FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide 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 teriparatid ikke effekten af digoxin på hjertet.
English: Always follow instructions provided below and on the back page when using the Terrosa Pen.
Danish: Følg altid vejledningen nedenfor og på bagsiden, når du bruger Terrosa Pen.
English: Seek immediate medical advice if you have any health concern.
Danish: Søg straks lægehjælphvis du har bekymringer relateret til dit helbred.
English: Gently hold a skin fold between the thumb and index finger.
Danish: Hold forsigtigt en hudfold mellem tommel- og pegefinger.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: Hypercalcaemia greater than 2.76 mmol/L, hyperuricaemia
Danish: Hyperkalcæmi over 2,76 mmol/l, hyperurikæmi
English: Do not try to force the dose knob any further.
Danish: Forsøg ikke at tvinge doseringsknappen videre.
English: Do not use Terrosa if it is, or has been, frozen.
Danish: Terrosa må ikke bruges, hvis det er eller har været nedfrosset.
English: The pen can be used with compatible pen needles.
Danish: Pennen kan bruges med kompatible kanyler.
English: Insert the needle straight and gently into the skin, as shown in the illustration.
Danish: Indsæt kanylen lige og forsigtigt i huden som vist i illustrationen.
English: Use a new needle for your injection on the following day.
Danish: Brug en ny kanyle til din injektion næste dag.
English: Brunnmattstrasse 6
Danish: Ypsomed AG Brunnmattstrasse 6
English: No metabolism or excretion studies have been performed with teriparatide but the peripheral metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney.
Danish: Der er ikke udført undersøgelser af metabolismen eller udskillelsen af teriparatid, men den perifere metabolisme af parathyreoideahormon menes at foregå fortrinsvist i lever og nyrer.
English: Terrosa is indicated in adults.
Danish: Terrosa er indiceret til voksne.
English: Other common side effects (affecting up to 1 in 10 people) include feeling sick, headache and dizziness.
Danish: Andre almindelige bivirkninger (som påvirker op til 1 ud af 10 personer) inkluderer kvalme, hovedpine og svimmelhed.
English: • other cases of exposure and wear, not in accordance with the instructions for use.
Danish: • anden eksponering og slid, som ikke er i overensstemmelse med brugsanvisningen.
English: Relative risk (95% CI) vs. placebo
Danish: Relativ risiko vs. placebo (95 % KI)
English: Answer
Danish: Svar
English: What Terrosa contains - The active substance is teriparatide.
Danish: Terrosa indeholder: - Aktive stof: Teriparatid.
English: {3x} Store in a refrigerator.
Danish: {3x} Opbevares i køleskab
English: The maximum total duration of treatment with teriparatide should be 24 months (see section 4.4).
Danish: Den maksimale totale behandlingsvarighed med teriparatid bør være 24 måneder (se pkt.
English: No needles are supplied with this medicinal product.
Danish: Der medfølger ingen kanyler med dette medicinske produkt.
English: Warning: Prevent the pen needle from bending or breaking.
Danish: Advarsel: Undgå, at penkanylen bøjer eller knækker.
English: Post-treatment management: Following treatment with teriparatide, 1,262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study.
Danish: Effekten på frakturer efter behandlingens ophør: Efter behandlingen med teriparatid indgik 1.262 af de postmenopausale kvinder fra det primære forsøg i et opfølgningsforsøg.
English: - Pre-existing hypercalcaemia.
Danish: - Præeksisterende hyperkalcæmi.
English: Terrosa contains the active substance teriparatide that is used to make the bones stronger, and to reduce the risk of fractures by stimulating bone formation.
Danish: Terrosa indeholder det aktive stof teriparatid, som anvendes til at styrke knoglerne og mindske risikoen for knoglebrud ved at fremme knogledannelse.
English: You can use Terrosa for up to 28 days after the first injection, as long as the cartridge/pen with the cartridge inserted is stored in a refrigerator (2 °C to 8 °C).
Danish: De kan anvende Terrosa i op til 28 dage efter den første indsprøjtning, så længe cylinderampullen/pennen med cylinderampullen isat opbevares i et køleskab (2 °C - 8 °C).
English: The Terrosa Pen has a service life of two years.
Danish: TerrosaPen har en levetid på to år.
English: • use contrary to the instructions for use
Danish: • brug i strid med brugsanvisningen
English: Note for healthcare professionals
Danish: Bemærkning til sundhedspersonale
English: In addition, 15 of 214 patients in the alendronate group (7.0%) had experienced a non-vertebral fracture compared with 16 of 214 patients in the teriparatide group (7.5%) (p=0.84).
Danish: Derudover havde 15 af 214 patienter i alendronat-gruppen (7,0 %) oplevet en non-vertebral fraktur sammenlignet med 16 af 214 patienter i teriparatid-gruppen (7,5 %) (p=0,84).
English: Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Danish: Teriparatid (rhPTH(1-34)) er den aktive del (134) af det endogene humane parathyreoideahormon.
English: Dispose of it correctly, for example, in a puncture-resistant sharps disposal container.
Danish: Bortskaf den korrekt, f.eks. i en beholder beregnet til skarpe genstande.
English: Terrosa must not be used with any other pen.
Danish: Terrosa må ikke bruges med andre penne.
English: The following convention has been used for the classification of the adverse reactions: very common
Danish: Følgende konvention er anvendt til at klassificere bivirkningerne: Meget almindelig ( ≥1/10),
English: Independent risk factors, for example, low BMD, age, the existence of previous fracture, family history of hip fractures, high bone turnover and low body mass index should be considered in order to identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.
Danish: Uafhængige risikofaktorer, f.eks. lav BMD (knoglemineraltæthed), alder, tidligere frakturer, hofte frakturer i familien, høj knogleomsætning og lavt BMI, bør tages i betragtning for at identificerede kvinder og mænd, der har forhøjet risiko for osteoporotiske frakturer, og som kan have gavn af behandling.
English: • Put the Terrosa Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.
Danish: • Sæt Terrosa Pen med indsat cylinderampul tilbage i køleskabet mellem 2 og 8 °C øjeblikkeligt efter brug.
English: • nerve pain in the leg
Danish: • nervesmerter i benene
English: Non-vertebral fragility fractures c
Danish: Ikke-vertebrale lavenergifrakturer c
English: Spillage from pen is observed.
Danish: Der observeres spild fra pennen.
English: Terrosa contains a clear and colourless solution.
Danish: Terrosa indeholder en klar og farveløs opløsning.
English: Paediatric population and young adults with open epiphyses The safety and efficacy of teriparatide in children and adolescents less than 18 years have not been established.
Danish: Pædiatrisk population og unge med åbne epifyser Teriparatids sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: - Unexplained elevations of alkaline phosphatase.
Danish: - Uforklarlig, forhøjet alkalisk fosfatase.
English: Needles and used cartridges must be disposed of separately and safely.
Danish: Kanyler og brugte cylinderampuller skal bortskaffes sikkert og separat.
English: This will keep the remaining Terrosa sterile and prevent leaking from the pen.
Danish: Derved forbliver den resterende Terrosa steril og lækage fra pennen forebygges.
English: In clinical trials the following reactions were reported at a ≥1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
Danish: I kliniske forsøg blev følgende reaktioner rapporteret med en frekvensforskel på ≥ 1 % forskel i frekvensen i forhold til placebo: Kvalme, opkastning, smerter i ekstremiteter, svimmelhed, depression og dyspnø.
English: • if you have ever had bone cancer or if other cancers have spread (metastasised) to your bones.
Danish: • hvis De har haft knoglecancer, eller hvis en anden cancer har spredt sig til knoglerne
English: However, the hyperuricaemia did not result in an increase in gout, arthralgia, or urolithiasis.
Danish: Denne hyperurikæmi resulterede dog hverken i en forøgelse af arthritis urica, ledsmerter eller urolithiasis.
English: • BD Micro-Fine Ultraneedles 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12.7, 8 or 5 mm length Pen needles from other manufacturers can be used according to their stated compatibility details.
Danish: • BD Micro-Fine Ultranåle 29 til 31 gauge (diameter 0,25-0,33 mm) og 12,7, 8 eller 5 mm længde Penkanyler fra andre producenter kan bruges i henhold til deres angivne kompatibilitetsoplysninger.
English: Some patients may feel dizzy after injecting Terrosa.
Danish: Nogle patienter kan føle sig svimle efter en indsprøjtning med Terrosa.
English: There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 micrograms/kg.
Danish: Der blev ikke set nogen vigtige virkninger hos drægtige rotter eller mus, som fik teriparatid i daglige doser på 30 til 1.000 mikrogram/kg.
English: Before using the pen device for the first time, the patient should read and understand the instructions on how to use the pen which are provided with the pen.
Danish: Inden pennen anvendes første gang, skal patienten læse og forstå den medfølgende brugsanvisning til pennen.
English: A: Remove the pen cap.
Danish: A: Fjern pennens hætte.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Use only with Terrosa Pen.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til brug med Terrosa Pen.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA02
Danish: Farmakoterapeutisk klassifikation: Calciumhomeostase, Parathyreoideahormoner og -analoger, ATCkode: H05AA02.
English: *Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.
Danish: *Teriparatid, rhPTH(1-34), der fremstilles i E.-coli ved hjælp af rekombinant DNA-teknologi, er identisk med den 34 N-terminale aminosyresekvens af det endogene humane parathyreoideahormon.
English: Note: If the cartridge contains less than 80 microliters, the dose knob cannot be turned clockwise up to the arrow sign.
Danish: Bemærk: Hvis cylinderampullen indeholder mindre end 80 mikroliter, kan doseringsknappen ikke drejes med uret op til pilen.
English: - Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis.
Danish: - Andre metaboliske knoglesygdomme (inklusive hyperparatyreoidisme og Pagets knoglesygdom) end primær osteoporose eller glukokortikoidinduceret osteoporose.
English: • Ypsomed mylifeClickfine 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12, 10, 8 or 6 mm length
Danish: • Ypsomed mylife Clickfine 29 til 31 gauge (diameter 0,25-0,33 mm) og 12, 10, 8 eller 6 mm længde
English: Of patients in the teriparatide trials, 82.8% of the teriparatide patients and 84.5% of the placebo patients reported at least 1 adverse event.
Danish: Af de patienter, som deltog i de kliniske forsøg med teriparatid, indberettede 82,8 % af teriparatidpatienterne og 84,5 % af placebo-patienterne mindst et tilfælde af bivirkninger.
English: Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e.g., low bone density [e.g., T-score ≤−2], sustained high dose glucocorticoid therapy [e.g., ≥7.5 mg/day for at least 6 months], high underlying disease activity, low sex steroid levels).
Danish: Præmenopausale kvinder med glukokortikoidinduceret osteoporose bør vurderes at have en høj risiko for at få fraktur, hvis de har en almindelig fraktur eller en kombination af risikofaktorer, som placerer dem i gruppen med høj risiko for at få fraktur (f.eks. lav knogletæthed [f.eks. T-score ≤ -2], langvarig behandling med høj dosis af glukokortikoid [f.eks. ≥ 7,5 mg dagligt i mindst 6 måneder], høj tilgrundliggende sygdomsaktivitet eller lave koncentrationer af kønshormoner).
English: The reusable fixed dose pen is designed for easy administration of Terrosa to treat osteoporosis.
Danish: Den genanvendelige faste doseringspen er beregnet til let administration af Terrosa til behandling af osteoporose.
English: Co-administration of raloxifene or hormone replacement therapy with teriparatide did not alter the effects of teriparatide on serum or urine calcium or on clinical adverse events.
Danish: Samtidig administration af raloxifen eller hormonal substitutionsterapi og teriparatid påvirkede hverken teriparatids effekt på serum- eller urincalcium eller de kliniske bivirkninger.
English: Setting the dose and injection”.
Danish: Indstilling af dosis og injektion”.
English: Fatigue, chest pain, asthenia, mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritus and minor bleeding at injection site
Danish: Træthed, brystsmerter, asteni, lette og forbigående reaktioner ved injektionsstedet, inklusive smerter, hævelse, erytem, lokaliseret blodudtrædning, kløe og mindre blødning ved injektionsstedet
English: The 24-month course of teriparatide should not be repeated over a patient's lifetime.
Danish: Forløbet med 24 måneders behandling med teriparatid bør ikke gentages i patientens levetid.
English: Cases of fainting have occured after teriparatide use.
Danish: Der er set tilfælde af besvimelse efter teriparatid-behandling.
English: In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83% had received previous osteoporosis therapy) were treated with teriparatide for up to 24 months.
Danish: I et åbent forsøg blev 503 postmenopausale kvinder med svær osteoporose og en lavenergifraktur inden for de foregående 3 år (83 % havde tidligere fået osteoporosebehandling) behandlet med teriparatid i op til 24 måneder.
English: Injecting Terrosa - Before you inject Terrosa, clean your skin where you intend to inject (thigh or abdomen) as instructed by your doctor.
Danish: Injektion af Terrosa - Inden injektion af Terrosa, skal huden renses på det tilsigtede injektionssted (låret eller maven) som anvist af lægen.
English: Disposal of Terrosa Pen and used accessories
Danish: Bortskaffelse af Terrosa Pen og brugt tilbehør
English: Needle is broken/curved/kinked.
Danish: 3. kanylen er ødelagt/bøjet/knækket.
English: In short-term clinical studies with teriparatide, isolated episodes of transient orthostatic hypotension were observed.
Danish: I kortvarige kliniske forsøg med teriparatid er der set isolerede tilfælde af forbigående ortostatisk hypotension.
English: Injection site erythema, injection site reaction
Danish: Erytem på injektionsstedet, reaktion på injektionsstedet
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosisenhed, dvs. den er i det væsentlige natrium-fri.
English: Posology The recommended dose of Terrosa is 20 micrograms administered once daily.
Danish: Dosering Den anbefalede dosis Terrosa er 20 mikrogram administreret en gang dagligt.
English: From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days within its shelf life at 2 °C to 8 °C.
Danish: Fra et mikrobiologisk perspektiv kan præparatet efter åbning opbevares i op til 28 dage inden for holdbarhedstiden ved 2-8 °C.
English: - After your injection, leave the needle in the skin for six seconds to make sure that you receive the whole dose.
Danish: - Lad kanylen blive siddende i huden i seks sekunder efter injektion for at sørge for, at De har modtaget hele dosen.
English: These are listed in the instruction for use for the pen.
Danish: De er angivet i brugsanvisningen til pennen.
English: Some patients have had severe back cramps or pain which led to admission into hospital.
Danish: Nogle patienter har haft alvorlige rygkramper eller smerter, der medførte indlæggelse.
English: Teriparatide may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
Danish: Teriparatid kan medføre mindre stigninger i udskillelsen af calcium i urinen, men forekomsten af hypercalcuri viste sig i de kliniske forsøg ikke at adskille sig fra den, som observeredes hos placebo-behandlede patienter.
English: The pen is customised for use with Terrosa only.
Danish: Pennen er udelukkende tilpasset til brug med Terrosa.
English: Pen preparation - First use/changing cartridges Follow the instructions every time you insert a new Terrosa cartridge into your Terrosa Pen.
Danish: Klargøring af pennen - Første brug/udskiftning af cylinderampuller Følg vejledningen, hver gang du indsætter en ny Terrosa cylinderampul i din Terrosa Pen.
English: No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 years).
Danish: Der er ikke fundet aldersrelaterede (fra 31 til 85 år) forskelle i teriparatids farmakokinetik.
English: The efficacy of teriparatide in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18month primary phase of a 36-month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/day).
Danish: Effekten af teriparatid hos mænd og kvinder (N=428), der fik langvarig systemisk glukokortikoidbehandling (ækvivalent med 5 mg eller mere prednison i mindst 3 måneder) blev vist i den 18 måneder primære fase i et 36 måneder, randomiseret, dobbeltblindet, comparator-kontrolleret forsøg (alendronat 10 mg/dag).
English: In clinical trials, 2.8% of teriparatide patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients.
Danish: I kliniske forsøg havde 2,8 % af de patienter, der blev behandlet med teriparatid, serumurinstofkoncentrationer over normalområdets øvre grænse, hvilket til sammenligning gjaldt 0,7 % af placebopatienterne.
English: At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 teriparatide patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the teriparatide group (1.7%) (p=0.01).
Danish: Ved 36 måneder viste en analyse af rygsøjlerøntgenbilleder af 169 alendronatpatienter og 173 teriparatid-patienter, at 13 patienter i alendronat-gruppen (7,7 %) havde oplevet en ny vertebral fraktur sammenlignet med 3 patienter i teriparatid-gruppen (1,7 %)(p=0,01).
English: Empty cartridges must not be refilled.
Danish: Tomme cylinderampuller må ikke fyldes op igen.
English: Because teriparatide transiently increases serum calcium, teriparatide should be used with caution in patients taking digitalis.
Danish: Da teriparatid forbigående øger serumcalcium, bør teriparatid anvendes med forsigtighed hos patienter i samtidig behandling med digitalis.
English: The amount of Terrosa left in the cartridge is less than 80 microlitres.
Danish: Mængden af Terrosa, der er tilbage i cylinderampullen, er mindre end 80 mikroliter.
English: Use your Terrosa Pen only as prescribed by your doctor, in this instructions for use and the Terrosa package leaflet.
Danish: Brug kun din Terrosa Pen, som anvist af din læge, og ifølge denne brugsanvisning i Terrosa indlægssedlen.
English: Tilting the pen may result in bending or breaking of the needle.
Danish: Vipning af pennen kan medføre, at kanylen bøjer eller knækker.
English: • increase in an enzyme called alkaline phosphatase.
Danish: • stigning i et enzym ved navn basisk fosfatase
English: The dose knob inadvertently turned clockwise after completing the injection.
Danish: Doseringsknappen drejede uforsætligt med uret efter udførelse af injektionen.
English: METHOD AND ROUTE(S) OF ADMINISTRATION The cartridge and pen pack should be used for treatment initiation.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Pakken med cylinderampul og pen skal bruges til at påbegynde behandling.
English: Elderly Dosage adjustment based on age is not required (see section 5.2).
Danish: Ældre Dosisjustering på baggrund af alder er ikke nødvendig (se pkt.
English: Teriparatide increases serum uric acid concentrations.
Danish: Teriparatid øger serumurinstofkoncentrationen.
English: For the correct use of this medicine it is very important to closely follow the detailed Instructions for Use of your pen which are provided with the pen.
Danish: For korrekt brug af medicinen, er det vigtigt nøje at følge den medfølgende brugsanvisning til pennen.
English: The pen and injection needles are not included with Terrosa.
Danish: Pennen og injektionsnålene følger ikke med Terrosa.
English: The pen must be primed and tested after inserting a new cartridge and prior the first injection from each cartridge.
Danish: Pennen skal klargøres og afprøves, når der er sat en ny cylinderampul i og inden den første injektion fra hver cylinderampul.
English: The pen needles must be used only once and the Terrosa cartridge must be used by one person only.
Danish: Penkanylerne må kun bruges én gang, og Terrosa cylinderampullen må kun bruges af én person.
English: The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.
Danish: Den gennemsnitlige stigning i BMD fra 18 til 24 måneder var 1,4 %, 1,2 % og 1,6 % for henholdsvis rygsøjle, hofte og lårbenshals.
English: • if you suffer from kidney problems (moderate renal impairment).
Danish: Hvis De har nyreproblemer (moderat nedsat nyrefunktion).
English: Teriparatide should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
Danish: Teriparatid frarådes til pædiatriske patienter (under 18 år), børn eller unge med åbne epifyser.
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: The recommended dose is 20 micrograms (corresponding to 80 microliters) given once a day by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Danish: Den anbefalede dosis er 20 mikrogram (svarende til 80 mikroliter) én gang om dagen, som gives som indsprøjtning under huden (subkutan injektion) i låret eller maven.
English: Setting the dose and injection
Danish: Indstilling af dosis og injektion
English: Nausea, vomiting, hiatus hernia, gastrooesophageal reflux disease
Danish: Kvalme, opkastning, hernie hiatus, gastroøsofageal refluks
English: - Prior external beam or implant radiation therapy to the skeleton.
Danish: - Tidligere ekstern strålebehandling eller brachyterapi af skelettet.
English: • your Terrosa Pen with inserted cartridge
Danish: • Din Terrosa Pen med indsat cylinderampul
English: G: Priming
Danish: G: Klargøring
English: Use a new needle for every injection.
Danish: Brug en ny kanyle til hver injektion.
English: • Store your Terrosa Pen, cartridges and pen needles out of reach of children.
Danish: • Opbevar din Terrosa Pen, cylinderampuller og penkanylerne utilgængeligt for børn.
English: • Pull off the peel foil.
Danish: • Træk folien af.