natgillin/translations-raw huggingface dataset:
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.
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.
Klargøring af ny fyldt pen - frigørelse af luft (klargøring)
Preparing the new pre-filled pen for use - releasing air (priming)
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (2 fyldte penne)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (2 Pre-filled pens)
Behandling af mistænkt overdosering skal omfatte midlertidig afbrydelse af behandlingen, monitorering af serumcalcium samt iværksættelse af passende støttebehandling som for eksempel væsketilskud.
Treatment of suspected overdose should include temporary discontinuation of Preotact, monitoring of serum calcium, and implementation of appropriate, supportive measures, such as hydration.
Knogleskørhed er en sygdom, der gør knoglerne tynde og skrøbelige.
Osteoporosis is a disease that causes bones to become thin and fragile.
Dette vil frigøre det meste af den overskudsluft, der er i pennen (klargøring).
This will release most of the air in the pre-filled pen and is called ‘priming'.
Du skal anvende Preotact med forsigtighed, hvis du er i behandling med hjertemedicin (f.eks. digoxin også kendt som digitalis).
You should use Preotact with caution if you receive heart medicine (e.g. digoxin also known as digitalis).
Det opstår især hos kvinder efter overgangsalderen.
It is especially common in women after the menopause.
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.
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.
• med præ-eksisterende hypercalcæmi eller andre forstyrrelser i calcium- og fosfatmetabolismen
• with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism
• har kræft i knoglerne
• if you have cancer of the bones;
Patienter med præ-eksisterende hypercalcuri
Patients with pre-existing hypercalciuria
Efter blanding
After mixing
De forventede symptomer på overdosering inkluderer forsinket hypercalcæmi, kvalme, opkastninger, svimmelhed og hovedpine.
The effects of overdose that might be expected include delayed hypercalcemia, nausea, vomiting, dizziness and headache.
Derfor skal Preotact anvendes med forsigtighed til patienter med aktiv eller tidligere urolithiasis.
Preotact should be used with caution in patients with active or previous urolithiasis.
Infektioner og parasitære sygdomme Ikke almindelig
Infections and infestations Uncommon
• smerter i arme og ben,
• pain in arms and legs (extremities),
I et 24-måneders studie med kombinationsterapi med alendronat (PaTH) blev Preotacts effekt på knoglestrukturen også evalueret ved QCT.
In the 24-month alendronate combination therapy study (PaTH), the effects of Preotact on bone architecture were also evaluated using QCT.
Patienter i behandling med hjerteglykosider
Patients receiving cardiac glucosides
Preotact øger urinsyrekoncentrationen i serum.
Preotact increases serum uric acid concentrations.
Generelt vil serumcalciumkoncentrationen vende tilbage til baseline inden for 24 timer efter indgivet dosis.
In general, serum calcium levels return to baseline levels 24 hours after dosing.
• Sprøjt dig selv lige efter, at du har taget pennen ud af køleskabet.
• Inject yourself with Preotact shortly after you have taken your pre-filled pen out of the refrigerator.
Patienter, der har vedvarende forhøjet serumcalcium (over øvre normalgrænse), skal undersøges for eventuel anden sygdom (f.eks. hyperparathyroidisme).
Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e.g. hyperparathyroidism).
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.
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.
• Brug ikke medicinen, hvis du kan se, at den er blevet uklar eller farvet.
• Do not use this medicine if you notice that it became cloudy or coloured.
Relativt få patienter inkluderet i fase III-studiet var < 5 år postmenopausalt og mellem 45 og 54 år (2 - 3 %).
Relatively few patients less than 5 years postmenopausal and 45-54 years of age were enrolled in the phase III study (2-3%).
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.
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.
Virkning på serumcalciumkoncentrationen
Effects on serum calcium concentrations
• Læg pennen tilbage i køleskabet lige efter, du har brugt den.
• Put the pre-filled pen back into the refrigerator immediately after you have used it.
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 %).
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%).
Forhøjet calcium/kreatinin-ratio i urin Forhøjet calcium i urinen
Urine calcium/creatinine ratio increased Urine calcium increased
For patienter, som tidligere har haft frakturer er NNT (numbers neaded to treat) 21 kvinder.
For patients with pre-existing fractures, number needed to treat (NNT) is 21 patients.
• Opbevar Preotact beskyttet mod lys.
• Keep Preotact protected from light
Hos de kvinder, der havde positivt respons for antistoffer, var der ingen evidens for hypersensitivitetsreaktioner, allergiske reaktioner, effekt på knoglemineraltæthed eller ændringer i serumcalcium.
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.
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.
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.
• Nålen skal pege lige op
• Point the needle end straight up
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.
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.
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.
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.
DEN FYLDTE PEN
THE PRE-FILLED PEN
Hvis du holder op med at tage Preotact
If you stop taking Preotact
Cirka 71,4 % af de patienter, der var i parathyreoideahormonbehandling rapporterede mindst en bivirkning.
Approximately 71.4% of the patients on parathyroid hormone reported at least one ADR.
Parathyreoideahormonets virkning på knoglerne afhænger af tilrettelæggelsen af den systemiske eksponering.
The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
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.
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.
Bland kun medicin i én pen ad gangen.
Only mix one pen at the time.
Parathyreoideahormonet fjernes effektivt fra blodbanen ved en receptormedieret proces i leveren og nedbrydes her til mindre peptidfragmenter.
Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments.
I begge behandlingsgrupper havde ca. 19 % af kvinderne haft mindst én tidligere vertebralfraktur ved baseline.
Overall, approximately 19% of the subjects in each treatment group had at least 1 prevalent vertebral fracture at baseline.
På samme måde blev volumetrisk trabekulær BMD af total-hofte forøget med 9; 6 og 2 % i de 3 grupper.
Similarly, volumetric trabecular BMD at the total hip increased by 9, 6, and 2%, respectively, in the 3 groups.
Tag Preotact, så længe din læge har fortalt dig.
Always use Preotact exactly as your doctor has told you.
Indholdet i cylinderampullen rekonstitueres i pennen.
The content of the cartridge is reconstituted in the pen.
• har en anden knoglesygdom (inklusive forøget produktion af parathyreoideahormon eller Pagets sygdom).
• if you have other bone disease (including hyperparathyroidism or Paget's disease);
Fragmenter af den aminoterminale ende nedbrydes yderligere i levercellen, mens fragmenterne fra carboxy-enden frigives til blodbanen og fjernes af nyrerne.
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.
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.
uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000), including isolated reports.
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.
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.
Der vil blive taget blodog/eller urinprøver for at måle kalkindholdet i dit blod eller din urin 1, 3 og 6 måneder efter behandlingsstart.
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.
Det vil sige, du kan betragte det som natriumfrit.
This means that it is essentially “sodium-free”.
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.
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.
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
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.
• Du må højst opbevare pennen med den færdigblandede medicin i 28 dage i køleskabet.
• You should keep the mixed pre-filled pen for maximum 28 days in the refrigerator.
• der er i, eller tidligere har gennemgået strålebehandling af skelettet
• if you shall have or previously have had radiation therapy to the skeleton;
• kvalme.
• nausea.
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.
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.
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.
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.
I den 28 dages periode kan den rekonstituerede opløsning opbevares i op til 7 dage ved temperaturer under 25 °C.
During the 28-day period the reconstituted solution can be stored for up to 7 days at temperatures below 25°C.
Stigningerne i BMD i total-hofte var henholdsvis 0,3; 1,9 og 3,0 % for de 3 behandlingsgrupper.
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively.
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.
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.
Fortyndet saltsyre (til pH-justering) Natriumhydroxid (til pH-justering)
Hydrochloric acid, dilute (for pH adjustment) Sodium hydroxide (for pH adjustment)
• Fjern nålen efter hver injektion og læg pennen tilbage i køleskabet ved 2-8 °C.
• Remove the needle after each daily injection and return the pre-filled pen to the refrigerator at 2-8°C.
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.
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.
Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 38 % i forhold til baseline efter 18 måneder.
Volumetric trabecular BMD at the lumbar spine increased by 38% over baseline at 18 months.
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.
Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP.
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.
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.
Stigningen i BMD for lumbal columna og lårbenshalsen var henholdsvis 6,8 % og 2,2 % hos patienter behandlet med Preotact.
The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact.
Tabellen nedenfor giver et overblik over alle bivirkninger (ADR), hvor hyppigheden er mindst 0,5 % højere i parathyreoideahormongruppen end i placebogruppen.
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.
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.
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.
Hvis du har glemt at tage Preotact
If you forget to use Preotact
Vigtige oplysninger, når du tager Preotact
Important information when using Preotact
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.
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.
Patienten skal instrueres grundigt i korrekt injektionsteknik (se pkt.
Patients must be trained to use the proper injection techniques (see section 6.6).
Ved lumbal columna forøgedes volumetrisk trabekulær BMD med 26; 13 og 11 % (Preotact, Preotact-alendronat og alendronat) efter 12 måneder.
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.
Der foreligger ikke komplette dyrestudier for reproduktionstoksisitet (se pkt.
Animal studies of reproductive toxicity are incomplete (see section 5.3).
Det er ikke nødvendigt med dosisjustering til patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30 - 80 ml/min).
No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min).
Hypercalcæmi var forbigående og sås hyppigst i de første 3 måneder af behandlingen.
The hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.
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.
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.
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.
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.
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.
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.
Fyldt pen (før blanding af medicinen): Må ikke opbevares ved temperaturer over 25 °C.
Pre-filled pen (before reconstitution): Do not store above 25°C.
Hypercalcæmi og/eller hypercalcuri afspejler de kendte farmakodynamiske virkninger af parathyreoideahormon i mavetarmkanalen, nyrerne og knoglerne.
Hypercalcemia and/or hypercalciuria reflect the known pharmacodynamic actions of parathyroid hormone in the gastrointestinal tract, the kidney, and the bone.
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.
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.
Hvis man oplever svimmelhed ved behandling med Preotact, bør man afholde sig fra at køre bil eller betjene maskiner indtil disse symptomer aftager.
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.
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.
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.
Pennen før blanding:
The pre-filled pen before mixing:
Hvis du har knogleskørhed, medfører det, at du er mere udsat for knoglebrud, især i ryg, hofter og håndled.
But if you have osteoporosis, it makes you more likely to break bones, especially in your spine, hips and wrists.
Cirkulerende carboxyterminale fragmenter filtreres gennem nyrerne og nedbrydes til endnu mindre fragmenter ved den tubulære reabsorption.
Circulating carboxy-terminal fragments are filtered by the kidney, but are subsequently broken to even smaller fragments during tubular reuptake.
2 stk. fyldte penne pr. pakning.
2 pre-filled pens per pack.
• dosering ændres til 100 mikrogram Preotact hver anden dag
• The frequency of Preotact dosing should be changed to 100 micrograms every other day
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.
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.
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.
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.
Farmakokinetikken for parathyreoideahormonet er ikke undersøgt hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min).
The pharmacokinetics of parathyroid hormone in patients with severe renal impairment (creatinine clearance of less than 30 ml/min) has not been investigated.
Behandling af forhøjet serumcalcium
Management of elevated serum calcium
Der er set forhøjede serumcalciumværdier under behandling med Preotact.
Elevated serum calcium was observed during Preotact treatment.
Når du har gjort det, er Preotact pennen klar til brug og medicinen er klar til at blive indsprøjtet under maveskindet.
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).
• Brug ikke resten af medicinen, hvis den har været opbevaret forkert.
• Do not use this medicine if it has not been stored correctly, even if it is not used up.