natgillin/translations-raw huggingface dataset:
Den anbefalede dosis er 100 mikrogram Preotact givet en gang dagligt som en subkutan injektion (under huden) i abdomen (maven).
The recommended dose is 100 micrograms of Preotact given once daily as a subcutaneous injection (under the skin) into the abdomen (tummy).
Når cylinderampullen sættes ind i den særlige injektionspen og pennen er skruet sammen, blandes pulver og solvens, så de til sammen udgør opløsningen til injektion.
When the cartridge is inserted in the special injection pen and the pen screwed together, the powder and solvent mix to make up the solution for injection.
Patienterne kan give sig selv indsprøjtningen, når de har lært at bruge de rigtige injektionsteknikker (der leveres en brugermanual sammen med pennen).
Patients may inject themselves once they have been trained to use the proper injection techniques (a user manual is supplied with the pen).
Patienterne kan også have behov for at tage calcium - og vitamin D- tilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
Patients may also need to take calcium and vitamin D supplements if they do not have enough from their diet.
Preotact kan anvendes i op til 24 måneder, patienterne kan derefter behandles med et bisphosphonat (et lægemiddel, som mindsker tabet af knoglemasse).
Preotact can be used for up to 24 months, patients can then be treated with a bisphosphonate (a medicine that reduces bone loss).
Det aktive stof i Preotact, parathyroidhormon, er identisk med det menneskelige parathyroidhormon.
The active substance in Preotact, parathyroid hormone, is identical to the human parathyroid hormone.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
How has Preotact been studied?
Hovedundersøgelsen var en stor undersøgelse af 2 532 kvinder med postmenopausal osteoporose.
The main study was a large study of 2,532 women with postmenopausal osteoporosis.
Preotact blev sammenlignet med placebo (uvirksom behandling).
Preotact was compared with placebo (dummy treatment).
Ca. to tredjedele af kvinderne fortsatte med at tage Preotact i op til 2 år, og deres knogletæthed blev målt.
About two-thirds of the women continued taking 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Knogletætheden var også hovedmålestokken i en anden undersøgelse, som så nærmere på brugen af Preotact med eller uden alendronat (et bisphosphonat).
The bone density was also the main measure in another study, which looked at the use of Preotact with or without alendronate (a biphosphonate).
Efter 18 måneder var der 42 vertebrale frakturer i placebogruppen (3, 37%) og 17 i Preotact- gruppen (1, 32%).
After 18 months, there were 42 vertebral fractures in the placebo group (3.37%) and 17 in the Preotact group (1.32%).
Dette viser, at Preotact hos kvinder, som tager det, i væsentlig grad mindsker risikoen for at få en vertebral fraktur i forhold til placebo.
This shows that Preotact significantly reduces the risk of having a vertebral fracture in the women who take it, in comparison to placebo.
Risikobegrænsningen var større hos kvinder, som allerede tidligere havde haft en brækket hvirvel, og hos kvinder, hvis score for knoglemassen i rygsøjlen allerede var lav ved undersøgelsens begyndelse, hvilket viser, at de har en mere skrøbelig rygsøjle.
The risk reduction was higher in women who already had a fractured vertebra in the past, and in women whose score for spine bone density was already low at the start of the study, indicating that they have a more fragile spine.
Undersøgelsen af Preotact med alendronat viste, at anvendelse af alendronat efter Preotact kunne bevirke yderligere forøgelser af knogletætheden.
The study of Preotact with alendronate showed that using alendronate after Preotact can bring further increases in the bone density.
De hyppigste bivirkninger er hypercalcæmi (øget calciumindhold i blodet), hypercalcuri (øget calciumindhold i urinen) og kvalme.
The most common side effects are hypercalcaemia (increased blood calcium), hypercalciuria (increased urine calcium), and nausea (feeling sick).
Den fuldstændige liste over alle de indberettede bivirkninger ved Preotact fremgår af indlægssedlen.
For the full list of all side effects reported with Preotact, see the Package Leaflet.
Preotact bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for parathyroidhormon eller et af de øvrige stoffer.
Preotact should not be used in people who may be hypersensitive (allergic) to parathyroid hormone or any of the other ingredients.
Preotact bør ikke anvendes til patienter: • som har fået stråleterapi på knoglerne, • som har en eventuel lidelse, der påvirker calciumbalancen i kroppen, • som har en knoglesygdom, der ikke er osteoporose, • med forhøjet alkalisk phosphatase (et enzym) af ukendte årsager, • med alvorlig nyre - eller leversygdom.
It should also not be used in patients: • who have had radiation therapy to the skeleton, • who have any disorder that affects the calcium balance in the body, • who have a bone disease that is not osteoporosis, • with unexplained high levels of alkaline phosphatase (an enzyme), • with severe kidney or liver disease
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Preotact er større end risiciene ved behandling af osteoporose hos postmenopausale kvinder, som er i højrisikogruppen for brud.
The Committee for Medicinal Products for Human Use (CHMP) decided that Preotact’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at high risk of fractures.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Preotact.
They recommended that Preotact be given marketing authorisation.
Andre oplysninger om Preotact:
Other information about Preotact:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Preotact til Nycomed Danmark ApS den 24. april 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Preotact to Nycomed Danmark ApS on 24 April 2006.
Den europæiske offentlige vurderingsrapport (EPAR) for Preotact kan ses i sin helhed her.
The full EPAR for Preotact is available here.
Dette sammendrag er sidst ajourført i marts 2006.
This summary was last updated in 03-2006.
Indgivelsesvej
Pharmaceutical Form Route of administration
EU/ 06/ 339/ 001
EU/ 06/ 339/ 001
pulver og solvens til injektionsvæske, opløsning
Powder and solvent for Subcutaneous use solution for injection
Tokammer cylinderampul
Powder: dual-chamber cartridge (glass); Solvent: dual-chamber cartridge
1, 61 mg (1, 4 mg/ ml)
1.61 mg (1.4 mg/ ml)
LÆGEMIDLETS NAVN
NAME OF THEMEDICINAL PRODUCT
Preotact 100 mikrogram pr. dosis pulver og solvens til injektionsvæske, opløsning.
Preotact 100 micrograms powder and solvent for solution for injection.
Preotact indeholder parathyreoideahormon fremstillet ved brug af en Escherchia coli- stamme, der er modificeret ved rekombinant DNA- teknologi.
Preotact contains parathyroid hormone manufactured using a strain of Escherichia coli modified by recombinant DNA technology.
Lægemidlet leveres i en tokammer cylinderampul.
The medicinal product is supplied in a dual-chamber cartridge.
Det første kammer indeholder 1, 61 mg parathyreoideahormon.
The first chamber contains 1.61 mg parathyroid hormone.
Hver dosis på 71, 4 mikroliter indeholder 100 mikrogram parathyreoideahormon.
Each dose of 71.4 microliter contains 100 micrograms parathyroid hormone.
Hver cylinderampul indeholder 14 doser.
Each cartridge contains 14 doses.
Det andet kammer indeholder en steril solvens til opløsning.
The second chamber contains a sterile solvent for reconstitution.
5. 1).
Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Den anbefalede dosis er 100 mikrogram parathyreoideahormon en gang daglig indgivet som subkutan injektion i abdomen.
The recommended dose is 100 micrograms of parathyroid hormone administered once-daily as a subcutaneous injection into the abdomen.
6. 6).
Patients must be trained to use the proper injection techniques (see section 6.6).
En manual med beskrivelse af korrekt brug af injektionspennen udleveres sammen med pennen.
A user manual is available with the Preotact pen to instruct patients on the correct use of the pen.
Pennen ligger ikke i pakningen med cylinderampullerne.
The pen is not included in the packs with cartridges.
Hvis det daglige indtag af calcium og vitamin D gennem kosten er utilstrækkeligt, bør der suppleres med calcium - og D- vitamintilskud.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
4. 4).
Data support continuous treatment with Preotact for up to 24 months (see section 4.4).
5. 1).
Following treatment with Preotact patients can be treated with a bisphosphonate to further increase bone mineral density (see section 5.1).
Særlige populationer Nedsat nyrefunktion Det er ikke nødvendigt med dosisjustering til patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30 – 80 ml/ min).
2 Specific populations Renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/ min).
Der foreligger ingen data for personer med svært nedsat
There is no data available in patients with severe renal impairment.
4. 3).
Preotact should therefore not be used in patients with severe renal impairment (see section 4.3).
Nedsat leverfunktion Det er ikke nødvendigt at reducere dosis til patienter med let til moderat nedsat leverfunktion (Child - Pugh score 7 – 9).
Hepatic impairment No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
4. 3).
Preotact should therefore not be used in patients with severe hepatic impairment (see section 4.3).
Børn og unge Preotact bør ikke anvendes til børn og unge under 18 år pga. mangel på data vedrørende sikkerhed og effekt.
Children and adolescents The safety and efficacy of Preotact in patients under 18 years have not been studied.
5. 2).
Elderly Dose adjustment based upon age is not required (see section 5.2).
(inkl. hyperparathyrodisme og Pagets Sygdom i knoglerne) • med uforklaret stigning i knoglespecifik alkalisk phosphatase • med svært nedsat nyrefunktion • med svært nedsat leverfunktion
Preotact is contraindicated in patients • with hypersensitivity to parathyroid hormone or to any of the excipients (see section 6.1) • who have previously received radiation therapy to the skeleton • with pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism • with metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’ s disease of the bone) • with unexplained elevations of bone-specific alkaline phosphatase • with severe renal impairment • with severe hepatic impairment
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen Patienter initieret til behandling med Preotact bør monitoreres for forhøjet calciumindhold i serum og/ eller urin efter 1, 3 og 6 måneders behandling.
Patients initiated on Preotact therapy should be monitored at months 1, 3 and 6 for elevated levels of serum and/ or urinary calcium.
Behandling af forhøjet serumcalcium Patienter, der har vedvarende forhøjet serumcalcium (over øvre normalgrænse), skal undersøges for eventuel anden sygdom (f. eks. hyperparathyroidisme).
Management of elevated serum calcium Patients with persistent elevated serum calcium (above the upper normal level) should be evaluated for underlying disease (e. g. hyperparathyroidism).
• tilskud af calcium og D- vitamin afbrydes • dosering ændres til 100 mikrogram Preotact hver anden dag • hvis de forhøjede værdier vedbliver, afbrydes behandlingen og patienten monitoreres indtil normalisering af værdierne
Calcium and vitamin D supplementation should be withdrawn The frequency of Preotact dosing should be changed to 100 micrograms every other day If elevated levels continue, Preotact therapy should be stopped and the patient monitored until the abnormal values have reverted to normal
Patienter med præ- eksisterende hypercalcæmi og eller hypercalcuri Preotacts effekt er undersøgt hos personer med præ- eksisterende hypercalcæmi og/ eller hypercalcuri.
Patients with pre-existing hypercalcemia and/or hypercalciuria Preotact has been studied in patients with pre-existing hypercalcemia and/or hypercalciuria.
Hos disse patienter sås en øget tendens til forværring af den præ- eksisterende hypercalcæmi og/ eller hypercalcuri ved behandling med Preotact.
In these patients, Preotact treatment was more likely to exacerbate their underlying hypercalcemia and/or hypercalciuria.
3 Preotacts effekt på patienter med aktiv urolithiasis er ikke undersøgt.
3 Preotact has not been studied in patients with active urolithiasis.
4. 5).
Caution should be exercised in patients receiving cardiac glucosides (see section 4.5).
5. 3).
Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of Preotact (see section 5.3).
Preotact indeholder meta- cresol, der kan forårsage allergiske reaktioner.
Preotact contains metacresol, which may cause allergic reactions.
Preotact indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
Parathyreoideahormon er et naturligt forekommende peptid, som ikke metaboliseres af og ikke hæmmer mikrosomale lægemiddelmetaboliserende leverenzymer (f. eks. cytochrom P450 isoenzymer).
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).
Kombinationsbehandling med parathyreoideahormon og alendronat har ikke vist en større effekt på knoglemineraltætheden efter afsluttet behandling i forhold til, hvis et af produkterne blev givet alene (Se pkt.
Combining parathyroid hormone with alendronate use has not been shown to provide any advantage over either form of treatment alone, when the end point of bone mineral density was evaluated.
5. 1).
(see section 5.1).
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.
From the knowledge of the mechanism of action, combined use of Preotact and cardiac glucosides may predispose patients to digitalis toxicity if hypercalcemia develops.
4. 6 Graviditet og amning Der foreligger ingen kliniske data om brug af parathyreoideahormon under graviditet og i forbindelse med amning.
There are no data available from the use of parathyroid hormone during pregnancy and lactation.
5. 3).
Animal studies of reproductive toxicity are incomplete (see section 5.3).
Preotact bør ikke anvendes under graviditet eller i forbindelse med amning.
Parathyroid hormone should not be used during pregnancy or breast-feeding.
Heraf fik 1341 parathoreiodeahormon.
The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2642 postmenopausal osteoporotic women of whom 1341 received parathyroid hormone.
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.
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.
Hypercalcæmi blev rapporteret hos 25, 3% og hypercalcuri forekom hos 39, 3% af de patienter, der var i Preotactbehandling.
Hypercalcemia was reported in 25.3% of patients and hypercalciuria in 39.3% of patients treated with Preotact.
4. 3; 4. 4 og 5. 1).
It was managed during the clinical programme by monitoring laboratory values and the use of a pre-specified management algorithm (see sections 4.3, 4.4, and 5.1).
Tabellen nedenfor giver et overblik over alle bivirkninger (ADR), hvor hyppigheden er mindst 0, 5% højere i parathyreoideahormongruppen end i placebogruppen.
4 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.
Meget almindelig (> 1/ 10); almindelig (> 1/ 100 og < 1/ 10); usædvanlig (> 1/ 1. 000 og < 1/ 100); sjælden (> 1/ 10. 000 og < 1/ 1000) og meget sjælden (< 1/ 10. 000) inklusive isolerede rapporter.
The following categories are used to rank the undesirable effects by frequency of occurrence: very common (> 1/10); common (> 1/100 and < 1/10); uncommon (> 1/1000 and < 1/100); rare (> 1/10,000 and < 1/1000); and very rare (< 1/10,000), including isolated reports.
N=1341 (%) Infektiøse og parasitære sygdomme Usædvanlig Influenza
N=1341 (%) Infections and Infestations Uncommon Influenza
Sygdomme i nervesystemet Almindelig Hovedpine Svimmelhed Usædvanlig
Metabolism and nutrition disorders Very common
Dysgeusi Parosmi
Hypercalcemia Common
0, 8 0, 7
25.3
Hjertesygdomme Almindelig
Blood calcium increased Uncommon
1, 0
3.1
Gastrointestinale sygdomme Meget almindelig Kvalme Almindelig
Blood alkaline phosphatase increased Anorexia Blood uric acid increased
13, 5
0.8 0.6 0.6
Opkastninger Constipation Dyspepsi
Nervous system disorders Common Headache Dizziness Uncommon
2, 5 1, 8 1, 3
9.3 3.9
5
Dysgeusia Parosmia
Organklasse
0.8 0.7
PTH N=1341 (%)
Cardiac disorders Common
Diare
Palpitations
Usædvanlig Abdominalsmerter
Gastrointestinal disorders Very common Nausea Common
0, 8
13.5
Sygdomme i bevægeapparatet og bindevæv Almindelig
Vomiting Constipation Dyspepsia Diarrhoea Uncommon
Muskelkramper Smerter i ekstremiteterne Rygsmerter
2.5 1.8 1.3 1.0
1, 1 1, 1 1, 0
Abdominal pain
39, 3
0.8
Forhøjet calcium/ kreatinin- ratio i urin Forhøjet calcium i urinen
Musculoskeletal, connective tissue and bone disorders Common Muscle cramp Pain in extremity Back pain
2, 9 2, 2
1.1 1.1 1.0
Almene lidelser og reaktioner på indgivelsesstedet Almindelig
Renal and urinary disorders
Erythem ved injektionssted Træthed Astheni Usædvanlig
5 Very common Hypercalciuria Common
2, 6 1, 8 1, 2
39.3
Irritation ved injektionssted
Urine calcium/creatinine ratio increased Urine calcium increased
0, 9
2.9 2.2
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.
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%).
Antistoffer mod parathyreoideahormon 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.
Antibodies to parathyroid hormone 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.
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 titer, there was no evidence of hypersensitivity reactions, allergic reactions, effects on bone mineral density response, or effects on serum calcium.
Tegn og symptomer I de kliniske afprøvninger er der konstateret 17 utilsigtede overdoseringstilfælde med Preotact.
Signs and symptoms In the Preotact clinical program, accidental overdose was reported for 17 subjects.
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.
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.
Behandling af overdosering Der findes ingen specifik antidot mod Preotact.
Overdose management There is no specific antidote for Preotact.
ATC- gruppe:
Pharmacotherapeutic group: parathyroid hormone, ATC code:
Virkningsmekanisme Preotact indeholder rekombinant humant parathyreoideahormon, som er identisk med det intakte humane 84- aminosyrepolypeptid.
Mechanism of action Preotact contains recombinant human parathyroid hormone which is identical to the full-length native 84-amino acid polypeptide.
Farmakodynamisk virkning Parathyreoideahormonets virkning på knoglerne afhænger af tilrettelæggelsen af den systemiske eksponering.
6 The skeletal effects of parathyroid hormone depend upon the pattern of systemic exposure.
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.
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.
Virkning på serumcalciumkoncentrationen Parathyreoideahormonet er den vigtigste regulator af serumcalciumhomeostasen.
Effects on serum calcium concentrations Parathyroid hormone is the principal regulator of serum calcium homeostasis.
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).
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.
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 placebo- treated patients.
Hypercalcæmi var forbigående og sås oftest i de første 3 måneder efter behandlingsstart.
The hypercalcemia was transient and was reported most frequently in the first 3 months of treatment.
4. 3 og 4. 4).
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).
Klinisk virkning Forekomst af frakturer 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.
Clinical efficacy Effect on fracture incidence 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.
Alle patienter fik dagligt tilskud af calcium (700 mg) og D- vitamin (400 IE).
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.
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.
Den gennemsnitlige T- score ved baseline var ca. ÷3, 0 i begge behandlingsgrupper.
The mean baseline lumbar T score was approximately -3.0 in each treatment group.
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.
17 (1.32%), p=0.001.