FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the company that markets Incresync will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal omfattede den mulige risiko for hjertesvigt og blærekræft ved lægemidler indeholdende pioglitazon, kriterier for udvælgelse af patienterne og nødvendigheden af regelmæssig gennemgang af behandlingen og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: For the full list of all side effects reported with Incresync, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Incresync fremgår af indlægssedlen.
English: The dose should be lowered in patients with moderately reduced kidney function.
Danish: Til patienter med moderat nedsat nyrefunktion bør anvendes en lavere dosis.
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Danish: Tilsammen nedsætter disse processer blodsukkeret og medvirker til at regulere type-2-sukkersygen.
English: The CHMP considered that adding alogliptin to existing treatment with pioglitazone with or without metformin had shown to produce modest but clinically relevant improvements in HbA1c.
Danish: CHMP fandt det påvist, at anvendelse af alogliptin som tillægsbehandling til eksisterende behandling med pioglitazon med eller uden metformin bevirker en beskeden, men klinisk relevant bedring i HbA1c.
English: For practical information about using Incresync, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Incresync, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: If patients were previously taking pioglitazone alone, the strength of Incresync that provides the same dose of pioglitazone should be used.
Danish: Har patienten tidligere fået pioglitazon alene, skal der anvendes den styrke af Incresync, der giver uændret dosis pioglitazon.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: What benefits of Incresync have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Incresync?
English: As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type-2 diabetes.
Danish: Tilsammen nedsætter de to aktive stoffer blodsukkeret og medvirker dermed til at regulere type 2-sukkersyge.
English: If patients were previously taking pioglitazone and alogliptin separately, Incresync should be used in a strength that continues to provide the same doses.
Danish: Har patienten tidligere fået pioglitazon og alogliptin hver for sig, skal Incresync anvendes i en styrke,
English: How does Incresync work?
Danish: Hvordan virker Incresync?
English: By blocking the breakdown of Incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Danish: Det får bugspytkirtlen til at producere mere insulin, når blodsukkeret er højt.
English: Date of first authorisation: 11 January 2017
Danish: Dato for første markedsføringstilladelse: 11 januar 2017
English: Do not repeat this before each daily injection, otherwise you will not have enough Movymia for 28 days.
Danish: Gentag ikke dette før hver daglige injektion, da du ellers ikke vil have nok Movymia til 28 dage.
English: Movymia can be given with or without food.
Danish: Movymia kan gives med eller uden mad.
English: Distributor: XXXXXXXXXXX
Danish: Distributør: XXXXXXXXXXX
English: • the pen being used with a medical device, accessories or consumables other than those recommended by XXXXXXXXXXX.
Danish: • at pennen bruges sammen med medicinsk udstyr, tilbehør eller forbrugsvarer end det, der anbefales af XXXXXXXXXXX.
English: The Movymia Pen has a service life of two years.
Danish: Movymia Pen har en levetid på to år.
English: The Movymia Pen can be disposed of according to the instructions of the local authorities.
Danish: Movymia Pen kan bortskaffes i henhold til de lokale myndigheders anvisninger.
English: • Do not use your Movymia Pen if it is damaged or if you have any doubts about its correct functioning.
Danish: • Brug ikke din Movymia Pen, hvis den er beskadiget, eller hvis du er i tvivl om, hvorvidt den fungerer korrekt.
English: If you have any questions concerning the use of the Movymia Pen, contact our customer service at any time.
Danish: Hvis du har spørgsmål angående brugen af Movymia Pen, kan du kontakte vores kundeservice når som helst.
English: Gyömrői út 19-21 1103 Budapest HUNGARY
Danish: Gyömrői út 19-21 1103 Budapest UNGARN
English: Your doctor will advise you and decide how long you should be treated with Movymia.
Danish: Deres læge kan råde Dem og beslutte, hvor længe De skal behandles med Movymia.
English: Movymia is a biosimilar medicinal product.
Danish: Movymia er et biosimilært lægemiddel.
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: Priming”.
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), and rare (≥1/10,000 to
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) og sjælden (≥1/10.000 til
English: d p≤0.025 compared with placebo.
Danish: p≤0.025 sammenlignet med placebo
English: • A damp cloth is sufficient to clean the Movymia Pen.
Danish: • En fugtig klud er nok til at rengøre Movymia Pen.
English: If, by mistake, you have used more Movymia than you should, contact your doctor or pharmacist.
Danish: Hvis De ved en fejltagelse har taget mere Movymia, end De skulle, skal De kontakte Deres læge eller apotek.
English: Do not use Movymia:
Danish: Brug ikke Movymia:
English: The Movymia Pen must not be used by blind or visually impaired patients without help from a trained able-bodied person.
Danish: Movymia Pen må ikke bruges af blinde eller synshæmmede patienter uden hjælp fra en oplært og rask person.
English: No needles are supplied with this medicinal product.
Danish: Der medfølger ingen nåle med dette medicinske produkt.
English: Follow the instructions given in the table if you have any questions regarding the use of Movymia Pen:
Danish: Følg instruktionerne i tabellen, hvis du har spørgsmål angående brugen af Movymia Pen:
English: Pregnancy Movymia is contraindicated for use during pregnancy (see section 4.3).
Danish: Graviditet Movymia er kontraindiceret under graviditet (se punkt 4.3).
English: Teriparatide has no or negligible influence on the ability to drive and use machines.
Danish: Teriparatid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Do not use your Movymia Pen to inject any other medicine (e.g. insulin).
Danish: Brug ikke Movymia Pen til injektion af anden medicin (f.eks. insulin).
English: Legal manufacturer: Ypsomed AG Brunnmattstrasse 6 3401 Burgdorf Switzerland
Danish: Ypsomed AG Brunnmattstrasse 6 3401 Burgdorf, Schweiz
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 micrograms) of a 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: The total duration of treatment with Movymia should not exceed 24 months.
Danish: Den totale behandlingstid med Movymia bør ikke overskride 24 måneder.
English: Fracture incidence in postmenopausal women
Danish: Forekomsten af frakturer hos postmenopausale kvinder
English: Children and adolescents Movymia should not be used in children and adolescents (aged less than 18 years).
Danish: Børn og unge Movymia må ikke bruges til børn og unge (under 18 år).
English: The Movymia 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: Movymia Pen kan bruges af patienter over 18 år, der injicerer sig selv, af sundhedspersoner og af tredjeparter såsom voksne familiemedlemmer.
English: Method of administration Movymia should be administered once daily by subcutaneous injection in the thigh or abdomen.
Danish: Administration Movymia skal administreres en gang dagligt ved subkutan injektion i lår eller abdomen.
English: The warranty covers manufacturing and material defects of your Movymia Pen for two years of use, from purchase.
Danish: Garantien dækker produktions- og materialefejl på din Movymia Pen i to år fra købsdatoen.
English: Major non-vertebral fragility fractures c (hip, radius, humerus, ribs and pelvis)
Danish: Store ikke-vertebrale lavenergifrakturer c (hofte, radius, humerus, ribben og bækken)
English: Never immerse the Movymia Pen in water, as this could damage the pen.
Danish: Nedsænk aldrig Movymia Pen i vand, da dette kan beskadige den.
English: Inject Movymia each day for as long as your doctor prescribes it for you.
Danish: De skal tage Movymia hver dag i så lang tid, som Deres læge har udskrevet det til Dem.
English: Do not use Movymia if it is, or has been, frozen.
Danish: Movymia må ikke bruges, hvis det er eller har været nedfrosset.
English: • Do not remove the cartridge from the Movymia Pen before it is empty.
Danish: • Fjern ikke cylinderampullen fra Movymia Pen, før den er tom.
English: Seek immediate medical advice if you have any health concern.
Danish: Søg straks lægehjælphvis, du har bekymringer relateret til dit helbred.
English: Movymia 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: Movymia indeholder det aktive stof teriparatid, som anvendes til at styrke knoglerne og mindske risikoen for knoglebrud ved at fremme knogledannelse.
English: Manufacturer Gedeon Richter Plc.
Danish: Fremstiller Gedeon Richter Plc.
English: Movymia is indicated in adults.
Danish: Movymia er indiceret til voksne.
English: • Ypsomed mylife Clickfine 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: Marketing Authorisation Holder STADA Arzneimittel AG Stadastrasse 2-18
Danish: Indehaver af markedsføringstilladelsen STADA Arzneimittel AG Stadastrasse 2-18
English: What Movymia contains - The active substance is teriparatide.
Danish: Movymia indeholder: - Aktive stof: Teriparatid.
English: Do not use Movymia if you are pregnant or breast-feeding.
Danish: De må ikke anvende Movymia, hvis De er gravid eller ammer.
English: Posology The recommended dose of Movymia is 20 micrograms administered once daily.
Danish: Dosering Den anbefalede dosis Movymia er 20 mikrogram administreret en gang dagligt.
English: You can use Movymia 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 Movymia 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: Movymia must not be used with any other pen.
Danish: Movymia må ikke bruges med andre penne.
English: • Put the Movymia Pen, with the cartridge inserted, back into the refrigerator between 2 and 8 °C immediately after use.
Danish: • Sæt Movymia Pen med indsat cylinderampul tilbage i køleskabet mellem 2 og 8 °C øjeblikkeligt efter brug.
English: The reusable fixed dose pen is designed for easy administration of Movymia to treat osteoporosis.
Danish: Den genanvendelige faste doseringspen er beregnet til let administration af Movymia til behandling af osteoporose.
English: Needle is broken/curved/kinked.
Danish: Kanylen er ødelagt/bøjet/knækket.
English: Always follow instructions provided below and on the back page when using the Movymia Pen.
Danish: Følg altid vejledningen nedenfor og på bagsiden, når du bruger Movymia Pen.
English: Question
Danish: Spørgsmål
English: • BD Micro-Fine Ultra needles 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 Ultra-nåle 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 Movymia.
Danish: Nogle patienter kan føle sig svimle efter en indsprøjtning med Movymia.
English: The cartridge and pen pack should be used for treatment initiation.
Danish: Pakken med cylinderampul og pen skal bruges til at påbegynde behandling.
English: The amount of Movymia left in the cartridge is less than 80 microlitres.
Danish: Mængden af Movymia, der er tilbage i cylinderampullen, er mindre end 80 mikroliter.
English: The pen and injection needles are not included with Movymia.
Danish: Pennen og injektionsnålene følger ikke med Movymia.
English: This will keep the remaining Movymia sterile and prevent leaking from the pen.
Danish: Derved forbliver den resterende Movymia steril og lækage fra pennen forebygges.
English: Movymia contains a clear and colourless solution.
Danish: Movymia indeholder en klar og farveløs opløsning.
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 placebobehandlede patienter.
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 18-month 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: Injecting Movymia - Before you inject Movymia, clean your skin where you intend to inject (thigh or abdomen) as instructed by your doctor.
Danish: Injektion af Movymia - Inden injektion af Movymia, skal huden renses på det tilsigtede injektionssted (låret eller maven) som anvist af lægen.
English: • Do not store the Movymia Pen with a needle attached as this may cause air bubbles to form in the cartridge.
Danish: • Opbevar ikke Movymia Pen med en påsat kanyle, da dette kan medføre, at der dannes luftbobler i cylinderampullen.
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: Disposal of Movymia Pen and used accessories
Danish: Bortskaffelse af Movymia Pen og brugt tilbehør
English: {Displayed in case of 1x and 3x cartridges only.
Danish: {Vises kun for 1x og 3x cylinderampuller.
English: For the first doses, inject Movymia in a place where you can sit or lie down right away if you get dizzy.
Danish: Når De tager de første doser af Movymia, så gør det et sted, hvor De har mulighed for at sidde eller ligge ned, hvis De skulle blive svimmel.
English: EU/1/16/1161/003 [cartridge and pen pack]
Danish: EU/1/16/1161/003 [pakke med cylinderampul og pen]
English: 1 Movymia cartridge 1 Movymia Pen
Danish: 1 Movymia cylinderampul 1 Movymia Pen
English: The pen is customised for use with Movymia only.
Danish: Pennen er udelukkende tilpasset til brug med Movymia.
English: New vertebral fracture (≥1) Multiple vertebral fractures (≥2) Non-vertebral fragility fractures
Danish: Ny vertebral fraktur (≥ 1)
English: The pen needles must be used only once and the Movymia cartridge must be used by one person only.
Danish: Penkanylerne må kun bruges én gang, og Movymia cylinderampullen må kun bruges af én person.
English: • Transport and store the Movymia Pen with inserted cartridge at temperatures specified in the Movymia package leaflet, provided separately.
Danish: • Transporter og opbevar Movymia Pen med isat cylinderampul ved temperaturerne angivet i Movymia indlægssedlen for, som leveres separat.
English: Use your Movymia Pen only as prescribed by your doctor, in this instructions for use and the Movymia package leaflet.
Danish: Brug kun din Movymia Pen, som anvist af din læge, og ifølge denne brugsanvisning i Movymia indlægssedlen.
English: • Store your Movymia Pen, cartridges and pen needles out of reach of children.
Danish: • Opbevar din Movymia Pen, cylinderampuller og penkanylerne utilgængeligt for børn.
English: Use only with Movymia Pen.
Danish: Kun til brug med Movymia Pen.
English: If you are a woman of child-bearing potential, you should use effective methods of contraception during use of Movymia.
Danish: Hvis De er kvinde i den fødedygtige alder, skal De anvende sikre præventionsmetoder, når de bruger Movymia.
English: Movymia contains sodium
Danish: Movymia indeholder natrium
English: EU/1/16/1161/001 [1 cartridge] EU/1/16/1161/002 [3 cartridges]
Danish: EU/1/16/1161/001 [1 cylinderampul] EU/1/16/1161/002 [3 cylinderampuller]
English: Movymia may increase calcium in your blood or urine.
Danish: Advarsler og forsigtighedsregler Movymia kan øge kalk (calcium) i blodet eller urinen.
English: If you stop using Movymia
Danish: Hvis De holder op med at bruge Movymia
English: If you forget to use Movymia
Danish: Hvis De har glemt at bruge Movymia
English: Movymia can be injected at meal times.
Danish: Movymia kan indsprøjtes i forbindelse med måltider.
English: • your Movymia Pen with inserted cartridge
Danish: • Din Movymia Pen med indsat cylinderampul
English: If pregnancy occurs, Movymia should be discontinued.
Danish: I tilfælde af graviditet, bør brugen af Movymia ophøre.
English: If you become pregnant while using Movymia, Movymia should be discontinued.
Danish: Hvis De bliver gravid, mens De bruger Movymia, skal behandlingen med Movymia ophøre.
English: Movymia Pen parts
Danish: Movymia Pen dele
English: What you need to know before you use Movymia
Danish: Det skal De vide, før de begynder at bruge Movymia
English: Read both the package leaflet of Movymia cartridge and the instructions for use of the Movymia Pen before use.
Danish: Læs både indlægssedlen for Movymia cylinderampul og brugsvejledningen for Movymia Pen inden brug.
English: Osteoporosis is also common in patients receiving medicines called corticosteroids.
Danish: Knogleskørhed er også almindeligt forekommende hos patienter, der får lægemidler som kaldes binyrebarkhormoner.
English: It should be administered exclusively with the Movymia Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions which are provided with the pen.
Danish: Lægemidlet skal udelukkende administreres ved brug af det genanvendelige Movymia Pen-multidosis lægemiddeladministrationssystem og injektionsnåle, der er angivet som kompatible i den medfølgende brugsanvisning til pennen.
English: Do not remove the cartridge from the pen during the 28 days of use.
Danish: Fjern ikke cylinderampullen fra pennen i løbet af brugsperioden på 28 dage.
English: Before inserting a cartridge in Movymia Pen write down the batch (Lot) number of the cartridge and its first injection date on a calendar.
Danish: Inden en cylinderampul sættes i Movymia Pen, skriv cylinderampullens batchnummer (lot-nummer) og den første injektionsdato ned i en kalender.
English: Insert a new Movymia cartridge into the cartridge holder, with the metal crimped cap of the cartridge first.
Danish: Indsæt en ny Movymia cylinderampul i holderen med den bølgeformede metalhætte på cylinderampullen først.
English: Some patients get dizzy or get a fast heartbeat after the first few doses of Movymia.
Danish: Nogle patienter oplever svimmelhed eller hjertebanken efter de første indsprøjtninger med Movymia.
English: If you are considering stopping Movymia treatment, please discuss this with your doctor.
Danish: Hvis De overvejer at holde op med at bruge Movymia, skal De tale med Deres læge om det først.
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), p<0.0001.
Danish: For de patienter der havde fået taget røntgenbillede af rygsøjlen ved baseline og som opfølgning, var hyppigheden af nye vertebrale frakturer 28/516 (5,4 %) hos teriparatid- og 64/533 (12,0 %) hos risedronatbehandlede patienter, relativ risiko (95 % CI) = 0,44 (0,29-0,68), p<0,0001.
English: Movymia should not be used if the solution is cloudy, coloured or contains visible particles.
Danish: Movymia må ikke bruges, hvis opløsningen er uklar, farvet eller indeholder synlige partikler.
English: Storage and care of Movymia Pen
Danish: Opbevaring og vedligeholdelse af Movymia Pen
English: 1 carton of Movymia cartridge (containing 1 cartridge) and 1 carton of Movymia Pen (containing 1 pen).
Danish: 1 karton med Movymia cylinderampul (med 1 cylinderampul) og 1 karton med Movymia Pen (med 1 pen).
English: However, for treatment initiation a cartridge and pen pack should be used containing one carton of Movymia cartridge and one carton of Movymia Pen.
Danish: Men ved påbegyndelse af behandlingen skal der anvendes en pakke med cylinderampul og pen, der indeholder en karton med en Movymia cylinderampul og en karton med en Movymia Pen.
English: Other medicines and Movymia
Danish: Brug af anden medicin sammen med Movymia
English: OUTER CARTON FOR CARTRIDGE AND PEN PACK
Danish: YDERKARTON FOR PAKKE MED CYLINDERAMPUL OG PEN
English: EU/1/16/1161/001 [1 cartridge] EU/1/16/1161/002 [3 cartridges] EU/1/16/1161/003 [cartridge and pen pack]
Danish: EU/1/16/1161/001 [1 cylinderampul] EU/1/16/1161/002 [3 cylinderampuller] EU/1/16/1161/003 [Pakke med cylinderampul og pen]
English: Needle cannot be attached.
Danish: Nålen kan ikke sættes fast.
English: Movymia cartridges are to be used in Movymia Pen reusable, multidose pen device exclusively and must not be used with any other pen.
Danish: Movymia cylinderampuller skal anvendes udelukkende i den genanvendelige Movymia Pen til flere doser og må ikke anvendes med nogen anden pen.
English: Women of childbearing potential / Contraception in females Women of childbearing potential should use effective methods of contraception during use of teriparatide.
Danish: Kvinder i den fertile alder/ Antikonception hos kvinder Kvinder i den fertile alder bør anvende effektiv prævention, hvis de behandles med teriparatid.
English: Movymia 20 micrograms/80 microliters solution for injection: 1 or 3 cartridge(s) packed in a plastic tray sealed with lid foil and packed in a carton.
Danish: Movymia 20 mikrogram/80 mikroliter injektionsvæske, opløsning: 1 eller 3 cylinderampul(ler) pakket i en plastbakke forseglet med et folielåg og pakket i en karton.
English: • using cartridges other than Movymia cartridges
Danish: • brug af andre cylinderampuller end Movymia cylinderampullerne