FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of Mimpara should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Danish: Doseringen af Mimpara skal titreres hver 2.-4. uge i sekventielle doser på 30 mg to gange dagligt, 60 mg to gange dagligt, 90 mg to gange dagligt og 90 mg tre eller fire gange dagligt efter behov for at reducere serumcalciumkoncentrationen til eller til under den øvre grænse for normalområdet.
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 toksicitet i studier af gravide rotter og kaniner, med undtagelse af lavere føtal kropsvægt hos rotter ved doser forbundet med toksicitet hos moderen (se pkt.
English: The mean serum calcium levels during the EAP were within the normal range for the cinacalcet treatment group.
Danish: De gennemsnitlige serumcalciumniveauer under EAP var inden for normalområdet for cinacalcet-gruppen.
English: Please tell your doctor if you experience any of the following which may be signs of low calcium levels: spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with Mimpara.
Danish: Fortæl det til Deres læge, hvis De oplever en eller flere af disse tilstande, som kan være tegn på lave calciumniveauer: spasmer, muskelspjæt eller muskelkramper, følelsesløshed eller prikken i fingre, tæer eller omkring munden, kramper, forvirring eller bevidstløshed, mens De er i behandling med Mimpara.
English: Instructions for taking Mimpara granules
Danish: Instruktioner til anvendelse af Mimpara granulat.
English: Talk to your doctor, pharmacist or nurse before taking Mimpara.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før De tager Mimpara.
English: Reduction of ≥ 30% from baseline in mean plasma iPTH during the EAP was achieved by 22% of patients in the cinacalcet + SOC group and 32% of patients in the SOC group.
Danish: Et fald på ≥ 30 % i forhold til baseline i gennemsnitlig plasma-iPTH under EAP blev opnået af 22 % af patienterne i cinacalcet + SOC-gruppen og 32 % af patienterne i SOC-gruppen.
English: Each bottle contains 30 tablets.
Danish: Hver flaske indeholder 30 tabletter.
English: In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.
Danish: Hvis De er gravid, kan lægen beslutte at ændre behandlingen, da Mimpara kan være skadeligt for fostret.
English: • If iPTH is < 150 pg/mL (15.9 pmol/L) and ≥ 100 pg/mL (10.6 pmol/L), decrease the dose of Mimpara to the next lower dose.
Danish: • Hvis iPTH er < 150 pg/ml (15,9 pmol/l) og ≥ 100 pg/ml (10,6 pmol/l), skal Mimpara-dosen sænkes til den næste lavere dosis.
English: • 4 to 6 capsules a day use at least 2 tablespoons (30 mL)
Danish: • 4 til 6 kapsler om dagen brug mindst 2 spiseskefulde (30 ml)
English: Children under the age of 18 with parathyroid cancer or primary hyperparathyroidism must not take Mimpara.
Danish: Børn og unge under 18 år med biskjoldbruskkirtelkræft eller primær hyperparatyroidisme må ikke få Mimpara.
English: In patients who have discontinued etelcalcetide, Mimpara should not be initiated until at least three subsequent haemodialysis sessions have been completed, at which time serum calcium should be measured.
Danish: Hos patienter, der har afbrudt behandlingen med etelcalcetid, bør Mimpara ikke påbegyndes, før der er udført mindst tre på hinanden følgende hæmodialysebehandlinger, hvorefter serumcalcium skal måles.
English: These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of medicines that are metabolised by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Danish: Disse data tyder på, at cinacalcet ikke vil påvirke farmakokinetikken af de lægemidler, som metaboliseres af CYP3A4 og CYP3A5, såsom visse immunsupprimerende midler, herunder ciclosporin og tacrolimus.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Danish: Farmakoterapeutisk klassifikation: Calciumhomeostase, anti-paratyroideamidler.
English: Therefore, serum calcium levels should be closely monitored in patients receiving Mimpara, particularly in patients with a history of a seizure disorder.
Danish: Serumcalciumniveauet skal derfor monitoreres nøje hos patienter, der får Mimpara, især patienter med krampelidelser i anamnesen.
English: PTH levels in Mimpara clinical trials were measured at the end of the dosing interval.
Danish: PTH-niveauet i kliniske forsøg med Mimpara blev målt sidst i doseringsintervallet.
English: They are oval-shaped and have “30”, “60” or “90” marked on one side and “AMG” on the other side.
Danish: Den er oval og har "30", "60" eller "90" markeret på den ene side og "AMG" på den anden side.
English: Decreased foetal weights were seen in rats at doses where dams had severe hypocalcaemia.
Danish: Lavere fostervægt blev registreret hos rotter ved doser, hvor moderdyrene oplevede svær hypokalcæmi.
English: Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Danish: Cinacalcet metaboliseres af flere enzymer, hovedsageligt CYP3A4 og CYP1A2 (bidraget fra CYP1A2 er ikke blevet karakteriseret klinisk).
English: Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Danish: Clearance af cinacalcet blev observeret som 36-38 % højere hos rygere end hos ikke-rygere.
English: Switch from etelcalcetide to Mimpara
Danish: Skift fra etelcalcetid til Mimpara
English: Mimpara 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: Mimpara skal titreres hver 2. til 4. uge til en maksimal dosis på 180 mg én gang dagligt for at opnå mål-paratyroideahormon (PTH) hos dialysepatienter på 150-300 pg/ml (15,9-31,8 pmol/l) i analysen af det intakte PTH (iPTH).
English: Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
Danish: Grå stær og linseuklarhed blev observeret ved toksicitets- og karcinogenicitetsstudier med gentagne doser hos gnavere, men blev ikke observeret hos hunde og aber eller i kliniske studier, hvor dannelsen af grå stær blev overvåget.
English: Study 3 was a 26-week, open-label, single-arm safety study in patients aged 8 months to < 6 years (mean age 3 years).
Danish: Studie 3 var et 26-ugers åbent sikkerhedstudie med en enkelt behandlingsarm med patienter i alderen 8 måneder til < 6 år (gennemsnitsalder 3 år).
English: Three, 6-month, double-blind, placebo-controlled clinical studies were conducted in ESRD patients with uncontrolled secondary HPT receiving dialysis (n = 1,136).
Danish: Der blev udført tre 6 måneder lange dobbeltblinde, placebokontrollerede kliniske studier med ESRD-patienter med ukontrolleret sekundær HPT, der gennemgik dialyse (n = 1.136).
English: Midazolam: Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam.
Danish: Midazolam: Co-administration af cinacalcet (90 mg) med oralt administreret midazolam (2 mg), et CYP3A4- og CYP3A5-substrat, ændrede ikke farmakokinetikken for midazolam.
English: PTH should be monitored approximately every 1-3 months during maintenance.
Danish: PTH skal måles ca. hver 1.-3. måned under vedligeholdelsesterapi.
English: Dose adjustment of Mimpara may be required if a patient receiving Mimpara initiates or discontinues therapy with a strong inhibitor (e.g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (e.g. rifampicin) of this enzyme.
Danish: Det kan være nødvendigt at justere dosen af Mimpara, hvis en patient, der er i behandling med Mimpara, påbegynder eller afbryder behandling med en stærk hæmmer (f.eks. ketoconazol, itraconazol, telithromycin, voriconazol eller ritonavir) eller induktor (f.eks. rifampicin) af dette enzym.
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 paratyroideahormon (PTH).
English: Study 1 was a double-blind, placebo-controlled study in which 43 patients aged 6 to < 18 years were randomised to receive either cinacalcet (n = 22) or placebo (n = 21).
Danish: Studie 1 var et dobbeltblindet, placebokontrolleret studie, hvor 43 patienter i alderen 6 til < 18 år blev randomiseret til at få enten cinacalcet (n = 22) eller placebo (n = 21).
English: • heart failure.
Danish: • hjertesvigt.
English: Medicinal products known to reduce serum calcium
Danish: Lægemidler, der vides at sænke serumcalcium
English: Hypersensitivity reactions including angioedema and urticaria have been identified during post-marketing use of Mimpara.
Danish: Der er påvist overfølsomhedsreaktioner, herunder angioødem og urticaria, i forbindelse med anvendelse af Mimpara efter markedsføring.
English: Study 2 was an open-label study in which 55 patients aged 6 to < 18 years (mean 13 years) were randomised to receive either cinacalcet in addition to standard of care (SOC, n = 27) or SOC alone (n = 28).
Danish: Studie 2 var et åbent studie, hvor 55 patienter i alderen 6 til < 18 år (gennemsnitsalder 13 år) blev randomiseret til at få enten cinacalcet udover standardbehandlingen (SOC, n = 27) eller SOC alene (n = 28).
English: In CKD patients receiving dialysis who were administered Mimpara, approximately 30% of patients had at least one serum calcium value less than 7.5 mg/dL (1.9 mmol/L).
Danish: Hos de CKD-patienter, der var i dialyse, og som indtog Mimpara, havde cirka 30 % af patienterne mindst én serumcalciumværdi på under 7,5 mg/dl (1,9 mmol/l).
English: Among all paediatric subjects exposed to cinacalcet in clinical studies a total of 19 subjects (24.1%; 64.5 per 100 subject years) had at least one adverse event of hypocalcaemia.
Danish: Blandt alle pædiatriske patienter, der fik cinacalcet i kliniske studier, havde i alt 19 patienter (24,1 %; 64,5 pr. 100 patientår) mindst én bivirkning af hypocalcæmi.
English: Dose adjustments of concomitant medicinal products may be required when Mimpara is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e.g. flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine).
Danish: Det kan være nødvendigt at justere dosen af samtidigt indtagne lægemidler, når Mimpara administreres med individuelt titrerede stoffer med et snævert terapeutisk indeks, der hovedsageligt metaboliseres af CYP2D6 (f.eks. flecainid, propafenon, metoprolol, desipramin, nortriptylin og clomipramin).
English: Dose adjustment in paediatric patients ≥ 3 to < 18 years of age Corrected Serum calcium value or clinical symptoms of hypocalcaemia
Danish: Dosisjustering hos pædiatriske patienter ≥ 3 til < 18 år Korrigeret serumcalciumværdi eller kliniske symptomer på hypocalcæmi
English: • Make sure remaining content from the top is also emptied on the food or liquid.
Danish: • Sørg for, at resterende indhold i den øverste del af kapslen også tømmes ud over maden eller væsken.
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 serumcalciumniveauet.
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 ved koncentrationer, der opnås klinisk, hverken som hæmmer af andre CYP-enzymer, herunder CYP1A2, CYP2C8, CYP2C9, CYP2C19 og CYP3A4, eller som induktor for CYP1A2, CYP2C19 og CYP3A4.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Mimpara findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: 25 subjects received at least one dose of cinacalcet and the mean maximum daily dose of cinacalcet was 0.55 mg/kg/day.
Danish: 25 patienter fik mindst én dosis cinacalcet, og den gennemsnitlige maksimale daglige dosis cinacalcet var 0,55 mg/kg/dag.
English: • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Danish: • primær HPT hos patienter, hvor der ville være indikation for paratyroidektomi på grundlag af serumcalciumniveauerne (som angivet i relevante behandlingsretningslinjer), men hos hvem paratyroidektomi ikke er klinisk mulig eller er kontraindiceret.
English: The percentage of patients who achieved the primary endpoint (≥ 30% reduction from baseline in mean plasma iPTH during the EAP; weeks 25 to 30) was 55% in the cinacalcet group and 19.0% in the placebo group (p = 0.02).
Danish: Procentdelen af patienter, der nåede det primære endepunkt (≥ 30 % reduktion i forhold til baseline i gennemsnitlig plasma-iPTH under EAP; uge 25 til 30), var 55 % i cinacalcet-gruppen og 19,0 % i placebogruppen (p = 0,02).
English: 10, 15, 30, 60, 90, and 120 15, 30, 60, 90, 120, and 180
Danish: 10; 15; 30; 60; 90 og 120 15; 30; 60; 90; 120 og 180
English: Cinacalcet is not indicated for CKD patients not on dialysis.
Danish: Cinacalcet er ikke indiceret til CKD-patienter, der ikke er i dialysebehandling.
English: If you used food to take Mimpara granules, drink something afterwards to make sure all the medicine is swallowed.
Danish: Tag noget at drikke bagefter, hvis De bruger mad til at tage Mimpara granulat, for at sikre, at al medicin synkes.
English: Protein binding of cinacalcet is not affected by impaired hepatic function.
Danish: Proteinbindingen for cinacalcet påvirkes ikke af svækket leverfunktion.
English: Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia secondary to hypocalcaemia.
Danish: Fald i serumcalcium kan desuden forlænge QT-intervallet og potentielt medføre ventrikulær arytmi sekundært til hypokalcæmi.
English: The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto-induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
Danish: Cinacalcets manglende påvirkning af de farmakokinetiske egenskaber for R- og S-warfarin og mangel på automatisk induktion efter multipel dosering hos patienter indikerer, at cinacalcet ikke er en induktor for CYP3A4, CYP1A2 og CYP2C9 hos mennesker.
English: In post-hoc analyses of pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and parathyroidectomy were lower in the cinacalcet group compared with the control group.
Danish: I indsamlede data fra kliniske studier, der løb over 6 og 12 måneder, blev Kaplan-Meier-estimater af knoglefraktur og paratyroidektomi sænket i cinacalcet-gruppen sammenlignet med kontrolgruppen.
English: Dextromethorphan: Multiple doses of 50 mg cinacalcet increased the AUC of 30 mg dextromethorphan (metabolised primarily by CYP2D6) by 11-fold in CYP2D6 extensive metabolisers.
Danish: Dextromethorphan: Flere doser af 50 mg cinacalcet øgede AUC for 30 mg dextromethorphan (der primært metaboliseres af CYP2D6) med 11 gange hos ekstensive CYP2D6-metabolisers.
English: - The active substance is cinacalcet.
Danish: - Aktivt stof: cinacalcet.
English: Mimpara with food and drink Mimpara should be taken with or shortly after food.
Danish: Brug af Mimpara sammen med mad og drikke Mimpara skal tages sammen med eller kort tid efter indtagelse af mad.
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/013 - 1 mg capsules for opening EU/1/04/292/014 - 2.5 mg capsules for opening EU/1/04/292/015 - 5 mg capsules for opening
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/013 - 1 mg kapsler til åbning EU/1/04/292/014 - 2,5 mg kapsler til åbning EU/1/04/292/015 - 5 mg kapsler til åbning
English: Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
Danish: Forgelatineret stivelse (majsstivelse) Mikrokrystallinsk cellulose Povidon
English: Dose adjustment based on PTH levels
Danish: Dosisjustering baseret på PTH-niveauer
English: • 1 to 3 capsules a day use at least 1 tablespoon (15 mL)
Danish: • 1 til 3 kapsler om dagen brug mindst 1 spiseskefuld (15 ml)
English: Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment (Child-Pugh classification), Mimpara should be used with caution in these patients and treatment should be closely monitored (see sections 4.2 and 5.2).
Danish: På grund af risikoen for 2 til 4 gange højere plasmaniveau af cinacalcet hos patienter med moderat til svær leverinsufficiens (Child-Pugh-klassifikation) skal Mimpara anvendes med forsigtighed hos disse patienter, og behandlingen skal monitoreres nøje (se pkt.
English: ANNEX III LABELLING AND PACKAGING LEAFLET
Danish: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: Mimpara should only be initiated for the treatment of secondary HPT in children ≥ 3 years old with ESRD on maintenance dialysis therapy, in whom secondary HPT is not adequately controlled with standard of care therapy, where serum calcium is in the upper range of, or above, the age-specified reference interval.
Danish: Mimpara bør kun initieres til behandling af sekundær HPT hos børn ≥ 3 år med ESRD, der er i vedligeholdelsesdialyseterapi, hvor sekundær HPT ikke kontrolleres tilstrækkeligt med standardbehandling, og hvor serumcalcium er i det øvre område af det aldersspecifikke referenceinterval eller derover.
English: The mean maximum daily dose of cinacalcet was 1.0 mg/kg/day.
Danish: Den gennemsnitlige maksimale daglige dosis cinacalcet var 1,0 mg/kg/dag.
English: Amorphous silicon dioxide
Danish: Amorf siliciumdioxid
English: Medicines such as these can affect how Mimpara works:
Danish: Nedenstående medicin kan have betydning for, hvordan Mimpara virker:
English: PTH levels should be assessed at least 12 hours after dosing with Mimpara.
Danish: PTH-niveauet bør vurderes mindst 12 timer efter dosering med Mimpara.
English: • a medicine used to treat HIV infection and AIDS (ritonavir);
Danish: • medicin, som anvendes til behandling af hiv og AIDS (ritonavir),
English: For instructions on how to use Mimpara granules, read the section at the end of this leaflet.
Danish: Der er instruktioner til anvendelse af Mimpara granulat i afsnittet sidst i denne indlægsseddel.
English: The usual starting dose of Mimpara for children aged 3 years to less than 18 years of age is no more than 0.20 mg/kg of body weight daily.
Danish: Den normale startdosis af Mimpara for børn i alderen 3 år og op til 18 år er maksimalt 0,20 mg/kg legemsvægt dagligt.
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: Nyreinsufficiens: Den farmakokinetiske profil for cinacalcet hos patienter med mild, moderat og svær nyreinsufficiens og hos patienter i hæmodialyse eller peritoneal dialyse er sammenlignelig med profilen hos raske frivillige forsøgspersoner.
English: Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment.
Danish: Calciumholdige fosfatbindere, D-vitamin-steroler og/eller justering af calciumkoncentrationerne i dialysevæske kan bruges til at hæve serumcalcium i overensstemmelse med den kliniske vurdering.
English: In each of the studies, the primary endpoint (proportion of patients with an iPTH ≤ 250 pg/mL (≤ 26.5 pmol/L)) was achieved by 41%, 46%, and 35% of patients receiving cinacalcet, compared with 4%, 7%, and 6% of patients receiving placebo.
Danish: I hver undersøgelse blev det primære endepunkt (andel af patienter med iPTH ≤250 pg/ml (≤26,5 pmol/l)) opnået af 41 %, 46 % og 35 % af de patienter, der blev behandlet med cinacalcet, sammenlignet med 4 %, 7 % og 6 % af patienterne i placebogruppen.
English: The capsules have a white body and coloured caps “1 mg” (dark green cap), “2.5 mg” (yellow cap) or “5 mg” (blue cap) marked on one side and “AMG” on the other side.
Danish: Kapslerne har en hvid kerne og farvede hætter, der er mærket “1 mg” (mørkegrøn hætte), “2,5 mg” (gul hætte) eller “5 mg” (blå hætte) på den ene side og “AMG” på den anden side.
English: Thereafter, as cinacalcet levels begin to decline, PTH levels increase until 12 hours post-dose, and then PTH suppression remains approximately constant to the end of the once daily dosing interval.
Danish: Når cinacalcet-niveauet derefter begynder at falde, stiger PTH-niveauet indtil 12 timer efter dosering, og derefter forbliver PTH-suppressionen tilnærmelsesvist konstant resten af doseringsintervallet (én gang dagligt).
English: Concurrent administration of other medicinal products known to reduce serum calcium and Mimpara may result in an increased risk of hypocalcaemia (see section 4.4).
Danish: Samtidig administration af andre lægemidler, der vides at sænke serumcalcium, og Mimpara kan medføre øget risiko for hypocalcæmi (se pkt.
English: There are no clinical data from the use of cinacalcet in pregnant women.
Danish: Der er ingen erfaring med anvendelse af cinacalcet til gravide.
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 (see sections 4.2 and 4.4).
Danish: Fordi doserne titreres for hver person på grundlag af sikkerheds- og effektparametre, kræves der ingen yderligere dosisjustering for personer med leversvækkelse (se pkt.
English: • reduced testosterone levels
Danish: • reducerede testosteronniveauer,
English: Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet (see section 4.8).
Danish: Der er indberettet tilfælde af QT-forlængelse og ventrikulær arytmi hos patienter, der blev behandlet med cinacalcet (se pkt.
English: Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in subjects with moderate impairment and approximately 4-fold higher in subjects with severe impairment.
Danish: Sammenlignet med personer med normal leverfunktion var den gennemsnitlige AUC for cinacalcet ca. det dobbelte hos personer med moderat svækkelse og ca. det 4-dobbelte hos personer med svær svækkelse.
English: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole and voriconazole);
Danish: • medicin, som anvendes til behandling af hud- og svampeinfektioner (ketoconazol, itraconazol og voriconazol),
English: Indigo carmine (E132)
Danish: Indigocarmin (E132)
English: • a medicine used to treat depression (fluvoxamine).
Danish: • medicin, der anvendes til behandling af depression (fluvoxamin).
English: • low calcium levels in the blood (hypocalcaemia).
Danish: • lave calciumniveauer i blodet (hypokalcæmi).
English: PHARMACEUTICAL FORM AND CONTENTS One bottle containing 30 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Én flaske indeholdende 30 tabletter.
English: Dose adjustment based on serum calcium levels
Danish: Dosisjustering baseret på serumcalciumniveauer