FrancophonIA/ELRC3.0 huggingface dataset:
English: The following potentially serious side effects can occur when using Natpar:
Danish: Følgende muligvis alvorlige bivirkninger kan opstå under behandling med Natpar:
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrede produkts handelsnavn og batchnummer ydeligt registreres.
English: Natpar did not adversely affect fertility or early embryonic development in rats, embryo-foetal development in rats and rabbits, or pre/post-natal development in rats.
Danish: Natpar havde ingen negativ indvirkning på fertiliteten eller den tidlige fosterudvikling hos rotter, den embryo-føtale udvikling hos rotter og kaniner eller den prænatale/postnatale udvikling hos rotter.
English: • antibodies (produced by your immune system) to Natpar
Danish: • antistoffer (der produceres af dit immunsystem) mod Natpar
English: • fatigue and lack of energy*
Danish: • træthed og mangel på energi*
English: *The value of ULN may vary by laboratory **Discontinue in patients receiving the lowest available dose
Danish: * ULN kan variere laboratorierne imellem ** Seponér hos patienter, der får den laveste tilgængelige dosis
English: • allergic reactions (hypersensitivity), such as: swelling of the face, lips, mouth, or tongue;
Danish: • allergiske reaktioner (overfølsomhed) som f.eks. hævelse af ansigtet, læber, mund eller tunge,
English: You may have forgotten to prime the pen as instructed in “New Pen Setup & Mixing” (Section B).
Danish: Du har muligvis glemt at prime pennen som anvist i ”Klargøring og blanding af ny pen” (afsnit B).
English: It is recommended to measure the albumin-corrected serum calcium 8-12 hours after dosing Natpar.
Danish: Det anbefales at måle albumin-korrigeret serumcalcium 8-12 timer efter administration af Natpar.
English: The risk for serious hypocalcaemia was greatest after the withdrawal of Natpar.
Danish: Risikoen for alvorlig hypokalcæmi var størst efter seponering af Natpar.
English: Consider reduction
Danish: Overvej at reducere
English: • Email Shire at medinfoEMEA@shire.com.
Danish: • E-mail Shire på medinfoEMEA@shire.com.
English: The recommended starting dose of Natpar is 50 micrograms per day.
Danish: Den anbefalede startdosis af Natpar er 50 mikrogram pr. dag.
English: There is limited information on the safety of Natpar in pregnant women.
Danish: Der er kun begrænset information om sikkerheden ved Natpar hos gravide kvinder.
English: The optimisation of parameters of calcium-phosphate metabolism should be in line with current therapeutic guidelines for the treatment of hypoparathyroidism.
Danish: Optimering af parametre for calcium-phosphat-metabolismen skal følge gældende terapeutiske retningslinjer for behandling af hypoparatyroidisme.
English: This step mixes the powder and liquid.
Danish: Dette trin blander pulveret med væsken.
English: Check the dose counter to see if there are any doses left, or check the “Discard On” date on the Medicine Tracker to see if it has been more than 14 days.
Danish: Tjek dosistælleren for at se, om der er flere doser tilbage, eller tjek datoen ”Kasseres den” på datoetiketten for at se, om der er gået mere end 14 dage.
English: If you stop using Natpar
Danish: Hvis du holder op med at bruge Natpar
English: What you need to know before you use Natpar 3.
Danish: Det skal du vide, før du begynder at tage Natpar 3.
English: After you have mixed the medicine, the Natpar pen is ready for use and the medicine can be injected under the skin of your thigh.
Danish: Når du har blandet medicinen, er Natpar-pennen klar til brug, og medicinen kan injiceres under huden på dit lår.
English: Randomisation was followed by a 12-week Natpar titration phase and a 12-week Natpar dose maintenance phase.
Danish: Efter randomiseringen fulgte en 12ugers fase med Natpar-titrering og en 12-ugers fase med Natpar-vedligeholdelsesdosis.
English: If, by mistake, you inject more than one dose of Natpar in a day, contact your doctor or pharmacist immediately.
Danish: Hvis du ved en fejl kommer til at injicere mere end én dosis Natpar samme dag, skal du omgående kontakte lægen eller apotekspersonalet.
English: Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is unknown.
Danish: Da rotter og mennesker har forskellig knoglefysiologi, er den kliniske relevans af disse fund ikke kendt.
English: What should I do if I accidentally push the yellow button before I'm supposed to?
Danish: Hvad skal jeg gøre, hvis jeg utilsigtet trykker på den gule knap, før jeg skal?
English: Discuss with your doctor if you want to stop treatment with Natpar.
Danish: Tal med lægen, hvis du ønsker at stoppe behandlingen med Natpar.
English: Severe hypercalcaemia may be a life-threatening condition requiring urgent medical care and careful monitoring (see section 4.4).
Danish: Svær hyperkalcæmi kan være en livstruende tilstand, der kræver akut lægehjælp og omhyggelig overvågning (se pkt.
English: Figure L The setup of your pen is complete.
Danish: Figur L Klargøring af pennen er fuldført.
English: • Follow these instructions each time you use your pen to ensure that you do not skip any steps.
Danish: • Du skal følge denne brugervejledning, hver gang du bruger din pen, så du ikke glemmer et af trinene.
English: Distribution Following intravenous administration, Natpar has a volume of distribution of 5.35 L at steady state.
Danish: Fordeling Efter intravenøs administration har Natpar et fordelingsvolumen ved steady state på 5,35 l.
English: The Instructions for Use of the Natpar Pre-filled Pen are included in 5 sections: A. Getting Started
Danish: Vejledningen i brug af Narpar fyldt pen er inddelt i 5 trin: A. Sådan kommer du i gang
English: • Do not use this medicine for more than 14 days after it has been mixed.
Danish: • Medicinen må højst bruges i 14 dage, efter at den er blevet blandet.
English: Since neurologic symptoms may be a sign of uncontrolled hypoparathyroidism, patients with disturbances in cognition or attention should be advised to refrain from driving or using machines until symptoms have subsided.
Danish: Da neurologiske symptomer kan være et tegn på ukontrolleret hypoparatyroidisme, skal patienter med forstyrrelser i kognition eller opmærksomhed informeres om, at de ikke må føre motorkøretøj eller betjene maskiner, før symptomerne har fortaget sig.
English: If your ability to concentrate is impaired, you should not drive or use machines until your ability to concentrate is improved.
Danish: Hvis din evne til at koncentrere dig er nedsat, må du ikke køre motorkøretøj eller betjene maskiner, før din koncentrationsevne er normal igen.
English: Treatment should be supervised by a physician or other qualified healthcare professional experienced in the management of patients with hypoparathyroidism.
Danish: Behandlingen skal superviseres af en læge eller anden specialist, der har erfaring i behandling af patienter med hypoparatyroidisme.
English: You may be given medicines to treat or help prevent these side effects, or you may be asked to stop some of the medicines you are taking.
Danish: Du vil eventuelt få medicin til at behandle eller forebygge disse bivirkninger, ligesom du eventuelt kan blive bedt om at holde op med at tage noget af din nuværende medicin.
English: After reconstitution, chemical and physical in-use stability of the solution has been demonstrated for up to 14 days when stored in a refrigerator (2°C - 8°C) and for up to 3 days when stored outside the refrigerator not above 25°C during the 14-day use period.
Danish: Efter rekonstitution er kemisk og fysisk i-brug-stabilitet påvist i op til 14 dage ved opbevaring i køleskab (2 °C-8 °C) og i op til 3 dage, når injektionsvæsken opbevares uden for køleskab ved temperaturer, der ikke overstiger 25 °C, i løbet af anvendelsesperioden på 14 dage.
English: - After 2 to 4 weeks, your doctor may adjust the dose.
Danish: - Lægen kan justere din dosis efter 2-4 uger.
English: 1 • Check the expiration date (EXP) on the pen (See Figure A).
Danish: 1 • Tjek udløbsdatoen (EXP) på pennen (se figur A).
English: Special populations Elderly
Danish: Særlige populationer Ældre
English: Save the cap for later use (See Figure D).
Danish: Gem hætten til senere brug (se figur D).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity, toxicity to fertility and general reproduction, and local tolerance.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, mutagenicitet, fertilitets- og reproduktionstoksicitet og lokal tolerance.
English: What if I see more than 1 or 2 drops of medicine leak from my skin or from the needle tip during or after an injection?
Danish: Hvad skal jeg gøre, hvis jeg ser mere end 1 eller 2 dråber medicin sive ud af huden eller fra nålespidsen under eller efter en injektion?
English: A minimal amount of Natpar is excreted in the milk of lactating rats.
Danish: En meget lille mængde Natpar udskilles i mælken hos diegivende rotter.
English: DO NOT SHAKE during or after reconstitution; shaking may cause denaturation of the active substance.
Danish: MÅ IKKE RYSTES under eller efter rekonstitutionen, da det kan denaturere det aktive stof.
English: • Get a new pen needle and set it next to the pen.
Danish: • Tag en ny penkanyle frem og anbring den ved siden af pennen.
English: What if I tighten the needle too much and it “clicks” and loosens?
Danish: Hvad skal jeg gøre, hvis jeg strammer kanylen for meget, og den ”klikker” og løsner sig?
English: Paediatric population Pharmacokinetic data in paediatric patients are not available.
Danish: Pædiatrisk population Der foreligger ingen farmakokinetiske data for pædiatriske patienter.
English: • You may want to also write down the ”Date Mixed” and “Discard On” date in a place where you will remember, like a personal calendar or mobile device.
Danish: • Det kan være en hjælp at notere datoerne ”Blandet den” og “Kasseres den” et sted, hvor du kan huske det, f.eks. en personlig kalender eller din mobiltelefon.
English: • Discard the used needle in a large, puncture-resistant sharps disposal container right away after use.
Danish: • Kassér den brugte kanyle i en stor, punktérfri beholder til skarpe genstande straks efter brug.
English: Make sure you do not unscrew the needle
Danish: Sørg for, at du ikke skruer kanylen af
English: Try re-tightening the needle.
Danish: Prøv at stramme kanylen igen.
English: Natpar should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Danish: Natpar bør anvendes med forsigtighed til patienter med aktiv eller nylig urolithiasis på grund af risikoen for forværring af denne tilstand.
English: At randomisation, active forms of vitamin D were reduced by 50% and patients were allocated to Natpar 50 micrograms daily or placebo.
Danish: Ved randomiseringen blev aktive former for D-vitamin reduceret med 50 %, og patienterne blev udvalgt til at få enten Natpar 50 mikrogram dagligt eller placebo.
English: - However, your doctor may start you on 25 micrograms per day based on a blood test result.
Danish: - Lægen kan dog give dig 25 mikrogram pr. dag som startdosis alt efter resultatet af din blodprøve.
English: Important: Dispose of your pen on the “Discard On” date even if you have medicine left in your pen.
Danish: Vigtigt: Du skal kassere din pen på datoen “Kasseres den”, også selv om der er resterende medicin i pennen.
English: No change, or decrease if active vitamin D was already discontinued before this titration step
Danish: Ingen ændring eller reducér, hvis aktivt Dvitamin allerede er seponeret før dette titreringstrin
English: Do not use your pen on or after the “Discard On” date.
Danish: Du må ikke bruge din pen på eller efter datoen “Kasseres den”.
English: Pharmacotherapeutic group: Calcium homeostasis, parathyroid hormones and analogues, ATC code: H05AA03
Danish: Farmakoterapeutisk klassifikation: Calciumhomøostase, parathyroideahormoner og analoger, ATC-kode: H05AA03
English: If the needle is not pointing straight up or the cartridge is screwed down too quickly during this step, medicine may leak from your pen.
Danish: Hvis kanylen ikke peger lige op, eller cylinderampullen skrues ned for hurtigt i dette trin, kan medicinen sive ud fra pennen.
English: • In the Medicine Tracker below (See Figure C):
Danish: • På Datoetiketten nedenfor (se figur C):
English: The reconstituted pre-filled pen should be discarded after the 14-day period.
Danish: Den rekonstituerede fyldte pen skal kasseres efter de 14 dage.
English: Natpar has the same primary amino acid sequence as endogenous parathyroid hormone and may be anticipated to have the same physiological actions.
Danish: Natpar har den samme primære aminosyresekvens som endogent parathyroideahormon og kan forventes at have samme fysiologiske virkninger.
English: Carton/pen label colours are used to indicate the different strengths:
Danish: Farverne på æsken/pennen anvendes til at angive de forskellige styrker:
English: It is strongly recommended that every time you receive a dose of Natpar, the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt, at du noterer præparatets navn og batchnummer, hver gang du tager en dosis Natpar, for at få en fortegnelse over de anvendte batches.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Exposure to PTH as measured by AUC0-last and baseline-corrected AUC0-last was approximately 3.9% and 2.5%, respectively, higher than that observed for subjects with normal renal function.
Danish: Eksponeringen for PTH i henhold til AUC0-last og baseline-korrigeret AUC0-last var henholdsvis ca. 3,9 % og 2,5 % højere end hos forsøgspersoner med normal nyrefunktion.
English: • After 5 minutes, if the liquid is colourless, go to the next step.
Danish: • Hvis væsken er farveløs efter 5 minutter, går du videre til næste trin.
English: Natpar has not been studied in patients with urolithiasis.
Danish: Natpar er ikke undersøgt hos patienter med urolithiasis.
English: No, do not re-use your pen needle.
Danish: Nej, du må ikke genbruge din penkanyle.
English: Your doctor may tell you to change the amount of calcium or vitamin D you take (in any form, including foods rich in calcium).
Danish: Lægen vil eventuelt fortælle dig, at du skal ændre den mængde kalcium eller D-vitamin, du tager (i alle former, også kalcium i fødevarer).
English: Above the upper limit of normal (ULN) (2.55 mmol/L)*
Danish: Over den øvre normalgrænse (ULN) (2,55 mmol/l)*
English: The calcium-raising effect of Natpar may diminish over time in some patients.
Danish: Natpars calcium-øgende virkning kan hos nogle patienter mindskes over tid.
English: Tighten the needle and make sure that the needle is on straight and the threads are lined up.
Danish: Stram nålen og sørg for, at nålen sidder lige på og gevindene er lige.
English: Non-interventional post-authorisation safety study (PASS): In order to collect long-term data on clinical efficacy and safety, the MAH should submit the results of a study based on data deriving from a registry of patients with hypoparathyroidism and who are treated with NATPAR.
Danish: Ikke-interventionel sikkerhedsundersøgelse efter tilladelse til markedsføring (PASS): For at indsamle langtidsdata om klinisk effekt og sikkerhed skal indehaveren af markedsføringstilladelsen indsende resultaterne fra et studie baseret på data fra et register over patienter med hypoparatyroidisme, som behandles med Natpar.
English: In monkeys receiving daily subcutaneous doses for 6 months, there was an increased occurrence of renal tubular mineralisation at exposure levels 2.7 times the clinical exposure levels at the highest dose.
Danish: Hos aber, der fik daglige subkutane doser i 6 måneder, sås en øget forekomst af renal tubulær mineralisering ved eksponeringer på 2,7 gange den kliniske eksponering ved den højeste dosis.
English: Important: It is recommended to switch thighs every day for your injection site.
Danish: Vigtigt: Det anbefales at skifte injektionssted til det andet lår hver dag.
English: Prior to initiating and during treatment with Natpar:
Danish: Før iværksættelse af og under behandling med Natpar:
English: • When your sharps disposal container is two thirds full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Danish: • Når beholderen til skarpe genstande er totredjedele fyldt, skal du følge de lokale retningslinjer for bortskaffelse af beholderen til skarpe genstande.
English: Parathyroid hormone receptors belong to the family of G-coupled protein receptors.
Danish: Parathyroideahormon-receptorer hører til familien af G-forbundne proteinreceptorer.
English: There are no data on the effects of Natpar on human fertility.
Danish: Der er ingen data vedrørende indvirkningen af Natpar på human fertilitet.
English: Patients received doses of 25 micrograms, 50 micrograms, 75 micrograms or 100 micrograms/day for up to approximately 60 months (mean 1161 days, range 41 to 1820 days).
Danish: Patienterne fik doser på 25 mikrogram, 50 mikrogram, 75 mikrogram eller 100 mikrogram/dag i op til omkring 60 måneder (gennemsnitligt 1161 dage (411820 dage)).
English: There are no data from the use of Natpar in pregnant women.
Danish: Der er ingen data fra anvendelse af Natpar til gravide kvinder.
English: Always store your pen in the refrigerator between 2°C to 8°C.
Danish: Opbevar altid din pen i køleskabet ved temperaturer mellem 2 °C- 8 °C.
English: No osteosarcomas have been observed in clinical trials.
Danish: Der er ikke set osteosarkomer i kliniske studier.
English: The safety and efficacy of Natpar in children less than 18 years of age have not yet been established.
Danish: Pædiatrisk population Natpars sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Can I re-use the pen needles?
Danish: Kan jeg genbruge penkanylerne?
English: 25 micrograms - Purple 50 micrograms - Red 75 micrograms - Grey 100 micrograms - Blue
Danish: 25 mikrogram - lilla 50 mikrogram - rød 75 mikrogram - grå 100 mikrogram - blå
English: Natpar is available in a pack with 2 pre-filled pens.
Danish: Natpar fås i en pakning med 2 fyldte penne.
English: A. Getting Started
Danish: A. Sådan kommer du i gang
English: Study 2 is a long-term, open-label extension study of daily subcutaneous dosing of Natpar in hypoparathyroidism patients who completed prior studies with Natpar.
Danish: Studie 2 er et åbent, længerevarende forlængelsesstudie til evaluering af daglig subkutan administration af Natpar hos hypoparatyroidisme-patienter, der tidligere har gennemført Natparstudier.
English: Adjust first
Danish: Justér først
English: This means that further evidence on this medicinal product is awaited.
Danish: Det betyder, at der forventes yderligere dokumentation for lægemidlet.
English: The needle must be pointing down at all times until after the injection so that the air stays away from the needle.
Danish: Kanylen skal pege ned hele tiden, indtil injektionen er gennemført, så luftboblerne forbliver væk fra kanylen.
English: These effects are more likely to occur: - when first starting Natpar, - if you change your Natpar dose, - if you miss one of your daily injections, - if you stop taking Natpar for a short time or altogether.
Danish: Disse bivirkninger kan typisk optræde: - i starten af Natpar-behandlingen - hvis din Natpar-dosis bliver ændret - hvis du glemmer en af dine daglige injektioner - hvis du holder op med at tage Natpar i et stykke tid eller helt holder op med at tage det.
English: • Keep the pen needle in your skin and slowly count to 10 while continuing to hold down the blue button.
Danish: • Lad kanylen blive siddende i huden og tæl langsomt til 10, mens du fortsat trykker på den blå knap.
English: There were no apparent differences in the serum total calcium concentration-time profiles between the 2 hepatic function groups.
Danish: Der var ingen åbenlyse forskelle mellem de 2 grupper, hvad angår totalkoncentration/tid-profilerne for serumcalcium.
English: If pre-dose serum calcium is below 1.87 mmol/L or above 2.55 mmol/L, this measurement should be repeated the following day.
Danish: Hvis serumcalcium er under 1,87 mmol/l eller over 2,55 mmol/l, skal målingen gentages den efterfølgende dag.
English: Abrupt interruption or discontinuation of Natpar can result in severe hypocalcaemia.
Danish: Pludselig afbrydelse eller seponering af Natpar kan medføre svær hypokalcæmi.
English: Available pharmacology data in animals have shown excretion of Natpar in milk (see section 5.3).
Danish: De tilgængelige farmakologiske data fra dyrestudier viser, at Natpar udskilles i mælk (se pkt.
English: This hormone controls the amount of calcium and phosphate in the blood and urine.
Danish: Dette hormon regulerer mængden af kalcium og fosfat i blodet og urinen.
English: • Continue to point the needle straight down.
Danish: • Fortsæt med at pege kanylen lige ned.
English: In order to further confirm the efficacy and safety of NATPAR in the treatment of patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone, the MAH should conduct a randomised controlled trial comparing NATPAR to Standard of Care and to alternative dosing according to an agreed protocol.
Danish: For yderligere at bekræfte Natpars effekt og sikkerhed ved behandling af patienter med kronisk hypoparatyroidisme, som ikke kan kontrolleres tilstrækkeligt med standardbehandling alene, skal indehaveren af markedsføringstilladelsen gennemføre et randomiseret, kontrolleret studie, der sammenligner Natpar med standardbehandling og med alternative doseringer i henhold til en aftalt protokol.
English: EXP Discard mixed pen after 14 days.
Danish: EXP Bortskaf rekonstituerede penne efter 14 dage.
English: Natpar is suitable for patient self-administration.
Danish: Natpar er velegnet til selvadministration.
English: A decision must be made whether to initiate or discontinue treatment with Natpar during pregnancy taking into account the known risks of therapy versus the benefit for the woman.
Danish: Det skal besluttes, om behandling med Natpar skal påbegyndes eller seponeres under graviditet, idet der tages højde for de kendte risici ved behandlingen i forhold til fordelene for kvinden.
English: Most of the hypocalcaemic events occurring in the clinical trials were mild to moderate in severity.
Danish: De fleste tilfælde af hypokalcæmi i de kliniske studier var lette til moderate i sværhedsgrad.
English: What if I see air bubbles floating in the medicine or the medicine appears foamy after mixing?
Danish: Hvad skal jeg gøre, hvis jeg ser luftbobler i medicinen, eller medicinen skummer efter blanding?
English: 18 • Put the pen cap back on your pen by pushing the cap until it clicks.
Danish: 18 • Sæt penhætten tilbage på pennen ved at skubbe, indtil hætten klikker.
English: Rats treated with daily injections of Natpar for 2 years had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to a non-genotoxic mechanism.
Danish: Rotter, der blev behandlet med daglige injektioner af Natpar i 2 år, udviste dosisafhængig, unormalt stor knogledannelse og øget forekomst af knogletumorer, herunder osteosarkom, højst sandsynligt som følge af en ikke-genotoksisk mekanisme.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: In the powder:
Danish: i pulveret:
English: Important: If the cartridge is hard to screw down all the way, tighten the needle and try to slowly screw down the cartridge again.
Danish: Vigtigt: Hvis det er svært at skrue cylinderampullen helt ned, skal du stramme kanylen og prøve at skrue langsomt ned igen.