FrancophonIA/ELRC3.0 huggingface dataset:
English: CKD patients not on dialysis
Danish: CKD-patienter, der ikke er i dialysebehandling
English: • Indigo carmine (E132) (1 mg and 5 mg capsules)
Danish: • Indigocarmin (E132) (1 mg og 5 mg kapsler)
English: 30 mg tablets are approximately 9.7 mm long and 6.0 mm wide.
Danish: 30 mg tabletter er cirka 9,7 mm lange og 6,0 mm brede.
English: Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate,
Danish: Opadry II grøn: (Lactosemonohydrat, hypromellose, titandioxid (E171), glyceroltriacetat, FD&C
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L), or in the presence of clinical symptoms of hypocalcaemia
Danish: < 8,4 mg/dl (2,1 mmol/l) og > 7,5 mg/dl (1,9 mmol/l) eller ved kliniske symptomer på hypocalcæmi
English: 60 mg tablets are approximately 12.2 mm long and 7.6 mm wide.
Danish: 60 mg tabletter er cirka 12,2 mm lange og 7,6 mm brede.
English: Cases of seizures have been reported in patients treated with Mimpara (see section 4.8).
Danish: Der er rapporteret tilfælde af krampeanfald hos patienter, der blev behandlet med Mimpara (se pkt.
English: • Printing ink: iron oxide black, shellac, propylene glycol
Danish: • Trykfarve: sort jernoxid, shellak, propylenglycol
English: Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Danish: Hos størstedelen af patienterne var nausea og opkastning let til moderat i sværhedsgrad og forbigående.
English: ≥ 12.5 to < 25
Danish: ≥ 12,5 til < 25
English: The recommended starting dose of Mimpara for adults is 30 mg twice per day.
Danish: Den anbefalede startdosis af Mimpara er for voksne 30 mg to gange daglig.
English: < 8.4 mg/dL (2.1 mmol/L) and > 7.5 mg/dL (1.9 mmol/L) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium
Danish: < 8,4 mg/dl (2,1 mmol/l) og > 7,5 mg/dl (1,9 mmol/l) eller vedvarende symptomer på hypocalcæmi på trods af forsøg på at forhøje serumcalcium
English: Possible signs of overdose include numbness or tingling around the mouth, muscle aches or cramps and seizures.
Danish: Tegn på en overdosis kan omfatte følelsesløshed eller en prikken omkring munden, muskelsmerter eller -kramper samt krampeanfald.
English: • Pre-gelatinised maize starch
Danish: • Pregelatineret majsstivelse,
English: Calcium carbonate: Co-administration of calcium carbonate (single 1,500 mg dose) did not alter the pharmacokinetics of cinacalcet.
Danish: Calciumcarbonat: Co-administration af calciumcarbonat (enkeltdosis på 1.500 mg) påvirkede ikke de farmakokinetiske egenskaber af cinacalcet.
English: Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).
Danish: Behandling af sekundær hyperparatyroidisme (HPT) hos børn i alderen 3 år og derover med slutstadium af nyresygdom (ESRD) i vedligeholdelsesdialyseterapi, hvor sekundær HPT ikke kontrolleres i tilstrækkelig grad med standardbehandling (se pkt.
English: • upper respiratory infection
Danish: • infektion i øvre luftveje,
English: LIST OF EXCIPIENTS Lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Laktosemonohydrat.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Mimpara must be taken orally, with or shortly after food.
Danish: Mimpara skal indtages gennem munden sammen med eller kort tid efter indtagelse af mad.
English: Nausea Vomiting
Danish: Nausea Opkastning
English: If you are being treated for secondary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) once per day.
Danish: Hvis De er under behandling for sekundær hyperparatyroidisme Den normale startdosis af Mimpara for voksne er 30 mg (én tablet) én gang dagligt.
English: The majority of patients (89%) were using vitamin D sterols at baseline.
Danish: Størstedelen af patienterne (89 %) brugte vitamin D-steroler ved baseline.
English: Different strengths of granules should not be mixed, in order to avoid dosing errors.
Danish: For at undgå doseringsfejl må forskellige styrker af granulat ikke blandes.
English: • low blood pressure (hypotension)
Danish: • lavt blodtryk,
English: Corrected serum calcium should be in the upper range of, or above, the age-specified reference interval prior to administration of first dose of Mimpara, and closely monitored (see section 4.4).
Danish: Korrigeret serumcalcium bør være i det øvre område af det aldersspecifikke referenceinterval eller derover inden administration af den første dosis Mimpara (se pkt.
English: • If you start to get numbness or tingling around the mouth, muscle aches or cramps and seizures.
Danish: • hvis De begynder at få følelsesløshed eller en prikken omkring munden, muskelsmerter ellerkramper eller krampeanfald.
English: Life threatening events and fatal outcomes associated with hypocalcaemia have been reported in adult and paediatric patients treated with Mimpara.
Danish: Der er indberettet livstruende hændelser og dødelige udfald i forbindelse med hypokalcæmi hos voksne og pædiatriske patienter, der blev behandlet med Mimpara.
English: Each 90 mg tablet contains 8.21 mg of lactose.
Danish: Mimpara 90 mg filmovertrukne tabletter Hver 90 mg tablet indeholder 8,21 mg lactose.
English: • loss (anorexia) or decrease of appetite
Danish: • appetitløshed eller nedsat appetit,
English: The mean (SD) iPTH concentrations at baseline were 757.1 (440.1) pg/mL for the cinacalcet group and 795.8 (537.9) pg/mL for the placebo group.
Danish: De gennemsnitlige (SD) iPTH-koncentrationer ved baseline var 757,1 (440,1) pg/ml i cinacalcet-gruppen og 795,8 (537,9) pg/ml i placebogruppen.
English: Parathyroid carcinoma and primary hyperparathyroidism in adults
Danish: Cancer i paratyroidea og primær hyperparatyroidisme hos voksne
English: Corrected Serum calcium level or clinical symptoms of hypocalcaemia
Danish: Korrigeret serumcalciumniveau eller kliniske symptomer på hypocalcæmi
English: Ensure serum calcium levels are within the normal range before Mimpara is initiated (see sections 4.4 and 4.8).
Danish: Sørg for, at serumcalciumniveauer er inden for det normale område, før Mimpara påbegyndes (se pkt.
English: Sevelamer: Co-administration of sevelamer (2,400 mg tid) did not affect the pharmacokinetics of cinacalcet.
Danish: Sevelamer: Co-administration af sevelamer (2.400 mg 3 gange dagligt) påvirkede ikke de farmakokinetiske egenskaber af cinacalcet.
English: Mimpara is also available as granules in capsules for opening.
Danish: Mimpara fås også som granulat i kapsler, der skal åbnes.
English: • Hold the capsule upright over the soft food or liquid.
Danish: • Hold kapslen lodret hen over søbemaden eller væsken.
English: ≥ 36 to < 50
Danish: ≥ 36 til < 50
English: Cataracts are known to occur in rodents as a result of hypocalcaemia.
Danish: Grå stær er bekræftet hos gnavere som et resultat af hypokalcæmi.
English: Corrected Serum calcium value or clinical symptoms of hypocalcaemia
Danish: Korrigeret serumcalciumværdi eller kliniske symptomer på hypocalcæmi
English: ≥ 25 to < 36
Danish: ≥ 25 til < 36
English: ≥ 50 to < 75
Danish: ≥ 50 til < 75
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Danish: • hævelse i ansigt, læber, mund, tunge eller hals, som kan give synke- eller åndedrætsbesvær
English: Dizziness and seizures have been reported by patients taking Mimpara.
Danish: Der er indberettet svimmelhed og krampeanfald fra patienter, som fik Mimpara.
English: If you are being treated for parathyroid cancer or primary hyperparathyroidism The usual starting dose for Mimpara in adults is 30 mg (one tablet) twice per day.
Danish: Hvis De er under behandling for biskjoldbruskkirtelkræft eller primær hyperparatyroidisme Den normale startdosis af Mimpara for voksne er 30 mg (én tablet) to gange dagligt.
English: Each 60 mg tablet contains 5.47 mg of lactose.
Danish: Mimpara 60 mg filmovertrukne tabletter Hver 60 mg tablet indeholder 5,47 mg lactose.
English: PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
Danish: PTH skal måles 1-4 uger efter påbegyndelse af Mimpara eller justering af Mimpara-dosis.
English: How to take Mimpara
Danish: Sådan skal De tage Mimpara
English: • Do not mix granules of different strengths to avoid incorrect dosing.
Danish: • For at undgå forkert dosering må granulat med forskellige styrker ikke blandes.
English: *If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days
Danish: *Korrigeret serumcalcium skal måles inden for 5-7 dage, hvis dosis har været seponeret.
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: Studierne viser, at CKD-patienter, der ikke er i dialyse, og som behandles med cinacalcet, har øget risiko for hypokalcæmi sammenlignet med ESRD-patienter, der er i dialyse og behandles med cinacalcet, hvilket kan skyldes lavere baseline-calciumniveauer og/eller resterende nyrefunktion.
English: Each capsule contains 1 mg, 2.5 mg or 5 mg of cinacalcet (as hydrochloride) granules.
Danish: Hver kapsel indeholder 1 mg, 2,5 mg eller 5 mg cinacalcet (som hydroklorid) granulat.
English: Dose adjustment based on serum calcium levels Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Danish: Dosisjustering baseret på serumcalciumniveauer Serumcalcium skal måles inden for 1 uge efter initiering eller dosisjustering af Mimpara.
English: INFORMATION IN BRAILLE mimpara 2.5 mg
Danish: INFORMATION I BRAILLESKRIFT mimpara 2,5 mg
English: Patients receiving Mimpara should not be given etelcalcetide (see section 4.4).
Danish: Patienter, der får Mimpara, må ikke få etelcalcetid (se pkt.
English: Each 30 mg tablet contains 2.74 mg of lactose.
Danish: Mimpara 30 mg filmovertrukne tabletter Hver 30 mg tablet indeholder 2,74 mg lactose.
English: 5, 10, 15, 30, and 60
Danish: 5; 10; 15; 30 og 60
English: The safety of Mimpara for the treatment of secondary HPT in paediatric patients with ESRD receiving dialysis was evaluated in two randomised controlled studies and one single-arm study (see section 5.1).
Danish: Mimparas sikkerhed i behandlingen af sekundær HPT hos pædiatriske patienter med ESRD, der er i dialysebehandling, blev undersøgt i to randomiserede, kontrollerede studier og et studie med en enkelt behandlingsarm (se pkt.
English: INFORMATION IN BRAILLE mimpara 1 mg
Danish: INFORMATION I BRAILLESKRIFT mimpara 1 mg
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.9 (0.5) mg/dL for the cinacalcet group and 9.9 (0.6) mg/dL for the placebo group.
Danish: De gennemsnitlige (SD) korrigerede totale serumcalciumkoncentrationer ved baseline var 9,9 (0,5) mg/dl i cinacalcet-gruppen og 9,9 (0,6) mg/dl i placebogruppen.
English: While opening it is recommended to hold the capsule upright over the small amount of soft food or liquid.
Danish: Det anbefales at holde kapslen lodret over den lille mængde søbemad eller væske, mens kapslen åbnes.
English: Hepatic Insufficiency: Mild hepatic impairment did not notably affect the pharmacokinetics of cinacalcet.
Danish: Leverinsufficiens: Let nedsat leverfunktion påvirkede ikke cinacalcets farmakokinetiske egenskaber i nævneværdig grad.
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 af cinacalcet.
English: Secondary hyperparathyroidism
Danish: Sekundær hyperparatyroidisme
English: Mimpara is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Danish: Mimpara fås i flasker med 30 mg, 60 mg eller 90 mg filmovertrukne tabletter i en æske.
English: Mimpara is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Danish: Mimpara fås i blisterpakninger med 30 mg, 60 mg eller 90 mg filmovertrukne tabletter.
English: What Mimpara looks like and contents of the pack Mimpara granules are white to off-white in appearance and are presented in capsules for opening.
Danish: Mimpara granulat er hvidt til offwhite og fås i kapsler, der skal åbnes.
English: The mean (SD) iPTH concentrations at baseline were 946 (635) pg/mL for the cinacalcet + SOC group and 1228 (732) pg/mL for the SOC group.
Danish: De gennemsnitlige (SD) iPTH-koncentrationer ved baseline var 946 (635) pg/ml i cinacalcet + SOC-gruppen og 1.228 (732) pg/ml i SOC-gruppen.
English: Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.
Danish: De og Deres læge skal afklare, om det er bedst at ophøre med amning eller afbryde behandlingen med Mimpara.
English: 5, 10, 15, 30, 60, and 90
Danish: 5; 10; 15; 30; 60 og 90
English: Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening Cinacalcet
Danish: Mimpara 1 mg granulat i kapsler til åbning Mimpara 2,5 mg granulat i kapsler til åbning Mimpara 5 mg granulat i kapsler til åbning Cinacalcet
English: If you forget to take Mimpara
Danish: Hvis De har taget for meget Mimpara
English: Seizures† Dizziness Paraesthesia Headache
Danish: Krampeanfald† Svimmelhed Paræstesi Hovedpine
English: Check with your doctor or pharmacist if you are unsure.
Danish: Spørg lægen, på apoteket eller sundhedspersonalet, hvis der er noget, De er i tvivl om.
English: The mean (SD) corrected total serum calcium concentrations at baseline were 9.8 (0.6) mg/dL for the cinacalcet + SOC group and 9.8 (0.6) mg/dL for the SOC group.
Danish: De gennemsnitlige (SD) korrigerede totale serumcalciumkoncentrationer ved baseline var 9,8 (0,6) mg/dl i cinacalcet + SOC-gruppen og 9,8 (0,6) mg/dl i SOC-gruppen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 30 mg, 60 mg eller 90 mg cinacalcet (som hydroklorid).
English: Investigational studies have shown that adult 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: Studier har vist, at voksne CKD-patienter, der ikke er i dialysebehandling, og som behandles med cinacalcet, har øget risiko for hypokalcæmi (serumcalcium < 8,4 mg/dl [2,1 mmol/l]) sammenlignet med CKD-patienter i dialysebehandling, der behandles med cinacalcet.
English: • Iron oxide yellow (E172) (1 mg and 2.5 mg capsules)
Danish: • Gul jernoxid (E172) (1 mg og 2,5 mg kapsler)
English: Closely monitor serum calcium (see section 4.5).
Danish: Serumcalcium skal monitoreres nøje (se pkt.
English: Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Danish: Serumcalcium skal måles inden for 1 uge efter initiering eller dosisjustering af Mimpara.
English: Mimpara daily dose in paediatric patients Patient dry weight (kg)
Danish: Daglig dosis Mimpara hos pædiatriske patienter
English: Do not swallow the capsules whole.
Danish: Kapslerne må ikke synkes hele.
English: Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Danish: Når vedligeholdelsesdosen er blevet fastslået, skal serumcalciumniveauet måles ca. 1 gang om måneden.
English: PHARMACEUTICAL FORM AND CONTENTS Granules in capsules for opening 30 capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Granulat i kapsler til åbning
English: Mimpara is also available as granules for paediatric use.
Danish: Mimpara fås også som granulat til børn.
English: • high potassium levels in the blood (hyperkalaemia)
Danish: • høje kaliumniveauer i blodet (hyperkaliæmi),
English: Capsule consists of a dark green colour cap, marked “AMG” and white opaque body, marked “1 mg”.
Danish: Kapsel bestående af en mørkegrøn hætte, mærket “AMG”, og en hvid, uigennemsigtig kerne, mærket “1 mg”.
English: Children who require doses lower than 30 mg, or who are unable to swallow tablets should receive Mimpara granules.
Danish: Børn, der har brug for lavere doser end 30 mg, eller som ikke kan synke tabletterne, bør få Mimpara som granulat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BLISTERPAKNING
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1 mg, 2.5 mg or 5 mg cinacalcet (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert granulat i kapsel til åbning indeholder 1 mg, 2,5 mg eller 5 mg cinacalcet (som hydroklorid).
English: Light green, oval (approximately 12.2 mm long and 7.6 mm wide), film-coated tablet marked “AMG” on one side and “60” on the other.
Danish: Lysegrøn, oval, filmovertrukket tablet (cirka 12,2 mm lang og 7,6 mm bred) mærket “AMG” på den ene side og “60” på den anden side.
English: Children who require doses of 30 mg or more and who are able to swallow tablets may receive appropriate doses of Mimpara tablets.
Danish: Børn, der har behov for doser på 30 mg eller derover, og som kan synke tabletter, kan få de relevante doser af Mimpara som tabletter.
English: Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets
Danish: Mimpara 30 mg filmovertrukne tabletter Mimpara 60 mg filmovertrukne tabletter Mimpara 90 mg filmovertrukne tabletter
English: • Tap the capsule gently so the contents settle on the bottom of the capsule (white part of capsule).
Danish: • Bank let på kapslen, så indholdet samler sig i bunden af kapslen
English: Capsule consists of a blue colour cap, marked “AMG” and white opaque body, marked “5 mg”.
Danish: Kapsel bestående af en blå hætte, mærket “AMG”, og en hvid, uigennemsigtig kerne, mærket “5 mg”.
English: Light green, oval (approximately 13.9 mm long and 8.7 mm wide), film-coated tablet marked “AMG” on one side and “90” on the other.
Danish: Lysegrøn, oval, filmovertrukket tablet (cirka 13,9 mm lang og 8,7 mm bred) mærket “AMG” på den ene side og “90” på den anden side.
English: There have been reports of idiosyncratic cases of hypotension and/or worsening heart failure in cinacalcet-treated patients with impaired cardiac function in post-marketing safety surveillance, the frequencies of which cannot be estimated from available data.
Danish: Hypotension og/eller forværring af hjerteinsufficiens I overvågningen af sikkerheden efter markedsføring har der været rapporteret idiosynkratiske tilfælde af hypotension og/eller forværring af hjerteinsufficiens hos cinacalcet-behandlede patienter med nedsat hjertefunktion.
English: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked “AMG” on one side and “30” on the other.
Danish: Lysegrøn, oval, filmovertrukket tablet (cirka 9,7 mm lang og 6,0 mm bred) mærket “AMG” på den ene side og “30” på den anden side.
English: The starting dose of cinacalcet was 0.20 mg/kg.
Danish: Den gennemsnitlige tørvægt ved baseline var 12 kg. Initialdosis af cinacalcet var 0,20 mg/kg.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 1 mg granules in capsules for opening Mimpara 2.5 mg granules in capsules for opening Mimpara 5 mg granules in capsules for opening
Danish: LÆGEMIDLETS NAVN Mimpara 1 mg granulat i kapsler til åbning Mimpara 2,5 mg granulat i kapsler til åbning Mimpara 5 mg granulat i kapsler til åbning
English: Capsule consists of a rich yellow colour cap, marked “AMG” and white opaque body, marked “2.5 mg”.
Danish: Kapsel bestående af en kraftigt gul hætte, mærket “AMG”, og en hvid, uigennemsigtig kerne, mærket “2,5 mg”.
English: FD&C Blue (E132), iron oxide yellow (E172))
Danish: glyceroltriacetat, FD&C blå (E132), gul jernoxid (E172)),
English: Children who require doses of 30 mg or more and who are able to swallow tablets may receive Mimpara tablets.
Danish: Børn, der har brug for doser på 30 mg og derover, og som kan synke tabletter, kan få Mimpara tabletter.
English: After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
Danish: Hvis der ikke opretholdes klinisk relevante reduktioner i serumcalciumniveauet, bør det overvejes at afbryde Mimparabehandlingen (se pkt.
English: INFORMATION IN BRAILLE mimpara 5 mg
Danish: INFORMATION I BRAILLESKRIFT mimpara 5 mg
English: Parathyroid carcinoma and Primary Hyperparathyroidism
Danish: Cancer i paratyroidea og primær hyperparatyroidisme
English: What Mimpara looks like and contents of the pack Mimpara is a light green film-coated tablet.
Danish: Mimpara er en lysegrøn, filmovertrukket tablet.
English: Closely monitor serum calcium levels (see section 4.2) and patient compliance during treatment with cinacalcet.
Danish: 4.2) og patientens komplians skal monitoreres nøje under behandling med cinacalcet.
English: During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara.
Danish: Under dosistitrering skal serumcalciumniveauet måles regelmæssigt og inden for 1 uge efter påbegyndelse af Mimpara eller justering af Mimpara-dosis.
English: †see section 4.4 *see section c c) Description of selected adverse reactions
Danish: c c) Beskrivelse af udvalgte bivirkninger
English: A fatal outcome was reported in a paediatric clinical trial patient with severe hypocalcaemia (see section 4.4).
Danish: Der blev indberettet et dødeligt tilfælde af alvorlig hypokalcæmi hos et barn i et klinisk forsøg (se pkt.
English: Administration using nasogastric or gastrostomy tubes
Danish: Indgivelse med anvendelse af en nasogastrisk sonde eller gastrostomisonde
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL FLASKE
English: 4.7 Effects on ability to drive and use machines Dizziness and seizures, which may have major influence on the ability to drive and use machines, have been reported by patients taking Mimpara (see section 4.4).
Danish: Der er rapporteret svimmelhed og krampeanfald hos patienter, der fik Mimpara, hvilket kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i væsentlig grad (se pkt.
English: Do not swallow the capsule.
Danish: Smid skallerne fra kapslen ud.
English: Hypocalcaemia (see sections 4.2 and 4.4).
Danish: 4.2 og 4.4).
English: INFORMATION IN BRAILLE mimpara 90
Danish: INFORMATION I BRAILLESKRIFT mimpara 90
English: • parathyroid carcinoma.
Danish: • cancer i paratyroidea,
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.
Danish: Det gælder især etelcalcetid eller anden medicin, der sænker niveauet af calcium i blodet.
English: INFORMATION IN BRAILLE mimpara 30
Danish: INFORMATION I BRAILLESKRIFT mimpara 30
English: INFORMATION IN BRAILLE mimpara 60
Danish: INFORMATION I BRAILLESKRIFT mimpara 60
English: • Colloidal anhydrous silica
Danish: • Kolloid vandfri silica.
English: Mimpara 30 mg film-coated tablets
Danish: Mimpara 30 mg filmovertrukne tabletter