FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.807; 95% CI: 0.678 to 0.962; p=0.0169).
Danish: Samlet overlevelse var statistisk signifikant bedre hos de patienter, som fik Cyramza plus paclitaxel, sammenlignet med dem, som fik placebo plus paclitaxel (HR 0,807; 95 % KI: 0,678 til 0,962; p=0,0169).
English: Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Danish: Figur 6: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus docetaxel versus placebo plus docetaxel i REVEL
English: Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
Danish: Figur 3: Kaplan-Meier-kurver for samlet overlevelse for Cyramza versus placebo i REGARD
English: In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
Danish: I RAISE-studiet var der hyppigere forekomst af grad ≥3 neutropeni ved øget ramucirumabeksponering.
English: Days 8 and 15: ≥1.0 x 109/L
Danish: Day 1: ≥ 1,5 x 109/l Dag 8 og 15: ≥ 1,0 x 109/l
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 1 level for 5-FU and irinotecan.
Danish: Udskyd 5-FU og irinotecan i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 1 niveau for 5-FU og irinotecan.
English: Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Danish: Figur 4: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus FOLFIRI versus placebo plus FOLFIRI i RAISE
English: - Each 50 ml vial contains 500 mg of ramucirumab.
Danish: - Hvert 50 ml hætteglas indeholder 500 mg ramucirumab.
English: Fistula
Danish: Udslæta
English: - Each 10 ml vial contains 100 mg of ramucirumab.
Danish: - Hvert 10 ml hætteglas indeholder 100 mg ramucirumab.
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).
Danish: Cyramza er indiceret som monoterapi til behandling af voksne patienter med fremskreden gastrisk cancer eller adenokarcinom i den gastroøsofagale overgang (GEJ) med sygdomsprogression efter tidligere platin- eller fluorpyrimidinbaseret kemoterapi, for hvem behandling med paclitaxel ikke er hensigtsmæssig.
English: For IV use after dilution.
Danish: brug efter fortynding.
English: Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Danish: Figur 2: Kaplan-Meier-kurver for progressionsfri overlevelse for Cyramza plus paclitaxel versus placebo plus paclitaxel i RAINBOW
English: Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Danish: Figur 1: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus paclitaxel versus placebo plus paclitaxel i RAINBOW
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for 5-FU and irinotecan.
Danish: Udskyd 5-FU og irinotecan i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 2 niveauer for 5-FU og irinotecan.
English: Each 50 ml vial contains 500 mg of ramucirumab.
Danish: Hvert 50 ml hætteglas indeholder 500 mg ramucirumab.
English: Each 10 ml vial contains 100 mg of ramucirumab.
Danish: Hvert 10 ml hætteglas indeholder 100 mg ramucirumab.
English: Ramucirumab treatment should be discontinued in patients who develop fistula (see section 4.2).
Danish: Ramucirumab skal seponeres permanent hos patienter, som udvikler fistler (se pkt.
English: Paclitaxel dose adjustments
Danish: Justering af paclitaxeldosis
English: Arterial thromboembolic eventsa
Danish: Arterielle tromboemboliske hændelsera
English: FOLFIRI dose adjustments
Danish: Dosisjustering af FOLFIRI
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan.
Danish: Hvis diarré er bedret til grad ≤1, reduceres med 1 dosisniveau for 5-FU og irinotecan.
English: There was an increase in median PFS of 1.2 months in favour of the Cyramza plus FOLFIRI arm: 5.7 months in the Cyramza plus FOLFIRI arm and 4.5 months in the placebo plus FOLFIRI arm. Efficacy results are shown in Table 10 and Figures 4 and 5.
Danish: Der var en øget median PFS på 1,2 måneder til fordel for Cyramza plus FOLFIRI: 5,7 måneder i Cyramza plus FOLFIRI-armen og 4,5 måneder i placebo plus FOLFIRI-armen.
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus paclitaxel arm: 4.4 months in the Cyramza plus paclitaxel arm and 2.9 months in the placebo plus paclitaxel arm.
Danish: Der var en stigning i den mediane progressionsfri overlevelse (PFS) på 1,5 måneder til fordel for Cyramza plus paclitaxel-gruppen: 4,4 måneder i Cyramza plus paclitaxel-gruppen og 2,9 måneder i placebo plus paclitaxel-gruppen.
English: Hazard ratio (95% CI) Stratified log-rank p-value Abbreviations: CI = confidence interval
Danish: Stratificeret log-rank p-værdi Forkortelser: KI = Konfidensinterval
English: Initial dose
Danish: Første dosisreduktion til
English: The ECOG PS was 1 for 72% of patients.
Danish: De 2 behandlingsgrupper var balanceret med hensyn til baseline-demografi og sygdomskarakteristika: ECOG PS var1 for 72 % af patienterne.
English: If diarrhoea has recovered to Grade ≤1, reduce by 2 dose levels for 5-FU and irinotecan.
Danish: Hvis diarré er bedret til grad ≤1, reduceres med 2 dosisniveauer for 5-FU og irinotecan.
English: Neutropeniaa Leukopeniaa,c Thrombocytopeniaa
Danish: Blod og lymfesystem Neutropenia Leukopenia,c
English: Figure 5: Kaplan-Meier curves of progression -free survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Danish: Figur 5: Kaplan-Meier-kurver for progressionsfri overlevelse for Cyramza plus FOLFIRI versus placebo plus FOLFIRI i RAISE
English: The median relative dose intensity of paclitaxel was 87.7% for the Cyramza plus paclitaxel arm and 93.2% for the placebo plus paclitaxel arm. A similar percentage of patients discontinued treatment due to adverse events: 12% of patients treated with Cyramza plus paclitaxel compared with 11% of patients treated with placebo plus paclitaxel.
Danish: Den mediane relative dosisintensitet af paclitaxel var 87,7 % for Cyramza plus paclitaxelgruppen og 93,2 % for placebo plus paclitaxel-gruppen.
English: Sodium restricted diet
Danish: Diæt med lavt natriumindhold
English: Post discontinuation systemic anti-cancer therapy was given to 47.9% of patients receiving Cyramza plus paclitaxel and 46.0% of patients receiving placebo plus paclitaxel.
Danish: 47,9 % af de patienter, som fik Cyramza plus paclitaxel, og 46,0 % af de patienter, som fik placebo plus paclitaxel, fik systemisk anticancerbehandling efter ophør med forsøgsbehandlingen.
English: Progression-free survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.635; 95% CI: 0.536 to 0.752; p<0.0001).
Danish: Progressionsfri overlevelse var statistisk signifikant forbedret hos de patienter, som fik Cyramza plus paclitaxel, sammenlignet med dem, som fik placebo plus paclitaxel (HR 0,635; 95 % KI: 0,536 til 0,752; p=0,0169).
English: C.
Danish: KI)
English: Vascular disorders Hypertensiona,d
Danish: Hypertensiona,d
English: No dose reductions are recommended (see sections 4.4 and 5.1).
Danish: Der foreligger ingen anbefalinger for dosisreduktion (se pkt.
English: Each 10 ml vial contains approximately 17 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert 10 ml hætteglas indeholder 17 mg natrium.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Må ikke rystes.
English: In HCC patients, hepatic encephalopathy was reported at a higher rate in the ramucirumab-treated patients compared to the placebo-treated patients (see section 4.8).
Danish: Der blev rapporteret om en øget forekomst af hepatisk encefalopati hos HCC-patienter i behandling med ramucirumab sammenlignet med placebo (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 mg/10 ml
English: Cmin prior to administration of the second, fourth and seventh dose of ramucirumab were 23.5 μg/ml (range of 2.9-76.5 μg/ml), 44.1 μg/ml (range of 4.2-137 μg/ml) and 60.2 μg/ml (range of
Danish: 76,5 μg/ml), 44,1 µg/ml (interval 4,2-137 µg/ml) og 60,2 µg/ml (interval 18,3-123 µg/ml).
English: Cyramza 10 mg/ml sterile concentrate ramucirumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Cyramza 10 mg/ml sterilt koncentrat ramucirumab
English: Tel: + 356 25600 500
Danish: Charles de Giorgio Ltd. Tel: + 356 25600 500
English: Rate - percent (95% CI)
Danish: Objektiv responsrate - procent (95 %
English: One ml of concentrate for solution for infusion contains 10 mg of ramucirumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml koncentrat til infusionsvæske, opløsning indeholder 10 mg ramucirumab.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: FARMAKOLOGISKE EGENSKABER
English: Thrombocytopeniaa Neutropeniaa
Danish: Neutrofile granulocytter
English: 10.5 months in the Cyramza plus docetaxel arm and 9.1 months in the placebo plus docetaxel arm. PFS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.762; 95% CI: 0.677 to 0.859; p<0.001).
Danish: PFS var statistisk signifikant bedre hos de patienter, der fik Cyramza plus docetaxel, sammenlignet med dem, som fik placebo plus docetaxel (HR 0,762; 95 % KI: 0,677-0,859; p<0,001).
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Danish: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
English: Cyramza can cause blood clots in your arteries.
Danish: - Arterierne blokeres af en blodprop ("arterielle tromboemboliske hændelser"): Cyramza kan forårsage blodpropper i arterierne.
English: Gastrointestinal disorders Stomatitis Diarrhoea
Danish: Stomatitis Diarré
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm. ORR was significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (22.9% vs. 13.6%, p<0.001).
Danish: Der var en øget median PFS på 1,5 måneder til fordel for Cyramza plus docetaxel-armen: 4,5 måneder i Cyramza plus docetaxelarmen og 3 måneder i placebo plus docetaxel-armen.
English: Tel: + 44-(0) 1256 315000
Danish: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: the geometric means of ramucirumab Cmin were 46.3 μg/ml (range of 7.7-119 μg/ml) and 65.1 μg/ml
Danish: Ved dosisregimet med 8 mg/kg ramucirumab hver 2. uge i kombination med FOLFIRI var de geometriske middelværdier af ramucirumab-Cmin i serum fra patienter med mCRC henholdsvis 46,3 μg/ml (interval 7,7-119 μg/ml) og 65,1 μg/ml (interval 14,5-205 μg/ml) inden administration af den 3. og 5. dosis ramucirumab.
English: Adults and elderly (> 65 years)
Danish: Voksne og ældre (> 65 år)
English: Opadry clear:
Danish: Opadry klar:
English: The volume of distribution is high (approximately 1,000 litres), indicating extensive distribution.
Danish: Distributionsvolumenet er højt (ca. 1.000 liter), hvilket indikerer omfattende distribution.
English: Please tell your doctor immediately:
Danish: Fortæl det straks til lægen:
English: The amount of food you use will depend on how many capsules you need to use every day:
Danish: Den anvendte mængde mad afhænger af hvor mange kapsler, De skal tage hver dag:
English: Your doctor will tell you how much Mimpara you must take.
Danish: Deres læge vil fortælle Dem, hvor meget Mimpara De skal tage.
English: 4.8 Undesirable effects a) Summary of the safety profile
Danish: 4.8 Bivirkninger a) Resumé af sikkerhedsprofilen
English: ATC code: H05BX01.
Danish: ATC-kode: H05BX01.
English: Bottle: 5 years.
Danish: Flaske: 5 år.
English: Mimpara has not been tested in pregnant women.
Danish: Mimpara er ikke blevet undersøgt på gravide kvinder.
English: No change in starting dose is necessary.
Danish: Det er ikke nødvendigt at ændre startdosis.
English: Insufficient data are available.
Danish: Der foreligger ikke tilstrækkelige data.
English: • Check that you have the correct strength of capsules.
Danish: • Kontrollér, at kapslernes styrke er den rigtige.
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics.
Danish: Der blev lavet en farmakokinetisk populationsanalyse for at evaluere virkningerne af demografiske karakteristika.
English: The dose can be increased to achieve a desired target iPTH range.
Danish: Dosen kan forhøjes for at opnå et ønsket mål-iPTH-område.
English: Restart at the next lower dose.
Danish: Reinitier ved næste lavere dosis.
English: Renal excretion of metabolites was the prevalent route of elimination of radioactivity.
Danish: Renal ekskretion af metabolitterne var den primære eliminationsvej af radioaktiviteten.
English: Steady state levels of cinacalcet are achieved within 7 days with minimal accumulation.
Danish: Steady state-niveauer for cinacalcet nås i løbet af 7 dage med minimal akkumulation.
English: Blister: 5 years.
Danish: Blisterpakning: 5 år.
English: These may be signs that your calcium levels are too low (hypocalcaemia).
Danish: Dette kan være tegn på, at Deres calciumniveauer er for lave (hypokalcæmi).
English: • Hold each capsule upright (with the coloured cap on top).
Danish: • Hold hver kapsel lodret (med den farvede hætte øverst).
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development.
Danish: Dyrestudier indikerer ingen direkte skadelige virkninger på graviditet, fødslen eller den postnatale udvikling.
English: At doses above 200 mg, the absorption was saturated probably due to poor solubility.
Danish: Ved doser over 200 mg var absorptionen mættet, sandsynligvis på grund af dårlig opløselighed.
English: 10 to < 12.5
Danish: 10 til < 12,5
English: The major circulating metabolites are inactive.
Danish: De cirkulerende hovedmetabolitter er inaktive.
English: Mixing granules in water for oral use is not recommended as it may lead to a bitter taste.
Danish: Blanding af granulatet i vand til oral anvendelse anbefales ikke, da det kan give en bitter smag.
English: The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks.
Danish: Dosen skal forhøjes fortløbende med de tilgængelige dosisniveauer (se tabel 1) og ikke oftere end hver 4. uge.
English: - The tablets are coated with:
Danish: - Tabletterne er overtrukket med:
English: Only the granules should be administered.
Danish: Det er kun granulatet, der skal indtages.
English: Flush with adequate volume for the used enteral tube.
Danish: Skyl med en tilstrækkelig mængde til den anvendte enterale slange.
English: If you have forgotten a dose of Mimpara, you should take your next dose as normal.
Danish: Hvis De har glemt at tage en dosis Mimpara, skal De tage den næste dosis som normalt.
English: The clinical relevance is unknown, however, the potential for cinacalcet to act on these secondary targets cannot be fully excluded.
Danish: Den kliniske relevans er ukendt, men muligheden for, at cinacalcet kan reagere med disse sekundære mål, kan ikke helt udelukkes.
English: In order to avoid dosing errors, capsules of different strengths (1, 2.5, or 5 mg) should not be mixed to achieve the desired dose.
Danish: For at undgå doseringsfejl må kapslerne med forskellige styrker (1, 2,5 eller 5 mg) ikke blandes for at opnå den ønskede dosis.
English: EU/1/04/292/001 - 30 mg carton with 14 tablets EU/1/04/292/002 - 30 mg carton with 28 tablets EU/1/04/292/003 - 30 mg carton with 84 tablets EU/1/04/292/004 - 30 mg bottle with 30 tablets EU/1/04/292/005 - 60 mg carton with 14 tablets EU/1/04/292/006 - 60 mg carton with 28 tablets EU/1/04/292/007 - 60 mg carton with 84 tablets EU/1/04/292/008 - 60 mg bottle with 30 tablets EU/1/04/292/009 - 90 mg carton with 14 tablets EU/1/04/292/010 - 90 mg carton with 28 tablets EU/1/04/292/011 - 90 mg carton with 84 tablets EU/1/04/292/012 - 90 mg bottle with 30 tablets
Danish: EU/1/04/292/001 - 30 mg æske med 14 tabletter EU/1/04/292/002 - 30 mg æske med 28 tabletter EU/1/04/292/003 - 30 mg æske med 84 tabletter EU/1/04/292/004 - 30 mg flaske med 30 tabletter EU/1/04/292/005 - 60 mg æske med 14 tabletter EU/1/04/292/006 - 60 mg æske med 28 tabletter EU/1/04/292/007 - 60 mg æske med 84 tabletter EU/1/04/292/008 - 60 mg flaske with 30 tabletter EU/1/04/292/009 - 90 mg æske med 14 tabletter EU/1/04/292/010 - 90 mg æske med 28 tabletter EU/1/04/292/011 - 90 mg æske med 84 tabletter EU/1/04/292/012 - 90 mg flaske med 30 tabletter
English: Seventeen patients received at least one dose of cinacalcet and 11 completed at least 12 weeks of treatment.
Danish: Sytten patienter fik mindst én dosis cinacalcet, og 11 fuldførte mindst 12 ugers behandling.
English: If you experience these side effects, do not drive or operate machines.
Danish: Hvis De oplever disse bivirkninger, må De ikke køre bil eller betjene maskiner.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • hver gang risikostyringssystemet ændres, især når der modtages nye oplysninger, som kan føre til betydelig ændring af fordels/risiko-profilen, eller når en vigtig milepæl er nået
English: If Mimpara treatment has been stopped for more than 14 days, restart at the recommended starting dose.
Danish: Hvis behandling med Mimpara har været seponeret i mere end 14 dage, reinitieres ved den anbefalede initialdosis.
English: Following careful benefit/risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Danish: Efter omhyggelig vurdering af nyttevirkning/risiko skal der tages en beslutning om enten at afbryde amningen eller behandlingen med Mimpara.
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 studier er lave på grund af den dosisbegrænsende hypokalcæmi, der blev observeret hos dyr.
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 dette studie viste ingen yderligere reduktioner af koncentrationerne af frit og totalt testosteron i en periode på 3 år hos patienter, der blev behandlet med Mimpara.
English: Open and sprinkle onto food.
Danish: Åbnes og drysses på mad.
English: Dose adjustment in paediatric patients ≥ 3 to < 18 years of age
Danish: Dosisjustering hos pædiatriske patienter ≥ 3 til < 18 år
English: Papaellinas Ltd Τηλ.
Danish: C. A. Papaellinas Ltd Τηλ.
English: In the event of overdose, patients should be monitored for signs and symptoms of hypocalcaemia, and treatment should be symptomatic and supportive.
Danish: I tilfælde af overdosis skal patienterne overvåges for tegn og symptomer på hypokalcæmi, og behandlingen bør være symptomatisk og understøttende.
English: Reduction of hypercalcaemia in adult patients with:
Danish: Reduktion af hyperkalcæmi hos voksne patienter med:
English: Tell your doctor if you are taking the following medicines.
Danish: Fortæl det til Deres læge, hvis De tager en eller flere af følgende lægemidler.
English: Mimpara reduces calcium levels.
Danish: Mimpara nedsætter calciumniveauerne.
English: METHOD AND ROUTE OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral brug.
English: The mean age at baseline was 13 (range 6 to 18) years.
Danish: Gennemsnitsalderen ved baseline var 13 (inden for intervallet 6 til 18) år.
English: The normal calcium range differs depending on the methods used by your local laboratory and the age of the child/patient.
Danish: Normalområdet for calcium varierer afhængigt af de metoder, der bruges af det lokale laboratorium, og af barnets/patientens alder.
English: If patient was receiving the lowest dose (1 mg/day) prior to discontinuation, restart at the same dose (1 mg/day).
Danish: Hvis patienten fik den laveste dosis (1 mg/dag) inden seponering, reinitieres ved den samme dosis (1 mg/dag).
English: For patients that can swallow you will need:
Danish: Til patienter, der kan synke, skal der bruges:
English: All of these effects were seen at a systemic exposure, on an AUC basis, approximately equivalent to the exposure in patients at the maximum dose for secondary HPT.
Danish: Alle disse virkninger blev observeret ved en systemisk eksponering på AUC-basis, omtrent svarende til eksponeringen hos patienter i den maksimale dosis til behandling af sekundær HPT.
English: The normal calcium range may differ depending on the methods used by your local laboratory.
Danish: Normalområdet for calcium kan variere afhængigt af de metoder, der bruges af det lokale laboratorium.
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 op med at ryge, kan cinacalcets plasmaniveau ændre sig, og det kan være nødvendigt at justere dosis.
English: • if you start or stop smoking, as this may affect the way Mimpara works.
Danish: • hvis De begynder eller holder op med at ryge, da det kan ændre virkningen af Mimpara.
English: Patients should drink fluids after oral administration to make sure all of the mixture is swallowed.
Danish: Patienten skal drikke væske efter oral indgivelse for at sikre, at hele blandingen synkes.
English: Date of latest renewal: 23 September 2009
Danish: Dato for første markedsføringstilladelse: 22. oktober 2004 Dato for seneste fornyelse: 23. september 2009
English: Tablets should be taken whole and should not be chewed, crushed or divided.
Danish: Tabletterne skal tages hele og må ikke tygges, knuses eller deles.
English: You should inform your doctor if you experience any of the signs of low calcium levels as described above.
Danish: De skal fortælle det til Deres læge, hvis De får et eller flere af de tegn på lave calciumniveauer, der beskrives ovenfor.
English: Do not take Mimpara if you have low levels of calcium in your blood.
Danish: Tag ikke Mimpara, hvis De har lave calciumniveauer i blodet.
English: The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Danish: Dosen kan forhøjes op til en maksimumdosis på 2,5 mg/kg/dag, der ikke overstiger en samlet daglig dosis på 180 mg.
English: The frequencies of the individual preferred terms including angioedema and urticaria cannot be estimated from available data.
Danish: Hyppigheden af de enkelte foretrukne termer, der inkluderer angioødem og urticaria, kan ikke estimeres ud fra de forhåndenværende data.
English: The switch from etelcalcetide to Mimpara and the appropriate wash out period has not been studied in patients.
Danish: Skiftet fra etelcalcetid til Mimpara og den relevante udvaskningsperiode er ikke undersøgt hos patienter.
English: The dose should be adjusted based on iPTH as shown below:
Danish: Dosen skal justeres på baggrund af iPTH som vist nedenfor:
English: iPTH concentrations from baseline were reduced by ≥ 30% in 71% (12 out of 17) of patients in the study.
Danish: iPTH-koncentrationerne i forhold til baseline blev reduceret med ≥ 30 % hos 71 % (12 ud af 17) af patienterne i studiet.
English: Hypotension and/or worsening heart failure
Danish: Hypotension og/eller forværring af hjerteinsufficiens