FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Ratiograstim been studied?
Danish: Hvordan blev Ratiograstim undersøgt?
English: What is Ratiograstim used for?
Danish: Hvad anvendes Ratiograstim til?
English: What benefit has Ratiograstim shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ratiograstim?
English: How is Ratiograstim used?
Danish: Hvordan anvendes Ratiograstim?
English: How does Ratiograstim work?
Danish: Hvordan virker Ratiograstim?
English: This summary was last updated in 05-2013.
Danish: Dette sammendrag blev sidst ajourført i 05-2013.
English: In children, these side effects are seen in between 1 and 10 patients in 100.
Danish: Hos børn ses disse bivirkninger hos mellem 1 og 10 patienter ud af 100.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq on on 16 February 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NutropinAq den 16. februar 2001.
English: They should use a different injection site each day.
Danish: Der skal vælges et nyt injektionssted hver dag.
English: This is a summary of the European public assessment report (EPAR) for NutropinAq.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for NutropinAq.
English: The full EPAR for NutropinAq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for NutropinAq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The doctor calculates the dose for each patient individually depending on the patient's condition.
Danish: Lægen beregner dosen for hver enkelt patient, afhængigt af tilstand.
English: Somatropin may interfere with the body's use of insulin.
Danish: Somatropin kan muligvis interferere med kroppens udnyttelse af insulin.
English: Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be started or adjusted.
Danish: Patientens blodsukkerniveauer skal kontrolleres under behandlingen, og behandling med insulin skal i nogle tilfælde muligvis iværksættes eller justeres.
English: NutropinAq is used to treat the following groups of children:
Danish: NutropinAq anvendes til behandling af følgende grupper af børn:
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Danish: Det fremskynder væksten i barndommen og puberteten og indvirker også på den måde, hvorpå kroppen håndterer proteiner, fedt og kulhydrater.
English: NutropinAq replaces the natural hormone.
Danish: NutropinAq erstatter det naturlige hormon.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NutropinAq.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for NutropinAq.
English: • children who fail to grow because of a lack of growth hormone;
Danish: • børn, som ikke vokser, fordi de mangler væksthormon,
English: Each cartridge contains 10 mg of the active substance somatropin.
Danish: Hver injektionssprøjte indeholder 10 mg af det aktive stof somatropin.
English: The main measures in the studies in children were the speed of growth during the study and the height at the end of the study.
Danish: De vigtigste mål for virkningen i undersøgelserne af børn var væksthastigheden i løbet af undersøgelsen og deres højde ved afslutningen af undersøgelsen.
English: The dose may need to be adjusted over time, depending on the patient's response, age and body weight.
Danish: Med tiden kan det være nødvendigt at tilpasse dosis efter ændringen i patientens respons, alder og kropsvægt.
English: The active substance in NutropinAq, somatropin, is identical to human growth hormone.
Danish: Det aktive stof i NutropinAq, somatropin, er identisk med det menneskelige væksthormon.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Danish: Det produceres via en metode, der er kendt som ‘rekombinant DNA-teknologi': Hormonet produceres af en bakterie, der har modtaget et gen (DNA), som gør den i stand til at producere somatropin.
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Danish: Dette kan være begyndt i voksenalderen eller barndommen og skal bekræftes ved en undersøgelse, inden behandlingen påbegyndes.
English: Other information about NutropinAq
Danish: Andre oplysninger om NutropinAq
English: The CHMP concluded that NutropinAq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved NutropinAq opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: • girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Danish: • piger fra 2 års alderen med lav højde på grund af Turner-syndrom (en sjælden genetisk lidelse, der rammer piger), bekræftet ved kromosomanalyse (DNA-test),
English: The patient or their carer can inject NutropinAq after training by a doctor or a nurse.
Danish: Patienten eller behandleren kan injicere NutropinAq efter at være blevet instrueret heri af en læge eller sygeplejerske.
English: For more information about treatment with NutropinAq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med NutropinAq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients).
Danish: NutropinAq blev undersøgt hos børn med vækstforstyrrelser forårsaget af væksthormonmangel (230 patienter), Turner-syndrom (117 patienter) eller nyresygdom (195 patienter).
English: NutropinAq has also been studied in 171 adults with growth hormone deficiency.
Danish: NutropinAq blev også undersøgt hos 171 voksne med væksthormonmangel.
English: The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull).
Danish: De alvorligste bivirkninger, der blev indberettet, var udvikling af neoplasmer (tumorer) og inkrationel hypertension (forhøjet tryk inde i kraniet).
English: NutropinAq treatment should be started and supervised by a doctor who has experience in the management of patients with growth disorders.
Danish: Behandling med NutropinAq skal overvåges af en læge, som har erfaring i behandling af patienter med vækstforstyrrelser.
English: NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other ingredients.
Danish: NutropinAq må ikke anvendes hos personer, som er overfølsomme (allergiske) over for somatropin eller et af de øvrige indholdsstoffer.
English: The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge.
Danish: Lægemidlet indgives en gang dagligt ved injektion under huden ved hjælp af en injektionspen, som er specielt fremstillet til brug sammen med cylinderampullen med NutropinAq.
English: Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq).
Danish: Andre mindre hyppige bivirkninger er reaktioner på injektionsstedet, hovedpine, usædvanlig stor spænding i musklerne (hypertoni), nedsat aktivitet af skjoldbruskkirtelen (hypothytoidisme), nedsat glukosetolerance, slaphed (asteni) og udvikling af antistoffer ( proteiner, der dannes som reaktion på NutropinAq).
English: • children (before puberty) who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.
Danish: • børn i førpubertetsalderen, som ikke vokser på grund af langvarig nyresygdom, indtil det tidspunkt, hvor de får foretaget en nyretransplantation.
English: NutropinAq must not be used when the patient has an active tumour or a lifethreatening illness.
Danish: NutropinAq må ikke anvendes til patienter med en aktiv tumor eller en livstruende sygdom.
English: For the full list of all side effects reported with NutropinAq, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved NutropinAq fremgår af indlægssedlen.
English: What is the risk associated with NutropinAq?
Danish: Hvilken risiko er der forbundet med NutropinAq?
English: NutropinAq must not be used for growth promotion in children with closed epiphyses (when the large bones have finished growing).
Danish: NutropinAq må ikke anvendes til vækstfremme hos børn med epifyselukning (når de store knogler er færdigudvoksede).
English: NutropinAq produced better growth in children than would have been expected without treatment.
Danish: Behandling med NutropinAq gav en betydelig bedre vækstrate end den vækstrate, der kunne forventes uden behandling.
English: In adults, NutropinAq increased lean body mass and reduced total body fat.
Danish: Hos voksne øgede NutropinAq den fedtfrie kropsmasse og nedsatte den samlede mængde af fedt i kroppen.
English: Why has NutropinAq been approved?
Danish: Hvorfor blev NutropinAq godkendt?
English: NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
Danish: NutropinAq anvendes også til at behandle voksne med væksthormonmangel (meget lave mængder væksthormon).
English: The main measures in the adult study were lean body mass and the decrease in total body fat.
Danish: De vigtigste mål for virkningen i undersøgelserne af voksne var den fedtfrie kropsmasse og faldet i den samlede mængde kropsaffedt.
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Danish: Et væksthormon er et stof, der udskilles af en kirtel, der sidder i bunden af hjernen, som kaldes hypofysen.
English: What is NutropinAq?
Danish: Hvad er NutropinAq?
English: In adults, the most common side effects with NutropinAq (seen in more than 1 patient in 10) are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling).
Danish: Hos voksne er de hyppigste bivirkninger ved NutropinAq (som optræder hos flere en 1 ud af 10 patienter) muskelsmerter, ledsmerter og ødem (hævelse).
English: EPAR summary for the public somatropin
Danish: EPAR - Sammendrag for offentligheden
English: NutropinAq is a solution for injection in a cartridge.
Danish: NutropinAq er en injektionsvæske, opløsning i en cylinderampul.
English: NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients, except in the studies of children with a lack of growth hormone where there was no comparison with any other group.
Danish: NutropinAq blev sammenlignet med placebo (en uvirksom behandling) eller med en gruppe af patienter, der ikke var blevet behandlet.
English: What is NutropinAq used for?
Danish: Hvad anvendes NutropinAq til?
English: How has NutropinAq been studied?
Danish: Hvordan blev NutropinAq undersøgt?
English: What benefit has NutropinAq shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved NutropinAq?
English: How is NutropinAq used?
Danish: Hvordan anvendes NutropinAq?
English: How does NutropinAq work?
Danish: Hvordan virker NutropinAq?
English: Strength Pharmaceutical Form Route of administration
Danish: EU-nummer Særnavn Styrke Lægemiddelform
English: Invented name
Danish: Indgivelsesvej
English: Both active substances have been available in the European Union (EU) for a number of years.
Danish: Begge aktive stoffer har været på markedet i EU i en årrække.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duavive den 16. december 2014.
English: Treatment should be for the shortest duration possible as long as benefits outweigh risks.
Danish: Behandlingen bør begrænses til kortest mulig tid og så længe fordelene opvejer risiciene.
English: The recommended dose of Duavive is one tablet once a day.
Danish: Den anbefalede dosis af Duavive er én tablet én gang dagligt.
English: Other information about Duavive
Danish: Andre oplysninger om Duavive
English: This is a summary of the European public assessment report (EPAR) for Duavive.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duavive.
English: The full EPAR and risk management plan summary for Duavive 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 Duavive findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Duavive anvendes så sikkert som muligt.
English: What is Duavive and what is it used for?
Danish: Hvad er Duavive, og hvad anvendes det til?
English: It must not be used in women who have had a stroke or heart attack.
Danish: Det må ikke bruges af kvinder, der har haft slagtilfælde eller hjerteanfald.
English: Why is Duavive approved?
Danish: Hvorfor blev Duavive godkendt?
English: What measures are being taken to ensure the safe and effective use of Duavive?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duavive?
English: Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former.
Danish: Fordi undersøgelserne med den højere styrke af kombinationen ikke tilfredsstillende viste, at denne styrke var mere effektiv end den godkendte styrke af Duavive, trak virksomheden ansøgningen tilbage om den højere styrke.
English: The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Danish: Den hyppigste bivirkning ved Duavive (som optræder hos mere end 1 ud af 10 patienter) er mavesmerter (abdominalsmerter).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive'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) konkluderede, at fordelene ved Duavive opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What are the risks associated with Duavive?
Danish: Hvilke risici er der forbundet med Duavive?
English: It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent.
Danish: Det må heller ikke bruges af kvinder, der kan tænkes at have eller har haft brystkræft eller andre østrogenafhængige former for kræft.
English: It is not intended to provide practical advice on how to use Duavive.
Danish: Det er ikke en praktisk vejledning i, hvordan Duavive bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, 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 Duavive, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Duavive conjugated oestrogens / bazedoxifene
Danish: Duavive konjugerede østrogener/bazedoxifen
English: For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Duavive, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).
Danish: Det anvendes hos kvinder, der stadig har deres livmoder og derfor ikke kan behandles med lægemidler afledt af hormonet progesteron (gestagenholdige lægemidler).
English: Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause.
Danish: Duavive er et lægemiddel, der anvendes til behandling af symptomer (såsom hedeture) som følge af lavt indhold i blodet af det kvindelige hormon østrogen hos kvinder, der har nået overgangsalderen.
English: Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.
Danish: Duavive indeholder derfor det aktive stof bazedoxifen, der blokerer virkningerne af østrogener på livmoderen og derved nedsætter risikoen for livmoderkræft.
English: The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.
Danish: Undersøgelsen registrerede virkningerne af Duavive på vulvovaginal atrofi, og der var bedring i nogle af tegnene på vaginal atrofi, men ikke i de mest generende symptomer i forhold til placebo.
English: Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Danish: Hvad sikkerheden angår, er den langsigtede risiko for fortykkelse af livmoderslimhinden (endometriehyperplasi) ikke fuldstændig undersøgt.
English: One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Danish: Det ene aktive stof i Duavive, konjugerede østrogener, virker som hormonerstatningsbehandling.
English: For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Duavive, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.
Danish: CHMP bemærkede også, at langsigtet anvendelse af Duavive medfører lige så stor risiko for slagtilfælde og blodpropper i venerne som konjugerede østrogener og bazedoxifen, når disse anvendes hver for sig.
English: Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Danish: Der var tilsvarende resultater med en større styrke af konjugeret østrogen (0,625 mg) plus bazedoxifen 20 mg, der blev sammenlignet med placebo.
English: For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Duavive fremgår af indlægssedlen.
English: How is Duavive used?
Danish: Hvordan anvendes Duavive?
English: Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3.
Danish: Duavive bevirkede desuden, at sværheden af daglige hedeture i gennemsnit faldt mere end med placebo: 0,9 mod 0,3.
English: Duavive can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Danish: Duavive indeholder de to aktive stoffer konjugerede østrogener og bazedoxifen.
English: What benefits of Duavive have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Duavive?
English: An additional study also looked at the effects of Duavive on osteoporosis.
Danish: Endnu en undersøgelse vedrørte desuden virkningerne af Duavive ved knogleskørhed.
English: Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems.
Danish: Det gælder dem, der lider af eller har ekstra risiko for blodpropper i venerne (venøs tromboembolisme) såsom blodpropper i de dybe vener (dyb venetrombose), blodpropper i lungerne (lungeemboli) og blodpropper i den bageste del af øjet (retinal venetrombose).
English: Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Konjugerede østrogener har været på markedet i mange år som hormonerstatningsbehandling, og bazedoxifen blev godkendt i 2009 til behandling af knogleskørhed hos kvinder, der har nået overgangsalderen.
English: It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.
Danish: Det erstatter de østrogene hormoner, der ikke længere dannes naturligt hos kvinder, som har nået overgangsalderen.
English: Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo.
Danish: Duavive er påvist at give bedring i symptomerne på østrogenmangel hos kvinder, der har nået overgangsalderen, når Duavive sammenlignes med placebo.
English: However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Danish: Hvis østrogener anvendes alene, kan de imidlertid medføre fortykkelse af livmoderslimhinden (endometriet).
English: How does Duavive work?
Danish: Hvordan virker Duavive?
English: Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area).
Danish: Duavive blev sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser hos 996 kvinder, der havde nået overgangsalderen.
English: One of the studies also looked at the effects of Duavive on osteoporosis; however, as there was no benefit of Duavive over the individual components the company withdrew its application for Duavive in the treatment of osteoporosis.
Danish: Da Duavive ikke viste fordele i forhold til de enkelte bestanddele, trak virksomheden sin ansøgning tilbage for Duavive til behandling af knogleskørhed.
English: Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Danish: Det må således ikke bruges hos kvinder, der kan blive gravide.