FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have cancer of the bones;
Danish: • har kræft i knoglerne
English: Patients with pre-existing hypercalciuria
Danish: Patienter med præ-eksisterende hypercalcuri
English: After mixing
Danish: Efter blanding
English: The effects of overdose that might be expected include delayed hypercalcemia, nausea, vomiting, dizziness and headache.
Danish: De forventede symptomer på overdosering inkluderer forsinket hypercalcæmi, kvalme, opkastninger, svimmelhed og hovedpine.
English: Preotact should be used with caution in patients with active or previous urolithiasis.
Danish: Derfor skal Preotact anvendes med forsigtighed til patienter med aktiv eller tidligere urolithiasis.
English: Infections and infestations Uncommon
Danish: Infektioner og parasitære sygdomme Ikke almindelig
English: • pain in arms and legs (extremities),
Danish: • smerter i arme og ben,
English: In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Danish: I et 24-måneders studie med kombinationsterapi med alendronat (PaTH) blev Preotacts effekt på knoglestrukturen også evalueret ved QCT.
English: Patients receiving cardiac glucosides
Danish: Patienter i behandling med hjerteglykosider
English: Preotact increases serum uric acid concentrations.
Danish: Preotact øger urinsyrekoncentrationen i serum.
English: In general, serum calcium levels return to baseline levels 24 hours after dosing.
Danish: Generelt vil serumcalciumkoncentrationen vende tilbage til baseline inden for 24 timer efter indgivet dosis.
English: • Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
Danish: • Sprøjt dig selv lige efter, at du har taget pennen ud af køleskabet.
English: Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e.g. hyperparathyroidism).
Danish: Patienter, der har vedvarende forhøjet serumcalcium (over øvre normalgrænse), skal undersøges for eventuel anden sygdom (f.eks. hyperparathyroidisme).
English: Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis.
Danish: Behandling af osteoporose med kombinations- og sekvensterapi PaTH-studiet var et National Institute of Health (NIH) sponsoreret, randomiseret, placebokontrolleret, 2-årigt, multicenter, dobbeltblindet studie med Preotact og alendronat som monoterapi eller kombinationsterapi til behandling af postmenopausal osteoporose.
English: • Do not use this medicine if you notice that it became cloudy or coloured.
Danish: • Brug ikke medicinen, hvis du kan se, at den er blevet uklar eller farvet.
English: Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
Danish: Relativt få patienter inkluderet i fase III-studiet var < 5 år postmenopausalt og mellem 45 og 54 år (2 - 3 %).
English: In the second year of the study women in the original Preotact group were randomly assigned to receive either alendronate or matching placebo, and women in the other two groups received alendronate.
Danish: I studiets 2. år blev kvinderne fra den oprindelige Preotactgruppe randomiseret til enten alendronat- eller placebobehandling og kvinderne fra de 2 andre grupper fik alendronat.
English: Effects on serum calcium concentrations
Danish: Virkning på serumcalciumkoncentrationen
English: • Put the pre-filled pen back into the refrigerator immediately after you have used it.
Danish: • Læg pennen tilbage i køleskabet lige efter, du har brugt den.
English: One year of therapy, showed the following results: the increases in lumbar spine BMD above baseline were similar in the Preotact and combination-therapy groups (6.3 and 6.1%, respectively), but were somewhat smaller in the alendronate group (4.6%).
Danish: Efter 1 års behandling sås følgende resultater: Stigningerne i BMD fra baseline for lumbal columna var ens i Preotact- og kombinationsbehandlingsgruppen (6,3 og 6,1 %), men var lidt mindre i alendronat-gruppen (4,6 %).
English: Urine calcium/creatinine ratio increased Urine calcium increased
Danish: Forhøjet calcium/kreatinin-ratio i urin Forhøjet calcium i urinen
English: For patients with pre-existing fractures, number needed to treat (NNT) is 21 patients.
Danish: For patienter, som tidligere har haft frakturer er NNT (numbers neaded to treat) 21 kvinder.
English: • Keep Preotact protected from light
Danish: • Opbevar Preotact beskyttet mod lys.
English: In these women with a positive titre, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.
Danish: Hos de kvinder, der havde positivt respons for antistoffer, var der ingen evidens for hypersensitivitetsreaktioner, allergiske reaktioner, effekt på knoglemineraltæthed eller ændringer i serumcalcium.
English: Although gout, arthralgia and nephrolithiasis were reported as ADRs, the relationship to elevations in uric acid due to Preotact administration has not been fully established.
Danish: Selv om gigt, ledsmerter og nefrolithiasis blev rapporteret som bivirkninger (ADR), er årsagssammenhængen i relation til stigningen i urinsyrekoncentrationen som følge af behandlingen med Preotact ikke fuldt etableret.
English: • Point the needle end straight up
Danish: • Nålen skal pege lige op
English: A total of 238 postmenopausal women, were randomly assigned to one of the following treatment groups; Preotact (100 micrograms parathyroid hormone), alendronate (10 mg), or the combination of both, and followed for 12 months.
Danish: I alt 238 postmenopausale kvinder blev randomiseret til en af de 3 følgende behandlinger: Preotact (100 mikrogram parathyreoideahormon), alendronat (10 mg) eller kombinationen af de to behandlinger.
English: Rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
Danish: Rotter, der blev behandlet næsten gennem hele levetiden med daglige injektioner, havde en dosisafhængig overdreven knogledannelse og en øget forekomst af knogletumorer inklusive osteosarkomer, hvilket mest sandsynligt skyldes en epigenetisk mekanisme.
English: THE PRE-FILLED PEN
Danish: DEN FYLDTE PEN
English: If you stop taking Preotact
Danish: Hvis du holder op med at tage Preotact
English: Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Danish: Cirka 71,4 % af de patienter, der var i parathyreoideahormonbehandling rapporterede mindst en bivirkning.
English: The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
Danish: Parathyreoideahormonets virkning på knoglerne afhænger af tilrettelæggelsen af den systemiske eksponering.
English: Of the 2,532 randomised intention-to-treat (ITT) patients, a total of 59 patients experienced at least one new vertebral fracture, placebo: 42 (3.37%) - Preotact: 17 (1.32%), p=0.001.
Danish: Ud af de 2532 randomiserede patienter (ITT, intention to treat) oplevede 59 patienter mindst en ny vertebralfraktur fordelt på 42 i placebogruppen (3,37 %) og 17 i Preotactgruppen (1,32 %), p=0,001.
English: Only mix one pen at the time.
Danish: Bland kun medicin i én pen ad gangen.
English: Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
Danish: Parathyreoideahormonet fjernes effektivt fra blodbanen ved en receptormedieret proces i leveren og nedbrydes her til mindre peptidfragmenter.
English: Overall, approximately 19% of the subjects in each treatment group had at least 1 prevalent vertebral fracture at baseline.
Danish: I begge behandlingsgrupper havde ca. 19 % af kvinderne haft mindst én tidligere vertebralfraktur ved baseline.
English: Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Danish: På samme måde blev volumetrisk trabekulær BMD af total-hofte forøget med 9; 6 og 2 % i de 3 grupper.
English: Always use Preotact exactly as your doctor has told you.
Danish: Tag Preotact, så længe din læge har fortalt dig.
English: The content of the cartridge is reconstituted in the pen.
Danish: Indholdet i cylinderampullen rekonstitueres i pennen.
English: • if you have other bone disease (including hyperparathyroidism or Paget's disease);
Danish: • har en anden knoglesygdom (inklusive forøget produktion af parathyreoideahormon eller Pagets sygdom).
English: The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney.
Danish: Fragmenter af den aminoterminale ende nedbrydes yderligere i levercellen, mens fragmenterne fra carboxy-enden frigives til blodbanen og fjernes af nyrerne.
English: uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000), including isolated reports.
Danish: Alle bivirkninger er klassificeret efter hyppighed på følgende måde: Meget almindelig (≧1/10); almindelig (≧1/100 til <1/10); ikke almindelig (≧ 1/1.000 til <1/100); sjælden (≧1/10.000 til <1/1.000) og meget sjælden (<1/10.000) inklusive isolerede rapporter.
English: Under normal physiologic conditions, full-length parathyroid hormone (1-84) constitutes only 5-30% of the circulating forms of the molecule, while 70-95% is present as carboxy-terminal fragments.
Danish: Ved normale fysiologiske forhold udgøres kun 5 - 30 % af de cirkulerende former af det intakte parathyreoideahormon (1-84), mens 70 - 95 % er til stede som carboxyterminale fragmenter.
English: Your doctor will perform blood and/or urine tests to measure the level of calcium in your blood and/or urine at month 1, 3 and 6 after starting your treatment with Preotact.
Danish: Der vil blive taget blodog/eller urinprøver for at måle kalkindholdet i dit blod eller din urin 1, 3 og 6 måneder efter behandlingsstart.
English: This means that it is essentially “sodium-free”.
Danish: Det vil sige, du kan betragte det som natriumfrit.
English: Treatment with Preotact reduced volumetric cortical bone BMD (measured at the distal radius and mid-shaft tibia), while periosteal circumference or indices of cortical bone strength were maintained.
Danish: Preotact reducerede den volumentriske kortikale knogle-BMD (målt i distal radius og midt på tibia), mens den periostale omkreds eller index for den kortikale knoglestyrke blev bibeholdt.
English: The occurrence of osteosarcoma only occurred at doses that produced systemic exposures > 27-times higher than that observed in humans at the 100 micrograms dose.
Danish: Forekomst af osteosarkomer sås udelukkende ved doser, der resulterede i en systemisk eksponering ≥ 27 gange højere end eksponeringen hos mennesker ved en dosis på 100
English: • You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
Danish: • Du må højst opbevare pennen med den færdigblandede medicin i 28 dage i køleskabet.
English: • if you shall have or previously have had radiation therapy to the skeleton;
Danish: • der er i, eller tidligere har gennemgået strålebehandling af skelettet
English: • nausea.
Danish: • kvalme.
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralization at exposure levels below clinical exposure levels.
Danish: Hos aber, der fik daglige subkutane doser gennem 6 måneder, fandt man øget forekomst af renal tubulær mineralisering ved doser lavere end de kliniske doser.
English: Patients in the Preotact treatment group had a 61% relative risk reduction of a new vertebral fracture at month 18 compared to the patients in the placebo group.
Danish: Patienterne i Preotactgruppen havde en relativ reduktion i risiko for en ny vertebralfraktur på 61% efter 18 måneders behandling i forhold til patienterne i placebogruppen.
English: During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Danish: I den 28 dages periode kan den rekonstituerede opløsning opbevares i op til 7 dage ved temperaturer under 25 °C.
English: Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
Danish: Stigningerne i BMD i total-hofte var henholdsvis 0,3; 1,9 og 3,0 % for de 3 behandlingsgrupper.
English: Serum calcium concentrations reach a maximum between 6 and 8 hours post dose and normally return to baseline by 20 to 24 hours after each administration of parathyroid hormone.
Danish: Serumcalciumværdien når et maksimum mellem 6 og 8 timer efter indgivet dosis og niveauet vil være tilbage ved baseline mellem 20 og 24 timer efter hver administration af parathyreoideahormon.
English: Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
Danish: Fortyndet saltsyre (til pH-justering) Natriumhydroxid (til pH-justering)
English: • Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
Danish: • Fjern nålen efter hver injektion og læg pennen tilbage i køleskabet ved 2-8 °C.
English: The most relevant fracture reduction was observed among patients at high risk of fractures such as patients with previous fractures and in patients with a lumbar spine T-score of < - 3.
Danish: Den mest relevante reduktion i frakturer blev konstateret blandt kvinder med høj risiko for frakturer, som for eksempel kvinder med tidligere frakturer eller kvinder med en lumbal columna T-score < ÷3.
English: Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
Danish: Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 38 % i forhold til baseline efter 18 måneder.
English: Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
Danish: Brug ikke Preotact efter den udløbsdato, der står på den fyldte pen og på kartonen efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: Physiological actions of parathyroid hormone include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular reabsorption of calcium and excretion of phosphate by the kidney.
Danish: Den fysiologiske virkning af parathyreoideahormon, inkluderer stimulering af knogledannelse ved direkte påvirkning af de knogledannende celler (osteoblaster), indirekte stigning i den intestinale calciumabsorption og øgning af den tubulære calciumreabsorption samt øget fosfatekskretion i nyrerne.
English: The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact.
Danish: Stigningen i BMD for lumbal columna og lårbenshalsen var henholdsvis 6,8 % og 2,2 % hos patienter behandlet med Preotact.
English: The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo.
Danish: Tabellen nedenfor giver et overblik over alle bivirkninger (ADR), hvor hyppigheden er mindst 0,5 % højere i parathyreoideahormongruppen end i placebogruppen.
English: The overall exposure and Cmax of parathyroid hormone were slightly increased (22% and 56%, respectively) in a group of 8 male and 8 female subjects with mild-to-moderate renal impairment (creatinine clearances of 30 to 80 ml/min) compared with a matched group of 16 subjects with normal renal function.
Danish: Den overordnede systemiske eksponering og Cmax var let forhøjede (henholdsvis 22 % og 56 %) i en gruppe bestående af 8 kvinder og 8 mænd med let til moderat nedsat nyrefunktion (kreatininclearance 30 - 80 ml/min) sammenlignet med en tilsvarende gruppe på 16 personer med normal nyrefunktion.
English: If you forget to use Preotact
Danish: Hvis du har glemt at tage Preotact
English: Important information when using Preotact
Danish: Vigtige oplysninger, når du tager Preotact
English: A total of 2532 patients (1286 Preotact and 1246 placebo), aged 45-94 years (8.1% 45-54 years and 11.4% > 75 years), were randomised to receive 100 micrograms/day or placebo with daily calcium (700 mg) and vitamin D (400 IU) supplementation.
Danish: I alt 2532 patienter (1286 fik Preotact og 1246 fik placebo) i aldersgruppen 45 - 94 år (8,1 % var mellem 45 og 54 år og 11,4 % ≥ 75 år) blev randomiseret og fik 100 mikrogram/dag eller placebo.
English: Patients must be trained to use the proper injection techniques (see section 6.6).
Danish: Patienten skal instrueres grundigt i korrekt injektionsteknik (se pkt.
English: Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months.
Danish: Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 26; 13 og 11 % (Preotact, Preotact-alendronat og alendronat) efter 12 måneder.
English: Animal studies of reproductive toxicity are incomplete (see section 5.3).
Danish: Der foreligger ikke komplette dyrestudier for reproduktionstoksisitet (se pkt.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Danish: Det er ikke nødvendigt med dosisjustering til patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30 - 80 ml/min).
English: The hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.
Danish: Hypercalcæmi var forbigående og sås hyppigst i de første 3 måneder af behandlingen.
English: Subcutaneous administration of 100 micrograms of parathyroid hormone into the abdomen produces a rapid increase in plasma parathyroid hormone levels and achieves a peak at 1 to 2 hours after dosing.
Danish: Subkutan administration af 100 mikrogram parathyreoideahormon i abdomen giver en hurtig stigning i plasmakoncentrationen af parathyreoideahormon og maksimal koncentration opnås 1 til 2 timer efter administration.
English: Based on two placebo-controlled studies involving 2642 postmenopausal osteoporotic women, hypercalcemia was reported in 25.3% of patients treated with Preotact compared to 4.3% of placebotreated patients.
Danish: I to placebokontrollerede studier, der involverede 2642 postmenopausale kvinder med osteoporose fik 25,3 % af de Preotact-behandlede patienter hypercalcæmi i forhold til 4,3 % af de placebobehandlede patienter.
English: At the end of year 2 (12 months after Preotact was discontinued), there was a 12.1% mean increase in dual energy X-ray absorptiometry (DXA) spine BMD for patients who received alendronate for the second year.
Danish: Ved afslutning på 2. år (12 måneder efter afbrydelse af Preotact) sås ved dual energy X-ray absorptiometri (DXA) en gennemsnitlig stigning på 12 % i BMD i columna hos patienter, behandlet med alendronat i år 2.
English: Pre-filled pen (before reconstitution): Do not store above 25°C.
Danish: Fyldt pen (før blanding af medicinen): Må ikke opbevares ved temperaturer over 25 °C.
English: Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
Danish: Hypercalcæmi og/eller hypercalcuri afspejler de kendte farmakodynamiske virkninger af parathyreoideahormon i mavetarmkanalen, nyrerne og knoglerne.
English: The container closure system is comprised of a dual-chamber cartridge, a center stopper, a crimp cap (containing a rubber seal) sealing the first chamber containing lyophilised powder and an end stopper sealing the second chamber containing the solvent for mixing.
Danish: Præparatet består af en tokammercylinderampul, en midterprop, en indfalset hætte (med en gummiforsegling), som forsegler det første kammer med det frysetørrede pulver, og en bundprop, der forsegler det andet kammer, der indeholder solvens.
English: As some episodes of dizziness have been described in patients treated with Preotact, patients should refrain from driving or using machines until symptoms have subsided.
Danish: Hvis man oplever svimmelhed ved behandling med Preotact, bør man afholde sig fra at køre bil eller betjene maskiner indtil disse symptomer aftager.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Danish: De prækliniske data baseret på konventionelle studier så som sikkerhedsfarmakologi, mutagenicitet, toksicitet i forhold til fertilitet og generel reproduktion samt lokal tolerance viser ingen speciel risiko for mennesker.
English: The pre-filled pen before mixing:
Danish: Pennen før blanding:
English: But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Danish: Hvis du har knogleskørhed, medfører det, at du er mere udsat for knoglebrud, især i ryg, hofter og håndled.
English: Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
Danish: Cirkulerende carboxyterminale fragmenter filtreres gennem nyrerne og nedbrydes til endnu mindre fragmenter ved den tubulære reabsorption.
English: 2 pre-filled pens per pack.
Danish: 2 stk. fyldte penne pr. pakning.
English: • The frequency of Preotact dosing should be changed to 100 micrograms every other day
Danish: • dosering ændres til 100 mikrogram Preotact hver anden dag
English: In a large phase III clinical study, antibodies to parathyroid hormone were detected in 3% of women receiving Preotact compared to 0.2% of women receiving placebo.
Danish: I et stort Fase III studie blev der fundet antistoffer mod parathyreoideahormon hos 3 % af de kvinder, der blev behandlet med Preotact til sammenligning med 0,2 % kvinder behandlet med placebo.
English: Systemic clearance of parathyroid hormone (45.3 l/hour) following an intravenous dose is close to normal liver plasma flow and is consistent with extensive hepatic metabolism of the active substance.
Danish: Efter en intravenøs dosis vil den systemiske clearance af parathyroideahormenet (45,3 l/time) være tæt på det normale leverplasmaflow og stemmer overens med en omfattende metabolisering af lægemidlet i leveren.
English: The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Danish: Farmakokinetikken for parathyreoideahormonet er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: Management of elevated serum calcium
Danish: Behandling af forhøjet serumcalcium
English: Elevated serum calcium was observed during Preotact treatment.
Danish: Der er set forhøjede serumcalciumværdier under behandling med Preotact.
English: After you do this, the Preotact pre-filled pen is ready for use and the medicine is ready to be injected into the abdomen (under the skin).
Danish: Når du har gjort det, er Preotact pennen klar til brug og medicinen er klar til at blive indsprøjtet under maveskindet.
English: • Do not use this medicine if it has not been stored correctly, even if it is not used up.
Danish: • Brug ikke resten af medicinen, hvis den har været opbevaret forkert.
English: For the patients who received placebo during the second year, the mean percent increase was 4.1% compared to baseline, but had decreased slightly compared to the end of 12 months of Preotact treatment.
Danish: De patienter, der fik placebo i år 2, havde en gennemsnitlig stigning på 4 % sammenlignet med baseline, men der var sket et lille fald i forhold til status efter 12 måneders Preotactbehandling.
English: Contents of the pack and other information.
Danish: Pakningsstørrelse og yderligere oplysninger
English: Antibodies to parathyroid hormone
Danish: Antistoffer mod parathyreoideahormon
English: • decreased muscle strength, muscle cramps, dizziness,
Danish: • svækket styrke i musklerne, muskelkramper, svimmelhed,