FrancophonIA/ELRC3.0 huggingface dataset:
English: It is normal to see small air bubbles in the medicine.
Danish: Det er normalt at se små luftbobler i medicinen.
English: This medicine has been given ‘conditional approval'.
Danish: Dette lægemiddel er godkendt under "betingede omstændigheder".
English: Keep using Natpar for as long as your doctor prescribes it for you.
Danish: Du skal blive ved med at tage Natpar i så lang tid, som lægen har ordineret det.
English: The apparent terminal half-life (t1/2) was 3.02 and 2.83 hours for the 50 and 100 micrograms dose, respectively.
Danish: Den tilsyneladende terminale halveringstid (t1/2) var henholdsvis 3,02 og 2,83 timer for doserne 50 og 100 mikrogram.
English: Natpar is a protein that is not metabolised by and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g., cytochrome P450 isoenzymes).
Danish: Natpar er et protein, der ikke metaboliseres af - og ikke hæmmer - hepatiske mikrosomale lægemiddelmetaboliserende enzymer (f.eks. CYP-isoenzymer).
English: Consider reducing or stopping Natpar and re-assess by means of serum calcium measurement
Danish: Overvej at reducere eller seponere Natpar og genvurdér på basis af en serumcalcium-måling
English: The final clinical study report should be submitted by:
Danish: Den endelige kliniske studierapport skal indsendes senest:
English: This step primes your pen by removing the air from the cartridge.
Danish: Dette trin primer pennen ved at fjerne luften fra cylinderampullen.
English: Very common (1/10) Common (1/100 to
Danish: Almindelige bivirkninger ( 1/100 til
English: If you forget to use Natpar
Danish: Hvis du har glemt at tage Natpar
English: What should I do if I lost the pen cap?
Danish: Hvad skal jeg gøre, hvis jeg mister penhætten?
English: In the kidney, PTH (1-84) increases renal tubular reabsorption of calcium and promotes phosphate excretion.
Danish: I nyrerne øger PTH (1-84) den tubulære reabsorption af calcium og fremmer udskillelsen af phosphat.
English: What should I do if the medicine is cloudy, coloured, or contains particles?
Danish: Hvad skal jeg gøre, hvis medicinen er uklar, farvet eller indeholder partikler?
English: How do I throw away my pen?
Danish: Hvordan bortskaffer jeg min pen?
English: The results demonstrate durability of the physiological effects of Natpar over 60 months including maintenance of mean albumin-corrected serum calcium levels (n=49, 2.11 ±0.19 mmol/L), a decrease from baseline in urinary calcium excretion (n=47, -2.23 ±5.9 mmol/24 h), a decrease in serum phosphate (n=49, -0.29 ±0.28 mmol/L) and the maintenance of normal calcium phosphate product (n=49, <4.4mmol
Danish: Resultaterne viser de vedvarende fysiologiske virkninger af Natpar over 60 måneder, herunder opretholdelse af gennemsnitligt albumin-korrigeret serumcalcium (n = 49, 2.11 ± 0.19 mmol/l), et fald fra baseline i urinudskillelsen af calcium (n = 47, -2.23 ± 5.9 mmol/24 timer), et fald i serumphosphat (n = 49, -0.29 ± 0.28 mmol/l) og opretholdelse af normalt calcium-phosphat-produkt (n = 49, < 4,4 mmol
English: You must use a new pen needle for each injection.
Danish: Du skal bruge en ny penkanyle til hver injektion.
English: Measurements of pre- and post-dose serum calcium should be repeated and confirmed to be within an acceptable range before titration to a higher dose of Natpar is considered.
Danish: Måling af serumcalcium før og efter administration bør gentages, og det skal bekræftes, at det ligger inden for et acceptabelt interval, før titrering til en højere dosis Natpar overvejes.
English: Vascular disorders hypertension*
Danish: Vaskulære sygdomme hypertension*
English: A responder was defined using a composite primary efficacy endpoint of at least a 50% reduction from the baseline active vitamin D dose AND at least a 50% reduction from the baseline oral calcium AND an albumin-corrected total serum calcium concentration maintained or normalised compared with the baseline value (≥1.875 mmol/L) and did not exceed the upper limit of the laboratory normal range.
Danish: En responder var defineret ved et sammensat primært effektmål bestående af mindst 50 % reduktion af dosen af aktivt D-vitamin i forhold til baseline OG mindst 50 % reduktion af dosen af oralt calcium i forhold til baseline OG en totalkoncentration af albumin-korrigeret serumcalcium, der blev opretholdt eller normaliseret sammenholdt med baseline (≥ 1,875 mmol/l) og ikke overskred laboratoriets øvre normalgrænse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FYLDT PEN
English: 4 • Hold the clear medicine cartridge with your fingers and point it straight up towards the ceiling.
Danish: 4 • Hold den klare cylinderampul indeholdende medicinen med fingrene og peg den lige op mod loftet.
English: You may need to change your Natpar dose or stop the injections for a short time.
Danish: Måske skal din Natpar-dosis ændres, eller du skal holde en kortere pause med injektionerne.
English: Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Natpar may trigger the development of antibodies.
Danish: Da peptidholdige lægemidler potentielt kan have immunogene egenskaber, kan administration af Natpar udløse dannelse af antistoffer.
English: Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves.
Danish: Et lavt kalciumniveau kan give problemer mange forskellige steder i kroppen, herunder knoglerne, hjertet, huden, musklerne, nyrerne, hjernen og nervesystemet.
English: If you push the yellow button accidentally or too soon, the blue button will pop out.
Danish: Hvis du utilsigtet trykker på den gule knap eller trykker på den for tidligt, vil den blå knap komme frem.
English: Lower than 2 mmol/L
Danish: Under 2 mmol/l
English: Do not place the pen under water.
Danish: Du må ikke nedsænke pennen i vand.
English: If signs or symptoms of a serious hypersensitivity reaction occur, treatment with Natpar should be discontinued and hypersensitivity reaction should be treated according to the standard of care.
Danish: Hvis der opstår tegn eller symptomer på alvorlige overfølsomhedsreaktioner, skal behandling med Natpar seponeres, og overfølsomhedsreaktionerne skal behandles i henhold til standardpleje.
English: • sodium hydroxide (for pH adjustment)
Danish: • Natriumhydroxid (til pH-justering)
English: • Leave the needle cap on until you are ready to inject your medicine.
Danish: • Lad kanylehætten blive siddende på, indtil du er klar til at injicere medicinen.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: When you first start using Natpar, a trainer will guide you through how to mix your Natpar pen and give your injections.
Danish: Første gang du bruger Natpar, vil sundhedspersonalet vise dig, hvordan du blander din Natpar-pen og giver dine injektioner.
English: Hypoparathyroidism is a disease caused by low levels of parathyroid hormone, which is produced by the parathyroid glands in the neck.
Danish: Hypoparatyroidisme er en sygdom, der skyldes lave niveauer af parathyroideahormon, som produceres af biskjoldbruskkirtlerne i halsen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Natpar in one or more subsets of the paediatric population in hypoparathyroidism (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Natpar i en eller flere undergrupper af den pædiatriske population med hypoparatyroidisme (se pkt.
English: What you need to know before you use Natpar Do not use Natpar - if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed in section 6)
Danish: Det skal du vide, før du begynder at tage Natpar Tag ikke Natpar: - hvis du er allergisk over for parathyroideahormon eller et af de øvrige indholdsstoffer i Natpar (angivet i punkt 6)
English: Following injection with Natpar, serum phosphate levels decrease proportionally to PTH(1-84) levels over the first 4 hours and persist over 24 hours post-injection.
Danish: Efter injektion af Natpar falder serumphosphat proportionalt med PTH(1-84)-niveauet i løbet af de første 4 timer; dette lavere niveau opretholdes i 24 timer efter injektionen.
English: Natpar is indicated as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Danish: Natpar er indiceret som tillægsbehandling hos voksne patienter med kronisk hypoparatyroidisme, som ikke er tilstrækkeligt reguleret med standardbehandling alene.
English: Read and understand these Instructions for Use before you start using the Natpar Pre-filled Pen.
Danish: Du skal læse og forstå disse anvisninger, inden du begynder at bruge Natpar fyldt pen.
English: Sodium chloride, mannitol, citric acid monohydrate, metacresol, sodium hydroxide (for pH adjustment), water for injections.
Danish: Natriumchlorid, mannitol, citronsyremonohydrat, metacresol, natriumhydroxid (til pH-justering), vand til injektionsvæsker.
English: You can pinch a fold of the skin if told by your doctor or nurse.
Danish: Du kan eventuelt knibe en hudfold sammen, hvis lægen eller sygeplejersken har sagt det.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: Calcium supplement
Danish: Calciumtilskud
English: Co-administration of alendronic acid and Natpar may lead to a reduction in the calcium sparing effect, which can interfere with the normalisation of serum calcium.
Danish: Samtidig administration af alendronsyre og Natpar kan medføre nedsat calciumbesparende effekt, hvilket kan interferere med normaliseringen af serumcalcium.
English: • water for injections
Danish: • Vand til injektionsvæsker
English: Across all clinical studies in patients with hypoparathyroidism following treatment with Natpar for up to 4 years, the immunogenicity incidence rate was 17/87 (19.5%) and did not appear to increase over time.
Danish: På tværs af alle kliniske studier med hypoparatyroidisme-patienter var incidensraten for immunogenicitet 17/87 (19,5 %) efter behandling med Natpar i op til 4 år, og der sås ingen stigning i incidensen over tid.
English: If needed, clean the pen by wiping the outside with a cloth dampened with water.
Danish: Rengør om nødvendigt pennen ved at aftørre ydersiden med en klud fugtet med vand.
English: The active substance is parathyroid hormone (rDNA).
Danish: Aktivt stof: parathyroideahormon (rDNA).
English: In this trial, patients with chronic hypoparathyroidism receiving calcium and active forms of vitamin D (vitamin D metabolite or analogues) were randomised to Natpar (n=84) or placebo (n=40).
Danish: I dette studie blev kroniske hypoparatyroidisme-patienter, der tog calcium og aktive former for D-vitamin (D-vitamin-metabolitter eller -analoger), randomiseret til enten Natpar (n = 84) eller placebo (n = 40).
English: A greater increase in the levels of 1,25-(OH)2D in serum were observed with the 50 micrograms dose than with the 100 micrograms dose, likely due to direct inhibition of the renal 25-hydroxyvitamin D-1-hydroxylase enzyme by serum calcium.
Danish: Der sås en større stigning i 1,25(OH)2-vitamin D-niveauet i serum efter 50 mikrogram end efter 100 mikrogram, hvilket sandsynligvis skyldes serumcalciums direkte hæmning af det renale enzym 25-hydroxy-vitamin D-1hydroxylase.
English: • Before attaching a new needle to your Natpar pen, check that the solution is clear and colourless.
Danish: • Før du sætter en ny nål på Natpar-pennen, skal du sikre dig, at injektionsvæsken er klar og farveløs.
English: If you are treated with Natpar, you may have side effects related to low or high levels of calcium in your blood (see section 4 for these side effects).
Danish: Hvis du behandles med Natpar, kan du få bivirkninger, der er forbundet med et lavt eller højt indhold af kalcium i blodet (se punkt 4 for at læse mere om disse bivirkninger).
English: Natpar has no or negligible influence on the ability to drive and use machines.
Danish: Natpar påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In vitro and in vivo studies demonstrated that the clearance of Natpar is primarily a hepatic process with a lesser role played by the kidneys.
Danish: In vitro- og in vivo-studier har vist, at clearance af Natpar primært sker via leveren og i mindre grad via nyrerne.
English: Do not use the Natpar Pre-filled Pen unless you have been shown the right way to give the injections by a doctor or nurse.
Danish: Du må ikke bruge Natpar fyldt pen, før en læge eller sygeplejerske har vist dig, hvordan du skal give injektionen.
English: Treatment with Natpar increases serum calcium concentration in hypoparathyroidism patients, and this increase occurs in a dose-related manner.
Danish: Behandling med Natpar øger serumcalcium hos hypoparatyroidisme-patienter, og denne stigning er dosisafhængig.
English: Continue following the instructions, being careful not to press the blue button until instructed to do so.
Danish: Fortsæt med at følge anvisningerne og undgå at trykke den blå knap ned, før det er meningen.
English: The inotropic effects of cardiac glycosides are affected by serum calcium levels.
Danish: Hjerteglykosiders inotrope effekt påvirkes af serumcalcium-niveauet.
English: • redness and pain at injection site
Danish: • rødme og ømhed på injektionsstedet
English: There have been post-marketing reports of hypersensitivity reactions in patients taking Natpar.
Danish: Efter markedsføring er der rapporteret tilfælde af overfølsomhedsreaktioner hos patienter, der tager Natpar.
English: Natpar should be used with caution in young adult patients with open epiphyses as these patients may be at increased risk for osteosarcoma (see section 4.3).
Danish: Natpar skal anvendes med forsigtighed hos unge patienter med åbne epifyseskiver, da disse patienter kan have øget risiko for osteosarkom (se pkt.
English: If your levels of parathyroid hormone are too low, you can have low blood calcium.
Danish: Hvis niveauet af parathyroideahormon i din krop er for lavt, kan kalciumniveauet i dit blod blive for lavt.
English: The cartridge is made of glass, with a rubber seal on top.
Danish: Cylinderampullen er lavet af glas og har en gummiforsegling i toppen.
English: • Write the date 14 days from today in the space next to “Discard On”.
Danish: • Skriv datoen 14 dage fra i dag på linjen “Kasseres den”.
English: If pre-dose serum calcium is >2.25 mmol/L, a starting dose of 25 micrograms can be considered.
Danish: Hvis serumcalcium er > 2,25 mmol/l før administration, kan en startdosis på 25 mikrogram overvejes.
English: • Discard all pens on the “Discard On” date, 14 days after mixing (see Medicine Tracker).
Danish: • Kassér alle penne på datoen “Kasseres den”, 14 dage efter blanding (se Datoetiket).
English: Before throwing away your pen, be sure to remove the pen needle and dispose of it as instructed in Step 17: “Discard your used needles.” Then discard your used pen in the sharps container.
Danish: Inden du kasserer din pen, skal du sørge for at fjerne penkanylen og bortskaffe den som anvist i trin 17: ”Kassér dine brugte nåle.” Kassér derefter din brugte pen i beholderen til skarpe genstande.
English: • fast or uneven heart beat*,
Danish: • hurtig eller uregelmæssig hjerterytme (puls)*,
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Ireland.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower, Dublin 2, Irland.
English: What should I do if the clear medicine cartridge is difficult to screw down?
Danish: Hvad skal jeg gøre, hvis det er svært at skrue den klare cylinderampul med medicin ned?
English: Animal data do not indicate any impairment of fertility.
Danish: Dyrestudier indikerer ikke nogen indvirkning på fertilitet.
English: In the post-marketing setting, cases of symptomatic hypocalcaemia, including cases that resulted in seizures, have been reported in patients being treated with Natpar.
Danish: Efter markedsføring er hændelser med symptomatisk hypokalcæmi, inklusive hændelser, der førte til slagtilfælde, blevet rapporteret hos patienter, behandlet med Natpar.
English: These medicines include calcium or vitamin D.
Danish: Der kan f.eks. være tale om kalcium eller D-vitamin.
English: Talk to your doctor or pharmacist before using Natpar if you suffer from kidney stones.
Danish: Tal med lægen eller apotekspersonalet før du bruger Natpar, hvis du lider af nyresten.
English: Natpar has no effect on your being able to drive or use machines.
Danish: Natpar påvirker ikke din evne til at køre bil eller betjene maskiner.
English: After mixing
Danish: Efter opblanding
English: Your doctor may tell you to take other medicines such as calcium supplements or vitamin D while you are taking Natpar.
Danish: Lægen kan vurdere, at du også skal tage andre midler som f.eks. kalciumtilskud eller D-vitamin, mens du tager Natpar.
English: Parathyroid hormone (rDNA) is injected using a pre-filled pen.
Danish: Parathyroideahormon (rDNA) injiceres ved hjælp af en fyldt pen.
English: You may need to take more calcium supplements if you have signs of low blood calcium; see section 4 for symptoms.
Danish: Du skal måske tage yderligere kalciumtilskud, hvis du har tegn på nedsat kalciumniveau i blodet (se punkt 4 for symptomer).
English: The safety and clinical efficacy of Natpar in adults with hypoparathyroidism is derived from 1 randomised, placebo-controlled study and an open-label extension study.
Danish: Natpars sikkerhed og kliniske virkning hos voksne hypoparatyroidisme-patienter er påvist i et randomiseret, placebo-kontrolleret studie og et åbent forlængelsesstudie.
English: If you do not wait 10 seconds after pressing the blue button, you may not receive your full dose.
Danish: Hvis du ikke venter i 10 sekunder, får du muligvis ikke hele din dosis.
English: Patients should be monitored until signs and symptoms resolve (see sections 4.3 and 4.8).
Danish: Patienterne skal monitoreres, indtil tegn og symptomer forsvinder (se pkt.
English: In these studies, Natpar was self-administered, with daily doses ranging from 25 to 100 micrograms per subcutaneous injection.
Danish: I disse studier blev Natpar selv-administreret med en daglig dosis på 25-100 mikrogram subkutant.
English: Phosphate
Danish: Phosphat
English: Do not touch the needle or the inside of the needle cap.
Danish: Du må ikke røre ved kanylen eller røre indersiden af kanylehætten.
English: Natpar is a synthetic form of parathyroid hormone that helps you keep calcium and phosphate levels in your blood and urine at a normal level.
Danish: Natpar er en syntetisk form for parathyroideahormon, som medvirker til at holde koncentrationen af kalcium og fosfat i blodet og urinen på et normalt niveau.
English: B. New Pen Setup and Mixing
Danish: B. Klargøring og blanding af ny pen
English: Patients must be trained on the proper injection techniques by the prescriber or nurse, in particular during initial use.
Danish: Den ordinerende læge eller en sygeplejerske skal undervise patienterne i korrekt injektionsteknik, især i starten.
English: If you have questions at any time, see the “Frequently Asked Questions” in Section E, contact your doctor or nurse, call Shire at +44 (0)800 055 6614, or email at medinfoEMEA@shire.com for help.
Danish: Hvis du har spørgsmål, kan du til enhver tid se ”Ofte stillede spørgsmål” i afsnit E, eller få hjælp ved at kontakte lægen eller sygeplejersken, ringe til Shire på +44 (0)800 055 6614 eller sende en e-mail til medinfoEMEA@shire.com.
English: Initiate treatment with 50 micrograms once daily as a subcutaneous injection in the thigh (alternate thigh every day).
Danish: Start behandlingen med 50 mikrogram én gang dagligt som subkutan injektion i låret (skift lår hver dag).
English: - if you are having or have had radiation therapy to the skeleton - if you have cancer of the bones or other cancer that has spread to your bones - if you are at increased risk of developing a bone cancer called osteosarcoma (for instance, if you have Paget's disease or other bone diseases) - if a blood test shows you have unexplained increases in bone alkaline phosphatase - if you have pseudohypoparathyroidism, a rare condition where the body does not respond adequately to the parathyroid hormone produced by the body
Danish: - hvis du skal gennemgå eller tidligere har gennemgået strålebehandling af skelettet - hvis du har knoglekræft eller andre kræftformer, der har spredt sig til dine knogler - hvis du har øget risiko for at udvikle en type knoglekræft, der kaldes osteosarkom (f.eks. hvis du har Pagets knoglesygdom eller en anden knoglesygdom) - hvis en blodprøve viser, at du har uforklarlige stigninger i knogle-specifik basisk fosfatase - hvis du har pseudohypoparatyroidisme, en sjælden tilstand, hvor kroppen ikke reagerer tilstrækkeligt på det parathyroideahormon, der produceres i kroppen.
English: In patients using active vitamin D, decrease the dose of active vitamin D by 50%, if pre-dose serum calcium is above 1.87 mmol/L.
Danish: Hos patienter, der tager aktivt D-vitamin, skal dosis af aktivt D-vitamin nedsættes med 50 %, hvis serumcalcium før administration er over 1,87 mmol/l.
English: The risk for serious hypocalcaemia is highest after Natpar is withheld, missed or abruptly discontinued, but can occur at any time.
Danish: Risikoen for alvorlig hypokalcæmi er højest efter seponering af Natpar, ved oversprunget dosis eller ved pludselig behandlingsafbrydelse, men det kan forekomme til enhver tid.
English: • Very common: high levels of calcium in your blood, which can occur more often when you start treatment with Natpar.
Danish: • Meget almindelig bivirkning: forhøjet kalciumniveau i blodet, som typisk kan opstå, når du starter på behandlingen med Natpar.
English: The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst én gang om året vurdere nye oplysninger om lægemidlet, og produktresuméet vil om nødvendigt blive ajourført.
English: 11 • Check if the yellow dose counter lines up with the number “14” (See Figure L).
Danish: 11 • Tjek, at den gule dosistæller er ud for nummer “14” (se figur L).
English: • Do NOT freeze your pen.
Danish: • Du må IKKE nedfryse pennen.
English: Natpar contains sodium
Danish: Natpar indeholder natrium
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion (total-score på 7-9 på Child-Pugh-skalaen).
English: The overall effect of PTH is to increase serum calcium concentration, to reduce urinary excretion of calcium and to lower serum phosphate concentration.
Danish: PTH's overordnede virkning er at øge serumcalcium, reducere urinudskillelsen af calcium og nedsætte serumphosphat.
English: Decrease or discontinue**
Danish: Reducér eller seponér**
English: The clinical study report should be submitted by:
Danish: Den kliniske studierapport skal indsendes senest:
English: Parathyroid hormone (rDNA) was evaluated in an open-label PK/PD study in which 7 patients with hypoparathyroidism received single subcutaneous doses of 50 and 100 micrograms with a 7-day washout interval between doses.
Danish: Parathyroideahormon (rDNA) er vurderet i et åbent farmakokinetisk/farmakodynamisk studie, hvor 7 patienter med hypoparatyroidisme fik en enkelt subkutan dosis på 50 og 100 mikrogram med en udvaskningsperiode på 7 dage mellem doserne.