FrancophonIA/ELRC3.0 huggingface dataset:
English: In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline.
Danish: I tre kliniske undersøgelser med dialysepatienter med kronisk nyresygdom (CKD - Chronic Kidney Disease) rapporterede fem procent af patienterne i både Parareg- og placebogrupperne krampeanfald ved baselinie.
English: Effect of cinacalcet on other medications
Danish: Cinacalcets virkning på andre lægemidler
English: Cinacalcet has been shown to cross the placental barrier in rabbits.
Danish: Der er registreret tilfælde, hvor cinacalcet har gennemtrængt placentamembranen hos kaniner.
English: The recommended starting dose for adults is 30 mg once per day.
Danish: Den anbefalede startdosis er for voksne 30 mg én gang dagligt.
English: Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
Danish: Baseret på in vitro-data er cinacalcet en stærk hæmmer af CYP2D6, men fungerer ikke som hæmmer af andre CYP-enzymer ved koncentrationer, der opnås klinisk, herunder CYP1A2, CYP2C8, CYP2C9, CYP2C19 og CYP3A4 eller induktor for CYP1A2, CYP2C19 og CYP3A4.
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole, voriconazole);
Danish: • lægemidler til behandling af hud- og svampeinfektioner (ketoconazol, itraconazol,
English: Dose adjustments of concomitant medications may be necessary (see section 4.5).
Danish: Det kan være nødvendigt at justere dosen af samtidigt indtagne lægemidler (se punkt 4.5).
English: Desipramine: Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90 % CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
Danish: Desipramin: Samtidig administration af 90 mg cinacalcet én gang dagligt med 50 mg desipramin, som er et tricyklisk antidepressivum, der primært metaboliseres af CYP2D6, øgede desipramineksponeringen betydeligt med ca. 3,6 gange (90 % CI 3.0, 4.4) i omfattende CYP2D6metabolitter.
English: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
Danish: Forgelatineret stivelse (majsstivelse) Mikrokrystallincellulose Povidon
English: Eighteen of 29 patients (62 %) with parathyroid carcinoma and 15 of 17 subjects (88 %) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/dl (≥ 0.25 mmol/l).
Danish: 18 af 29 (62 %) patienter med cancer i parathyroidea samt 15 af 17 (88 %) patienter med primær HPT opnåede en reduktion i serumkalciumniveauet på ≥ 1 mg/dl (≥ 0,25 mmol/l).
English: 6.5 Nature and contents of container
Danish: 6.5 Emballage (art og indhold)
English: Dose adjustment of Parareg may be required if a patient receiving Parareg initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Danish: Det kan være nødvendigt at justere dosen af Parareg, hvis en patient, der er i behandling med Parareg, påbegynder eller afbryder behandling med en stærk hæmmer (f.eks. ketoconazol, itraconazol, telithromycin, voriconazol eller ritonavir) eller induktor (f.eks. rifampicin) for dette enzym (se punkt
English: • Povidone
Danish: • Povidon,
English: This can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma.
Danish: Det kan medføre et for lavt kalciumniveau i knoglerne, som kan give smerter i knoglerne, knoglebrud og hjerte-kar-sygdom, nyresten, psykiske lidelser og koma.
English: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172)
Danish: (Laktosemonohydrat, hypromellose, titaniumdioxid (E171), glyceroltriacetat, FD&C blå (E132), jernoxid gul (E172))
English: Musculoskeletal, connective tissue and bone disorders Common: myalgia
Danish: Sygdomme i det muskuloskeletale væv og knoglerne Almindelig: myalgi
English: If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Parareg is 30 mg (one tablet) twice per day.
Danish: Hvis De er under behandling for cancer i parathyroidea eller primær hyperparathyreoidisme Den normale startdosis for Parareg er 30 mg (én tablet) to gange dagligt Hvis De tager mere Parareg, end De bør
English: Amgen Europe B.V. Minervum 7061
Danish: Minervum 7061
English: • to treat secondary hyperparathyroidism in patients with kidney disease on dialysis.
Danish: • at behandle sekundær hyperparathyreoidisme hos patienter med nyresygdom, der er i dialyse,
English: • seizures (fits or convulsions).
Danish: • krampeanfald (anfald eller kramper).
English: • Crospovidone
Danish: • Crospovidon,
English: Lactose monohydrate
Danish: Laktosemonohydrat
English: Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Danish: Når vedligeholdelsesdosen er blevet fastslået, skal serumkalciumniveauet måles ca. 1 gang om måneden.
English: • Magnesium stearate
Danish: • Magnesiumstearat,
English: Uncommon side effects (seen in more than 1 in 1000 people taking Parareg):
Danish: Ikke almindelige bivirkninger (observeret hos mere end 0,1 % af de personer, som tager Parareg):
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Your doctor will discuss with if you should discontinue either breast-feeding or treatment with Parareg.
Danish: De og deres læge skal afklare, om det er bedst at ophøre med amning eller afbryde behandlingen med Parareg.
English: • numbness or tingling sensation (paraesthesia)
Danish: • følelsesløshed eller prikkende fornemmelse (paræstesier),
English: Marketing Authorisation Holder: Dompé Biotec S.p.A.
Danish: Indehaver af markedsføringstilladelse: Dompé Biotec S.p.A.
English: Hepatic impairment
Danish: Hepatisk svækkelse
English: • medicines used to treat changes in heart rate (flecainide and propafenone);
Danish: • lægemidler mod hjerterytme forstyrrelser (flecainid og propafenon),
English: If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg.
Danish: Ved vedvarende hypocalcæmi skal dosen reduceres, eller administrationen af Parareg skal afbrydes.
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Parareg.
Danish: Under dosistitrering skal serumkalciumniveauet måles regelmæssigt og inden for 1 uge efter påbegyndelse af Parareg eller justering af Parareg-dosis.
English: After taking Parareg a very small number of patients with heart failure had worsening of their condition.
Danish: I meget få tilfælde hos patienter med hjertesvigt blev dette forværret, efter indtagelse af Parareg.
English: 14 tablets 28 tablets 84 tablets
Danish: 84 tabletter
English: • Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide (E171),
Danish: • Opadry grøn (indeholder laktosemonohydrat, hypromellose, titaniumdioxid
English: Very common side effects (seen in more than 1 in 10 people taking Parareg): • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Danish: Meget almindelige bivirkninger (ses hos mere end 10 % af de personer, der tager Parareg) • kvalme og opkastning.
English: Cataracts are known to occur in rodents as a result of hypocalcaemia.
Danish: Grå stær er bekræftet hos gnavere som et resultat af hypocalcæmi.
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Danish: Serumkalcium skal måles inden for 1 uge efter påbegyndelse af Parareg eller justering af Pararegdosis.
English: Nervous system disorders Common: dizziness, paraesthesia Uncommon: seizures
Danish: Sygdomme i nervesystemet Almindelig: svimmelhed, paræstesier Usædvanlig: krampeanfald
English: Either the intact PTH (iPTH) or biointact PTH (biPTH) may be used to measure PTH levels; treatment with Parareg does not alter the relationship between iPTH and biPTH.
Danish: Enten den intakte PTH (iPTH) eller biointakte PTH (biPTH) kan bruges til at måle PTH-niveauet.
English: Calcium carbonate: Co-administration of calcium carbonate (single 1500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Danish: Kalciumkarbonat: Co-administration af kalciumkarbonat (enkelt dosis på 1500 mg) påvirkede ikke de farmakokinetiske egenskaber for cinacalcet.
English: Sevelamer: Co-administration of sevelamer (2400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Danish: Sevelamer: Co-administration af sevelamer (2400 mg 3 gange dagligt) påvirkede ikke de farmakokinetiske egenskaber for cinacalcet.
English: Magnesium stearate Colloidal anhydrous silica
Danish: Magnesiumstearat Kolloid vandfri silika
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http://www.emea.europa.eu/
English: nausea, vomiting Uncommon: dyspepsia, diarrhoea
Danish: Usædvanlig: dyspepsi, diarre
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg of cinacalcet (as hydrochloride).
Danish: Hver filmovertrukket tablet indeholder 30 mg, 60 mg eller 90 mg cinacalcet (som hydroklorid).
English: Parareg is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Danish: Parareg fås i blisterpakninger med 30 mg, 60 mg eller 90 mg filmovertrukne tabletter.
English: • Carnauba wax
Danish: • Carnaubavoks,
English: Parareg should be taken with or shortly after food.
Danish: Hvordan man tager Parareg sammen med mad og drikkevarer Parareg skal tages sammen med eller kort tid efter indtagelse af mad.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL DÅSE
English: NAME OF THE MARKETING AUTHORISATION HOLDER Dompé Biotec S.p.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Dompé Biotec S.p.A.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept.
English: glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
Danish: (E171),glyceroltriacetat, FD&C blå (E132), jernoxid gul (E172)),
English: Because doses are titrated for each subject based on safety and efficacy parameters, no additional dose adjustment is necessary for subjects with hepatic impairment.
Danish: Fordi doserne titreres for hver person på grundlag af sikkerheds- og effektparametre, kræves der ingen yderligere dosisjustering for personer med hepatisk svækkelse (se punkt 4.2 og 4.4).
English: Taking other medicines
Danish: Indtagelse af anden medicin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BLISTERPAKNING
English: These studies show that CKD patients not undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Danish: Undersøgelserne viser, at CKDpatienter, der ikke er i dialyse og behandles med cinacalcet, har øget risiko for hypocalcæmi sammenlignet med ESRD-patienter, der er i dialyse og behandles med cinacalcet, hvilket kan skyldes lavere baselinie-kalciumniveauer og/eller resterende nyrefunktion.
English: The printing ink contains: shellac glaze, iron oxide black (E172).
Danish: Trykfarven indeholder: schellakglasering, jernoxid sort (E172).
English: Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g., flecainide, propafenone, metoprolol given in heart failure, desimipramine, nortriptyline, clomipramine) (see section 4.4).
Danish: Det kan være nødvendigt at justere dosen af samtidigt indtagne lægemidler, når Parareg administreres med individuelt titrerede stoffer med et snævert terapeutisk indeks, der hovedsageligt metaboliseres af CYP2D6 (f.eks. flecainid, propafenon, metoprolol administreret ved hjertesvigt, desipramin, nortriptylin og clomipramin) (se punkt 4.4).
English: Pantoprazole: Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
Danish: Pantoprazol: Co-administration af pantoprazol (80 mg 1 gang dagligt) påvirkede ikke de farmakokinetiske egenskaber for cinacalcet.
English: The other ingredients are:
Danish: De øvrige indholdsstoffer i Parareg er:
English: • parathyroid carcinoma.
Danish: • cancer i parathyroidea,
English: After titration to the maximum dose of Parareg, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Parareg therapy should be considered (see section 5.1).
Danish: Hvis der ikke opretholdes klinisk relevante reduktioner i serumkalciumniveauet, bør det overvejes at afbryde Parareg-behandlingen (se punkt 5.1).
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Parareg is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Danish: Parareg fås i dåse med 30 mg, 60 mg eller 90 mg filmovertrukne tabletter i en æske.
English: rash reduced testosterone levels
Danish: • reducerede testosteronniveauer.
English: • Colloidal anhydrous silica.
Danish: • Kolloid-vandfrit silika.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: Kontakt Deres læge eller apoteket, hvis De har yderligere spørgsmål vedrørende brugen af dette produkt.
English: 30 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “30” on the other.
Danish: 30 mg: Lysegrønne, ovale, filmovertrukne tabletter mærket “AMGEN” på den ene side og “30” på den anden side.
English: 90 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “90” on the other.
Danish: 90 mg: Lysegrønne, ovale, filmovertrukne tabletter mærket “AMGEN” på den ene side og “90” på den anden side.
English: 60 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “60” on the other.
Danish: 60 mg: Lysegrønne, ovale, filmovertrukne tabletter mærket “AMGEN” på den ene side og “60” på den anden side.
English: • seizures
Danish: • svimmelhed,
English: Seizures
Danish: Krampeanfald
English: In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
Danish: I postmarketingundersøgelser af sikkerheden er der registreret isolerede, idiosynkratiske tilfælde af hypotension og/eller forværret hjertesvigt hos patienter med nedsat hjertefunktion.
English: If you have further questions, please ask your doctor or pharmacist.
Danish: Kontakt Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: Blister: 4 years.
Danish: 6.3 Opbevaringstid Blisterpakning: 4 år.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE DÅSE
English: EU/1/04/293/004
Danish: EU/1/04/293/001-003 EU/1/04/293/004
English: • Pre-gelatinised maize starch
Danish: • Forgelatineret majsstivelse,
English: • dizziness
Danish: • udslæt,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/293/012
English: 6.6 Special precautions for disposal
Danish: 6.6 Særlige forholdsregler ved bortskaffelse Ingen særlige forholdsregler.
English: NAME OF THE MEDICINAL PRODUCT Parareg 30 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Parareg 30 mg filmovertrukne tabletter.
English: EU/1/04/293/008
Danish: EU/1/04/293/005-007 EU/1/04/293/008
English: Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/dl [2.1 mmol/l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual kidney function.
Danish: Forsøg har vist, at CKD-patienter, der ikke er i dialysebehandling, og behandles med cinacalcet har øget risiko for hypocalcæmi (serum-kalcium-niveauer < 8,4 mg/dl [2,1 mmol/l]).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/293/008
English: NAME OF THE MEDICINAL PRODUCT Parareg 90 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Parareg 90 mg filmovertrukne tabletter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 30 mg cinacalcet (som hydroklorid).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg cinacalcet (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 90 mg cinacalcet (som hydroklorid).
English: General disorders and administration site conditions Common: asthenia
Danish: Generelle sygdomme og problemer med indgiftssted Almindelig: asteni
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60 mg cinacalcet (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 60 mg cinacalcet (som hydroklorid).
English: NAME OF THE MEDICINAL PRODUCT Parareg 60 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Parareg 60 mg filmovertrukne tabletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/293/004
English: NAME OF THE MEDICINAL PRODUCT Parareg 90 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Parareg 90 mg filmovertrukne tabletter Cinacalcet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/005 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/005 - æske med 14 tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/009 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/009 - æske med 14 tabletter
English: NAME OF THE MEDICINAL PRODUCT Parareg 30 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Parareg 30 mg filmovertrukne tabletter Cinacalcet
English: EU/1/04/293/011 - carton of 84 tablets
Danish: EU/1/04/292/011 - æske med 84 tabletter
English: NAME OF THE MEDICINAL PRODUCT Parareg 60 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Parareg 60 mg filmovertrukne tabletter Cinacalcet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/001 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/001 - æske med 14 tabletter
English: Tablet Coat
Danish: Tabletovertræk
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of cinacalcet (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 30 mg cinacalcet (som hydroklorid)
English: EU/1/04/293/010 - carton of 28 tablets
Danish: EU/1/04/292/010 - æske med 28 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 90 mg of cinacalcet (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 90 mg cinacalcet (som hydroklorid)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg of cinacalcet (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 60 mg cinacalcet (som hydroklorid)
English: Investigations Common: hypocalcaemia (see section 4.4), reduced testosterone levels (see section 4.4)
Danish: Almindelig: hypocalcæmi (se punkt 4.4), reducerede testosteronniveauer (se punkt 4.4) Cancer i parathyroidea og primær hyperparathyreoidisme Sikkerhedsprofilen for Parareg hos disse patientpopulationer stemmer generelt overens med det, der ses hos patienter med kroniske nyresygdomme.
English: NAME OF THE MEDICINAL PRODUCT Parareg 90 mg tablet
Danish: LÆGEMIDLETS NAVN Parareg 90 mg tablet Cinacalcet
English: EU/1/04/293/003 - carton of 84 tablets
Danish: EU/1/04/292/003 - æske med 84 tabletter
English: Do not take Parareg:
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE PARAREG De bør ikke tage Parareg:
English: EU/1/04/293/007 - carton of 84 tablets
Danish: EU/1/04/292/007 - æske med 84 tabletter
English: EU/1/04/293/006 - carton of 28 tablets
Danish: EU/1/04/292/006 - æske med 28 tabletter
English: Not applicable.
Danish: Opbevares utilgængeligt for børn.
English: EU/1/04/293/002 - carton of 28 tablets
Danish: EU/1/04/292/002 - æske med 28 tabletter
English: EU/1/04/293/012
Danish: EU/1/04/293/009-011 EU/1/04/293/004
English: NAME OF THE MEDICINAL PRODUCT Parareg 30 mg tablet
Danish: LÆGEMIDLETS NAVN Parareg 30 mg tablet Cinacalcet
English: NAME OF THE MEDICINAL PRODUCT Parareg 60 mg tablet
Danish: LÆGEMIDLETS NAVN Parareg 60 mg tablet Cinacalcet
English: Take special care with Parareg:
Danish: Vær særlig forsigtig med at anvende Parareg
English: Skin and subcutaneous tissue disorders Common: rash
Danish: Hudsygdomme og sygdomme i det subkutane væv
English: Opadry clear:
Danish: Opadry klar: Opacode sort, trykfarve:
English: The plant is cultivated or gathered to obtain the seeds for medicinal use.
Danish: Planten dyrkes eller indsamles for at høste frøene til medicinsk anvendelse.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Danish: Det betyder, at der findes litteraturoplysninger med videnskabeligdokumentation for virkning og sikkerhed ved denne anvendelse i en periode på mindst 10 år i EU.
English: It should be taken during the day at least half an hour to one hour before or after taking other medicines and not immediately before bedtime.
Danish: De skal tages om dagen mindst ½-1 time før eller efter eventuel anden medicin og ikke lige før sengetid.
English: Herbal medicine: summary for the public
Danish: Plantelægemiddel - sammendrag til offentligheden
English: EMA/HMPC/313600/2013
Danish: EMA/HMPC/313600/2013 Udvalget for Plantelægemidler (HMPC)
English: If constipation does not resolve after three days, a doctor or pharmacist should be consulted.
Danish: Hvis forstoppelsen ikke aftagerr efter tre dage, bør der søges råd hos en læge eller på apoteket.
English: When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Danish: Ved håndtering af pulverpræparater bør man derfor undgå at indånde pulveret, da dette kan medføre allergisk overfølsomhed og eventuel udvikling af allergi.
English: Studies that were carried out in patients with irritable bowel disease did not show an effect on the disease itself but showed benefits in those patients who were also suffering from constipation.
Danish: Undersøgelser hos patienter med irritabel tyktarm viste ikke virkning på selve sygdommen, men gavnlig virkning hos de patienter, der desuden havde forstoppelse.
English: Ispaghula husk is the common name for the seed coats of the plant Plantago ovata Forssk.
Danish: Ispaghula-frøskaller er fællesnavnet for frøskaller fra planten Plantago ovata Forssk.