FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also occur in patients receiving glucocorticoids.
Danish: Det kan også opstå hos patienter, som får glukokortikoider.
English: Women with other diseases or on therapies that may affect bone were excluded from this study.
Danish: Kvinder med andre sygdomme eller i andre behandlinger, der kan påvirke knoglemassen, var udelukket fra dette studie.
English: If a dose of Prolia is missed, the injection should be administered as soon as possible.
Danish: Hvis en dosis af Prolia springes over, skal injektionen gives så hurtigt som muligt.
English: Patients who did not complete the study for any reason had higher on-treatment fracture rates.
Danish: Patienter, der ikke fuldførte studiet, uanset årsagen, havde højere frakturrater under behandlingen.
English: Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study.
Danish: Patienter med eGFR < 30 ml/min/1,73 m2 blev udelukket fra studiet.
English: • Outer area of upper arm (only if someone else is giving you the injection).
Danish: • forsiden af overarmen (kun, hvis en anden person giver dig injektionen)
English: Use the peel-off stickers to mark the next injection date on your personal calendar and/or the reminder card to keep a record of the next injection date.
Danish: Brug klistermærkerne til at markere den næste injektionsdato i din kalender og/eller huskekortet til at holde styr på næste injektionsdato.
English: Concomitant glucocorticoid treatment is an additional risk factor for hypocalcaemia.
Danish: Samtidig glukokortikoidbehandling er en yderligere risikofaktor for hypokalcæmi.
English: A no observed adverse effect level for reproductive effects was not established.
Danish: Der blev ikke fastlagt et niveau for ingen observeret reproduktionsmæssig påvirkning.
English: The risk of ONJ increases in patients treated for a long time (may affect up to 1 in 200 people if treated for 10 years).
Danish: Risikoen for ONJ er forhøjet hos patienter, der behandles i lang tid (kan ramme op til 1 ud af 200 personer, hvis behandlingen varer i 10 år).
English: • are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
Danish: • får lægemidler, der kaldes for kortikosteroider (for eksempel prednisolon eller dexamethason).
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Danish: • Det er vigtigt, at du ikke forsøger at give dig selv injektionen, medmindre du har fået instruktioner af din læge eller sundhedspersonalet.
English: A total of 2,626 subjects (58% of the women included in the extension study i.e. 34% of the women included in the pivotal study) completed the extension study.
Danish: I alt 2.626 patienter (58 % af kvinderne, der var inkluderet i forlængelsesstudiet, dvs. 34 % af kvinderne inkluderet i det pivotale studie) fuldførte forlængelsesstudiet.
English: It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du er i behandling med et andet lægemiddel, der indeholder denosumab.
English: It is important to identify patients at risk for hypocalcaemia.
Danish: Det er vigtigt at identificere patienter med risiko for hypokalcæmi.
English: Date of latest renewal: 15 January 2015
Danish: Dato for første markedsføringstilladelse: 26. maj 2010 Dato for seneste fornyelse: 15. januar 2015
English: This can eventually lead to a condition called osteoporosis.
Danish: Dette kan med tiden føre til en tilstand, der kaldes osteoporose (knogleskørhed).
English: Temporary interruption of treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Danish: Midlertidig afbrydelse af behandlingen, indtil tilstanden svinder, og de bidragende risikofaktorer om muligt er minimeret, bør overvejes.
English: The study was not powered to show a difference in fractures.
Danish: Studiet havde ikke statistisk styrke til at vise en forskel i frakturer.
English: The pharmacokinetic profile in paediatric populations has not been assessed.
Danish: Den farmakokinetiske profil i pædiatriske populationer er ikke undersøgt.
English: • don't receive routine dental care or have not had a dental check-up for a long time.
Danish: • ikke jævnligt går til tandlæge eller ikke har fået tjekket dine tænder i lang tid.
English: Very common Very common Rare
Danish: Meget almindelig Meget almindelig Sjælden
English: Do not touch the cleaned area of the skin.
Danish: Rør ikke ved det afrensede område af huden.
English: Problems with your mouth, teeth or jaw
Danish: Problemer med mund, tænder eller kæbe
English: Standard tests to investigate the genotoxicity potential of denosumab have not been evaluated, since such tests are not relevant for this molecule.
Danish: Standardtester til undersøgelse af denosumabs genotoksiske potentiale er ikke blevet evalueret, da sådanne test ikke er relevante for dette molekyle.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see section 4.4).
Danish: Behovet for fortsat behandling bør revurderes regelmæssigt baseret på denosumabs fordele og potentielle risici hos den enkelte patient, især efter 5 års brug eller mere (se pkt.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer ikke direkte eller indirekte skadelige virkninger for så vidt angår fertiliteten (se pkt.
English: Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Prolia.
Danish: Din læge vil udlevere et patientkort til dig, der indeholder vigtige sikkerhedsoplysninger, du skal være opmærksom på inden og under din behandling med Prolia.
English: - The active substance is denosumab.
Danish: - Aktivt stof: denosumab.
English: Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe og systemorganklasse er bivirkningerne opstillet efter faldende alvorlighed.
English: The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established.
Danish: Den optimale samlede varighed af antiresorptiv behandling af osteoporose (herunder både denosumab og bisfosfonater) er ikke fastlagt.
English: A trend was observed between higher body weight and lower exposure based on AUC and Cmax.
Danish: Der blev observeret en tendens til lavere eksponering ved højere legemsvægt baseret på AUC og Cmax.
English: Prolia has not been tested in pregnant women.
Danish: Prolia er ikke blevet testet på gravide kvinder.
English: • have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
Danish: • tidligere er blevet behandlet med bisfosfonater (bruges til behandling eller forebyggelse af knoglelidelser).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Prolia is used to treat:
Danish: Prolia bruges til behandling af:
English: Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture.
Danish: Patienter med sådanne symptomer bør undersøges for ufuldstændig femurfraktur.
English: The following convention has been used for the classification of the adverse reactions (see table 1): 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) and not known (cannot be estimated from the available data).
Danish: Nedenstående konvention er anvendt til klassifikation af bivirkningerne (se tabel 1): 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), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There are no or limited amount of data from the use of denosumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af denosumab til gravide kvinder.
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Danish: Metabolisme og eliminering forventes at følge immunglobuliners udskillelsesveje, hvilket fører til nedbrydning til små peptider og de enkelte aminosyrer.
English: The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Danish: Behandlingsstart/nye behandlingsforløb bør udsættes hos patienter med ikke-ophelede, åbne bløddelslæsioner i munden.
English: 0-3 years *p < 0.0001, **p < 0.0001 - exploratory analysis
Danish: *p < 0,0001, **p < 0,0001 - eksploratorisk analyse
English: Efficacy and safety of Prolia once every 6 months for 1 year were investigated in 242 men aged 31-84 years.
Danish: Effekten og sikkerheden af Prolia én gang hver 6. måned i 1 år blev undersøgt hos 242 mænd i alderen 31-84 år.
English: The best places to inject are the top of your thighs and the abdomen.
Danish: Det bedste sted at give injektionen er øverst på lårene og på maven.
English: Sodium hydroxide (for pH adjustment)* Sorbitol (E420)
Danish: Natriumhydroxid (til justering af pH)* Sorbitol (E420)
English: Prolia has no or negligible influence on the ability to drive and use machines.
Danish: Prolia påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: However, the trend is not considered clinically important, since pharmacodynamic effects based on bone turnover markers and BMD increases were consistent across a wide range of body weight.
Danish: Tendensen anses dog ikke for at være klinisk vigtig, da de farmakodynamiske effekter baseret på knogleomsætningsmarkører og BMD-øgning var konsistente over et bredt legemsvægts-interval.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Prolia administration.
Danish: Under behandlingen bør invasive tandbehandlinger kun gennemføres efter nøje overvejelse og undgås tæt på tidspunktet for administration af Prolia.
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX04
Danish: Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme - andre lægemidler, med virkning på knoglestruktur og mineralisering, ATC-kode: M05BX04
English: • bone, joint, and/or muscle pain which is sometimes severe, • arm or leg pain (pain in extremity).
Danish: • smerter i knogler, led og/eller muskler, der sommetider kan være alvorlige, • smerter i arme eller ben (smerter i ekstremiteter).
English: The carcinogenic potential of denosumab has not been evaluated in long-term animal studies.
Danish: Denosumabs karcinogene potentiale er ikke blevet undersøgt i langsigtede dyrestudier.
English: Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks after the initial dose.
Danish: Monitorering af calciumniveauerne anbefales inden hver dosis og, hos patienter, der er prædisponerede for hypokalcæmi, inden for to uger efter den første dosis.
English: • if you have low calcium levels in the blood (hypocalcaemia).
Danish: • hvis du har lave niveauer af calcium i blodet (hypokalcæmi).
English: These data indicate that continued treatment with Prolia is required to maintain the effect of the medicinal product.
Danish: Disse data indikerer, at fortsat behandling med Prolia er nødvendig for at bevare præparatets effekt.
English: Put the needle fully into the skin as shown by your doctor or healthcare provider.
Danish: Før kanylen helt ind i huden, som din læge eller sygeplejerske har vist det.
English: Age (28-87 years), race and disease state (low bone mass or osteoporosis; prostate or breast cancer) do not appear to significantly affect the pharmacokinetics of denosumab.
Danish: Alder (28-87 år), race og sygdomsstatus (lav knoglemasse eller osteoporose; prostata- eller brystcancer) synes ikke at påvirke denosumabs farmakokinetik i signifikant grad.
English: Push the plunger with a slow constant pressure, always keeping the skin pinched.
Danish: Tryk stemplet ind med et langsomt, konstant tryk, mens du hele tiden klemmer huden sammen.
English: At 2 years, the corresponding numbers were 4.1% versus 5.8% for new radiological vertebral fractures and 5.3% versus 3.8% for non-vertebral fractures.
Danish: Efter 2 år var de tilsvarende tal 4,1 % kontra 5,8 % for nye radiologiske vertebrale frakturer og 5,3 % kontra 3,8 % for ikke-vertebrale frakturer.
English: • if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for denosumab eller et af de øvrige indholdsstoffer i Prolia (angivet i punkt 6).
English: The most common side effects with Prolia (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity.
Danish: De mest almindelige bivirkninger af Prolia (observeret hos mere end én patient ud af ti) er smerter i bevægeapparatet og smerter i ekstremiteter.
English: MedDRA system organ class Frequency category
Danish: MedDRA-systemorganklasse Hyppighed
English: Tell your doctor if you have or have ever had severe kidney problems, kidney failure or have needed dialysis or are taking medicines called glucocorticoids (such as prednisolone or dexamethasone), which may increase your risk of getting low blood calcium if you do not take calcium supplements.
Danish: Fortæl det til din læge, hvis du har eller nogensinde har haft alvorlige nyreproblemer, nyresvigt eller har haft behov for dialyse, eller hvis du tager lægemidler, der kaldes glukokortikoider (som for eksempel prednisolon eller dexamethason), idet det kan øge din risiko for at få lave niveauer af calcium i blodet, hvis du ikke tager calciumtilskud.
English: Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Danish: 6 måneder efter fødslen viste de knoglerelaterede ændringer tegn på bedring og tandfrembruddet var ikke påvirket.
English: The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Danish: Behandlingsplanen for patienter, der udvikler ONJ, skal udarbejdes i tæt samarbejde mellem den behandlende læge og en tandlæge eller tandkirurg med ekspertise inden for ONJ.
English: Musculoskeletal pain leading to discontinuation of study treatment was uncommon.
Danish: Smerter i bevægeapparatet, som førte til seponering af studiebehandlingen, var ikke almindeligt.
English: • Before administration, the solution should be inspected.
Danish: • Opløsningen skal kontrolleres inden indgivelse.
English: There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour.
Danish: Der var ingen tegn på maternelle skader før fødslen, og uønskede virkninger hos mødrene under fødslen optrådte sjældent.
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 5 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Danish: Med anvendelse af et sensitivt immunassay blev < 1 % af patienter behandlet med denosumab i op til 5 år testet positive for ikke-neutraliserende bindende antistoffer uden tegn på ændret farmakokinetik, toksicitet eller klinisk respons.
English: DO NOT warm it in any other way, for example, in a microwave or in hot water.
Danish: Injektionssprøjten må IKKE opvarmes på nogen anden måde, for eksempel i mikrobølgeovn eller varmt vand.
English: The reduction in the incidence of new vertebral fractures, hip fractures and non-vertebral fractures by Prolia over 3 years were consistent regardless of the 10-year baseline fracture risk.
Danish: Faldet i incidensen af nye vertebrale frakturer, hoftefrakturer og non-vertebrale frakturer ved behandling med Prolia i løbet af 3 år var konsekvent, uanset den 10-årige frakturrisiko ved baseline.
English: You must inject the entire content (1 mL) of the Prolia pre-filled syringe and it should be injected once every 6 months as instructed by your doctor.
Danish: Du skal injicere hele indholdet (1 ml) af den fyldte injektionssprøjte med Prolia, og det skal injiceres hver 6. måned i overensstemmelse med din læges instruktioner.
English: Before receiving treatment, tell your doctor or nurse (health care professional) if you:
Danish: Fortæl det inden behandlingen til din læge eller sygeplejerske (sundhedspersonalet), hvis du:
English: Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
Danish: Der kan også opstå osteoporose hos mænd af flere forskellige grunde, blandt andet alder og/eller lavt niveau af det mandlige hormon testosteron.
English: Any effects of Prolia are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Danish: Eventuelle virkninger af Prolia vil sandsynligvis være forstærkede i graviditetens andet og tredje trimester, da monoklonale antistoffer transporteres gennem placenta på en lineær måde, efterhånden som graviditeten skrider frem, og den største mængde overføres i tredje trimester.
English: Surgery or medicines that stop the production of oestrogen or testosterone used to treat patients with breast or prostate cancer can also lead to bone loss.
Danish: Operation eller medicin, der standser produktionen af østrogen eller testosteron, og som bruges til at behandle patienter med brystkræft eller prostatakræft, kan også føre til knogletab.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Danish: De mulige risikofaktorer for osteonekrose i ydre øregang omfatter anvendelse af steroider og kemoterapi og/eller lokale risikofaktorer såsom infektion eller traume.
English: Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose.
Danish: Knogleomsætningsmarkørerne nåede generelt niveauerne fra før behandlingsstart inden for 9 måneder efter den sidste dosis.
English: Every 6 months Amgen Europe B.V.
Danish: Hver 6. måned Amgen Europe B.V.
English: Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important in these patients, see above.
Danish: Tilstrækkelig indtagelse af calcium og vitamin D og regelmæssig monitorering af calcium er særligt vigtigt hos disse patienter, se ovenfor.
English: • Prolia is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: • Prolia gives som en injektion i vævet lige under huden (subkutan injektion).
English: Prolia is not recommended in paediatric patients (age < 18) as the safety and efficacy of Prolia in these patients have not been established.
Danish: Prolia anbefales ikke til børn (< 18 år), da sikkerheden og effekten af Prolia til disse patienter ikke er fastlagt.
English: In a study of 55 patients with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab.
Danish: I et studie med 55 patienter med forskellige grader af nyrefunktion, herunder patienter i dialyse, havde graden af den nedsatte nyrefunktion ingen effekt på denosumabs farmakokinetik.
English: Find a comfortable, well-lit, clean surface and put all the equipment within reach.
Danish: Find et behageligt, rent sted, hvor belysningen er god, og anbring alt udstyret inden for rækkevidde.
English: Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones, especially in the spine, hips and wrists.
Danish: Mange patienter med osteoporose har ingen symptomer, men har alligevel risiko for at få knoglebrud - især i rygrad, hofter og håndled.
English: You should not take Prolia together with another medicine containing denosumab.
Danish: Du må ikke bruge Prolia sammen med et andet lægemiddel, der indeholder denosumab.
English: Prolia is not recommended for use if you are pregnant.
Danish: Prolia anbefales ikke, hvis du er gravid.
English: However, due to its character it is unlikely that denosumab has any potential for genotoxicity.
Danish: Som følge af denosumabs beskaffenhed er det dog usandsynligt, at det har noget genotoksisk potentiale.
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Danish: Generelt elimineres monoklonale antistoffer ikke gennem metaboliske mekanismer i leveren.
English: No accumulation or change in denosumab pharmacokinetics with time was observed upon subcutaneous multiple-dosing of 60 mg once every 6 months.
Danish: Der blev ikke observeret akkumulering eller ændring i denosumabs farmakokinetik med tiden efter subkutan multidosering med 60 mg én gang hver 6. måned.
English: 1 Includes clinical vertebral fractures and non-vertebral fractures.
Danish: 1 Inkluderer kliniske vertebrale frakturer og non-vertebrale frakturer.
English: No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 ml/min).
Danish: Der foreligger ingen data for patienter med langvarig systemisk glukokortikoidbehandling og alvorligt nedsat nyrefunktion (GFR < 30 ml/min).
English: Oestrogen helps keep bones healthy.
Danish: Østrogen er med til at holde knoglerne sunde og raske.
English: Prolia contains sorbitol
Danish: Prolia indeholder sorbitol
English: Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis.
Danish: Patienterne skal tilrådes at søge læge med det samme, hvis de får tegn eller symptomer på cellulitis.
English: In dose ranging studies, denosumab exhibited non-linear, dose-dependent pharmacokinetics, with lower clearance at higher doses or concentrations, but approximately dose-proportional increases in exposures for doses of 60 mg and greater.
Danish: I studier af dosisintervaller udviste denosumab non-lineær, dosisafhængig farmakokinetik med lavere clearance ved højere doser eller koncentrationer, men omtrent dosisproportionelle stigninger i eksponeringer ved doser på 60 mg og derover.
English: • potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Danish: • styrken af lægemidlet, som hæmmer knogleresorptionen (øget risiko ved meget potente forbindelser), indgivelsesvej (øget risiko ved parenteral administration) samt den kumulative dosis af knogleresorptionsbehandlingen.
English: No data are available on the effect of denosumab on human fertility.
Danish: Der foreligger ingen data vedrørende virkningen af denosumab på den humane fertilitet.
English: Treatment with Prolia makes bone stronger and less likely to break.
Danish: Behandling med Prolia gør knoglerne stærkere og mindre tilbøjelige til at få brud.
English: Proportion of women with fracture (%)+
Danish: Andel af kvinder med fraktur (%)