natgillin/translations-raw huggingface dataset:
CHMP konkluderede, at fordelene ved NutropinAq opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP concluded that NutropinAq's benefits are greater than its risks and recommended that it be given marketing authorisation.
• 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),
• girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Patienten eller behandleren kan injicere NutropinAq efter at være blevet instrueret heri af en læge eller sygeplejerske.
The patient or their carer can inject NutropinAq after training by a doctor or a nurse.
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.
For more information about treatment with NutropinAq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
NutropinAq blev undersøgt hos børn med vækstforstyrrelser forårsaget af væksthormonmangel (230 patienter), Turner-syndrom (117 patienter) eller nyresygdom (195 patienter).
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).
NutropinAq blev også undersøgt hos 171 voksne med væksthormonmangel.
NutropinAq has also been studied in 171 adults with growth hormone deficiency.
De alvorligste bivirkninger, der blev indberettet, var udvikling af neoplasmer (tumorer) og inkrationel hypertension (forhøjet tryk inde i kraniet).
The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull).
Behandling med NutropinAq skal overvåges af en læge, som har erfaring i behandling af patienter med vækstforstyrrelser.
NutropinAq treatment should be started and supervised by a doctor who has experience in the management of patients with growth disorders.
NutropinAq må ikke anvendes hos personer, som er overfølsomme (allergiske) over for somatropin eller et af de øvrige indholdsstoffer.
NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other ingredients.
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.
The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge.
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).
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).
• børn i førpubertetsalderen, som ikke vokser på grund af langvarig nyresygdom, indtil det tidspunkt, hvor de får foretaget en nyretransplantation.
• children (before puberty) who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.
NutropinAq må ikke anvendes til patienter med en aktiv tumor eller en livstruende sygdom.
NutropinAq must not be used when the patient has an active tumour or a lifethreatening illness.
Den fuldstændige liste over alle de indberettede bivirkninger ved NutropinAq fremgår af indlægssedlen.
For the full list of all side effects reported with NutropinAq, see the package leaflet.
Hvilken risiko er der forbundet med NutropinAq?
What is the risk associated with NutropinAq?
NutropinAq må ikke anvendes til vækstfremme hos børn med epifyselukning (når de store knogler er færdigudvoksede).
NutropinAq must not be used for growth promotion in children with closed epiphyses (when the large bones have finished growing).
Behandling med NutropinAq gav en betydelig bedre vækstrate end den vækstrate, der kunne forventes uden behandling.
NutropinAq produced better growth in children than would have been expected without treatment.
Hos voksne øgede NutropinAq den fedtfrie kropsmasse og nedsatte den samlede mængde af fedt i kroppen.
In adults, NutropinAq increased lean body mass and reduced total body fat.
Hvorfor blev NutropinAq godkendt?
Why has NutropinAq been approved?
NutropinAq anvendes også til at behandle voksne med væksthormonmangel (meget lave mængder væksthormon).
NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
De vigtigste mål for virkningen i undersøgelserne af voksne var den fedtfrie kropsmasse og faldet i den samlede mængde kropsaffedt.
The main measures in the adult study were lean body mass and the decrease in total body fat.
Et væksthormon er et stof, der udskilles af en kirtel, der sidder i bunden af hjernen, som kaldes hypofysen.
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Hvad er NutropinAq?
What is NutropinAq?
Hos voksne er de hyppigste bivirkninger ved NutropinAq (som optræder hos flere en 1 ud af 10 patienter) muskelsmerter, ledsmerter og ødem (hævelse).
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).
EPAR - Sammendrag for offentligheden
EPAR summary for the public somatropin
NutropinAq er en injektionsvæske, opløsning i en cylinderampul.
NutropinAq is a solution for injection in a cartridge.
NutropinAq blev sammenlignet med placebo (en uvirksom behandling) eller med en gruppe af patienter, der ikke var blevet behandlet.
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.
Hvad anvendes NutropinAq til?
What is NutropinAq used for?
Hvordan blev NutropinAq undersøgt?
How has NutropinAq been studied?
Hvilken fordel viser undersøgelserne, at der er ved NutropinAq?
What benefit has NutropinAq shown during the studies?
Hvordan anvendes NutropinAq?
How is NutropinAq used?
Hvordan virker NutropinAq?
How does NutropinAq work?
EU-nummer Særnavn Styrke Lægemiddelform
Strength Pharmaceutical Form Route of administration
Indgivelsesvej
Invented name
Begge aktive stoffer har været på markedet i EU i en årrække.
Both active substances have been available in the European Union (EU) for a number of years.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duavive den 16. december 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Behandlingen bør begrænses til kortest mulig tid og så længe fordelene opvejer risiciene.
Treatment should be for the shortest duration possible as long as benefits outweigh risks.
Den anbefalede dosis af Duavive er én tablet én gang dagligt.
The recommended dose of Duavive is one tablet once a day.
Andre oplysninger om Duavive
Other information about Duavive
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duavive.
This is a summary of the European public assessment report (EPAR) for Duavive.
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.
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.
Der er udarbejdet en risikostyringsplan for at sikre, at Duavive anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Hvad er Duavive, og hvad anvendes det til?
What is Duavive and what is it used for?
Det må ikke bruges af kvinder, der har haft slagtilfælde eller hjerteanfald.
It must not be used in women who have had a stroke or heart attack.
Hvorfor blev Duavive godkendt?
Why is Duavive approved?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duavive?
What measures are being taken to ensure the safe and effective use of Duavive?
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.
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.
Den hyppigste bivirkning ved Duavive (som optræder hos mere end 1 ud af 10 patienter) er mavesmerter (abdominalsmerter).
The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Duavive opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Hvilke risici er der forbundet med Duavive?
What are the risks associated with Duavive?
Det må heller ikke bruges af kvinder, der kan tænkes at have eller har haft brystkræft eller andre østrogenafhængige former for kræft.
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.
Det er ikke en praktisk vejledning i, hvordan Duavive bør anvendes.
It is not intended to provide practical advice on how to use Duavive.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Duavive, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
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.
Duavive konjugerede østrogener/bazedoxifen
Duavive conjugated oestrogens / bazedoxifene
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.
For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det anvendes hos kvinder, der stadig har deres livmoder og derfor ikke kan behandles med lægemidler afledt af hormonet progesteron (gestagenholdige lægemidler).
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).
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.
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.
Duavive indeholder derfor det aktive stof bazedoxifen, der blokerer virkningerne af østrogener på livmoderen og derved nedsætter risikoen for livmoderkræft.
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.
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.
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.
Hvad sikkerheden angår, er den langsigtede risiko for fortykkelse af livmoderslimhinden (endometriehyperplasi) ikke fuldstændig undersøgt.
Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Det ene aktive stof i Duavive, konjugerede østrogener, virker som hormonerstatningsbehandling.
One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Hvis du ønsker praktisk vejledning om anvendelsen af Duavive, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.
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.
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.
Der var tilsvarende resultater med en større styrke af konjugeret østrogen (0,625 mg) plus bazedoxifen 20 mg, der blev sammenlignet med placebo.
Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Den fuldstændige liste over bivirkninger og begrænsninger ved Duavive fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Hvordan anvendes Duavive?
How is Duavive used?
Duavive bevirkede desuden, at sværheden af daglige hedeture i gennemsnit faldt mere end med placebo: 0,9 mod 0,3.
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.
Lægemidlet udleveres kun efter recept.
Duavive can only be obtained with a prescription.
Duavive indeholder de to aktive stoffer konjugerede østrogener og bazedoxifen.
Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Hvilke fordele viser undersøgelserne, at der er ved Duavive?
What benefits of Duavive have been shown in studies?
Endnu en undersøgelse vedrørte desuden virkningerne af Duavive ved knogleskørhed.
An additional study also looked at the effects of Duavive on osteoporosis.
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).
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.
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.
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.
Det erstatter de østrogene hormoner, der ikke længere dannes naturligt hos kvinder, som har nået overgangsalderen.
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.
Duavive er påvist at give bedring i symptomerne på østrogenmangel hos kvinder, der har nået overgangsalderen, når Duavive sammenlignes med placebo.
Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo.
Hvis østrogener anvendes alene, kan de imidlertid medføre fortykkelse af livmoderslimhinden (endometriet).
However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Hvordan virker Duavive?
How does Duavive work?
Duavive blev sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser hos 996 kvinder, der havde nået overgangsalderen.
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).
Da Duavive ikke viste fordele i forhold til de enkelte bestanddele, trak virksomheden sin ansøgning tilbage for Duavive til behandling af knogleskørhed.
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.
Det må således ikke bruges hos kvinder, der kan blive gravide.
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.
Det fås som tabletter med modificeret udløsning (med 0,45 mg konjugerede østrogener og 20 mg bazedoxifen).
It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
I undersøgelsen af virkningerne på hedeture fik patienterne i 12 uger Duavive (konjugeret østrogen 0,45 mg og bazedoxifen 20 mg).
In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
De iagttagne virkninger af behandlingen var mindre end med andre behandlinger (gestagenholdige lægemidler).
Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Yderligere information om NovoEight findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/novoeight.
Further information on NovoEight can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/novoeight.
NovoEight fik en markedsføringstilladelse med gyldighed i hele EU den 13. november 2013.
NovoEight received a marketing authorisation valid throughout the European Union on 13 November
Som for alle lægemidler bliver data vedrørende brugen af NovoEight løbende overvåget.
As for all medicines, data on the use of NovoEight are continuously monitored.
Disse hæmmere er antistoffer, som immunsystemet (kroppens naturlige forsvar) producerer mod faktor VIII.
These inhibitors are antibodies that the immune system (the body's natural defences) produces against factor VIII.
Andre oplysninger om NovoEight
Other information about NovoEight
En oversigt over NovoEight, og hvorfor det er godkendt i EU
An overview of NovoEight and why it is authorised in the EU
Sjældne tilfælde af overfølsomhedsreaktioner (allergi) kan forekomme ved brug af NovoEight og kan i nogle tilfælde udvikle sig til alvorlige allergiske reaktioner.
Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NovoEight?
What measures are being taken to ensure the safe and effective use of NovoEight?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved NovoEight opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that NovoEight's benefits are greater than its risks and it can be authorised for use in the EU.
Lægemidlet indeholder det aktive stof turoctocog alfa.
The medicine contains the active substance turoctocog alfa.
Det aktive stof i NovoEight, turoctocog alfa, virker på samme måde som naturlig faktor VIII og hjælper blodet med at størkne.
The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot.
Dosis og hyppighed af behandlingerne afhænger af, om lægemidlet skal anvendes til behandling eller forebyggelse af blødning såvel som af hæmofiliens sværhedsgrad, blødningens omfang og lokalisering og patientens alder og tilstand.
The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and condition.
NovoEight fås kun på recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
NovoEight can only be obtained with a prescription, and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
De indberettede bivirkninger ved NovoEight vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with NovoEight are carefully evaluated and any necessary action taken to protect patients.
NovoEight må ikke gives til patienter med allergi over for hamsterproteiner.
NovoEight must not be used in patients who are allergic to hamster protein.
I det første studie, der omfattede 150 patienter i alderen 12 år og opefter, havde unge, som fik NovoEight til forebyggelse af blødning, i gennemsnit 5,55 blødningsepisoder om året, og voksne havde i gennemsnit 6,68 blødningsepisoder om året.
In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year.
NovoEight var effektivt til forebyggelse og behandling af blødningsepisoder i to hovedstudier med i alt 213 patienter med hæmofili A. I ingen af studierne blev NovoEight sammenlignet med andre lægemidler.
NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
I det andet studie, der omfattede 63 børn under 12 år, havde de børn, der fik NovoEight, i gennemsnit 5,33 blødningsepisoder om året.
In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year.
NovoEight gives som injektion i en vene.
NovoEight is available for injection into a vein.
Hvad er NovoEight, og hvad anvendes det til?
What is NovoEight and what is it used for?
Hvis du ønsker mere information om anvendelsen af NovoEight, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using NovoEight, see the package leaflet or contact your doctor or pharmacist.
Patienten selv eller dennes omsorgsperson kan injicere NovoEight derhjemme, når de er blevet instrueret i det.
Patients or their carers may be able to inject NovoEight themselves once they have been trained.
NovoEights sikkerhedsprofil vurderes også at svare til sikkerhedsprofilen ved andre faktor VIII-produkter.
The safety profile of NovoEight was also considered similar to other factor VIII products.
Endvidere fortog 89,4 % af blødningsepisoderne sig efter 1-2 doser NovoEight.
In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.