FrancophonIA/ELRC3.0 huggingface dataset:
English: The glass dual-chamber cartridge inside the pen is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal.
Danish: Glasampullen i pennen har to kamre og er af type I-glas og forsynet med 2 gummipropper (brombutylgummi) samt en aluminiumshætte med gummiforsegling (brombutylgummi).
English: The goal of treatment with Natpar is to achieve calcaemic control and to reduce symptoms (see also section 4.4).
Danish: Formålet med Natpar-behandlingen er at opnå et velkontrolleret calcium-niveau og reducere symptomerne (se også pkt.
English: Do not use this medicine after the expiry date which is stated on the pen and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pennen og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The dose of Natpar may be increased by 25 microgram increments approximately every 2 to 4 weeks, up to a maximum daily dose of 100 micrograms.
Danish: Natpar-dosis kan øges i trin a 25 mikrogram ca. hver 2.-4. uge op til en maksimal daglig dosis på 100 mikrogram.
English: Adverse reactions for Natpar-treated patients in the placebo-controlled study and in post-marketing experience are listed below by MedDRA system organ class and frequency.
Danish: Bivirkningerne hos Natpar-behandlede patienter i det placebokontrollerede studie og efter markedsføring er opstillet nedenfor i henhold til MedDRA-systemorganklasse og hyppighed.
English: Hypercalcaemia commonly occurred during the titration period, during which doses of oral calcium, active vitamin D, and Natpar were being adjusted.
Danish: Hyperkalcæmi forekom hyppigt i titreringsperioden, hvor doserne af oralt calcium, aktivt D-vitamin og Natpar blev justeret.
English: Excipient(s) with known effect Each dose contains 0.32 mg of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver dosis indeholder 0,32 mg natrium.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof
English: Breast-feeding It is unknown whether Natpar is excreted in human milk.
Danish: Amning Det er ukendt, om Natpar udskilles i human mælk.
English: In the placebo-controlled study in adults with hypoparathyroidism, the incidence of anti-parathyroid hormone (PTH) antibodies was 8.8% (3/34) and 5.9% (1/17) in patients who received subcutaneous administration of 50 to 100 micrograms Natpar or placebo once daily for 24 weeks, respectively.
Danish: I det placebokontrollerede studie med voksne hypoparatyroidisme-patienter var incidensen af anti-parathyroideahormon (PTH)-antistoffer henholdsvis 8,8 % (3/34) og 5,9 % (1/17) efter subkutan administration af henholdsvis 50100 mikrogram Natpar og placebo én gang dagligt i 24 uger.
English: Your doctor will decide whether to start treatment with Natpar.
Danish: Din læge vil vurdere, om du skal påbegynde Natpar-behandlingen.
English: The ‘Natpar pre-filled pen' is called ‘Natpar pen' or ‘pen' in this leaflet.
Danish: Natpar fyldt pen omtales som Natpar-pen eller blot pen i denne indlægsseddel.
English: How to use the pre-filled pen
Danish: Sådan skal du bruge den fyldte pen
English: Repeat steps 4 and 5 until target pre-dose serum calcium concentration is within the range of 2.0-2.25 mmol/L, active vitamin D has been discontinued and calcium supplementation is sufficient to meet daily requirements.
Danish: Gentag trin 4 og 5, indtil målniveauet for serumcalcium før administration er i intervallet 2,02,25 mmol/l, aktivt D-vitamin er seponeret, og calciumtilskud er tilstrækkeligt til at opfylde patientens daglige behov.
English: Clinical studies of Natpar did not include sufficient numbers of subjects aged 65 and over to determine whether response in these subjects is different from younger subjects.
Danish: De kliniske studier med Natpar inkluderede ikke tilstrækkeligt mange forsøgspersoner i alderen 65 år og derover til at klarlægge, om responsen hos ældre er anderledes end hos yngre personer.
English: In the placebo-controlled study, 9.5% (8/84) Natpar-treated patients and 15% (6/40) placebo-treated patients experienced an injection site reaction, all of which were mild or moderate in severity.
Danish: I det placebo-kontrollerede studie oplevede 9,5 % (8/84) af de Natpar-behandlede patienter og 15 % (6/40) i placebogruppen en reaktion på injektionsstedet, som i alle tilfælde var let eller moderat.
English: • Attach a new disposable needle every day before you use the pre-filled pen and discard the used needles after one use (See Step 17: “Discard your used needles”).
Danish: • Du skal sætte en ny engangskanyle på pennen hver dag, før du bruger den fyldte pen, og kassere de brugte kanyler efter hver brug (se trin 17: ”Kassér dine brugte nåle”).
English: 5 • If the remaining liquid is colourless and today's date is before the “Discard On” date (See Medicine Tracker), go to Step 6.
Danish: 5 • Hvis den resterende væske er farveløs, og dags dato er før datoen “Kasseres den” (se Datoetiket), skal du gå til trin 6.
English: 7 • Hold the pen and point it straight up towards the ceiling.
Danish: 7 • Hold pennen og peg den lige op mod loftet.
English: Metabolism and nutrition disorders hypercalcaemia, hypocalcaemia hypomagnesaemia tetany
Danish: Metabolisme og ernæring hyperkalcæmi, hypokalcæmi hypomagnesiæmi
English: If severe hypercalcaemia (>3.0 mmol/L or above upper limit of normal with symptoms) develops, hydration and temporarily stopping Natpar, calcium and active vitamin D should be considered until serum calcium returns to the normal range.
Danish: Hvis der udvikles svær hyperkalcæmi (> 3,0 mmol/l eller over den øvre normalgrænse med symptomer), bør hydrering og midlertidig behandlingsafbrydelse af Natpar, calcium og aktivt D-vitamin overvejes, indtil serumcalcium igen er normalt.
English: Use in elderly patients
Danish: Ældre patienter
English: Serum 1,25-(OH)2D increases following a single dose of Natpar to maximum levels at about 12 hours with a return to near baseline levels by 24 hours.
Danish: Efter en enkelt dosis af Natpar stiger serum-1,25(OH)2-vitamin D; maksimumniveauet nås efter ca. 12 timer og vender tilbage til et niveau tæt på baseline efter 24 timer.
English: Combined use of Natpar and cardiac glycosides (e.g., digoxin or digitoxin) may predispose patients to digitalis toxicity if hypercalcaemia develops.
Danish: Samtidig brug af Natpar og hjerteglykosider (f.eks. digoxin eller digitoxin) kan prædisponere for digitalistoksicitet, hvis patienten udvikler hyperkalcæmi.
English: • Store in a refrigerator (2°C to 8°C).
Danish: • Opbevares i køleskab (2 °C-8 °C).
English: A pharmacokinetic study in non-hypoparathyroidism subjects was conducted in 6 men and 6 women with moderate hepatic impairment (Child-Pugh Classification of 7-9 [Grade B]) as compared with a matched group of 12 subjects with normal hepatic function.
Danish: Der er gennemført et farmakokinetisk studie med en gruppe forsøgspersoner uden hypoparatyroidisme (6 mænd og 6 kvinder med moderat nedsat leverfunktion (7-9 på Child-Pugh-skalaen [grad B])), der blev sammenlignet med en kontrolgruppe på 12 forsøgspersoner med normal leverfunktion.
English: Natpar has been shown to pass into breast milk in rats, but it is not known if Natpar would pass into breast milk in humans.
Danish: Det er vist, at Natpar udskilles i mælken hos rotter, men det vides ikke, om det udskilles i mælken hos mennesker.
English: The mean percent change from baseline in oral calcium was -51.8% (SD 44.6) in subjects receiving Natpar compared to 6.5% (SD 38.5) in the placebo group (p<0.001).
Danish: Den gennemsnitlige ændring i oralt calcium sammenholdt med baseline var -51,8% (SD 44,6) i Natpar-gruppen versus 6,5 % (SD 38,5) i placebogruppen (p < 0,001).
English: After a single injection of parathyroid hormone (rDNA), the mean serum total calcium reached its peak level between 10 and 12 hours.
Danish: Efter en enkelt injektion af parathyroideahormon (rDNA) opnås en gennemsnitlig maksimal serumkoncentration af total-calcium inden for 10-12 timer.
English: Hypercalcaemia may be minimised by following the recommended dosing, the monitoring information, and asking patients about any symptoms of hypercalcaemia.
Danish: Forekomsten af hyperkalcæmi kan minimeres ved at følge den anbefalede dosering, tage højde for monitoreringsdata og udspørge patienterne om alle symptomer på hyperkalcæmi.
English: • citric acid monohydrate
Danish: • Citronsyremonohydrat
English: It is not known if Natpar has any effects on fertility.
Danish: Det vides ikke, om Natpar påvirker frugtbarheden.
English: • Check that the yellow dose counter lines up with the black dot (See Figure E).
Danish: • Tjek, at den gule dosistæller er ud for den sorte prik (se figur E).
English: Hypercalcaemia of any cause may predispose to digitalis toxicity.
Danish: Hyperkalcæmi kan, uanset oprindelsesårsag, prædisponere for digitalistoksicitet.
English: PTH has a variety of critical physiological functions that include its central role in modulating serum calcium and phosphate levels within tightly regulated levels, regulating renal calcium and phosphate excretion, activating vitamin D, and maintaining normal bone turnover.
Danish: Parathyroideahormon har en række vigtige fysiologiske funktioner og spiller f.eks. en central rolle i moduleringen af serumcalcium og serumphosphat inden for nøje regulerede niveauer, reguleringen af nyrernes udskillelse af calcium og phosphat, aktiveringen af D-vitamin og opretholdelsen af en normal knogleomsætning.
English: The pharmacokinetics of Natpar following subcutaneous administration in the thigh of hypoparathyroidism subjects was consistent with that observed in healthy post-menopausal women who received parathyroid hormone in the thigh and abdomen.
Danish: Natpars farmakokinetik efter subkutan administration i låret hos patienter med hypoparatyroidisme svarede til den, der sås hos raske postmenopausale kvinder, som fik parathyroideahormon administreret i låret og abdomen.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 2 pre-filled pens
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning i fyldt pen 2 fyldte penne
English: No, you should only use 31G x 8mm, 31G x 5mm or 32G x 4mm pen needles.
Danish: Nej, du må kun bruge 31G x 8 mm, 31G x 5 mm eller 32G x 4 mm penkanyler.
English: 8 • Use an alcohol wipe to clean the injection site area of the thigh (See Figure O).
Danish: 8 • Brug en spritserviet til at rengøre injektionsstedet på låret (se figur O).
English: No dose adjustment for Natpar is recommended in patients with mild to moderate hepatic impairment.
Danish: Det anbefales ikke at justere Natpar-dosis hos patienter med let til moderat nedsat leverfunktion.
English: Severe renal or hepatic disease
Danish: Svær nyre- eller leversygdom
English: It is normal to see small air bubbles in the liquid.
Danish: Det er normalt at se små luftbobler i væsken.
English: Try again to slowly screw down the cartridge.
Danish: Prøv at skrue cylinderampullen langsomt ned igen.
English: Your doctor or nurse will train you on how to use the Natpar pre-filled pen.
Danish: Lægen eller sundhedspersonalet vil vise dig, hvordan du bruger Natpar fyldt pen.
English: Avoid areas with scars, bruises, redness, or moles.
Danish: Undgå områder med ar, blå mærker, rødmen eller modermærker.
English: The maximum mean increases of serum calcium, which occurred at 12 hours, were approximately 0.125 mmol/L and 0.175 mmol/L with the 50 micrograms and 100 micrograms dose, respectively.
Danish: Den maksimale gennemsnitlige stigning i serumcalcium, der sås efter 12 timer, var henholdsvis ca. 0,125 mmol/l og 0,175 mmol/l for doserne 50 og 100 mikrogram.
English: If serum concentration of 25-OH vitamin D is low then appropriate supplementation may restore serum calcium response to Natpar (see section 4.2).
Danish: Hvis serumniveauet af 25-OH-D-vitamin er lavt, kan et passende tilskud reetablere serum-calciumresponsen på Natpar (se pkt.
English: In the kidney, parathyroid hormone and C-terminal fragments are cleared by glomerular filtration.
Danish: I nyrerne elimineres parathyroideahormon og Cterminale fragmenter ved glomerulær filtration.
English: The most frequent adverse reactions among patients treated with Natpar were hypercalcaemia, hypocalcaemia, and their associated clinical manifestations including headache, diarrhoea, vomiting, paraesthesia, hypoaesthesia and hypercalciuria.
Danish: De hyppigst forekommende bivirkninger hos patienter i behandling med Natpar er hyperkalcæmi og hypokalcæmi og de dermed forbundne kliniske manifestationer, herunder hovedpine, diarré, opkastning, paræstesi, hypæstesi og hyperkalciuri.
English: PTH exerts its action via cell-surface parathyroid hormone receptors, present in bone, kidney and nerve tissue.
Danish: PTH virker gennem parathyroideahormon-receptorer på celleoverflader i knogle-, nyre- og nervevæv.
English: Pregnancy, breast-feeding and fertility
Danish: Graviditet, amning og fertilitet
English: Greater than 2.25 mmol/L and below the upper limit of normal (2.55 mmol/L)*
Danish: Over 2,25 mmol/l og under den øvre normalgrænse (2,55 mmol/l)*
English: The dose of Natpar varies from person to person.
Danish: Det er forskelligt fra person til person, hvor stor dosis skal være.
English: Inject in the other thigh the following day and continue to alternate between the two.
Danish: Injicér i det andet lår næste dag (fortsæt med at skifte lår hver dag).
English: In patients using calcium supplements, maintain calcium supplement dose.
Danish: Patienter, der tager calciumtilskud, skal fortsætte med samme dosis calciumtilskud.
English: Following a single 100 micrograms subcutaneous dose, the mean Cmax and baseline-corrected Cmax values were 18% to 20% greater in the moderately impaired subjects than in those with normal function.
Danish: Efter en enkelt subkutan injektion af 100 mikrogram var gennemsnitlig Cmax og baseline-korrigeret Cmax 1820 % højere hos personer med moderat nedsat leverfunktion end hos personer med normal leverfunktion.
English: • If there are remaining doses in the pen and the “Discard On” date has not passed (see Medicine Tracker), place the pen in the refrigerator (see “How to Store your Medicine” (Section D) below).
Danish: • Hvis der er resterende doser i pennen, og datoen “Kasseres den” ikke er overskredet (se Datoetiket), skal du anbringe pennen i køleskabet (se “Sådan opbevarer du din medicin” (afsnit D) nedenfor).
English: Endogenous parathyroid hormone (PTH) is secreted by the parathyroid glands as a polypeptide of 84 amino acids.
Danish: Endogent parathyroideahormon (PTH) udskilles af biskjoldbruskkirtlerne som et polypeptid bestående af 84 aminosyrer.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: Natpar should be used with caution in patients with severe renal or hepatic disease because they have not been evaluated in clinical trials.
Danish: Natpar skal anvendes med forsigtighed hos patienter med svært nedsat nyre- eller leverfunktion, da sådanne patienter ikke er blevet evalueret i kliniske studier.
English: Each dose must be administered as a subcutaneous injection once a day in alternating thighs.
Danish: Hver dosis skal administreres som en subkutan injektion i låret én gang dagligt (der skal skiftes lår hver dag).
English: Adjust dose of active vitamin D or calcium supplement or both based on serum calcium value and clinical assessment (i.e., signs and symptoms of hypocalcaemia or hypercalcaemia).
Danish: Justér dosis af aktivt D-vitamin og/eller calciumtilskud baseret på serumcalcium og en klinisk vurdering (dvs. symptomer på hypo- eller hyperkalcæmi).
English: At Week 24, for patients who completed the study, 34/79 (43%) Natpar patients were independent of active vitamin D treatment and were receiving no more than 500 mg of calcium citrate, compared with 2/33 (6.1%) placebo patients (p<0.001).
Danish: Blandt de patienter, der gennemførte studiet, var 34/79 (43 %) af Natpar-patienterne uafhængige af aktivt D-vitamin i uge 24 og fik højst 500 mg calciumcitrat, mens dette kun var tilfældet for 2/33 (6,1 %) af placebo-patienterne (p < 0,001).
English: • If needed, clean your pen by wiping the outside with a cloth dampened with water.
Danish: • Rengør om nødvendigt pennen ved at tørre den af udenpå med klud fugtet med vand.
English: • Do not shake your pen.
Danish: • Ryst ikke pennen.
English: General disorders and administration site conditions asthenia*, chest pain fatigue, injection site reactions, thirst*
Danish: Almene symptomer og reaktioner på administrationsstedet asteni*, brystsmerter træthed, smerter på injektionsstedet, tørst*
English: All adverse reactions identified in post-marketing experience are italicised.
Danish: Alle bivirkninger, der er rapporteret efter markedsføring, er i kursiv.
English: *These side effects may be related to high level of calcium in your blood.
Danish: * Disse bivirkninger kan skyldes høje kalciumniveauer i blodet.
English: • Very common: low levels of calcium in your blood; this can occur more often if you suddenly stop taking Natpar.
Danish: • Meget almindelig bivirkning: nedsat kalciumniveau i blodet, som typisk kan opstå, hvis du pludseligt stopper behandlingen med Natpar.
English: In addition, 87% (73/84) of patients treated with Natpar showed a ≥50% reduction in oral active vitamin D versus 45% (18/40) in the placebo group.
Danish: Desuden fik 87 % (73/84) af Natpar-patienterne reduceret deres dosis af oralt aktivt D-vitamin med ≥ 50 % versus 45 % (18/40) af placebopatienterne.
English: The MAH should collect data on clinical hard endpoints (bone, soft tissue calcifications and renal function), together with data on hypercalciuria and quality of life.
Danish: Indehaveren af markedsføringstilladelsen skal indsamle data om hårde kliniske effektmål (knogler, bløddelsforkalkning og nyrefunktion) samt data om hyperkalciuri og livskvalitet.
English: The MAH shall plan to include regular progress reports of the registry in the PSUR.
Danish: PSUR'erne fra indehaveren af markeds-føringstilladelsen skal inkludere regelmæssige rapporter om udviklingen baseret på patient-registeret.
English: Other medicines and Natpar
Danish: Brug af anden medicin sammen med Natpar
English: If post-dose serum calcium remains >ULN, oral calcium supplementation should be further reduced or discontinued (see also adjustment table under Initiating Natpar).
Danish: Hvis serumcalcium efter administration fortsat ligger over den øvre normalgrænse, bør det orale kalciumtilskud yderligere reduceres eller seponeres (se også justeringstabellen under Start af behandling med Natpar).
English: No studies were conducted in patients on renal dialysis.
Danish: Der er ikke gennemført studier med patienter i dialyse.
English: For instructions on reconstitution of the medicinal product before administration and for using the pre-filled pen, see section 6.6 and the instructions included with the package leaflet.
Danish: For instruktioner om rekonstitution af lægemidlet før administration og om brug af den fyldte pen, se pkt.
English: Downward titration to a minimum of 25 micrograms can occur at any time.
Danish: Der kan når som helst foretages nedtitrering til en minimumsdosis på 25 mikrogram.
English: Pharmacokinetics following a single 100 micrograms subcutaneous dose of Natpar was evaluated in 16 non-impaired subjects (creatinine clearance (CLcr) >80 mL/min) and 16 subjects with renal impairment.
Danish: Farmakokinetikken efter subkutan injektion af en enkelt dosis Natpar på 100 mikrogram blev vurderet hos 16 forsøgspersoner med normal nyrefunktion (kreatininclearance (CLcr) > 80 ml/min) og 16 forsøgspersoner med nedsat nyrefunktion.
English: 10 • While holding the pen with the needle cap pointing straight up, press the blue button on a flat surface until you hear or feel a ‘hard' click (See Figure K) and the blue button stays in.
Danish: 10 • Hold pennen med kanylehætten pegende lige op, og tryk den blå knap mod en flad overflade, indtil du hører eller føler et ‘hårdt' klik (se figur K), og den blå knap forbliver inde.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: • Press the blue button down all the way until you hear or feel 2 clicks, and continue holding the button down.
Danish: • Tryk den blå knap helt ned, indtil du hører eller mærker 2 klik.
English: Read the package leaflet in full before using Natpar.
Danish: Læs hele indlægssedlen i pakningen, før du bruger Natpar.
English: 5 • Hold the pen body with the needle pointing straight up towards the ceiling (See Figure G).
Danish: 5 • Hold selve pennen med kanylen pegende lige op mod loftet (se figur G).
English: Natpar dosage adjustments after the initiation period Serum calcium concentration must be monitored during titration (see section 4.4).
Danish: Dosisjustering af Natpar efter initieringsperioden Serumcalcium skal monitoreres under titreringen (se pkt.
English: *Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Danish: *Parathyroideahormon (rDNA), fremstillet i E. coli ved rekombinant DNA-teknologi, er identisk med 84-aminosyresekvensen i endogent humant parathyroideahormon.
English: • diarrhoea*
Danish: • diarré*,
English: Read the instructions for use provided in the package leaflet before using the reusable pen.
Danish: Læs brugervejledningen i indlægssedlen inden brug af den genanvendelige pen.
English: Calcium, vitamin D, or Natpar doses may need to be reduced if post-dose hypercalcaemia is observed, even if pre-dose calcium concentrations are acceptable (see section 4.2).
Danish: Det kan være nødvendigt at reducere dosis af calcium, Dvitamin eller Natpar, hvis der efter administration ses hyperkalcæmi, også selvom calcium-niveauet før administration er acceptabelt (se pkt.
English: *Signs and symptoms potentially associated with hypercalcaemia that were observed in the clinical trials.
Danish: * Symptomer, der muligvis er forbundet med hyperkalcæmi, som sås i de kliniske studier.
English: Suggested adjustments to Natpar, active vitamin D and calcium supplements based on serum calcium levels are provided below:
Danish: Det anbefales at justere dosis af Natpar, aktivt D-vitamin og calciumtilskud på basis af serumcalcium på følgende måde:
English: Hypercalcaemia was reported in clinical trials with Natpar.
Danish: Der er indberettet tilfælde af hyperkalcæmi i kliniske studier med Natpar.
English: • thirst*
Danish: • tørst*
English: A decision must be made whether to discontinue breast-feeding or to discontinue therapy with Natpar, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Natpar skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • If the pen is empty (there is no liquid remaining, or the dose counter shows “0”) or today is the “Discard On” date noted on your Medicine Tracker, discard the pen and follow the instructions in “Getting Started” (Section A) with a new pen.
Danish: • Hvis pennen er tom (ingen væske tilbage, eller dosistælleren viser “0”) eller i dag er datoen “Kasseres den” skrevet på datoetiketten, skal du kassere pennen og følge anvisningerne i “Sådan kommer du i gang” (afsnit A) med en ny pen.
English: Gender No clinically relevant gender differences were observed in the REPLACE study.
Danish: Køn I REPLACE-studiet sås ingen klinisk relevante kønsrelaterede forskelle.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE