FrancophonIA/ELRC3.0 huggingface dataset:
English: Xromi is a medicine used in adults, adolescents and children over two years of age who have sickle cell disease, a genetic disease where the red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle).
Danish: Xromi er et lægemiddel, der anvendes til voksne, unge og børn over to år, som har seglcellesygdom, en genetisk sygdom, hvor de røde blodlegemer bliver stive og klæbrige, og skifter fra at være runde til at være halvmåneformede (som et segl).
English: The safety issues with hydroxycarbamide are well understood, and Xromi has been shown to be bioequivalent to an authorised hydroxycarbamide medicine.
Danish: De sikkerhedsmæssige spørgsmål ved hydroxycarbamid er klarlagt, og Xromi har vist sig at være bioækvivalent med et godkendt hydroxycarbamidlægemiddel.
English: What are the risks associated with Xromi?
Danish: Hvilke risici er der forbundet med Xromi?
English: It also carried out a study that showed Xromi is bioequivalent to the reference medicine, Hydrea.
Danish: Den har også udført et studie, der har vist, at lægemidlet er bioækvivalent med referencelægemidlet, Hydrea.
English: The reference medicine for Xromi is Hydrea.
Danish: Referencelægemidlet for Xromi er Hydrea.
English: The active substance in Xromi is hydroxycarbamide.
Danish: Det aktive stof i Xromi er hydroxycarbamid.
English: Xromi can only be obtained with a prescription and treatment must be supervised by a healthcare professional experienced in the management of sickle cell disease.
Danish: Lægemidlet fås kun på recept, og ordineringen og behandlingen bør overvåges af en sundhedsperson med erfaring i behandling af seglcellesygdom.
English: For the full list of side effects of Xromi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Xromi fremgår af indlægssedlen.
English: How is Xromi used?
Danish: Hvordan anvendes Xromi?
English: Patients are usually started at a daily dose of 15 mg for each kg of body weight, and increased if necessary every 8 weeks to a maximum of 35 mg per kg.
Danish: Patienterne starter normalt med en daglig dosis på 15 mg for hver kg kropsvægt og øges om nødvendigt hver 8. uge til højst 35 mg pr. kg. Lægemidlet leveres med to orale sprøjter til afmåling af dosis: en lille rød sprøjte til afmåling af doser på op til i alt 300 mg (3 ml væske) og en større hvid sprøjte til doser, der overstiger dette.
English: How does Xromi work?
Danish: Hvordan virker Xromi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xromi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xromi.
English: What benefits of Xromi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xromi?
English: telephone number: XXXXXXXXXXX e-mail: XXXXXXXXXXX
Danish: telefonnummer: XXXXXXXXXXX e-mail: XXXXXXXXXXX
English: First use: 1.
Danish: Første anvendelse: 1.
English: The warranty does not cover damages caused by:
Danish: Garantien dækker ikke skader forårsaget af:
English: Make sure you have ready:
Danish: Sørg for at have følgende klar:
English: QR code to be included
Danish: QR-kode skal inkluderes
English: This is not necessary when the rod is already in the starting position, such as at the very first use.
Danish: Dette er ikke nødvendigt, når stangen allerede sidder i startpositionen, f.eks. ved allerførste brug.
English: Wash your hands carefully with soap to minimise the risk of infection.
Danish: Vask dine hænder grundigt med sæbe for at minimere risikoen for infektion.
English: Terrosa can be given with or without food.
Danish: Terrosa kan gives med eller uden mad.
English: In this case continue with step “2.
Danish: I dette tilfælde skal du fortsætte til trin “2.
English: The primary objective of the study was to collect safety data of teriparatide.
Danish: Det primære formål med forsøget var at indsamle sikkerhedsdata vedrørende teriparatid.
English: Do not repeat this before each daily injection, otherwise you will not have enough Terrosa for 28 days.
Danish: Gentag ikke dette før hver daglig injektion, da du ellers ikke vil have nok Terrosa til 28 dage.
English: • improper or careless use, handling or cleaning
Danish: • forkert eller uforsigtig brug, håndtering eller rengøring
English: The Terrosa Pen can be disposed of according to the instructions of the local authorities.
Danish: Terrosa Pen kan bortskaffes i henhold til de lokale myndigheders anvisninger.
English: Make sure that there are at least 28 days remaining before its expiry date.
Danish: Sørg for, at der er mindst 28 dage tilbage inden udløbsdatoen.
English: Teriparatide (N = 541) (%)
Danish: Teriparatid (N = 541) (%)
English: If no drops emerge, repeat step G until you see some drops.
Danish: Hvis der ikke fremkommer nogen dråber, skal du gentage trin G, indtil du ser nogle dråber.
English: Protect it from water, dust and moisture.
Danish: Beskyt den mod vand, støv og fugt.
English: It is limited to replacement of the pen.
Danish: Den er begrænset til udskiftning af pennen.
English: Consult your doctor in the case of hearing or handling problems.
Danish: Kontakt din læge i tilfælde af hørelses- eller håndteringsproblemer.
English: These reactions usually occur soon after injection.
Danish: Disse reaktioner forekommer som regel lige efter injektion.
English: Local, healthcare professional or institutional policies may replace the instructions regarding needle handling and disposal.
Danish: Lokale, sundhedsprofessionelle eller institutionelle politikker kan erstatte anvisningerne angående håndtering og bortskaffelse af kanylen.
English: Organ System Class
Danish: Organsystemklasse
English: • Select an appropriate injection site and prepare your skin as recommended by your doctor.
Danish: • Vælg et egnet injektionssted, og klargør din hud, som din læge har anbefalet.
English: ........................{the grey-shaded text refers to the 3x pack size}
Danish: ........................{den gråtonede tekst henviser til 3x pakningsstørrelsen}
English: There is no specific antidote for teriparatide.
Danish: Der findes ingen specifik antidot til teriparatid.
English: Do not use alcohol, other solvents or cleaning agents.
Danish: Brug ikke alkohol, andre opløsningsmidler eller rengøringsmidler.
English: Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.
Danish: Gentag ikke trin G mere end fire gange, men følg anvisningerne i afsnittet Fejlfinding på bagsiden.
English: A small air bubble will not affect the dose, or harm.
Danish: En lille luftboble vil ikke påvirke dosen eller medføre skade.
English: If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible on that day.
Danish: Hvis De glemmer en injektion, eller ikke kan tage Deres medicin på det sædvanlige tidspunkt, skal De tage den snarest muligt samme dag.
English: Check if the display is at the start position to make sure that the full dose has been injected.
Danish: Kontrollér, om displayet er i startpositionen for at sikre, at den fulde dosis er blevet injiceret.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 January 2017
Danish: Dato for første markedsføringstilladelse: 04 januar 2017
English: • Do not use your Terrosa Pen if it is damaged or if you have any doubts about its correct functioning.
Danish: • Brug ikke din Terrosa Pen, hvis den er beskadiget, eller hvis du er i tvivl om, hvorvidt den fungerer korrekt.
English: Do not press the push button.
Danish: Tryk ikke på trykknappen.
English: Your doctor will advise you and decide how long you should be treated with Terrosa.
Danish: Deres læge kan råde Dem og beslutte, hvor længe De skal behandles med Terrosa.
English: If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection.
Danish: Hvis instruktionerne ikke følges, er der risiko for forkert medicinering, unøjagtig dosering, overførsel af sygdomme eller infektion.
English: • swelling, mainly in the hands, feet and legs.
Danish: • hævelser, hovedsagelig af hænder, fødder og ben
English: If you have any questions concerning the use of the Terrosa Pen, contact our customer service at any time.
Danish: Hvis du har spørgsmål angående brugen af Terrosa Pen, kan du kontakte vores kundeservice når som helst.
English: Make sure that the two indicator stripes are aligned.
Danish: Sørg for, at de to indikatorstriber flugter.
English: • Pull out the pen slowly.
Danish: • Træk langsomt pennen ud.
English: Overdose experience based on post-marketing spontaneous reports
Danish: Erfaring med overdosering baseret på spontane indberetninger efter markedsføringen af præparatet
English: Never share your pen with others.
Danish: Del aldrig pennen med andre.
English: Contact customer service if the second needle cannot be attached.
Danish: Kontakt kundeservice, hvis den anden kanyle ikke kan sættes fast.
English: Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely empty.
Danish: Hver cylinderampul skal bortskaffes på forsvarlig vis 28 dage efter første brug, også selvom den ikke er fuldstændig tom.
English: Use another needle instead.
Danish: Brug en anden kanyle i stedet.
English: 4.7 Effects on ability to drive and use machines Teriparatide has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Teriparatid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Do not repeat the injection on the same day.
Danish: Gentag ikke injektionen på den samme dag.
English: Women of childbearing potential / Contraception in females
Danish: Kvinder i den fertile alder/ Antikonception hos kvinder
English: Therefore, teriparatide should be used with caution.
Danish: Derfor skal teriparatid anvendes med forsigtighed.
English: Chemical in-use stability has been demonstrated for 28 days at 2 - 8 °C.
Danish: Kemisk stabilitet under brug er bevist i 28 dage ved 2-8 °C.
English: The pivotal study included 1,637 postmenopausal women (mean age 69.5 years).
Danish: Det primære forsøg omfattede 1.637 postmenopausale kvinder (gennemsnitsalder: 69,5 år).
English: Otherwise tell your doctor.
Danish: I modsat fald skal De fortælle det til Deres læge.
English: New vertebral fracture (≥1) a
Danish: Ny vertebral fraktur (≥ 1) a
English: Do not use Terrosa:
Danish: Brug ikke Terrosa:
English: QR code to be included www.terrosapatient.com
Danish: QR-kode skal inkluderes www.terrosapatient.com
English: • A damp cloth is sufficient to clean the Terrosa Pen.
Danish: • En fugtig klud er nok til at rengøre Terrosa Pen.
English: d p≤0.025 compared with placebo.
Danish: d p≤0.025 sammenlignet med placebo
English: Terrosa is a biosimilar medicinal product.
Danish: Terrosa er et biosimilært lægemiddel.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to
Danish: almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100) og sjælden (≥1/10.000 til
English: • dropping, impact, application of force, contact with fluids
Danish: • tab, påvirkning, anvendelse af magt, kontakt med væske
English: This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.
Danish: Det er vigtigt, da noget medicin (f.eks. digoxin/digitalis, medicin til behandling af hjertesygdomme) kan påvirke teriparatid og omvendt.
English: Set the dose and complete the injection as described in section “2.
Danish: Indstil dosen, og gennemfør injektionen som beskrevet i afsnit “2.
English: Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Danish: Teriparatid bør anvendes med forsigtighed hos patienter med aktiv eller nylig urolithiasis, da det muligvis kan forværre tilstanden.
English: • Handle your pen with care.
Danish: • Håndter din pen forsigtigt.
English: The Terrosa Pen must not be used by blind or visually impaired patients without help from a trained able-bodied person.
Danish: Terrosa Pen må ikke bruges af blinde eller synshæmmede patienter uden hjælp fra en oplært og rask person.
English: 3401 Burgdorf, Switzerland
Danish: 3401 Burgdorf, Schweiz
English: F: Attach a new pen needle as follows: • Pull off the peel foil.
Danish: F: Fastgør en ny kanyle i pennen således: • Træk folien af.
English: This helps you to know when the 28 daily doses per cartridge are used.
Danish: På denne måde vil du vide, hvornår de 28 daglige doser pr. ampul er brugt.
English: Do not use the pen needle if the packaging is damaged or not opened by yourself.
Danish: Brug ikke penkanylen, hvis emballagen er beskadiget eller ikke er åbnet af dig selv.
English: D: Push back the threaded rod carefully with your finger, in a straight line and as far as it will go.
Danish: D: Skub forsigtigt stangen med gevind tilbage med din finger i en lige linje, så langt som den kan komme.
English: Follow the instructions presented in this instructions for use.
Danish: Følg instruktionerne i denne brugsvejledning.
English: If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a few days or weeks.
Danish: Hvis De oplever ubehag rundt om injektionsstedet, såsom rødmen i huden, smerter, hævelser, kløe, blå mærker eller mindre blødninger (som kan forekomme hos op til 1 ud af 10 personer), skal dette aftage i løbet af få dage eller uger.
English: - Wash your hands before handling the cartridge or pen.
Danish: - Vask hænderne inden håndtering af cylinderampullen eller pennen.
English: 680 subjects were randomised to teriparatide and 680 subjects were randomised to oral risedronate 35 mg/week.
Danish: 680 patienter blev randomiseret til teriparatid og 680 patienter blev randomiseret til oral risedronat 35 mg/uge.
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: Do not use your Terrosa Pen to inject any other medicine (e.g. insulin).
Danish: Brug ikke Terrosa Pen til injektion af anden medicin (f.eks. insulin).
English: Teriparatide is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Danish: Teriparatid elimineres ved hepatisk og ekstrahepatisk clearance (ca. 62 l/time hos kvinder og 94 l/time hos mænd).
English: In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral 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: To avoid medication errors make sure that the date when starting to use a new cartridge is at least 28 days before its expiry date.
Danish: For at undgå medicineringsfejl sørg for, at datoen ved ibrugtagning af en ny cylinderampul er mindst 28 dage fra udløbsdatoen.
English: Fracture incidence in postmenopausal women Placebo (N = 544) (%)
Danish: Forekomsten af frakturer hos postmenopausale kvinder Placebo (N = 544) (%)
English: Pregnancy Terrosa is contraindicated for use during pregnancy (see section 4.3).
Danish: Graviditet Terrosa er kontraindiceret under graviditet (se punkt 4.3).
English: The skeletal effects of teriparatide depend upon the pattern of systemic exposure.
Danish: Teriparatids virkninger på skelettet afhænger af, hvordan den systemiske eksponering tilrettelægges.
English: Colourless, clear solution for injection with a pH of 3.8 - 4.5.
Danish: Farveløs, klar injektionsvæske, opløsning med en pH-værdi på 3,8-4,5.
English: How do I reset the dose knob to the start position?
Danish: Hvordan nulstiller jeg doseringsknappen til startpositionen?
English: Change the needle and repeat the priming as described in pen preparation sections “F” and “G”.
Danish: Udskift kanylen, og gentag klargøringen som beskrevet i klargøringsafsnit “F” og “G”.
English: The half-life of teriparatide is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from the injection site.
Danish: Halveringstiden for teriparatid er ca. 1 time ved subkutan administration, hvilket svarer til den tid, absorptionen fra injektionsstedet tager.
English: • the pen being used with a medical device, accessories or consumables other than those recommended by Gedeon Richter Plc.
Danish: • at pennen bruges sammen med medicinsk udstyr,tilbehør eller forbrugsvarer end det, der anbefales af Gedeon Richter Plc.
English: In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 micrograms) of a teriparatide pen have been administered as a single dose.
Danish: 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: Keep the needle in the skin fold for a further 6 seconds.
Danish: Hold kanylen inde i hudfolden i yderligere 6 sekunder.
English: Never immerse the Terrosa Pen in water, as this could damage the pen.
Danish: Nedsænk aldrig Terrosa Pen i vand, da dette kan beskadige den.
English: No medicine comes out of the needle during pen preparation step “G: Priming”.
Danish: Der kommer ikke noget medicin ud af kanylen under klargøringstrinnet “G: Klargøring”.
English: Children and adolescents Terrosa should not be used in children and adolescents (aged less than 18 years).
Danish: Børn og unge Terrosa må ikke bruges til børn og unge (under 18 år).
English: Do not prime again after the first dose.
Danish: Den skal ikke klargøres igen efter den første dosis.
English: Use a new injection needle for each injection to prevent contamination and safely dispose of the needle after use.
Danish: Brug en ny injektionskanyle til hver injektion for at forhindre kontaminering og bortskaf kanylen på sikker vis efter brug.
English: If, by mistake, you have used more Terrosa than you should, contact your doctor or pharmacist.
Danish: Hvis De ved en fejltagelse har taget mere Terrosa, end De skulle, skal De kontakte Deres læge eller apotek.
English: Therefore, if blood samples for serum calcium measurements are taken, this should be done at least 16 hours after the most recent teriparatide injection.
Danish: Hvis der skal tages blodprøver for serumcalcium fra en patient, bør dette derfor gøres mindst 16 timer efter den seneste teriparatid-injektion.
English: Broken needles can get stuck in the skin.
Danish: Knækkede kanyler kan sidde fast i huden.
English: The warranty covers manufacturing and material defects of your Terrosa Pen for two years of use, from purchase.
Danish: Garantien dækker produktions- og materialefejl på din Terrosa Pen i to år fra købsdatoen.
English: The Terrosa Pen can be used by self-injecting patients above the age of 18 years, healthcare professionals or third parties such as, for instance, adult relatives.
Danish: Terrosa Pen kan bruges af patienter over 18 år, der injicerer sig selv, af sundhedspersoner og af tredjeparter såsom voksne familiemedlemmer.
English: Results from up to 24 months (median: 19 months) treatment with teriparatide demonstrate statistically significant fracture reduction (Table 1).
Danish: Resultaterne af behandling med teriparatid i op til 24 måneder (median: 19 måneder) viste en statistisk signifikant reduktion af frakturer (se tabel 1).
English: B: Remove the cartridge holder by turning it (bayonet coupling).
Danish: B: Fjern cylinderampulholderen ved at dreje den (bajonetkobling).
English: Immediately consult the doctor if a broken needle gets stuck in the skin.
Danish: Kontakt straks lægen, hvis der sidder en knækket kanyle fast i huden.
English: • Re-attach the pen cap after each use.
Danish: • Sæt pennens hætte på igen efter hver brug.
English: • if you have high levels of calcium in your blood (hypercalcaemia).
Danish: • hvis De har forhøjede niveauer af calcium i blodet (hyperkalcæmi).
English: E: Attach the cartridge holder to the housing by turning it 90 degrees, until it stops.
Danish: E: Sæt cylinderampulholderen fast til kabinettet ved at dreje den 90 grader, indtil den stopper.
English: After each injection, the pen should be returned to the refrigerator.
Danish: Efter hver injektion skal pennen lægges tilbage i køleskabet.
English: Note: There is no need to change the needle when using directly after the pen preparation.
Danish: Bemærk: Der er ingen grund til at udskifte kanylen, når du bruger den direkte efter klargøring af pennen.
English: Method of administration Terrosa should be administered once daily by subcutaneous injection in the thigh or abdomen.
Danish: Administration Terrosa skal administreres en gang dagligt ved subkutan injektion i lår eller abdomen.
English: The most common side effects are pain in limb (which may affect more than 1 in 10 people).
Danish: De mest almindelige bivirkninger er smerter i arme og ben (som kan forekomme hos flere end 1 ud af 10 patienter).
English: Inject Terrosa each day for as long as your doctor prescribes it for you.
Danish: De skal tage Terrosa hver dag i så lang tid, som Deres læge har udskrevet det til Dem.
English: Hypercalcaemia greater than 3.25 mmol/L
Danish: Hyperkalcæmi over 3,25 mmol/l
English: Make sure the display shows an arrow sign and the two indicator stripes are aligned.
Danish: Sørg for, at displayet viser en pil, og at de to indikatorstriber flugter.
English: Teriparatide has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Danish: Teriparatid er undersøgt i farmakodynamiske interaktionsstudier med hydrochlorthiazid.
English: Display does not return to start position after injection.
Danish: Displayet venter ikke tilbage til startpositionen efter injektion.
English: During dose dialling the pen provides an audible clicking sound and a noticeable resistance.
Danish: Under justering af dosen afgiver pennen et hørbart klik og en mærkbar modstand.
English: Warning: Ensure the use of the correct drug liquid.
Danish: Advarsel: Sørg for at du bruger den korrekte medicinopløsning.
English: Teriparatide 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: Teriparatid blev administreret i enkeltdoser på op til 100 mikrogram samt i gentagne doser på op til 60 mikrogram/dag i 6 uger.
English: • Do not remove the cartridge from the Terrosa Pen before it is empty.
Danish: • Fjern ikke cylinderampullen fra Terrosa Pen, før den er tom.
English: • To set the fixed daily dose of 80 microliters, turn the dose knob clockwise until it stops and cannot be rotated any further.
Danish: • For at indstille den faste daglige dosis på 80 mikroliter skal du dreje doseringsknappen med uret, indtil den stopper og ikke kan drejes yderligere.
English: Treatment of suspected overdose should include transitory discontinuation of teriparatide, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
Danish: Behandling af en formodet overdosis bør inkludere midlertidig seponering af teriparatid, monitorering af serumcalcium og indledning af relevante støttende foranstaltninger, som f.eks. hydrering.
English: The total duration of treatment with Terrosa should not exceed 24 months.
Danish: Den totale behandlingstid med Terrosa bør ikke overskride 24 måneder.
English: Teriparatide has not been studied in patients with active urolithiasis.
Danish: Teriparatid er ikke undersøgt hos patienter med aktiv urolithiasis.