FrancophonIA/ELRC3.0 huggingface dataset:
English: • swelling, mainly in the hands, feet and legs.
Danish: • hævelser, hovedsagelig af hænder, fødder og ben.
English: • Write down your first injection date on a calendar.
Danish: • Nedskriv datoen for Deres første indsprøjtning i en kalender.
English: Risk Factors
Danish: Risikofaktorer
English: Therefore, FORSTEO should be used with caution.
Danish: Derfor skal FORSTEO anvendes med forsigtighed.
English: • During injection, you may hear one or more clicks - this is a normal device operation.
Danish: • Under indsprøjtning kan De muligvis høre et eller flere klik - dette er normalt for pennen.
English: Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C.
Danish: Kemisk, fysisk og mikrobiologisk stabilitet under brug er bevist i 28 dage ved 2-8°C.
English: D. I cannot get the needle off.
Danish: D. Jeg kan ikke få nålen af.
English: There is no specific antidote for FORSTEO.
Danish: Der findes ingen specifik antidot til FORSTEO.
English: C. I see an air bubble in my FORSTEO.
Danish: C. Jeg kan se en luftboble i min FORSTEO-pen.
English: Your doctor will advise you and decide how long you should be treated with FORSTEO.
Danish: Deres læge kan råde Dem og beslutte, hvor længe De skal behandles med FORSTEO.
English: Sixty-nine percent of patients completed the 18-month primary phase.
Danish: 69 % af patienterne gennemførte den 18 måneder lange primære fase.
English: To help you remember to take your medicine, inject it at about the same time each day.
Danish: Som en hjælp til at huske at tage Deres medicin, bør De tage indsprøjtningen på omtrent samme tidspunkt hver dag.
English: Treatment should only be initiated if the benefit clearly outweighs risks in this population.
Danish: Behandlingen af denne patientgruppe bør kun påbegyndes, hvis fordelene klart opvejer risiciene.
English: Follow the directions carefully when using the pen.
Danish: Følg instruktionerne nøje, når De anvender pennen.
English: This indicates that you have now used all the medicine that can be injected accurately even though you may still see some medicine left in the cartridge.
Danish: Dette viser, at De nu har brugt al den medicin, som kan indsprøjtes nøjagtigt, skønt De af og til kan se noget medicin, der er efterladt i cylinderampullen.
English: No clinically significant interactions were noted.
Danish: Der blev ikke fundet nogen klinisk signifikante interaktioner.
English: These may be signs there is too much calcium in your blood.
Danish: Dette kan være tegn på, der er for meget kalk i Deres blod.
English: This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83).
Danish: Dette studie inkluderede postmenopausale kvinder (N=277), præmenopausale kvinder (N=67) og mænd (N=83).
English: If you do not feel better, you should call a doctor before you continue treatment.
Danish: Hvis De ikke får det bedre, skal De kontakte lægen, før de fortsætter med behandlingen.
English: Younger adult population
Danish: Den yngre, voksne population
English: The volume of distribution is approximately 1.7 L/kg.
Danish: Fordelingsvolumenet er ca. 1,7 l/kg.
English: This user manual was last revised in {MM/YYYY}
Danish: Denne brugervejledning blev senest ændret {MM/ÅÅÅÅ}
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Danish: Med baggrund i de knoglefysiologiske forskelle mellem rotter og mennesker er den kliniske relevans af disse fund sandsynligvis lille.
English: Each pen should be used by only one patient.
Danish: Hver pen er beregnet til brug af én patient.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency web site.
Danish: Denne indlægsseddel findes på alle EU/EØS-sprog på det Europæiske Lægemiddelagenturs hjemmeside.
English: New vertebral fracture (≥1) a
Danish: Ny vertebral fraktur (≥1)a
English: To reset the FORSTEO, follow the steps below.
Danish: Sådan skal De tage FORSTEO
English: Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours.
Danish: Et tilfælde begyndte typisk inden for 4 timer efter doseringen og forsvandt spontant i løbet af få minutter til få timer.
English: These patients should refrain from driving or the use of machines until symptoms have subsided.
Danish: Disse patienter bør ikke føre bil og betjene maskiner, før symptomerne er aftaget.
English: It produced no teratogenic effects in rats, mice or rabbits.
Danish: Der sås ingen teratogen effekt på rotter, mus eller kaniner.
English: Routine calcium monitoring during therapy is not required.
Danish: Rutinemæssig monitorering af calcium er ikke nødvendigt under behandlingen.
English: Date of first use:
Danish: Dato for første ibrugtagning:
English: • The FORSTEO contains 28 days of medicine.
Danish: • FORSTEO indeholder medicin til 28 dage.
English: During this observational period, other osteoporosis treatments were allowed and additional assessment of vertebral fractures was performed.
Danish: I denne observationsperiode var anden osteoporosebehandling tilladt, og yderligere vurdering af vertebrale frakturer blev foretaget.
English: Children and adolescents FORSTEO should not be used in children and adolescents (less than 18 years).
Danish: Børn og unge FORSTEO må ikke bruges til børn og unge (under 18 år).
English: Other Important Notes
Danish: Andre vigtige oplysninger
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr dosis, dvs. den er i det væsentlige natriumfri.
English: INFORMATION IN BRAILLE FORSTEO
Danish: INFORMATION I BRAILLESKRIFT FORSTEO
English: The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000).
Danish: Følgende konvention er anvendt til at klassificere bivirkningerne: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1.000) meget sjælden (<1/10.000).
English: FORSTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Danish: FORSTEO bør anvendes med forsigtighed hos patienter med aktiv eller nylig urolithiasis, da det muligvis kan forværre tilstanden.
English: • Do not transfer the medicine into a syringe.
Danish: • Overfør ikke medicinen til en sprøjte.
English: The pivotal study included 1637 postmenopausal women (mean age 69.5 years).
Danish: Det primære forsøg omfattede 1637 postmenopausale kvinder (gennemsnitsalder: 69,5 år).
English: FORSTEO has no or negligible influence on the ability to drive and use machines.
Danish: FORSTEO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: You can use FORSTEO for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).
Danish: De kan anvende FORSTEO-pennen i op til 28 dage efter den første indsprøjtning, så længe pennen opbevares i et køleskab (2°C - 8°C).
English: In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.
Danish: Hos postmenopausale kvinder er der påvist en signifikant reduktion i forekomsten af vertebrale og ikke-vertebrale frakturer, men ikke hoftefrakturer.
English: In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis can occur.
Danish: Der kan i sjældne tilfælde opstå alvorlige og potentielt livstruende allergiske reaktioner, herunder anafylaksi.
English: FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Danish: FORSTEO blev administreret i enkeltdoser på op til 100 mikrogram samt i gentagne doser på op til 60 mikrogram/dag i 6 uger.
English: At baseline, 35 % of patients had a vertebral fracture and 59 % had a non-vertebral fracture.
Danish: Ved baseline havde 35 % af patienterne haft en vertebral fraktur, og 59 % af patienterne havde haft en ikke-vertebral fraktur.
English: Biostransformation
Danish: Biotransformation
English: Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent FORSTEO injection.
Danish: Hvis der skal tages blodprøver for serumcalcium fra en patient, bør dette derfor gøres mindst 16 timer efter den seneste FORSTEO-injektion.
English: • Contact your doctor or pharmacist if you notice any of the following:
Danish: • Kontakt firmaet, lægen eller apotekspersonalet, hvis De bemærker noget af følgende:
English: Teriparatide did not increase the incidence of any other type of neoplasia in rats.
Danish: Teriparatid øgede ikke forekomsten af nogen anden form for neoplasi hos rotter.
English: Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84).
Danish: Dyreforsøg har vist, at svært nedsat hepatisk blodomløb nedsætter eksponeringen af PTH til det primære nedbrydningssystem (Kupffers stjerneceller) og dermed clearance af PTH(1-84).
English: Fracture Incidence in Postmenopausal Women: Placebo (N = 544) (%)
Danish: Forekomsten af frakturer hos postmenopausale kvinder: Placebo (N = 544) (%)
English: The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.
Danish: Embryotoksiciteten, som blev set hos kaniner, kan muligvis være relateret til deres meget større følsomhed over for virkningerne af PTH på calciumioniseret blod sammenlignet med gnavere.
English: No fatalities associated with overdose have been reported.
Danish: Der er ikke rapporteret om dødsfald i forbindelse med overdosering.
English: • The FORSTEO is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device.
Danish: • FORSTEO frarådes til brug af blinde eller synshæmmede uden hjælp af en person, der er instrueret i rigtig brug af pennen.
English: Remember to use a new needle every time you inject to be sure your FORSTEO will work properly.
Danish: Husk at bruge en ny nål hver gang De sprøjter ind for at sikre, Deres FORSTEO-pen virker rigtigt.
English: Dosage adjustment based on age is not required.
Danish: Det er ikke nødvendigt at justere dosis på baggrund af alder.
English: 680 subjects were randomised to Forsteo and 680 subjects were randomised to oral risedronate 35 mg/week.
Danish: 680 patienter blev randomiseret til Forsteo og 680 patienter blev randomiseret til oral risedronat 35 mg/uge.
English: Red stripe
Danish: Rød stribe
English: You should not receive more than one treatment course of 24 months over your lifetime.
Danish: De bør ikke få mere end én behandlingskur på 24 måneder i Deres levetid.
English: Pregnancy FORSTEO is contraindicated for use during pregnancy (see section 4.3).
Danish: Graviditet FORSTEO er kontraindiceret under graviditet (se punkt 4.3).
English: Serum and urine calcium
Danish: Serum- og urincalcium
English: FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Danish: FORSTEO elimineres ved hepatisk og ekstrahepatisk clearance (ca. 62 l/time hos kvinder og 94 l/time hos mænd).
English: Check to make sure the red stripe shows.
Danish: Kontroller, at den røde stribe viser sig.
English: Pull off white cap
Danish: Træk den hvide hætte af
English: Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy.
Danish: Generelt blev disse antistoffer først påvist efter 12 måneders behandling og aftog efter seponering af behandlingen.
English: Never share your FORSTEO pen with others.
Danish: Del ikke Deres FORSTEO-pen med andre.
English: Overdose experience based on post-marketing spontaneous reports In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose.
Danish: Erfaring med overdosering baseret på spontane indberetninger efter markedsføringen af præparatet: Efter markedsføringen har der været tilfælde af medicineringsfejl, hvor hele indholdet af pennen med teriparatid (op til 800 mikrogram) blev administreret som en enkelt dosis.
English: No needles are supplied with the product.
Danish: Der medfølger ikke nåle med produktet.
English: FORSTEO is indicated in adults.
Danish: FORSTEO er indiceret til voksne.
English: The pens are available in cartons containing one or three pens.
Danish: Pennene fås i pakninger med en eller tre penne.
English: • Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the cartridge.
Danish: • Opbevar ikke FORSTEO-pennen med påsat nål, da dette kan medføre, at der dannes luftbobler i cylinderampullen.
English: In some cases, no adverse events occurred as a result of the overdose.
Danish: I nogle tilfælde blev der ikke observeret bivirkninger som resultat af overdoseringen.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
Danish: Hver FORSTEO-pakning indeholder en brugervejledning, der udførligt beskriver brugen af pennen.
English: • if you have had radiation therapy involving your bones.
Danish: • hvis De har fået strålebehandling, som påvirker Deres knogler.
English: 6) Point the needle down into an empty container.
Danish: 6) Lad nålen pege ned i en tom beholder.
English: Solution
Danish: Løsning
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinier.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003
Danish: Dato for første markedsføringstilladelse: 10. juni 2003
English: Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded.
Danish: Indtil yderligere kliniske data foreligger, bør den anbefalede behandlingsvarighed på 24 måneder ikke overskrides.
English: Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
Danish: Behandling af en formodet overdosis bør inkludere midlertidig seponering af FORSTEO, monitorering af serumcalcium og indledning af relevante støttende foranstaltninger, som f.eks. hydrering.
English: Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).
Danish: I stedet SKAL De nulstille FORSTEO-pennen (se Fejlfinding Punkt A).
English: The half-life of FORSTEO is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from the injection site.
Danish: Halveringstiden for FORSTEO er ca. 1 time ved subkutan administration, hvilket svarer til den tid, absorptionen fra injektionsstedet tager.
English: The FORSTEO is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use.
Danish: FORSTEO-pennen er fremstillet til at sprøjte den fulde dosis ind, hver gang den anvendes i henhold til anvisningerne i afsnittet Brugsvejledning.
English: If the yellow shaft does not show, you have completed the injection steps correctly.
Danish: Hvis det gule skaft ikke er synligt, så har De udført indsprøjtningstrinene korrekt.
English: In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin.
Danish: I et studie med 15 raske forsøgspersoner, der fik digoxin dagligt, indtil steady state var nået, påvirkede en enkelt dosis FORSTEO ikke effekten af digoxin på hjertet.
English: Lumbar spine BMD significantly increased by 3 months.
Danish: BMD i lænderygsøjlen var steget signifikant efter 3 måneder.
English: The effect of teriparatide on human foetal development has not been studied.
Danish: Teriparatids påvirkning af fostrets udvikling er ikke undersøgt hos mennesker.
English: FORSTEO contains sodium:
Danish: FORSTEO indeholder natrium:
English: The black injection button will be all the way in to show that the full dose has been injected from the FORSTEO.
Danish: Den sorte indsprøjtningsknap vil være fuldstændigt inde for at vise, at den fulde dosis er indsprøjtet fra FORSTEOpennen.
English: Twenty-eight percent of patients had one or more radiographic vertebral fractures at baseline.
Danish: 28 % af patienterne havde en eller flere vertebrale frakturer ved baseline.
English: Results from up to 24 months (median: 19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 1).
Danish: Resultaterne af behandling med FORSTEO i op til 24 måneder (median: 19 måneder) viste en statistisk signifikant reduktion af frakturer (se tabel 1).
English: If you experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection (frequency is common), this should clear up in a few days or weeks.
Danish: Hvis De får ubehag i form af rødmen i huden, smerter, hævelser, kløe, blå mærker eller mindre blødninger omkring indsprøjtningsstedet (hyppigheden er almindelig), skal dette aftage i løbet af få dage eller uger.
English: However, sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity.
Danish: Sporadiske rapporter har imidlertid antydet, at hyperkalcæmi kan prædisponere patienter for digitalistoksicitet.
English: • pain in the muscles and pain in the joints.
Danish: • smerter i muskler og led.
English: Do not share your pen or your needles as this may risk transmission of infectious agents.
Danish: De må ikke dele pen eller nåle med andre, da der er risiko for, at smitsomme stoffer kan overføres.
English: The mean (median) vitamin D intake for the teriparatide arm was 1433 IU/day (1400 IU/day) and for the risedronate arm was 1191 IU/day (900 IU/day).
Danish: Middelindtag (median) vitamin D for teriparatid-armen var 1433 IE/dag (1400 IE/dag) og for risedronat-armen var det 1191 IE/dag (900 IE/dag).
English: If you feel dizzy you should not drive or use machines until you feel better.
Danish: Hvis De føler Dem svimmel, må De ikke køre bil eller betjene værktøj eller maskiner, før De har det bedre.
English: FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Danish: FORSTEO er undersøgt i farmakodynamiske interaktionsstudier med hydrochlorthiazid.
English: Uncommon: Hypercalcaemia greater than 2.76 mmol/L, hyperuricemia Rare: Hypercalcaemia greater than 3.25 mmol/L
Danish: Ikke almindelig: Hyperkalcæmi over 2,76 mmol/l, hyperurikæmi Sjælden: Hyperkalcæmi over 3,25 mmol/l Psykiske forstyrrelser
English: The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
Danish: FORSTEOs virkninger på skelettet afhænger af, hvordan den systemiske eksponering tilrettelægges.
English: Becton, Dickinson and Company pen needles can be used.
Danish: Pen-nåle fra Becton, Dickinson og Company kan anvendes.
English: Your pen contains 28 days of medicine.
Danish: Pennen indeholder medicin til 28 dage.
English: • Never store the FORSTEO in the freezer.
Danish: • Opbevar aldrig FORSTEO i fryseren.
English: • Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
Danish: • Andre metaboliske knoglesygdomme (inklusive hyperparatyreoidisme og Pagets knoglesygdom) end primær osteoporose eller glukokortikoidinduceret osteoporose.
English: A 24-month, randomized, double-blind, comparator-controlled Phase 4 study included 1,360 postmenopausal women with established osteoporosis.
Danish: Et 24 måneder, randomiseret, dobbeltblindet comparator-kontrolleret fase 4 forsøg inkluderede 1360 postmenopausale kvinder med konstateret osteoporose.
English: Inject FORSTEO each day for as long as your doctor prescribes it for you.
Danish: De skal tage FORSTEO hver dag i så lang tid, som Deres læge har udskrevet det til Dem.
English: FORSTEO (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Danish: FORSTEO (rhPTH(1-34)) er den aktive del (134) af det endogene humane parathyreoideahormon.
English: Pharmaco-therapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05 AA02.
Danish: Farmakoterapeutisk klassifikation: Calciumhomeostase, Parathyreoideahormoner og -analoger, ATCkode: H05AA02.
English: • reduced kidney function, including renal failure
Danish: • nedsat nyrefunktion, inklusive nyresvigt
English: • If the FORSTEO has been left out of the refrigerator, do not throw the pen away.
Danish: • Hvis FORSTEO-pennen har været efterladt uden for køleskabet, så kasser ikke pennen.
English: Relative risk (95% CI) vs. placebo
Danish: Relativ risiko vs. placebo (95% KI)
English: Patients must be trained to use the proper injection techniques (see section 6.6).
Danish: Patienter skal undervises i at bruge korrekte injektionsteknikker (se pkt.
English: Osteoporosis is a disease that causes your bones to become thin and fragile.
Danish: Knogleskørhed er en sygdom, der gør dine knogler tynde og skrøbelige.
English: Some patients have experienced severe back cramps or pain which lead to hospitalisation.
Danish: Nogle patienter har oplevet alvorlige rygkramper eller smerter, der medførte indlæggelse.
English: 437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.
Danish: 437 patienter (gennemsnitsalder: 58,7 år) indgik i et forsøg med mænd med hypogonadisk (defineret ved lavt niveau af fri testosteron om morgenen eller forhøjet FSH eller LH) eller idiopatisk osteoporose.
English: The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension.
Danish: De bivirkninger, som kan forventes ved overdosering, er forsinket hyperkalcæmi og risiko for ortostatisk hypotension.
English: • if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Danish: • Hvis De lider af vedvarende kvalme, opkastning, forstoppelse, nedsat energi eller muskelsvaghed.
English: If you stop taking FORSTEO
Danish: Hvis De holder op med at bruge FORSTEO
English: There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
Danish: Der var ingen tegn på overfølsomhedsreaktioner, allergiske reaktioner, effekt på serumcalcium eller effekt på knoglemineraltætheden (BMD).
English: Transient, orthostatic hypotension or dizziness was observed in some patients.
Danish: Forbigående ortostatisk hypotension eller svimmelhed er observeret hos nogle patienter.
English: • Pre-existing hypercalcaemia
Danish: • Præeksisterende hyperkalcæmi
English: OTHER Store in a refrigerator
Danish: ANDET Opbevares i køleskab
English: Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenetic mechanism.
Danish: Rotter, som var i næsten livsvarig behandling med daglige injektioner, fik dosisafhængig overdreven knogledannelse og havde øget forekomst af osteosarkom, der højst sandsynligt skyldes en epigenetisk mekanisme.