke nødvendigt at reducere dosis til patienter med let til moderat nedsat leverfunktion (ChildPugh score 7 - 9).
English: Reconstituted solution: Store in a refrigerator (2-8°C).
Danish: Rekonstitueret opløsning: Opbevares i køleskab (2-8 °C).
English: From the knowledge of the mechanism of action, combined use of Preotact and cardiac glucosides may predispose patients to digitalis toxicity if hypercalcemia develops (see section 4.4).
Danish: Med baggrund i kendskabet til virkningsmekanismen, kan samtidig behandling med Preotact og et hjerteglykosid prædisponere patienter til en digitalisforgiftning, i de tilfælde hvor der udvikles hypercalcæmi (Se pkt.
English: Preotact is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Danish: Preotact er indiceret til behandling af osteoporose hos postmenopausale kvinder med høj frakturrisiko (se pkt.
English: • with skeletal malignancies or bone metastases.
Danish: • med malignitet i skelettet eller knoglemetastaser
English: What you need to know before you use Preotact
Danish: Det skal du vide før du begynder at tage Preotact
English: • Do not store the pre-filled pen with the needle on.
Danish: • Opbevar ikke pennen med nålen på.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Denne indlægsseddel blev senest godkendt den Du kan finde yderligere information om Preotact på Det Europæiske Lægemiddelagenturs hjemmeside: www.ema.europa.eu
English: Injection site erythema
Danish: Erythem ved injektionssted
English: For the mean change in hip BMD, there was a 4.5% increase from baseline with one year of alendronate compared to a 0.1% decrease after one year of placebo.
Danish: Med hensyn til den gennemsnitlige ændring i knoglemineraltæthed for total-hofte sås en 4,5 % stigning i forhold til baseline efter 1 års alendronatbehandling og et 0,1 % fald efter 1 års placebobehandling.
English: Before it is used for the first time, the medicine in the Preotact pre-filled pen has to be mixed (please refer to the “Instructions for use”).
Danish: Fremgangsmåde Før den fyldte Preotact pen bruges første gang, skal medicinen blandes (læs brugervejledningen)
English: The recommended dose of Preotact is 100 micrograms per day.
Danish: Dosering Den sædvanlige dosis er 100 mikrogram dagligt.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede)
English: In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalciuria.
Danish: Hos disse patienter sås en øget tendens til forværring af den præ-eksisterende hypercalcuri ved behandling med Preotact.
English: Reconstituted solution: 28 days
Danish: EXP Færdigblandet opløsning: 28 dage.
English: Do not push it back until you are instructed to do so in this leaflet.
Danish: Tryk ikke knappen ind igen, før brugervejledningen fortæller, at du skal gøre det.
English: For all subjects who received parathyroid hormone 100 micrograms blood uric acid increase was reported for 8 subjects (0.6%) and hyperuricemia was reported for 5 subjects (0.4%).
Danish: Blandt personer i gruppen, der fik parathyreoideahormon 100 mikrogram, sås en stigning i urinsyrekoncentrationen hos 8 personer (0,6 %) og 5 personer (0,4 %) fik konstateret hyperuricæmi.
English: Parathyroid hormone should not be used in women of childbearing potential, during pregnancy or breast-feeding.
Danish: Preotact bør ikke anvendes til kvinder i den fertile alder, under graviditet eller i forbindelse med amning.
English: • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism
Danish: • med andre metaboliske knoglesygdomme end primær osteoporose.
English: • have a high level of calcium in your urine;
Danish: • har et højt kalkindhold i urinen
English: Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Danish: Efter endt behandling med Preotact kan der efterfølgende behandles med et bisphosphonat for at opnå en yderligere øgning af knoglemineraltætheden (se pkt.
English: Talk to your doctor or pharmacist before using Preotact if you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før du tager Preotact, hvis du
English: Pre-filled pen(after reconstitution): Store in a refrigerator (2-8°C).
Danish: Fyldt pen (efter blanding af medicinen): Opbevares i køleskab (2-8 °C).
English: • reddening of the skin (erythema) at injection site,
Danish: • rødme (erytem) omkring indsprøjtningsstedet,
English: Preotact has been studied in patients with pre-existing hypercalciuria.
Danish: Preotacts effekt er undersøgt hos personer med præ-eksisterende hypercalcuri.
English: No studies have been conducted in patients with severe hepatic impairment.
Danish: Der er ikke gennemført studier på patienter med svært nedsat leverfunktion.
English: • water for injections
Danish: • vand til injektionsvæsker.
English: Ask your pharmacist how to throw away any medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal aflevere medicinrester.
English: Preotact has not been studied in patients with active urolithiasis.
Danish: Preotacts effekt på patienter med aktiv urolithiasis er ikke undersøgt.
English: Once the product is reconstituted it can be stored outside the refrigerator at temperatures below 25°C for up to 7 days during the 28 day use period (see section 6.3).
Danish: Det rekonstituerede lægemiddel kan opbevares uden for køleskab ved temperaturer under 25 °C i op til 7 dage i løbet af den 28 dage periode (se pkt.
English: The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent.
Danish: Det ene kammer indeholder 1,61 mg parathyreoideahormon som pulver, og det andet kammer indeholder 1,13 ml opløsningsvæske.
English: • You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C)
Danish: • Du kan opbevare pennen med den færdigblandede medicin uden for køleskab (under 25 °C) i op til
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled pen
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: • with hypersensitivity to parathyroid hormone or to any of the excipients (see section 6.1)
Danish: • med overfølsomhed over for parathyreoideahormon eller et eller flere af hjælpestofferne i produktet (se pkt.
English: Effect on fracture incidence
Danish: Forekomst af frakturer
English: • Release residual air (prime the pen)
Danish: • Frigøre overskudsluft (klargøring)
English: • Press the yellow release button to release the blue injection button.
Danish: • Tryk på den gule udløserknap for at udløse den blå injektionsknap
English: • Never store your pre-filled pen with the needle attached.
Danish: • Opbevar aldrig pennen med nålen siddende på.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning.
English: Preotact is used to treat osteoporosis in women past menopause with high risk of fractures.
Danish: Preotact bruges til at behandle knogleskørhed (osteoporose) hos kvinder med høj risiko for knoglebrud efter overgangsalderen.
English: Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001).
Danish: Endvidere sås signifikante stigninger i hofte-BMD efter 18 måneders behandling på henholdsvis 1,0; 1,8 og 1,0 % (total, lårbenshals, trochanter) mod ÷1,1; ÷0,7 og ÷0,6 % for placebo (p<0,001).
English: • You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C.
Danish: • Du kan opbevare pennen med færdigblandet medicin i op til 7 dage ved stuetemperatur (ved temperaturer mellem 2-25 °C).
English: Pharmacotherapeutic group: Calcium homeostatis, parathyroid hormones and analogues, ATC code: H05AA03.
Danish: Farmakoterapeutisk klassifikation: Calciumhomeostase, parathyreoideahormoner- og analoger.
English: Your doctor may advise you to take supplementary calcium and vitamin D. Your doctor will tell you how much you should take each day.
Danish: Lægen vil fortælle dig, hvor meget du skal tage hver dag.
English: • if you suffer from severe liver disease;
Danish: • har en alvorlig leversygdom.
English: It may also cause back pain, loss of height, and a curved back.
Danish: Knogleskørhed kan også forårsage rygsmerter, sammenfald i ryggen (højden formindskes) eller krum ryg.
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone.
Danish: Efter opløsning indeholder hver dosis på 71,4 mikroliter 100 mikrogram parathyreoideahormon.
English: Please see how to use the pen in the Instructions for use manual.
Danish: Se i brugervejledningen, hvordan pennen skal anvendes.
English: • Screw the pre-filled pen together until the clear front part and the pen body meet.
Danish: • Skru pennen sammen, så den klare forende rører penneskaftet.
English: • Store in a refrigerator (2-8°C).
Danish: • Skal opbevares i køleskabet ved 2-8 °C.
English: Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Danish: Preotact bør derfor ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: Do not use Preotact • if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed
Danish: • er allergisk over for parathyreoideahormon eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Danish: Hvis det daglige indtag af calcium og vitamin D gennem kosten er utilstrækkeligt, bør der suppleres med calcium- og D-vitamintilskud.
English: In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p<0.001).
Danish: Efter 18 måneders behandling med Preotact sås en stigning på 6,5 % i BMD i lumbal culumna sammenlignet med ÷0,3 % for placebo (p<0,001).
English: After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in Escherichia coli by recombinant DNA technology For a full list of excipients, see section 6.1.
Danish: Efter rekonstitution indeholder hver dosis på 71,4 mikroliter, 100 mikrogram parathyreoideahormon fremstillet i Escherichia coli ved hjælp af rekombinant DNA teknologi.
English: • Take your daily dose or store the pre-filled pen
Danish: • Tage din daglige dosis eller lægge pennen i køleskab.
English: Preotact is available in packs of 2 pre-filled pens.
Danish: Preotact fås i pakker med 2 fyldte penne.
English: Blood alkaline phosphatase increased Anorexia
Danish: Forhøjet calcium i blodet Ikke almindelig Øget alkalisk fosfatase i blodet Anoreksi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Preotact 100 mikrogram pulver og solvens til injektionsvæske, opløsning Parathyreoideahormon
English: Press the yellow release button to release the blue injection button.
Danish: Tryk på den gule udløserknap for at udløse den blå injektionsknap.
English: • if you suffer from high calcium levels in your blood or other disturbances in the calcium
Danish: • har for højt kalkindhold i blodet eller urinen eller andre forstyrrelser i din kalk- og fosfatbalance.
English: There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function.
Danish: I et studie gennemført på 6 kvinder og 6 mænd med moderat nedsat leverfunktion sås en moderat stigning på cirka 20 % af den gennemsnitlige systemiske eksponering, korrigeret for baseline (AUC) og sammenlignet med en matchende gruppe på 12 personer med normal leverfunktion.
English: • If you drop your pre-filled pen you must replace it.
Danish: • Hvis du taber pennen, skal du kassere den og tage en ny i brug.
English: Preotact reduces the risk of breaking spinal bones because it increases your bone quality and strength.
Danish: Preotact forbedrer knoglernes struktur og styrke og mindsker derved risikoen for brud i ryggen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1,61 mg parathyreoideahormon og 1,13 ml solvens (14 doser).
English: The absolute bioavailability of 100 micrograms of parathyroid hormone after subcutaneous administration in the abdomen is 55%.
Danish: Den absolutte biotilgængelighed efter subkutan adminstration af 100 mikrogram parathyreoideahormon i abdomen er
English: • Do not use the medicine if it is cloudy or coloured (if it is unclear).
Danish: • Brug ikke medicinen, hvis væsken er uklar eller farvet.
English: The solvent contains
Danish: Preotact indeholder
English: • irritation of the skin at the injection site,
Danish: • hudirritation omkring indsprøjtningsstedet,
English: It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3 and 4.4).
Danish: Hypercalcæmi blev i det kliniske program håndteret ved monitorering af laboratorieværdier og anvendelse af en præ-specificeret behandlingsalgorithme (se pkt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not shake the reconstituted solution Read the package leaflet before use Subcutaneous use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Ryst ikke den færdigblandede opløsning.
English: • Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4).
Danish: (Se billede 3 og 4).
English: The medicinal product is supplied in a pre-filled pen containing a dual-chamber cartridge.
Danish: Lægemidlet bliver leveret i en fyldt pen indeholdende en tokammercylinderampul.
English: Use each needle only once.
Danish: Brug kun hver nål til 1 injektion
English: • Put the outer needle cover on.
Danish: • Påsæt det ydre nålehylster
English: Asthenia
Danish: Astheni
English: Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen Parathyroid hormone
Danish: Preotact 100 mikrogram pulver og solvens til injektionsvæske, opløsning i en fyldt pen Parathyreoideahormon
English: In the Preotact clinical program, accidental overdose has been reported.
Danish: Tegn og symptomer I de kliniske afprøvninger er der konstateret utilsigtede overdoseringstilfælde med Preotact.
English: Each pre-filled pen contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent.
Danish: Hver fyldt pen indeholder 1,61 mg parathyreoideahormon som pulver og 1,13 ml solvens.
English: • with severe renal impairment
Danish: • med svært nedsat nyrefunktion
English: There is no data available in patients with severe renal impairment.
Danish: Der foreligger ingen data for personer med svært nedsat nyrefunktion.
English: • increased level of uric acid in the blood,
Danish: • øget indhold af urinsyre i blodet,
English: Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
Danish: Hver fyldt pen indeholder 1,61 mg parathyreoideahormon svarende til 14 doser.
English: Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager Preotact.
English: Abdominal pain
Danish: Ikke almindelig Abdominalsmerter
English: The volume of distribution at steady-state following intravenous administration is approximately 5.4 l. Interindividual variability in the volume of distribution of parathyroid hormone is about 40%.
Danish: Fordelingsvolumenet ved steady state efter intravenøs administration er cirka 5,41.
English: • Never share your pre-filled pen with anyone.
Danish: • Den fyldte pen er personlig, lån den aldrig ud til andre.
English: NAME OF THE MEDICINAL PRODUCT Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen.
Danish: LÆGEMIDLETS NAVN Preotact 100 mikrogram pulver og solvens til injektionsvæske, opløsning, i fyldt pen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 1,61 mg parathyreoideahormon svarende til 14 doser.
English: Pull both needle covers off. Save the outer needle cover as you will need it to remove the needle after the injection.
Danish: Du skal bruge det til at fjerne nålen med efter injektionen.
English: Do not shake the pre-filled pen
Danish: Pennen må ikke rystes
English: • increased level of calcium in the urine,
Danish: • forhøjet indhold af kalk i urinen
English: The other ingredients are: The powder contains:
Danish: Øvrige indholdsstoffer:
English: When you receive your pre-filled pen the dose counter is at , to show that it is full.
Danish: Når du åbner pakningen med den fyldte pen, står tælleren på .
English: • The priming should be done every time you mix a new pre-filled pen.
Danish: • Du skal klargøre pennen (fjerne overskudsluften), når du har blandet medicin i en ny fyldt pen