FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduction of hypercalcaemia in patients with:
Danish: Reduktion af hypercalcæmi hos patienter med:
English: Pharmacovigilance system
Danish: Farmakovigilanssystem
English: Testosterone Levels
Danish: Testosteronniveau
English: In this leaflet What Parareg is and what it is used for
Danish: HVAD PARAREG ER, OG HVAD DET ANVENDES TIL
English: Each bottle contains 30 tablets.
Danish: Hver dåse indeholder 30 tabletter.
English: However, it is advisable to wait and see how you feel after taking Parareg and before driving or operating machinery.
Danish: De tilrådes alligevel vente og se, hvordan de har det, efter De tager Parareg, før de kører bil eller bruger maskiner.
English: Interactions
Danish: Interaktion
English: It is recommended that Parareg be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).
Danish: Det anbefales, at Parareg tages sammen med mad eller kort efter et måltid, da studier har vist, at cinacalcets biotilgængelighed øges, når det tages sammen med mad (se punkt 5.2).
English: Manufacturer:
Danish: Fremstilleren:
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG Ikke relevant.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at farmakovigilanssystemet som beskrevet i version 3 i Modul 1.8.1. i ansøgningen om markedsføringstilladelse er på plads og fungerer inden og imens produktet er på markedet.
English: Via San Martino 12 I-20122 Milan Italy
Danish: Via San Martino 12 I-20122 Milan Italien
English: Safety margins from the toxicology studies are small due to the dose-limiting hypocalcaemia observed in the animal models.
Danish: Sikkerhedsmarginerne fra de toksikologiske undersøgelser er lave på grund af den dosisbegrænsende hypocalcæmi, der blev observeret hos dyr.
English: Film-coated tablet (tablet).
Danish: Filmovertrukket tablet (tablet).
English: • Opadry clear (containing hypromellose, macrogol)
Danish: • Opadry klar (indeholder hypromellose, makrogol).
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Danish: Blisterpakning i Aclar/PVC/PVAc/aluminium indeholdende 14 tabletter.
English: What Parareg looks like and contents of the pack
Danish: Hvordan Parareg ser ud og pakkens indhold
English: (or) Do not use Parareg after the expiry date which is stated on the outer carton and on the bottle.
Danish: (eller) Brug ikke Mimpara efter udløbsdatoen, som er angivet på æsken og på dåsen.
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Parareg.
Danish: Efter omhyggelig vurdering af nyttevirkning/risiko skal der tages en beslutning om enten at afbryde amningen eller behandlingen med Parareg.
English: If you forget to take Parareg
Danish: Hvis De glemmer at tage Parareg
English: Parareg should not affect your ability to drive and use machines.
Danish: Parareg burde ikke påvirke evnen til at køre bil eller bruge maskiner.
English: What Parareg contains
Danish: Hvad Parareg indeholder
English: Testosterone levels are often below the normal range in patients with end-stage renal disease.
Danish: Testosteronniveauet ligger ofte under normalområdet hos patienter i slutstadet af renal sygdom.
English: The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate and severe hepatic impairment, respectively.
Danish: Den gennemsnitlige halveringstid for cinacalcet forlænges med henholdsvis 33 % og 70 % hos patienter med moderat og svær hepatisk svækkelse.
English: • DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
Danish: • DE BØR IKKE tage Parareg, hvis De er overfølsom (allergisk) over for cinacalcet eller et af de øvrige indholdsstoffer i Parareg.
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Danish: De gennemsnitlige reduktioner i serum Ca x P, calcium og fosfor var henholdsvis 14 %, 7 % og 8 %.
English: Doses titrated up to 300 mg once daily have been safely administered to patients receiving dialysis.
Danish: Doser titreret op til 300 mg én gang dagligt er blevet administreret til dialysepatienter på sikker vis.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apotek til råds, inden De tager nogen form for medicin.
English: Each blister pack contains either 14, 28 or 84 tablets in a carton.
Danish: Hver blisterpakning indeholder enten 14, 28 eller 84 tabletter i en æske.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: 66% of patients were receiving vitamin D sterols at study entry, and > 90% were receiving phosphate binders.
Danish: 66 % af patienterne fik administreret D-vitamin-steroler ved undersøgelsens start, og > 90 % fik administreret fosfatbindere.
English: As so few cases have been seen it is not known whether they are due to Parareg, or not.
Danish: Da der er registreret ganske få tilfælde af disse mulige bivirkninger, vides det ikke, om de skyldes Parareg eller ikke.
English: In pregnant rats, there were slight decreases in body weight and food consumption at the highest dose.
Danish: Hos gravide rotter var der en let sænkning i kropsvægt og fødeindtagelse ved den højeste dosis.
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Danish: En åben udvidelse af denne undersøgelse viste ingen yderligere reduktioner af koncentrationerne af fri og total testosteron i en periode på 3 år hos patienter, der blev behandlet med Parareg.
English: For oral use Read the package leaflet before use.
Danish: Til oral brug Læs indlægssedlen inden brug.
English: Data presented from controlled studies include 656 patients who received Parareg and 470 patients who received placebo for up to 6 months.
Danish: Dataene fra kontrollerede undersøgelser omfatter 656 patienter, som fik tildelt Parareg, og 470 patienter, der fik tildelt placebo i op til 6 måneder.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af indvirkningen på evnen til at føre bil eller bruge maskiner.
English: The non-teratogenic dose in rats was 4.4 times, on an AUC basis, the maximum dose for secondary HPT.
Danish: Den ikke-teratogene dosis hos rotter var 4,4 gange, på AUC-basis, den maksimale dosis for sekundær HPT.
English: The most frequent ADRs in these patient populations were nausea and vomiting.
Danish: De mest almindelige bivirkningsreaktioner hos disse patientpopulationer var kvalme og opkastning.
English: Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
Danish: Cirka 60 % af de patienter, der blev behandlet med cinacalcet, opnåede en reduktion på ≥ 30 % i iPTH-niveauet, og denne virkning var konsekvent for hele spektret af baselinie-iPTH-niveauer.
English: Information regarding the pharmacokinetic/pharmacodynamic (PK/PD) profile of cinacalcet is given in section 5.1
Danish: Information om den farmakokinetiske/farmakodynamiske (PK/PD) profil for cinacalcet kan findes i punkt 5.1.
English: If a patient stops or starts smoking, cinacalcet plasma levels may change and dose adjustment may be necessary.
Danish: Hvis en patient begynder eller holder med at ryge, kan cinacalcets plasmaniveau ændre sig, og det kan være nødvendigt at justere dosis.
English: Increases in plasma cinacalcet concentration are similar, regardless of the fat content of the meal.
Danish: Stigningen i plasma-cinacalcet-koncentrationen er den samme uanset måltidets fedtindhold.
English: Parareg is used:
Danish: Parareg bruges til:
English: Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Danish: Parareg virker ved at kontrollere niveauet af parathyroideahormon (PTH), kalcium og fosfor i kroppen.
English: Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Danish: Pakkestørrelser på 1 blisterpakning (14 tabletter), 2 blisterpakninger (28 tabletter), 6 blisterpakninger (84 tabletter) pr. æske.
English: Hepatic Insufficiency
Danish: Hepatisk insufficiens
English: Carnauba Wax Opadry II green:
Danish: Carnaubavoks Opadry II grøn:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version of 9 November 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen påtager sig at gennemføre undersøgelserne og yderligere farmakovigilansaktiviteter, der er nærmere beskrevet i farmakovigilansplanen som aftalt i version 1 (9. november 2007) af risikostyringsplanen (RMP) i Modul 1.8.2. i ansøgningen om markedsføringstilladelse og eventuelle efterfølgende opdateringer af RMP, som er godkendt af CHMP.
English: No embryonal/foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3).
Danish: Der blev ikke observeret nogen embryonal/føtal toxicitet i undersøgelser af gravide rotter og kaniner, med undtagelse af lavere føtal kropsvægt hos rotter ved doser forbundet med toxicitet hos moderen (se punkt 5.3).
English: If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures you should tell you doctor immediately.
Danish: Hvis De oplever følelsesløshed eller sitren omkring munden, muskelømhed eller kramper og anfald, bør De straks fortælle det til Deres læge.
English: Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Danish: Demografi og baseliniekarakteristika var repræsentativt for dialysepatientgruppen med sekundær HPT.
English: Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Danish: Kvalme og opkastning var af mild til moderat art og af forbigående art hos de fleste patienter.
English: After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Danish: Efter administration af en 75 mg mærket dosis til raske frivillige forsøgspersoner blev cinacalcet metaboliseret hurtigt og i stort omfang ved oxidering efterfulgt af konjugation.
English: Adverse reactions, defined as adverse events considered at least possibly attributable to cinacalcet treatment based on best-evidence assessment of causality and reported in excess of placebo in doubleblind clinical studies are listed below using the following convention: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare
Danish: Bivirkninger, som med rimelighed kan henføres til cinacalcetbehandling på grundlag af vurdering af årsag, og som blev rapporteret i højere grad end ved behandling med placebo i kliniske undersøgelser med dobbelt-blindforsøg, er anført nedenfor ved hjælp af følgende konvention: meget almindelig (> 1/10), almindelig (> 1/100, < 1/10), usædvanlig (> 1/1.000, < 1/100), sjælden (> 1/10.000, < 1/1.000), meget sjælden (< 1/10.000).
English: For a full list of excipients, see section 6.1.
Danish: En liste over alle hjælpestoffer er anført under punkt 6.1.
English: It is not known whether cinacalcet is excreted in human milk.
Danish: Det vides ikke, hvorvidt cinacalcet udskilles i human mælk.
English: Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ml (77.8 and 72.4 pmol/l) for the cinacalcet and placebo groups, respectively.
Danish: De gennemsnitlige baselinie-iPTH-koncentrationer i de 3 undersøgelser var henholdsvis 733 og 683 pg/ml (77,8 og 72,4 pmol/l) for grupperne med cinacalcet og placebo.
English: Children and adolescents: The pharmacokinetics of cinacalcet have not been studied in patients < 18 years of age.
Danish: Børn og unge: De farmakokinetiske egenskaber for cinacalcet er ikke blevet undersøgt hos patienter under 18 år.
English: Metabolism and nutrition disorders Common: anorexia
Danish: Metabolisme og ernæringssygdomme Almindelig: anoreksi
English: Parareg may affect how the following work:
Danish: Parareg kan have betydning for, hvordan følgende virker:
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Danish: Der var ingen påvirkning af fertiliteten hos hanner og hunner ved eksponeringer på op til 4 gange en human dosis på 180 mg/dag (sikkerhedsmarginerne i den lille patientgruppe, der fik administreret en maksimal klinisk dosis på 360 mg dagligt, ville være ca. det halve af det ovenfor oplyste).
English: Immune system disorders Uncommon: hypersensitivity reactions
Danish: Forstyrrelser i immunsystemet Usædvanlig: hypersensitivitetsreaktioner
English: The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Danish: Den kalciumfølende receptor på overfladen af parathyroideas hovedcelle er den primære regulator af PTH-udskillelsen.
English: The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Danish: Reduktionen i PTH forbindes med et samtidigt fald i serumkalciumniveauet.
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Parareg 30 mg film-coated tablets Parareg 60 mg film-coated tablets Parareg 90 mg film-coated tablets Cinacalcet Read all of this leaflet carefully before you start taking this medicine.
Danish: INDLÆGSSEDDEL - INFORMATION TIL BRUGEREN Parareg 30 mg filmovertrukne tabletter Parareg 60 mg filmovertrukne tabletter Parareg 90 mg filmovertrukne tabletter Cinacalcet Læs hele denne indlægsseddel omhyggeligt, inden De begynder at tage dette lægemiddel.
English: Parareg must be taken orally, with or shortly after food.
Danish: Parareg skal indtages oralt sammen med eller kort tid efter indtagelse af mad.
English: Please tell your doctor if you are taking the following medicines.
Danish: Fortæl det til Deres læge, hvis De tager et eller flere af følgende lægemidler.
English: Reductions in PTH levels correlate with cinacalcet concentration.
Danish: Reduktioner i PTH-niveauerne stemmer overens med cinacalcet-koncentrationen.
English: PTH should be monitored approximately every 1-3 months during maintenance.
Danish: PTH skal måles ca. hver 1-3 måneder under vedligeholdelsesterapi.
English: Cinacalcet did not show any genotoxic or carcinogenic potential.
Danish: Cinacalcet viste ikke nogen tegn på at være genotoksisk eller carcinogent.
English: If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/or vitamin D sterols should be reduced or therapy discontinued.
Danish: Hvis PTH-niveauet falder til under det anbefalede målområde hos patienter, der behandles med Parareg, skal dosen af Parareg og/eller Dvitamin-steroler reduceres, eller behandlingen skal afbrydes.
English: Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
Danish: Cinacalcet udskilles i mælken hos ammende rotter med en høj mælk/plasma-ratio.
English: Parareg treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Danish: Parareg-behandling må ikke påbegyndes hos patienter med et serumkalciumniveau (justeret for albumin), der ligger under den nedre grænse i normalområdet.
English: Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Danish: På grundlag af sammenligninger mellem undersøgelser er den absolutte biotilgængelighed for cinacalcet hos fastende forsøgspersoner blevet anslået til ca. 20-25 %.
English: The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Danish: Det primære endepunkt for undersøgelsen var en reduktion af serumkalcium på ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: Potential manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Danish: Potentielle manifestationer af hypocalcæmi kan omfatte paræstesier, myalgi, kramper, tetani og konvulsioner.
English: Crospovidone
Danish: Crospovidon
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR
English: After oral administration of Parareg, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Danish: Efter oral administration af Parareg opnås den maksimale plasma-cinacalcet-koncentration efter ca. 26 timer.
English: • diarrhoea
Danish: • diarré,
English: Discontinuation of therapy as a result of undesirable effects was mainly due to nausea (1% placebo; 5% cinacalcet) and vomiting (< 1% placebo; 4% cinacalcet).
Danish: Afbrydelse af behandlingen som et resultat af uønskede virkninger skyldtes hovedsageligt kvalme (1 % placebo, 5 % cinacalcet) og opkastning (< 1 % placebo, 4 % cinacalcet).
English: PTH levels should be assessed at least 12 hours after dosing with Parareg.
Danish: PTH-niveauet bør vurderes mindst 12 timer efter dosering med Parareg.
English: It is used to treat problems with organs called parathyroid glands.
Danish: Det bruges til behandling af sygdomme, der skyldes problemer med organer kaldet biskjoldbruskkirtlerne.
English: Administration of Parareg with food results in an approximate 50 - 80% increase in cinacalcet bioavailability.
Danish: Administration af Parareg sammen med mad giver en stigning på ca. 50-80 % i biotilgængeligheden for cinacalcet.
English: Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6): Cinacalcet is a strong inhibitor of CYP2D6.
Danish: Lægemidler metaboliseret af enzymet P450 2D6 (CYP2D6): Cinacalcet er en stærk hæmmer af CYP2D6.
English: Because doses are titrated for each subject, no additional dose adjustment is necessary based on gender.
Danish: Da doserne titreres for hver forsøgsperson, er det ikke nødvendigt med yderligere justering af dosis på grund af køn.
English: The pharmacokinetics of cinacalcet does not change over time.
Danish: De farmakokinetiske egenskaber for cinacalcet ændres ikke med tiden.
English: Since cinacalcet is highly protein-bound, haemodialysis is not an effective treatment for overdosage.
Danish: Da cinacalcet er meget proteinbundet, er hæmodialyse ikke en effektiv form for behandling ved overdosering.
English: Parareg is a light green film-coated tablet.
Danish: Parareg er en lysegrøn filmovertrukket tablet.
English: Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium.
Danish: Cinacalcet er et kalciummimetisk stof, der sænker PTH-niveauerne direkte ved at øge den kalciumfølende receptors følsomhed over for ekstracellulær kalcium.
English: Pharmacotherapeutic group: anti-parathyroid agents.
Danish: Farmakoterapeutisk klassifikation: anti-parathyroideamidler.
English: Cinacalcet was administered at doses ranging from 30 mg twice daily to 90 mg four times daily.
Danish: Cinacalcet blev administreret i doser fra 30 mg to gange dagligt til 90 mg fire gange dagligt.
English: The effect of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
Danish: Effekten af CYP1A2-hæmmere (f.eks. fluvoxamin, ciprofloxacin) på cinacalcets plasmaniveau kendes ikke.
English: The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH).
Danish: Biskjoldbruskkirtlerne er fire små kirtler i halsen, tæt ved skjoldbruskkirtlen, som producerer parathyroideahormon (PTH).
English: Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum human dose for secondary HPT (180 mg daily).
Danish: Cinacalcet var ikke teratogent hos kaniner ved en dosis på 0,4 gange, på AUC-basis, den maksimale humane dosis for sekundær HPT (180 mg dagligt).
English: The risk of having seizures is higher if you have had them before;
Danish: Risikoen for at få krampeanfald er større, hvis De tidligere har haft krampeanfald,
English: PTH levels in Parareg clinical trials were measured at the end of the dosing interval.
Danish: PTH-niveauerne i kliniske forsøg med Parareg blev målt sidst i doseringsintervallet.
English: Parareg should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the intact PTH (iPTH) assay.
Danish: Parareg skal titreres hver 2 til 4 uger til en maksimal dosis på 180 mg én gang dagligt for at opnå mål-parathyroideahormon (PTH) hos dialysepatienter på mellem 150-300 pg/ml (15,9-31,8 pmol/l) i analysen af den intakte PTH (iPTH).
English: Significant reductions in iPTH, serum calcium-phosphorus product (Ca x P), calcium, and phosphorus were observed in the cinacalcet treated patients compared with placebo-treated patients receiving standard of care, and the results were consistent across the 3 studies.
Danish: Der blev observeret signifikante reduktioner i iPTH, serumkalcium-fosforprodukt (Ca x P), kalcium og fosfor hos de patienter, der blev behandlet med cinacalcet, sammenlignet med de patienter, der gennemgik standard-placebobehandling, og resultaterne var konsekvente i alle 3 undersøgelser.
English: It is not known whether Parareg is excreted in human milk.
Danish: Det vides ikke, hvorvidt Parareg udskilles i modermælk.
English: Renal Insufficiency: The pharmacokinetic profile of cinacalcet in patients with mild, moderate, and severe renal insufficiency, and those on haemodialysis or peritoneal dialysis is comparable to that in healthy volunteers.
Danish: Renal insufficiens: Den farmakokinetiske profil for cinacalcet hos patienter med mild, moderat og svær renal insufficiens og hos patienter i hæmodialyse eller peritoneal dialyse er at sammenligne med profilen hos raske frivillige forsøgspersoner.
English: Elderly: There are no clinically relevant differences due to age in the pharmacokinetics of cinacalcet.
Danish: Ældre personer: Der var ingen klinisk relevante forskelle forårsaget af alder i de farmakokinetiske egenskaber for cinacalcet.
English: After absorption, cinacalcet concentrations decline in a biphasic fashion with an initial half-life of approximately 6 hours and a terminal half-life of 30 to 40 hours.
Danish: Efter optagelse falder cinacalcet-koncentrationerne tofaset med en indledende halveringstid på ca. 6 timer og en endelig halveringstid på 30 til 40 timer.
English: Warfarin: Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Danish: Warfarin: Flere orale doser af cinacalcet påvirkede ikke de farmakokinetiske eller farmakodynamiske egenskaber (målt med protrombintid og koagulationsfaktor VII) for warfarin.