FrancophonIA/ELRC3.0 huggingface dataset:
English: Secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism Based on available data from patients receiving cinacalcet in placebo-controlled studies and single-arm studies the most commonly reported adverse reactions were nausea and vomiting.
Danish: De hyppigst indberettede bivirkninger er nausea og opkastning baseret på de tilgængelige data fra patienter, der har fået cinacalcet i placebokontrollerede studier og enkeltarms-studier.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 2.5 mg granules in capsules for opening cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 2,5 mg granulat i kapsler til åbning cinacalcet
English: Mimpara 90 mg film-coated tablets
Danish: Mimpara 90 mg filmovertrukne tabletter
English: Mimpara 1 mg granules in capsules for opening
Danish: Mimpara 1 mg granulat i kapsler til åbning
English: What Mimpara is and what it is used for What you need to know before you take Mimpara How to take Mimpara
Danish: Det skal De vide, før De begynder at tage Mimpara Sådan skal De tage Mimpara Bivirkninger
English: Corrected total serum calcium is above age-specified lower limit of normal, and
Danish: Korrigeret total serumcalcium er over den aldersspecifikke nedre grænse af normalområdet, og symptomerne på hypocalcæmi er svundet.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 1 mg granules in capsules for opening cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 1 mg granulat i kapsler til åbning cinacalcet
English: Mimpara 2.5 mg granules in capsules for opening
Danish: Mimpara 2,5 mg granulat i kapsler til åbning
English: Mimpara 1 mg granules in capsules for opening Gelatin
Danish: Mimpara 1 mg granulat i kapsler til åbning Gelatine
English: • Hives (urticaria)
Danish: • nældefeber (urticaria),
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 2.5 mg of cinacalcet (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 2,5 mg cinacalcet (som hydroklorid).
English: Mimpara 5 mg granules in capsules for opening
Danish: Mimpara 5 mg granulat i kapsler til åbning
English: Mimpara 60 mg film-coated tablets
Danish: Mimpara 60 mg filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/009 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/009 - æske med 14 tabletter
English: Mimpara 2.5 mg granules in capsules for opening Gelatin
Danish: Mimpara 2,5 mg granulat i kapsler til åbning Gelatine
English: If serum calcium levels decrease below the normal range or symptoms of hypocalcaemia occur, appropriate dose adjustment steps should be taken as shown in table 2 below:
Danish: Relevante foranstaltninger til justering af dosen skal træffes, som vist i nedenstående tabel 2, hvis serumcalciumniveauerne falder til under normalområdet, eller der opstår symptomer på hypocalcæmi:
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/005 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/005 - æske med 14 tabletter
English: • Gently squeeze the top and twist slightly to remove, taking care not to spill the contents.
Danish: • Tryk forsigtigt på toppen og drej en smule for at åbne kapslen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEETIKET
English: MARKETING AUTHORISATION NUMBERS EU/1/04/292/001 - carton of 14 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/001 - æske med 14 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 1 mg of cinacalcet (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 1 mg cinacalcet (som hydroklorid).
English: STATEMENT OF ACTIVE SUBSTANCE 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: Mimpara 5 mg granules in capsules for opening Gelatin
Danish: Mimpara 5 mg granulat i kapsler til åbning Gelatine
English: STATEMENT OF ACTIVE SUBSTANCE 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/1/04/292/011 - carton of 84 tablets
Danish: EU/1/04/292/011 - æske med 84 tabletter
English: NAME OF THE MEDICINAL PRODUCT Mimpara 5 mg granules in capsules for opening cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 5 mg granulat i kapsler til åbning cinacalcet
English: b) Tabulated list of adverse reactions
Danish: b) Liste over bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Mimpara 90 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 90 mg filmovertrukne tabletter Cinacalcet
English: STATEMENT OF ACTIVE SUBSTANCE 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: MARKETING AUTHORISATION NUMBER EU/1/04/292/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/008
English: NAME OF THE MEDICINAL PRODUCT Mimpara 60 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 60 mg filmovertrukne tabletter Cinacalcet
English: EU/1/04/292/010 - carton of 28 tablets
Danish: EU/1/04/292/010 - æske med 28 tabletter
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 5 mg of cinacalcet (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 5 mg cinacalcet (som hydroklorid).
English: NAME OF THE MEDICINAL PRODUCT Mimpara 30 mg film-coated tablets Cinacalcet
Danish: LÆGEMIDLETS NAVN Mimpara 30 mg filmovertrukne tabletter Cinacalcet
English: EU/1/04/292/003 - carton of 84 tablets
Danish: EU/1/04/292/003 - æske med 84 tabletter
English: EU/1/04/292/007 - carton of 84 tablets
Danish: EU/1/04/292/007 - æske med 84 tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE
English: EU/1/04/292/006 - carton of 28 tablets
Danish: EU/1/04/292/006 - æske med 28 tabletter
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/004
English: 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 (see section 4.8).
Danish: En kausal årsagssammenhæng med cinacalcet kunne ikke helt udelukkes, men tilfældene kan afhjælpes ved at reducere serumcalciumniveauet (se pkt.
English: Iron oxide yellow (E172) Indigo carmine (E132)
Danish: blå (E132), gul jernoxid (E172))
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/012
English: The granules should be taken with or shortly after food Mimpara is also available as tablets.
Danish: Granulatet skal tages sammen med mad eller kort tid efter et måltid.
English: NAME OF THE MEDICINAL PRODUCT Mimpara 90 mg tablet
Danish: LÆGEMIDLETS NAVN Mimpara 90 mg tablet Cinacalcet
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/014
English: EU/1/04/292/002 - carton of 28 tablets
Danish: EU/1/04/292/002 - æske med 28 tabletter
English: Stop treatment with Mimpara.
Danish: Seponer Mimpara.
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/015
English: MARKETING AUTHORISATION NUMBER EU/1/04/292/013
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/292/013
English: NAME OF THE MEDICINAL PRODUCT Mimpara 30 mg tablet
Danish: LÆGEMIDLETS NAVN Mimpara 30 mg tablet Cinacalcet
English: 1, 2.5, 5, 7.5, 10 and 15
Danish: 1; 2,5; 5; 7,5; 10 og 15
English: Musculoskeletal and connective tissue disorders
Danish: Muskelspasmer Rygsmerter
English: Tablet coat
Danish: Selve tabletten
English: NAME OF THE MEDICINAL PRODUCT Mimpara 60 mg tablet
Danish: LÆGEMIDLETS NAVN Mimpara 60 mg tablet Cinacalcet
English: The capsule shell is not for ingestion.
Danish: Selve kapslen er ikke beregnet til at blive indtaget.
English: Hypocalcaemia† Hyperkalaemia Reduced testosterone levels†
Danish: Hypokalcæmi† Hyperkaliæmi
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere oplysninger fremgår af resuméet af risikostyringsplanen .
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ulunar Breezhaler on 23 April 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ulunar Breezhaler den 23. april 2014.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend use in reducing exacerbations.
Danish: CHMP fandt imidlertid, at dets virkning i form af nedsættelse af andelen af tilbagefald var for lille til, at det bør anbefales til reduktion af tilbagefald.
English: The full EPAR and risk management plan summary for Ulunar Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Ulunar Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This medicine is the same as Ultibro Breezhaler, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Ultibro Breezhaler, som allerede er godkendt i Den Europæiske Union (EU).
English: This is a summary of the European public assessment report (EPAR) for Ulunar Breezhaler.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ulunar Breezhaler.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ulunar Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Ulunar Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Ulunar Breezhaler is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ulunar Breezhaler anvendes så sikkert som muligt.
English: Ulunar Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Danish: Ulunar Breezhaler var genstand for to hovedundersøgelser, hvori der i alt deltog 2 667 patienter med KOL.
English: It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Danish: Det virker ved at binde sig til beta-2-adrenerge receptorer, der findes i musklerne i mange organer, herunder luftvejene.
English: In patients with severely reduced kidney function Ulunar Breezhaler should only be used after a careful benefit-risk assessment.
Danish: Hos patienter med stærkt nedsat nyrefunktion bør Ulunar Breezhaler kun anvendes efter nøje afvejning af fordelene i forhold til risiciene.
English: Ulunar Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Danish: Ulunar Breezhaler er et lægemiddel, der indeholder to aktive stoffer, nemlig indacaterol (85 mikrogram) og glycopyrronium (43 mikrogram).
English: The company that makes Ultibro Breezhaler has agreed that its scientific data can be used for Ulunar Breezhaler (‘informed consent').
Danish: Virksomheden, som fremstiller Ultibro Breezhaler, har givet tilladelse til, at dens videnskabelige oplysninger må anvendes for Ulunar Breezhaler (informeret samtykke).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ulunar Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ulunar Breezhaler, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What measures are being taken to ensure the safe and effective use of Ulunar Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ulunar Breezhaler?
English: The most common side effects with Ulunar Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Danish: De hyppigste bivirkninger ved Ulunar Breezhaler (som kan forekomme hos flere end 1 ud af 10 patienter) er infektioner i de øvre luftveje (forkølelse).
English: What is Ulunar Breezhaler and what is it used for?
Danish: Hvad er Ulunar Breezhaler, og hvad anvendes det til?
English: Ulunar Breezhaler indacaterol / glycopyrronium
Danish: Indacaterol/glycopyrronium
English: Ulunar Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml more than glycopyrronium alone.
Danish: Ulunar Breezhaler øgede desuden FEV1 med 70 ml mere end indacaterol alene og 90 ml mere end glycopyrronium alene.
English: The effects of Ulunar Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Danish: Virkningerne af Ulunar Breezhaler til lindring af symptomerne på KOL havde klinisk betydning.
English: Why is Ulunar Breezhaler approved?
Danish: Hvorfor er Ulunar Breezhaler blevet godkendt?
English: For more information about treatment with Ulunar Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ulunar Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is taken at the same time each day using the Ulunar Breezhaler device.
Danish: Det skal tages på samme klokkeslæt hver dag ved hjælp af Ulunar Breezhaler-inhalatoren.
English: The reduction in the rate of exacerbations was 10 to 12% higher with Ulunar Breezhaler than with tiotropium and glycopyrronium.
Danish: Faldet i andelen af tilbagefald var 10-12 % større med Ulunar Breezhaler end med tiotropium og glycopyrronium.
English: The first study showed that treatment with Ulunar Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Danish: Den første undersøgelse viste, at Ulunar Breezhaler var mere effektivt end placebo og i gennemsnit øgede FEV1 med 200 ml mere.
English: Other information about Ulunar Breezhaler
Danish: Andre oplysninger om Ulunar Breezhaler
English: It is not intended to provide practical advice on how to use Ulunar Breezhaler.
Danish: Det er ikke en praktisk vejledning i, hvordan Ulunar Breezhaler bør anvendes.
English: Ulunar Breezhaler is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Danish: Ulunar Breezhaler leveres som inhalationspulver i kapsler og udleveres kun efter recept.
English: In both studies, the main measure of effectiveness was how Ulunar Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Danish: I begge undersøgelser blev virkningen hovedsagelig bedømt på, hvordan 26 ugers behandling med Ulunar Breezhaler forbedrede patienternes forcerede udåndingsvolumen (FEV1, der er den maksimale mængde luft, en person kan udånde på et sekund).
English: The active substances in Ulunar Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Danish: Begge aktive stoffer i Ulunar Breezhaler, indacaterol og glycopyrronium, udvider luftvejene og forbedrer vejrtrækningen ved KOL, men de virker på forskellige måder.
English: What are the risks associated with Ulunar Breezhaler?
Danish: Hvilke risici er der forbundet med Ulunar Breezhaler?
English: Regarding its safety, Ulunar Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Danish: Vedrørende sikkerheden er Ulunar Breezhaler sammenligneligt med indacaterol og glycopyrronium, når disse anvendes hver for sig.
English: In the second study the average increase in FEV1 was 140 ml more with Ulunar Breezhaler treatment than with treatment with fluticasone and salmeterol.
Danish: I den anden undersøgelse var den gennemsnitlige stigning i FEV1 140 ml større med Ulunar Breezhaler end med fluticason og salmeterol.
English: For practical information about using Ulunar Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ulunar Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: A third study investigated the effects of Ulunar Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Danish: En tredje undersøgelse så på virkningerne af 64 ugers behandling med Ulunar Breezhaler på andelen af tilbagefald, sammenlignet med glycopyrronium eller tiotropium (andre midler mod KOL).
English: How is Ulunar Breezhaler used?
Danish: Hvordan anvendes Ulunar Breezhaler?
English: Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.
Danish: Det er almindeligt at behandle KOL med en kombination af muskarine receptorantagonister og langtidsvirkende beta-2-agonister.
English: While one study compared the effects of Ulunar Breezhaler with those of placebo (a dummy inhalation), or indacaterol or glycopyrronium alone, the other study compared Ulunar Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Danish: Den ene undersøgelse sammenlignede virkningerne af Ulunar Breezhaler med virkningerne af placebo (en virkningsløs inhalator) eller med indacaterol eller glycopyrronium alene.
English: What benefits of Ulunar Breezhaler have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ulunar Breezhaler?
English: How does Ulunar Breezhaler work?
Danish: Hvordan virker Ulunar Breezhaler?
English: This summary was last updated in 1-2006 ©EMEA 2006
Danish: Dette sammendrag blev sidst ajourført i 1-2006.©EMEA 2006
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Monotard to Novo Nordisk A/S in on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Monotard til Novo Nordisk A/S den 7. oktober 2002.
English: Other information about Monotard:
Danish: Andre oplysninger om Monotard:
English: The Committee for Medicinal products for Human Use (CHMP) decided that Monotard's benefits are greater than its risks for the treatment of diabetes.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Monotard er større end risiciene ved behandling af diabetes.
English: Monotard is used in patients with diabetes mellitus.
Danish: Monotard anvendes til patienter med diabetes mellitus.
English: Monotard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Danish: Det kan også være nødvendigt at justere doseringen af Monotard, når det gives sammen med en række andre lægemidler, der kan indvirke på blodsukkeret (den fuldstændige liste fremgår af indlægssedlen).
English: Monotard may cause hypoglycaemia (low blood sugar).
Danish: Monotard kan forårsage hypoglykæmi (lavt blodsukker).
English: Monotard is given subcutaneously (under the skin) by injection, usually in the thigh.
Danish: Monotard gives subkutant (under huden) gennem injektion, sædvanligvis i låret.
English: Monotard is supplied as 40 or 100 IU strengths in vials.
Danish: Monotard leveres i styrkerne 40 eller 100 IE i hætteglas.
English: They recommended that Monotard be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Monotard.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MONOTARD EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) MONOTARD EPAR - sammendrag for offentligheden
English: Monotard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Danish: Monotard bør ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for insulin human (rDNA) eller et af de øvrige stoffer.
English: Monotard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin effectively.
Danish: Monotard kan anvendes til type 1-diabetes, når bugspytkirtlen ikke kan producere insulin, og til type 2-diabetes, når kroppen ikke er i stand til at udnytte insulin effektivt.
English: Monotard contains insulin mixed with another substance, zinc, in particles from which the insulin is absorbed much more slowly during the day; and this gives Monotard a longer duration of action.
Danish: Monotard indeholder insulin blandet med et andet stof, zink, i partikler, hvorfra insulinen absorberes meget langsommere i løbet af dagen, og dette giver Monotard en længere virkning.
English: Monotard was effective for both Type 1 and Type 2 diabetes.
Danish: Monotard var effektivt til behandling af såvel type 1- som type 2-diabetes.
English: Monotard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the doctor's recommendation.
Danish: Monotard er en langtidsvirkende insulin, som kan gives en eller to gange dagligt som injektion med eller uden en hurtigt virkende insulin (til måltider), alt efter hvad lægen anbefaler.
English: Monotard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Danish: Monotard medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau, der svarede til det, der var observeret for anden human insulin.
English: What is the risk associated with Monotard?
Danish: Hvilke risici er der forbundet med Monotard?
English: Monotard contains the active ingredient insulin human (rDNA).
Danish: Monotard indeholder det aktive stof insulin human (rDNA).
English: Monotard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Danish: Monotard er blevet undersøgt ved både type 1- og type 2-diabetes, og det er blevet sammenlignet med andre former for insulin (insulin fra svin, human insulin).
English: Why has Monotard been approved?
Danish: Hvorfor er Monotard blevet godkendt?
English: Monotard is an insulin suspension for injection.
Danish: Monotard er insulin i form af en injektionsvæske, suspension.
English: For the full description of the side effects reported with Monotard, please see the Package Leaflet.
Danish: Den fuldstændige beskrivelse af de indberettede bivirkninger ved Monotard fremgår af indlægssedlen.
English: What is Monotard?
Danish: Hvad er Monotard?
English: What is Monotard used for?
Danish: Hvad anvendes Monotard til?
English: What benefit has Monotard shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Monotard?
English: The full EPAR for Monotard is available here.
Danish: Den europæiske offentlige vurderingsrapport (EPAR) for Monotard kan ses i sin helhed her.
English: How is Monotard used?
Danish: Hvordan anvendes Monotard?
English: Monotard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Monotard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Danish: Det aktive stof i Monotard, insulin human (rDNA), produceres via en metode, der er kendt som ‘rekombinant teknologi'.
English: How does Monotard work?
Danish: Hvordan virker Monotard?